The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

Abstract

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices

“…For example, NHS England and Amgros (the Danish procurement body) sought strategies to ensure rapid biosimilar adoption and generate immediate savings [ 54 , 61 ]. In Norway and the Netherlands, the originator manufacturer was able to retain market share by offering steep discounts [ 62 ]. Although the biosimilar market entry of adalimumab biosimilars may have been a unique casus, as a multitude of competitors were lined up to enter simultaneously the market to compete with the number one blockbuster drug worldwide, lessons can be derived, such as the importance of well in advance preparing and planning for biosimilar market entry [ 54 , 55 ].…”

Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: Findings and implications

“…27,39 However, physicians and health authorities need to instigate policies to enhance the use of biosimilars in B&H building on successful experiences in other countries. 18,44 These include educational policies to address concerns and lack of trust with biosimilars given the impact of the nocebo effect in this area, 44,45 alongside prescribing targets and restrictions for more expensive originators. 10,43,44 Otherwise, there will continue to be limited use of biosimilars.…”

The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future

“…The limited number of Western European countries and regions for comparative purposes included Italy, Spain (Catalonia) and the UK (Scotland). These countries and regions were chosen as they have instigated multiple activities to enhance biosimilar use ( 54 , 80 – 83 ).…”

“…Greater discounts for insulin glargine biosimilar will enhance formulary listing/reimbursement where there are still concerns with the current role and value of long-acting insulin analogues vs. NPH and other insulins as seen in the current WHO EML ⚬ Introduce target prescribing goals (quality indicators) for starting patients on 100 IU/ml biosimilar insulin glargine where possible when prescribing a long-acting insulin analogue. In addition, seek to introduce switching targets provided suitable educational support and funding is in place to address concerns when patients are switched between different devices alongside other demand-side measures to enhance preferential prescribing of biosimilars including financial incentives ( 80 , 108 , 173 ). This recognizes that any quality target introduced by health authorities must be acceptable to key stakeholder groups and measurable ( 174 , 175 ).…”