1. Why was a Biosimilars Initiative implemented?
Biologic drugs account for some of the New Brunswick public drug plans’ largest expenditures. Increasing the use of biosimilars will provide savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.
2. Has a Biosimilars Initiative that switches patients been done in other provinces?
Yes. Most provinces in Canada have implemented a Biosimilars Initiative. In addition, biosimilars switching has been performed extensively in Europe, where countries have had over 15 years of experience with biosimilars.
3. Does switching to a biosimilar impact patient outcomes?
Health Canada’s approval process requires that studies demonstrate no clinically meaningful differences in immunogenicity between the biosimilar and the originator biologic. Health Canada indicates that patients and health care providers can be confident that biosimilars are effective and safe for each of their authorized indications, and that no differences in efficacy and safety are expected following a change in routine use between an originator biologic and its biosimilar in an authorized indication.
4. What is the process for switching patients?
Prescribers play an important role in the switching process. As a trusted and experienced information source, a prescriber may set the tone of the discussion, facilitate continuity of care, and empower the patient to understand and realize the best outcomes. The following steps may help patients with their switch to a biosimilar.
- Identify a patient using a biologic included in the Biosimilars Initiative.
- Discuss switching to a biosimilar with the patient. Appointments may be in-person or virtual (phone or video call).
- Initiate enrolment in the patient support program for the biosimilar (if applicable).
- Write your patient a new prescription, indicating the chosen biosimilar.
5. How do I identify patients using a biologic included in the Biosimilars Initiative?
To assist in identifying patients, prescribers may request a list of their patients who are using a biologic that is included in the initiative by submitting the Patient List Request Form.
6. Do I need to write a new prescription for a biosimilar?
Yes. After discussing the biosimilar switch with your patient, initiate enrolment in the patient support program (if applicable). Write a new prescription for your patient, indicating the change to the chosen biosimilar.
7. If the originator biologic requires special authorization (SA), do I need to submit a new request for the corresponding biosimilar?
No, SA requests do not need to be submitted for patients who are switching. When biosimilar brands are listed as benefits, they are added to existing SA approvals.
8. What if I can’t see patients before the end of the switch period?
If you cannot prescribe a biosimilar for your patients by the end of the switch period, their originator biologic drug will no longer be covered by the New Brunswick Drug Plans. The coverage end date for each biologic is specified in the table above.
9. What if a patient cannot be switched to a biosimilar?
If a patient is unable to switch for medical reasons, you may submit an SA request for exceptional coverage of the originator biologic. The request must clearly indicate the medical reason why the patient cannot switch. Requests are reviewed on a case-by-case basis.
10. Which biosimilars are covered?
The originator biologics included in the initiative and the respective biosimilars that are covered by the NB Drug Plans are listed in the table above.
11. Where can I find more information on biosimilars and switching?
Links to information on biosimilars and studies about switching are listed below under “Additional Information and Studies”.