When can we use brand names in claims when reference uses generic?
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Hi PAAB,
We're looking for clarification on when we can use brand names in claims when the reference uses the generic name.
It is our understanding based on the previous approval of APS that we can use a brand name in a place in therapy claim when the Canadian guidelines only uses the generic.
E.g.: Copy in APS says "Start with BRAND NAME X - guidelines for the treatment of disease X". This claim is supported by a guideline reference which states that "generic name X" is recommended as first-line therapy for disease X.
Can you clarify if the same applies to combination therapies? For example, BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?
If the answer to the above bolded question is no, can you kindly clarify why this is different from using a brand name in an APS when the guidelines referenced uses generic?
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Hey @maryssa
We’re not sure of the specifics to the case that you’re referencing in the beginning of the question so we cannot confirm your understanding. We can provide general guidance on place in therapy claims.
Place in therapy can be supported by guidelines when it’s consistent with the indication. The PAAB document “What constitutes current medical opinion & practice” states “PAAB has received requests from consensus groups to ensure that the proprietary drug name [brand name] is not included within a claim directly referring to the guideline if the guideline recommendation only cites the non-proprietary drug name [generic name]”. We refer you to the examples in the above-mentioned document. Therefore, a claim that a product is recommended first-line per guidelines X, would require that the brand name be specifically mentioned in the guideline recommendation. Otherwise, the generic name should be used.
For the second scenario (“BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?), the answer is no, as per the principle outlined above (consistency with the authorized indication). We are also aware of cases where Drug Y does not have an authorized indication for combination with Drug X. If the question was intended to be in reference to guidelines, the above response (direct mention by brand name in the guidelines) would also be required.
