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Everything that’s happening with biosimilars in Canada

The slow but steady adoption of biosimilars is big news. With provinces increasingly making the switch to biosimilar medications, the biosimilar wave has started across Canada.

Take the recent success of B.C., whose switching policy for biologics led the share of lower-cost biosimilar drugs to soar to 65 per cent by the end of 2021 from seven per cent of the eligible amount for biologics in January 2019, according to The TELUS Health 2022 Drug Data Trends and National Benchmarks report.

B.C.’s encouraging results are leading other provinces to launch biosimilar switching programs to reduce drug costs and open up more funding for new drug treatments. In late December, Ontario became the most recent province to introduce a transitioning policy, adding biosimilar medications to the Ontario Drug Benefit Program in 2023. Saskatchewan also implemented a biosimilars switching policy.

Currently, seven provinces and one territory have adopted biosimilar switching policies.

And more biosimilar medications are in the pipeline, promising even more savings. These are predominantly medications used to treat macular degeneration, a serious eye condition that can cause blindness and affects 2.5 million Canadians; a medication that treats a rare blood disorder; and a drug that treats autoimmune conditions.

“The more biosimilars come out and the more provinces to implement switching, the more pressure there will be on everyone to do it,” says Vicky Lee, Manager, Pharmacy Consulting with TELUS Health who tracks drug approvals and biosimilar developments in TELUS’ Pipeline Report. “And more private payors will jump in.”

“We are now seeing more and more uptake,” she says.

The optimal time for a switch

The increased interest of the provinces in biosimilars couldn’t come at a better time, according to TELUS’s Health data. It finds that four of the top 10 medication categories are dominated by high-cost, specialty drugs prescribed for a very small group of patients.

The data also shows that less than two per cent of claimants submit annual eligible amounts that exceed $10,000 and account for 40 per cent of the total eligible amount in 2021. In many cases, these high-cost claimants are taking medications to treat rare diseases, which can cost hundreds of thousands of dollars annually.

As a result, biosimilars can offer lots of cost savings, especially as more emerge to treat rare diseases. One biosimilar for Soliris (eculizumab), previously considered the world’s most expensive drug, could be approved by Health Canada as early as mid-2023, according to Lee. This drug, which treats paroxysmal nocturnal hemoglobinuria, a very rare, life-threatening blood disease that affects one to 10 people per million, costs approximately $700,000 per year.

Two other biosimilars are also expected to launch this year that treat macular degeneration. One is Byooviz, which replaces Lucentis and which was approved by Health Canada In March 2022. This drug will likely be sold for a price which is 35% to 40% lower than the originator.

The other biosimilar that treats macular degeneration is Eylea, which will likely launch before June 2024. There are many additional biosimilars that treat macular degeneration are in various stages of clinical trial development, according to Lee.

And Lee on says that late 2023 or 2024 will bring yet more biosimilar options. She says biosimilar options for Stelara, which treats Crohn’s disease, ulcerative colitis, psoriasis and psoriatic arthritis, are in the works. In January 2023, JAMP Pharma filed a submission seeking approval for a biosimilar version of Stelara. This drug is high cost and most commonly prescribed medications covered by private drug plans.

Lee says that despite the progress being made, it will take several months before new biosimilars are added to the provincial formulary, and more time before they are added to provincial switching initiatives. She says that in some cases, litigation between drug manufacturers can also tie up the approval process, leading to additional delays. Currently, there are nine submissions for biosimilars under review by Health Canada.

“It can take a long time,” she says. “Health Canada usually takes around 11 months to approve a new drug once they accept a submission.”

B.C. continues to see biosimilar breakthroughs

B.C.’s story has sparked increased biosimilar adoption. Its biosimilars initiative began in November 2019 and involves mandatory switching from nine originator biologics for which biosimilars are available.

In January 2019, TELUS Health’s claims data for private drug plans in B.C. found that biosimilar biologics represented 7% of eligible costs for biologics that had biosimilar options. Two months after the B.C. biosimilar switching policy began to roll out, that share had climbed to 20%. In 2020, growth was steady, reaching 33% in December; it then accelerated sharply in 2021 to reach 65%.

TELUS Health attributes B.C.’s success with biosimilars to the province’s universal PharmaCare plan, which led many private plans to follow the government’s switching policy. This meant they avoided picking up the costs of originator drugs  prescribed to their plan members who chose not to switch to the biosimilar medication used to treat their condition.

Ontario moves to switching policy

Ontario wants to invest in innovative drug therapies and to increase the number of life-saving drugs it offers under the provincial plan. In order to generate those funds, it plans to transition to biosimilars starting in March 2023. As of March 31, those patients receiving coverage under the Ontario Drug Benefit program for Copaxone, Enbrel, Humalog, Humira, Lantus, NovoRapid, Remicade, and Rituxan, will be required to transition to the biosimilar version by December 29, 2023.

The government recently released guidance around this switching period, recommending that patients discuss a transition plan with their health care providers. It also states that exemptions will be considered for patients in certain clinical circumstances on a case-by-case basis in consultation with their health care provider.

Ontario’s approach is founded in research that illustrates that mandated switching leads to the biggest uptake, rather than merely listing biosimilars on public formularies. However, as the Ontario Ministry of Health has signaled, its switching policy will be accompanied by physician and patient education and access to the reference drug if it is medically warranted.

Private payors to follow suit

Lee says that Ontario’s biosimilar announcement will lead private payors to expand their own switching initiatives. “As Ontario does this, private payors will join in,” she says.

She says many plan sponsors will be encouraged by the dramatic savings they will be able to achieve and the prospect of offering even more drugs to their members. In the case for rheumatoid arthritis, for example, TELUS’s Drug Trends Report predicts that public switching policies will increasingly result in more prescriptions for lower-cost biosimilar biologics for the autoimmune conditions. This will in turn be echoed in the private payor space.

Lee says plan sponsors should be aware that these switching initiatives may generate questions from plan members that they will need to be equipped to answer.

But she’s confident the increasing uptake of the provinces will be the catalyst for change—and a tool in ensuring plan sustainability going forward.

“Every little bit of savings you can reinvest is beneficial,” she says.

Note: Product Listing Agreements (PLA) are a viable cost-saving alternative to biosimilars. Plan sponsors should discuss this option with their insurers.