The previous Individual Clinical Review mechanism is being transitioned and access to new drugs is now available through two more direct options : Conditional Listings and an Exceptional Access program. Already there has been progress :

In the past year :

• 263 individual products have been listed, including 38 new brand name drugs
• 27 of these new brand name drugs were made available through Conditional Listings
• 11 of these new brand name drugs are being reimbursed through Exceptional Access
• 4 of the top 10 products that were previously requested through the Individual Clinical Review have moved to conditional listing - eliminating 40,000 (or 25%) requests per year

Conditional Listings

A 'conditional listing' is a new Formulary listing that is intended to provide access to new and existing drugs under certain conditions. Conditional listings are established through negotiated agreements between manufacturers and the Executive Officer, and may include :

• Commitment to promote appropriate use
• Requirement to collect outcomes data
• Requirement to gather further evidence related to clinical or economic information for future consideration by CED
• Expenditure contracts

Criteria for reimbursement may be published in the Formulary as therapeutic notes and it is the responsibility of the prescriber to prescribe the drug to ODB recipients in accordance with the listed criteria. Conditional listings will allow ODB recipients to access new drugs on a conditional basis while the information that might support continued listing is in the process of being collected and reviewed. Conditional listings will also ease the administrative burden on prescribers as no forms or Limited Use codes are required.

Exceptional Access

Exceptional Access is intended to handle requests for drugs not funded under the Ontario Drug Benefit Program. Through this progress, individuals with uncommon clinical circumstances could be provided exceptional access to certain drugs. Each case is reviewed individually, according to specific criteria by either internal or by external experts. The ministry is working on options to speed up the application and decision-making process, including a phone or web-based system.

See also :

• Rapid Review Process Progress
• Aligning Funding Policies