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June 21, 2004
Mr. Roger
Williams
Senior Vice President and CEO
United States Pharmacopeia
12601
Twinbrook Parkway
Rockville, MD 208572-1790 Dear
Mr. Williams: On
behalf of the millions of patients our organizations are dedicated to helping
as they fight disease, we are writing request an opportunity to meet with you
and provide input to the United States Pharmacopeia (USP) as it takes on the extremely
important task of developing a model therapeutic classification system for the
new Medicare prescription drug program. Since
the model classification system USP develops will directly impact how 40 million
senior and disabled patients gain access to medicines in the new Medicare drug
benefit program - and serve as a potential model for the organization of private
drug benefit programs affecting millions more - we urge USP to be deliberate,
comprehensive and open-minded. Above all, we believe it is imperative that USP
be continually conscious of the many important implications that a drug classification
system has for patient care. As USP moves forward, we ask that we be given ample
opportunity to participate in the process by providing USP with additional input
on issues of particular interest in specific therapeutic areas.
In the interim, we ask that USP consider the following principles for a model
therapeutic class system, and take them into account when establishing your internal
processes for completing this important task. 1.
A model drug therapeutic classification system for Medicare must be designed to
ensure that all seniors and disabled beneficiaries have access to medications
that the prescribing doctor and patient believe will best meet the patient's health
needs. For
example: Under the proposed classification system for the new Medicare discount
card program, cephalosporins are not divided into subclasses even though standards
of practice dictate the use of broad spectrum cephalosporins in chronically ill
patients, particularly for those from high-risk environments such as nursing home
residents. If
the Medicare discount card program's therapeutic classifications were adopted
in whole by USP for use in the new Medicare Part D program, a plan sponsor could
meet the law's basic requirement that coverage be provided for drugs within each
class without providing coverage for any broad spectrum cephalosporins
2.
When developing a model therapeutic classification system, attention must be given
to the high incidence of co-morbidities and potential for adverse pharmaceutical
interactions in the Medicare population. For
example: Some atypical antipsychotic agents cause weight gain in patients.
Such agents would be clinically inappropriate for obese patients or patients with
diabetes. A model classification system should recognize this potential and distinguish
between agents that permit greater glycemic control when necessary.
3. Clinical practice guidelines developed by specialty organizations and experts
in geriatric medicine should guide the development of Medicare's model therapeutic
drug classification system. For
example: Pain management specialists routinely utilize multiple low-dose narcotics
to maximize pain reduction and reduce side effects. This is standard practice
in both the management of acute and chronic pain. The Medicare discount card therapeutic
class system does not distinguish between short-acting and sustained release narcotics.
If used as the basis for Medicare coverage, this classification could result in
plans only covering short-acting and no sustained release narcotics - thereby
impeding current practice standards. For
example: currently alendronate and risedronate (two bisphosphonates), calcitionin
and raxloxifene (classified as antiresorptive medications), and parathyroid hormone
(classified as a bone formation medication) are approved by the U.S. Food and
Drug Administration (FDA) for prevention and/or treatment of osteoporosis. While
estrogens appear on the Medicare Discount Card Therapeutic Class System, results
from the Women's Health Initiative led the FDA to recommend that when estrogen
use is considered solely for the prevention of osteoporosis, approved non-estrogen
treatments should first be carefully considered.
4.
The model classification system should account for the variability in response
to certain medicines among racial, ethnic and other vulnerable patient subpopulations
and take into consideration the importance of medication compliance. For
example: A recent edition of the Medical Letter stated that one of the leading
high potency statins was not appropriate for Asian patients. However,
the proposed Medicare discount card classification system does not distinguish
between low and high potency statins. Thus, if it were used in the new Medicare
drug benefit program, it is possible plans could provide coverage for only one
or no high potency statin. This could create problems for those in need of a powerful
anti-hyperlipidemia therapy - especially if the patient was of Asian decent. To
avoid potential problems like these, an ideal therapeutic classification model
would distinguish between high and low potency statins and call for a variety
of therapeutic choices within each class.
5. To support immediate access to optimal care, the model therapeutic classification
system must be reviewed, updated, and augmented if necessary, on a regular and
timely basis to ensure the proper classification of new therapies. For
example: The Medicare discount card program's drug classification system fails
to include any subcategorization for N-methyl D-aspartate antagonists (NMDA),
a new class of agents used to treat advanced stages of Alzheimer's disease. Instead,
that classification system only includes an older class of agents, cholinesterase
inhibitors, which are only approved for the treatment of early and middle stage
Alzheimer's. Although the first NMDA was approved for use in the U.S. in October
of last year, the existing Medicare classification system that was finalized by
CMS in December doesn't account for this new class of medicines. This omission
underscores the need for USP to adopt specific procedures and timeframes for continually
reviewing and updating the model therapeutic classification system it develops.
6.
A model drug therapeutic classification system for Medicare must be designed to
ensure that all seniors and beneficiaries have access to medications that the
prescribing doctors believe is most appropriate to treat a number of complex and
chronic health conditions. For
example: according to the Lupus Foundation of America, no new medications
for the treatment of lupus have been approved by the Food and Drug Administration
(FDA) in nearly 40 years. Consequently,
many patients with lupus must depend on prescription medications that were originally
designed to treat other health conditions in order to manage this multisystemic
disease that can affect virtually any organ system. Patients with autoimmune diseases
and other health conditions require a wide latitude of prescription medications
in order to achieve optimal health.
Thank
you very much for considering these issues and recommendations as USP works to
develop its model therapeutic class system for Medicare. We
feel strongly that the end result of USP's efforts will be far better - and ultimately
be far more responsive and supportive of the needs of patients and providers in
the health system - if these principles are incorporated into USP's model system.
Our organizations
and the patients we represent look forward to working with USP and providing you
additional input as the process of identifying appropriate categories and subcategories
of different therapeutic agents begins in earnest. Mr. Andrew Sperling, Director,
Federal Government Relations with the National Alliance for the Mentally Ill,
will be the point of contact to set up an appointment for our patient groups.
Sincerely,
Alzheimer's
Association
Epilepsy Foundation
Lupus Foundation of America
National
Coalition for Women with Heart Disease
National Alliance for the Mentally
Ill
National Grange
National Osteoporosis Foundation
Parkinson's
Action Network | 
