Unapproved Products and the Drug Pricing Compendia

Most medical foods, nutritional supplements, dietary supplements, probiotics, and multivitamins are considered unapproved products according to the Food and Drug Administration (FDA).  The FDA defines dietary supplements as “products taken by mouth that contain a ‘dietary ingredient’. Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.”  While the FDA requires prescription drugs to meet safety, efficacy, and quality standards, these same requirements are not in place for the aforementioned products.  Unlike prescription drugs, dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases.

Knowing that the same rigorous standards are not applied to dietary supplements, many wonder how the drug compendia providers handle these products.  Drug compendia subscriptions are purchased by numerous stakeholders, including PBMs and health plans, who rely on this information to make formulary coverage decisions.  In an effort to provide their customers with the needed information, compendia publish specific fields to distinguish between prescription, OTC, and unapproved products.

First Databank (FDB) may mark these products as ‘Other’ in the “Rx/Non-Rx Indicator” field, while Wolters Kluwer’s Medi-Span has the “Marketing Category” field to specify whether a product is an “unapproved homeopathic”, “unapproved other”, “medical food”, or “dietary supplement”, among others.  Elsevier Gold Standard uses the “License Type Name” field to list some products as “dietary supplements” or “medical foods”.  Although Cerner Multum is not as granular in their identification, most unapproved products can be identified by searching the “nutritional products” or “alternative medicines” categories.

As payers focus on additional ways to reduce spend, eliminating coverage for unapproved products is an increasing area of focus.  In PHSL’s fall newsletter on 2020 Formulary Exclusion Lists, we found that CVS is making a strong push to exclude high cost dietary supplement agents, with 25 additional dietary supplements excluded in 2020.  To aid in identification of these unapproved products, FDB has announced the addition of a “Q” code to their existing Class value field.  The already existing Class values of “F” and “O” will remain.  “F” will designate prescription drugs and medical devices as defined in the Food Drug and Cosmetic Act, including bulk drug ingredients.  “O” drugs will include non-prescription drug or medical devices.  FDB will create a new “Q” Class value for “products that are neither drugs nor devices, such as dietary supplements (including prenatal and other vitamins), medical foods, herbal preparations, and bulk flavorings or colorants.”  This change will enable stakeholders to more easily identify unapproved products, but what to do with this information remains at the discretion of the FDB customer.  Medi-Span has not announced a corresponding update to their drug compendium, but PHSL will continue to monitor for new developments on this topic.  PHSL can assist manufacturer clients in assessing their current product portfolio and helping to determine potential impact.


Posted: December 2019

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