Health and Community Services

Exceptional Review Process

Under the Exceptional Review Process (formerly known as Non-Funded), the Medical Practitioner designated by the Minister will consider requests for drugs with a Notice of compliance (NOC) from Health Canada and are considered under the NLPDP special authorization process. This would require the health care provider to apply in writing providing detailed documentation as outlined below. In cases where a health care provider does not provide supporting clinical evidence as well as clinical and funding alternatives, the request will not be reviewed or considered under the Exceptional Review process.

Detailed Documentation

Diagnosis

  • Please provide detailed information outlining specific diagnosis noting any relevant severity of symptoms, patient co-morbidities, allergies, or other relevant patient specific information to indicate a rare clinical situation.
  • The severity of the disease/condition.

Supporting Clinical Evidence

  • Please provide published evidence to support the request. The minimum acceptable level of evidence is case-series or multiple case reports where n > 25 in total.
  • The evidence of efficacy must be overwhelmingly in favour of the drug. Ideally, randomized controlled trial data (RCT) should be available. Individual case reports, Phase I and II trials and expert opinion provide the lowest level of evidence however it may be considered to support Exceptional Review for rare diseases or medical conditions.

Safety evidence to support the potential benefits must outweigh the risks.

Clinical Alternatives

  • Please provide detailed information outlining failure of ALL appropriate alternatives available in the NLPDP benefit list AND all appropriate non-pharmacological alternatives. Failure of other clinically appropriate and/ or less expensive alternatives not funded by NLPDP that may be considered through this Exceptional Review process or those funded through other agencies (i.e. Regional Health Authority) must be considered.

Funding Alternatives

  • Before funding is considered, documentation must be supplied outlining that the patient cannot enroll in a clinical trial AND other funding options (including compassionate supply through the manufacturer, funding under other programs etc.) are have been exhausted.

The medical practitioner designated by the minister would then review the information and make a decision. The decision of that consultant with respect to the special authorization is final.

Policy

Exceptional Review requests will not be accepted:

  1. If the drug requested is not listed on the NLPDP benefit list under Special Authorization. Only drugs designated as Special Authorization are considered under the Exceptional Review Process.
  2. If the drug requested is listed on the NLPDP benefit list under Special Authorization, but the beneficiary has already been denied* coverage, it will not be considered for exceptional review and denied.

  3. *Exceptions may apply when additional compelling evidence is presented that was not provided with the original request. Once an Exceptional Review request is finalized it is forwarded to the medical practitioner for assessment and decision.
  4. If the drug will not be reviewed by one of the expert committees it will not be considered for the exceptional review process and denied.
  5. If a drug is undergoing review by one of the expert committees utilized by the Program it will not be considered for the exceptional review process and will be denied.
  6. If the drug has been reviewed by one of the expert committees and is not recommended for coverage it will not be considered for the Exceptional Review process and denied.

The Exceptional Review Process is intended to be a mechanism for a final appeal to the NLPDP for a drug that is considered under Special Authorization, but has not been reviewed for the requested indication (diagnosis).

Internal Process

For any eligible Exceptional review request, a pharmacist within the Pharmaceutical Services Division will review the clinical evidence provided by the requesting healthcare provider. If the evidence is incomplete, the clinical pharmacist will communicate with the requesting healthcare provider. The pharmacist will review what was submitted and complete an additional search for available clinical and economic evidence through the Drug Information Centre through the School of Pharmacy and/or other published journal, or other available resources.

The medical practitioner designated by the minister would then review the information and make a decision. The decision of that consultant with respect to the special authorization is final.

Exceptional Review Process FlowchartPDF Icon

Frequently Asked Questions – BeneficiaryPDF Icon

Frequently Asked Questions – Health Care ProviderPDF Icon

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