Piloting the Addition of New Perspectives to Economic Evaluations of Drugs

We are testing a new approach that brings the societal perspective to our economic evaluations of certain new drugs.

When a drug sponsor submits a drug to our Drug Reimbursement Review program for review, they provide an economic model as part of their evidence package. As described in our Procedures for CADTH Reimbursement Reviews, the health care payer perspective is presented as the base-case analysis, meaning only the costs incurred by the public payer are included in the model. Examples of these costs include costs of the drug, hospitalization, and outpatient visits.

When a societal perspective is used in an economic model, it expands the considerations to include both health care payer costs and associated costs that fall outside the health care system. Examples of societal costs may include costs incurred by patients taking time off for treatment, productivity costs to society from patients being unable to work, and costs to other government sectors.

CADTH will consider societal perspectives for drugs reviewed through the complex review process effective for newly received applications targeting the December 2024 expert committee meetings (i.e., oncology files received on or after June 25, 2024 or non-oncology files received on or after July 10, 2024). Applications reviewed through the complex process will continue to be accepted for review without including a societal perspective until October 1, 2024. After this date, the inclusion of a societal will be required, or the sponsor will need to provide a rationale for why it is not included. 

Drugs eligible for the complex review process include cell and gene therapies, drugs that are first-in-class, drugs reviewed through Health Canada’s expedited pathways, and drugs that have an undefined place in therapy.

A complex review is conducted in a manner similar to a standard review but involves greater consultation with clinical experts (e.g., convening a pan-Canadian panel of specialists), greater consideration of non-randomized studies, a more detailed examination of potential implementation issues, and may include an additional review and consideration of potential ethical issues. Eligibility for review through the complex review process will be confirmed by CADTH at the time of accepting the file for review.

Through a test-and-learn approach, we will explore ways of ensuring that the results of the societal perspective analyses are robustly validated and presented. The pharmacoeconomic reports in our Reimbursement Reviews for complex reviews will present the results from both perspectives.

Toward a Common Approach

This pilot approach to considering the societal perspective is in-line with the approaches used at other health technology assessment organizations in Canada. The Institut national d'excellence en santé et en services sociaux (INESSS) requires manufacturers to submit both the health care payer and societal perspectives. The Public Health Agency of Canada also uses 2 reference cases (health care payer and societal) when the National Advisory Committee on Immunization (NACI) evaluates vaccines and vaccination programs.

More Information

Drug sponsors or consultants that have questions about this process should contact us at [email protected].

Related Information

Guidelines for the Economic Evaluation of Health Technologies: Canada