Drugs and Devices Division
Limited Use Drug Products
Drug products reimbursed under the ODB program are evaluated and recommended for listing by the ministry's external expert drug advisory committee, the Committee to Evaluate Drugs (CED)). Limited Use (LU) drugs are those drugs recommended by the CED as having value in specific circumstances, although they may not be appropriate for general listing in the Formulary/CDI.
Limited Use drugs may:
- have the potential for widespread use outside the indications for which benefit has been demonstrated;
- be useful but are associated with predictable severe adverse effects and a less toxic alternative is available as a benefit;
- be very costly and a lower-cost alternative is available as a general benefit.
As a result, the CED may recommend that a drug product be listed as a LU product in the Formulary and be reimbursed only when specific clinical criteria/conditions have been met. Designating certain drugs as LU benefits provides an opportunity to make drugs available as formulary benefits, under certain conditions, with relatively easy access in lieu of a more involved process like the Exceptional Access program. The legislative authority, allowing the ministry to reimburse certain drug products as LU benefits, is provided for in the regulations under the Ontario Drug Benefit Act which indicate that “The executive officer may require that, in respect of a specified drug product or class of drug products, specified clinical criteria must be met for the executive officer to pay an amount in respect of the supplying of that drug product or class of drug products for particular patients or a particular class of patients.” Â Payment can be made only when the specific clinical criteria have been met.
For the complete list of Limited Use products, please search the e-Formulary.
For more information on the Limited Use process, please refer to section XII of the downloadable Formulary.