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McFarland, Daniel Curtis, Katherine Ornstein e Randall F. Holcombe. "Hospital size and demographics associated with HCAHPS and implications for hospital value-based purchasing (HVBP)." Journal of Clinical Oncology 32, n.º 30_suppl (20 de outubro de 2014): 38. http://dx.doi.org/10.1200/jco.2014.32.30_suppl.38.
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38 Background: Hospital Consumer Assessments of Healthcare Providers and Systems (HCAHPS) scores appear to be lower in densely populated areas and for urban academic medical centers (AMC). These patient satisfaction scores contribute to CMS reimbursement. We hypothesized that demographics and hospital factors such as size were significant determinants of HCAHPS. Methods: HCAHPS, hospital bed, and county demographics were obtained from the Hospital Compare, American Hospital Directory, and US Census Bureau websites, respectively. An aggregate positive score was created for each hospital. Multivariate regression modeling was performed for the aggregate positive score and all ten dimensions of HCAHPS. Standardized partial regression coefficients were used to assess strengths of postulated predictors (Table). A predictive formula based on the 4 strongest predictors was developed. An adjustment model corrected for demographic and hospital factors. Hospitals were rescored using this model to generate an adjusted score (WIPSAS – weighted individual patient satisfaction score). HCAHPS hospital ranking was compared to WIPSAS ranking for all NY State hospitals. HCAHPS were obtained from 3,192 hospitals and demographic data collected from 3,144 counties. Results: ‘Hospital beds’ and ‘non-English speaking’ were the strongest negative predictors while ‘% Bachelor’s’ and ‘white alone’ were the strongest positive predictors of HCAHPS. The adjusted r2 was.22 for the model and.155 for the predictive formula. WIPSAS altered the ranking in NY State. The adjusted ranking moved 3 AMCs into the top ten (prior #42, #43, #46). Conclusions: Demographic and hospital factors influence HCAHPS. Adjusted scores may be more representative of a hospital’s actual performance. CMS should utilize WIPSAS adjusted scores in order to more fairly calculate HVBP reimbursements. [Table: see text]
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Palomäki, A., J. Paltta, L. Pirilä, H. K. Heikkilä, P. Isomäki, J. Huhtakangas, T. Sokka-Isler, O. Kaipiainen-Seppänen e K. Eklund. "AB1251 VALIDITY OF RHEUMATOID ARTHRITIS DIAGNOSES IN FINNISH BIOBANK PATIENTS". Annals of the Rheumatic Diseases 79, Suppl 1 (junho de 2020): 1917.1–1917. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3890.
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Background:Finnish healthcare registers are used in medical research, but there is little data about the validity of these registers in rheumatology.Objectives:The aim of our study was to determine the validity of rheumatoid arthritis (RA) diagnoses in patients participating in the Finnish Biobanks.Methods:We reviewed the electronic patient charts of 125 patients with at least one visit with a diagnosis of seropositive RA, 125 patients with at least one visit with a diagnosis of seronegative RA and 250 age-and-sex matched controls. Patients were randomly selected from Finnish biobank participants. We evaluated whether the patients’ diagnosis of RA recorded in the hospital discharge registry at the participating hospital was correct according to chart review and expert opinion. In the control group it was investigated whether the diagnosis of RA was written in the patients’ chart, but the diagnosis code was not recorded.Results:The positive predictive value (PPV) of a single hospital registry diagnosis of seropositive RA was 0.74 but rose to 0.98 in patients with a special reimbursement for seropositive RA and 0.98 in anti-citrullinated protein antibody positive patients. For seronegative RA, the PPV of a diagnosis was 0.72 and in patients with a special reimbursement for seronegative RA 0.89. The PPV was higher in patients with more than one visit with the diagnosis: 0.92 if the patients had at least 5 visits with seropositive RA and 0.88 with at least 5 visits with seronegative RA. Negative predictive value for RA diagnosis was 0.99.Conclusion:These results demonstrate that the validity of RA diagnoses in healthcare registers can be markedly improved with data about special reimbursement for medication, number of visits and serological data.Disclosure of Interests:Antti Palomäki Consultant of: Pfizer, Speakers bureau: Pfizer, Sanofi, MSD, Johanna Paltta Consultant of: Lilly, Abbvie, Laura Pirilä Consultant of: Novartis, MSD Finland, Roche, Bristol-Myers-Squibb, Pfizer, Sanofi, Abbvie, Oy Eli LIlly Finland Ab, UCB Pharma Oy Finland, Jansen-Cilag, Mylan, Sandoz, Boehringer-Ingelheim, Paid instructor for: Boehringer -Ingelheim, MSD Finland, Speakers bureau: Boehringer-Ingelheim, Pfizer Finland, Hanna-Kaisa Heikkilä: None declared, Pia Isomäki Consultant of: Abbvie, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, Johanna Huhtakangas Consultant of: Boehringer Ingelheim, Tuulikki Sokka-Isler: None declared, Oili Kaipiainen-Seppänen Speakers bureau: Boehringer Ingelheim, Kari Eklund Consultant of: Celgene, Lilly, Speakers bureau: Pfizer, Roche
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Xu, Junfang, Xin Wang, Hongying Hao, Jian Wang e Stephen Nicholas. "Impact of hierarchical hospital reform on patients with diabetes in China: a retrospective observational analysis". BMJ Open 11, n.º 4 (abril de 2021): e041731. http://dx.doi.org/10.1136/bmjopen-2020-041731.
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ObjectivesWe assess whether China’s diabetes pilot hierarchical diagnosis and treatment reforms shifted patient healthcare-seeking behaviour towards primary health institutions (PHIs) and away from secondary and tertiary hospitals. From the patients’ perspective, we evaluate whether the hierarchical system saw the decline of average hospital cost, out-of-pocket (OOP) expenses and the increase of reimbursement rate in PHIs. From the health system’s perspective, we also assessed whether the share of PHIs in total costs, total visits and reimbursement rate increased and the share of secondary and tertiary hospitals decreased.MethodsData were collected from the health insurance bureau of 11 cities in Shandong Province, China between 2015 and 2017, which included 9 118 518 outpatient visits and 622 739 inpatient visits. For both inpatients and outpatients and the health system, we analysed health services-seeking characteristics including hospital costs, hospital visits, OOP expense and reimbursements of hospital costs. Binary logistic regression was conducted to analyse the influencing factors of seeking PHI health services.ResultsPHIs remained the lowest hospital cost provider, but average hospital costs declined across all three healthcare levels of PHIs, secondary hospitals and tertiary hospitals from 2015 to 2017. The hierarchical system aimed to shift patients to PHIs, increasing PHIs’ share of total hospital costs. However, the PHI share of total outpatient costs declined 12.0%, while rising 15.0% in secondary hospitals, the opposite of the goal of the hierarchical medical system. Average outpatient visits rose roughly at the same rate in PHIs (5.1%) as secondary hospitals (6.8%), with no evidence of a shift in patient visits between hospital levels over 2015–2017. Average inpatient visits fell across all levels of hospitals, with no significant difference in the rate of decline between PHIs (9.4%) and secondary (7.5%) and tertiary (7.8%) hospitals. For outpatient and inpatient services, the binary logistic regression showed that over the 2015–2017 period patients with diabetes increasingly used higher level hospitals rather than PHIs (p<0.05). The only success of the hierarchical medical system was the relative fall of OOP outpatient expenses, which fell more rapidly in PHIs (13.7%) than secondary (5.0%) and tertiary (3.5%) hospitals. However, inpatient OOP expenses fell only 2.2% for PHIs, less than half that of secondary (5.5%) and tertiary (7.4%) hospitals, the opposite of the aim of the hierarchical system reform.ConclusionsThe implementation of the hierarchical medical system for patients with diabetes did not achieve its goal of increasing PHI utilisation and decreasing secondary and tertiary hospital utilisation. Enhancing the utilisation of PHIs for diabetes and other patients requires further health reform, including educating patients on PHI use, further reforming the health insurance schemes, improving PHI facilities and encouraging referrals to PHIs from higher level hospitals.
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Deitelzweig, Steven, Stephen Thompson, Jay Lin, Donna McMorrow e Barbara Johnson. "Impact of CMS VTE Hospital Acquired Conditions (HAC) Policy on Hospital Cost and Revenue Associated with Major Surgical Hip and Knee Procedures." Blood 116, n.º 21 (19 de novembro de 2010): 3824. http://dx.doi.org/10.1182/blood.v116.21.3824.3824.
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Abstract Abstract 3824 Background: The Centers for Medicare and Medicaid Services (CMS) recently executed a policy which denies reimbursement for preventable hospital acquired conditions (HAC) (“never events”). Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing major surgical hip or knee procedures was a condition selected for implementation as part of this policy in fiscal year 2009 (beginning October 2008). The objective of this analysis was to estimate the financial impact of this policy change on US hospitals. Methods: Discharge-level hospital administrative records were extracted from the Thomson Reuters MarketScan® Hospital Drug Database for patients undergoing CMS-defined surgical hip and knee procedures (total hip/knee replacement, partial hip replacement, and hip resurfacing). Discharged patients meeting the following criteria were included: admission and discharge between October 2007 and September 2008, age ≥ 18 years, Medicare as primary payer, valid CMS hospital ID and no evidence of DVT/PE on admission. The frequency of CMS defined VTE was assessed and the economic impact of the CMS HAC policy was estimated. Revenue impact, the amount of revenue lost per hospital due to CMS policy implementation, was calculated per year and per VTE discharge using the old and new CMS reimbursement rules. The incremental cost impact, the additional cost to hospitals due to VTE among hip/knee surgery patients, was also determined. Results: A total of 107 hospitals were identified to have at least one eligible surgical hip and knee surgery discharge. The total number of such discharges was 26,144. On average, there were 244.34 CMS-defined hip/knee surgery discharges per hospital. The majority of discharged patients were from urban hospitals (83.37%) in the Southern US (73.07%), without teaching status (87.98%) and with a licensed bed size of 300–499 beds (31.90%). VTE occurred in an average (± standard deviation) of 4.25 ± 6.05 hip/knee surgery discharges per hospital; DVT and PE occurred in 2.44 ± 5.11 and 1.81 ± 1.89 discharges per hospital, respectively. The average length of hospital stay was 7.56 ± 2.88 days in hip/knee discharges with VTE, compared to 4.08 ± 0.59 days in discharges without VTE. Anticoagulation was ordered in 94.70% of discharged patients with DVT and in 89.06% of discharged patients with PE. Under the CMS HAC policy for VTE, the mean loss of revenue per hospital per year was estimated to be $8,453 (95% confidence interval [CI] 6,902 – 10,005). Per VTE, the average hospital revenue loss was $2,704 per hospital per year. The mean incremental cost for a hip/knee discharge with VTE, per hospital was $6,581; for DVT and PE, incremental cost impacts were $6,751 and $8,092, respectively. The annual cost impact per hospital for hip/knee discharges with VTE was estimated at $31,609 [95% CI 23,714 – 39,505]. Conclusions: The CMS policy on average caused a loss of hospital revenue (≂f$8,500 per year). Additionally, when a VTE event does occur in patients undergoing surgical hip and knee procedures, it is associated with high incremental hospital costs (≂f$32,000). These significant costs will no longer be reimbursed under the new CMS HAC policy. Subsequently, hospitals will be responsible for covering them. Therefore, now more than ever, reducing VTE rates through appropriate prophylaxis of at-risk patients is vital in order for hospitals to lessen the economic impact associated with treating VTE events. The drive to encourage hospitals to provide more efficient and effective healthcare is becoming particularly relevant now that models of health care reform, such as the “Accountable Care Organization”, are being piloted as part of the Senate's Healthcare Reform Bill. This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support in the preparation of this abstract provided by Katherine Roberts, PhD of Excerpta Medica, funded by sanofi-aventis U.S., Inc. Disclosures: Deitelzweig: sanofi-aventis: Honoraria, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Honoraria, Research Funding, Speakers Bureau; Scios: Honoraria, Research Funding, Speakers Bureau; Pfizer: Speakers Bureau. Thompson:sanofi-aventis US Inc.: Employment. Lin:sanofi-aventis US Inc.: Employment, Research Funding. McMorrow:sanofi-aventis US Inc : Research Funding. Johnson:sanofi-aventis US Inc: Research Funding.
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Álvarez Roman, Teresa, Elena Monzón Manzano, Ihosvany Fernandez-Bello, Mónica Martín, María Isabel Rivas Pollmar, Raul Justo Sanz, Sara García Barcenilla et al. "Real Life Experience in Clinical Practice with Recombinant Coagulation FVIII-Fc Fusion Protein". Blood 134, Supplement_1 (13 de novembro de 2019): 4929. http://dx.doi.org/10.1182/blood-2019-127878.
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Introduction: Efmoroctocog alfa (Elocta®) is a recombinant coagulation FVIII-Fc (rFVIIIFc), a fully recombinant fusion protein produced in human embryonic kidney cells, with an extended half-life used for the treatment and prevention of bleeding in patients with severe hemophilia A. Using rFVIIIFc for the treatment of severe hemophilia A patients received the approval of reimbursement in Spain at the end of 2016. Therefore, there are no many comparative data published about real life use of rFVIIIFc. Objective: This work aims to describe characteristics of the treatment of severe hemophilia A patients with rFVIIIFc and to compare its results with those previously obtained employing other FVIII products. Methods: This was an open-label non-interventional retrospective study reviewing patient characteristics and treatment outcomes before and after the use of rFVIIIFc. The La Paz University Hospital Ethics Committee approved the experimental protocol. Patients with severe hemophilia A without inhibitors being treated with rFVIIIFc since at least six months before study approval by Ethics Committee were included. The following data were collected for patients included in the study: dose (IU/kg) and prophylaxis treatment regimen, number of spontaneous and traumatic bleedings, annual bleeding rate (ABR) and FVIII trough level. The statistical analysis on the variables listed above comparing before and after rFVIIIFc usage was performed by the Biostatistics Unit of La Paz University Hospital with the statistical package SPSS v.18.0 (SPSS Inc., Chicago, IL, USA). Results: Twenty two severe hemophilia A patients (median age: 20 years old, ranging from 6 to 63 years) on prophylaxis with rFVIIIFc were considered to be included in this study, but two were excluded due to lack of data. Median follow-up period was 14 months (ranging from 6 to 28 months). Nineteen severe hemophilia A patients have been previously treated with rFVIII (two of them with other extended half-life product) and one with plasma-derived FVIII. Eight of the ten severe hemophilia A patients who presented an ABR greater than 0 with previous treatments reduced their ABR when treated with rFVIIIFc (Table 1). Among those patients with an ABR=0 with previously used FVIII products, only one increased to an ABR=1 when treated with Elocta® due to a traumatic bleeding. Table 1 shows ABR across all patients before and after rFVIIIFc. There was no difference in dose per injection between other FVIII products and rFVIIIFc (median dose for patients treated with other FVIII products: 46.0 IU/kg, ranging from 26 to 65 IU/kg; median dose for patients treated with rFVIIIFc: 46.5 IU/kg, ranging from 26 to 65 IU/kg). Nevertheless, a reduction was observed in administration frequency. Among the twelve patients who received treatment with other FVIII products every 48 hours, eleven came to receive rFVIIIFc 3 times a week and the one previously receiving a plasma-derived FVIII, to twice a week. Five of the patients receiving treatment 3 times a week reduced its frequency to twice per week. Three patients maintained the same schedule of administration. To note, one of the two patients receiving another prolonged half-life product maintained the schedule of treatment and the other reduced its frequency from every 48 hours to 3 times a week. FVIII trough level in plasma (% of FVIII), expressed as median (25th-75th percentile), was 1.1 (0.1-4.0) for rFVIIIFc treatment and 0.2 (0.0-1.9) for other FVIII products (p=0.06). Conclusions: 85% of the severe hemophilia A patients from our cohort reduced the weekly dose administration after beginning treatment with rFVIIIFc. Most of the patients increased plasma trough level of FVIII with rFVIIIFc. 45% of patients reduced and 40% kept their ABR=0 when they changed rFVIIIFc. These data suggest that treatment with rFVIIIFc gives a higher protection to severe hemophilia A patients. However, further research with larger sample size is required to investigate this. This work was supported by SOBI. NB holds a tenure track grant from FIS-FONDOS FEDER (CP14/00024). Disclosures Álvarez Roman: Takeda: Research Funding; Amgen: Consultancy, Speakers Bureau; NovoNordisk: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; CSL Behring: Consultancy, Speakers Bureau; Sobi: Consultancy, Speakers Bureau. Fernandez-Bello:Novartis, Pfizer, ROCHE, Stago: Speakers Bureau. Martín:SOBI: Research Funding; Novartis, Pfizer, ROCHE, Novo Nordisk: Speakers Bureau. Rivas Pollmar:Novartis, Pfizer, ROCHE, Novo Nordisk: Speakers Bureau; SOBI: Research Funding. García Barcenilla:Bayer, Pfizer, Takeda, Novartis: Speakers Bureau; SOBI: Research Funding. Canales:SOBI: Research Funding; iQone: Honoraria; Karyopharm: Honoraria; Novartis: Honoraria; Takeda: Speakers Bureau; Gilead: Honoraria; Celgene: Honoraria; Janssen: Honoraria, Speakers Bureau; F. Hoffmann-La Roche Ltd: Honoraria, Speakers Bureau; Sandoz: Honoraria. Butta:Roche, Pfizer: Speakers Bureau; Novartis: Consultancy. Jimenez-Yuste:Bayer, CSL Behring, Grifols, Novo Nordisk, Octapharma, Pfizer, Roche, Sobi, Shire: Consultancy, Honoraria, Other: reimbursement for attending symposia/congresses , Research Funding, Speakers Bureau.
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Palomäki, A., T. Laitinen, J. Koskela, A. Palotie e N. Mars. "OP0007 MUC5B PROMOTER VARIANT AND LONG-TERM INCIDENCE OF INTERSTITIAL LUNG DISEASE IN PATIENTS WITH RHEUMATOID ARTHRITIS: A POPULATION BIOBANK STUDY OF 250,000 INDIVIDUALS". Annals of the Rheumatic Diseases 80, Suppl 1 (19 de maio de 2021): 4.2–4. http://dx.doi.org/10.1136/annrheumdis-2021-eular.619.
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Background:The promoter variant rs35705950 in MUC5B is the strongest known genetic risk factor for rheumatoid arthritis-associated interstitial lung disease (RA-ILD) [1]. There is, however, no large-scale data on the impact of MUC5B on the long-term incidence of RA-ILD.Objectives:To describe long term risk of RA-ILD in RA patients carrying MUC5B variant compared to non-carriers with RA.Methods:FinnGen is a collection of epidemiological cohorts and hospital biobank samples, linking genotypes with up to 46 years of follow-up within nationwide registries. Diagnoses of RA and ILD were identified from the Finnish national hospital discharge, medication reimbursement and cause-of-death registries. We estimated lifetime risks of ILD by age 80. MUC5B is a common variant and has an allele frequency of 0.1 in the Finnish population.Results:Out of the 248,400 individuals, 5534 patients have been diagnosed with RA, out of whom 178 (3.2%) developed ILD. MUC5B was a strong predictor of ILD in RA patients (HR 2.14, 95%CI 1.56-2.92). In patients with RA, MUC5B conferred a lifetime risk of 14.5% (95%CI 10.7-18.1%), compared to 5.2% (4.1-6.2%) in MUC5B non-carriers with RA (Figure). In the population, MUC5B carriers and MUC5B non-carriers had lifetime risks of 3.9% and 1.3%, respectively. The risk difference started to emerge at age 65. The risk was highest in men with RA who are MUC5B carriers: 18.5% (11.1-25.2%) developed ILD, compared to 8.5% (6.1-10.9%) of MUC5B non-carriers with RA.Conclusion:We report findings from a large longitudinal study, showing that MUC5B confers a considerable lifetime risk of RA-ILD, and contributes to increased morbidity. These findings have clinical implications for improving identification of RA patients at high risk of developing ILD.References:[1]Juge P-A, Lee JS, Ebstein E, et al. MUC5B Promoter Variant and Rheumatoid Arthritis with Interstitial Lung Disease. N Engl J Med 2018;379:2209–19Disclosure of Interests:Antti Palomäki Speakers bureau: MSD, Pfizer, Sanofi, Consultant of: Pfizer, Abbvie, Tarja Laitinen: None declared, Jukka Koskela Speakers bureau: Pfizer, Aarno Palotie: None declared, Nina Mars: None declared
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Koschmieder, Steffen, Susanne Isfort, Dominik Wolf, Florian H. Heidel, Philippe Schafhausen, Martin Griesshammer, Denise Wolleschak et al. "Ruxolitinib Shows Efficacy in Patients with Newly-Diagnosed Polycythemia Vera: Futility Analysis of the Randomized Ruxo-BEAT Clinical Trial of the German Study Group for Myeloproliferative Neoplasms". Blood 134, Supplement_1 (13 de novembro de 2019): 2944. http://dx.doi.org/10.1182/blood-2019-123985.
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Introduction: Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) characterized by expansion of the granulocytic, erythrocytic, and megakaryocytic lineages in the bone marrow and peripheral blood, and in most cases, by the presence of a JAK2 mutation. Survival of patients with PV is decreased compared with age-matched controls, and this is mainly due to thromboembolic complications followed by progression to post-PV myelofibrosis and acute leukemia. While no curative treatment exists, cytoreductive treatment with hydroxyurea (HU) or ropeginterferon is approved in EU for first-line therapy, and ruxolitinib (RUX) is approved in EU and US for second-line therapy in patients with HU intolerance or resistance. The current futility analysis assesses the efficacy of ruxolitinib in newly-diagnosed PV treated within the Ruxo-BEAT trial. Methods: This clinical trial entitled "Ruxolitinib versus Best Available Therapy in patients with high-risk Polycythemia Vera or high-risk Essential Thrombocythemia" (Ruxo-BEAT; NCT02577926) is a multicenter, open-label, two-arm phase-IIb trial with a target population of 380 pts with PV and ET. Patients in first-line PV and in first and later lines ET are randomized in a 1:1 manner to receive either RUX or best available therapy (BAT). Crossover from BAT to RUX is possible in eligible patients after 6 months. Patients with PV in the RUX arm receive a starting dose of 10 mg bid and may increase their dose up to 20 mg bid. Primary endpoint is the rate of complete clinicohematologic response rate (CHR) at month 6 as defined by Barosi et al Blood 2009. Secondary endpoints include differences in the absence of phlebotomies, spleen size, patient-reported outcomes, and survival. This is a pre-specified futility analysis of RUX in the PV arm, after 50 PV patients had been enrolled. Of the 50 patients, 28 patients with newly-diagnosed PV were randomized into the RUX arm and were analyzed (a maximum of 6 weeks of HU, anagrelide, or interferon therapy was allowed). The PV arm would have to be closed if no favorable trend were observed for RUX for any of the following variables: (1) improvement (decrease) in the hematocrit level during 6 months of treatment, (2) improvement (decrease) of the JAK2V617F allele burden during 6 months of treatment, or (3) improvement of one of the following three symptom variables assessed by physician´s judgement or via MPN Symptom Assessment Form (MPN-SAF) during 6 months of treatment: pruritus, night sweats, or bone pain. Differences between screening (Hct) or baseline (all other variables) and end of month 6 (all variables) were calculated using Fisher´s exact test (for physician-assessed pruritus and night sweats) or the Wilcoxon matched-pairs signed rank test (all other variables). Results: 28 patients received RUX for at least 6 months. After 6 months, the mean hematocrit level decreased from 45.9+/-5.6% to 41.0+/-5.0% (mean+/-SD) (p=0.0003). The number of phlebotomies calculated per year decreased from 4.2+/-3.9% to 0.96+/-2.1 (p=0.0009). Mean JAK2V617F allele burden decreased from 50.2+/28.4% to 44.0+/-28.5% (p=0.0039). The percentage of patients, as assessed by the physician, with pruritus or night sweats decreased from 41% to 26% (trending with p=0.13), and from 30% to 11% (p=0.02), respectively. The points reported by patients themselves on the MPN-SAF survey for pruritus decreased from 2.7+/-3.0 to 1.3+/-1.5 (p=0.0095) and there was a strong trend for reduction of night sweat points (from 3.1+/-3.6 to 1.6+/-2.4; p=0.0579), while the points for bone pain remained unaltered (2.0+/-2.8 to 1.4+/-2.2; p=0.215). Conclusion: Treatment with ruxolitinib in first line PV is efficient regarding the above-mentioned endpoints. Recruitment of our trial will be ongoing. In order not to weaken the study´s statistical power, comparison of both arms was not performed. Disclosures Koschmieder: Ariad: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers-Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Incyte: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Shire: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis Foundation: Research Funding; CTI: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AOP Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Isfort:Mundipharma: Other: Travel reimbursement; Amgen: Other: Travel reimbursement; Hexal: Other: Travel reimbursement; BMS: Honoraria; Ariad: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Other: Travel reimbursement; Novartis: Consultancy, Honoraria, Other: Travel reimbursement; Roche: Other: Travel reimbursement; Alexion: Other: Travel reimbursement. Schafhausen:Novartis: Consultancy, Honoraria; Incyte: Consultancy, Equity Ownership, Honoraria. Griesshammer:Novartis: Consultancy, Honoraria, Speakers Bureau. Platzbecker:Abbvie: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Döhner:CTI Biopharma: Consultancy, Honoraria; Daiichi: Honoraria; Jazz: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Janssen: Honoraria. Jost:Abbvie: Consultancy, Patents & Royalties: Royalty payments for the drug compound ABT-199, Research Funding; Bohringer: Consultancy, Research Funding; BMS: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Celgene: Other: Travel Support; Novartis: Research Funding. von Bubnoff:Novartis: Research Funding. Stegelmann:Novartis: Consultancy, Honoraria; Incyte: Consultancy, Honoraria. Crysandt:Amgem: Other: travel grant; celgene: Other: travel grant; Pfizer: Other: travel grant; Gilead: Other: travel grant; Incyte: Membership on an entity's Board of Directors or advisory committees. Gezer:AMGEM: Membership on an entity's Board of Directors or advisory committees. Brümmendorf:Merck: Consultancy; Pfizer: Consultancy, Research Funding; University Hospital of the RWTH Aachen: Employment; Janssen: Consultancy; Ariad: Consultancy; Novartis: Consultancy, Research Funding. OffLabel Disclosure: Ruxolitinib as first-line treatment in newly-diagnosed PV
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Dunavin, Neil, Lih-Wen Mau, Christa Lea Meyer, Clint Divine, Al-Ola Abdallah, Susan Leppke, Anita D'Souza et al. "Health Care Reimbursement and Service Utilization Among Medicare Beneficiaries with Multiple Myeloma Receiving Autologous Hematopoietic Cell Transplantation in Inpatient and Outpatient Settings". Blood 132, Supplement 1 (29 de novembro de 2018): 832. http://dx.doi.org/10.1182/blood-2018-99-118423.
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Abstract Introduction: Inpatient services are the leading drivers of cost for autologous hematopoietic cell transplantation (HCT), and the number of Medicare beneficiaries who receive autologous HCT is increasing. Using a merged dataset of Center for International Blood and Marrow Transplant Research (CIBMTR) transplant and outcomes data and Centers for Medicare and Medicaid Services (CMS) Medicare administrative claims data, we examined reimbursement and service utilization among Medicare beneficiaries with multiple myeloma (MM) who received IP and OP autologous HCT. Methods: This was a multicenter retrospective cohort study. A total of 11,358 HCT recipients from 2010-2012 were identified in the CMS Medicare database; 9,055 (80%) were linked with CIBMTR data. Selection criteria included first HCT for MM, diagnosis-to-HCT time between 0 and 18 months, and continuous enrollment for 30 days prior to index and 100 days post-HCT or until death. For IP-HCT, the index period for reimbursement and service utilization was day of admission for HCT through discharge date. For OP-HCT, the index period was day -2 through HCT date to capture the conditioning regimen. Total IP and OP service days from 30 days prior to index and 100 days post-HCT, and subsequent admissions post the HCT index period were calculated. Total reimbursement consisted of all payments made to providers (Medicare payments for Part A & B services, secondary payer, and patient responsibility of deductibles, coinsurance, and copayments), which was adjusted by a weighted generalized linear model (GLM). Patient responsibility was assessed separately and adjusted by the same GLM. Kaplan-Meier method was used for overall survival (OS) analysis; potential factors associated with OS were adjusted by Cox regression modeling. Results: The final cohort comprised 1,640 patients; 1,445 (88%) received IP-HCT (126 centers) and 195 (12%) OP-HCT (24 centers). Patient characteristics, functional status, disease status, and HCT year were similar between groups except a higher percentage of IP-HCT recipients were 70 years and older (IP-HCT: 31%, OP-HCT: 19%; P=0.0003), and a lower percentage of IP-HCT recipients received full dose melphalan 200 mg/m2 (IP-HCT: 68%, OP-HCT: 90%; P=0.0036). There was a significant difference between the cohorts in the utilization of IP services (IP-HCT group: median 19 days, OP-HCT group: 4 days; P < 0.0001) and OP services (IP-HCT group: median 16 days, OP-HCT group: 33 days; P < 0.0001) at day 100. Adjusted total mean reimbursement for the IP-HCT group ($83,380 [95% CI: $78,958-$88,051]) was higher than the OP-HCT group ($55,721 [95% CI: $38,595-$80,446]) (P= 0.0301) (Figure). Factors associated with total reimbursement in the GLM were transplant setting, age, sex, comorbidity index, diagnosis-to-HCT time, and melphalan dose. Adjusted total patient responsibility for the IP-HCT group was $4,567 (95% CI: $4,210- $4,955) and $7,372 ($4,218- $12,884) (P=0.0902) for the OP-HCT group. Within 100 days post-HCT, 107/195 (55%) OP-HCT recipients had at least one subsequent admission, compared to 348/1,445 (24%) IP-HCT recipients (P < 0.0001). OS at 100 days was high for both HCT settings and adjusted OS was not significantly different by transplant setting (IP-HCT 98% [95% CI: 97%-99%]; OP-HCT 99% [95% CI: 98%-100%; P=0.1903) Conclusions: Reimbursement and service utilization varied by HCT setting for Medicare beneficiaries with MM. Total reimbursement for 100 days post-HCT was $27,659 higher for IP-HCT than OP-HCT, after adjusting for patient and HCT-related characteristics. After the HCT index period, approximately 1 in 4 IP-HCT recipients required re-hospitalization within 100 days, whereas 1 in 2 OP-HCT recipients required subsequent hospitalization. Many factors influence the decision between IP or OP autologous HCT, including: center experience, severity of disease, patient co-morbidities, access to caregivers, proximity of lodging, cost to the patient, and reimbursement for services to the hospital system. The CIBMTR-CMS merged database is a new resource to support ongoing efforts to inform transplant centers and healthcare systems about provision of care options in the Medicare population. Figure. Figure. Disclosures Ganguly: Janssen: Consultancy; Amgen: Consultancy; Seattle Genetics: Speakers Bureau; Daiichi Sankyo: Research Funding.
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Meunier, Godelieve, Loïc Ysebaert, Phi Linh Nguyen-Thi, Stephane Lepretre, Anne Quinquenel, Jehan Dupuis, Richard Lemal et al. "First Line Chronic Lymphocytic Leukemia Immunochemotherapy for the Elderly Patients over 79 Years Is Feasible, and Achieves Good Results: A Filo Retrospective Study". Blood 126, n.º 23 (3 de dezembro de 2015): 4170. http://dx.doi.org/10.1182/blood.v126.23.4170.4170.
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Abstract Introduction: Median age of Chronic Lymphocytic Leukemia (CLL) patients is 72 years with 40% older than 75 and 22.8% over 80 years. Important therapeutic progresses have been made, including chemo-immunotherapy as well as the recent use of targeted therapies, leading to progression-free-survival (PFS) and overall survival (OS) improvements. Although the elderly represents the largest subgroup of CLL patients, they are underrepresented in clinical studies and little is known about their clinical characteristics, treatment and outcome. Consequently, results from trials cannot be directly translated into clinical practice for these patients. Bairey et al (Ann Hematol, 2011) reported a series of 214 patients (80 years or older) diagnosed in Israel between 1979 and 2009 with a mean age of 84. However, in this cohort, 56% of the patients had a Rai stage 0 and only 53 received treatment. Median survival was 56 months. Methods: We performed a retrospective study of CLL patients aged 80 or more at initiation of first line therapy. Patients were treated between 2003 and 2013, in 17 hospitals affiliated to the French Innovative Leukemia Organisation (FILO). We report here a cohort of 201 such CLL patients, and describe their clinical and biological characteristics, treatment options and outcome. Results: Patients' median age was 83.4 years (80-92), 29% were older than 85 years, and the sex ratio was 60% male/40% female. Performance status (97%≤ 2) and nutritional status (median Corporal Mass Index of 25.3 kg/m²) were preserved. The median Cumulative Index Rating Scale (CIRS) comorbidity score was 5. More precisely in term of fitness, 57.8% patients were characterized as "go-go" with a CIRS ≤ 6 and organ comorbidities <3. The median creatinine clearance was 48 mL/min (Cockroft formula). Most patients lived at home (89.5%), often with familial or professional help (72%). A complete geriatric assessment was performed for 6.1% of them. Diagnosis relied on a Royal Marsden Hospital (RMH) score > 3, and CD38 was positive in 43,4% of the 129 cases tested (64%). Cytogenetic data were available for 42% of the patients. Isolated abnormalities were deletion 13q (38.1%), trisomy 12 (21.4%), deletion 17q (10.7%) or deletion 11q (7.1%). Besides, associated chromosomic abnormalities were detected, mainly by fluorescence in situ hybridization (FISH) and complex karyotypes (1.2%). At treatment initiation, Binet stage was either A (27.2%), B (28.7%) or C (41.5%). Therapies consisted mainly in Chlorambucil (65.5%), Bendamustine (10.5%) and Rituximab (44.3%). Indeed, therapy regimens were composed of Chlorambucil alone (45.3%) or chemo-immunotherapy (48.3%) including Rituximab+Chlorambucil (22.7%), Rituximab+Bendamustine (10.4%), Rituximab+Cyclophosphamide+Dexamethasone (5.5%) or Rituximab+Fludarabine+Cyclophosphamide (5.5%). In term of tolerance, 20.2% of the patients required hospitalization and 10% of these cases were febrile neutropenia. Finally, 31.8% required a dose reduction of chemotherapy. The Overall Response Rate was 65.9% with 31.4% of clinical complete remission. The median OS and PFS (from treatment initiation) were 48.6 and 18 months, respectively (cf. Survival curves). Afterwards, an important number of patients (41.3%) remained fit enough to receive a second line treatment. In univariate analysis, only comorbidities evaluated by the CIRS had a significant impact on survival (p=0.03). Indeed patients identified as fit by a CIRS score ≤ 6 and no organ comorbidity > 3 had a better outcome. Conclusion: We report a large series of elderly CLL patients, who received first line treatment at a median age of 83. Median OS was about 4 years, which is less than normal population of the same age. Our results suggest that treatment (including immunochemotherapy) is feasible, even in this very old population. Different bias are possible in this retrospective study including the selection of only fit patients, the low percentage of geriatric evaluation, and the possible undertreatment of this population since chlorambucil was the most frequent treatment. In the future, prospective trials should target this population. Oncogeriatric evaluation and new targeted therapies should be part of such future trials. Figure 1. Survival curve 1: Overall Survival Figure 1. Survival curve 1: Overall Survival Figure 2. Survival curve 2: Progression Free Survival Figure 2. Survival curve 2: Progression Free Survival Disclosures Dupuis: ROCHE: Speakers Bureau; ABBVIE: Membership on an entity's Board of Directors or advisory committees. Aurran-Schleinitz:CSLBehring: Honoraria; Janssen: Honoraria. Cymbalista:Karyopharm: Honoraria; Gilead: Honoraria; Roche: Honoraria; Janssen: Honoraria, Research Funding. Dilhuydy:Roche: Honoraria, Other: Travel reimbursement; Janssen: Honoraria, Other: Travel reimbursement; Mundipharma: Honoraria. Cazin:GILEAD,: Honoraria; ROCHE: Consultancy; MUNDIPHARMA: Honoraria, Research Funding; NOVARTIS: Honoraria. Leblond:Roche: Consultancy, Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; GSK: Consultancy, Honoraria, Speakers Bureau; Mundipharma: Honoraria; Gilead: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau. Cartron:Sanofi: Honoraria; Gilead: Honoraria; Celgene: Honoraria; GSK: Honoraria; Roche: Consultancy, Honoraria.
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Monzón Manzano, Elena, Ihosvany Fernandez-Bello, Raul Justo Sanz, Larissa Valor, Francisco Javier López-Longo, Angel Robles, Teresa Álvarez Roman, Miguel A. Canales, Victor Jimenez-Yuste e Nora Butta. "Prothrombotic State, Platelet Activation and Netosis in Systemic Lupus Erythematosus". Blood 134, Supplement_1 (13 de novembro de 2019): 1141. http://dx.doi.org/10.1182/blood-2019-127991.
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Introduction: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown origin characterized by a hypercoagulable state and a high mortality rate. Mechanisms that cause the accelerated deterioration of cardiovascular health in SLE are unknown. Objectives: to characterize the prothrombotic state in SLE patients by global coagulation assays and the contribution of platelets, endothelial damage, microparticles and neutrophil extracellular traps (NETs) in their prothombotic profile. Material and methods: 72 patients and 90 healthy controls were recruited. Patients were classified according to clinical characteristics in: 32 with lupus (SLE group), 29 with SLE and antiphospholipid antibodies (aFL, SLE+aFL group) and 12 who met the criteria for SLE and antiphospholipid syndrome (APS, SLE+APS group). Experimental protocol was approved by La Paz University Hospital Ethics Committee. Venous blood collected in BD sodium citrate tubes (3.2%) was centrifuged at 150 g for 20 min at 23ºC to obtain platelet-rich plasma (PRP). PPP was obtained by centrifugation at 1500 g for 15 min at 23ºC. To obtain neutrophils, whole blood was centrifuged to 1600 rpm 25 min using a Ficoll gradient and red cells were lysed. Rotational thromboelastometry (ROTEM®) was performed in naTEM condition. Clotting time (CT, time from start of measurement until initiation of clotting [in seconds]); alpha angle (tangent to the curve at 2-mm amplitude [in degrees]), Ax (clot firmness at time x, [in mm]) and maximum clot firmness (MCF, [in mm]) were recorded. Procoagulant activity associated to microparticle's content of tissue factor was determined in PPP by Calibrated Automated Thrombogram (CAT) using MP-reagent (4 mM phospholipids, Diagnostica Stago, Spain). We evaluated the endogenous thrombin potential (ETP, the total amount of thrombin generated over time); the lag time (the time to the beginning of the explosive burst of thrombin generation); the peak height of the curve (the maximum thrombin concentration produced) and the time to the peak. Thrombin generation associated to NETs was also measured by CAT. Neutrophils from healthy controls or from LES patients were stimulated with 100 nM PMA in RPMI medium during 45 min at 37º and then cocultivated with PRP adjusted to 105 platelets/µL. NETs formation was verified by fluorescent microscopy performed with DAPI and an anti-myeloperoxidase antibody. Plasma levels of LDL-ox, E-Selectin and PAI-1 were determined by Elisa (R&D Systems, MN, USA and Affymetrix eBioscience, Vienna, Austria, respectively). Platelet activation was analysed by flow cytometry (FCM, FACScan, BD Biosciences). Fibrinogen receptor activation was evaluated through PAC1-FITC binding and release of granule's content was assessed with monoclonal antibodies (mAbs) anti-CD63 and anti P-selectin in quiescent and 100 µM TRAP and 10 µM ADP stimulated platelets. Data were analysed with Graphpad prism and p ≤0.05 was stablished as statistical significance. Results: PAI-1 plasma level was increased in all patient's groups, whereas LDL-ox and E-selectin showed no differences with control cohort (Fig.1). ROTEM demonstrated a procoagulant profile in SLE and SLE+aPL but not in SLE+APS group (Fig. 2). PAI-1 levels correlated with several ROTEM parameters (Table 1). SLE patients and SLE+aFL showed a basal platelet activation. Moreover, SLE group exposed more P-selectin and CD63 than controls (Fig.3). Regarding thrombin generation associated to tissue-factor content of microparticles, no differences were observed between SLE patients and healthy controls. On the other hand, SLE patients had an increased peak of thrombin generation related to NETs formation (control group: 170.3± 58.0, SLE patients: 230.6±39.3, p=0.019). Conclusions: ROTEM® detected a hypercoagulable state in SLE and SLE+aPL patients. The hypercoagulable state might be linked to increased PAI-1 plasma levels and basal platelet activation in SLE and SLE+aPL groups. Moreover, neutrophils from SLE patients seemed to present a basal activation that induced a NETs-related procoagulant state in these patients. SLE+APS patients did not show a hypercoagulable state perhaps because of the presence of lupus anticoagulant and/or to therapeutic treatment of these patients. This work was supported by grants from the FIS-FONDOS FEDER (PI15/01457, NB). NVB holds a Miguel Servet tenure track grant from FIS-FONDOS FEDER (CP14/00024). Disclosures Fernandez-Bello: Novartis, Pfizer, ROCHE, Stago: Speakers Bureau. Robles:ABBVIE, SANDOZ FARMACEUTICA: Speakers Bureau. Álvarez Roman:Sobi: Consultancy, Speakers Bureau; CSL Behring: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Takeda: Research Funding; NovoNordisk: Consultancy, Speakers Bureau. Canales:Celgene: Honoraria; Gilead: Honoraria; Novartis: Honoraria; Janssen: Honoraria, Speakers Bureau; Sandoz: Honoraria; iQone: Honoraria; Takeda: Speakers Bureau; SOBI: Research Funding; Karyopharm: Honoraria; F. Hoffmann-La Roche Ltd: Honoraria, Speakers Bureau. Jimenez-Yuste:Bayer, CSL Behring, Grifols, Novo Nordisk, Octapharma, Pfizer, Roche, Sobi, Shire: Consultancy, Honoraria, Other: reimbursement for attending symposia/congresses , Research Funding, Speakers Bureau. Butta:Novartis: Consultancy; Roche, Pfizer: Speakers Bureau.
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Schlenk, Richard F., Stefan Schönsteiner, Katharina Krempel, Anja Neumann, Walter Fiedler, Peter Brossart, Bernd Hertenstein et al. "Cost-Effectiveness Analysis of Arsenic Trioxide in Combination with All-Trans Retinoic Acid in Acute Promyelocytic Leukemia with Pretreatment White Blood Counts <10G/L". Blood 124, n.º 21 (6 de dezembro de 2014): 2636. http://dx.doi.org/10.1182/blood.v124.21.2636.2636.
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Abstract Background: Chemotherapy-free treatment with arsenic trioxide and all-trans retinoic acid (ATO/ATRA) of patients with acute promyelocytic leukemia (APL) with presenting white blood counts (WBC) < 10 G/l has been shown to be at least equivalent or even better with regard to survival and quality of life compared to standard treatment according to the AIDA scheme which includes idarubicin, mitoxantrone in combination with ATRA followed by a two-year maintenance therapy with 6-mercaptopurin, methotrexate and ATRA (Lo Coco F et al., N. Engl. J. Med. 2013;369(2):111-21; Efficace F et al J Clin Oncol. 2014 accepted). Aims: To evaluate costs in relation to benefits in a cost-effectiveness analysis comparing ATO/ATRA to standard treatment with AIDA in newly diagnosed APL with WBC<10G/l from a third party payers perspective Methods: The study included 55 patients with newly diagnosed APL treated in Germany within the APL0406 study (NCT00482833), n=29 in the experimental arm (ATO) and n=26 in the standard arm (AIDA). Costs were calculated based on data of treated patients to determine average estimates as of 2014. Costs were calculated based on the background of the German Diagnosis-Related Groups system including additional reimbursement for platelet transfusions and ATO as well as payment for out-patient treatment and care. Costs for 1 mg arsenic trioxide were 46.17€ both for in-patient and out-patient treatment. Results: For induction therapy all patients were hospitalized. The median hospital stay, the proportion of patients with severe complications comprising coagulopathy, differentiation syndrome, and fever triggering a higher DRG grouping, as well as median amount of platelet transfusion were 30 days (range, 16-47 days) and 33 days (range, 21-80 days) (p=0.13), 67% (20/29) and 81% (21/26) (p=0.37), 5 (range, 0-32) and 10 (range, 0-30) (p=0.13) for the ATO-arm and the AIDA-arm, respectively. The median amount of administered ATO was 290mg (range, 100-780mg) in the ATO-arm. Total costs for induction therapy were calculated with 27,211€ and 15,472€ for the ATO-arm and the AIDA-arm, respectively. During the 4 consolidation cycles in the ATO-arm, 21 of 94 cycles were administered on an in-patient basis (median duration of hospital stay, 20 days; range, 1-30 days). In 8 patients initially treated on an out-patient basis hospitalization due to fever/infection was necessary with a median duration of 19 days (range, 3-51days). One patient received a single platelet transfusion during 94 consolidation cycles. Total costs for all 4 consolidation cycles including in- and out-patient treatment were calculated with 56,305€. During the 3 consolidation cycles in the AIDA-arm, 36 of 67 cycles were administered on an in-patient basis (median duration of hospital stay, 9 days; range, 1-30 days). In 12 patients initially treated on an out-patient basis a total of 14 hospitalizations due to fever/infection were necessary (median duration, 13 days; range, 6-31days). In 10 patients, 11 platelet transfusions were given during 67 consolidation cycles. Combining the in-patient and out-patient treatment cost of all 3 consolidation cycles including rare complications of fever and platelet transfusion, total costs were calculated with 17,159€. In addition, a maintenance therapy of 2 years with 24 cycles was intended; n=15 patients received a median of 10 cycles (range 7-14 cycles). The preterm cessation of maintenance therapy in all patients was due to cytopenias and drug intolerance. Therefore, costs for 10 cycles were estimated as average costs of maintenance therapy with a total amount of 4,264€. The higher total costs in the ATO/ATRA-arm of 85,516€ (49,402€ attributed to ATO) per patient as compared to the AIDA-arm of 36,895€ per patient were accompanied by a significantly better event-free and overall survival reported in the original report (Lo Coco F et al. N Engl J Med. 2013;369(2):111-21) at 2 years of 97% and 99% compared to 86% and 91%, respectively. Based on the published overall survival data with ATO/ATRA we calculated numbers-needed-to-treat to save one life based on follow-up data of 2 years. By using the average risk difference approach a number of 14 patients has been calculated (95%-confidence interval, 12-17). Conclusions: Treatment with ATO/ATRA in newly diagnosed APL with WBC<10G/l was associated with 2.3-time higher costs. At least 14 patients have to be treated with ATO to save one additional life. Disclosures Schlenk: TEVA Pharma GmbH: Research Funding, Speakers Bureau. Fiedler:TEVA: Travel reimbursement for meeting attendance Other. Ehninger:Celgene: Research Funding; GEMoaB Monoclonals GmbH: Equity Ownership, Honoraria. Döhner:TEVA: Research Funding. Lo Coco:TEVA: Consultancy, Speakers Bureau; Lundbeck: Consultancy, Speakers Bureau. Platzbecker:TEVA: Research Funding, Speakers Bureau.
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McGuirk, Joseph P., Clint Divine, Seung Hyun Moon, Aastha Chandak, Zhiji Zhang e Genovefa A. Papanicolaou. "Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation". Blood 136, Supplement 1 (5 de novembro de 2020): 42–43. http://dx.doi.org/10.1182/blood-2020-133799.
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Introduction: Hemorrhagic cystitis (HC) due to viral infections, such as BK virus, cytomegalovirus and/or adenovirus, after Allogeneic Hematopoietic Cell Transplantation (allo-HCT) causes morbidity and mortality, impacts quality of life, and poses a substantial burden to the health care system. Virus-associated HC (V-HC) occurs in up to 25% and 54% of pediatric and adult allo-HCT recipients respectively. V-HC is associated with incapacitating pain, life-disturbing urinary symptoms, and in severe forms, severe hematuria requiring transfusion support, bladder obstruction, renal impairment and increased mortality. At present, management is purely supportive as there are no approved or recommended anti-virals for V-HC. The impact of V-HC on health resource utilization (HRU) and HCT outcomes has not been studied at a national level. The objective of this study was to compare the economic burden, HRU and clinical outcomes among allo-HCT recipients with V-HC to those without V-HC using a large US claims database. Methods: A US claims database obtained from the Decision Resources Group Real World Evidence Data Repository was used to identify patients with first (index) allo-HCT procedure from 1/1/2012-12/31/2017. The 1-year period prior to the index allo-HCT was considered as the baseline period. Although, there are diagnosis codes in the International Classification of Diseases (ICD-9 or ICD-10) coding system for HC, there are no specific diagnosis codes to identify V-HC. Hence, an algorithm was developed through clinical guidance to identify these patients among those with HC diagnosis codes (Figure 1). Outcomes were examined in the 1-year post allo-HCT and included total healthcare reimbursements, HRU and clinical outcomes for allo-HCT patients with vs. without V-HC. Total reimbursements were estimated from submitted charges using a reimbursement-to-charge ratio of 0.425 and were reported in 2019 US dollars, adjusted using the medical care component of the US Consumer Price Index. Further, a generalized linear model was used to determine adjusted reimbursements stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, number of comorbidities, baseline costs, and follow-up time. Results: Of 13,363 allo-HCT recipients, 759 (5.7%) patients met the criteria for V-HC. Total unadjusted mean reimbursement was $632,870 (SD=$640,815) for patients with V-HC and $340,469 (SD=$377,591) for patients without V-HC (Table 1). In multivariable model after adjusting for confounders, the adjusted reimbursements were significantly higher for V-HC patients with and without GVHD compared to patients without V-HC (p<.0001) (Figure 2). V-HC was associated with increased hospital length of stay (LOS) and readmission rates. Patients with V-HC had 7.9 additional days in the hospital (35.5 vs 27.6 days; p<.0001) and 6.1 additional days (34.3 vs. 28.2 days; p=0.0009) in the intensive care unit (ICU) for the index hospitalization, as compared to patients without V-HC (Table 1). The hospital readmission rate was higher for allo-HCT patients with V-HC compared to those without V-HC (3.5 vs. 1.9 per person yr; p<.0001), resulting in 12.9 more days in the hospital (50.0 days vs. 37.1 days; p<.0001) and 7.3 more days in the ICU (25.8 days vs. 18.5 days; p<.0001) after the index hospitalization (Table 1). V-HC was associated with increased mortality in patients with GVHD and increased risk of renal impairment in all allo-HCT patients. Among patients with GVHD, those with V-HC had significantly higher all-cause mortality as compared to those without V-HC (23.2% vs. 18.4%; p=0.0035) (Table 2). When stratified by GVHD, there were no significant differences in the baseline risk for renal impairment; while V-HC was associated with increased risk for renal impairment in the follow-up period in patients with or without GVHD (p<.0001 for both) (Table 2). Conclusions: Allo-HCT patients with V-HC have significantly higher healthcare reimbursements, health resource utilization, and worse clinical outcomes including renal impairment, irrespective of the presence of GVHD; with significantly higher all-cause mortality in the presence of GVHD. Our results highlight the unmet clinical need for effective strategies to prevent and treat V-HC in HCT recipients that may also reduce costs among these patients. Disclosures McGuirk: Pluristem Ltd: Research Funding; Juno Therapeutics: Consultancy, Honoraria, Research Funding; Astellas: Research Funding; Kite Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau; Fresenius Biotech: Research Funding; Novartis: Research Funding; Gamida Cell: Research Funding; Bellicum Pharmaceutical: Research Funding; Allo Vir: Consultancy, Honoraria, Research Funding. Moon:AlloVir, Inc.: Current Employment, Current equity holder in publicly-traded company. Chandak:AlloVir, Inc.: Other: Independent contractor. Zhang:AlloVir, Inc.: Other: Independent contractor. Papanicolaou:Chimerix: Other: Consulting and other fees, Research Funding; Astellas Pharma: Other: Consulting and other fees, Research Funding; Merck & Co.: Other: Consulting and other fees, Research Funding; Octapharma: Other: Consulting and other fees; Partner Therapeutics: Other: Consulting and other fees; ADMA Biologics: Other: Consulting and other fees; Shionogi: Other: Consulting and other fees; Cidara: Other: Consulting and other fees; Amplyx: Other: Consulting and other fees; Siemens: Other; Takeda: Research Funding.
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Kaufman, Brystana, Diane Holland, Catherine Vanderboom, Cory Ingram, Alice Chun, Erica Langan, Henry Baer-Benson e Joan Griffin. "EVALUATING IMPLEMENTATION COSTS FOR A TRANSITIONAL PALLIATIVE CARE INTERVENTION TO SUPPORT RURAL CAREGIVERS". Innovation in Aging 6, Supplement_1 (1 de novembro de 2022): 213. http://dx.doi.org/10.1093/geroni/igac059.850.
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Abstract Compared to urban caregivers, rural caregivers experience greater burdens accessing coordinated care for their loved ones during and after hospital discharge. The impact of technology-enhanced transitional palliative care (TPC) on patient and caregiver outcomes is currently being evaluated in a randomized control trial. This study evaluates resource use and health system costs of this caregiver-focused TPC intervention. Rural caregivers of hospitalized patients in Minnesota, Wisconsin, and Iowa were enrolled in an 8-week intervention consisting of video visits, conducted by a registered nurse, supplemented with phone calls and texts (n=207). Labor costs were estimated using the Bureau for Labor Statistics median hourly rate for a registered nurse and compared to a scenario analysis using a nurse practitioner or social worker wages. Hours spent conducting the visits and charting were calculated using study data. A one-way sensitivity analysis estimated resource use over a range of visits per caregiver and time per visit. Caregivers received 8.8 visits on average over the study period at 45 minutes per visit. In the base case, TPC cost $330 per caregiver facilitated by a registered nurse, compared to $281 and $489 if facilitated by a social worker or nurse practitioner, respectively. The number of visits had the greatest influence on total costs of the intervention (low of $198, high of $463). TPC is a feasible, low cost strategy to enhance caregiver support in rural areas. These results pose an opportunity to consider reimbursement mechanisms to evaluate the sustainability of transitional palliative care interventions to support caregivers.
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Lai, Sheng Jie, T. Wangteeraprasert, T. Sermkaew, O. Nararak, S. Binsard, M. Phanawadee, I. Ieowongjaroen et al. "Evaluation of Three Main Tuberculosis Case Reporting Systems in Satun Province, Thailand, 2011". Outbreak, Surveillance, Investigation & Response (OSIR) Journal 7, n.º 3 (29 de setembro de 2014): 16–23. http://dx.doi.org/10.59096/osir.v7i3.263288.
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Three main tuberculosis (TB) reporting systems were operating in Thailand: notifiable disease surveillance (R506), TB registration and control in Bureau of Tuberculosis (BTB) and TB report for reimbursement in National Health Security Office (NHSO). A cross-sectional study was conducted in Satun Province in July 2011 to determine whether the three systems responded well to the objectives of TB surveillance. Patients diagnosed with TB and received anti-TB drugs at least once in 2010 from three hospitals were compared with TB cases reported in three systems. In the hospitals, 170 TB cases, including 95 new smear positive pulmonary TB cases, were reviewed. Coverage and positive predictive value were 73% and 83% for R506, 87% and 100% for BTB, and 79% and 99% for NHSO respectively. Success rate (82%) of all cases was lower than that was reported in BTB (96%). Median duration from diagnosis to reporting in R506, BTB and NHSO were six, 61 and two days respectively. All systems had sufficient budget, human resources and regular training. In addition, all systems had good capacity to achieve the major objectives of TB surveillance and their specific objectives. However, the systems had total 295 variables which resulted in high workload for reporting. Integrating three systems as one national TB reporting system was recommended to improve coverage, timeliness and success rate.
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Byrne, Jenny, Joanne Ewing, Adam J. Mead, Heather Oakervee, Gavin Campbell, Ian Amott, Andrew Goringe et al. "Sequence of Second Generation Tyrosine Kinase Inhibitors (TKIs) in the Treatment of Patients with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia - Real World Experience in the UK". Blood 134, Supplement_1 (13 de novembro de 2019): 3434. http://dx.doi.org/10.1182/blood-2019-122893.
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Background: The prognosis of patients with chronic-phase myeloid leukaemia (CML) has drastically improved with the introduction of tyrosine kinase inhibitors (TKIs). During the period of this study, availability of treatment options in the UK were limited and determined by the date reimbursement was granted and when restrictions on the use of individual licensed TKIs were removed. Currently, imatinib, nilotinib and dasatinib are reimbursed for 1st line treatment (1L) with bosutinib and ponatinib reimbursed for 2nd line or subsequent lines of treatment. Aims: The primary aim was to determine the sequence of 2nd generation (2G) TKIs (nilotinib, dasatinib, bosutinib) in patients with chronic-phase Philadelphia chromosome-positive (Ph+) CML who had received their 3rd and subsequent lines of TKIs in a real world UK setting. Methods: A multi-centre, retrospective, chart review was undertaken in the UK from November 2018 to July 2019. To be included, patients had to be aged ≥18 with chronic phase Ph+ CML who had started a third line of TKI treatment between June 2013 and February 2018. Patients were excluded if they had >3-month gap in treatment before progression or relapse, or were treated with a 2G TKI within an interventional clinical study during third line treatment. At each line, molecular responses, cytogenetic responses, duration of therapy and reasons for stopping were recorded until the date of last hospital follow-up or death. Overall survival was determined from date of initiation of 3rd or 4th line TKI therapy until death by any cause. Results: An interim analysis was undertaken for 65 patients from 11 sites. Median age at diagnosis was 53.0 years. 50.8% were male and 49.2% were female. Of these 65 patients, 48 patients were still being treated at the end of observation (29 patients in 3rd, 18 in 4th and 1 in 5th line). Patient demographics are typical of CML populations. Throughout the study, imatinib was 1L treatment of choice for the majority of patients (57/65; 88%) and this held true (21/22; 95%) even when nilotinib and dasatinib were reimbursed for use 1L. Nilotinib was most commonly prescribed in 2L (42/65; 56%), reflecting the greater availability of this drug during the study period. Dasatinib and bosutinib constituted 22% and 4% respectively of 2L treatments. The most frequent sequencing pathway observed was I1-N2-D3 (Table 1, Fig. 1). 19 other pathways at low frequencies were observed across 39 patients. 97% of patients (63/65) achieved an optimal response at any time as defined by the 2013 ELN guidelines (Table 2) during the observation period. Of the 31 (48%) patients who were resistant to 1L, 24 (37%) achieved a response in 2L and of the 7 (10.7%) patients who were resistant to 1L and 2L, 5 (7.7%) achieved a response in 3L. At the end of the observation period, only 2 (3%) patients never achieved a response. In 3L: 29 (45%) patients are still ongoing, 4 died, 3 were lost to follow up and 3 underwent transplantation. In 4L: 18 (69%) are still ongoing, 3 died, and 3 underwent transplantation. Median overall survival for L3 was 21 months and 12 months in L4. In all lines of treatment, the main cause of switching away from imatinib was lack of efficacy (61%), and for all 2G TKIs the main cause was intolerance (66%). During the period when only imatinib was available in 1L, median duration of 1L treatment was longer at 26 months for patients failing to respond vs 9 months when nilotinib and dasatinib were also available. Conclusions: In this UK real-world study, for patients requiring 3 or more lines of treatment, sequencing of TKIs may have been determined by drug reimbursement. As availability of TKIs increased, time to switch therapy decreased for all patients, suggesting that clinicians were following guidelines and switching treatments more readily. However, initial 1L prescribing behaviour has not changed in this observation period despite better access to 2G TKI, and there appears to be a trend of physicians preferring to repeat 2G TKIs treatment sequences that yield a favourable outcome. Disclosures Byrne: Ariad/Incyte: Honoraria, Speakers Bureau. Ewing:Novartis: Honoraria, Other: Meeting attendance sponsorship ; Bristol Myers-Squibb: Other: Meeting attendance sponsorship . Mead:Novartis: Consultancy, Honoraria, Other: Travel/accommodation expenses, Research Funding, Speakers Bureau; Bristol Myers-Squibb: Consultancy; CTI: Honoraria, Research Funding; Pfizer: Consultancy; Celgene: Consultancy, Research Funding. Oakervee:Novartis: Honoraria; Pfizer: Honoraria; Bristol Myers-Squibb: Honoraria. Campbell:Novartis: Consultancy, Other: Educational support; Takeda: Consultancy, Other: Educational support; Bristol Myers-Squibb: Other: Educational support; Roche: Other: Educational support; Celgene: Other: Educational support. Amott:Celgene: Other: Meeting attendance sponsorship . Goringe:Novartis: Consultancy, Other: Speaker. Heartin:Celgene: Other: Speaker's fees; Janssen: Other: Speaker's fees; Takeda: Other: Speaker's fees; Alexion: Other: Speaker's fees; Novartis: Other: Speaker's fees. Dimitriadou:Celgene: Other: Meeting attendance sponsorship . Arami:Takeda: Other: Meeting attendance sponsorship ; Gilead: Other: Meeting attendance sponsorship ; Roche: Other: Meeting attendance sponsorship ; Celgene: Other: Meeting attendance sponsorship . Neelakantan:Novartis: Honoraria; Celgene: Honoraria. Frewin:Novartis: Consultancy, Other: Meeting attendance sponsorship ; AbbVie: Other: Meeting attendance sponsorship . Pillai:Celgene: Honoraria. De Lavallade:BMS: Honoraria, Research Funding, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Incyte biosciences: Honoraria, Research Funding, Speakers Bureau. Cross:Novartis: Consultancy, Research Funding; Incyte: Consultancy. Thompson:Incyte: Employment.
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McBride, Ali, e Daniel O. Persky. "Impact of Treatment Sequencing on Outcomes and Costs in Relapsed Follicular or Other Low Grade B-Cell Non-Hodgkin Lymphoma - Results of an Evidence-Based Budget Impact Model". Blood 136, Supplement 1 (5 de novembro de 2020): 14–15. http://dx.doi.org/10.1182/blood-2020-141748.
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Introduction: The choice of initial therapy in follicular lymphoma can be a key determinant in future therapy, as irreversible toxicities with first line regimens can impact the patient's ability to tolerate future treatment. Minimizing drug exposure will result in less frequent occurrence of significant adverse events and associated treatment costs. In the era of COVID-19 pandemic, there is additional benefit to minimizing the number of patient visits and hospital admissions. Limited information exists related to the outcomes and associated costs of existing treatment sequences. Additionally, treatment administration at different types of clinical sites results in varied reimbursement models, making informed evaluation of clinical and financial evidence challenging. Methods: The current study applies a budget impact model methodology in order to describe the associated impact of treatment selection and sequencing on outcomes and costs in the treatment of relapsed or refractory low-grade follicular lymphoma in first line therapy followed by Consolidation and also in first line therapy to second line therapy. Key model inputs included: Number of treatment cycles, number of days a treatment was received, duration of response (DOR), rate of side effects and associated costs, and total treatment costs, including drugs, medical treatment, laboratory testing and adverse event costs. Treatment outcomes were based on the published literature that summarized the overall response rate, median DOR, and toxicity. Treatment regimen costs were evaluated based on payer pricing, Wholesale Acquisition Cost (WAC), Average Selling Price (ASP) and Average Wholesale Price (AWP) and modified to adjust for weight-based dosing and negotiate payer reimbursement rates. Associated medical costs for medical treatment and supportive care were estimated using current Medicare fee schedule rates. Included were seven options for first line therapy of follicular lymphoma from 2020 NCCN Guidelines - (Bendamustine + rituximab (BR); Bendamustine + Obinutuzumab (OB); CHOP rituximab (RCHOP); CHOP + Obinutuzumab (OCHOP); CVP+ rituximab (RCVP); CVP + Obinutuzumab (OCVP); Lenalidomide + rituximab (R2)), followed by three for Consolidation (Rituximab maintenance (RM); Obinutuzumab maintenance (O); Radioimmunotherapy (RIT with 90 Y-ibritumomab tiuxetan (Y90-IT, Zevalin)) and three Second Line therapy options (RIT; Lenalidomide only; Lenalidomide + Obinutuzumab (LO)). Results: The treatment sequence of first line BR followed by Consolidation with RIT Y90 (Zevalin) had the longest predicted DOR (2586 days). The associated treatment sequence costs were $212,485 for BR followed by Y90-IT, compared with $233, 388 for BR followed by rituximab maintenance, which had a predicted DOR of 2478 days. The predicted DOR for treatment sequences starting with OCHOP, OCVP and RCHOP and followed by RIT with Y90-IT was approximately 1000 days less than BR followed by Y90-IT for a cost difference of $4,421, $12,914 and $25,826, respectively. The treatment sequence of first line BR followed by Second Line RIT Y90-IT had the second longest predicted DOR of 2586 days at costs of $212,485, compared to 2778 days for BR followed by LO, at a total sequence costs of $796,695. Conclusion: The use of Y90-IT in Consolidation or Second Line treatment demonstrated desired patient outcomes at one of the lowest cost profiles. Additionally, Y90-IT administration can be completed in only two clinic visits, reducing patient travel and contact, improving safety in an era of COVID-19 precautionary measures and reducing cost. Figure 1. Duration of Response and Total Sequence Costs for Twelve First Line to Consolidation and First Line to Second Line Treatment Regimens. Disclosures McBride: Merck: Speakers Bureau; Coherus BioSciences: Consultancy, Speakers Bureau; Pfizer: Consultancy; Bristol-Myers Squibb: Consultancy; MorphoSys: Consultancy; Sandoz: Consultancy.
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Xie, Jing, Alan Yong, Catherine Waweru, Thuy Anh Sorof, Ravi K. Goyal, Keith L. Davis, George Follows e Peter Hillmen. "Real-World Treatment Patterns and Adverse Events in Patients with Chronic Lymphocytic Leukemia Treated with Ibrutinib in the UK: A Preliminary Analysis". Blood 134, Supplement_1 (13 de novembro de 2019): 5885. http://dx.doi.org/10.1182/blood-2019-123025.
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Introduction: Bruton tyrosine kinase (BTK) is a critical component of the B-cell receptor pathway, and is a validated target for the treatment of chronic lymphocytic leukemia (CLL). Ibrutinib is a first-generation, covalent, small molecule BTK inhibitor approved for the treatment of CLL. We present a preliminary analysis of treatment patterns and adverse events (AEs) in patients with CLL treated with ibrutinib in a real-world setting. Methods: A retrospective chart review is being conducted among patients diagnosed with CLL and treated with ibrutinib in oncology centers throughout the UK; the target sample size for the study is 250 patients. Patients are eligible if they initiated ibrutinib after diagnosis of CLL, between January 2017 and June 2018, with at least 12 months of follow-up data available, with the exception that patients who died less than 12 months after ibrutinib initiation remained eligible. Hematology/oncology physicians reviewed medical records and completed web-based data collection forms. Baseline medical history information and data on treatment characteristics and AEs were collected. By June 2019, a total of 151 medical records (60% of the target sample size) had been abstracted. All analyses were descriptive in nature and were performed in SAS v9.4 or later (Cary, NC, USA). Results: Twenty-two physicians from specialist cancer centers or tertiary referral treatment centers (45.5%), teaching hospitals (31.8%) and non-teaching hospitals (22.7%) submitted data on ibrutinib-treated patients. The median follow-up for this interim sample of 151 patients was 16.1 months (range: 2.8-27.5 months) from ibrutinib initiation (index date) and 61.7 months (range: 11.6-264.1 months) from initial CLL diagnosis (Table 1). Median age was 71 years, 56% were male, 22.5% of patients had del(17p) mutation and 24.5% had TP53 mutations/aberrations. Of the 151 patients, 24.5% (n=37) initiated ibrutinib as first-line therapy while 75.5% (n=114) initiated ibrutinib as second- or later-line treatment. Median time to initiation of ibrutinib was 3.8 months (range: 0.3-123.7 months) for first-line therapy after initial CLL diagnosis and 22.3 months (range: 0.2-242.2 months) for second-line therapy after end of first-line therapy. Other therapies that patients received besides ibrutinib included the combination of fludarabine, cyclophosphamide, and rituximab (first-line, 22.5%; second-line, 1.7%), bendamustine plus rituximab (first-line, 19.9%; second-line, 15.5%), and chlorambucil plus rituximab (first-line, 10.6%; second-line, 1.7%). The most common AEs observed during ibrutinib therapy were bruising (19.9%), cytopenias (18.5%), diarrhea (15.2%), and arthralgia (11.3%) (Table 2). Conclusion: This preliminary analysis describes patient characteristics and treatment patterns in ibrutinib-treated patients in the UK. We found that the majority of ibrutinib use was in the second-line or later, reflecting the current UK public reimbursement situation. AEs such as bruising and cytopenias were commonly reported in patients treated with ibrutinib, and future analyses from this study will determine how these AEs and others affect dosing, treatment discontinuation and healthcare resource utilization. Disclosures Xie: AstraZeneca: Employment. Yong:AstraZeneca: Employment, Equity Ownership. Waweru:AstraZeneca: Employment, Equity Ownership. Sorof:Acerta Pharma: Employment. Goyal:RTI Health Solutions: Employment. Davis:RTI Health Solutions: Employment. Follows:Roche: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Abbvie: Consultancy, Honoraria, Speakers Bureau; AstraZeneca: Consultancy, Honoraria, Speakers Bureau. Hillmen:Apellis: Research Funding; Gilead: Research Funding; Roche: Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses, Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding; Acerta: Membership on an entity's Board of Directors or advisory committees.
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Shi, Jianwei, Rui Liu, Hua Jiang, Chunxu Wang, Yue Xiao, Nana Liu, Zhaoxin Wang e Leiyu Shi. "Moving towards a better path? A mixed-method examination of China’s reforms to remedy medical corruption from pharmaceutical firms". BMJ Open 8, n.º 2 (fevereiro de 2018): e018513. http://dx.doi.org/10.1136/bmjopen-2017-018513.
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ObjectivesFew studies have systematically examined the effects of the existing regulations for alleviating corruption in China. This study assesses the effectiveness of China’s reforms to curb medical corruption.MethodsWe used mixed methods for the evaluation of existing countermeasures. First, qualitative informant interviews based on the Donabedian model were conducted to obtain experts’ evaluation of various kinds of countermeasures. Second, using data from ‘China Judgements Online’, we analysed the trend of occurrence and the characteristics of the medical corruption cases in recent years to reflect the overall effects of these countermeasures in China.ResultsSince 1990s, China has implemented three main categories of countermeasures to oppose medical corruption: fines and criminal penalties, health policy regulations, and reporting scheme policy. Information from the interviews showed that first the level of fines and criminal penalties for medical corruption behaviours may not be sufficient. Second, health policy regulations are also insufficient. Although the National Reimbursement Drug List and Essential Drug List were implemented, they were incomplete and created additional opportunities for corruption. Moreover, the new programme that centralised the purchase of pharmaceuticals found that most purchasing committees were not independent, and the selection criteria for bidding lacked scientific evidence. Third, the reporting scheme for commercial bribery records by the health bureau was executed poorly. In addition, quantitative online data showed no obvious decrease of institutional medical corruption in recent years, and most criminals have been committing crimes for a long time before getting detected, which further demonstrated the low effectiveness of the above countermeasures.ConclusionsAlthough existing countermeasures have exerted certain effects according to Chinese experts, more rigorous legislation and well-functioning administrative mechanisms are needed. Fundamentally, financial incentives for hospitals/physicians and the health insurance system should be improved.
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Sharman, Jeff P., John M. Burke, Habte A. Yimer, Michael A. Boxer, Sunil Babu, Jia Li, Yong Mun e Alexey Danilov. "Final Results from the Multicenter, Open-Label, Phase II GIBB Study of Obinutuzumab+Bendamustine in Previously Untreated Patients with Chronic Lymphocytic Leukemia". Blood 134, Supplement_1 (13 de novembro de 2019): 4317. http://dx.doi.org/10.1182/blood-2019-122482.
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Background: Bendamustine+rituximab (BR) is an effective chemoimmunotherapy for newly diagnosed chronic lymphocytic leukemia (CLL) and is the most commonly used chemoimmunotherapy in CLL patients requiring therapy (Seymour et al. Cancer. 2019). In a phase III study, the anti-CD20 antibody obinutuzumab (G) showed improved survival in combination with chlorambucil (clb) compared with rituximab (R)+clb, suggesting that G may be a better anti-CD20 monoclonal antibody to combine with bendamustine (B). Here, we report the final study results for the phase II, single-arm, open-label GIBB study (NCT02320487), in which the combination of bendamustine+obinutuzumab (BG) was evaluated in previously untreated patients with CLL. This is also one of the first studies to characterize the evolution of minimal residual disease (MRD) status over time in previously untreated CLL patients receiving chemoimmunotherapy. Methods: Newly diagnosed patients requiring treatment for CLL had ECOG PS 0-2, and adequate cell counts and organ function. BG treatment was given IV over six 28-day (d) cycles and included obinutuzumab (cycle 1: 100 mg d1, 900 mg d2, and 1000 mg on d8 and d15, and cycles 2-6: 1000 mg d1 of each cycle) plus bendamustine (90 mg/m2 cycle 1: d2 and d3; and cycles 2-6: d1 and d2). The primary end point was complete response (CR), including CR and incomplete CR (CRi), per 2008 iwCLL guidelines after induction treatment. Secondary end points included progression-free survival (PFS) and overall survival (OS). MRD negativity (MRD−) was defined as < 1 cell per 10,000 leukocytes (ie, 10−4) and was measured at baseline, end of treatment (28 d after cycle 6), clinical response assessment, and every 6 months thereafter for ≤ 2 years. Results: Overall, 102 patients were enrolled on this study. Patients had a median age of 61 years (range, 35-90), and 97% had ECOG PS of 0-1. Of 74 patients evaluated for IgVH status, 49 patients (66%) had unmutated IgVH. Overall, 79% of patients completed 6 cycles of BG. 50% of patients achieved a CR/CRi (95% CI, 40%-60%), which contributed to an 89% overall response rate (95% CI, 82%-95%). At a median follow-up of 34.3 mo, median PFS was 35.5 mo (95% CI, 35.0 mo to not reached) and median OS was not reached (Figure 1). Seven patients died during the study (3 from cardiac events not attributed to treatment by investigators and 4 from other non-progressive disease causes). The most common grade 3/4 treatment-emergent adverse events (> 5%) were neutropenia (25%), infusion-related reactions (9%), anemia (8%), thrombocytopenia (8%), pneumonia (6%), and tumor lysis syndrome (6%). The rate of grade 3/4 febrile neutropenia was 5%. Achievement of MRD− in evaluable peripheral blood and bone marrow at the clinical response assessment was shown in 33/74 (45%; 95% CI, 33%-57%) and 30/51 (59%; 95% CI, 44%-72%) patients, respectively. In the 79 patients (77%) who achieved MRD− in peripheral blood throughout the study, the median duration of MRD− response was 28.9 mo (95% CI, 23.0 to not reached). Of these 79 MRD− patients, 28 became MRD+, and the median time from identification of MRD+ status to progressive disease/death was 10.5 mo (95% CI, 6.3-17.9). An exploratory Cox proportional multivariate analysis identified 2 factors that were significantly associated with longer durations of MRD− responses: mutated (vs unmutated) IgVH with a HR = 0.13 (95% CI, 0.03-0.61), and CD38 ≥ 30% (vs < 30%) with a HR = 0.35 (95% CI, 0.14-0.92). When stratified by IgVH status, the PFS distributions for IgVH mutated and unmutated groups were similar (Figure 1). Median OS was not reached in all patients and irrespective of IgVH status. Conclusions: Final results for the GIBB study showed that the BG combination was an effective regimen for previously untreated patients with CLL, with no unexpected safety signals. Complete response and MRD− in peripheral blood were achieved in approximately half of all patients after induction treatment and persisted over time. IgVH mutated status was associated with a longer duration of MRD− and median PFS. In summary, BG is a clinically active CLL regimen with durable MRD− rates over time; overall outcomes are consistent with other firstline studies of anti-CD20 antibody and bendamustine combinations. Disclosures Sharman: Janssen: Consultancy, Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding; Genentech: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; TG Therapeutics: Consultancy, Honoraria, Research Funding; Acerta: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding. Burke:Celgene: Consultancy; Gilead: Consultancy; Roche/Genentech: Consultancy. Yimer:Amgen: Consultancy; Puma Biotechnology: Equity Ownership; Clovis Oncology: Equity Ownership; Celgene: Honoraria; Seattle Genetics: Honoraria; Janssen: Speakers Bureau; AstraZeneca: Speakers Bureau. Boxer:Rigel: Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Arizona Oncology: Employment; Incyte: Speakers Bureau; Gerson Lerman: Consultancy; Best Doctors: Consultancy; Abbvie: Honoraria, Speakers Bureau. Babu:Fort Wayne Medical Oncology & Hematology: Employment; Bristol Myers Squibb: Consultancy, Research Funding; Fort Wayne Medical Oncology & Hematology: Equity Ownership; Abbvie: Research Funding; Eli Lilly: Honoraria, Research Funding; Pfizer: Research Funding; Genentech: Research Funding; Janssen: Research Funding; Alexion: Honoraria, Research Funding, Speakers Bureau; Novartis: Research Funding; Incyte: Research Funding; AstraZeneca: Honoraria; Lutheran Hospital, Fort Wayne, Indiana: Membership on an entity's Board of Directors or advisory committees. Li:Roche: Equity Ownership; Genentech: Employment. Mun:Genentech: Employment, Equity Ownership. Danilov:Curis: Consultancy; Verastem Oncology: Consultancy, Other: Travel Reimbursement , Research Funding; Abbvie: Consultancy; Bristol-Meyers Squibb: Research Funding; MEI: Research Funding; Seattle Genetics: Consultancy; Janssen: Consultancy; Aptose Biosciences: Research Funding; Takeda Oncology: Research Funding; AstraZeneca: Consultancy, Research Funding; Pharmacyclics: Consultancy; Gilead Sciences: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; TG Therapeutics: Consultancy; Bayer Oncology: Consultancy, Research Funding; Celgene: Consultancy. OffLabel Disclosure: Yes, this was an investigational clinical study of the combination therapy of obinutuzumab and bendamustine in previously untreated patients with chronic lymphocytic leukemia.
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Abe, M. A. "Hospital Reimbursement Schemes". Medical Care 23, n.º 9 (setembro de 1985): 1055–66. http://dx.doi.org/10.1097/00005650-198509000-00004.
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Foulon, Stephanie, Pascale Cony-Makhoul, Agnes Guerci-Bresler, Marc Delord, Eric Solary, Alain Monnereau, Julia Bonastre e Pascale Tubert Bitter. "Using Healthcare Claims Data to Analyze the Prevalence of Chronic Myeloid Leukemia in France: A Nationwide Population-Based Study". Blood 132, Supplement 1 (29 de novembro de 2018): 3015. http://dx.doi.org/10.1182/blood-2018-99-111489.
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Abstract Background: In France, as in many other countries, nationwide data on prevalence are rarely available and recent prevalence estimates of Chronic Myeloid Leukemia (CML) are scarce. Improved overall survival following the introduction of tyrosine kinase inhibitors (TKIs) is expected to have increased the prevalence of CML in Western countries. Aim: We sought to estimate and analyze the prevalence of CML in France for the year 2014 using a large health care claim-based dataset. Methods: Using the French national health insurance database that covers 98.8% of the French population (66 million people) we implemented a 3-step approach. First, focusing on the 2006-2014 period, we selected: 1) all patients treated with a TKI (ie, imatinib, dasatinib, nilotinib, bosutinib or ponatinib) and/or 2) identified by the ICD-10 diagnosis code C92.1 (Chronic Myeloid Leukemia, BCR/ABL-positive) among hospital discharge diagnoses and/or 3) identified by the ICD-10 diagnosis code C92 (myeloid leukemia) for coinsurance exemption. Then, we developed a claim-based algorithm to identify CML cases. Case definition was based on 1) identifying any TKI reimbursement lasting ≥ 2 months and 2) excluding patients receiving TKIs for diseases other than CML including Phi+ Acute Lymphoblastic Leukemia, Gastrointestinal Stromal Tumor, Stromal or other connective tissue tumor, and hypereosinophilic disease. Finally, prevalent CML cases were those identified by the algorithm above and having ≥ 1 healthcare reimbursement during the year 2014 and still alive on December, 31st 2014. The internal validity of the algorithm was tested on a random sample of 100 potential CML cases fulfilling ≥ 1/3 selection criteria in step 1 by comparing the results of the algorithm with the opinion of two hematologists (gold standard). For each individual, hematologists reviewed patient demographics and the sequence of care from 2006 to 2014 including healthcare resource utilization (ie, all hospitalizations and ICD-10 diagnosis codes, all medication use, all specialist consultations with date and specialist type). In addition, we assessed the external validity of the algorithm by comparing the number of incident CML patients in 2014 as identified in the French national health insurance database with the number of incident CML cases recorded in the French cancer registries for respective departments (i.e. ~ 20% of the French territory). Results: There were 10,789 prevalent CML cases in 2014 out of 68,067 individuals from the French national health insurance database who fulfilled the selection criteria for the overall 2006-2014 period. Eighty-nine percent of the prevalent CML cases were identified by at least two out of three selection criteria (TKI, ICD-10 code C92.1 among hospital discharge diagnoses, ICD-10 code C92 for coinsurance exemption). There was a 96% concordance rate (internal validity) between the algorithm and the opinion of the hematologists. For the year 2014, 162 and 150 incident CML patients were identified by the algorithm and the French cancer registries, respectively (high external validity). Median age [Inter-Quartile Range] of the prevalent population of CML patients was 63 years [51-73], with slightly more males affected (55%). On December, 31st 2014, the crude prevalence of CML was estimated at 16.3 per 100,000 inhabitants [95% confidence interval (CI) 16.0-16.6]. The crude prevalence of CML was 18.5 per 100,000 in men (95% CI 18.0-19.0) and 14.2 per 100,000 in women (95% CI 13.8-14.6). The crude prevalence of CML was less than 1.6 per 100,000 (95% CI 1.2-2.0) before 20 years of age, progressively increasing to 19.4 per 100,000 (95% CI 18.1-20.7) among those with 50-54 and reaching a peak of 48.2 per 100,000 (95% CI 45.3-51.1) at 75-79 years. There was a male preponderance in CML prevalence in all age groups. The crude prevalence of CML varied in a ratio of one to two throughout the French territory (from 10.2 to 23.8 per 100,000 inhabitants). Conclusion: Healthcare claims data are increasingly used to estimate epidemiological parameters worldwide. This approach is particularly relevant for rare diseases and administrative databases with high population coverage. Countries without national cohorts or cancer registries could easily use our algorithm to estimate their prevalence of CML. Disclosures Cony-Makhoul: Pfizer: Consultancy; BMS: Consultancy, Speakers Bureau; Incyte: Other: Travels for attending to Congress; Novartis: Consultancy, Other: Writing support, Travels for attending to Congress. Guerci-Bresler:Pfizer: Other: Fees for symposiums and boards; Novartis: Consultancy, Other: Fees for symposiums and boards; Incyte: Other: Fees for symposiums and boards; BMS: Other: Fees for symposiums and boards; Pfizer: Other: Travel fees for Congress. Delord:Incyte: Consultancy.
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Welton, John M., e Kathy Harris. "Hospital Billing and Reimbursement". JONA: The Journal of Nursing Administration 37, n.º 4 (abril de 2007): 164–66. http://dx.doi.org/10.1097/01.nna.0000266846.77178.23.
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&NA;. "Changes in Hospital Reimbursement". Obstetric Anesthesia Digest 10, n.º 3 (outubro de 1990): 123. http://dx.doi.org/10.1097/00132582-199010000-00002.
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Begum, J., e M. Nisar. "POS1200-HPR IL-17 OR TNF INHIBITORS - REAL WORLD IMPACT OF SHARED DECISION MAKING IN A NURSE LED BIOLOGICS SERVICE". Annals of the Rheumatic Diseases 82, Suppl 1 (30 de maio de 2023): 932.2–933. http://dx.doi.org/10.1136/annrheumdis-2023-eular.920.
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BackgroundSince the availability of anti TNF biosimilars and the push from reimbursement panels to use them first line, real world data regarding therapeutic choice in biologic naive population is sparse.ObjectivesEvaluate the reasons for nurse led service choosing IL17 antagonists in biologic naïve SpA patients, in a shared decision making model, despite the availability of cheaper anti TNF biosimilar.MethodsWe conducted a retrospective analysis of our electronic register for people with PsA and AS from 1994 up to and including April 2022 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. All patients were evaluated in biologics service led by clinical specialist nurses.ResultsPsA.90 patients were prescribed Secukinumab since its availability in the UK. Mean age was 51 yrs (24-80) and 56 (62%) were women. All were prescribed since the adoption of Adalimumab biosimilar. Median duration of therapy was 551 days (62-1284). Mean TJC and SJC were 8.14 (1-64) and 3.15 (1-57) at initiation which improved at six months to 6.28 (1-46) and 2.77 (1-18) respectively. 24 (27%) were biologic naïve; 18 had it for better efficacy (six had axial disease, four with enthesitis and eight with concomitant moderate to severe psoriasis) and six for relative anti TNF contraindications including three with treated solid organ neoplasms, one with BMI>35 and two for concurrent chronic infections including HIV.AS.47 patients were prescribed Secukinumab. Mean age was 54 (27-79) and half were women. Median duration of therapy was 679 days (51-1154). Mean BASDAI was 3.3 (0-9.2) at initiation which improved to 2.1 (0-7.5). 11 (23%) were biologic naïve; five had it for better efficacy and six for relative anti TNF contraindications including three with treated cancers, two with latent TB and one for MS.ConclusionTo our knowledge this is the first dedicated retrospective review of a large real world spondyloarthritis cohort evaluating reasons for biologic choice. Nearly a quarter of patients were prescribed Secukinumab prior to cheaper adalimumab biosimilar despite it being commissioned first choice agent in the region. Clinicians including nurse specialists chose it for better efficacy in various SpA domains. Relative contraindication to anti TNF drugs, which would not have been considered significant in the past, was the second reason. Efficacy and safety outcomes were comparable to other biologics. This confirms that shared decision making process demands flexibility and limiting choice goes against clinical acumen and patient preference. Opting only for lower drug acquisition tariff is unlikely to be cost effective as the disease progresses whilst patients struggle with inappropriate prescription and thus delay biologics which are more likely to be efficacious and retained longer. Hence there is an urgent need to review prescribing guidelines to allow earlier employment of appropriate advanced therapies in the treatment paradigm with significant benefits to both patients and the health economy.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsJulie Begum: None declared, Muhammad Nisar Speakers bureau: Novarti.s.
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Chanan-Khan, Asher, Paula Cramer, Fatih Demirkan, Graeme Fraser, Rodrigo Santucci Silva, Halyna Pylypenko, Sebastian Grosicki et al. "Insights into the Management of Adverse Events in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Experience from the Phase 3 HELIOS Study of Ibrutinib Combined with Bendamustine/Rituximab". Blood 126, n.º 23 (3 de dezembro de 2015): 2936. http://dx.doi.org/10.1182/blood.v126.23.2936.2936.
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Abstract Introduction Ibrutinib has become a new standard of care in patients with previously treated CLL/SLL based on the phase 3 RESONATE study (Byrd, et al. NEJM 2014) and other trials evaluating ibrutinib mainly as a single agent in CLL. The first randomized, double-blind, placebo-controlled phase 3 study (HELIOS) investigating ibrutinib in combination with bendamustine and rituximab (BR) was recently reported (Chanan-Khan, et al. ASCO 2015), with ibrutinib significantly extending progression-free survival and reducing the risk of progression/death by 80%. The study design provides an opportunity to examine the overall safety and management of adverse events (AEs) with ibrutinib and placebo in a blinded manner that previously has not been possible. Here we examine the safety and management of AEs with ibrutinib + BR vs placebo + BR in HELIOS. Methods Patients with active CLL/SLL following ≥ 1 prior line of systemic therapy were randomized 1:1 to receive BR (≤ 6 cycles) with either ibrutinib 420 mg daily or placebo (n = 289 in each group). Safety was a secondary end point. Results Median exposure to ibrutinib and placebo was 14.7 and 12.8 months, respectively. Rates of infection in the ibrutinib + BR and placebo + BR arms were similar (all-grade, 70.4%; grade ≥ 3, 26.8% vs all-grade, 70.0%; grade ≥ 3, 22.6%, respectively) but exposure-adjusted analysis reveals an overall lower rate of infections with ibrutinib + BR vs placebo + BR (10.3/100 vs 11.2/100 patient-months), with similar rates of grade ≥ 3 infections (2.4/100 patient-months each arm). Rates of all-grade (grade 3/4) anemia were 22.3% (3.5%) with ibrutinib + BR and 28.9% (8.0%) with placebo + BR. Patients also required fewer transfusions with ibrutinib + BR (23%) vs placebo + BR (29%), the majority of which were red blood cell transfusions. Similar proportions of patients used growth factors in both arms (54% vs 52%, respectively). Grade 3/4 neutropenia was reported at similar rates in both arms (53.7% vs 50.5%, respectively); however, fewer patients discontinued due to treatment-related neutropenia with ibrutinib + BR (1.0%) vs placebo + BR (2.8%). Rates of thrombocytopenia were slightly higher with ibrutinib + BR (30.7%) than placebo + BR (24.0%), but rates of grade 3/4 events were similar between arms (15.0% each arm). Atrial fibrillation (AF) was observed more frequently in patients on ibrutinib + BR than placebo + BR (7.3% vs 2.8% overall and 2.8% vs 0.7% grade 3/4, respectively). However, only 4 patients with grade 3/4 AF discontinued therapy in the ibrutinib arm. No patients with grade 1/2 AF discontinued treatment. One-third of patients held ibrutinib treatment to manage AF, with all restarting at the same dose (420 mg). Median (range) time to onset was 3.0 (0.3-17.5) months with ibrutinib + BR and 2.4 (0.6-18.9) months with placebo + BR. Importantly, in those with a prior history of AF or abnormal heart rhythm, only 7/25 receiving ibrutinib + BR and 2/22 receiving placebo + BR developed AF/atrial flutter on study. The rates of any-grade bleeding were 31.0% and 14.6%, respectively, with the majority being grade 1 (77.5% and 69.0%, respectively). Low rates of grade 3/4 major bleeding were observed in the ibrutinib + BR (2.1%) and placebo + BR (1.7%) arms. Many patients (41.8% ibrutinib + BR, 41.1% placebo + BR) were receiving concomitant anticoagulant/antiplatelet medication. A low rate of treatment-related lymphocytosis was observed in both arms (7.0% ibrutinib + BR, 5.9% placebo + BR). The majority of cases resolved within 2 weeks. Conclusions In this randomized, double-blind, placebo-controlled trial, the addition of ibrutinib to BR was well tolerated and did not significantly impact the safety profile of BR. In addition, ibrutinib was associated with reduced rates of anemia and transfusional support. Consistent with its known toxicity profile, patients in the ibrutinib + BR arm had higher rates of bleeding (mostly grade 1 or 2) and AF; however, few patients discontinued therapy as a result of these AEs. A prior history of AF or abnormal heart rhythm did not lead to recurrent episodes in the majority of cases. Taken together, the results from HELIOS establish the significant efficacy of ibrutinib and also the overall positive risk-benefit profile of ibrutinib + BR. Disclosures Cramer: Janssen: Other: Travel grant, Research Funding, Speakers Bureau; Hoffman LaRoche: Other: Travel grant, Research Funding, Speakers Bureau; Astellas: Other: Travel grant; Glaxo Smith Klein/Novartis: Research Funding; Gilead: Other: Travel grant, Research Funding; Mundipharma: Other: Travel grant. Demirkan:Celgene: Other: Travel reimbursement; Amgen: Consultancy. Fraser:Hoffman LaRoche: Consultancy, Honoraria; Janssen: Honoraria, Research Funding, Speakers Bureau; Celgene: Honoraria, Research Funding. Santucci Silva:Janssen: Other: Travel reimbursement, Research Funding; GSK: Research Funding; Celgene: Research Funding; Merck: Research Funding; Novartis: Other: Travel reimbursement; Hoffman LaRoche: Other: Travel reimbursement, Research Funding. Janssens:Roche: Consultancy, Speakers Bureau; Mundipharma: Speakers Bureau; Janssen: Consultancy. Goy:Allos, Biogen Idec, Celgene, Genentech, and Millennium. Gilead: Speakers Bureau; Celgene: Consultancy, Research Funding, Speakers Bureau. Mayer:Janssen: Research Funding. Dilhuydy:Roche: Honoraria, Other: Travel reimbursement; Janssen: Honoraria, Other: Travel reimbursement; Mundipharma: Honoraria. Bartlett:Medimmune: Research Funding; Novartis: Research Funding; Pfizer: Research Funding; Genentech: Research Funding; ImaginAB: Research Funding; Astra Zeneca: Research Funding; Pharmacyclics: Research Funding; Janssen: Research Funding; Gilead: Consultancy; Seattle Genetics: Consultancy, Research Funding; Millenium: Research Funding; Celgene: Research Funding. Rule:Roche: Consultancy, Other: Travel reimbursement; Gilead: Research Funding; Celgene: Consultancy, Other: Travel reimbursement; J&J: Consultancy, Other: Travel reimbursement, Research Funding. Sun:Janssen/J&J: Employment, Equity Ownership. Phelps:Janssen/J&J: Employment, Equity Ownership. Mahler:Janssen: Employment, Other: Travel reimbursement. Salman:Janssen/J&J: Employment, Equity Ownership. Howes:Janssen/J&J: Employment, Equity Ownership. Hallek:AbbVie: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Roche: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Gilead: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Pharmacyclics: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Celgene: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Boehringher Ingelheim: Honoraria, Other: Speakers Bureau and/or Advisory Boards; Mundipharma: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Janssen: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding.
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Cramer, Paula, Asher Chanan-Khan, Graeme Fraser, Fatih Demirkan, Rodrigo Santucci Silva, Halyna Pylypenko, Sebastian Grosicki et al. "Improvement of Quality of Response with Ibrutinib Plus Bendamustine/Rituximab Vs Placebo Plus Bendamustine/Rituximab for Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)". Blood 126, n.º 23 (3 de dezembro de 2015): 2938. http://dx.doi.org/10.1182/blood.v126.23.2938.2938.
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Abstract Introduction Recent results from the HELIOS phase 3 study in relapsed/refractory CLL/SLL demonstrated that the addition of ibrutinib to chemoimmunotherapy with bendamustine/rituximab (BR) leads to an 80% reduction in risk of progression or death compared with placebo + BR (Chanan-Khan et al. ASCO 2015). In addition to prolongation of progression-free survival (PFS; median not reached vs 13.3 months; hazard ratio: 0.203, 95% confidence interval: 0.150-0.276, p<0.0001), overall response rate (ORR) and rates of complete response (CR) or CR with incomplete marrow recovery (CRi) were significantly improved with ibrutinib + BR (ORR: 82.7% vs 67.8%; CR/CRi: 10.4% vs 2.8%). Here we report additional analyses on the quality of response with ibrutinib combined with BR. Methods In total, 578 patients (pts) with relapsed/refractory CLL/SLL requiring treatment were randomized 1:1 (289 per arm) to receive BR (≤ 6 cycles) with either ibrutinib (420 mg daily) or placebo. Purine analog refractoriness (yes vs no) and number of prior therapies (1 vs > 1) were stratification factors. Pts with deletion 17p (del17p; > 20% of cells) were excluded. All pts were required to have ≥ 1 abnormal lymph node (LN; defined as a measurable lesion > 1.5 cm). The primary end point was independent review committee (IRC)-assessed PFS. In this analysis, individual parameters of response (LN, spleen, overall radiology, absolute lymphocyte count [ALC], complete blood count [CBC], and bone marrow [BM]) were evaluated. Minimal residual disease (MRD) was assessed by flow cytometry using an 8-color panel (Rawstron AC, et al. Leukemia. 2007;21:956-964); MRD samples were collected at confirmation of suspected CR (bone marrow) and every 3 months thereafter (peripheral blood). Rate of MRD-negative response was defined as the proportion of pts who reached negative disease status (< 0.01%, ie, < 1 CLL cell/10,000 leukocytes) in any sample. Reported MRD rates are based on the intent-to-treat (ITT) population. Results The ORR assessed by the IRC was 82.7% with ibrutinib + BR vs 67.8% with placebo + BR (p < 0.0001), and was consistent with ORR reported by the treating physician (investigator assessed) (ORR: 86.2% vs 68.9%, p < 0.0001). However, rates of CR/CRi were higher by investigator assessment (21.4%, ibrutinib + BR vs 5.9%, placebo + BR) than IRC (10.4% vs 2.8%). The IRC employed an independent evaluation of radiological scans including stringent evaluation of LN and volumetric assessment of spleen size-the main reasons for the difference in CR/CRi rates between investigator and IRC assessment. At baseline, similar proportions of pts in each arm had bulky disease defined as LN > 5 cm (54%-58%) or abnormal spleen (~40%) as assessed by IRC. Complete resolution of previous CLL/SLL manifestations as assessed by the IRC was achieved more often in the ibrutinib + BR arm in comparison with placebo + BR for LN (34.6% vs 15.2%), spleen (56.7% vs 37.0%), overall radiology (21.1% vs 9.0%), and BM (19.7% vs 5.9%). Rates of normalization of ALC (> 90%) and CBC (> 70%) were high and similar in the 2 arms. MRD was assessed in 120 pts treated with ibrutinib + BR and 57 pts treated with placebo + BR and was negative in 37 pts and 14 pts, respectively, which corresponds with an MRD-negative response rate of 12.8% vs 4.8% for ibrutinib + BR vs placebo + BR (p = 0.0011). Investigator-determined responses by different levels of MRD are shown in Table 1. The percentage of pts with an MRD level < 1% was higher with ibrutinib + BR vs placebo + BR (32.2% vs 11.8%). Moreover, the percentage of pts with an MRD level < 0.1% was higher for ibrutinib + BR vs placebo + BR (24.6% vs 7.6%) suggesting that the depth of response with ibrutinib + BR was superior. Kaplan-Meier plots by MRD level (Figure 1) show that a lower MRD level was associated with a longer PFS. However, pts in the ibrutinib + BR arm had a more sustained response at every MRD level compared with pts in the placebo + BR arm. Conclusions Pts treated with ibrutinib + BR showed not only a higher ORR, but also a greater depth of response, with more CRs and a higher rate of resolution of LN, spleen, and BM involvement. Furthermore, the rate and depth of MRD negativity was improved, and appeared to last longer in pts treated with ibrutinib + BR compared with pts receiving placebo + BR. With a median follow up of 17 months in the ibrutinib + BR arm, no MRD-negative pts and few MRD-positive pts had progressed, thus evaluating a trend in PFS with MRD negativity is currently limited in this arm. Disclosures Cramer: Gilead: Other: Travel grant, Research Funding; Glaxo Smith Klein/Novartis: Research Funding; Astellas: Other: Travel grant; Mundipharma: Other: Travel grant; Janssen: Other: Travel grant, Research Funding, Speakers Bureau; Hoffman LaRoche: Other: Travel grant, Research Funding, Speakers Bureau. Off Label Use: Combination of bendamustine, obinutuzumab and ibrutinib for treatment of CLL. Fraser:Hoffman LaRoche: Consultancy, Honoraria; Janssen: Honoraria, Research Funding, Speakers Bureau; Celgene: Honoraria, Research Funding. Demirkan:Amgen: Consultancy; Celgene: Other: Travel reimbursement. Santucci Silva:Merck: Research Funding; Celgene: Research Funding; GSK: Research Funding; Janssen: Other: Travel reimbursement, Research Funding; Hoffman LaRoche: Other: Travel reimbursement, Research Funding; Novartis: Other: Travel reimbursement. Janssens:Mundipharma: Speakers Bureau; Roche: Consultancy, Speakers Bureau; Janssen: Consultancy. Goy:Allos, Biogen Idec, Celgene, Genentech, and Millennium. Gilead: Speakers Bureau; Celgene: Consultancy, Research Funding, Speakers Bureau. Mayer:Janssen: Research Funding. Dilhuydy:Roche: Honoraria, Other: Travel reimbursement; Janssen: Honoraria, Other: Travel reimbursement; Mundipharma: Honoraria. Bartlett:Millenium: Research Funding; Medimmune: Research Funding; Novartis: Research Funding; Pfizer: Research Funding; Genentech: Research Funding; ImaginAB: Research Funding; Astra Zeneca: Research Funding; Pharmacyclics: Research Funding; Janssen: Research Funding; Gilead: Consultancy; Seattle Genetics: Consultancy, Research Funding; Celgene: Research Funding. Rule:Roche: Consultancy, Other: Travel reimbursement; J&J: Consultancy, Other: Travel reimbursement, Research Funding; Celgene: Consultancy, Other: Travel reimbursement; Gilead: Research Funding. Sun:Janssen/J&J: Employment, Equity Ownership. Phelps:Janssen/J&J: Employment, Equity Ownership. Mahler:Janssen: Employment, Other: Travel reimbursement. Salman:Janssen/J&J: Employment, Equity Ownership. Schaffer:Janssen: Employment. Balasubramanian:Pharmacyclics LLC, an AbbVie Company: Equity Ownership; Janssen: Employment, Equity Ownership. Howes:Janssen/J&J: Employment, Equity Ownership. Hallek:AbbVie: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Celgene: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Pharmacyclics: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Gilead: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Boehringher Ingelheim: Honoraria, Other: Speakers Bureau and/or Advisory Boards; Roche: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Mundipharma: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding; Janssen: Honoraria, Other: Speakers Bureau and/or Advisory Boards, Research Funding.
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Bunker, J. P., e R. W. Schaffarzick. "Reimbursement Incentives for Hospital Care". Annual Review of Public Health 7, n.º 1 (maio de 1986): 391–409. http://dx.doi.org/10.1146/annurev.pu.07.050186.002135.
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Hui, Clayton, Haroon Kisana, John R. Martin, Chad Stecher e Joshua Hustedt. "Trends in Medicare Physician and Facility Fee Reimbursement in Orthopaedic Foot and Ankle". Foot & Ankle Orthopaedics 7, n.º 1 (janeiro de 2022): 2473011421S0025. http://dx.doi.org/10.1177/2473011421s00254.
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Category: Ankle; Ankle Arthritis; Arthroscopy; Bunion; Diabetes; Hindfoot; Lesser Toes; Midfoot/Forefoot; Sports; Trauma Introduction/Purpose: The purpose of the study was to examine the trends in physician and facility reimbursement for the orthopaedic foot and ankle subspecialty utilizing the 23 most common foot and ankle surgeries based on national payment amounts. Methods: The Current Procedural Terminology (CPT) codes and corresponding Medicare Severity - Diagnosis Related Group (MS-DRG) codes for the 23 most common orthopaedic foot and ankle surgeries were identified. With the CPT codes, physician reimbursement was obtained through querying the Medicare Physician Fee Schedule (MPFS) for the work, malpractice, and practice expense relative value units (RVU) and then multiplying the total RVUs by the yearly conversion factor. CPT codes were also utilized to gather hospital outpatient reimbursement data from the Hospital Outpatient Prospective Payment System (OPPS) database. Hospital inpatient reimbursement rates were obtained from the Hospital Inpatient Prospective Payment System (IPPS) database utilizing the MS-DRG codes. All amounts were then adjusted for inflation using the Consumer Price Index (CPI). Results: From 2008 to 2021, physician reimbursement for the 23 most common orthopaedic foot and ankle surgeries decreased by 20%, with a mean Compound Annual Growth Rate (CAGR) of -1.7%. Hospital inpatient reimbursement increased by 34.7% with a mean CAGR of 2.3%; while outpatient hospital reimbursement increased by 97.2% with a mean CAGR of 5.1%. Conclusion: Over the past 13 years, physician reimbursement for common orthopaedic foot and ankle surgeries has declined while hospital reimbursement has increased. The larger increase in outpatient reimbursement compared to inpatient reimbursement highlights how CMS aims to transition surgeries from the inpatient setting to the more efficient and less expensive outpatient setting. This downward pressure on physician reimbursement while incentivizing outpatient services could have many unintended consequences on the landscape of foot and ankle practice in the US.
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Curtiss, Frederic R., e Beverly L. Black. "Reimbursement considerations about hospital outpatient dispensing". American Journal of Health-System Pharmacy 42, n.º 5 (1 de maio de 1985): 1046–48. http://dx.doi.org/10.1093/ajhp/42.5.1046a.
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Wang, Chan, e You-hua Chen. "Reimbursement and hospital competition in China". Economic Research-Ekonomska Istraživanja 30, n.º 1 (janeiro de 2017): 1209–23. http://dx.doi.org/10.1080/1331677x.2017.1340177.
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McClellan, Mark. "Hospital Reimbursement Incentives: An Empirical Analysis". Journal of Economics & Management Strategy 6, n.º 1 (1 de março de 1997): 91–128. http://dx.doi.org/10.1162/105864097567048.
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McClellan, Mark. "Hospital Reimbursement Incentives: An Empirical Analysis". Journal of Economics Management Strategy 6, n.º 1 (março de 1997): 91–128. http://dx.doi.org/10.1111/j.1430-9134.1997.00091.x.
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Linton, O. W. "Medicare amendments change teaching hospital reimbursement." Radiology 161, n.º 2 (novembro de 1986): 567–68. http://dx.doi.org/10.1148/radiology.161.2.3532198.
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Palley, Michael A. "Hospital information systems and DRG reimbursement". Information & Management 20, n.º 3 (março de 1991): 227–34. http://dx.doi.org/10.1016/0378-7206(91)90057-9.
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Harris, Burton H., Kathryn Dirkes Bass e Mary D. O'Brien. "Hospital reimbursement for pediatric trauma care". Journal of Pediatric Surgery 31, n.º 1 (janeiro de 1996): 78–81. http://dx.doi.org/10.1016/s0022-3468(96)90323-1.
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Seldon, James R. "Hospital cost-shifting under fractional reimbursement". Atlantic Economic Journal 14, n.º 1 (março de 1986): 50–58. http://dx.doi.org/10.1007/bf02303510.
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Stoffel, Victoria, Justin M. Camacho, Connor Heeb, Saishi Cui, Jalene Y. Shim, Salvatore J. Pacella, Amanda A. Gosman e Chris M. Reid. "Unveiling the Hidden Discrepancies Between Medicare Physician Reimbursement Rates and Inflation Across Different Surgical Specialties". Annals of Plastic Surgery 92, n.º 5S (maio de 2024): S340—S344. http://dx.doi.org/10.1097/sap.0000000000003806.
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Objective This study aimed to analyze the trends of Medicare physician reimbursement from 2011 to 2021 and compare the rates across different surgical specialties. Background Knowledge of Medicare is essential because of its significant contribution in physician reimbursements. Previous studies across surgical specialties have demonstrated that Medicare, despite keeping up with inflation in some areas, has remained flat when accounting for physician reimbursement. Study Design The Physician/Supplier Procedure Summary data for the calendar year 2021 were queried to extract the top 50% of Current Procedural Terminology codes based on case volume. The Physician Fee Schedule look-up tool was accessed, and the physician reimbursement fee was abstracted. Weighted mean reimbursement was adjusted for inflation. Growth rate and compound annual growth rate were calculated. Projection of future inflation and reimbursement rates were also calculated using the US Bureau of Labor Statistics. Results After adjusting for inflation, the weighted mean reimbursement across surgical specialties decreased by −22.5%. The largest reimbursement decrease was within the field of general surgery (−33.3%), followed by otolaryngology (−31.5%), vascular surgery (−23.3%), and plastic surgery (−22.8%). There was a significant decrease in median case volume across all specialties between 2011 and 2021 (P < 0.001). Conclusions This study demonstrated that, when adjusted for inflation, over the study period, there has been a consistent decrease in reimbursement for all specialties analyzed. Awareness of the current downward trends in Medicare physician reimbursement should be a priority for all surgeons, as means of advocating for compensation and to maintain surgical care feasible and accessible to all patients.
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Wolf, Sarah, Ingrid Zechmeister-Koss, Nicole Grössmann e Claudia Wild. "Evaluating options for decision making on costly hospital drugs in Austria". International Journal of Technology Assessment in Health Care 36, n.º 3 (14 de maio de 2020): 277–84. http://dx.doi.org/10.1017/s0266462320000276.
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ObjectivesThe aim of this study was to suggest options for a national and standardized process for the reimbursement of costly drugs provided in Austrian hospitals.MethodsFor answering the research questions, reimbursement processes of ten countries were investigated and the strengths and weaknesses of elaborated options of actions were analyzed, resulting in suggestions for solutions in the Austrian reimbursement processes for hospital drugs.ResultsBased on the information derived from the international analysis and the deliberation of the strengths and weaknesses on optional approaches, as well as, on the consideration of the existing reimbursement processes in Austria, three options to reorganize the current decentralized inpatient reimbursement process in Austria were suggested. The first option presents a process following the established processes of the decision making for outpatient drugs. The second option suggests stronger coordination of and cooperation across the existing processes of the nine regional “Pharmaceutical and Therapeutics Committees”. The third option proposes to expand the already established reimbursement process for non-drug interventions.ConclusionsEvidence-based, transparent, fair and efficient resource allocations are needed for priority setting decisions. However, a decision process can be based on the best available evidence, can be fair and transparent, although it might be substantially more time-consuming. Thus, a pragmatic balance between quality, transparency and timeliness is crucial.
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Sinzobahamvya, Nicodème, Thorsten Kopp, Claudia Arenz, Hedwig C. Blaschczok, Viktor Hraska e Boulos Asfour. "Reimbursement by current German Diagnosis-Related Groups system penalises complex congenital heart surgery". Cardiology in the Young 24, n.º 2 (13 de maio de 2013): 344–50. http://dx.doi.org/10.1017/s1047951113000437.
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AbstractA total of 458 hospital stays during the year 2011 were analysed to determine whether reimbursement by the current German Diagnosis-Related Groups system covers the costs incurred during hospital stay for congenital heart surgery. The costs of every hospital stay were estimated according to the guidelines of the Institute for the Hospital Remuneration System, an institute responsible for encoding hospital reimbursement in Germany. Cost-weight values of the year 2012 were applied for reimbursement. Related additional compensations were also included. Hospital costs ranged from 8896.26 to 193,671.94 euros per case, with a mean of 30,597 and standard deviation of 25,032 euros. Reimbursement varied from 8630.35 to 173,710.65 euros, with a mean of 25,514 and standard deviation of 18,497 euros: an underfunding of 17%. Fifty-nine per cent (271/458) of cases were classified, according to Aristotle complexity score, in higher comprehensive complexity: Levels 4–6. Costs highly correlated with complexity levels (Spearman's r coefficient = 0.89) and the regression was linear. Underfunding increased, linearly, from 6% for procedures with Level 1, lowest comprehensive complexity, to 23% for those with Level 6, highest complexity. In conclusion, this study demonstrates that reimbursement by the current German Diagnosis-Related Groups system increasingly penalises complex congenital heart surgery. Aristotle complexity score could help to correct this prejudicial situation.
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Merritt-Myrick, Samirah, e David Harris III. "Successful Billing Strategies in the Hospital Industry". International Journal of Human Resource Studies 11, n.º 1 (15 de janeiro de 2020): 85. http://dx.doi.org/10.5296/ijhrs.v11i1.18212.
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This paper explores the negative impact of changing Medicare regulations have on hospital profitability. Findings indicate that the successful strategies billing managers could use to ensure Medicare reimbursement and profitability include remaining up to date with Medicare changing compliance regulations, enhancing communication with staff, multiple departments, and Medicare, and adopting a robust billing system and other systems that compliment billing. Since the implementation of changes, hospitals continued to foster criterion to ensure successful Medicare reimbursement, thereby remaining in operation to continue to support the healthcare needs of families in the local communities. The biggest obstacle for hospitals is the ever-revolving Medicare reform and the effects it has on lowering reimbursement for the hospital industry. Hospitals that are affected by reform report issues that relate to the Medicare Prospective Payment System (PPS), payment for performance, and value-based payments.
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Donovan, Melissa J., Daniel E. Ramirez, Gregory D. Crenshaw, Taylor A. Smith, Hernan A. Bazan e W. Charles Sternbergh. "Hospital Reimbursement for Carotid Stenting and Endarterectomy". Journal of Endovascular Therapy 21, n.º 2 (abril de 2014): 296–302. http://dx.doi.org/10.1583/13-4549.1.
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Degrassat-Théas, A., M. Bensadon, C. Rieu, M. Angalakuditi, C. Le Pen e P. Paubel. "Hospital Reimbursement Price Cap for Cancer Drugs". PharmacoEconomics 30, n.º 7 (julho de 2012): 565–73. http://dx.doi.org/10.2165/11588320-000000000-00000.
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Sederer, Lloyd I., Susan V. Eisen, Diana Dill, Mollie C. Grob, Michele L. Gougeon e Steven M. Mirin. "Case-Based Reimbursement for Psychiatric Hospital Care". Psychiatric Services 43, n.º 11 (novembro de 1992): 1120–26. http://dx.doi.org/10.1176/ps.43.11.1120.
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Bowers, Mary Lou. "A Reimbursement Primer for Hospital Oncology Programs". Oncology Issues 19, n.º 3 (maio de 2004): 41–44. http://dx.doi.org/10.1080/10463356.2004.11883195.
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Pope, Gregory C. "Hospital nonprice competition and medicare reimbursement policy". Journal of Health Economics 8, n.º 2 (junho de 1989): 147–72. http://dx.doi.org/10.1016/0167-6296(89)90001-5.
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Rodrigues, Jose. "Hospital utilization and reimbursement method in Brazil". International Journal of Health Planning and Management 4, n.º 1 (janeiro de 1989): 3–15. http://dx.doi.org/10.1002/hpm.4740040103.
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Milcent, Carine. "Hospital ownership, reimbursement systems and mortality rates". Health Economics 14, n.º 11 (2005): 1151–68. http://dx.doi.org/10.1002/hec.1010.
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Wolf, Sarah, e Claudia Wild. "PP87 Inpatient Drug Reimbursement: Approaches For A Democratic Process". International Journal of Technology Assessment in Health Care 35, S1 (2019): 54–55. http://dx.doi.org/10.1017/s0266462319002289.
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IntroductionIn the context of limited healthcare resources and high healthcare expenditures, the introduction of new, cost-intensive medicines forces decision-makers to prioritize drug funding, especially in the areas of orphan diseases and oncology. In democratic societies, health policy decisions need to be evidence-based, transparent, fair, and efficient. Therefore, in some countries standardized (transparent) processes exist. In Austria, decisions on the reimbursement of new medicines have not been made for a long time. The aim of the present study was to develop different scenarios for a standardized, centralized reimbursement process for expensive hospital drugs in Austria that favors democratic decisions.MethodsA multi-stage approach was undertaken. Firstly, the reimbursement processes (only for original preparations) in Austria and other selected countries were investigated. Secondly, the strengths and weaknesses of these processes were analyzed based on predefined criteria, following the concepts of “accountability for reasonableness” (A4R) and “deliberative decision making”. Thirdly, scenarios for an Austria-wide uniform reimbursement process for hospital drugs were developed.ResultsThree scenarios were identified: (i) a reimbursement process for hospital drugs that follows the existing reimbursement process in the outpatient sector in Austria; (ii) a cooperative of decentralized Pharmaceutical and Therapeutics Committees for procurement, use, and reimbursement decisions for hospital drugs; and (iii) an adaptation of the existing reimbursement process of non-drug, highly specialized technologies to pharmaceutical interventions.ConclusionsAccording to the concepts of A4R and deliberative decision making, a transparent, evidence-based, fair, and efficient allocation of limited healthcare resources is indispensable for justifying decisions on health funding priorities in democracies. However, these criteria can be diametrically opposed. For example, methods, processes, and decisions can be evidence based, transparent, and fair, but also significantly more time consuming. Thus, a balance between the individual options for action is necessary, and priorities must be set.
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Smith, Brian S., Walter S. Schroeder e Gary R. Tataronis. "Hospital Reimbursement for Adult Patients with Severe Sepsis Treated with Drotrecogin Alfa (Activated)". Hospital Pharmacy 40, n.º 2 (fevereiro de 2005): 146–53. http://dx.doi.org/10.1177/001857870504000206.
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Purpose Patients with severe sepsis are critically ill and use a high level of health care resources. The high resource utilization and lack of a specific diagnosis related group may lead to a significant loss in revenue for health care organizations secondary to inadequate reimbursement. The primary objective of this study is to quantify the difference in total cost and reimbursement in patients with severe sepsis treated with drotrecogin alfa (activated) (DAA) at our institution. Methods All patients between December 2001 and December 2003 diagnosed with severe sepsis and treated with DAA were evaluated. Demographic data, primary payer, diagnosis related group, hospital length of stay, length of medical/surgical stay, length of Intensive Care Unit stay, days on mechanical ventilation, total costs, and total reimbursement were determined by chart review and our institution's information systems. Results Data from a total of 71 patients were included. The total treatment cost was $6,294,590, and the total reimbursement received was $4,295,950. This represents a loss of $1,998,640 or $28,150 per patient. The primary factor contributing to this loss was Intensive Care Unit length of stay (P = 0.011). Conclusion Management of patients with severe sepsis is costly and strains hospital resources. The current reimbursement system does not allow for appropriate compensation. Therefore, in addition to efforts directed toward improved treatment strategies for severe sepsis, health care practitioners must target interventions to reduce hospital length of stay and maximize reimbursement.
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Goetz, Gregor, Dimitra Panteli, Reinhard Busse e Claudia Wild. "PP112 Reimbursement Decisions for Medical Services in Austria: An Analysis of Influencing Factors for the Hospital Individual Services Catalogue". International Journal of Technology Assessment in Health Care 38, S1 (dezembro de 2022): S77. http://dx.doi.org/10.1017/s0266462322002355.
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IntroductionThis study aims to (i) describe the (evidence-based) reimbursement process of hospital individual services, (ii) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (iii) elaborate potential aspects that play a role in the decision-making process in Austria.MethodsThe reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analyzed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decisionmakers.ResultsOne hundred and eighteen evidence-based recommendations were analyzed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organizational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).ConclusionsThere is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.