Biosimilars Initiative for health professionals

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 either:

• HLTH 5860 – Denosumab patient list request (PDF, 968KB) (only for patients with PharmaCare coverage)
• HLTH 5849 – Ustekinumab patient list request (PDF, 976KB) (only for patients with PharmaCare coverage)

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. 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 applicable coverage form for a biologic to request consideration of a coverage 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 a biologic product that may be affected by a PharmaCare coverage transition:

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. 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.
3. Encourage the patient to view the PharmaCare webpage Biosimilars Initiative for patients for information on biosimilars, including common concerns patients may have when switching to biosimilars and how biosimilars differ from originator biologics.

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:

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. Refer to Biosimilar biologic drugs in Canada: Fact Sheet.

Drug decision summaries

Additional reading