September 17, 2004

Lynn Lang
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville MD 20852-1790


Dear Ms. Lang:

The Consortium for Citizens with Disabilities (CCD) Health Task Force urges the U.S. Pharmacopeia (USP) to significantly revise the draft Model Guidelines regarding drug categories and classes. CCD is a Washington-based coalition of national disability organizations that advocates on behalf of the 54 million people with disabilities and chronic conditions in the United States. Over 13 million Medicare beneficiaries have a disability or chronic health condition. The poorest and most vulnerable are dual eligibles, who (more than other Medicare beneficiaries) rely extensively on prescription drug coverage to meet their basic health care needs.

While we recognize the complexity of standardizing classes of medications, CCD is gravely concerned that the draft Model Guidelines are a barrier to the creation of formularies that will provide Medicare beneficiaries with a quality drug benefit. The USP framework lacks specificity creating an insufficient number of classes to ensure that people with disabilities and chronic health conditions will have access to the safest, most effective drugs for their individual circumstances.

The broad classification scheme will allow and even promote formularies with far fewer choices of medications for a number of disorders and illnesses than what is commonly seen in the private sector or other federal and state formularies. It is also alarming that the draft classification in several areas appears biased toward older, less effective medications.

Creating a second-class drug benefit for Medicare beneficiaries that relies on older less effective medications was not the intent of Congress in passing the Medicare Prescription Drug, Improvement and Modernization Act of 2003. A drug may be inexpensive and effective but if the individual cannot tolerate it or take it safely the drug becomes useless.

When designing formularies to serve older Americans and people with disabilities special attention must be paid to the side effect profiles, the capacity of drugs to worsen conditions common to the elderly and people with disabilities, contraindications, interactions with other medications and appropriate dosage forms –this argues for a wider range of drugs being available to this population. Individuals with cognitive impairments may be less able to articulate problems with side effects making it more important for the doctor to be able to prescribe the best medication for the individual. The availability of alternative formulations of a drug, such as extended release versions, may also be important to effectively managing these serious and complex medical conditions.

For these reasons the CCD Health Task Force encourages the USP to recommend in their materials accompanying the Model Guidelines that Medicare drug plans include an open formulary for certain targeted beneficiaries with disabilities. To ensure that these special populations have adequate, timely and appropriate access to medically necessary medications, we believe they must be exempt from all formulary restrictions and they must further be protected from tiered cost-sharing that could create insurmountable access barriers.

Furthermore, the CCD Health Task Force urges the USP to revise and improve the Model Guidelines. At a minimum, the recommended subdivisions described in the draft Model Guidelines must become classes. However, even with that improvement significant revisions must be made including the addition of new classes. Though the USP has argued that the Model Guidelines are a disease-based approach it is not clear that there are pharmacologic classes for the therapies used to treat multiple sclerosis, attention deficit hyperactivity disorder, anxiety, and others.

The lack of coverage for the multiple sclerosis immunomodulating therapies in the USP Model Guidelines must be addressed. Specifically, no category appears to cover the current FDA-approved disease-modifying agents for multiple sclerosis --Avonex, Betaseron, Rebif, and Copaxone. The USP draft guidelines do not reflect the current medical practice and treatment for multiple sclerosis. As the multiple sclerosis therapies currently have no approved indications other than for the treatment of multiple sclerosis and for the reasons above, the we recommend that the USP adopt the following classes under the therapeutic category of Immonological Agents that would be mandatory in all Medicare prescription drug plans: Immunomodulators – beta interferon 1-b; Immunomodulators – beta interferon 1-a and Immunomodulators – copolymers.

In the case of the anti-convulsants, even if the recommended subdivisions are made into pharmacologic classes, the listing would not be comprehensive and would still favor the older medications. Nearly all of the first line treatments for seizures and all of the drugs approved after 1978 would fall under “other anticonvulsants.” At a minimum USP must create additional classes based on mechanisms of action for the anti-convulsants. Anti-convulsants are not interchangeable and physicians must have access to the broad array of medications in order to choose what medication will work best for the individual.

Similarly, CCD is concerned that the classes for drugs used to treat mental illness are too broad or non-existent and if adopted will likely cause harmful disruptions in care for individuals eligible for both Medicare and Medicaid and inadequate coverage for other beneficiaries. For example in the category of anti-depressants, the Model Guidelines inappropriately group the newer more effective reuptake inhibitors including the Selective Serotonin Reuptake Inhibitors with the tricyclics, which have more dangerous side effects. Moreover, reuptake inhibitors themselves have different mechanisms of actions and should not all be grouped into one class. They affect brain chemistry in distinct ways, have singular side effects, and some evidence shows that their effectiveness varies depending on the type of depression. For these reasons, it is more appropriate to use the list of drug classes for anti-depressants developed for the Medicare discount card which establishes seven separate classes.

In the classification of anti-psychotics, USP has incorporated some recognition of the importance of covering newer, more effective medications in establishing a separate category for atypical anti-psychotics. But, even this category is overly broad. Newer, atypical anti-psychotics have been shown to be more effective and display fewer side effects. Nonetheless, even within the proposed class of atypicals, anti-psychotics are even less interchangeable than SSRIs. Research shows that different antipsychotic medications (including atypicals) affect separate portions of the brain and affect the brain in very different ways. There are two or more distinct types of atypical anti-psychotics each of which has different chemical structures, mechanisms of action, and clinical outcomes. As a result, they have varied clinical outcomes and side effects.

The USP proposed guidelines include one broad category for “Bipolar Agents” which we presume is meant to cover treatments for bipolar disorder, but no classes are included to ensure coverage of the many different treatments for this complex disease. Individuals with bipolar disorder typically take a variety of medications including anti-convulsants, anti-depressants, and anti-anxiety medications. This is a devastating disease that requires individualized and comprehensive treatment. The inclusion of this broad category without further specification of the types of medications that must be covered will likely cause confusion among health plans offering the Medicare drug benefit.

It also underscores the need for the USP to include assurances in the Model Guidelines that doctors will be able to prescribe medications regardless of diagnosis. The Model Guidelines should also clarify that plans cannot block access to clinically appropriate combination drug therapies and clinically appropriate off-label uses of drugs.

In addition, CCD recommends that USP add a description of how the classes and categories will be updated as new drugs become available that do not currently fall into the proposed classification system. A process should be in place to assure ready access to new drugs as they are approved by the FDA. This is a particularly urgent issue for people with life-threatening illnesses, those individuals who live with debilitating side effects from their current medications and for people with conditions where there are no effective treatments.

Finally, we recommend that USP provide assurances that medications needed for lower-incidence disabilities or disorders that fall into larger pharmalogic categories will be accessible. In some instances it may be critical to require coverage for more than two drugs per class. Anti-HIV drugs are yet another example of medications that are not interchangeable in terms of efficacy or side effects and vary significantly for an individual in terms of resistance, tolerance and drug interactions. For people with disabilities, upfront access to medically necessary medications is preferable to relying on cumbersome appeals or exception processes.

The CCD Health Task Force appreciates the opportunity to comment on the proposed Model Guidelines. For more information contact one of the Task Force Co-Chairs: Kirsten Beronio (National Mental Health Association) 202-675-8413, Liz Savage (The Arc and United Cerebral Palsy) 202-783-2229, Kathy McGinley (National Association of Protection and Advocacy Systems) 202-408-9514) or Peter Thomas (American Academy of Physical Medicine and Rehabilitation) 202-466-6550.

On behalf of:

American Academy of Physical Medicine and Rehabilitation
American Association on Mental Retardation
American Association of People with Disabilities
American Medical Rehabilitation Providers Association
American Therapeutic Recreation Association
Association of Academic Physiatrists
Association of University Centers on Disabilities
Bazelon Center for Mental Health Law
Center on Disability Issues and the Health Professions
Easter Seals
Epilepsy Foundation
Family Voices
National Alliance for the Mentally Ill
National Association of County Behavioral Health Directors
National Association for the Advancement of Orthotics and Prosthetics
National Association of Protection and Advocacy Systems
National Association of Social Workers
National Mental Health Association
National Multiple Sclerosis Society
Paralyzed Veterans of America
The Arc of the United States
Title II Community AIDS National Network
United Cerebral Palsy
United Spinal Association
Volunteers of America
World Institute on Disability