@jennifer-carroll Thank you !

@jennifer-carroll Thank you for clearing that up!

Hello @mimic909 The indication (and at minimum lowest level fair balance) is required for all pieces which have a link to therapeutic use or contain marketing benefit claims about the product both explicit or implicit (Code section 2.10 and 2.4). The “branch of medicine (ex. Hematology)” alludes to a drug’s therapeutic use and would require indication and fair balance. The document Tips_and_checklist_for_creating_and_selecting_fair_balance provides assistance for selection of the level of fair balance. Additionally, PAAB Q&A 303 highlighting the exemption criteria which “branch of medicine” would not qualify for, 317 on inclusion of the indication, and 740 provides another example of a claim that would prompt inclusion of indication and fair balance.

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.

Hello @dmauri For a non-comparative claim regarding patient satisfaction of a patient support program (PSP), PAAB could consider data on file from the manufacturer. In other words, the sponsor’s lack of involvement does not apply in this case. The survey methodology, data, and analysis should be submitted for consideration to assess the question which may impact content required in the APS. PAAB can provide an opinion on the questions in advance (in the context of the anticipated claims) to ensure that they are asked in a manner that would be considered acceptable. As an example, it must be clear that the question is about the program and not the product or outcomes/effects of the product. Satisfaction with the program cannot be extrapolated to satisfaction with the product.

Hello @emc070 “Trusted” accords a status to the HCP’s choice to prescribe. This has both efficacy and safety implications which are not substantiated. It would also not be acceptable to equate a HCP’s choice to prescribe a product to their “trust” in said product. This type of claim would not be acceptable. Remember that market experience data should not be given clinical implications or equated to “trust” in the product.

@jennifer-carroll Thank you for clarifying!

@jennifer-carroll Thanks Jen! I hadn't seen that "Supplementary Guidelines for Market Share Claims" before and that is really helpful!

@jennifer-carroll Sounds good, thank you!

@lora_nolan There may be opportunity to include the final analysis providing it meets all the requirements set forth in our Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising. As we do not have the actual TMA and published paper for review, we are unable to provide a definitive answer. We suggest submitting an opinion if you remain unclear after consulting the guidance document.

@jennifer-carroll Okay I understand now, so saying "#1 dispensed ProteinX inhibitor for DiseaseA" would be misleading if 90% of those dispensings were really for the off-label treatment of DiseaseB? Yep, that makes sense, thank you!

@jennifer-carroll Thanks so much!!

@carbonad We are unable to provide reviews for acceptability on proposed claims or APS on PAAB Forum as this is for general queries. The formal review process will assess the indication and respective formularies to determine acceptability of a claim, i.e. alignment of potential criteria with the indication. For your consideration, there is an option to submit an opinion request with all the relevant PM and formulary support if that is preferred over a complete preclearance review. For the claim noted, in general, inclusion of the indication and a coverage claim would require inclusion of appropriate fair balance, disclosure of the provinces that are providing coverage and if special authorization or criteria are required. Please note that RAMQ has specific requirements for provincial coverage claims. For referencing requirements, the latter format is acceptable. As space is a noted concern, if geo-targeting is an option, the message could be limited only to “Now on provincial formulary (special authorization may apply)” and be only served on browsers known to be in one of the covered provinces. Please see the following resource for formulary claims including RAMQ requirements, PAAB : Resources : Advisory - Provincial Formulary Coverage Statements.

Hello @username Please see Q&A 647 .

@jennifer-carroll Thank you very much Jen!!

Hey @mbos A balanced and complete presentation of the AE profile from the TMA which reflect the same content and context, would be acceptable.

Hey @fernand Generally, promotion of place in therapy claims from consensus guidelines should be within the limitations of the indication and terms of market authorization. As it sounds like this is an off-label recommendation, it would not be acceptable. The Marketing Benefits Claims document also includes this definition.

@jennifer-carroll Thank you!

Good Morning @matt-s17 Apologies for the delayed response. In addition to a letter from med/reg confirming that they are actual patients, the presentation would be required to include the statistically significant data from the study for the endpoint being presented. The images should therefore reflect the average response. It would not be acceptable to select images that show the best-case scenario for patients. The pictures would also have to be disclaimed with “Actual patient. May not be representative of all patients.”. As with patient images, they should only appear in a clinical context and with the supporting data (e.g., if you’re going to place them on a summary page, the quantification will require repeating).