Biosimilar drugs emerged in the early 2000s, and the pCPA recognized they’re highly effective treatment options that also bring significant savings for public drug plans.
To date, we’ve completed more than 100 negotiations for biosimilar drugs.
pan-Canadian approach
The pCPA is the initial point of contact for manufacturers wanting to negotiate public reimbursement for biosimilar drugs. We can leverage different pathways to support timely negotiation for biosimilar drugs — including our standard negotiation process and targeted negotiation process. The difference in the case of biosimilar drugs is how and when they enter our negotiation processes (see the biosimilar review process).
Supporting the uptake of biosimilar drugs
We undertook many collaborations to support the adoption and use of biosimilar drugs in Canada.
pan-Canadian oncology biosimilars initiative
The adoption of biosimilar drugs into cancer treatment required multiple considerations to ensure maximal uptake and optimal pricing, as well as maintaining high quality care and patient outcomes.
Recognizing these unique considerations, we partnered with Cancer Care Ontario (CCO, now part of Ontario Health) in 2019 to implement the pan-canadian oncology biosimilars initiative (pCOBI). This cancer-specific strategy aimed to drive the use and acceptance of oncology biosimilar drugs while considering the different environments in which biologics are used to treat cancer.
In 2018 we co-hosted the pan-Canadian oncology biosimilars summit. Feedback from the participants informed the development of an action plan, which addressed 6 priority areas:
- Education
- Clinical operations
- Clinical guidance
- Reimbursement
- Evaluation
- Reinvestment
This led to the establishment of 2 pan-Canadian working groups including clinicians, health administrators, and patient representatives from across Canada. The education working group guided the development of comprehensive educational resources for both patients and clinicians. The clinical operations working group developed a position statement to support hospitals and cancer centres in preparing for the implementation of oncology biosimilar drugs. The resources developed by both working groups are available on the pCOBI webpage.
The other 4 priority areas were addressed by jurisdictions as they gained more experience treating patients with oncology biosimilar drugs.
The pCOBI’s work laid the foundation for the successful adoption of oncology biosimilar drugs across Canada and continues to support the evolution of cancer drug funding policies.
National consultation on the use and implementation of biosimilar drugs
In 2019 we collaborated with Canada's Drug Agency (CDA-AMC, then known as CADTH) for extensive consultations and engagement exercises regarding the implementation and expanded use of biosimilar drugs in Canada.
This process provided an opportunity to understand how partners, including clinicians, patient groups, private payers, group purchasing organizations, and industry representatives, view the opportunity presented by biosimilar drugs.
The online consultation summary report and in-person consultation summary report capture the key themes and feedback we received.
pan-Canadian biosimilars initiative evaluation framework
In 2020 we supported a project led by Ontario Health (CCO) to develop an evaluation framework related to biosimilar-drug implementation across oncology and non-oncology settings. The goal was to allow the healthcare system to examine the impact of jurisdictional approaches for biosimilar-drug implementation on drug use and uptake, cost savings, patient experiences, and outcomes, as well as to assess education and resource needs.
A pan-Canadian evaluation working group was established to identify priorities for evaluation and provide input on data collection relating to key evaluation questions and indicators across several domains. We consulted interested parties on the importance of evaluation questions and indicators, as well as the feasibility of data collection and analysis.
These activities resulted in the development of a set of evaluation questions and indicators for measuring and monitoring current and future approaches for biosimilar-drug implementation.
Both the biosimilar initiative evaluation framework report and the biosimilar evaluation framework toolkit can be found on the CCO website.
For manufacturers
Use this section to access forms, guidance, and key information related to biosimilar-drug price negotiations with the pCPA.
Processes
Biosimilar review process
How to initiate discussions with the pCPA
Standard negotiation process
The main negotiation pathway for most brand-name drugs and some biosimilar drugs
Targeted negotiation process
A streamlined pathway for non-complex negotiations, including drugs comparable to others already available in the market
Forms
Manufacturers seeking public reimbursement for a biosimilar drug, and prepared to enter negotiations, should notify the pCPA if they have their Health Canada Notice of Compliance (NOC) or expect to receive it within the next 6 months.
Please refer to relevant process pages and resources for more information.
Resources
Explore key reference documents to support your submissions.