Managed Care - November 2008 - (Page 47)

TOMORROW’S MEDICINE mid-September, a new drug was approved by the FDA for treatment of the chorea, the first drug officially approved with an indication specific to HD. The drug, whose generic name is tetrabenazine and brand name is Xenazine, was developed by Cambridge Laboratories and will be marketed by Ovation Pharmaceuticals. It should be available late this fall. The price has not been announced. Tetrabenazine causes depletion of monoamines and is given orally. The precise mechanism by which tetrabenazine decreases chorea is unknown but is thought to be related to its effect as a reversible depletory of dopamine, serotonin, norepinephrine, and histamine from nerve terminals. The agent inhibits a transport molecule called vesicular monoamine transporter type 2 (VMAT2). or placebo (n=6). The treatment effect was similar to the results in Study 1. Warnings Tetrabenazine has several boxed warnings. It can increase the risk of depression and suicidal thoughts and behavior in patients with HD. A potentially fatal symptom complex which has been called neuroleptic malignant syndrome (NMS) has been reported in association with drugs that reduce dopaminergic transmission, including tetrabenazine. NMS consists of hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability. Laboratory abnormalities may include creatinine phosphokinase elevations, myoglobinuria, rhabdomyolysis, and acute renal failure. If diagnosed, treatment consists of immediate discontinuation of tetrabenazine, intensive treatment of symptoms and concomitant treatment of any other serious medical problems that are present. Clinical studies Clinical study 1 consisted of a randomized, double-blind, placebo-controlled multicenter trial conducted in ambulatory patients with the diagnosis of HD. Results from this study demonstrated a decline by five units in the total chorea score as measured at week 9 and 12 (averaged) in those on active drug as compared to a 1.5-unit decrease in the placebo group. Incidentally, the total chorea score in subjects receiving active drug returned to the pre-treatment baseline within one week of discontinuing the drug. Of note is that measures of functional capacity and cognition showed no difference between active drug and placebo. Study 2 was performed in patients who had been treated with open-label tetrabenazine for at least two months (with a mean duration of two years). Eighteen patients were randomized to receive active drug (n=12) at the same dose The author is a director in the value-based health department at Genentech Inc. During the last three years, before taking the Genentech position, he received honoraria or other financial benefits from: Amgen, Amylin Pharmaceuticals, AstraZeneca, Biogen Idec, Centocor, Galderma, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Procter & Gamble, Q-Med, Sanofi-Aventis, Teva Pharmaceuticals Industries, UCB, and Wyeth. The views expressed in Tomorrow’s Medicine are the author’s alone. Managed care implications The prevalence of HD varies greatly according to ethnicity and location. A health plan may expect to see about 10 symptomatic patients for every 100,000 people in its plan. This drug offers a significant opportunity to health plans to assist in the management of these patients through a joint effort with the treating physician. Since the price has not been determined, budget impact is unknown at this time. As the first drug approved specifically for the treatment of HD, this drug demonstrates a continued advancement, albeit one that took more than 130 years to achieve, again showing the promise of Tomorrow’s Medicine. MC ADVERTISING INDEX HEALTH DIALOG Health Plans 5 MDDATACOR Quality Improvement Solutions 21 MEDIMMUNE, INC. Synagis C2,1 NOVO NORDISK, INC. Levemir C3,C4 WYETH PHARMACEUTICALS Effexor XR 29–31 Pristiq 11–13 NOVEMBER 2008 / MANAGED CARE 47

Table of Contents Feed for the Digital Edition of Managed Care - November 2008

Managed Care - November 2008 Editor’s Memo Contents News and Commentary Legislation & Regulation Letters Medication Management Compensation Monitor Do It Yourself for Less Biomarkers Promise, but Do They Deliver? Oncologists Complain About Drug Payment Consider Blood Pressure Self-Monitoring Q&A: Keep Industry in the Game Formulary Files Plan Watch Tomorrow’s Medicine Outlook Respiratory Syncytial Virus Managed Care Considerations Contents Continuing Education Objectives RSV Disease in the Pediatric Population In the Trenches RSV Infection in the Adult Population Health Plan Medical Director Health Plan Pharmacy Director RSV Issues and Solutions Assessment/Evaluation/Certificate Request Post-Test

Managed Care - November 2008

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