Biosimilars Initiative for health professionals

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.

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.

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:

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:

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