An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain

Abstract

BackgroundThe availability of biosimilar medicines in Southern European markets has allowed purchasing biologics at a lower cost for healthcare systems. However, the capacity to seize this cost-reduction opportunity in the long run depends on fostering a sustainable competitive environment for all the market players involved. Diverse policies and information campaigns have been launched in Italy, Portugal and Spain to support uptake of “best-value” biologics (BVB). Despite these measures, the utilization of lower-cost biologics in certain regions is low, especially when it comes to the treatment of chronic conditions.ObjectiveWe aim to identify biosimilar uptake determinants in hospital environments in Italy, Portugal and Spain, using the class of TNF-alpha inhibitors as an example.MethodsThis is a mixed-methods study based on (1) the quantitative analysis of regional uptake data for TNF-alpha inhibitor biosimilars and (2) the qualitative processing of semi-structured interviews capturing experts’ views on uptake determinants for biosimilars.ResultsThe organization of multi-stakeholder information campaigns supporting TNF-alpha inhibitor biosimilars use in Italy, Portugal and Spain has resulted in an increased familiarity of healthcare professionals and patients with the prescription/use of these products. However, barriers persist that impede high biosimilars uptake, especially in chronic patient populations eligible for a switch. These are: (1) the late publication of position statements on biosimilars interchangeability by regulatory health authorities; (2) the vague positioning of (national/regional) health authorities on best switching practices (including multiple biosimilar-to-biosimilar switches); (3) the existence of policy frameworks that do not necessarily support the initiation of switching protocols; (4) the establishment of sometimes inefficient purchasing procedures that limit biosimilars potential to compete for market shares. Diverse approaches taken regionally to address these barriers have contributed to heterogeneous TNF-alpha inhibitor biosimilars uptake across Southern Europe.ConclusionOur research signaled the limited reach of biosimilar policies implemented locally, if not supported by a national policy framework. This study highlights the need for the coordinated implementation of policy measures fostering biosimilars use at the regional and national level in Italy, Portugal and Spain. These measures should account for the particularities of off-patent biologic and biosimilar markets and should jointly address supply- and demand-side challenges.

Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review

“…A study by Kim et al [ 33 ] found that demand-side policies used in the UK and France have been more effective than the supply-side price linking policy used alongside few demand-side policies, where the volume of the originator brand of infliximab actually increased. A study by Barcina Lacosta et al [ 34 ] lists the existence of policy frameworks that do not necessarily support the initiation of switching protocols as one of four key barriers to biosimilar uptake.…”

Patient’s and Consultant’s Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study

“…If this study were replicated, it is hypothesised that consultants' responses would likely vary due to increased experience working with the pharmacy team. For instance, embedding a pharmacist in the gastroenterology inflammatory bowel disease standards and the practice of patient-centred care, which has successfully expanded into rheumatology and dermatology clinics, underscores the importance of pharmacist involvement [19,40,41]. Pharmacists, as medicinal product specialists, can mitigate barriers and dispel misconceptions about for other healthcare professionals and patients, potentially streamlining communication and improving adherence to treatments.…”

“…Real-world data and publications of position statements from the Royal Colleges, British Society of Gastroenterology (BSG), British Society of Rheumatology (BSR), and British Association of Dermatology (BAD) also provide patients and consultants with reassurance [18,19].…”

Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly

“…In Europe, the ratio of biosimilar to reference drug users varies, often changing over time in favor of biosimilars [ 22 – 28 ]. This trend is most pronounced in countries where substitution is mandatory, and determined by tenders.…”

“…In order to encourage wider uptake of biosimilars, various countries are implementing different incentive systems [ 19 , 33 – 36 ]. Studies from various European countries, including Poland, show that the share of off-patent drugs is steadily decreasing, at the expense of more modern on-patent therapies [ 10 , 21 , 22 , 30 ]. While selecting the cheapest drug from the off-patent group guarantees its market share, there is no priority over other on-patent drugs, often with different modes of action.…”