Hey @constance

The information from the TMA relating to each individual product promoted does not necessarily need to be visually separated into its own distinct module within a co-promotional tool though this does appear to be one approach that would likely satisfy the statement. In essence, there should be clear delineation between characteristics/features that pertain specifically to each product. When presenting a group of products’ indications and/or various data, it is important that they appear clearly separate from each other so as not to suggest combination use, additive effect or comparative claims as some examples. In addition, when presenting features of the products, switching back and forth, grouping or mixing presentations may create erroneous impressions or lack of clarity. It’s not possible to provide an exhaustive list given the variability between products, therapeutic classes, claims placement, headline/subhead positioning and emphasis, creative, etc. If this is in reference to a specific piece, we suggest submitting for an opinion or a consult meeting.

@jennifer-carroll Thank you Jennifer!

Hi @constance

General enrollment based on geography may be considered when presented in a clear manner and with adequate disclosure of the pertinent PSP program information. For the highlighting of patient characteristics such as gender and age, acceptability is dependent on the balance of the APS content and supporting data as there will be subgroup emphasis considerations with such highlighting.

Hello @constance

Similar to our response above, a description of the outcomes for assessment and the listed study information noted in your question, may be included in an APS in a non-promotional manner , prominently disclaimed for the off label uses, and also prominently labeled “Ongoing studies”, in a separate tab/page that is away from the promotional content of the APS. Please also see this Q&A 223 for additional information on the presentation of ongoing studies in a non-promotional manner.

Hey @kshulist

An image that supports the evidence presented in the piece from an RCT, would be considered acceptable even if it was from a patient in an RWE trial. PAAB does not request confirmation that it is from a patient in the trial being presented who had the average response. The visual simply needs to reflect what would commonly be seen as “consistent with” the magnitude of effect demonstrated in the RCT.

If the evidentiary basis of support is the RWE, use of the images would not be acceptable.

@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.