carcinoma (mRCC). The purpose of this study was to assess the budget impact of including sunitinib as first-line therapy (1L) option for mRCC patients, within a 3 year time horizon from the payer perspective in Argentina. METHODS: An excelbased budget impact model (BIM) was adapted to the context of Argentina to determine the incremental cost of introducing sunitinib in the 1L for patients with mRCC. The analysis was conducted with 2 comparators based on Argentina treatment pattern: pazopanib and sunitinib. Epidemiology data of mRCC was obtained from the literature. The drugs costs were obtained from ANMAT's National Drug Vademecum. The costs of drug administration and patient monitoring, and adverse events costs were estimated through a microcosting approach, based on published data and expert opinion, and were based on tariffs from healthcare institutions (social security and private sector) of Argentina. The market share of the different drugs was based on market studies and assumptions. The budget impact is reported in terms of annual budget impact, per-member per-year (PMPY) and per-patient per-year (PPPY). RESULTS: In Argentina assuming a population of 1 million people, patients eligible for 1L treatment were estimated at 27. The net budget impact estimated for the introduction of sunitinib was -$9,250.08 each year. The cumulative net budget impact was -$27,750.24, representing an impact of -1.94% compared to a scenario without sunitinib. The incremental cost PMPY was -$0.01, and the incremental cost PPPY was -$338.48. In one-way sensitivity analysis the price of sunitinib was the only one that showed a significant influence on the results. CONCLUSIONS: Our results suggest that the inclusion of sunitinib as a therapeutic option in patients with mRCC could generate budgetary savings compared to treatment with pazopanib.OBJECTIVES: Acute lymphoblastic leukemia (ALL) in adults is an acute and frequently fatal rare disease associated with high rates of relapse and substantial humanistic and economic burden. The primary objective of this study was to evaluate the budget impact (BI) of the implementation of inotuzumab ozogamicin as a treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). METHODS: A BI model was built in Excel to evaluate the economic impact of inotuzumab for the treatment of ALL in Bulgaria. For the base case analysis, the model was developed and populated with epidemiologic local data and compares the total budgetary costs (direct costs only) of a scenario with inotuzumab versus a scenario without inotuzumab. Costs were calculated according to the Positive Drug List (PDL) as of March 2018. The base case time horizon in the model was 5 years. RESULTS: The BI analysis estimated that the inclusion of inotuzumab in the reimbursement list would bring a saving of -4 917 BGN in the first year of incorporation, reaching -14 750 BGN savings in year five. The cumulative impact over 5-year time horizon corresponds to a total saving of -49 168 BGN. The sensiti...
Objectives: Chronic HCV infection is associated with a significant health burden. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The introduction of direct-acting antivirals (DAAs) has dramatically changed hepatitis C treatment and sustained virologic response rates (SVR) of > 90% were observed in clinical trials. Especially interferon-free regimens allow a shorter treatment duration and show favorable toxicity profile. Nevertheless new treatment options were accompanied with higher pharmaceutical costs. The aim of the current study was to analyze outcomes and treatment costs in a realworld setting. MethOds: Data were derived from the German Hepatitis C-Registry (DHC-R). The DHC-R is a prospective, multicenter real-world registry study comprising approximately 10,500 patients. Patients are treated at the discretion of the physician. This analysis included all patients with HCV genotype (GT) 1 and 3 who initiated and finished treatment between 02/2014 and 02/2017 and were documented in the pharmacoeconomic substudy. Results: A total of 2,673 patients receiving antiviral treatment were analyzed; 88.0% had GT-1 and 12.0% GT-3 infection. Mean age was 54.6 years, 52.3% were male. Estimated mean duration of infection was 20.6 years. About half of the population (48.1%) was treatment-naïve and 30.2% had liver cirrhosis. 93.5% of all patients achieved SVR (GT-1: 94.0%, GT-3: 89.1%). Average total treatment costs were € 67,979 (€ 67,131 pharmaceutical costs, € 824 ambulatory care, € 24 hospital costs). Treatment costs were considerably lower in GT-1 compared to 650 vs. € 85,039). Average costs per SVR (cure) of € 69,841 for GT-1 and € 95,443 for GT-3 were calculated. cOnclusiOns: This analysis confirms high SVR rates for newly introduced DAAs in a real-world setting. Although costs for antiviral treatment have further increased, costs per SVR estimated are comparable to first generation DAAs. Detailed analyses stratified by treatment status, degree of cirrhosis and regimen should follow.
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