APA added its voice to a wide-ranging chorus of dissatisfaction at a public
hearing last month on the proposed framework of drug categories and classes to
be covered by the new Medicare Part D prescription drug benefit that starts in
2006. The framework, said APA and others, is wholly inadequate to address the
diverse clinical needs of a heterogeneous patient population, such as those
with mental illness.
The proposed framework of categories and classes, referred to as the Model
Guidelines, was developed by the United States Pharmacopeia (USP). The USP was
contracted by the Centers for Medicare and Medicaid Services (CMS) to produce
a list of categories and classes that must be covered by any private
prescription drug plan (PDP) or Medicare Advantage plan seeking to participate
in Medicare Part D (Psychiatric News, December 19, 2003).
Under the Medicare Prescription Drug Improvement and Modernization Act
(MMA), signed into law by President Bush last December, any drug plan
participating in Medicare Part D would be required to cover at least two
medications "within each therapeutic category and class of covered Part
D drugs, although not necessarily all drugs within such classes."
In accord with the MMA, CMS noted two key objectives regarding the
therapeutic categories and classes: to prevent undue discouragement of
enrollment by intended beneficiaries and to prevent discriminatory formulary
practices by drug plans.
"Our preliminary evaluation is straightforward," Steven Daviss,
M.D., president of the Maryland Psychiatric Society, testified on behalf of
APA. "The USP draft categories and classes compress the available
pharmacologic agents in a manner that is inconsistent with appropriate
organizing principles for these drugs and inconsistent with accepted practice
in the field. We find that the draft categories and classes are wholly
The USP noted in the draft Model Guidelines that indeed the guidelines are
not a formulary—"they represent a first step in helping plans
develop their formulary structures." The USP established an Expert
Committee to develop the guidelines and also formed "advisory
forums" to represent beneficiaries, drug plans, pharmaceutical
manufacturers, and providers.
In all, the expert committee was made up of 18 members from academia, the
National Institutes of Health, large health systems and health insurers, and
pharmacy benefit providers. The four advisory forums drew input from an
equally broad array of experts, representing 20 groups. For example, AARP and
Consumers Union representatives served on the beneficiary advisory forum, and
the providers advisory forum was made up of representatives from the American
Academy of Family Physicians, American College of Physicians, American
Geriatrics Society, and American Nurses Association. Representing pharmacists
as providers were the Academy of Managed Care Pharmacy, American Society of
Consultant Pharmacists, and American Society of Health System Pharmacists.
Between January and August, the Expert Committee met numerous times and
contracted with outside consultants to advise in the development process. The
committee developed a classification system "that begins with a
disease-linked therapeutic category (generally reflective of indication),
follows with pharmacologic class (primarily based on mechanism of action), and
includes a further subdivision where needed."
With respect to psychotropic medications, the Model Guidelines propose six
broad categories with eight classes of medications and nine subdivisions (see
table at right).
"We believe that the draft Model Guidelines fail to adequately
account for different mechanisms of action of the psychotropic drugs used in
persons with mental illnesses," Daviss told Psychiatric
At least two drugs from each category would have to be covered by any PDP
participating in Medicare Part D. For example, only two anticonvulsants would
need to be on a formulary, as well as two anxiolytics and two "bipolar
agents." None of these three categories, however, is broken down into
different classes of medications. Bipolar agents could include many
anticonvulsants and most newer antipsychotics, yet there is no requirement
that any more than the two least-expensive "bipolar agents" would
have to be covered.
In the proposed antipsychotic therapeutic category, APA testified,"
differentiation between phenothiazine and non-phenothiazine
antipsychotics has little clinical significance." In addition,"
the proposed non-phenothiazine, atypical class lumps together six very
different medications which exert their clinical effects through at least two
separate mechanisms of action."
Likewise, the antidepressant category is divided into two classes, with the
serotonin reuptake inhibitors, norepinephrine reuptake inhibitors, combined
serotonin-norepinephrine reuptake inhibitors, and the tricyclics all lumped
together. Thus, a PDP's formulary could cover a generic tricyclic and generic
fluoxetine only and still meet the requirements of the Model Guidelines.
The lack of appropriate access to prevailing first-line treatments carries
a high probability of discouraging enrollment of certain beneficiaries in a
Medicare PDP, Daviss stressed. The guidelines would also allow PDPs to"
risk-select" by offering older or less expensive and less
effective agents, thereby again discouraging patients currently stabilized on
newer, higher-cost medications from enrolling.
"Any formulary guidelines, therefore, or framework for therapeutic
categories and classes that force a pharmacological homogeneity, which does
not in fact exist, onto a highly heterogeneous clinical population and classes
of pharmacologic agents may well be discriminatory on their face. Similarly
situated patients with mental illness will not likely have equal access to
appropriate first-line treatments."
The public hearing was well attended, and the vast majority of those
speaking during the comment period expressed concern on a number of
John Gates, M.D., representing the American Academy of Neurology, noted
that the persons most likely to be covered under Medicare Part D will be those
who have multiple comorbidities and need access to a wide variety of drugs at
different times. The standard approach "of two medications from each
category or class is unacceptably restrictive," he said.
Gates also stressed that it is poor judgment to decide whether to include a
medication in a formulary on the basis of cost alone. The decision, he said,
must be multifaceted, and above all else, "the sum of efficacy plus
tolerability is the true measure of a medication's success or effectiveness.
It does not matter how effective a low-cost medication is if patients cannot
tolerate its adverse effects."
Representatives from the American Society of Health System Pharmacists and
the American Society of Consultant Pharmacists suggested that the development
strategy of the Model Guidelines was fundamentally flawed. Both noted in oral
testimony that many disparities existed in the weight given to various
categories and classes.
For example, ASCP noted that in the list of categories, "35 or more
antihypertensive combination products are lumped into a single
category," and "all 23 cephalosporin antibiotics" are also
combined in a single category. Finally, they noted, "SSRI and SNRI
antidepressant medications are combined... despite distinct pharmacological
differences." Expanding and separating these drugs into more distinct
groups "would help ensure access to an adequate number of these critical
In oral testimony APA's Daviss reiterated APA's request to be considered"
a participant in the USP deliberation process" and formally
included in "one-on-one" consultation with CMS and the USP in the
development of the final
"This is 2004," Daviss stressed. "These historic changes
to Medicare need to bring the treatment of mental illness into the 21st
century. Americans with mental illness deserve an alternative, flexible
classification system for psychotropic medications that accounts for mechanism
of action, side-effect profile, and metabolism so that citizens will have a
safe and clinically reasonable choice—regardless of race, gender, age,
liver action, renal function, or other illness comorbidity."
More information on the USP Model Guidelines can be accessed online
by clicking on "USP to play a critical role in creating Medicare Model