Analysis of evergreening and policy options Dutch National Healthcare Institute
The Dutch National Healthcare Institute (ZIN) is committed to effectively addressing the phenomenon of “evergreening” when evaluating pharmaceuticals. Evergreening is a strategy of manufacturers to hinder competition from biosimilars and generics by obtaining additional patents. ZIN asked SiRM to conduct comprehensive research to understand evergreening, its implications and the potential actions ZIN can undertake.
The Healthcare Institute of the Netherlands (ZIN) is committed to effectively addressing the phenomenon of “evergreening” when evaluating pharmaceuticals. ZIN has commissioned the consultancy firm SiRM to conduct comprehensive research to understand evergreening, its implications and the potential actions ZIN can undertake. To explore these research questions, we conducted thorough deskresearch and approximately 20 interviews and organised three group discussions involving stakeholders from ZIN and the Ministry of Health, Welfare, and Sport (VWS).
Multiple definitions of evergreening exist in the literature. In this study, we define evergreening as a strategy manufacturers employ to hinder competition from biosimilars and generics by obtaining additional patents. Such patents may involve minor modifications to the original drug – such as dosing frequency, combination therapy, or formulation changes – that offer user benefits but no significant clinical advantages. Additionally, manufacturers may seek patents for aspects unrelated to the original drug, such as manufacturing characteristics. This strategy aims to maximise a drug’s revenues after the original patent’s expiry by maintaining a high price and/or a significant market share through the evergreened product. Manufacturers also employ other revenue-maximising strategies beyond the scope of this study.
Successful evergreening results in higher societal expenditures because it impedes the impact of biosimilar and generic competition on drug prices. The increased spending primarily stems from the absence or delay of a potential decrease in expenditures. Furthermore, the success of evergreening may vary across drug groups, and it potentially delays access to modified drugs with marginal user benefits (manufacturers wait to bring them to market until the original drug is close to patent expiry). Lastly, evergreening may lead to reduced investments in new drug development.
While the Dutch government has limited influence on patent legislation, it can collaborate with health insurers to mitigate evergreening’s negative impact on drug expenditures through reimbursement policies. ZIN can play a crucial role in determining the eventual price paid for evergreened drugs, particularly regarding the outpatient and costly inpatient drugs it assesses. Therefore, ZIN can anticipate the original drug’s future patent status when advising on evergreened drugs and critically evaluate the cost-effectiveness of the original drug. Furthermore, ZIN can support stakeholders in addressing evergreening more effectively.
