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Compassionate Review Drug Policy Expanded

Ontario Providing Greater Access To Critical Drugs

January 21, 2011

Ontario is expanding its compassionate review policy so that more patients with rare clinical circumstances can potentially benefit from coverage under Ontario Public Drug Programs (OPDP).

As of January 19, 2011, the Executive Officer of the OPDP will consider requests to cover drugs in cases where an individual has been urgently hospitalized due to an immediate life, limb or organ-threatening condition and the requested drug therapy is directly related to the condition that resulted in the hospitalization. Interim coverage of the drug will be for a maximum period of six months and will begin once the patient is discharged from hospital.

The province will consider covering drugs that have been reviewed by the Committee to Evaluate Drugs (CED) and where Ontario is in funding negotiations with the manufacturer. Previously, applicants could not be approved for coverage in cases where the CED had made a recommendation, but the ministry was still in negotiations with the manufacturer.

The expanded policy responds to a recommendation from a 2010 report of the Ontario Citizens´ Council on funding for drugs for rare diseases.

QUICK FACTS

• The CED, a committee of medical experts and patients, conducts a thorough assessment of drug submissions from manufacturers relating to scientific evidence, clinical experience and patient perspective. The CED then makes a recommendation on whether or not a drug should be listed in the Ontario Drug Benefit formulary or funded through the Exceptional Access Program on a case-by-case basis.
• The Compassionate Review Policy was developed in 2009 to allow access to drugs where the manufacturer has not made a submission to the ministry and the CED has not reviewed, and where there are rare clinical circumstances in immediately life, limb or organ-threatening conditions.
• Approximately 250 applications are reviewed under the Compassionate Review Policy each year
• The Executive Officer decides on funding/drug coverage through Ontario´s drug programs and the Exceptional Access mechanism, negotiates agreements with manufacturers of drug products, and provides payments under the Ontario public drug programs. The position was created in 2006.
• Doctors can apply through the Exceptional Access Program at the Exceptional Access Program, 3rd Floor, 5700 Yonge St.. North York, ON M2M 4K5, Fax : 416-327-7526 or 1-866-811-9908.

LEARN MORE

Read more about Ontario Public Drug Programs.
Read more about the Ontario Citizens´ Council.
Read more about the Exceptional Access Program