APA has expressed "extreme concern" over the lack of a
therapeutic category for medications used to treat substance use disorders in
the proposed revision of the United States Pharmacopeia's (USP) Model
Guidelines for prescription drug plan (PDP) formularies participating in the
Medicare Part D drug benefit.
Following provisions of the Medicare Modernization Act (MMA) that created
the Part D drug benefit, USP was charged by the Centers for Medicare and
Medicaid Services (CMS) to develop a uniform set of guidelines that CMS could
use to evaluate individual PDPs' proposed formularies.
The MMA also specified that USP is to periodically update those model
guidelines to ensure that they include a complete and accurate listing of the
drug categories, classes, and key drug types that all Part D formularies must
cover (see page 1). USP
recently released its proposed revisions for the Model Guidelines to be used
in 2007 and invited public comment, as required by the MMA.
In a letter signed by APA President Steven Sharfstein, M.D.; Michael
Gendel, M.D., president of the American Academy of Addiction Psychiatry;
Elizabeth Howell, M.D., president of the American Society of Addiction
Medicine; and Michael Brooks, D.O., president of the American Osteopathic
Academy of Addiction Medicine, the four organizations told USP that a specific
category should be added to the model guidelines to encompass the FDA-approved
medications currently used to treat addictions.
While these medications produce their clinical effects through different
mechanisms of action, they can generally be divided into two main classes:
medications used to treat withdrawal symptoms and medications used to deter
future use of a substance of abuse. Based on that guiding principle, APA and
the other organizations strongly recommended that a new therapeutic category
of "Addictions Treatment Agents" be added to the revised
guidelines (see table at left).
Within the new category, drugs would be subdivided into a pharmacologic
class of "Deterrents," which would include key drug types for
medications used to deter alcohol or opioid use.
The second drug class, labeled "Withdrawal Agents," would
contain three key drug types—medications used as alcohol detoxification,
nicotine detoxification, and opioid detoxification.
Some addiction treatment medications are listed in the USP revision for
2007. However, they are lumped into the broad category of "Antidotes,
Deterrents, and Toxicologic Agents" along with "Ion Exchange
Resins" and antivenins. This listing "seems an inappropriate
categorization," the presidents of the four organizations wrote.
Substance use disorders, they continued, are highly prevalent medical
conditions with significant morbidity and mortality. "Given the proven
effectiveness and evidence base of these pharmacologic treatments, our
organizations strongly believe that these medications should be included in
the revised guidelines." ▪