438 - I would like to do a price per month comparison of a number of products. The official indications may vary slightly and some of the products would be OTC and some prescriptions. Is this possible and do you have any advice. Secondly what are acceptable pricing sources? Thank you.
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Per s5.1 of the PAAB code, the compared products must have an indication in common and the comparison must be related to that use. The variation in indication you’ve identified would therefore be cause for removal of at least some comparators.As prices may vary by source, please note that all compared prices must come from a single independent source which is reflective of national price. This is to ensure a levelled field for the comparison. The commissioner has had to rule on complaints of selective sourcing of prices in comparative claims in the past.The sourcing requirement and the indication requirement may make it challenging to include both Rx & non-Rx options. Additionally, some products would be associated with a dispensing fee while others would not. Plan accordingly when setting up the submission.Although there are some circumstances in which it would be acceptable, cost per month might be problematic on multiple levels. For example, it might suggest a pharmacoeconomic advantage to the sponsor’s product (i.e. suggesting that treating the condition with this product for a month costs less than treating it with another option). Per s5.10.1, claims may not convey (or even imply) a value comparison based on price information alone. High quality pharmacoeconomic studies are required to support pharmacoeconomic messages. A per month basis may also inflate the differences between products in an undue fashion. For example, some options may require a less lengthy treatment duration.When it results in a fair comparison, it may be advisable to structure the price comparison per dosage form (e.g. per tablet) instead. If this would be unfair (e.g. due to variability in dosing schedule), it may be advisable to structure the claim in terms of price per day.Careful to use the term “price” rather than “cost” to further reduce the risk of conveying an unsubstantiated pharmacoeconomic message. Also careful not use auxiliary elements such as images or text which accord pharmacoeconomic meaning to the presentation.Claims must adhere to all PAAB code provisions so you may wish to consider submitting a written opinion (see fee schedule on our website) when you have a concrete idea of how you’d like to proceed. I haven’t tried to foresee all potential issues so the reader should not assume this is an exhaustive assessment of the matter.
