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How Drugs Are Approved : Review Process

Types of Listing Recommendations

General Benefit (GB)

General Benefit drug products are listed in the Formulary and reimbursed to ODB-eligible recipients without specific conditions.

Conditional Listing (CL)

A Conditional Listing category is intended to provide access to new and existing drugs listed in the Formulary under specific conditions and based on the recommendations of the CED. These conditions may include but are not limited to :

  • commitment to promote appropriate use where there may be concerns about inappropriate use or "off-label" use
  • use in specific subgroup of patients
  • requirement for outcomes data
  • requirement for other, specific evidence to meet identified gaps in clinical or economic information
  • mechanism to monitor and enforce conditions
  • requirement for the Committee to Evaluate Drugs to further review the drug in a specific timeframe

Conditional listings are set up through partnership agreements between manufacturers and the Executive Officer.

Limited Use (LU)

Limited Use drug products demonstrate efficacy, safety, and cost-effectiveness for certain specific indications and are reimbursed for ODB recipients only when prescribed according to criteria/conditions outlined for each product in the Formulary. LU listed drug products are being reviewed to determine if there are opportunities to transition a product to a Conditional or General Benefit listing.

See also :

For more information
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