Managed Care - September 2008 - (Page 51)

TOMORROW’S MEDICINE mandibular study, OraVerse accelerated the recovery of the perception of normal appearance and function by 60 minutes (40 percent improvement), the recovery of normal function by 60 minutes (50 percent improvement), and the recovery of normal sensation in the tongue by 65 minutes (52 percent improvement). Return to normal In maxillary study, the recovery of the perception of normal appearance and function was reduced by 60 minutes (50 percent) and the recovery of normal function was reduced by 45 minutes (43 percent). A pediatric double-blinded, randomized, multicenter controlled study was conducted in dental patients who had received 2 percent lidocaine with 1:100,000 epinephrine. The study included 152 patients ages 4–11 who received a half-cartridge of local anesthetic if they weighed more than 15 kg but less than 30 kg and one half or one full cartridge if they weighed more than 30 kg. The median time to normal lip sensation in patients 6–11 years old was reduced by 75 minutes (56 percent). Within one hour after administration of OraVerse, 44 patients (61 percent) reported normal lip sensation while only nine patients (21 percent) in the control group reported normal lip sensation. OraVerse is now approved by the Food and Drug Administration for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and of the associated functional deficits. OraVerse is not recommended for use in children who are under 6 years old or weigh less than 15 kg. Dosage ranges from one-half to two cartridges. Each cartridge contains 0.4 mg of phentolamine mesylate in a total volume of 1.7 ml. 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. There are no listed contraindications and the warnings appear to be generally concerning those who have received phentolamine mesylate for hypotensive episodes. Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agent, but such effects are uncommon after administration of OraVerse. The only relatively common adverse reaction was injection site pain. OraVerse has not been studied in pregnant women and is category C. It is not known whether OraVerse is excreted in human milk. Managed care implications In general, dental coverage has not included therapies considered “not medically necessary” such as whitening treatments or nitrous oxide (commonly used to allay anxiety by those of us who are inclined to request it). OraVerse might in some ways be considered in the same category. But for some populations, the risk of self harm from not having feeling in the tongue and lips may actually lead to medically necessary requests from dentists. It could be appropriate for patients with marginal mental abilities and other cognition problems. For the most part, OraVerse is likely to be a self-pay medication, but one which many of us may personally find useful. It is priced by the manufacturer at about $12.50, depending on size of order, which is a small price to pay for the ability to smile, talk and, most of all, not drool, upon returning to the office! MC ADVERTISING INDEX AMCP EDUCATIONAL CONFERENCE 40 CENTOCOR INC. Corporate 23 FOREST LABORATORIES Bystolic 17–18 Namenda 35–36 HEALTH DIALOG Health Plans 3 MDDATACOR Quality Improvement Solutions 9 MEDIMEDIA INFORMATION TECHNOLOGIES Formulary Navigator 33 MEDIMMUNE, INC. Synagis 43–44 NOVO NORDISK, INC. Levemir C3,C4 WELLPOINT nextRx C2 WYETH PHARMACEUTICALS Effexor 27–29 SEPTEMBER 2008 / MANAGED CARE 51

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Managed Care - September 2008 Editor’s Memo Contents Legislation & Regulation News and Commentary Medication Management Compensation Monitor Archimedes Lends Hippocrates a Hand Some Other Predictive Modeling Programs Messing With Medicare Advantage The Trouble With MAC MedPAC’s Suggestions Sound Familiar The Leader in Patient Satisfaction Formulary Files Plan Watch Tomorrow’s Medicine Ad Index Outlook

Managed Care - September 2008

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