IBD: Crohn's Disease
BC Biosimilars Initiative: Phase Two – Information
CDHF is Canada’s trusted source for timely information on the BC Biosimilars Initiative: Phase Two
What is Changing?
BC PharmaCare coverage is changing for people who take Remicade® (infliximab) for the treatment of Crohn’s disease or ulcerative colitis.
Patients currently receiving the biologic drug infliximab, marketed as Remicade®, will see this coverage discontinued, with new coverage provided for the biosimilar versions of infliximab: Inflectra® and Renflexis™.
If you are currently receiving Remicade® to treat your Crohn’s disease or ulcerative colitis and you depend on BC PharmaCare coverage, you need to make an appointment with your gastroenterologist (GI) to discuss this policy change.
Between September 5, 2019 and March 5, 2020 anyone with existing Special Authority coverage for Remicade® will be required to switch to either Inflectra® or Renflexis™. This provides a six-month time frame to switch to the new biosimilar.
As of March 6th, 2020, BC PharmaCare will only cover the biosimilar versions of infliximab: Inflectra® and Renflexis™, for patients living with Crohn’s disease or ulcerative colitis.
BC Pharmacare will consider requests from physicians for patients with exceptional medical requirements that may prevent them from switching to a biosimilar.
What is a Biosimilar?
A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference or originator biologic drug).
Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.
Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved 15 biosimilars including 3 anti-TNF therapies: INFLECTRA® (inflixmab), RENFLEXIS® (infliximab) and HADLIMA® (adalimumab).
Quality and Safety Around Biosimilars
To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug.
Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.
Transitioning to a Biosimilar is Safe and Effective
Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.
Frequently Asked Questions
1. What is a Biologic?
Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.
2. What is a Biosimilar?
A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.
3. What do experts say about the safety and efficacy of biosimilars?
Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the biologic. The biosimilars involved in BC PharmaCare’s Biosimilars Initiative have been approved by Health Canada and are already in widespread use.
4. Do I have to switch to a biosimilar?
If you receive coverage through BC PharmaCare and you currently take Remicade® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (March 5, 2020) to avoid any disruption to your coverage.
There may be medical reasons why some patients cannot switch to a biosimilar. Your gastroenterologist can help you determine if it is medically necessary to remain on a biologic (originator) drug. Your gastroenterologist can submit a Special Authority Request to ask BC PharmaCare to consider continued coverage of the reference biologic drug.
5. What are the benefits of biosimilars?
Biosimilars are developed and approved based in part on data generated during the research and development of the reference biologic drug. Extensive structural and functional studies demonstrate a high degree of similarity between the biosimilar and reference biologic drug, with clinical trials in humans confirming no clinically meaningful difference in efficacy. The difference in development processes allow for biosimilars to be launched at lower prices than the reference biologics representing the potential for major cost savings that can be reinvested into the healthcare system.
Due to the cost savings provided by biosimilars, the launch of infliximab biosimilars in Canada allowed Ulcerative Colitis patients in BC, QC, NB, NS, and NL to have access to infliximab for the first time. The reference biologic (Remicade®) was not covered for Ulcerative Colitis in these provinces.
A healthy and competitive drug market can support more manufacturers to produce new and affordable drugs. Biosimilars will enable patients to have access to many other life-saving treatments. Phase 1 of BC Biosimilar Initiatives allowed BC Pharmacare to cover 2 new innovative medicines for patients with diabetes and psoriatic arthritis (Taltz and Jardiance). Phase 1 also provided Accelerated Access to biologics for Rheumatology patients.
6. Why is coverage changing in BC?
As new treatments are developed, BC PharmaCare must review which drugs are covered and carefully consider how to best meet the needs of B.C. residents. Since the introduction of biologic drugs in the 1980s, these treatments have become the biggest drug expense in Canada. As patents on biologic drugs begin to expire, other manufacturers can start producing highly similar versions of the medication with no differences, at a much lower cost. These versions are called biosimilars. Remicade is B.C.’s second largest biologic expense. By switching to a biosimilar version, you are helping save millions of dollars every year. This is an opportunity to maximize resources, expand coverage for new treatments, and improve patient access to more medications.
7. How do I maintain my Infliximab® coverage?
To maintain your coverage:
- Make an appointment to speak with your GI who prescribes your Remicade® to discuss switching from Remicade® to Inflectra® or Renflexis®
- Your GI can explain the switch process, answer any questions you may have, register you with the new patient support program, have your new prescription into place.
- Make sure you have spoken with your GI and initiated your biosimilar switch by March 5th, 2020.
8. Are there patient support programs?
Yes. Biosimilar manufacturers are providing patient support programs (PSP) and services, and access to infusion centres similar to that of the reference biologic drug . Your prescriber can initiate the enrolment process into a PSP for you, if applicable.