Update: Formulary Review Practices
-
Happy Wednesday @Agency and @Manufacturer
PAAB has made changes to formulary review practices.
NEW
When a product used as indicated would be covered, the sponsor can include the formulary coverage even if the criteria is broader than the indication (e.g., the indication is for moderate to severe condition X and the criteria is for condition X), provided that the indication is presented prominently directly before the criteria to establish the context. The indication should reflect the same condition as the criteria and, at a bare minimum, the font size should be 75% of the size of the criteria. This is similar to treatment guidance used for fair balance.Note: This applies even if the indication is already included elsewhere in the APS.
There should also be NO undue emphasis on the broader condition or criteria, (e.g., bolding, callout, headline, etc.,) such that it appears as off-label promotion.
Reminder: When applying the above provisions, overt off-label criteria continue not to be acceptable in drug advertising per code section 3.1.
See our revised formulary advisory page which combines all three formulary resources into one location.
-
Happy Wednesday @Agency and @Manufacturer
PAAB has made changes to formulary review practices.
NEW
When a product used as indicated would be covered, the sponsor can include the formulary coverage even if the criteria is broader than the indication (e.g., the indication is for moderate to severe condition X and the criteria is for condition X), provided that the indication is presented prominently directly before the criteria to establish the context. The indication should reflect the same condition as the criteria and, at a bare minimum, the font size should be 75% of the size of the criteria. This is similar to treatment guidance used for fair balance.Note: This applies even if the indication is already included elsewhere in the APS.
There should also be NO undue emphasis on the broader condition or criteria, (e.g., bolding, callout, headline, etc.,) such that it appears as off-label promotion.
Reminder: When applying the above provisions, overt off-label criteria continue not to be acceptable in drug advertising per code section 3.1.
See our revised formulary advisory page which combines all three formulary resources into one location.
Hi, I would appreciate your guidance on a question regarding formulary claims. I have read the Guidance Documents regarding formulary coverage and understand that in order to be exempt, a simple statement like "Product X: Now on provincial formulary (regular benefit)" is exempt (no mention of
disease/therapeutic information). If we include a pack shot of the product, I am assuming it still meets the exemption criteria? This was not mentioned explicitly and I wanted to be sure. Thanks very much. -
Hi, I would appreciate your guidance on a question regarding formulary claims. I have read the Guidance Documents regarding formulary coverage and understand that in order to be exempt, a simple statement like "Product X: Now on provincial formulary (regular benefit)" is exempt (no mention of
disease/therapeutic information). If we include a pack shot of the product, I am assuming it still meets the exemption criteria? This was not mentioned explicitly and I wanted to be sure. Thanks very much.Hello @mhe
The messages noted as “Exempt” are when they are stand alone messages. If a pack shot was added that contained no mention or link to therapeutic use and had no visible claims (e.g., once-daily, dosed in the morning) than it may still fall into an exempt presentation. If there are claims or a link to therapeutic use, the piece would not be exempt and would require review. Note that you can blur the images/claims/copy on the pack shot. This would also rendering the piece exempt.
-
Hello @mhe
The messages noted as “Exempt” are when they are stand alone messages. If a pack shot was added that contained no mention or link to therapeutic use and had no visible claims (e.g., once-daily, dosed in the morning) than it may still fall into an exempt presentation. If there are claims or a link to therapeutic use, the piece would not be exempt and would require review. Note that you can blur the images/claims/copy on the pack shot. This would also rendering the piece exempt.
@jennifer-carroll Thank you for the quick response
-
@jennifer-carroll We note that the guidance states "For products that are being reimbursed according to criteria that are not publicly posted, please consult the PAAB for case-by-case consideration."
We’ve noticed that Ontario has been quite tardy in making their EAP listings and coverage criteria public. For example, at the time of writing this, their EAP coverage criteria document is extremely out of date (March 1): https://files.ontario.ca/moh-frequently-requested-drugs.pdf
We’ve noted that products covered by the EAP have taken a while to be integrated into this search function: https://www.ontario.ca/check-medication-coverage/
Considering that Ontario EAP coverage is quite an important landmark and communication objective for most applicable brands, this poses an issue to many clients. This is especially true since in the absence of timely listings on Ontario Government websites, timely communications from manufacturers regarding new EAP listing are all the more important.
Can PAAB provide direction for what agencies and clients should do if EAP listings or criteria are late?
-
@jennifer-carroll We note that the guidance states "For products that are being reimbursed according to criteria that are not publicly posted, please consult the PAAB for case-by-case consideration."
We’ve noticed that Ontario has been quite tardy in making their EAP listings and coverage criteria public. For example, at the time of writing this, their EAP coverage criteria document is extremely out of date (March 1): https://files.ontario.ca/moh-frequently-requested-drugs.pdf
We’ve noted that products covered by the EAP have taken a while to be integrated into this search function: https://www.ontario.ca/check-medication-coverage/
Considering that Ontario EAP coverage is quite an important landmark and communication objective for most applicable brands, this poses an issue to many clients. This is especially true since in the absence of timely listings on Ontario Government websites, timely communications from manufacturers regarding new EAP listing are all the more important.
Can PAAB provide direction for what agencies and clients should do if EAP listings or criteria are late?
Hello @dmauri
PAAB practice has been to accept communications from formulary bodies to the manufacturer which confirm listing and criteria in the absence of published coverage criteria. In the absence of these letters, we have accepted an attestation from the sponsor that confirms the EAP listing and that the government/ministry has no objection to the marketing of this criteria. The client can proceed with submitting pieces which communicate the listing and criteria.
