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Objectives: Budget impact and cost-effectiveness analysis are often required by payers when discussing drug reimbursement. We hereby present a cost-minimization (CMA) and budget impact analysis (BIA) regarding the incorporation of certolizumab pegol (CZP) for the treatment of patients with Crohn’s disease, a debilitating condition that affects the digestive tract. Methods: Considering that the scientific literature demonstrates CZP as effective as the alternatives (infliximab and adalimumab), a CMA was conducted, including a Markov 10-year time horizon modeling. Focusing on the assumptions for both CMA and BIA, a total of 36 stakeholders from the private sector were surveyed regarding treatment and disease-related costs. For the BIA, drug acquisition costs, administration costs, no population growth and an immunobiologic drug (bDMARD) switching rate of 5% were also considered. We assumed that CZP would gradually gain market share until it reaches 20% of new or switching patients in the fourth year. In addition, probability sensitivity analyses were performed. Results: In the cost-minimization, the calculated costs for 10-year treatment were BRL149k (infliximab); BRL118k (adalimumab) and BRL83k (CZP). Probabilistic sensitivity analysis was conducted with 1,000 random simulations, with CZP being less costly than its comparators in all simulations. Additionally, the BIA result indicates that CZP is a cost-saving intervention, with a predicted five-year impact of BRL317k for every 100-patient cohort. Conclusions: Certolizumab pegol was shown to be not only effective but also a cost-saving drug when compared to other anti-TNF drugs available for the Brazilian private healthcare system. RESUMO Objetivos: Análises de impacto orçamentário e de custo-efetividade são, com frequência, exigidas por pagadores para a decisão sobre incorporação de drogas. Por esse motivo, apresentaremos uma análise de custo-minimização e de impacto orçamentário do certolizumabe pegol (CZP) para o tratamento de pacientes com doença de Crohn, doença crônica e debilitante que afeta o trato digestivo. Métodos: Trinta e seis pagadores privados foram entrevistados para que fosse possível Received on: 02/26/2017. Approved for publication on: 04/03/2017. 1. IMS Health, São Paulo, SP, Brazil. 2. UCB Biopharma, São Paulo, SP, Brazil. 3. UCB Biopharma Sprl. Brussels, Belgium. 4. UCB Pharma Ltd., Slough, England. Information on support received as financing, equipment or drugs: Ricardo Papaléo Rosim, Andreas de Souza Duva and André Fabre Ballalai Ferraz are employees of IMS Health, which was sponsored by the company that markets the drug certolizumab pegol, UCB Biopharma, to perform these analyses. Arcangela Valle and Érico Carmo are employees of UCB Biopharma. Corresponding author: Érico V. S. Carmo. Av. Brigadeiro Faria Lima, 4300 – Itaim Bibi, São Paulo, SP, Brazil. 04538-132. Telephone: (+55 11) 3847-1780 / (+ 55 11) 98378-1299. E-mail: erico.carmo@ucb.com ORIGINAL ARTICLE ARTIGO ORIGINAL Palavras-chave: doença de Crohn, certolizumabe pegol, avaliação de tecnologias em saúde, infliximabe; adalimumabe, produtos biológicos DOI: 10.21115/JBES.v9.n1.p44-53

jornal brasileiro de economia da saúde

Cost-minimization and budget impact analysis of certolizumab pegol for patients with Crohn’s disease, moderate or severe, with relapse after conventional treatment from the perspective of the Brazilian private payer