Health
UCP Calls on U.S. Pharmacopeia to Revise Guidelines
On September 17, 2004, The Arc and UCP Public Policy Collaboration submitted comments to the U.S. Pharmacopeia (USP), a nongovernmental entity charged by Congress to develop Model Guidelines listing drug classes and categories to be used by private plans in developing their new Medicare prescription drug benefit. Our comments urge the USP to significantly revise the model guidelines by establishing more classes and categories to insure that the drugs people with significant disabilities need will be included, and assure that doctors will be able to prescribe medications regardless of diagnosis. We also urged the USP to include provisions describing how the classes and categories will be updated as new drugs become available which do not fall into the current classification.
The following letter outlines UCP and The Arc's concerns:
September 17, 2004
Lynn Lang
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville MD 20852-1790
Dear Ms. Lang:
The Arc and UCP Public Policy Collaboration urges the U.S. Pharmacopeia (USP) to significantly revise its draft Model Guidelines regarding drug categories and classes. The Arc is a national membership organization made up of people with mental retardation and related developmental disabilities, their families, friends, interested citizens, and professionals in the disability field. For more than half a century, over 900 state and local chapters of The Arc have worked throughout the nation to ensure that their constituents have the supports and services they need, are accepted in their communities and have control of their own lives. United Cerebral Palsy (UCP) has been committed to progress for people with disabilities for the last 50 years. The national office and its nationwide network of approximately 100 affiliates strive to ensure the inclusion of people with disabilities in every facet of society. UCP affiliates serve more than 170,000 children and adults with disabilities and their families every day.
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. Many people with developmental disabilities are eligible for Medicare and Medicaid benefits and have complex health conditions that require prescription drugs.
Every person with a developmental disability is a unique individual, with different medical problems, which mirror the range of health problems that occur in the general population. Mental retardation and cerebral palsy are often associated with neurological conditions that require medication treatment, increasing the risk for drug interactions. For example, the prevalence of epilepsy may be as high as 40% in those with profound mental retardation. Similarly, a recent study found that approximately 38% of children with cerebral palsy have epilepsy. Psychiatric and behavioral problems occur in individuals with mental retardation at 3–6 times the rate in the general population. Individuals with cerebral palsy may also use medications to treat dystonia and muscle spasticity. As a result, The Arc and UCP have both general concerns about the Model Guidelines and specific issues with how the classification system will deal with medications used to treat mental illness, behavioral challenges, seizures, dystonia and muscle spasticity.
While we recognize the complexity of standardizing classes of medications, The Arc and UCP are gravely concerned that the draft Model Guidelines will constitute a serious 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 effectively articulate problems with side effects making it more important for the doctor to be able to prescribe the best medication for the individual. Often that process takes time since many people with significant disabilities must try multiple medications and only after much experimentation find the medication that is most effective for their circumstance. 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 Arc and UCP encourage 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 Arc and UCP urge 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. It is also not clear where a therapy like Botox, which is used to treat muscle spasticity, would fall in the proposed classification.
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 beyond the current recommended subdivisions. 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, The Arc and UCP are concerned that the classes for drugs used to treat mental illness and behavioral challenges 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 seven separate classes for anti-depressants developed for the Medicare discount card.
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, especially for people with mental retardation and other developmental disabilities 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, The Arc and UCP recommend 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 chronic conditions where there are no effective treatments.
Finally, we urge that USP provide assurances that medications needed for lower-incidence disabilities or disorders that fall into larger pharmalogic categories will be accessible. For example, baclofen, which many people with cerebral palsy use, would likely fall in the broad class of Centrally Acting Skeletal Muscle Relaxants where many other therapies with a broad range of uses would also be categorized. In some instances it may be critical to require coverage for more than two drugs per class. For people with disabilities, especially those with cognitive impairments, upfront access to medically necessary medications is preferable to relying on cumbersome appeals or exception processes.
The Arc and UCP appreciate the opportunity to comment on the proposed Model Guidelines. If you have questions about our comments please contact us.
Sincerely,
Stephen Bennett
President & CEO
United Cerebral Palsy
Steven M. Eidelman
Executive Director
The Arc of the United States