Cost-Effectiveness of Secukinumab Versus Other Biologics in the Treatment of Psoriatic Arthritis: An Argentinean Perspective.

OBJECTIVE: Psoriatic arthritis (PsA) is a chronic, systemic inflammatory disease. This study assessed the cost-effectiveness of secukinumab, an interleukin-17A inhibitor, versus other biologics in PsA from the Argentinean social security perspective. METHODS: A semi-Markov model evaluated subcutaneous (sc) treatment with secukinumab 150 mg and 300 mg against other sc treatments such as adalimumab, certolizumab pegol, etanercept, golimumab, ustekinumab, and intravenous treatment infliximab in biologic-naïve (with or without moderate to severe psoriasis) and biologic-experienced PsA patients over a lifetime horizon. Response to treatments was determined using the PsA Response Criteria (PsARC) at 12 weeks. Model inputs were derived from randomized controlled trials, network meta-analyses, published literature, and other Argentinean sources. Model outcomes included quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratios. Sensitivity analyses and alternative scenarios with a higher cost option were also conducted. RESULTS: Among biologic-naïve PsA patients without psoriasis, secukinumab 150 mg provided the highest QALYs (7.18) versus all sc biologics at the lowest cost ($3 755 678 Argentine peso), thus dominating them. Among biologic-naïve PsA patients with psoriasis and biologic-experienced PsA patients, secukinumab 300 mg provided highest QALYs (6.99 and 7.53, respectively), dominated infliximab, and was cost-effective versus other sc biologics. Deterministic sensitivity analyses indicated sensitivity of results to variation in PsARC rates, drug acquisition costs, Health Assessment Questionnaire change, and utilities. A probabilistic sensitivity analysis showed maximum net monetary benefits with both secukinumab doses. Results from an alternative scenario analysis were similar to base-case analysis. CONCLUSIONS: For both biologic-naïve and experienced PsA patients, secukinumab is either a dominant or cost-effective treatment option compared with other biologics in Argentina.

Impacto orçamentário para o Sistema Único de Saúde da incorporação do infliximabe biossimilar no tratamento de artrite reumatóide / Budgetary impact of the incorporation of biosimilar infliximab in the treatment of rheumatoid arthritis from the perspective of the Brazilian Public Health System

A artrite reumatoide (AR) é uma doença inflamatória crônica, autoimune, que afeta as articulações, podendo produzir sintomas sistêmicos. O infliximabe é um medicamento biológico incorporado no Sistema Único de Saúde (SUS) para o tratamento da AR, que teve um biossimilar aprovado em 2015. Além do biossimilar, existe um produto derivado de uma Parceria de Desenvolvimento Produtivo (PDP). Este estudo estimou o impacto orçamentário da incorporação do infliximabe biossimilar no tratamento da AR no SUS. O impacto orçamentário da incorporação do produto da PDP foi contemplado como um dos objetivos secundários. As estimativas foram calculadas pelo método de demanda aferida para um horizonte temporal de cinco anos. Foram estimadas duas estratégias de uso: (A) apenas casos novos de AR recebendo o infliximabe inovador utilizarão o biossimilar (ou o produto da PDP) e (B) tanto os casos novos como 50% daqueles já em uso do infliximabe inovador utilizarão o biossimilar (idem). As projeções da população com AR foram realizadas a partir dos dados presentes no Datasus e da "quota de mercado"1 do infliximabe. Adicionalmente, foram realizadas análises de sensibilidade univariadas, considerando uma difusão progressiva dos dois produtos e de pior e melhor cenário. A incorporação do infliximabe biossimilar e do produto de PDP para casos novos (estratégia A) implicariam em economias de -R$ 284.430.468,79 e -R$ 366.194.377,69, respectivamente, em cinco anos. Esses valores representariam reduções de 19% e 24%, respectivamente, nos gastos em saúde de infliximabe para o tratamento de AR. Na estratégia B, onde também são considerados parte dos pacientes em terapia de manutenção as economias geradas seriam de -R$ 419.006.071,14 para o biossimilar e -R$ 539.455.804,86 para o produto da PDP. Na análise de sensibilidade por difusão progressiva, as economias reduzem se a -R$ 178.544.332,95 (estratégia A) e -R$ 263.639.280,49 (estratégia B) para o biossimilar e -R$ 229.869.645,03 (estratégia A) e -R$ 339.426.443 (estratégia B). Na análise de melhor cenário, os resultados apontaram para economias de -R$ 1.011.789.713,83 e -R$ 1.222.955.301,30 para o biossimilar e produto da PDP, respectivamente. Já no pior cenário, as estimativas mostram que a introdução das tecnologias analisadas produziria um ônus ao sistema de saúde de R$ 8.552.019,91 (para o biossimilar) e R$ 5.366.519,91 para o produto da PDP. A incorporação do produto biossimilar no tratamento da AR proporcionaria redução dos gastos, tornando possível uma alocação de recursos mais eficiente para o tratamento dessa doença.

Rheumatoid arthritis (AR) is a chronic, autoimmune, inflammatory disease that affects the joints, but also may produce systemic symptoms. Infliximab is a biologic drug incorporated into the Brazilian Public Health System (SUS) for the treatment of AR, which had a biosimilar approved in 2015. In Brazil, in addition to biosimilar, there is a product derived from a public-private partnership (PDP). This study aimed to estimate the budgetary impact of the incorporation of biosimilar infliximab in the treatment of AR in SUS. The budgetary impact of the incorporation of the PDP product was considered as one of the secondary objectives. Estimates were calculated using a measured demand approach over a five-year time horizon. Two strategies of utilization was estimated for the biosimilar product or PDP: (A) only new cases that would receive the innovative infliximab will use the biosimilar (or the PDP product) and (B) both new cases and 50% of those already in use of the innovative infliximab will use biosimilar (idem). The projections of the AR population were based on data from Datasus and the "market share" of infliximab. In addition, univariate sensitivity analyzes were performed, considering the progressive diffusion and analyses of "best-case scenario" and "worst-case scenario". The incorporation of biosimilar infliximab and PDP product for new cases (strategy A) would save -R$ 284,430,468.79 and -R$ 366,194,377.69, respectively, in five years. These values would represent reductions of 19% and 24%, respectively, in the health expenditures of infliximab for the treatment of AR. In strategy B, where part of the maintenance therapy patients were also considered, the savings would be -R$ 419,006,071.14 for biosimilar and -R$ 539,455,804.86 for the PDP product. For both drugs, the practiced price was the parameter with the greatest impact on the cost savings estimates, both in strategy A and B. In the sensitivity analysis by progressive diffusion the savings would decrease to -R$ 178,544,332.95 (strategy A) and -R $ 263,639,280.49 (strategy B) for biosimilar and -R $ 229,869,645.03 (strategy A) and -R$ 339,426,443 (Strategy B). In the analysis of best-case scenario, the results showed savings of -R$ 1,011,789,713.83 and -R$ 1,222,955,301.30 for biosimilar and PDP products, respectively. On the other hand, in the worst-case scenario the introduction of the analyzed technologies would result in a health system burden of R$ 8,552,019.91 for the biosimilar and R$ 5,366,519.91 for the PDP product. The incorporation of the biosimilar product in the treatment of AR would reduce the health care expenditures for this treatment, allowing the budget manger to allocate resources more efficiently for the treatment of AR.