Managed Care - December 2008 - (Page 48)

TOMORROW’S MEDICINE avoid the peaks of plasma concentrations. With a patch, the physician can withdraw the active ingredient simply by removing the patch, which is impossible to do after ingestion or injection. Skin reactions top the list in terms of common adverse events. Clinical trials The safety of Sancuso was studied in a total of 404 patients undergoing chemotherapy in two double-blind comparator studies. The comparator was oral granisetron 2 mg for 1 to 5 days. Constipation was the most common adverse reaction in the trials. The only other adverse event that occurred with a frequency of 3 percent or greater was headache at 3 percent (as compared with 0.7 percent in the orally treated population). The efficacy trial of Sancuso consisted of a phase 3 non-inferiority, randomized, parallel group, double-blind, double-dummy study performed in the United States and abroad that consisted of 641 patients ages 16–86 receiving moderately or highly emetogenic multi-day chemotherapy. The granisetron patch was applied 24 to 48 hours before the first dose of chemotherapy and kept in place for seven days. Oral granisetron was administered daily one hour before each chemotherapy dose. Efficacy was measured from the first administration of chemotherapy until 24 hours after the start of the last day’s chemotherapy. The primary endpoint was the proportion of patients who did not vomit and/or retch, experienced no more than mild nausea, and were not given rescue medication from the first administration until 24 hours after the last dose. The desired endpoint was achieved in 60.2 percent of Sancuso patients and 64.8 percent of oralADVERTISING INDEX CENTOCOR, INC. Corporate 7 Remicade 35–39 FOREST LABORATORIES Namenda 17–18 HEALTH DIALOG Health Plans 27 MDDATACOR Quality Improvement Solutions 3 MEDIMMUNE, INC. Synagis 31–32 WELLPOINT nextRx C2 WYETH PHARMACEUTICALS Pristiq 50,C3,C4 dosage granisetron patients, resulting in a difference of 4.89 percent, which was within the 95 percent confidence limits proving noninferiority. The company has priced Sancuso at $285 per patch, which compares to a price from www.drugstore.com of $45 for 2 one milligram generic granisetron tablets and $131.99 for the branded Kytril version of granisetron. Managed care implications As is the case with most transdermal delivery releases of existing drugs, there are advantages and disadvantages for the new entry. Obviously the adhesiveness of the patch is important as is the risk of skin reactions. For this product, there is another consideration. This product must be applied at least 24 hours before chemotherapy administration. Failure to do so can result in suboptimal plasma levels resulting in lack of efficacy and resultant additional use of medical resources. In addition, not all people need to use it for the full seven days of duration. If only an initial dose of an oral 5-HT 3 medication is needed, the remaining therapy might be a waste of money. Careful attention to the daily need for medication may result in some savings. Because of the prolonged administration of the active ingredient, Sancuso may be able to compete with palonosetron, which has a unique 5-HT3 indication for delayed CINE in moderately emetogenic therapies. But Sancuso was not studied in this scenario. Overall, Sancuso has demonstrated that a transdermal version of the 5-HT3 class of drugs is at least as good as the oral form. This version gives managed care and treating oncologists yet another way to customize therapy to prevent CINE. MC 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. 48 MANAGED CARE / DECEMBER 2008 http://www.drugstore.com

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Managed Care - December 2008 Editor's Memo Contents Legislation & Regulation News and Commentary Medication Management Compensation Monitor ICD-10 Offers Huge Opportunity, Challenge Part D at a Crossroads Plans Can Weather the Financial Crisis DM vs. Medical Home? Tackle Prediabetes Reasonable Approach to Morning Sickness Formulary Files Tomorrow's Medicine Outlook

Managed Care - December 2008

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