Overview
The pCPA endorses a clear and consistent national approach that encourages appropriate use of biologics aligned with the pCPA mandate to enhance patient access to clinically relevant and cost-effective drug treatment options. Through in-depth consultations with the pharmaceutical industry, the pCPA developed guiding principles for biosimilars and related reference biologics with the intent to guide policy, reimbursement practices and negotiations.
- 2016 pCPA issued the First Principles for Subsequent Entry Biologics (SEBs) to guide negotiations and inform expectations for biologics and biosimilars.
- 2018 Biologics Policy Directions & pCPA Negotiations was created to further guide and define the process on how biologic and biosimilar products will be negotiated and considered for reimbursement by Canada’s public drug plans.
- 2019 pCPA created the Review Process & pCPA Negotiations Update which outlines the pCPA’s negotiation process for biosimilars in response to Health Technology Assessment (HTA) review changes.
2016 - First Principles for Subsequent Entry Biologics (SEBs)
2018 - Biologics Policy Directions & pCPA Negotiations
For Manufacturers
Manufacturers that intend to launch a biosimilar product into the Canadian market and intend to negotiate with pCPA for public reimbursement should submit the Manufacturer Notification of Intent to Negotiate a Biosimilar form to [email protected] to initiate discussions with the pCPA.
Manufacturer Notification of Intent to Negotiate a Biosimilar
Stakeholder Consultations:
- Pan-Canadian Oncology Biosimilars Initiative
pCPA partnered with Cancer Care Ontario (CCO) on a joint oncology biosimilars initiative that recognized the unique considerations in the implementation of oncology biosimilars. The arrival of therapeutic oncology biosimilars in Canada, which began in 2019, offered the potential to bring significant savings to provincial, territorial and federal public drug plans.
However, the adoption of biosimilars into the oncology setting required multiple considerations to ensure maximal uptake and optimal pricing while maintaining high quality care and patient outcomes. Recognizing these unique considerations, the pCPA and CCO partnered to implement the pan-Canadian Oncology Biosimilars Initiative (pCOBI). The pCOBI was a cancer-specific strategy that aimed to drive the use and acceptance of oncology biosimilars while considering the different environments in which biologics are used to treat cancer.
On November 16, 2018, the pCPA and CCO co-hosted the pan-Canadian Oncology Biosimilars Summit, bringing together patients, patient advocates, clinicians, agencies and other stakeholders from across the country to discuss the use of oncology biosimilars in Canada. The feedback from the participants informed the development of an action plan, which addressed six priority areas: education, clinical operations, clinical guidance, reimbursement, evaluation and reinvestment.
Pan-Canadian working groups were established for two major priority areas, education and clinical operations. The working groups included 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 assist hospitals and cancer centers appropriately prepare for the implementation of oncology biosimilars. The resources developed by both working groups are accessible on the pCOBI webpage.
The other four priority areas, clinical guidance, reimbursement, evaluation and reinvestment, will be addressed by jurisdictions as they gain more experience treating patients with oncology biosimilars. The pCOBI’s work has paved the way for an emerging oncology biosimilar market in Canada by preparing patients, clinicians and hospitals for biosimilar implementation, and supporting pCPA’s overall biosimilar strategy. The savings achieved through the implementation of therapeutic oncology biosimilars in Canada will support cancer system sustainability and enhance access to innovative treatments for patients.
- National Consultation on the Use and Implementation of Biosimilars
pCPA engaged with the Canada's Drug Agency (formerly CADTH) in November 2019, to conduct an extensive stakeholder consultation and engagement exercise on the subject of implementation and expanded use of biosimilars in Canada.
This consultation process provided an opportunity to understand how stakeholders including clinicians, patient group leaders, private payers, group purchasing organizations, and industry representatives, view the opportunity presented by biosimilars.
It also allowed an opportunity to provide input to jurisdictions that may be considering policy options to ensure a competitive and sustainable market for both biosimilar and innovator drugs, increase appropriate use of biosimilar treatments, and reduce the overall cost burden to enable savings to be redirected into the healthcare system.
The final reports on the National Consultation on the Use and Implementation of Biosimilars for both in person and online summarizes the key themes and feedback pCPA received from its stakeholder consultation.
- pan-Canadian Biosimilars Initiative Evaluation Framework
In 2020, the pCPA supported a project led by Ontario Health (Cancer Care Ontario) to develop an evaluation framework and measurement plan relating to biosimilar implementation across both the oncology and non-oncology settings. The goal was to enable the health care system to examine the impact of jurisdictional approaches for biosimilar implementation on drug utilization 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. Stakeholders were consulted 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 approached for biosimilar implementation.
Both the Biosimilar Initiative Evaluation Framework Report and the Biosimilar Evaluation Framework Toolkit can be found on the CCO website as tools for jurisdictions to use to support the evaluation of biosimilar implementations.