National formulary

At the heart of our plasma protein and related products program is the national formulary. We manage the formulary of products on behalf of provincial and territorial ministries of health (not including Quebec).

Products listed on the formulary are accessible to clinicians in Canada for use in caring for their patients. Approximately 50 products are listed on the formulary. All products provided through our formulary program are funded by the provincial and territorial health ministries at no cost for patients, whether the treatment is administered in a hospital or clinic or in a patient’s home.

Product Selection Process

How do products get on the formulary?

Any new product needs to be licensed by Health Canada before it will be considered for the national formulary. Submissions from manufacturers for new categories of products that are new to the formulary must be approved by provincial and territorial ministries of health (excluding Quebec) and meet certain eligibility criteria before the submission is assessed by Canadian Blood Services and the Canadian Agency for Drugs and Technologies in Health (CADTH). CADTH reviews the medical evidence for the product, how it compares with similar products and whether the product would bring good value to tight health-care budgets. After receiving a recommendation from CADTH, we review their findings and look at what the impact would be on Canadian health systems and key stakeholder groups, namely patients, health care providers and health ministries. Once our assessment is completed, it is submitted for final approval by the ministries of health.

Submissions from manufacturers for new brands of products which fall under an already approved category are assessed by Canadian Blood Services through an open and competitive procurement process.

*An interim product selection process is in place as we work collaboratively with health ministries and CADTH toward a longer-term process. For more information, see the interim review process.

New Category Product

This is a product that represents an entirely new class of products not currently available on the national formulary. For example, immunoglobulin is a category of products in which there are multiple brands.

New Brand Product

This is a new brand of product that, if added, would fall within a category or group of products that is already available on the national formulary.