Objetivo: O presente artigo visa disponibilizar aos gestores da saúde dados sobre o impacto orçamentário da incorporação dos inibidores de PARP (iPARPs) para o tratamento de primeira linha de manutenção de câncer de ovário avançado, gBRCA mutado, sob a perspectiva do sistema de saúde suplementar. Métodos: Adotou-se o método epidemiológico, tendo como comparador a vigilância ativa em um horizonte temporal de cinco anos. Foram considerados apenas os custos de tratamento medicamentoso na análise, utilizando o pressuposto conservador de que os custos da vigilância ativa são nulos. Além disso, construiu-se uma análise de sensibilidade determinística. Resultados: O impacto orçamentário dos iPARPs na população-alvo em todo o sistema foi de R$ 78,1 milhões em cinco anos acumulados. A análise de sensibilidade apontou que o resultado do impacto orçamentário varia de R$ 54,6 milhões a R$ 101,6 milhões. A taxa de difusão da tecnologia e os parâmetros epidemiológicos foram os que exerceram a maior influência na variabilidade dos resultados. Conclusão: Os dados sugerem que a incorporação dos iPARPs na população selecionada gera um impacto orçamentário gerenciável.
A473among advanced ovarian cancer (OC) patients from two large US healthcare claims databases. Methods: The MarketScan Commercial Claims & Medicare (CCMC) and Surveillance, Epidemiology, and End Results-Medicare (SEER-M) databases were used to identify females aged ≥ 18 years diagnosed with advanced OC (including EOC, fallopian tube [FTC] and primary peritoneal cancer [PPC]) and receiving first-line treatment (i.e. the first claim for any chemotherapy within 90 days post-OC diagnosis) between 1/1/2010 and 12/31/2015. Patients were followed from their initial diagnosis of OC (i.e. index date) until death, loss-to-follow-up or end-of-study period to assess and compare their clinical characteristics and treatment patterns. Results: A total of 7,825 advanced OC patients were identified (N= 6,170 in CCMC, N= 1,655 in SEER-M). Majority of patients were diagnosed with EOC (CCMC: 89%, SEER-M: 80%), and the mean age (SD) at diagnosis was 59 (11) and 75 (6) years, respectively. The median follow-up time was 1.4 and 2.3 years, respectively. Staging information was only available for the SEER-M cohort; 65% of patients were diagnosed with stage III or IV disease. The mean (SD) time from index to initiation of first-line treatment was 35 (20) days in the CCMC cohort and 51 ( 19) days in the SEER-M cohort. Advanced OC patients most frequently received platinum-/taxane-based regimens, with carboplatin/paclitaxel used in 63% and 67% of patients, respectively. Bevacizumabcontaining regimens were utilized in 7% of CCMC OC patients and 5% of SEER-M OC patients, with bevacizumab/carboplatin/paclitaxel combination being the most common. ConClusions: Results: suggest that platinum-containing chemotherapy remains the standard-of-care for advanced OC patients in the US. Despite differences in age between the two OC cohorts, similar treatment patterns were observed.
A875substantially higher objective response rates favouring patients receiving nivolumab (25.1% vs 5.4%; odds ratio: 5.98, P< 0.001) was observed in this trial. The aim of this analysis was to compare the monthly cost per responder with nivolumab versus everolimus in the Brazilian private healthcare system perspective. Methods: This analysis was based on investigator-based patient-level data from a randomized phase III trial. ORR was defined as the proportion of patients who achieved a partial or complete response. Costs were calculated based on drug, administration, and managing of grade 1-4 treatment related adverse events (TRAEs) reported on Checkmate 025. Drug costs for nivolumab and everolimus were obtained from the official Brazilian price list (Feb/2017) by CMED. The management of TRAEs was obtained through a Delphi panel, followed by microcosting of resources obtained from public sources (Kairos and Simpro Magazine n105/2016 for drugs and materials, CBHPM 2016 for medical appointments and procedures, and UNIDAS National Research 2015 for hospitalizations). Monthly cost per objective response was calculated by dividing the average monthly cost per patient by ORR. Results: Median duration of treatment was 5.
Objectives: Assess the relative clinical and economic value of Ipilimumab as second-line treatment of metastatic melanoma compared with other metastatic cancers agents in Brazil. MethOds: A literature review of clinical data supporting approval of various metastatic cancers agents meeting the following criteria: market and price approval in Brazil within the last 10 years, OS as primary/secondary endpoints in clinical trials, median OS at time of regulatory approval and availability of Kaplan-Meier OS curves, was conducted. The studies selected provided data to analyze changes in median/mean OS, on 1-year survival rate in absolute (i.e. months) and relative (i.e. percent of improvement) terms and NNT at 1 year to avoid one death. Clinical outcomes were associated with drug costs, which were obtained from the official Brazilian price list issued on 20/Jan/2015 by CMED. Results: Relative to other agents, ipilimumab demonstrated absolute improvement in mean OS of 6.1 months (versus 0.1-6.4 months), a relative improvement in mean OS of 53% (versus 1.3-34.3%), absolute improvement in median OS of 3.7 months versus 0-13.3 months (76,92% were ≤ 4 months with other agents), relative improvement in median OS of 57.8% (vs 0-63.3%), absolute improvement in 1-year survival rate (20.3% versus 0-15.0%), relative improvement in 1-year survival rate (80.2% versus 4.2-81.5%) and the lowest NNT at 1 year to avoid 1 death (5 patients versus 6.47-31.5 patients). Ipilimumab's relative value was confirmed when plotting each drug's clinical performance vs total drug costs. cOnclusiOns: Results document that second-line ipilimumab demonstrates relative median OS and absolute mean OS improvements. Ipilimumab achieved the greatest relative mean OS improvement, absolute 1-year survival rate improvement and the lowest NNT at 1 year. Comparative analysis demonstrates the clinical and economic value of Ipilumumab. This analysis provides health-care decision makers another tool in their decision making process.
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