Biosimilars Initiative for Pharmacies
The Biosimilars Initiative, launched May 27, 2019, will switch many PharmaCare-covered patients using originator (biologic) drugs to their biosimilar versions. In the Initiative's first phase, patients taking Remicade®, Enbrel®, and Lantus® will be switched to a biosimilar by November 25, 2019. In phase two (September 5, 2019 — March 5, 2020), patients taking Remicade for gastrointestinal (GI) conditions will be switched to a biosimilar. For details on the affected indications and biosimilar brands, see PharmaCare coverage changes below.
The three biologic drugs affected are among the largest drug expenditures in the province, totalling $125 million in 2018. Meanwhile, approved biosimilar versions, which are more cost-effective and equally safe and effective, are underused. The Biosimilars Initiative is a result of PharmaCare’s evidence-informed strategy to better optimize our public resources, find opportunities to apply value to new treatments and services, and improve access to biologic medicines for patients.
During the switch period for each phase, PharmaCare will cover both originator and biosimilar drugs for the affected indications to allow time for patients to discuss the switch and their biosimilar options with their prescriber. Following the end of a switch period, PharmaCare will only cover the biosimilar versions for the affected indications, without exceptional coverage of an originator biologic.
Phase one of the Biosimilar Initiative occurs between May 27 and November 25, 2019. During this phase, patients with PharmaCare coverage for originator drugs for the following indications will be switched to the biosimilar versions. All originator and biosimilar brands will be covered during the switch period to allow patients time to switch. Following the end of a switch period, PharmaCare will only cover biosimilars for affected indications.
|Phase One: May 27, 2019 — November 25, 2019|
|etanercept||Enbrel ®||Brenzys ®||
|insulin glargine||Lantus ®||Basaglar ™||
Diabetes (Type 1 and 2)
*At this time, Erelzi is the only etanercept biosimilar with an approved indication for psoriatic arthritis.
Plan W (First Nations Health Benefits) beneficiaries who take Lantus are encouraged to switch to Basaglar, however their Lantus coverage will not end on November 26, 2019. Etanercept and infliximab changes do still affect Plan W patients.
Note: Patients using Enbrel for plaque psoriasis are not affected at this time.
In phase two, PharmaCare-covered patients taking Remicade for Crohn’s disease or ulcerative colitis will be switched to the biosimilar version of infliximab. The switch period occurs from September 5, 2019 — March 5, 2020, during which time PharmaCare will cover all three brands of infliximab for GI. After the switch period ends, Remicade will no longer be covered without exceptional request.
|Phase Two: September 5, 2019 — March 5, 2020|
**Pediatric patients on Remicade will be switched to an infliximab biosimilar. PharmaCare is working closely with B.C. Children's Hospital to accomplish this, and pediatric patients may not be switched on the same timeline as adult patients.
Pharmacists may claim a Biosimilar Patient Support Fee for identifying affected patients and providing them with information to assist their switch to a biosimilar, as described in the Patient Support Process below. This $15 fee can be claimed once for each affected PHN, even if the patient uses more than one biologic. Fees for submitted claims will only be paid during the switch period of an active phase for eligible patients.
Biosimilar Patient Support Fees are entered as a PIN in PharmaNet and are paid monthly to pharmacies, in accordance with the usual monthly payment schedule.
|Phase One||May 27, 2019 — November 25, 2019||66128196|
|Phase Two||September 5, 2019 — March 5, 2020||66128199|
During direct interactions with a patient (e.g., patient inquiry, prescription dispense or a medication review), if you notice that a patient’s medication record indicates current use of Enbrel, Remicade, or Lantus:
- Confirm the patient will be affected.
- Initiate a conversation to confirm they are using the drug for the affected indication.
- Check whether they have active PharmaCare coverage or Special Authority for that drug.
- Check whether they have already been provided support for the switch by another pharmacy (i.e., the Patient Support Fee for Pharmacists PIN has not been claimed for that patient).
- Provide the patient with the Ministry of Health Patient Information Sheet for their drug.
- Inform the patient that they may be affected by the biosimilar switch. Encourage them to see their prescriber for a new prescription before the respective switch period ends to maintain PharmaCare coverage of their medication.
- Submit a claim in PharmaNet for the appropriate Biosimilar Patient Support Fee for Pharmacists.
Note: A pharmacist’s conversation with a patient is critical in setting the tone for biosimilar switching. See the Biosimilars FAQ for Pharmacists for tips on how to approach biosimilar discussions with an affected patient.
An existing special authority (SA) approval for an affected patient taking an originator drug (Enbrel, Remicade, Lantus) remains in effect until its next renewal date, if applicable. The patient must meet with their prescriber for a new biosimilar prescription.
New SA requests and renewals for etanercept, infliximab, and insulin glargine will only be granted for the approved biosimilar brands.
For patients with a clinical requirement that prevents switching, their prescriber can submit a new SA request for exceptional coverage of the originator. A clear medical reason must be provided in the request. Exceptional requests are reviewed by Special Authority on a case-by-case basis.
Note that patients are expected to trial a biosimilar (unless there is a medical exception). If the trial has been attempted and halted, the trial must be well documented and a rationale for halting must be included in the request for exceptional coverage.
Many European nations have required that patients taking biologics under publicly funded coverage plans switch to biosimilars. Biosimilar transition clinical trials and registry data findings are regularly reported at the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) annual scientific meetings. There are now more than 75 research studies on biosimilars in rheumatology, gastroenterology, dermatology and other diseases, which collectively show little to no clinical differences between biosimilars and their biologic originators, either when used with treatment-naïve patients, or for patients switching to a biosimilar. The majority of switching studies also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.
Current research presented at ACR and EULAR indicate that switching from an originator drug to the biosimilar is safe and effective for the majority of patients. There is no scientific reason to expect a different clinical outcome, but patient perspectives should be considered.
Health Canada is responsible for ensuring the safety and efficacy of all new drugs on the market including biosimilars. In order for a biosimilar to be approved for use in Canada, Health Canada evaluates functional, structural, and clinical studies comparing biosimilars to their biologic originators. Authorized biosimilars are shown to be highly similar to their originators and Health Canada expects no meaningful differences in switching from routine use of an originator drug to a biosimilar for an approved indication.
In B.C., the Ministry of Health will be carefully monitoring biosimilar drug usage, patient outcomes, and feedback from patients and healthcare practitioners both during and after the Biosimilars Initiative.
For more information and reading materials, see Resources for Pharmacists and FAQ below.
PharmaCare is committed to supporting health practitioners throughout the Biosimilars Initiative. For answers to frequently asked questions, please see the Biosimilars FAQ for Pharmacists.
If you are interested, the PharmaCare team will also host call-in information sessions during the switch periods. Please subscribe to this page to receive notifications of the sessions, which will include the conference number. You can find an up-to-date schedule of information sessions below:
|Dates to be determined|
*If you require additional copies of the Biosimilars Pharmacy Guide or patient information sheets, contact PharmaCare.
For more information, see:
- PharmaCare Newsletter 19-003
- PharmaCare Newsletter 19-007
- Biosimilars Pharmacist Guide
- Biosimilars FAQ for Pharmacists
- Drug Decision Summaries for:
- Health Canada Fact Sheet: Biosimilars
- International Coalition of Medicines Regulatory Authorities Biosimilars Statement (PDF)
- Arthritis Consumer Experts Biosim Exchange Research
- The Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
- Canadian Digestive Health Foundation
Evidence and additional reading:
- Biosimilars in the EU: Information Guide for Healthcare Professionals
- Clinical study for: Switching to Insulin Glargine Biosimilar
- Clinical study: Similar efficacy and safety between insulin glargine biosimilar and biologic (Lantus)
- Clinical study: Non-medical Switch from originator infliximab to biosimilar (rheumatology)
- Clinical study: Non-medical switch from originator etanercept to biosimilar (rheumatology)
- Drug Discontinuation in Studies Including a Switch from an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review
- ECCO: Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease
- Efficacious transition from reference infliximab to biosimilar infliximab in clinical practice
- NOR-SWITCH study: non-medical switching for all indications, originator infliximab to biosimilar
- Patient information: How Biologics and Biosimilars Work
- Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes