British Columbia continues to lead the way across Canada by expanding its biosimilars program to include another patient group, while using cost savings to introduce new improvements in patient care.
Approximately 1,700 gastroenterology patients on the drug infliximab will have six months to transition their prescription from the biologic version to one of two biosimilar options. Infliximab is a drug that is administered by infusion and treats the inflammatory bowel disease (IBD) conditions Crohn’s disease and ulcerative colitis. The infliximab biologic is known as Remicade, and the infliximab biosimilars are known as Inflectra and Renflexis. After March 5, 2020, PharmaCare will no longer provide coverage for Remicade for these indications.
“The evidence clearly shows that these patients can transition from original biologics to biosimilars safely and effectively, which are key considerations that have always been our top priorities with this change,” said Adrian Dix, Minister of Health. “We know that the use of biosimilars in other countries has worked extremely well in ensuring people get the medication they need and it’s time we caught up. By using biosimilars in B.C., we will be putting about $96.6 million back into health care over the next three years.”
B.C. is reinvesting these savings into more resources for complex IBD patients by providing funding for more nursing support and granting full coverage of a new non-invasive diagnostic test called the fecal calprotectin test. The test assesses intestinal inflammation and will help physicians and patients to better understand and manage their condition.
“I was honoured to offer my expertise as part of government’s consultation process leading up to the biosimilars policy,” said Dr. Brian Bressler, clinical associate professor of medicine, division of gastroenterology, UBC and founder of the IBD Centre of BC. “Given the existing international evidence on biosimilars for the management of IBD, I have confidence in their efficacy and safety. Using biosimilars and reinvesting the substantial cost savings into more comprehensive care for IBD patients is an innovative model that will provide my patients with more resources that they desperately need and will improve their quality of care.”
B.C. is following evidence-based results from a number of international jurisdictions that have more than 10 years of experience with these innovative drugs.
Despite clear evidence to support the use of biosimilars – highly similar versions of biologics that cost anywhere from 25% to 50% less – Canada has a significantly lower use rate for biosimilars compared to other jurisdictions, at approximately 8%. Other nations have upwards of 50% to 95%.
To provide further clarity around biosimilars, Health Canada recently updated its information to confirm that patients and health-care providers can have confidence that they are effective and safe for each of their authorized indications, and no clinical differences are expected following a change between a biosimilar and its reference biologic drug (1). Other federal organizations also support the use of biosimilars.
“Canadian Digestive Health Foundation knowledge translation enables patients and their health-care professionals to have an informed dialogue when making decisions regarding treatment,” said Jeff Suggitt, CEO, Canadian Digestive Health Foundation (CDHF). “It is important to stress with biosimilars that the rigorous standards for authorization set by Heath Canada means that both patients and health-care providers can have the same confidence in the quality, safety and efficacy of a biosimilar that they have with the biologic. Patients and health-care professionals should also know that the money saved through biosimilar policies can be reinvested into the health care system – which is what B.C. is doing. Some patients may not be medically able to transition to a biosimilar, so CDHF recommends that patients speak with their gastroenterologist to determine if it is medically necessary to remain on the biologic drug.”
Bioengineered drugs, known as biologics, collectively are the single biggest expense for public drug plans and their costs continue to climb. In 2018, B.C. spent $84.2 million on Remicade, and in 2017, Canada spent $1.1 billion on the drug. Since Remicade was first approved for sale by the federal government in 2001, British Columbia has spent more than $671 million to fund it.
The initial biosimilars program announcement in May 2019 highlighted that about 20,700 British Columbians living with either ankylosing spondylitis, diabetes, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis would have six months to work with their health-care team to transition their prescription from the biologic to the biosimilar drug by Nov. 25, 2019.
As of Aug. 15, 2019, many patients have already met with their prescriber and switched from the biologic drug to a biosimilar version well in advance of the November deadline. Roughly 355 people, or 18% of PharmaCare-covered patients taking Enbrel, have switched to Brenzys or Erelzi. Seventy people, or 17% of patients, switched from Remicade to Inflectra or Renflexis, and 2,078 people, or 11% of patients, moved from Lantus to Basaglar. As well, infusion centres have been set up for Inflectra and Renflexis and are available throughout the province, and physician use and patient enrolment at these centres is growing rapidly.
“The use of biosimilars allows us to support new drug listings and improve patient care. I am proud of the enhancements that we have made to PharmaCare over the past year, and we will continue to find ways to better support patients by making improvements to the system as a whole,” Dix added.
With the immediate savings from the increased use of biosimilars, two new drug listings were added to PharmaCare (Jardiance, a diabetes drug and Taltz, a psoriatic arthritis drug) and coverage of several existing rheumatology drugs were enhanced to increase patient access.
Exceptions may be granted for patients whose physicians determine they are medically unable to transition to the biosimilar drug. Exceptional coverage requests will be reviewed by PharmaCare’s Special Authority branch on a case-by-case basis, in consultation with physician-led advisory committees as needed. Patients or health-care providers with questions about transitioning to a biosimilar can access support by emailing Biosimilars.Initiative@gov.bc.ca or calling 1 844 915-5005, Monday to Friday, from 8:30 a.m. to 4:30 p.m.
1. Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html
- This announcement continues to work toward improving access to prescription drugs for British Columbians.
- In January 2019, B.C. made a $105-million investment, over three years, to reduce and/or eliminate deductibles and co-payments for lower-income British Columbians.
- B.C. also held a leading role in the national Generics 2.0 agreement to lower costs of the most commonly prescribed drugs and actively participates in the pan-Canadian Pharmaceutical Alliance to negotiate for lower drug costs for all Canadians.
- British Columbia will continue to work to make sure everyone can afford and receive the medication they need.
For more information about biosimilars: www2.gov.bc.ca/biosimilars
Three backgrounders follow.