How does this happen? Well, the answer is clouded in much mystery and unanswered questions. Was the physician even aware he prescribed a Non-FDA approved patch? We can only assume that no discussion of FDA approval, safety, or costs were considered before prescribing. The result is that the paying client of the pharmacy benefit finds out about the exorbitant cost on the quarterly plan review. So, the plan is adjusted to not allow any further payment for that Non-FDA approved patch. The patient is delivered the bad news that their patch will no longer be a covered item under the pharmacy benefit. Here is the twist: turns out the patch did not even work on the patient and was discarded after a couple of uses, so they were not planning to refill it! Ouch!
So what was in the patch?
Lidocaine and menthol.
Really?!
There are menthol and capsaisin pain patches available for purchase by a pharmacy for resale that are also not approved, as well as a whole plethora of other patches and topical agents which present the same financial implications to the paying client.
Note the Orange Book reference. Here is an example: Sinelee-Orange Book Therapeutic Equivalence Code NA= NA (Not Applicable) - Products that are not reviewed by the FDA such as those marketed before 1938, vitamins, and nutritional supplements. NDC: 69263-0021-15 (box, 3 pouches, 5 each Capsaicin 0.05%, Menthol 5%, Medicated topical patch)
It’s an easy mistake to assume that all products with a National Drug Code (NDC) are FDA approved. Not necessarily. An NDC is comprised of three parts: 1) Labeler code 4 or 5 digits long, 2) product code 3 or 4 digits long, 3) package code 1 or 2 digits. For CMS classification, they now require that all NDC’s have 11 digits. If CMS does not require that a particular product be classified under their designation, it can have 10 digits. FDA assigns the Labeler code. Labeler assigns product code and package code. If one looks at the Orange Book for designation, one will find these unapproved drugs under marketing information/marketing category of an unapproved drug other. Bottom line: NDC does not equate to FDA approval.
Vigilance is required to identify, address, and catch these items. PBM’s are likely to pass these products through for payment under the category Unapproved Drugs Other. Equally important is a strategy for addressing similar, future products entering the market.
APC can monitor your plan for specific directions as to how or whether these products should be a part of the pharmacy benefit. New FDA approved treatments that have demonstrated their safety and efficacy through clinical trials can already be a hefty financial responsibility. APC can help the plan focus resources for approved therapies and new cures for Hepatitis C and other innovative treatments to come which truly offer clinical outcome improvement and positively impact member lives.
