How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

Biosimilars/Research | Posted 21/06/2019 post-comment0 Post your comment

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, reimbursement and policies on market entry and use of medicines. This decentralized responsibility results in diverging approaches towards market entry and uptake of biosimilars and contributes to variation in the use of biosimilars across European countries, and even within countries differences in biosimilar uptake levels exist. The latter is the case for the 21 counties of Sweden, implying that decisions taken by their county councils play a role in market access of biosimilars, alongside policy measures and incentives provided at the national level.

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Via analysis of market data and local interviews, Moorkens et al. studied these regional-level market dynamics for biosimilar and originator infliximab and etanercept in the 21 counties of Sweden, in order to come up with drivers and enablers in the Swedish healthcare system to leverage competition from biosimilars [1, 2]. Sweden is an interesting country to study these dynamics, as infliximab is an in-hospital product paid for at the county level and etanercept is an outpatient product, reimbursed via a centralized budget. The study resulted in two reviews, one on infliximab in the hospital setting [1] and one on etanercept in the outpatient setting [2].

Market shares of both biosimilar infliximab and etanercept varied widely between the Swedish counties, 18%−96% and 40%−82%, respectively in 2017. The initial uptake of biosimilar infliximab in 2015 was slow and varied widely, with later abrupt increments in biosimilar market shares coinciding with the expiration of existing contracts for the originator product. For biosimilar etanercept, which first entered the market in 2016, also early and late adopters could be distinguished across counties.

Simple regression analysis on the infliximab data set, which included discounts from (tender) contracts, showed that 59% of the variability in biosimilar market shares can be explained by the relative difference in discounted price between the biosimilar and the originator product, with higher biosimilar market shares with increasing differences in discounted price. For etanercept, when taking into account a gainsharing agreement between the county councils and government, authors’ estimates of actual costs for the counties to use the different etanercept products reveal only small price differences between products, limiting incentives to start switching patients. Furthermore, as prescriptions for treatment with etanercept are often provided for a year, two approaches are possible to switch patients: 1) active pullback of prescriptions resulting in additional workload that might not be compensated for by savings resulting from the lower-priced product; or 2) wait until the patient’s next visit.

In addition, qualitative analysis of the interview data indicated that the attitude of key opinion leaders and clinic heads, local guidelines and initiatives, and whose budget it affects are drivers in the decision-making process and may affect the extend to which competition from biosimilars is leveraged in a county. These factors become more important when price differences are limited, as is the case for etanercept.

Variation in biosimilar infliximab market shares between Swedish counties is thus largely explained by the discounted price difference between biosimilar and originator product, and counties used different strategies to leverage such biosimilar competition. Prices for etanercept products are coordinated nationally, but still regional variation in biosimilar etanercept market share can be seen. This suggests that counties react differently to price differences and highlights the role of local policy and practices. For both infliximab and etanercept, the presence of key opinion leaders, local guidelines and gainsharing arrangements seem to play a role in market dynamics.

Conflict of interest
The author of the research paper [1, 2] declared that there was no conflict of interest.

Abstracted by Evelien Moorkens, PhD Researcher Market Access Biosimilars, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

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

Pharmaceutical policy interventions in times of economic recession

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Related article
International policies for interchangeability, switching and substitution of biosimilars

1. Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: part 1-biosimilar and originator infliximab in the hospital setting. BioDrugs. 2019;33(3):285-97.
2. Moorkens E, Simoens S, Troein P, et al. Different policy measures and practices between Swedish counties influence market dynamics: part 2-biosimilar and originator etanercept in the outpatient setting. BioDrugs. 2019;33(3):299-306.

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