Biosimilars Initiative for Prescribers
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 medications for patients. Six-month switch periods take place during each phase where PharmaCare covers both originator and biosimilar drugs for the affected indications, providing time for patients to understand the switch and discuss their biosimilar options with their prescriber. Following the end of a switch period, PharmaCare only covers the biosimilar versions for the affected indications, unless there is exceptional coverage of an originator biologic.
Launched in May 2019, the Initiative aims to switch many PharmaCare-covered patients using originator biologic drugs to the biosimilar versions of their medication. Currently, the Initiative is entering a rituximab phase, changing coverage for patients using rituximab. Rituxan®, the originator brand of rituximab, represents one of Canada’s top 10 highest biologic expenditures; B.C. spent $19.8 million on Rituxan in 2019. Rituximab biosimilars which are significantly more affordable and just as safe and effective, have just been made available on the market. The Initiative is taking this opportunity to switch patients taking Rituxan to an approved biosimilar version of their medication.
Switching patients to biosimilar medications has not only proven to be cost-effective, it is also equally as safe and effective as using the biologic (See Evidence for Biosimilar Switching and Resources for Prescribers and FAQ). In the Initiative’s first two phases, coverage changed for patients taking Enbrel®, Remicade®, and Lantus® for certain indications (see Phase One and Phase Two). These three biologic drugs represented some of the largest drug expenditures in B.C., totalling $125 million in 2018. Yet Health Canada-approved biosimilar versions, with no clinically meaningful differences, were underused. The switches made by the Biosimilars Initiative works to improve the usage of biosimilar medications, allows for a competitive drug market, and helps to reinvest significant savings back into our healthcare system.
Biosimilar uptake in earlier phases proved to be very positive, with PharmaNet data seeing 73% and 78% of total patients successfully switched in Phase One and Two respectively. Data for the current rituximab phase will be posted when available.
Currently, the Biosimilars Initiative is in a rituximab phase, occurring between August 20, 2020 and February 18, 2021. During this six-month period, patients with PharmaCare coverage for Rituxan will be switched to a biosimilar option. Rituxan and all approved biosimilar brands will be covered during the switch period to allow patients time to switch. Following the end of a switch period, PharmaCare only covers the biosimilar(s) for the affected indications. If your patient cannot switch for a medical reason, see What about patients who cannot switch?
|RITUXIMAB PHASE: August 20, 2020 – February 18, 2021|
granulomatosis with polyangiitis (GPA)
*Riximyo is not yet indicated for MPA or GPA at this time.
Phase Two ran between September 5, 2019 and March 5, 2020. PharmaCare patients taking Remicade for Crohn’s disease or ulcerative colitis were switched to the biosimilar versions shown in the table below.
|PHASE TWO: September 5, 2019 – March 5, 2020|
*Pediatric patients on Remicade are also switching 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 is available as an MSP covered test for patients who met 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
Phase One of the Biosimilar Initiative occurred between May 27 and November 25, 2019. During this phase, PharmaCare-covered patients taking originator drugs for the indications below were switched to the biosimilar versions to maintain their coverage.
|PHASE ONE: May 27, 2019 – November 25, 2019|
|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.
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.
You can complete and submit a Patient List Request [HLTH 5842] form.
Within two weeks, PharmaCare will send you a list of covered patients who have filled an originator prescription (Rituxan) written by you in the past nine 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 the SA department. 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 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 restricted to certain prescribers.
|Biosimilar Switch||Prescriber||Fee Code|
|August 20, 2020—February 18, 2021||Rheumatologists, neurologists, dermatologists, respirologists, hematologists, internal medicine specialists.||97013|
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.
|Number of Patients (Cohort) on Originator Drug||# Patients with Biosimilar PNET Claims||% of Patients|
Note: Cohort size was determined using past prescribing history recorded on PharmaNet and may not reflect a true number of affected patients. The switch percentages are not expected to be 100%; some patients may have switched to a different biologic not included in the Initiative, or some may have ceased treatment entirely for one reason or another. The total number of patients does not necessarily constitute a number of distinct individuals especially since patients that are on Lantus might also be on Enbrel or Remicade.
Data are rounded to the nearest tenth.
|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.
|# 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: Numbers are rounded to the nearest tenth. Data continues to be collected for patient support fee claims and will be updated when ready.
|Patient Group||Number of Patients (Cohort)||# Patients with Biosimilar PNET Claims||% of Patients|
Note: Data are rounded to the nearest tenth.
|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.
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 require additional copies of the Biosimilars Prescriber Guide or patient information sheets, please contact PharmaCare.
For more information, see:
- PharmaCare Newsletter 19-003
- PharmaCare Newsletter 19-007
- PharmaCare Newsletter 20-016
- 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
- Arthritis Society: Biologics/Biosimilars for the Treatment of Inflammatory Arthritis
- Canadian Digestive Health Foundation
Evidence and additional reading:
- 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
- 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 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.