Drug tendering: drug supply and shortage implications for the uptake of biosimilars

Abstract

Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market. Consequently, drug shortages can occur, resulting in changes to treatment plans to products that may have lower efficacy and/or an increased risk of adverse effects. Therefore, care must be taken to ensure that tendering does not negatively impact patient care or the health care system. A large and expanding portion of total pharmaceutical expenditure is for biologic therapies. These agents have revolutionized the treatment of many diseases, including cancer and inflammatory conditions; however, patient access to biologic drugs can be limited due to availability, insurance coverage, and cost. As branded biologic therapies reach the end of patent- and data-protection periods, biosimilars are being approved as lower-cost alternatives. Biosimilars are products that are highly similar to the originator product with no clinically meaningful differences in terms of safety, purity, or potency. As more biosimilars receive regulatory approval and adoption increases, these therapies are expected to have an impact on global health care spending and should result in overall savings. However, the use of tendering to maximize the potential benefits of biosimilars has varied across the world. Therefore, the objectives of this review are to examine the drug-tendering process and its implications on drug supply and drug shortages, as well as to describe biosimilars and how tendering may influence their uptake.

Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching

“…At least one observational study of switching led to a hypothesis that switching from one agent to another may lead to a similar loss of response as seen with episodic treatment [ 10 ]; further to this, it is theorized that some patients may not have an immediate loss of response but could be potentially harmed if there is a need to switch back to the first product [ 10 ]. This flags a potential concern in an era of formulary management through preferred listings and tendering arrangements for specific products [ 11 ].…”

Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust

“…In the U.S., for example, it has been proposed that a so‐called “rebate trap” (whereby rebates offered by the manufacturer of an originator could be withdrawn in response to biosimilar competition) may create the incentive for payers to favor originators over less‐costly biosimilars, and thus act as a barrier to uptake . In contrast, significant penetration of biosimilars has been achieved in Norway via initiatives such as competitive drug tendering and commitment from the government to fund the NOR‐SWITCH study, which aimed to provide evidence about the effects of switching from originator infliximab to an infliximab biosimilar . Such examples illustrate the importance of considering the role of health care systems, policymakers, and payers in the uptake of biosimilars.…”

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

“…This is of relevance based on the decentralized organization of the German healthcare system, where the German regions are responsible for managing prescription and drug budget control activities. Regional differences in biosimilar policies and practices have been associated with the heterogeneous uptake of biosimilars between product classes and across regions [ 15 , 16 , 17 , 18 ]. In Germany, differences in biosimilar market shares were described for TNFα inhibitors at the end of 2018: in Westphalia-Lippe and Lower Saxony, biosimilar uptake was two times higher than in Baden-Württemberg.…”