reporting criteria for special authorization products
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Hello PAAB! In cases where provincial formulary coverage of a product is restricted (e.g., special authorization) do all of the coverage criteria, definitions, and notes have to be included with the APS or can you simply link to them (via a "See Coverage Criteria" button) on the corresponding page on the provincial formulary web site. As well, if a criterion is one where we have no data in our PM, do we have to disclaim the criteria in some way? (i.e. "Product X has not been studied for this criterion"?
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Hello PAAB! In cases where provincial formulary coverage of a product is restricted (e.g., special authorization) do all of the coverage criteria, definitions, and notes have to be included with the APS or can you simply link to them (via a "See Coverage Criteria" button) on the corresponding page on the provincial formulary web site. As well, if a criterion is one where we have no data in our PM, do we have to disclaim the criteria in some way? (i.e. "Product X has not been studied for this criterion"?
Hi @constance
Please see PAAB resource Provincial Formulary Coverage Statements
Per the guidance document, the requirement for full formulary criteria disclosure is dependent on the nature of the claim e.g. inclusion of coverage codes requires disclosure of the full coverage criteria. Criterion are usually restrictions for coverage and act as qualification. Criteria generally do not require disclaimers if they are consistent and do not extend beyond the indication. Per the above reference, the indication acts as the limitations for initial consideration. There may be scenarios where disclaimers may be requested. This would be a case based assessment.
