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Avalere Report Shows Unapproved Prescription Drugs Dropped from CMS Formulary Reference File
Date:5/15/2008

tly by Avalere Health brings to light important issues regarding the availability of information regarding unapproved drug products, changes to prescription drug coverage, and the resulting impact on patients, pharmacists, and others. APhA views this work as a positive contribution to healthcare discussions on improving medication use and advancing patient care."

CMS reduced the number of drugs on its "Formulary Reference File" -- the tool used by Part D plans to shape their Part D drug formularies -- from 7,100 to 5,500 in 2008. Using its DataFrame(R) database tool, CMS's public use file data, and public reference materials from the FDA, Avalere researchers sought to explain why drugs were deleted from this CMS file, what types of drugs were dropped, and how pharmacists, patients, and health plans may have been affected by CMS' changes.

Avalere found that CMS dropped drug codes from the Formulary Reference File that were connected to: a) unapproved FDA drugs; b) discontinued drugs; c) Part A or Part B products; d) products with redundant codes; and e) products not reimbursable under statute (such as nonprescription medications, and agents used for anorexia, weight loss, weight gain, or for cosmetic purposes).

CMS's changes to the CY 2008 Reference File had significant ripple effects to plans, patients, physicians, and pharmacists. For patients, changes in the formularies could result in their need to pay out-of-pocket for non-covered drugs, or transition to a comparable drug. Plans have the authority to decide whether or not to pay for the deleted drugs.

Unapproved prescription drugs listed in the formularies were likely older products cleared for marketing before 1962, the year that the FDA began requiring proof of efficacy. Before the requirement, drugs were approved based on safety, in compliance with the Federal Food, Drug, and Cosmetic Act of 1938. The products in this category were overwhelmingly medications used for sedation, pain
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SOURCE Avalere Health
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