National formulary
What is a formulary?
A formulary is an official list of the medications that are available to be prescribed. The formulary also offers details that may be relevant to clinicians, such as appropriate uses for a particular product, recommended guidelines for patient care and information for proper administration of the product by clinicians or patients. All products are reviewed prior to being listed on the national formulary.
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. Once an 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.
Meeting Canadians’ needs
As a national program, we are committed to meeting the needs of patients in Canada while being good stewards of health-care resources. To do the most good for the most people in the most cost-effective way, we need to ensure that our national formulary is informed by the best evidence. We know that the same products can be used in different ways, and that use may evolve with new research and clinical practice, so we look for trends in how products are being used and we adjust the formulary, where needed, to keep meeting patients’ needs now and in the future.
Meeting unique patients’ needs
Some plasma protein and related products are recommended for use in specific patient populations but are not appropriate for universal access. Our Special Authorization Program (for products ordered using the Request for Patient Designated Plasma Protein Products form) allows products to be available for patients who meet certain criteria. This ensures the formulary continues to do the most good for the most people in an evidence-based and fiscally-responsible manner.
