A health economic guide to market access of biosimilars

Abstract

Introduction:Little is known about market access to biosimilars from a health economic perspective, except for studies that compute the budget impact of biosimilar use.Areas covered: This comprehensive health economic guide to the market access of biosimilars focuses on the role of biosimilars in pharmaceutical innovation and competition, the objective of biopharmaceutical policy, the budget impact of biosimilars, and the cost-effectiveness of biologic therapy in the presence of biosimilars. Expert opinion: We argue that the objective of biopharmaceutical policy in a health system should be to create a competitive and sustainable market for off-patent reference biologics, biosimilars, and nextgeneration biologics that makes biologic therapy available to patients at the lowest cost. Market access of biosimilars can contribute to this objective as a result of the lower price of biosimilars and price competition with alternative therapies. The resulting improvement in the cost-effectiveness of biologic therapy needs to be accounted for by revisiting reimbursement decisions and conditions. When examining the cost-effectiveness of biologic therapy following patent expiry, stakeholders need to consider residual uncertainties at the time of biosimilar marketing authorization, the nocebo effect, market entry of a second-generation reference biologic with a different administration form than the biosimilar, and value-added services.

Minimum Manufacturing Costs, National Prices, and Estimated Global Availability of New Repurposed Therapies for Coronavirus Disease 2019

“…High prices of JAK inhibitors and monoclonal antibodies are barriers for patient access in healthcare systems requiring out-of-pocket copayments or LMIC settings. The entry of biosimilars can lead to significant price reductions, even if not on the scale of chemical medications [ 43 , 44 ]. One reason for higher biosimilar costs could be the overly cumbersome regulatory pathway [ 45 ] that many have argued for reform.…”

Minimum manufacturing costs, national prices and estimated global availability of new repurposed therapies for COVID-19

“…High prices of JAK inhibitors and monoclonal antibodies are barriers for patient access in healthcare systems requiring out-of-pocket co-payments or LMIC settings. The entry of biosimilars can lead to significant price reductions, even if not on the scale of chemical medications [43,44]. One reason for higher biosimilar costs could be the overly cumbersome regulatory pathway [45] that many have argued for reform.…”

“…The high prices of JAK inhibitors and monoclonal antibodies exposed from the national drug price databases are key barriers for many LMIC patients and for patients in healthcare systems requiring out-of-pocket co-payments. We note that entry of biosimilars can lead to significant price reductions even if not on the scale of chemical medications [48,49], and a reason for high biosimilar costs is the regulatory pathway that many critiqued as being overly cumbersome and should be overhauled [50]. If greater emphasis is placed on encouraging biosimilar entry, prices for tocilizumab and sarilumab could be much lower and allow for greater availability.…”

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis

“…Moreover, price reductions induced by biosimilar market entry alter the cost-effectiveness of biological therapy. Policymakers should therefore reconsider reimbursement modalities within the entire therapeutic class after the market entry of biosimilar medicines (Moorkens et al, 2020b;Simoens and Vulto, 2021). In order to stimulate the use of the best-value biological medicine, the Belgian reimbursement agency should bring their reimbursement modalities in line with the recommendation of European clinical guidelines to consider societal costs.…”