Policy Barriers Limit Biosimilar Access in Some European Nations

While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.

A paper newly published in Biomed Research International describes factors that limit the increased use of biosimilars in 10 nations where financial constraints are greater than they are elsewhere in Europe.

In 2015, using a survey that collected feedback from 2 policy experts (1 from a public agency and 1 from a private entity) each in Bulgaria, Czech Republic, Hungary, Kazakhstan, Latvia, Lithuania, Poland, Romania, Russia, and Slovakia, researchers sought to understand the policy environment in each country to the eventual uptake of trastuzumab, rituximab, and infliximab biosimilars.

Across the countries, a number of key barriers to patient access to biologic therapy were identified, including:

• Volume limits on the number of patients who can be treated with a biologic product under public reimbursement
• Waiting lists for treatment (even for oncology indications)
• Limited-duration treatment with a biologic
• Nonreimbursement of complementary diagnostics
• Additional patient eligibility criteria
• Restricted reimbursement (for example, reimbursement only for metastatic disease).

The respondents said that the key benefit of biosimilars would be increased access to treatment; cost savings and the increased number of treatment options were mentioned only as secondary benefits.

The participants identified the following issues as limiting patient access to biosimilars:

• Extrapolation of indications. In Bulgaria and Slovakia, clinicians face restrictions on the use of biosimilars in indications that rely on extrapolated data.
• Concerns about switching. Many clinicians remain concerned about immunogenicity after switching from a reference to a biosimilar. Because of these concerns, all nations but Russia reported that they regularly review pharmacovigilance data on biosimilars according to European Medicines Agency criteria.
• Nonmandatory switching. Although in many countries, both treatment-naïve patients and treated patients are expected to use the lowest-priced or tender-winning drug, in other nations, the tender-winning drug is only given to patients not previously treated.

While the authors note that the generalizability of their findings are limited by the small number of policy experts engaged in each country’s survey, they write that their findings indicate a need for more affordable biologic therapies in these less wealthy nations.

“Policy makers have to take a strategic approach to increase societal benefit from biosimilar medicines,” conclude the authors. “Relying on free-market incentives may not be strong enough; hence, active government interventions instead of ‘passive disinvestment’ policies are needed to correct for current access limitations.”

Reference

Inotai A, Csandi M, Petrova G, et al. Patient access, unmet medical need, expected benefits, and concerns related to the utilisation of biosimilars in Eastern European countries: a survey of experts [published online January 10, 2018]. Biomed Res Int. doi: 10.1155/2018/9597362.