September 17, 2004
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852-1790
Re: Comments on USP Draft Model Guidelines
Dear Ms. Lang:
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 United States Pharmacopeia's (USP) Medicare Prescription Drug Benefit Draft Model Guidelines for drug categories and classes in Medicare Part D. The AUA is the premier professional association for the advancement of urologic patient care, and works to promote the highest standards of urological clinical care through education, research and the formulation of health care policy.
General comment about the draft model guidelinesWe understand that USP chose to not duplicate classes throughout the Draft Model Guidelines, even though several classes of drugs could be listed multiple times if they apply to several therapeutic categories. This choice was based on the assumption that prescription drug plans will support the use of those classes of drugs whenever appropriate. However, it may not be safe to make that assumption. To make it explicitly clear, we suggest listing each class of drugs under every category where they would be appropriately placed. This would also make it easier to review future versions of the categories and classes, especially for reviewers who are focusing on a narrow portion of the categories rather than the entire list.
Urology-specific comments about the draft model guidelinesThe draft drug categories and classes were reviewed by various urologists across the United States who are experts in treating a variety of urological disorders and diseases. Our reviewers identified potential problems in the draft guidelines that could affect the treatment of stone disease, benign prostatic hyperplasia (BPH) and prostate cancer. These problems and recommended solutions to assure that the current standards of care are not jeopardized for urology patients are outlined in our comments below.
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.
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.
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.
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.
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 rhudson@AUAnet.org.
Brendan M. Fox, MD