Canada's HTA Body Releases Report on International Biosimilar Policies

The Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian entity responsible for health technology assessments, has released a new report that explores international policies related to biosimilar and the factors that facilitate their use.

According to CADTH, during 2016, the 30 top-selling biologics in Canada accounted for 24% of all pharmaceutical sales in the country, but 13 biologics could face biosimilar competition in Canada within the next 3 years, with a potential to generate substantial savings. “However, for a health care system to realize these cost savings, successful market uptake of biosimilars will depend on various factors, such as number and timing of entrants into the market, patient and health care provider’s understanding and acceptance of biosimilars versus biologics, cost of biosimilars, pricing policies, payer coverage and utilization policies, and policies around interchangeability and substitution,” wrote CADTH, and the report seeks to identify the international policies best suited to providing a context favorable to biosimilar use.

The report’s authors relied on literature in Medline, Embase, PubMed, and the Cochrane Library, and present findings on 4 postmarket-related policies for the United States, Australia, New Zealand, Finland, France, Germany, the Netherlands, Norway, and the United Kingdom.

Interchangeability, Switching, and Substitution

While the United States is the only nation to hold a legal definition of interchangeability that guides pharmacy-level substitution, a variety of other policies exist worldwide. In the United Kingdom, switching is managed at the providers’ discretion, and substitution at the pharmacy level is not recommended. In Germany, prescriber-led switching is encouraged. In France, patients can be switched at any time, but pharmacy-level substitution can only take place for treatment-naïve patients and with notification to the prescriber. The Netherlands permits new patients to receive biosimilars immediately, but leaves the decision to switch to prescribers. Norway similarly leaves the decision to switch to prescribers, but considers switching among reference products and biosimilars safe at any time in treatment. While automatic substitution is not permitted in Finland, switching among biosimilars and the reference at any time is permitted so long as documentation is provided. In Australia, the government actively encourages the use of biosimilars for treatment-naïve patients, and physicians may choose to switch established patients. Pharmacy-level substitution is permitted for some products. No substitution is permitted in New Zealand, where the decision to switch remains with the clinician.

Supply-Side Policies

Free pricing policies are in place for biosimilars in the United States and United Kingdom, but UK policies subject biosimilars to the Pharmaceutical Price Regulation Scheme, which sets price ceilings. The UK system also makes use of tendering procedures in both the outpatient and hospital pharmacy contexts.

In Germany, which uses internal reference pricing, the costs for biosimilars cannot exceed the cost of the reference biologic, and insurance plans can negotiate prices through tenders. German patients also must pay the difference between the retail price and the reference reimbursement price, incentivizing patients to choose cheaper products.

In France, biosimilar prices are negotiated between pharmaceutical companies and the government, with a compulsory discount on biosimilars that ranges from 10% to 20%. The Netherlands uses a reference pricing system for biosimilars, setting the price of the biosimilar at the same price as the reference. However, tenders are used to generate further discounts. In Norway, the price of a biosimilar cannot exceed that of the reference, and mandatory discounts increase with time and the number of market entrants. Finland caps the price of the first reimbursable biosimilar at a 30% discount to the reference, and the prices of the reference biologics are renegotiated once a biosimilar has launched.

Beginning in October 2018, Australia put in place a mandatory discount of 25% on the price of the reference when a biosimilar is introduced. As an incentive to prescribe cheaper drugs, pharmacists are currently allowed to keep the difference when dispensing medicines that are cheaper than the government’s reimbursement price.

Prescribing Incentives

While no prescribing incentives are in place in the United States, new Medicare Part B reimbursement rules could provide an indirect incentive to physicians to prescribe biosimilars. Meanwhile, in the United Kingdom, providers and clinical commissioners have entered into gain-share agreements that allow health systems to keep a portion of cost savings from using biosimilars. Germany uses a similar approach, and also sets national, regional, and local prescribing quotas for some biosimilars. Additionally, German physicians who exceed their pharmaceutical budget substantially must repay the amount about 115% if no justification can be provided.

France is expected to implement a new framework to promote biosimilars by setting up new contracts with hospitals, but currently, no specific policies are in place. By contrast, Finland and Norway compel physicians to choose the least expensive products.

Australia offers a faster and simpler preapproval process for biosimilars while maintaining higher requirements for reference biologics, although prescribers remain in control of which drugs are prescribed.

Promotion and Education

In the United States, both the FDA and industry are engaged in efforts to educate stakeholders, and likewise, the European Medicines Agency has published a range of informational materials.

The United Kingdom has also produced a commissioning framework for biologic medicines, and drug-specific clinical practice guidelines also facilitate the use of biosimilars. In Germany, France, Norway, and the Netherlands, specific educational programs focus on physician awareness. In Australia, the government has launched an awareness initiative that targets both providers and patients.

While the report identified a number of policy options for the Canadian healthcare system, wrote CADTH, “Whether similar policy mechanisms can be applied in the Canadian setting will depend on a complex interplay of factors and the coordinated engagement of a number of stakeholders.”