Biosimilars Initiative for Prescribers
The Biosimilars Initiative is PharmaCare’s evidence-informed strategy to better optimize B.C.’s public resources, get the best value for new treatments and services, and improve access to medications for patients.
After biosimilar medications have been reviewed and approved, the Initiative transitions PharmaCare-covered patients taking biologic originator drugs to biosimilar versions, which are shown to be as safe and effective. Six-month switch periods give patients time can visit their prescriber and discuss their biosimilar options. If patients want to maintain PharmaCare coverage of their medication, their prescriber must write them a new prescription for an authorized biosimilar. Following the end of a switch period, PharmaCare only covers the biosimilar versions for listed indications, unless there is a medical reason for exceptional coverage of an originator drug.
Since its launch in May 2019, the Initiative has successfully switched many PharmaCare-covered patients on an originator to an approved biosimilar. The safety and efficacy of switching to biosimilars is supported by a large body of evidence (See Evidence for Biosimilar Switching and Resources for Prescribers and FAQ). Health Canada only approves biosimilars for use in Canada after evaluating functional, structural, and clinical studies comparing biosimilars to their originators. Authorized biosimilars are shown to be highly similar to the originators and Health Canada expects no meaningful differences in switching from routine use of an originator drug to a biosimilar for an approved indication.
Switching patients to biosimilar medications is also cost-effective, because biosimilars are more affordable than originators. Until the implementation of the Initiative, biosimilar medications went largely underused in B.C. The savings gained from the switches work to balance the usage of these medications, allow for a competitive drug market, and help to reinvest significant funds back into our healthcare system.
Biosimilar uptake in earlier phases proved to be very positive, with PharmaNet data seeing 73 per cent and 78 per cent of total patients successfully switched in phases one and two respectively. Data for the recent switch periods will be posted when available.
|Switching adalimumab (Humira®) and etanercept (Enbrel®): April 7, 2021 to October 6, 2021|
|plaque psoriasis (for adults)|
*Hadlima and Hyrimoz aren't indicated for pediatric Crohn's disease.
Currently, the Biosimilars Initiative is switching PharmaCare patients covered for adalimumab (Humira®) or etanercept (Enbrel®) to approved biosimilar options, occurring between April 7, 2021 and October 6, 2021.
During this six-month period, patients with PharmaCare coverage for Humira or Enbrel will be switched to an appropriate biosimilar, listed above, if they wish to receive continued coverage. Humira, Enbrel, and all listed biosimilars will be covered during the switch period to allow patients time to meet with their prescriber, discuss their biosimilar options, and switch. After a switch period, PharmaCare will only cover authorized biosimilars for the affected indications.
If your patient cannot switch for a medical reason, see What about patients who cannot switch?
|Switch period||Drug (Originator)||Biosimilar(s)||Conditions include|
|Phase One (May 27, 2019 to November 25, 2019)||etanercept (Enbrel®)||
psoriatic arthritis (PsA)*
*only Brenzys was indicated for PsA at this time
|insulin glargine (Lantus®)||Basaglar®||diabetes (Type 1 and 2)|
|Phase Two (September 5, 2019 to March 5, 2020)||infliximab (Remicade®)||
|rituximab phase (August 20, 2020 to February 18, 2021)||rituximab (Rituxan®)||Truxima®||
granulomatosis with polyangiitis (GPA)
microscopic polyangiitis (MPA)
relapsing-remitting multiple sclerosisrheumatoid arthritis
*Riximyo is not yet approved to treat GPA or MPA
Note: On February 18, 2021, the PharmaCare formulary added Brenzys for the treatment of psoriatic arthritis, and the biosimilar infliximab Avsola™ for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.
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 their best outcomes. Follow the steps below to help a 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 health professionals.
- Identify a patient who will lose PharmaCare coverage if they don't switch.
- 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 a specific biosimilar.
- 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, with clear rationale.
You can complete and submit a Patient List Request [HLTH 5843] form.
Within two weeks, PharmaCare will send you a list of covered patients who have filled an originator prescription (Humira or Enbrel) written by you in the past six months.
For patients who are unable to switch for medical reasons, you may submit a new Special Authority (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 SA. If additional input is required, the request may also be reviewed by the appropriate 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 qualifying 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 restricted to certain prescribers.
|Biosimilar Switch: April 7, 2021 to October 6, 2021||Prescriber||Fee Code|
|Humira®||Gastroenterologists, rheumatologists, dermatologists, internal medicine specialists (includes pediatric gastroenterology and rheumatology specialists)||97014|
|Enbrel®||dermatologists, internal medicine specialists||97010|
A patient’s existing Special Authority (SA) approval for an originator drug (Humira or Enbrel) remains in effect until its next renewal date or October 6, 2021, whichever comes first. The patient must meet with their prescriber for a new biosimilar prescription if they wish to maintain PharmaCare coverage.
New SA requests and renewals for adalimumab or etanercept 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.
At this time, there are no changes in coverage criteria for adalimumab or etanercept for any indications.
For a list of updated forms, see the adalimumab criteria page or the etanercept criteria page.
Many European nations have switched patients under their publicly-funded coverage plans from originators 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 neurological disorders, 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.
In Canada, 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, Health Canada evaluates functional, structural, and clinical studies comparing biosimilars to their 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.
During Phase One, 73% of patients transitioned to a biosimilar, and during Phase Two, 78% transitioned. Over 90% of PharmaCare patients taking infliximab, etanercept and insulin glargine, new and existing, are now taking biosimilars.
|Patient Group||Prescriber Specialization||Total Prescribers*/All Prescribers**||% of All Prescribers|
|Physicians/Nurses excluding endocrinologists||3,416/3,906||87%|
*Total Prescribers indicates the number of unique practitioners whose patients had at least one PharmaCare accepted claim for the biosimilar drug.
**All Prescribers corresponds to the number of practitioners per specialty whose patients had at least one PharmaCare accepted claim for the originator drug within six months prior to Phase One. Prescribers not actively licensed by the College are excluded.
***Gastroenterology specialization for the Remicade patient group shows that over 100% of prescribers switched patients. This is because not all practitioners prescribing a biosimilar may have been captured within six months prior to Phase One or are new prescribers.
|Patient Group||Prescriber Specialization||Total Prescribers*/All Prescribers**||% of All Prescribers|
*Total Prescriber Count corresponds to the number of unique practitioners whose patients had at least one PharmaCare accepted claim for the biosimilar drug.
**All Prescribers corresponds to the number of gastroenterologists whose patients had at least one PharmaCare accepted claim for Remicade within six months prior to Phase Two. Prescribers not actively licensed by the College are excluded.
Note: Data continues to be collected and this table will be updated when ready.
|# Patients with Biosimilar PNET Claims||# Paid Patient Support Fee Claims||% Paid Support Fees against Accepted Biosimilar Claims|
|Phase One and Two||16,120||10,870||68%|
Note: Data continues to be collected for patient support fee claims and will be updated when ready.
PharmaCare is committed to supporting health practitioners throughout the Biosimilars Initiative. For answers to frequently asked questions and a list of patient support programs, please see the Biosimilars FAQ for health professionals.
If you require additional copies of the Biosimilars reference sheet or patient information sheets, please contact PharmaCare.
- Biosimilars FAQ for health professionals
- PharmaCare Newsletter (search for specific biosimilar switch announcement)
- Patient List Request form (HLTH 5843)
Drug Decision Summaries for:
- etanercept - plaque psoriasis
- etanercept - Phase One
- insulin glargine
- rituximab (Truxima)
- rituximab (Riximyo)
- rituximab (Ruxience)
Biosimilars Prescriber Guides and reference sheets
- adalimumab and etanercept switch - prescriber reference sheet
- rituximab prescribers
- Phase Two - Gastroenterologists
- Phase One - Dermatologists
- Phase One - rheumatologists
- Phase One - Endocrinologists/GPs
- Health Canada Fact Sheet: Biosimilars
- International Coalition of Medicines Regulatory Authorities Biosimilars Statement (PDF)
- Arthritis Consumer Experts Biosim Exchange Research
- Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
- Canadian Digestive Health Foundation
Evidence and additional reading:
- Switching from Reference to Biosimilar Adalimumab for Patients with Various Inflammatory Conditions (CADTH)
- Switching from Reference to Biosimilar Etanercept for Patients with Plaque Psoriasis (CADTH)
- Clinical study: Non-medical switch from originator etanercept to biosimilar (rheumatology)
- Clinical study: Non-medical Switch from originator infliximab to biosimilar (rheumatology)
- 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
- Clinical study for: Switching to Insulin Glargine Biosimilar
- Clinical study: Similar efficacy and safety between insulin glargine biosimilar and biologic (Lantus)
- Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis
- Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis
- Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis
- Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial
- Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial
- A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis
- Comparative assessment of clinical response in patients with rheumatoid arthritis between PF‐05280586, a proposed rituximab biosimilar, and rituximab
- Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis
- Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)
- Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study
- A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis
- Riximyo receiving regulatory approval for GPA and MPA in Europe (PDF)
- European Medicines Agency (EMA) review and appraisal for Riximyo
- Australian clinical evaluation report for Riximyo (PDF)
- Biosimilars in the EU: Information Guide for Healthcare Professionals
- Drug Discontinuation in Studies Including a Switch from an Originator to a Biosimilar Monoclonal Antibody: A Systematic Literature Review
- 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 originator biologic and biosimilar drugs, answers to frequently asked questions, and more.
PharmaCare will have mailed you patient information sheets. The same information is available online and downloadable at Patient Information Sheets.