Fostering Biosimilar Policies for a Sustainable Future

March 28, 2019
Kelly Davio

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

In her opening keynote speech, Ruth Lopert, BMed, MMedSc, health policy analyst in the health division, Organisation for Economic Co-operation and Development (OECD), a group that advises member countries on health system resource use, highlighted the fact that, while 90% of the global biosimilars market is in Europe, there remains wide variation in availability and uptake of biosimilars. “That heterogeneity occurs across countries and across settings of care,” she said. “I was struck by the extent of their variability…across a single continent that has a single regulator.”

The growing cost of drugs, however, makes biosimilar adoption a pressing issue, and maintaining access to treatment will require profound transformations in health systems. In 2016, she explained, pharmaceuticals comprised 17% of all health spending in the European Union, excluding drugs used in hospitals. In some countries, particularly those with low resources, pharmaceuticals totaled an even larger share: Bulgaria, for example, spent 40% of its health resources on prescription drugs, and more than 70% of households’ out-of-pocket medical spending goes to drugs.

In order to enhance biosimilar uptake and free up healthcare resources, nations will have to address the hesitancy around biosimilars by promoting their acceptability among prescribers and patients, and by creating “nudges” for biosimilar prescribing.

Regulatory challenges must also be addressed, and, Lopert emphasized, the regulatory environment is not only about approvals; issues that touch on biosimilars also include nomenclature, requirements for bridging studies, and approaches the use of global reference products, as well as intellectual property issues.

Finally, said Lopert, nations must promote competition, and “not just competition, but healthy competition” that encourages multiple developers to remain in the market. The competition that delivers the lowest prices, said Lopert, is not necessarily healthy; while single-winner tenders are attractive to payers for short-term cost-saving, they may not be ultimately sustainable.

In a panel discussion following Lopert’s keynote, Peter Goliaš, director, of the Slovakian think tank the Institute for Economic and Social Reform, asked an international group of panelists about their biosimilar policy hurdles, about which policies will be needed to realize the potential of biosimilars, and about how stakeholders can balance short-term cost savings against long-term sustainability of the market.

Judit Bidló, PharmD, MSc, deputy director of the National Health Insurance Fund Administration of Hungary, explained that, in her country, the uptake of biosimilar infliximab has reached nearly 100%, but the uptake of biosimilar insulins has been low—below 5%. According to Bidló, the reasons for this fact are not yet clear, and officials would like to better understand these figures. He suggested that one factor could be the fact that providers do not yet feel a pressure to prescribe biosimilars, adding, “if there is no punishment, only some recommendations,” it is difficult to influence prescriber behavior through prescribing quotas. Additionally, there is no price sensitivity for patients in Hungary, as there is no copayment for biologics.

Flora Mulder, senior policy advisor in the Ministry of Health, Welfare, and Sports in the Netherlands, added that biosimilar insulin has also seen slow uptake in the Netherlands. However, the Netherlands does not have a specific policy on biosimilars. While the country does undertake educational activities, “We try to promote competition” among alternatives, not to promote biosimilars pe se."

Marta Pastor Fàbregas, health economist in the Catalan Health Service (CatSalut), one of 17 healthcare services operating in Spain’s tax-based universal healthcare system, said that, when CatSalut realized that its biosimilar uptake was among the lowest across Spain’s services (9.1% versus a national average of 14.7%), it decided to require hospitals to use biosimilars in at least 80% of new patients, and also to provide economic incentives for hospitals that reach that indicator. The system is also now using flat rates for payment for certain therapies that use biosimilars’ price as the benchmark for payment; using higher-cost therapies could result in losses, while using the biosimilar would result in full payment.

These policies, said Fàbregas, have resulted in modest improvement in biosimilar uptake, with CatSalut now using 11.1% biosimilars, and the region intends to continue to refine its approach as it seeks longer-term results.

Gustaf Befrits, MSc, health economist for Stockholm County Council, Sweden, explained that, unlike neighboring Nordic countries, in Sweden, switching to biosimilars is not actively promoted, but switching stable patients is not actively discouraged. On the supply side, biosimilars are encouraged through the use of confidential discount agreements in the tendering process; on the demand side, through gain sharing and expanded patient access, both of which help encourage physicians to use biosimilars. “If we get the physicians along, we will have an easier time,” he said.

In Sweden’s 2018 tender for trastuzumab, he explained, the council used complete gain sharing, in which any savings made from the biosimilar tender winner, Ontruzant (which was introduced at “a very advantageous price”) were retained by the budget holder, such as a hospital.

“There’s a clear indication that more patient are getting access to [trastuzumab] since we introduced Ontruzant,” he said, and physicians and patients alike have been accepting of a need to return to intravenous infusions from subcutaneous brand-name Herceptin in order to use the biosimilar. “In general, we have had no pushback,” said Befrits, who credited local social culture and a desire to benefit other patients through expanded access as driving factors of this acceptance.

Finally, Beata Ambroziewicz, president of the Polish Union of Patient Organizations and board member of the Polish Cancer Patient Coalition, Poland, brought the discussion to the patient perspective: “Everything that we are discussing today, but more importantly, what we are doing or not doing, has a great impact on patient lives, now and in the future,” she said. Ambroziewicz added that, in Poland, communication about biosimilars has been polarized form the outset: on the one hand, proponents of biosimilars were eager to undertake nonmedical switching of all patients, and on the other, those who were skeptical argued against switching any patients.

“Somehow we lost the meaning of the switch from the medical point of view,” she said, and added that misinformation is creating a lack of trust among patients: “We’re losing patients who could really benefit from the biosimilar treatment.”