Biosimilars Initiative for health professionals

Last updated: February 1, 2023

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Background

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.


Latest biosimilar listings

January 24, 2023
Drug Originator Biosimilar Conditions include:
insulin aspart NovoRapid®

Kirsty® 100 units/mL in a 3 mL pre-filled pen

  • type 1 & 2 diabetes mellitus

Coverage extension of Humalog and NovoRapid for patients using certain insulin pumps

INSULIN PUMP USERS ONLY: Switching insulin lispro (Humalog®) and insulin aspart (NovoRapid®)
Insulin pump Rapid-acting insulin approved for compatible use PharmaCare coverage Conditions
Omnipod Admelog® (insulin lispro biosimilar—regular benefit) Indefinite
  • type 1 diabetes
  • type 2 diabetes
Omnipod NovoRapid® (insulin aspart originator— non-benefit) Until November 30, 2023
Medtronic
Ypsomed
Tandem*
Humalog® (insulin lispro originator— non-benefit)
NovoRapid® (insulin aspart originator— non-benefit)
Until November 30, 2023

*Tandem insulin pump is also approved for use with Admelog. PharmaCare coverage for this item may change to reflect this compatibility. 

Coverage for Humalog and NovoRapid is extended until November 30, 2023, only for those currently using Medtronic, Ypsomed and Tandem insulin pumps. Those using the Omnipod pump with NovoRapid will also be automatically covered until November 30, 2023.

The extension of coverage is automatic, and doesn’t require any additional Special Authority request.

At this time, only the Omnipod pump has been approved by Health Canada for compatibility with Admelog.

For more information, see PharmaCare Newsletter 22-005 (PDF) and PharmaCare Newsletter 22-011 (PDF).

If a pump is approved for use with a listed biosimilar before or after November 30, 2023, our coverage policy may change, with advance notice in the 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
filgrastim (Neupogen®)
(January 31, 2017 to July 30, 2017)
filgrastim (Neupogen®) Grastofil®
  • prevention and treatment of neutropenia
Phase One
(May 27, 2019 to November 25, 2019)
etanercept (Enbrel®) Brenzys®
  • ankylosing spondylitis
  • rheumatoid arthritis
Erelzi®
  • ankylosing spondylitis
  • psoriatic arthritis
  • rheumatoid arthritis
infliximab (Remicade®) Inflectra®
  • ankylosing spondylitis
  • plaque psoriasis
  • psoriatic arthritis
  • rheumatoid arthritis
Renflexis®
insulin glargine (Lantus®) Basaglar®
  • diabetes (type 1 and 2)
Phase Two
(September 5, 2019 to March 5, 2020)
infliximab (Remicade®) Inflectra®
  • Crohn’s disease
  • ulcerative colitis
Renflexis®
Rituximab Phase
(August 20, 2020 to February 18, 2021)
rituximab (Rituxan®) Truxima®
  • granulomatosis with polyangiitis (GPA)
  • microscopic polyangiitis (MPA)
  • relapsing-remitting multiple sclerosis
  • rheumatoid arthritis
Riximyo®
Ruxience™
adalimumab (Humira®) and etanercept (Enbrel®)
(April 7, 2021 to October 6, 2021)
adalimumab (Humira®) Amgevita®
Hadlima®*
Hulio®
Hyrimoz®
Idacio®

*Hadlima is not indicated for pediatric Crohn’s disease.
  • ankylosing spondylitis
  • Crohn’s disease
  • hidradenitis suppurativa (for adults)
  • plaque psoriasis (for adults)
  • polyarticular juvenile idiopathic arthritis
  • psoriatic arthritis
  • rheumatoid arthritis
  • ulcerative colitis
etanercept (Enbrel®) Brenzys®
Erelzi®
  • plaque psoriasis (for adults)
insulin lispro (Humalog®) and insulin aspart (NovoRapid®)
(November 30, 2021 to May 29, 2022)
insulin lispro (Humalog®) Admelog®
  • type 1 diabetes
  • type 2 diabetes
insulin aspart (NovoRapid®) Trurapi®
enoxaparin (Lovenox®)
(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®
  • prophylaxis and treatment of venous thromboembolism (VTE)
filgrastim (Neupogen®)
(Biosimilar listed March 22, 2022. This is the second filgrastim biosimilar, and no switching is required for most patients).
filgrastim (Neupogen®) Nivestym™
  • prevention and treatment of neutropenia
adalimumab (Humira®)
Biosimilar listed August 18, 2022. No switching required.
adalimumab (Humira®) Hulio® 20 mg/0.4 mL prefilled syringe
Abrilada®
Simlandi*
Yuflyma*

*Simlandi and Yuflyma are high-concentration (100 mg/mL) doses. They are currently not indicated for pediatric Crohn's disease.
  • ankylosing spondylitis
  • Crohn’s disease
  • hidradenitis suppurativa (for adults)
  • plaque psoriasis (for adults)
  • polyarticular juvenile idiopathic arthritis
  • psoriatic arthritis
  • rheumatoid arthritis
  • ulcerative colitis
insulin aspart (NovoRapid®)
Biosimilar listed January 24, 2023. No switching required.
insulin aspart (NovoRapid®) Kirsty® 100 units/mL in a 3 mL pre-filled pen
  • type 1 & 2 diabetes mellitus

How do I support the patient?

  1. 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.
  2. Discuss switching to a biosimilar with the patient.
  3. Write your patient a new prescription, clearly indicating a specific biosimilar.
  4. Initiate enrolment in the patient support program for the biosimilar (if applicable).
  5. Submit the Biosimilar Patient Support Fee code with your MSP billing.
  6. 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 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®:

  1. Confirm the patient will be affected.
    • Initiate a conversation to confirm they are using the drug for the listed condition
    • Check whether they have active PharmaCare coverage or Special Authority for that drug
    • Ask if another pharmacy has provided support for the switch
  2. Provide the patient with the Ministry of Health patient information sheet for their drug.
  3. 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.
  4. Submit a claim in PharmaNet for the appropriate biosimilar patient support fee for pharmacists.

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 Canada’s Regulatory Decision Summary Search to find when and why certain biosimilar drugs have been approved in accordance with the Food and Drug Regulations.

>> 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.

Drug decision summaries



Additional reading

adalimumab

etanercept

infliximab

insulin aspart

insulin glargine

insulin lispro

rituximab

General

 


Contact

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)
Email: Biosimilars.Initiative@gov.bc.ca