Advisory Council Supports Biosimilars in Call for Universal Public Drug Coverage in Canada

A Canadian advisory council is recommending the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a $15.3 billion (approximately US $11,408,521,500) universal, single-payer, public system for pharmaceutical coverage.

Although Canada has universal healthcare, it does not have single-payer drug coverage. There are more than 100 public prescription drug plans and more than 100,000 private plans, all with their own premiums, co-payments, deductibles, and annual limits.

The report, A Prescription for Canada: Achieving Pharmacare for All, contains 2 recommendations that pertain to the use of biosimilars. One recommendation says that there should be formulary management policies, including requiring biosimilar substitution and to encourage patients and providers to choose the most cost-effective therapies. Prescribers and patients will need better support via information that reinforces the safety, efficacy, and benefits of biosimilars, the report said.

The second recommendation says that the Canadian drug agency should also work to increase awareness about the equivalency of generics to brand-name drugs and the rationale for the greater use of generics and biosimilars in order to keep pharmaceutical care affordable.

Canada's use of biosimilars has been low relative to other countries because of a combination of factors, including limited awareness of clinical and scientific evidence supporting their use and strong efforts by brand-name biologic companies to retain market share, the report said. The report said biosimilars make up less than 7% of the biologic market in 2017 while the Organisation for Economic Co-operation and Development average is more than 30%. Seven of the top 10 prescription drugs in Canada are biologics.

The report said about CAN $3 billion (approximately US $2.2 billion) of current spending on biologics will be coming off patent over the next decade, which will provide an opportunity for pharmaceutical savings through the use of biosimilars. A drug sharing model (DSM) included in the report assumes that biologics gradually lose 40% of their market share to biosimilars over 10 years. The biosimilar discount relative to biologics coming off patent is estimated at 20%.

In a statement, Biosimilars Canada, a division of the Canadian Generic Pharmaceutical Association, praised the council's conclusion about biosimilars. "Switching or transitioning patients from original biologic treatments to their corresponding biosimilar medicines is the responsible choice for those who manage drug budgets," said Jim Keon, president of Biosimilars Canada. "Such policies are also consistent with Health Canada's recommendation that decisions should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction."

Canada has made some strides to developing its biosimilars landscape. This spring, the country’s regulator approved the first rituximab biosimilar (Truxima) to treat both cancer and rheumatoid arthritis. Some Canadian health plans are beginning to transition patients from brand-name infliximab (Remicade) and etanercept (Enbrel) to biosimilar options.

Among the 60 recommendations, there are also 5 recommendations relating to affording costly drugs for rare diseases. The recommendations call for a national strategy, set a pathway for the consideration of drugs for rare diseases, and set up a national expert panel to work with patients and clinicians to determine which rare disease drugs should be funded for which patients. The report also calls for structured real-world evidence on the impact of rare disease drugs, and recommends that the drug agency negotiate performance-based funding agreements with drug manufacturers. Besides a performance-based pricing agreement, the report also suggested that the country could use reference-based reimbursement where a drug plan would limit reimbursement to a reference standard, usually the lowest price drug or the average of drug prices in a category. Patients who use more expensive drugs would cover the difference out of pocket. If medical reasons prevent the use of the less expensive drug, full coverage for the more expensive drug would be provided with a special authorization.

The report also recommends that the Canadian drug agency ensure that decisions on expensive drugs for rare diseases are transparent.

In addition, the 5 principles contained in the Canada Health Act—that care is universal, comprehensive, accessible, portable, and public—should be apply to national pharmaceutical coverage.

Canada spent C$34 billion on prescription medicine in 2018, the second-highest spending category after hospitals. The report said only the United States and Switzerland pay more for prescription drugs, but 1 in 5 Canadians struggle to pay for prescription medicine and 3 million don't fill their prescriptions due to affordability. The report said Canada is the only country in the world with universal healthcare that does not provide universal coverage for prescription drugs.