Challenges with implementing benefit-sharing programmes for biologicals in Europe

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Diverse policies have been implemented across Europe to support the rational prescribing of biologicals. Policies limiting the reimbursement of high-cost pharmaceuticals and applying prescription quotas for ‘best-value’ biologicals (BVB) have often been combined with educational campaigns about biosimilars and with benefit-sharing (gainsharing) initiatives [1, 2].


Although the literature on best-practices to implement educational initiatives for biosimilars is abundant [3], little is known about how to best implement benefit-sharing programmes and in what settings. Benefit-sharing programmes are incentive schemes established through multistakeholder collaboration (health authorities/payers/insurers, hospital financial departments, healthcare professionals) to generate consensus around the broad societal value offered by biosimilars and to support the prescription of BVB. The goal of these programmes is to generate savings that can be shared among the stakeholders involved, and that can be reinvested to increase patients’ access to treatments, improve quality of care and fund innovation [4].

To address knowledge gaps regarding the conduct of benefit-sharing programmes in the field of biologicals, author Teresa Barcina Lacosta and colleagues investigated benefit-sharing experiences across Europe [5]. The authors carried out a literature review and performed a series of semi-structured interviews with experts involved in benefit-sharing programmes (Ireland, Portugal, the UK, Germany, Italy, the Netherlands, Poland, Romania). According to this research, it is important for future benefit-sharing implementers to adapt the design/implementation of these programmes to the specific regulatory and political environment of the country, and to the characteristics of the healthcare system and the clinical setting. In some cases, e.g. if the savings potential associated with the use of BVB is low, it may not be economically feasible for the payer to apply benefit-sharing approaches.

Despite the variable design characteristics of the studied benefit-sharing cases and the different implementation environments, the authors detected a generalized lack of transparency regarding:
1. The outcomes achieved via benefit-sharing
2. The distribution and reinvestment of savings
3. How patients’ participation in benefit-sharing programmes specifically improved their care

Notwithstanding these challenges, the implementation of benefit-sharing initiatives can help align differing stakeholders’ views regarding the value of biosimilars and support the rational and cost-effective prescribing of biologicals. To minimize the limitations associated with the implementation of benefit-sharing programmes, careful planning and monitored execution are required. With this in mind, Barcina et al., formulated a series of recommendations to unlock the potential of benefit-sharing programmes implemented in the future, see Table 1.

Table 1: Recommendations to unlock the potential of benefit-sharing programmes for biologicals
Setting-up and timely monitoring of success indicators for benefit-sharing
Including quality of care parameters such as success indicators
Establishing clear pathways for the transparent distribution and reinvestment of savings
Transparently communicating with patients about the outcomes of benefit-sharing programmes


Conflict of interest
The authors of the research paper [5] reported conflict of interest, including being a founder of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL), as well as being involved in a stakeholder roundtable, having participated in advisory board meetings and having contributed to studies on biologicals and biosimilars. For full details of the authors’ conflict of interest, see the research paper [5].

Abstracted by Teresa Barcina Lacosta, PhD Researcher, Market Dynamics and Sustainability of Off-Patent Biologics and Biosimilar Medicines, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

Editor’s comment
Readers interested to learn more about policies to encourage the use of biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Can local policies on biosimilars optimize the use of freed resources – experiences from Italy

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2. Moorkens E, et al. Learnings from regional market dynamics of originator and biosimilar infliximab and etanercept in Germany. Pharmaceuticals (Basel). 2020;13(10):324.
3. Vandenplas Y, Simoens S, Van Wilder P, et al. Informing patients about biosimilar medicines: the role of European patient associations. Pharmaceuticals (Basel). 2021;14(2):117.
4. Duggan B, Smith A, Barry M. Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland. Int J Clin Pharm. 2021;43(5):1251-6.
5. Barcina Lacosta T, et al. Qualitative analysis of the design and implementation of benefit-sharing programs for biologics across Europe. BioDrugs. 2022;36(2):217-29.

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