What does it mean if a drug product is listed as "off formulary"?

When a drug product is listed as "off formulary," it generally indicates that the specific product is a brand name medication that is not covered under the Ontario Drug Benefit (ODB) program. Being "off formulary" means that patients may have to pay the full cost of the drug out of pocket unless they have private insurance that may cover it. This status can occur for various reasons, such as the product not meeting certain effectiveness or safety criteria necessary for coverage under the ODB guidelines.

In the context of drug coverage, being off formulary contrasts with formulary medications, which are approved by the ODB for reimbursement based on their demonstrated effectiveness and relative cost. It is crucial for healthcare professionals and patients to understand these classifications, as they directly impact access to necessary medications and out-of-pocket expenses for patients.