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AUA Comments to CMS on Draft Formulatory Review Criteria

December 29, 2004

Mark McClellan, MD, PhD
Department of Health & Human Services
Centers for Medicare & Medicaid Services
Submitted via E-mail to:

Re: Draft formulary review criteria for Medicare prescription drug benefit

Dear Dr. McClellan:

On behalf of the American Urological Association (AUA), representing 10,000 practicing urologists in the United States, I am pleased to submit comments on the Centers for Medicare & Medicaid Service's (CMS) December 3, 2004 Guidelines for Reviewing Prescription Drug Plan Formularies and Procedures (the Guidelines). We applaud CMS's goal of assuring that beneficiaries receive clinically appropriate medications at the lowest possible cost under the new Medicare Part D prescription drug benefit. And, to assure that Medicare beneficiaries have adequate access to urological drugs, we offer the following comments regarding formulary list review for CMS's consideration.

Formulary list review
According to the Guidelines, when reviewing formulary lists for approval, CMS may use a variety of benchmarks to confirm that the specific drugs in each category and class provide a sufficient breadth of drugs necessary to treat all disease states in a non-discriminatory way. The Guidelines state that CMS will consider widely accepted treatment guidelines as one benchmark, and CMS seeks comment as to the types of treatment guidelines that should be considered in their review of formularies. As the national medical association for urologists, the AUA develops treatment guidelines for many urological diseases, many of which involve the use of drug intervention at some point. Here is a list of pertinent guidelines:

  1. Guideline on the Pharmacologic Management of Premature Ejaculation
  2. Guideline on the Management of Benign Prostatic Hyperplasia (BPH)
  3. Guideline on the Management of Priapism
  4. The Management of Non-Muscle-Invasive Bladder Cancer (Stages Ta, T1 and Tis),
  5. The Management of Primary Vesicoureteral Reflux in Children

Also, it is important to note that treatment guidelines may not always reflect the most recent science, including labeled indications as well as off-label uses. For example, the AUA's 1996 Guideline on the Treatment of Organic Erectile Dysfunction does not include the use of sildenafil citrate (Viagra), which was approved in the U.S. in 1998. Therefore, it is also important for CMS to rely on other benchmarks, including medical journals, for formulary review. Regarding off-label uses, it is important that CMS have a process for coverage consideration of off-label uses.

USP draft model guidelines
CMS should also be aware of the following problems with the USP draft model guidelines that were identified by expert urologists who reviewed them:

  1. Stone disease—The majority of agents urologists use to treat patients with nephrolithiasis are covered with a few exceptions: D-penicillamine and Thiola for patients with cystinuria, and Lithostat for patients with struvite stones. None of the existing categories would be appropriate for these agents. We recommend that a new category be created for them.

  2. Benign prostatic hyperplasia (BPH)—BPH is treated using two major pharmacologic classes of drugs: alpha-adrenergic blockers and 5-alpha reductase inhibitors (ARI). Furthermore, combination therapy with an alpha- blocker and a 5-ARI has been shown to prevent disease progression and urinary retention. Currently, BPH drugs are lumped together in Class 114, "BPH Agents." Because only two drugs are required to be covered under each drug class, listing all BPH drugs in one class could potentially eliminate one of the two pharmacologic drug classes for BPH treatment, which would limit treatment options for elderly men with BPH. Therefore, the "BPH Agents" class should be divided into more classes to assure that the appropriate therapy, including combination therapy, is available for Medicare beneficiaries. The three specific classes of BPH agents that should be included in the guidelines are: non-uroselective alpha-blockers; uroselective alpha-blockers and 5-alpha reductase inhibitors.

    These are the specific pharmacologic classes and mechanisms of action that are widely recognized by physicians, each of these classes has demonstrated benefits in men with BPH and each class has unique side-effect profiles that are critical in the physician's choice of treatment for BPH. The selection of a drug to treat BPH depends on a number of factors including age, co-morbidities, size of the prostate, concomitant medications and tolerability. Thus, this level of specificity and granularity will allow physicians to individualize the choice of medication for the elderly and guarantee the flexibility to change medications if the elderly patient fails to respond to the initial medication or develops side-effects.

  3. Prostate cancer—The draft guidelines list antiandrogens as a recommended subdivision in class 123, "Sex Hormones/Modifiers" under the Therapeutic Category of "Hormones, Suppressant". However, when used for the treatment of prostate cancer, antiandrogens would be more properly placed under class 43, "Antineoplastics, Other" in the Therapeutic Category of Antineoplastics. Antiandrogens are oral medications including Casodex, Nilandron, and Flutamide that block a receptor site on the cell where testosterone latches on to the cell.

  4. Also, under the Therapeutic Category of Antineoplastics, an additional class should be added for "Luteinizing hormone-releasing hormone (LH/RH) agonists." Also known as gonadotropin-releasing hormone analogs or GnRH, LH/RH agonists are synthetic medications commonly used for hormone manipulation to treat hormone dependent cancers such as prostate cancer, which is driven by testosterone. LHRH is an injection that interferes with the pituitary gland and stops the production of testosterone by the testicles. Adding this additional class to the category of antineoplastics would maintain consistency with the terminology used to describe the service of providing these drugs to Medicare beneficiaries with prostate cancer.

Thank you for considering our comments. If you have any questions or need additional information, please contact Robin Hudson, AUA Manager of Regulatory Affairs, at 410-689-3762 or>


Brendan M. Fox, MD


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