Policy Differences Among European Nations Affect Biosimilar Uptake

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives. A paper newly published in PLOS One provides an overview of the initiatives and policies that have influenced biosimilar uptake in 24 European countries, and makes recommendations as to how to create a sustainable market for biosimilars in Europe.

Obtaining data from a questionnaire administered to country experts, validated by additional exerts, and supplemented with relevant literature, the researchers considered the biosimilar experience in 24 countries, (20 EU member states* and Iceland, Norway, Russia, and Serbia). At the time the study was conducted, biosimilars had been launched in Europe for the following products: filgrastim, somatropin, erythropoietin alfa, insulin glargine, follitropin, infliximab, and etanercept.

Funding

The researchers found that, as of April 2017, there existed discrepancies between biosimilars that were available in a given country and those that were funded by health systems. For example, in Austria, while insulin and follitropin biosimilars are available, they are not funded. Estonia, Iceland, and Russia did not fund available epoetin biosimilars. Available etanercept biosimilars were not funded in Bulgaria, Croatia, Estonia, Finland, Slovenia, Russia, or Serbia. In fact, only 1 country studied—Germany—had all registered biosimilars available and funded by its health system.

Pricing

In all countries studied, the most frequent biosimilar pricing mechanism in ambulatory care was pricing at a percentage below the price of the originator product and the use of a maximum price. However, most countries used multiple price mechanisms to determine the price of a biosimilar in ambulatory care.

For example, in Iceland, the price of a biosimilar must not be higher than the lowest wholesale price available across 4 other countries: Denmark, Norway, Sweden, and Finland. When a biosimilar is on the market, the price of the reference product must be reduced to 80% of the original price.

By contrast, in Malta, a maximum price is set through reference pricing for national procurement, and the government procures medicines by tendering. Because specifications for procurement rely on international nonproprietary names (INNs) for drugs, biosimilars and originator products compete on the same procurement procedure.

Meanwhile, in Germany, the price of a biosimilar is freely set by the manufacturer, and discounts are negotiated through tenders with healthcare funds.

Reimbursement

Reimbursement is governed by national authorities in all countries studied, and in Italy, the United Kingdom, and Russia, regional budgets are also involved. In most countries, reimbursement is granted for all indications of a biosimilar that are authorized; in Croatia and Serbia, reimbursement is only granted for indications in which a clinical trial was conducted.

Some countries, such as Malta, have a fail-first policy; a product not approved as first-line treatment must be used after treatment failure of another product has been demonstrated.

In two-thirds of the countries studied, originator products and biosimilars are subject to internal reference pricing, in which a common reimbursement level is set for a group of products.

Demand-Side Policies

Approximately half of the countries studied have incentives for physicians to prescribe biosimilars. For example, France encourages physicians to prescribe biosimilar insulin glargine in ambulatory care in at least 20% of cases. In Germany, quotas exist for some biosimilars in region-specific economic targets. In Austria, physicians are called upon to prescribe the most cost-effective options available. In Norway, physicians have to follow a set ranking to select the cheapest product available unless clinical factors dictate otherwise.

Substitution

Substitution at the pharmacy level is not permitted in most of the countries studied, with the exception of Estonia (where prescribing employs INNs alone; substitution may therefore occur in biologic-naïve or experienced patients), France, Latvia, Poland, and Russia.

Recommendations

The experts surveyed gave recommendations for overcoming obstacles to biosimilar uptake, including the following:

• Increase patient and provider education efforts, especially related to safety and efficacy, as well as to switching and substitution.
• Support competitive price systems to create a sustainable market.
• Involve more stakeholders in supporting switching to biosimilars, shifting the burden for conducting switches away from prescribers alone.
• Provide, via the EMA, more guidance on biosimilar substitution to EU member states.
• Promote rational prescribing and adherence to prescribing measures.
• Include all stakeholders in an effort to more efficiently allocate available healthcare resources.

The authors of the paper conclude that, while most of the countries investigated have policies that promote biosimilars, more must be done to educate patients and prescribers about biosimilars in order to create trust and help sustain the biosimilar marketplace.

*Austria, Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Malta, Netherlands, Poland, Portugal, Slovenia, Spain, Sweden, and the United Kingdom.