Lynn Lang
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, Maryland 20852-1790
Re: Comments to the Draft Model Guidelines

October 8, 2003

Dear Ms. Lang,

The Alzheimer's Association appreciates the opportunity to comment on the Draft Model Guidelines developed by the United States Pharmacopeia (USP) pursuant to the Medicare Prescription, Drug, Improvement and Modernization Act of 2003 (MMA). The Alzheimer's Association is the premier source of information and support for the 4.5 million Americans with Alzheimer's disease. Through its national network of chapters, it offers a broad range of programs and services for people with the disease, their families, and caregivers and represents their interests on Alzheimer-related issues before federal, state, and local government and with health and long term care providers. The largest private funder of Alzheimer research, the Association has committed nearly $150 million toward research into the causes, treatment, prevention, and cure of Alzheimer's disease.

General Comments

In its introduction to the model guidelines, USP states that a primary goal of the expert committee was “to assure beneficiary access to the drugs they need, preventing substantial discouragement from enrollment.” This is a laudable goal especially since these Model Guidelines will serve as a “safe harbor” for any prescription drug plan that uses them to develop its own formulary. As USP undertakes the revision process, it should ensure that these guidelines are sufficiently inclusive to permit doctors to effectively treat their Medicare patients. Access to the most effective medical treatment must be paramount to the benefits of prescription drug plans to negotiate the best drug prices.

We are concerned that the guidelines may encourage the use of older drugs that often result in increased side effects and adverse reactions in older, frailer beneficiaries, such as those with Alzheimer’s disease. With impaired memory and judgment, individuals with Alzheimer’s disease may not be able to recognize, understand or report early signs of adverse reactions until it results in an acute episode.

Due to the increased age, lower metabolism and co-existing conditions of this population, physicians require a wider range and greater flexibility when treating their patients. Ninety-five percent of Medicare beneficiaries with dementia have one or more other chronic conditions, including congestive heart failure (28%), diabetes (21%), chronic obstructive pulmonary disease (17%) and coronary heart disease (30%). These patients are taking a combination of medications to appropriately manage these conditions. It is a delicate balance that requires access to specific medications to enhance the care to the beneficiaries. The data that would inform a physician about the risks and benefits of changing such medications, even among the same class, is missing or inadequate. The Model Guidelines must be revised to provide for sufficient granularity to ensure that Medicare beneficiaries will have access to the medications that their physicians deem necessary to treat them. The exceptions process, which is burdens ome and time-consuming, is not an appropriate solution to an inadequate classification system or formulary.

The MMA requires that the Model Guidelines be revised “from time to time” to reflect the changes in therapeutic uses of Part D drugs and to cover new FDA-approved drugs. There is nothing in the draft Model Guidelines that reflect a plan that provides for this review procedure. Given the recent increase in research and development of drugs for Alzheimer’s disease that would benefit the Medicare population, this process should be expedited and require automatic inclusion of these drugs within 30 days of FDA approval.

Specific Comments

We believe that the third column of the Draft Model Guidelines, “Recommended Subdivisions,” should be equivalent to the first two columns, therapeutic category and pharmacologic class. Plans would be required to offer at least two drugs in the third column, thereby assuring beneficiaries access to statins, pain medications, anticonvulsants, hormone replacements and other medications which they are most frequently prescribed. Without this modification, many Medicare beneficiaries would be forced to change their current medications to drugs with unpredictable results.

Of particular concern to individuals with Alzheimer’s disease is access to medications to treat neuropsychiatric symptoms. In a recent study, Prevalence of Neuropsychiatric Symptoms in Dementia and Mild Cognitive Impairment; Results form the Cardiovascular Study, JAMA, September 25, 2002-Vol 288, No. 12, 1475, researchers found a high prevalence (60-80%) of neuropsychiatric symptoms in participants with dementia. These symptoms include agitation, depression, apathy, anxiety, delusions, hallucinations and sleep impairment and have serious adverse consequences on the patients. Appropriate treatment of these symptoms provides substantial benefits to these individuals. Other studies have shown that therapeutic interventions can improve function, reduce disruptive behavior and mitigate excess disability for individuals with Alzheimer’s disease.

Accordingly we make the following recommendations to revise the draft Model Guidelines:

1. Antidepressants (15-17): The antidepressants should be five classes: Monoamine Oxidase Inhibitors - Type A, SSRI, SNRI, Tricyclics and Other. The current pharmacologic class of Reuptake Inhibitors, which includes SNRI, SSRI and Tricyclics, is erroneous since they each work differently on different receptors and have different effects on clinical profile. In addition, trycyclics is an older generation of antidepressants that produce significant side effects in the elderly population.

2. Antipsychotics (54-56): We are pleased that the Draft Guidelines includes three classes of antipsychotics and encourage their inclusion in the final guidelines. Given the current pharmacologic classes, it is unclear in which group a phenothiazine atypical would be considered. This should be clarified in the final guidelines to assure their inclusion in one of the antipsychotic classes.

3. Anxiolytics (70) - Under anxiolytics and sedatives, it is important to include sedative hypnotics to treat sleep disturbances which are prevalent for individuals with dementia. We are disappointed and concerned that Benzodiazepines, a group of medications commonly prescribed to Alzheimer’s patients for the treatment of insomnia and anxiety, has been specifically excluded from and will not be covered by the Medicare prescription drug benefit.

4. Memory Enhancers- Dementia (128-129) – We are pleased that the Model guidelines include cholinesterase inhibitors and glutamate pathway modifiers. We recommend that this category name be changed to be called antidementia drugs or similar, since they do not improve memory in normal individuals. We also suggest that class #128 be called cholinesterase inhibitors since their action is primarily centered in the CNS, not the PNS. We believe that the inclusion of all three cholinesterase inhibitors should be considered. Research confirms that patients’ responses to the individual agents vary widely. Therefore clinicians require access to the full selection of these drugs in order to prescribe the best agent for a particular patient. In addition, if only two of the drugs are covered, some patients may be forced to cease a medication in the middle of its course. It is an unknown risk to discontinue patients from an agent during the course of treatment and should be avoided.

We appreciate the opportunity to comment on these Model Guidelines. The Alzheimer’s Association is ready to work with you, and to assist in identifying appropriate clinical experts, to assure access to medically necessary drugs for beneficiaries with dementia. Please feel free to contact Leslie B. Fried, Director of the Association’s Medicare Advocacy Project, (202) 662-8684, to further discuss these matters.

Sincerely,

Bonnie Hogue
Director, Federal and State Policy

Leslie B. Fried
Director, Medicare Advocacy Project

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