Biosimilars Initiative for health professionals

Effective March 22, 2022, PharmaCare is de-listing Lovenox and listing biosimilar versions Inclunox, Noromby and Redesca.

Existing patients taking Lovenox will keep their PharmaCare coverage until it expires. As of March 22, only enoxaparin biosimilars will be covered for new starts or renewals of prior coverage.

On this page:


Background

The Biosimilars Initiative (“the Initiative”) transitions PharmaCare-covered patients taking originator drugs to equally safe and effective biosimilar versions. The Biosimilars 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 six 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, 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 for exceptional coverage of the originator).

Since the evidence-based Biosimilars Initiative was launched in May 2019, many patients have successfully switched from a PharmaCare covered originator to a covered biosimilar.

In 2021, at least 85% of PharmaCare covered patients were on a covered biosimilar:

  • adalimumab (85%)
  • etanercept (95%)
  • infliximab (99%)
  • insulin glargine (97%)
  • rituximab (98%)

This includes patients switched from the originator medication as well as patients who started treatment on a biosimilar (and were not previously on the originator medication).

Patients who switched to PharmaCare-covered biosimilars

For Phase 1 and 2 of the biosimilar transition, by the end of June 2020, the percent of PharmaCare covered patients switched from the originator to a covered biosimilar were:

  • 84% of PharmaCare patients taking infliximab for diagnoses including rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis.
  • 85% of PharmaCare patients taking etanercept for diagnoses including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis.
  • 73% of patients taking insulin glargine for diabetes.
  • 83% of patients taking infliximab for Crohn’s disease or ulcerative colitis.

For the more recent transition phases, by the end of December 2021, the percentage of PharmaCare covered patients switched from the originator to a covered biosimilar were:

  • 81% of patients who were taking adalimumab for diagnoses including ankylosing spondylitis, Crohn’s disease, hidradenitis suppurativa (for adults), plaque psoriasis (for adults), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis.
  • 71% of patients taking etanercept for plaque psoriasis.
  • 70% of patients taking rituximab for diagnoses including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), relapsing-remitting multiple sclerosis, rheumatoid arthritis.

All switches are planned in consultation with prescribers and stakeholders.

Medication dispensation patterns and administrative health outcomes were monitored to detect potential adverse effects on patients as a result of the Initiative. See “Monitoring of Biosimilar Policy in B.C.” under Evidence and other reading for published studies.


Latest biosimilar listings

March 22, 2022
Drug Originator Biosimilar Conditions include:
enoxaparin Lovenox®
Lovenox® HP
Inclunox®; Inclunox® HP; Noromby®; Noromby® HP; Redesca®; Redesca® HP
  • prevention and treatment of venous thromboembolism
filgrastim* Neupogen® Nivestym™
  • prevention and treatment of neutropenia

*Of note: the first filgrastim biosimilar Grastofil® was listed in 2017

Effective March 22, 2022, PharmaCare is de-listing Lovenox and listing biosimilar versions Inclunox, Noromby, and Redesca for the same indications, with the exception of cancer-associated thrombosis (CAT). Existing patients taking Lovenox will keep their PharmaCare coverage until it expires. As of March 22, only enoxaparin biosimilars will be covered for new starts or renewals of prior coverage.

For CAT, Limited Coverage criteria will change. Dalteparin and tinzaparin will both change to first-line treatment (from second-line), removing the requirement for patients to try warfarin first. Enoxaparin biosimilars will also be added as covered first-line treatment options for CAT. The biosimilar listings result in costs savings for the province, which offsets the costs for modifying treatment options for CAT.

Also effective March 22, 2022, PharmaCare is adding a second biosimilar filgrastim called Nivestym to its formulary. Most patients in BC have already successfully transitioned from the originator filgrastim (Neupogen) to the biosimilar Grastofil in 2017. However, a small number of patients who could not transition to Grastofil for reasons such as such as certain dosage formulations not being available, can now safely transition to Nivestym.


Current switch period

Switching insulin lispro (Humalog®) and insulin aspart (NovoRapid®):
November 30, 2021 to May 29, 2022
Drug Originator Biosimilar Conditions include:
insulin lispro Humalog® Admelog®
  • type 1 diabetes
  • type 2 diabetes
insulin aspart NovoRapid® Trurapi®

On November 30, 2021, Admelog and Trurapi are added as regular benefits on the PharmaCare formulary. From November 30, 2021 to May 29, 2022, existing PharmaCare patients taking Humalog or NovoRapid must switch to an approved biosimilar in order to receive continued coverage.

Beginning December 15, 2021, PharmaCare no longer covers Humalog and NovoRapid for new patients. Only the biosimilar versions will be covered by PharmaCare for new starts.

Patients with coverage for Humalog Mix25, Humalog Mix50 or NovoMix 30 before December 15, 2021 will not need to switch. Their coverage will continue. However, new patients will not be covered for these products after December 15, 2021 as they will be delisted.

During the six-month switch period, Humalog and NovoRapid will remain covered for existing patients. This allows them time to be informed about the change, discuss their switching options with a prescriber or pharmacist, and if applicable, obtain a new insulin pen device. New pens may be ordered through your usual distributor or directly from Sanofi. Email Sanofi.Diabetes@SanofiCanada.com or call their customer service number (1-800-265-7927). 

To maintain their PharmaCare coverage, patients must switch to an eligible option by May 29, 2022.

Effective May 30, 2022, PharmaCare will no longer cover Humalog and NovoRapid. Special Authority requests for patients who are unable to transition to biosimilars will be considered on an exceptional, case-by-case basis.

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, 2022

Medtronic

Ypsomed

Tandem*

Humalog® (insulin lispro originator— non-benefit)

NovoRapid® (insulin aspart originator— non-benefit)

Until November 30, 2022

*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, 2022, 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, 2022.

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).

If a pump is approved for use with a listed biosimilar before or after November 30, 2022, our coverage policy may change, with advance notice in the PharmaCare Newsletter.

Retail pricing

At the same time, PharmaCare is changing its pricing policy for all listed rapid-acting insulins (RAIs), including the newly added biosimilars. Previously, all RAIs were covered up to their maximum allowable cost (MAC), resulting in partial coverage for many RAIs where patients were responsible for costs above the MAC.

Effective November 30, 2021, PharmaCare will cover all listed RAIs at the retail price. This includes the biosimilars and insulin glulisine (Apidra®). The change to retail pricing means patients will be fully covered for RAIs (subject to any deductible or family maximum). They will no longer have unexpected out-of-pocket costs.


 
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

Note: On February 18, 2021, the PharmaCare formulary added Brenzys for the treatment of psoriatic arthritis and the biosimilar infliximab, and Avsola™ for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

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 patients 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.

A biosimilar patient support fee is offered in recognition of the effort involved in contacting patients and supporting their switch to a biosimilar. The $50 fee is billable to MSP in addition to other services billed on the same date of service, using the Teleplan claims system.

The fee can be claimed once per qualifying patient starting December 4, 2021, and for the duration of the transition period, regardless of whether the patient switches to a biosimilar.

See the table below for fee codes, which are active during their respective phase periods. Note fee codes are restricted by prescriber type.

Switch Period: Nov 30, 2021 to May 29, 2022 Prescriber  Fee Code
biosimilar insulin lispro (e.g. Admelog) Any 97015
biosimilar insulin aspart (e.g. Trurapi) Any 97016

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.

See Tips for talking to patients about biosimilars for tips on how to approach biosimilar discussions with a patient.

Pharmacists may claim the biosimilar patient support fee for identifying patients and providing information to assist their switch to a biosimilar. This $15 fee can be claimed once for each affected PHN, even if the patient uses more than one drug involved. Fee claims will only be paid during the active switch period.

Biosimilar patient support fees are entered as a PIN in PharmaNet and paid monthly to pharmacies, in accordance with the usual monthly payment schedule.

Switch Period Effective Dates PIN
insulin aspart and insulin lispro November 30, 2021 to May 29, 2022 66128298

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 them to PharmaCare's patient information sheets, which summarize 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. See Biosimilar biologic drugs in Canada: Fact Sheet.

Drug Decision Summaries



Additional reading

insulin aspart

insulin lispro

adalimumab

etanercept

infliximab

 

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