Abstract
BACKGROUND: Diverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and offer regional guidance. OBJECTIVES: This study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the different counties of Sweden, and examine the influence of local policy measures and practices, in addition to national policy. METHODS: This study was performed in three steps: (1) a structured review of the literature on (biosimilar) policies in Sweden; (2) analysis of market data on the counties' originator and biosimilar etanercept uptake (quarter two 2012 to quarter four 2017) provided by IQVIA™; and (3) discussion of findings in face-to-face semi-structured interviews with the national pricing and reimbursement agency, key experts in the county councils of Skåne, Västra Götaland and Stockholm, and an industry representative. RESULTS: Notwithstanding the existence of a national managed entry agreement for etanercept, wide variations in biosimilar market shares between counties were observed (40-82% in 2017). Over time, early and late adopters of biosimilar etanercept can be distinguished. In quarter four 2017, biosimilar market shares of all counties slightly decreased in accordance with the lower priced originator product from 1 October 2017. As prescriptions for treatment with etanercept are often provided for a year, two approaches are possible to switch patients: active pullback of prescriptions resulting in additional workload, or wait until the patient's next visit. Qualitative analysis indicated that the choice to use the biosimilar or the originator product depends on differences in rebated prices of the biosimilar and originator product, the presence of key opinion leaders, local guidelines, and financial streams and local gainsharing arrangements. Our estimates of current rebated prices and costs after gainsharing for the county councils and Government reveal only limited price differences between products. CONCLUSIONS: Regional variations in use of biosimilar etanercept can be seen although prices are coordinated nationally. This suggests that counties react differently to price differences and highlights the role of local policy and attitudes of stakeholders towards biosimilars and switching. It seems that some counties are hesitant to switch patients, as it is associated with an increased administrative workload that might not be compensated for by savings associated with a lower priced product.