Alberta will force 26,000 patients on government-sponsored drug plans to switch from expensive drugs that are known as biologics to cheaper near-copies of the medications, a move that will save the province hundreds of millions of dollars in the coming years.
The major policy change in favour of the less-expensive versions, called biosimilars, will take effect by next summer and is expected to save $227-million to $380-million over the next four years. Alberta will become the second province after British Columbia to stop covering some of the brand-name biologic drugs that have driven significant increases in prescription-drug spending across the country.
But the provincial government intends to go even further than B.C., including more drugs in the first phase of its plan and introducing a tiered framework that will limit drug choices for patients with rheumatoid arthritis and Crohn’s disease who are starting biologics for the first time.
“We’re expanding the [biosimilars] initiative to make sure that our drug programs in Alberta are going to be sustainable," Alberta Health Minister Tyler Shandro said in an exclusive interview. “We committed in the last election that we would find efficiencies and make sure that we were investing those savings.”
The government is working to rein in Alberta’s health-care spending more broadly, an effort that has already drawn the ire of health-care workers’ unions and the Alberta Medical Association.
The province’s initiative is likely to earn plaudits from those who see promoting the less-expensive medications as a sensible way to free up money for other health-care priorities.
However, some gastroenterologists and patient advocacy groups, including Crohn’s and Colitis Canada, have expressed concern that inflammatory bowel disease patients forced to switch won’t do as well on the cheaper drugs.
Health Canada and drug regulators around the world say biosimilars are as safe and effective as the original drugs they mimic.
Biologics are complex medications produced from living organisms and injected or infused into patients. They have dramatically improved the health of people with debilitating diseases such as rheumatoid arthritis and Crohn’s disease – chronic illnesses for which there used to be few good treatment options.
In Alberta, government spending on biologics skyrocketed to $238-million in 2018-19, up from just $21-million a decade earlier.
Four of the top five drugs in terms of public spending in Alberta are biologics. At the top of that list is Remicade, also known as infliximab, an intravenous infusion for rheumatoid arthritis, Crohn’s disease and ulcerative colitis, which cost the provincial government as much as $91.2-million last year – more than any other single drug.
The list price for Remicade in Alberta is $962.68 a vial, while the biosimilar versions, Inflectra and Renflexis, sell for $525 and $493 a vial, respectively. (List prices don’t reflect the confidential discount deals that are now commonplace in the global pharmaceutical industry, meaning the Alberta government could be paying less.)
Biosimilars are almost like generics: They are cheaper near-copies of original biologic drugs whose patents have expired. However, biologics, unlike simple chemical pills, can’t be replicated perfectly from batch to batch, even within the same brand.
That complexity has allowed some opponents to argue that biosimilars aren’t as safe or effective as original biologics, especially for patients who are being asked to switch for financial instead of health reasons.
But the bulk of the international evidence – mainly from Europe, where more than 40 approved biosimilars are available – has shown no significant differences in safety or efficacy after switching.
Alberta’s plan will require existing patients on government-sponsored drug plans to switch to the biosimilar versions of Remicade and four other drugs: Enbrel, which treats rheumatoid arthritis; Lantus, a long-acting insulin for diabetics; and Neulasta and Neupogen, both of which boost white-cell counts for chemotherapy patients.
Existing users of a drug called Copaxone for multiple sclerosis will be switched to a complex generic at the same time. The government is including the drug in its initiative even though it is not technically a biologic.
The changes are expected to affect about 22,000 Albertans with diabetes, 2,000 with Crohn’s disease or ulcerative colitis, 1,400 with rheumatic diseases, 750 with multiple sclerosis, 450 with low white-blood cell counts and 35 with plaque psoriasis.
The changes, which kick in July 1, 2020, do not apply to patients with private insurance or patients who pay out of pocket for their prescription drugs.
Children and pregnant women will be exempt. Physicians who believe there is a medical reason why a patient should not switch will be allowed to apply to the province for an exemption.
For patients with Crohn’s disease, rheumatoid arthritis and related rheumatic diseases who are either starting biologics for the first time or switching away from a biologic that has stopped working, a new tiered framework means they will have to try cheaper biologic options first.
For example, Crohn’s patients new to biologics will first have to try one of the two Remicade biosimilars or another IV drug called Entyvio before they are allowed to access public coverage of Humira, an expensive treatment that patients can self-inject but for which biosimilar alternatives are not yet available in Canada.
Current Humira patients will be allowed to retain government coverage for the drug.