Biosimilars Initiative for Prescribers
PharmaCare launched the first phase of the Biosimilars Initiative on May 27, 2019 with the goal of switching patients using Enbrel®, Remicade®, and Lantus® for certain indications to their biosimilar versions by November 25, 2019. In its second phase (September 5, 2019 — March 5, 2020), the Initiative will switch patients using Remicade for gastrointestinal (GI) indications (Crohn's disease or ulcerative colitis) to a biosimilar version. 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 that are more cost-effective and just as safe and effective are underused. The Biosimilars Initiative is a result of PharmaCare’s evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to biologic medications for patients.
During each switch period, PharmaCare will cover both biologic and biosimilar versions of the affected drugs, to allow time for patients to discuss the switch with their prescriber. After the switch periods end, PharmaCare will cover only the biosimilar versions of etanercept, infliximab, and insulin glargine for the affected indications.
Phase one of the Biosimilar Initiative occurs between May 27 and November 25, 2019. During this phase, patients taking originator drugs for the following indications will be switched to the biosimilar versions.
|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.
Patients using Enbrel for plaque psoriasis are not affected at this time.
Phase two runs between September 5, 2019 and March 5, 2020. Patients taking Remicade for Crohn’s disease or ulcerative colitis will be switched to the biosimilar versions shown below.
|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.
As a note, the Ministry of Health approved a new fee for service laboratory Fecal Calprotectin (FC) testing for patients receiving biologic agents. Starting August 15, 2019, FC laboratory testing will be available as an MSP covered test for patients who meet this criterion. The Ministry will be monitoring the FC laboratory testing post-implementation and reviewing its impacts and outcomes.
For more details on FC testing, see www.bcaplm.ca
Prescribers play an important role in the switching process. As a trusted and experienced information source, a healthcare professional may set the tone of the discussion, facilitate continuity of care, and empower the patient to understand and realize the best outcomes. Follow the steps below to help an affected patient with their switch to a biosimilar before the respective switch period ends. For tips on how to approach a neutral or positive discussion with a patient, see the Biosimilars FAQ for prescribers.
- Identify an affected patient.
- Discuss switching to a biosimilar with the patient.
- Initiate enrolment in the patient support program for the biosimilar (if applicable). Write your patient a new prescription, clearly indicating the chosen biosimilar brand.
- Submit the Biosimilar Patient Support Fee code with your MSP billing.
- For any patients unable to switch due to a medical reason, submit a new Special Authority request for exceptional coverage of the respective biologic.
- For GI patients, provide ongoing monitoring and support using the FC test and nursing resources where appropriate.
You can complete and submit a Patient List Request [HLTH 5841] form.
Within two weeks, PharmaCare will send you a list of covered patients who have filled an originator prescription (Remicade, Enbrel, Lantus) written by you in the past six months.
For patients who are unable to switch for medical reasons, you may submit a new SA request for exceptional coverage of the originator drug. Clearly identify in the request why the patient cannot switch.
Exceptional requests are reviewed on a case-by-case basis by Special Authority. If additional input is required, the request may also be reviewed by the Drug Benefit and Adjudication Advisory Committee. Given the processing time involved, exceptional requests should be submitted as soon as possible to avoid uninterrupted coverage.
The Biosimilar Patient Support Fees are $50.00 fee items billable to MSP in addition to other services billed on the same date of service, using the Teleplan claims system. They are being offered in recognition of the additional effort involved in contacting patients and supporting their switch to a biosimilar product.
The fee can be claimed once per affected patient during the switch period, regardless of whether that patient switches to a biosimilar.
See the table below for fee codes, which are active during their respective phase periods. Note some claim fees are limited to certain prescribers.
|Biosimilar Switch||Prescriber||Fee Code|
|Lantus to biosimilar insulin glargine||No limits to note||97011|
|Enbrel to biosimilar etanercept||Rheumatologists, internal medicine specialists||97010|
|Remicade to biosimilar infliximab||Gastroenterologists, rheumatologists, dermatologists, internal medicine specialists||97009|
|GI nursing support fee||Gastroenterologists, internal medicine specialists. See below.||97012|
Gastroenterologists are also able to bill MSP for nursing staff to support care of GI patients. This is a $60.00 fee payable once every six months for patients with a confirmed diagnosis of Crohn’s disease or ulcerative colitis. The fee (fee code 97012) must be billed in addition to a consultation or visit on the same date of service and is only payable when a Registered Nurse or Licensed Practical Nurse is present. Claims must include the ICD-9 code for IBD (555 or 556).
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 Prescribers 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 prescribers.
If you are interested, the PharmaCare team will also host call-in information sessions during the transition 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 Prescriber Guide or patient information sheets, contact PharmaCare.
For more information, see:
- PharmaCare Newsletter 19-003
- PharmaCare Newsletter 19-007
- Biosimilars FAQ for prescribers
- Drug Decision Summaries for:
- Biosimilars Prescriber Guides 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
Patient resources are available online at www.gov.bc.ca/biosimilars. There patients can find more detailed information about biosimilar switching, how it affects them, the difference between biologic and biosimilar drugs, answers to frequently asked questions, and more.
PharmaCare will have mailed you patient brochures. The same information is available as downloadable and printable Patient Information Sheets. If you would like more printed tri-fold brochures, please email PharmaCare at Biosimilars.Initiative@gov.bc.ca.