Reporting formulary criteria when dosing is off-label
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Hi there,
Our drug is now on some provincial formularies (special authorization). In the formulary bulletin, the tablet strength given at the top is 15 mg and 30 mg, and then the criteria says "For the treatment of DISEASE in patients 12 years of age and older..."
However, in the PM, only patients between the ages 18-64 are recommended to increase their dose to 30 mg. 30 mg is not recommended for ages 12-17 or 65+.
Would this be considered off-label to the PM dosing? (The formulary bulletin doesn't explicitly say that the 30 mg is for all ages, however, it also doesn't clarify the recommended strength per age).
If this is considered off-label, how do we go about reporting the formulary criteria? Do we still report it verbatim?
We have reviewed the guidance found here https://www.paab.ca/resources/provincial-formulary-coverage-statements/ but are still unsure about our situation since it says "When applying the above provisions, overt off-label criteria continue not to be acceptable in drug advertising per code section 3.1." What does PAAB consider "overt off-label criteria"?
Any help would be much appreciated! Thank you!
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Hello @kshulist
From the information provided, it appears as though the formulary criteria are not overtly off-label. However, we would first have to see the TMA and listing in order to analyze the restrictions regarding the higher dose for the two mentioned populations. The rationale is that, based on your description, if the “15mg” and “30mg” in the formulary listing is presented only in the context of the available dosage strengths covered for the drug rather than dosing directives, it would not appear to be considered off-label. In the latter case (i.e. formulary listing appears as dosing), the dosing in the formulary appears broadly stated but can be easily limited by inclusion of the TMA dosing recommendations. It would be different if the formulary listing stated overtly “30 mg for use in patients 12 and up” which is off label. It’s likely, given no other issues with the listing, we would simply request the indication as well as the dosing recommendations for the two mentioned populations be presented upfront, as body-copy in the APS, prior to the presentation of the formulary criteria to establish the context.
