Biosimilars Initiative for health professionals
PharmaCare will provide transitional coverage for the insulin lispro originator (Humalog) for people using Medtronic, Ypsomed, and Omnipod insulin pumps until May 30, 2024. This is to allow time to switch to the insulin lispro biosimilar (Admelog).
Coverage for the insulin aspart originator (NovoRapid) is extended up to November 30, 2024 for people using Medtronic, Tandem, Omnipod, and Ypsomed insulin pumps. Coverage policy may change with advance notice.
Last updated: December 1, 2023
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The Biosimilars Initiative transitions PharmaCare-covered patients taking originator drugs to equally safe and effective biosimilar versions. This initiative optimizes B.C.’s public resources to get the best value for new treatments and services and to improve patient access to medicines.
A switch period of 6 months gives a patient time to meet with their prescriber and discuss their biosimilar options. If a patient wants continued PharmaCare coverage of their medication after the switch period, their prescriber writes a new prescription for an approved biosimilar. Following the switch period, PharmaCare covers only the biosimilar (unless there is a medical reason to provide exceptional coverage of the originator).
Since the evidence-based Biosimilars Initiative was launched in May 2019, many patients have successfully switched from an originator to a covered biosimilar.
In 2021, at least 85% of PharmaCare-covered patients were on a covered biosimilar for the following medications:
- adalimumab (85%)
- etanercept (95%)
- infliximab (99%)
- insulin glargine (97%)
- rituximab (98%)
This includes patients who switched from the originator medication and patients who started treatment on a biosimilar and were not previously on the originator medication.
Patients who switched to PharmaCare-covered biosimilars
For Phases 1 and 2 of the biosimilar transition, by the end of June 2020, the percentage of PharmaCare-covered patients who had switched from the originator to a covered biosimilar were:
- 84% for those taking infliximab for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis or psoriatic arthritis
- 85% for those taking etanercept for rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis
- 73% for those taking insulin glargine for diabetes
- 83% for those taking infliximab for Crohn’s disease or ulcerative colitis
At the end of December 2021, following another transition phase, the percentage of PharmaCare-covered patients who had switched from the originator to a covered biosimilar were:
- 81% for those taking adalimumab for ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa (adults), plaque psoriasis (adults), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis
- 71% for those taking etanercept for plaque psoriasis
- 70% for those taking rituximab for granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), relapsing-remitting multiple sclerosis or rheumatoid arthritis
All switches are planned in consultation with prescribers and healthcare partners.
Medication dispensation patterns and administrative health outcomes were monitored to detect potential adverse effects. See “Monitoring of Biosimilar Policy in B.C.” under Evidence and other reading for published studies.
Transitional coverage of Humalog for patients using certain insulin pumps
PharmaCare is providing transition coverage for individuals using the insulin lispro originator (Humalog®) with Omnipod®, Ypsomed, and Medtronic™ pumps to May 30, 2024. This 6-month transition period will allow people time to switch to the insulin lispro biosimilar (Admelog®).
Admelog® has been approved by Health Canada for use with these insulin pumps and is a regular PharmaCare benefit. New approvals for insulin pumps will be expected to use the insulin lispro biosimilar Admelog®. Coverage for patients newly starting on insulin pumps will expand over time as insulin pumps get approval for use with the insulin aspart biosimilars Kirsty™ and Trurapi®. For more information and the full announcement, see the upcoming December PharmaCare newsletter.
Coverage extension of NovoRapid for patients using certain insulin pumps
|INSULIN PUMP USERS ONLY: Coverage extension of insulin aspart (NovoRapid®)|
|Insulin pump||Rapid-acting insulin approved for compatible use||PharmaCare coverage||Conditions|
|NovoRapid® (insulin aspart originator— non-benefit)||Until November 30, 2024||
Effective November 30, 2023, PharmaCare will extend coverage for people currently covered for the insulin aspart originator (NovoRapid®) who are using Medtronic™, Ypsomed, Tandem, and Omnipod® pumps.
This coverage is being extended for 12 months until November 30, 2024 as Health Canada has not yet approved these insulin pumps for use with the insulin biosimilars Kirsty™ and Trurapi®, which are available in formulations that are regular PharmaCare benefits. PharmaCare anticipates Health Canada will approve these pumps for use with these biosimilars by the end of the current extension.
The coverage extension to November 30, 2024 is automatic for people who had already qualified for the previous extension and still filling the originator insulin (to November 30, 2023), announced in May 2022, and doesn't require a Special Authority request.
For more information and the full announcement, see the upcoming December PharmaCare newsletter.
Retail pricing for rapid-acting insulins
PharmaCare covers all listed rapid-acting insulins at the retail price. This includes covered biosimilars and insulin glulisine (Apidra®). This means patients are fully covered for these insulins, subject to any deductible or family maximum.
|Transition period (if applicable)||Drug (originator)||Biosimilar(s)||Conditions include|
(January 31, 2017 to July 30, 2017)
(May 27, 2019 to November 25, 2019)
|insulin glargine (Lantus®)||Basaglar®||
(September 5, 2019 to March 5, 2020)
(August 20, 2020 to February 18, 2021)
|adalimumab (Humira®) and etanercept (Enbrel®)
(April 7, 2021 to October 6, 2021)
*Hadlima is not indicated for pediatric Crohn’s disease.
|insulin lispro (Humalog®) and insulin aspart (NovoRapid®)
(November 30, 2021 to May 29, 2022 with an extension given to some patients using insulin pumps as compatibility was not initially approved by Health Canada)
|insulin lispro (Humalog®)||Admelog®||
|insulin aspart (NovoRapid®)||Trurapi®|
(Biosimilars listed March 22, 2022. No switching required. Existing PharmaCare patients taking Lovenox keep their currently approved coverage until it expires.)
|enoxaparin (Lovenox®, Lovenox® HP)
||Inclunox®, Inclunox HP®
Noromby®; Noromby HP®
Redesca®, Redesca HP®
(Biosimilar listed March 22, 2022. This is the second filgrastim biosimilar, and no switching is required for most patients).
Biosimilar listed August 18, 2022. No switching required.
|adalimumab (Humira®)||Hulio® 20 mg/0.4 mL prefilled syringe
*Simlandi and Yuflyma are high-concentration (100 mg/mL) doses. They are currently not indicated for pediatric Crohn's disease.
|insulin aspart (NovoRapid®)
Biosimilar listed January 24, 2023. No switching required for most patients.
|insulin aspart (NovoRapid®)||Kirsty® 100 units/mL in a 3 mL pre-filled pen||
Biosimilar listed June 1, 2023.
|Lovenox®, Lovenox® HP||Elonox®, Elonox® HP||
How do I support the patient?
- Identify a patient who will lose PharmaCare coverage if they don't switch. You can request a list of covered patients using HLTH 5844 - Patient List Request (PDF, 533KB) form. PharmaCare will send a list within 2 weeks, of patients who filled a prescription for the originator drug within the past 6 months.
- Discuss switching to a biosimilar with the patient.
- Write your patient a new prescription, clearly indicating a specific biosimilar.
- Initiate enrolment in the patient support program for the biosimilar (if applicable).
- 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.
What if I can't see the patient before the end of the switch period?
If you can't write a new biosimilar prescription for a patient by the final day of a switch period, their coverage for the originator drug will expire at the end of that day, unless exceptional coverage is in place (see below). For a patient to get PharmaCare coverage for a regular benefit biosimilar following a switch period, write the biosimilar prescription as soon as possible; coverage will be activated when the prescription is filled. If the biosimilar requires Special Authority, submit a new request as soon as you can.
PharmaCare coverage extensions may be considered on a case-by-case basis in situations where despite best efforts, a prescriber is unable to initiate a switch for a patient within the six-month transition window. Prescribers can use the PharmaCare prescriber line to request an extension.
What about patients who can't switch?
Sometimes medical reasons prevent a patient from switching to a biosimilar. In such cases, the patient’s prescriber may submit an exceptional request for Special Authority (SA) coverage of the originator drug. In the request, the prescriber must clearly identify why the patient is unable to switch. Forms are listed on the SA eForms platform or a drug’s criteria page.
Note that patients are expected to trial a biosimilar (unless there is a medical exception). If a trial has been attempted and stopped, the rationale for stopping the trial must be documented in the request for exceptional coverage. The complications must be unlikely to recur or intensify if the patient resumes taking the originator.
SA reviews exceptional requests on a case-by-case basis. The request may also be reviewed by the appropriate Drug Benefit and Adjudication Advisory Committee, if needed. Exceptional requests should be submitted as soon as possible to avoid uninterrupted coverage.
During interactions with a patient (e.g. patient inquiry, prescription dispense or medication review), if you notice that a patient’s medication record indicates current use of Humalog® or NovoRapid®:
- Confirm the patient will be affected.
- 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 switch period ends to maintain PharmaCare coverage.
Refer to Tips for talking to patients about biosimilars for tips on how to approach biosimilar discussions with a patient.
Prescribers and pharmacists are a trusted source of information, expertise, and experience. As a trusted expert, you may set the tone of the discussion, facilitate continuity of care, and empower the patient to understand and realize their best outcomes.
Treatment-naïve patients started on a biosimilar tend to accept biosimilars without issues. Treatment-experienced, stable patients using an originator biologic may need more support.
The most critical information patients need to know is that biosimilars:
- Are safe and effective
- Work similarly to their current medication
- Add no increased risk of adverse reactions
- Don’t involve major changes to their routines or dosing
- Are accompanied by patient support programs, if applicable
- Are available at nearby infusions centres (if applicable), though it may be a different infusion centre than they currently attend
- Are well studied; switch programs have been successful around the world
The nocebo effect
The nocebo effect is when a patient’s negative expectations affect their treatment outcomes. A patient’s mindset can impact their symptoms and their sense of well-being. The nocebo effect can arise due to one’s mental health state, language barriers, use of online media as an information source, the setting in which they receive information, and other factors that are out of the control of healthcare professionals.
To guard against a potential nocebo effect:
- Acknowledge the nocebo effect
- Speak face-to-face (or via video conferencing) when possible
- Get informed about biosimilars
- Be attentive and empathetic
- Promote a neutral or positive outlook
- Give balanced information about desired effects and adverse effects
- Suggest a plan for follow-up
- Direct patients to PharmaCare's patient information sheets that explain coverage changes
Originator drugs are made from organic cells, which have natural variability. They are often large and complex in structure. Biosimilar drugs are highly similar, but not identical, to the originators. Biosimilars usually enter the market following the expiry of originator patents. Manufacturers can produce biosimilar versions at a much lower cost.
For approved use in Canada, biosimilars undergo thorough testing. Evaluations must find no clinically meaningful differences in efficacy and safety compared to their originators.
Originator drugs are Canada’s largest drug expense, with costs increasing at an unsustainable rate. The Initiative’s targeted originators historically represent some of the largest drug expenditures in B.C. Since biosimilars are more affordable than originators, PharmaCare can invest savings in more treatment options. Until the Initiative, biosimilar medications went largely underused in B.C.
The safety and efficacy of switching to biosimilars is supported by a large body of international evidence. Many European nations have switched patients under their publicly-funded coverage plans. More than 75 research studies on biosimilars in rheumatology, gastroenterology, dermatology, diabetes and other neurological disorders 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. Most switching studies have also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.
Patient perspectives are also valuable. In B.C., the Ministry of Health carefully monitors biosimilar drug usage, patient outcomes, and feedback from patients and healthcare practitioners.
>> Search the PharmaCare Formulary to see which biosimilars are available for PharmaCare coverage.
Health Canada approves biosimilars for use in Canada after evaluating functional, structural, and clinical studies comparing them to their originators. Health Canada expects no meaningful differences in switching from routine use of an originator drug to a biosimilar for an approved indication. Refer to Biosimilar biologic drugs in Canada: Fact Sheet.
- HLTH 5844 - Insulin Aspart/Insulin Lispro Patient List Request (PDF, 533KB)
- PharmaCare Newsletter (search for specific biosimilar switch announcement)
Drug decision summaries
- Health Canada Fact Sheet: Biosimilars
- International Coalition of Medicines Regulatory Authorities Biosimilars Statement (PDF, 625KB)
- Arthritis Consumer Experts Biosimilars Exchange Research
- Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
- Canadian Digestive Health Foundation
Monitoring biosimilar policy in B.C.
- Brand name to biosimilar drugs for rheumatoid arthritis in B.C.
- Originator to biosimilar etanercept in B.C.
- Originator to biosimilar infliximab in patients with inflammatory arthritis and psoriasis in B.C.
- Originator to biosimilar infliximab in patients with inflammatory bowel diseases in B.C.
- Originator to biosimilar insulin glargine in B.C.
- CADTH: Switching From Reference to Biosimilar Adalimumab for Patients with Various Inflammatory Conditions
- CADTH: Switching from Reference to Biosimilar Etanercept for Patients with Plaque Psoriasis
- 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
- CADTH: Switching from Reference to Biosimilar Insulin Aspart for Patients with Diabetes Mellitus (Type 1 or 2)
- Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1)
- Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin
- Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial
- Clinical study: Switching to Insulin Glargine Biosimilar
- Clinical study: Similar efficacy and safety between insulin glargine biosimilar and biologic (Lantus)
- CADTH: Switching from Reference to Biosimilar Insulin Lispro for Patients with Diabetes Mellitus (Type 1 or 2)
- Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study
- Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study
- Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump
- 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
- 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
- A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis
- 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
If you have further questions or feedback, please contact the Biosimilars team by:
Phone: 1-844-915-5005 (Monday to Friday, 8:30 am to 4:30 pm Pacific time)