|
Back to index of statementes Dr. Mark McClellan 20201 June 12, 2006 Re: Access to Alzheimer’s drugs Dear Dr. McClellan, On behalf of the Alzheimer’s Association and its constituents, we applaud your efforts over the past two years to implement a new outpatient prescription drug benefit for Medicare beneficiaries. We appreciate the numerous opportunities to work with you and your staff to address the difficulties that are inevitable when developing a new and complex program. It is in the spirit of our collaboration that we request a meeting with you to discuss serious problems that some Medicare beneficiaries are having accessing their Alzheimer’s drugs in a few Medicare prescription drug plans after March 31, 2006, the end of the initial transition period. Over the past two months, we have received a significant number of complaints regarding the use of prior authorization for the four Alzheimer’s drugs: Aricept, Exelon, Razadyne and Namenda. The vast majority of the complaints are about three national or near-national plans: Medco, RxAmerica and Silverscript (Caremark). Based on the April 27, 2006, data released by the Centers for Medicare and Medicaid Services (CMS), these plans have approximately 8% of the market share for total enrollment. Contrary to all of the other national plans, these three plans require prior authorization for all of the FDA-approved medications for Alzheimer’s drugs. The other national plans do not require prior authorization for any of the Alzheimer’s drugs on their formularies. Inappropriate Use of the Mini-Mental Score Examination The general criterion for the prior authorization review is diagnosis of Alzheimer’s disease and score on the Mini-Mental Score Examination (MMSE). These plans appear to restrict access to these medications based on the individual’s MMSE and the FDA labeling of the respective drugs. As you know, cholinesterase inhibitors have been approved for mild to moderate disease and memantine for moderate to severe. The precise delineations among these states are imprecise. The MMSE is a commonly used screening tool but is not an appropriate measure for obtaining approval for medications. It is the clinical judgment of the treating physician that should determine whether and which drug is appropriate, at what stage and for how long. The MMSE is too coarse to make this determination especially since the categorization of an individual as to mild, moderate or severe is based on more facets than just a score on a test. The MMSE does not account for function (activities of daily living) or other measures which are equally as important in making a clinical assessment of stage of the disease progression. In addition, there are educational, cultural and other factors that influence a test score which could adversely affect lower educated or culturally diverse individuals. “Off-Label” Use of Medications In a March 30, 2006, meeting with representatives of beneficiary and disease organizations, you stated that it is not appropriate for Part D plans to limit the dosage and usage of medications to the FDA labeling. We concur with and support your position. It is standard clinical practice for physicians to prescribe off-label use of medications that they believe will benefit their patients. In the case of people with Alzheimer’s disease, it is the current standard of care and practice for doctors to prescribe Alzheimer’s drugs for patients which may fall outside the severity or duration of the FDA-approved drugs, but for which the patients continue to benefit. Since FDA-approval of the Alzheimer’s drugs, there have been recent studies that indicate that there are positive effects on patients who continue the medication outside of the FDA-approved label. Pertinent studies include:
Miscellaneous Issues In a recent complaint from a physician in Sikeston, Missouri, patients were denied the Alzheimer’s drugs when the he answered affirmatively to the question “Is the disease progressing?” The FDA approved these medications to treat the symptoms of Alzheimer’s disease only. None of the Alzheimer’s drugs cure or stop the underlying course of the disease. The denial of prior authorization due to disease progression is improper and unacceptable. Silverscript/Caremark appears to require an MMSE every three months. As discussed above, the use of the MMSE is inappropriate. In addition, the requirement that the MMSE be administered every three months will increase Part B costs for insupportable and invalid purposes. Conclusion We believe that the use of prior authorization for Alzheimer’s drugs is inappropriate. In addition, while some at CMS believe that the denial of prior authorization can be addressed through the exceptions and appeals process, this approach is unrealistic and unreasonable. Neither frail patients nor their physicians can be expected to navigate the plan system and file additional documentation in order to obtain to these medications that are on the plan’s formulary. The unfortunate consequence will be that patients will not receive the medications from which they will benefit. The Alzheimer’s Association believes the prescribing physician is in the paramount position to determine whether the FDA-approved medications are appropriate, including those that may be considered “off-label” prescriptions. We do not believe this should be a decision by a drug plan and certainly not one that relies on a single, inappropriate score. We appreciate your attention to this matter and request your assistance in correcting what we strongly believe to be a faulty policy by a small minority of plans. Yours truly, Vice President of Advocacy and Public Policy 
|
