Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Abstract

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature reviews, followed by exploratory qualitative interviews (N = 10) with payers and physician key opinion leaders (KOLs) selected based on input from regional industry experts (payers) and PubMed search (KOLs). Interviews were 60 minutes, using a structured set of questions, in local language. Results: Respondents place the budget impact of the originator product and clinicians' acceptability as the most relevant drivers for the adoption of biosimilars. Payers and KOLs alike expect biosimilars to demonstrate non-inferiority versus originator in phase 3 RCTs (randomized clinical trials) to support bioequivalence, safety and efficacy claims. Payers' comfort in providing access to biosimilars across disease areas and expectations for cost savings vary by markets, according to previous experience with other biosimilars and confidence in the regulatory evaluation. As a result, payer discount requirements for public access range from 5-30% across markets, with KOLs stating that they likely will consider biosimilars for all patients at discount levels greater than 20-25%. Conclusion: Although payers and physicians alike cited the importance of bioequivalent safety and efficacy, they ultimately will look to regulators for guidance on which biosimilar products have provided sufficient evidence, and for which indications. While the level of discount versus the branded originator varied by market, biosimilars have the potential to gain broad penetration with cost-sensitive public payers and also with clinically-oriented physicians across Latin American markets.