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ARIZONA HEALTH CARE COST CONTAINMENT SYSTEM Prior Authorization Protocol
Therapeutic Class: Smoking Cessation Aids
Formulary Status:
Medication Classes:
Nicotine Patch - Nicoderm CQ , Nicotrol , Habitrol Bupropion - Wellbutrin , Wellbutrin XL , Zyban FDA Approved Indications
All products are FDA approved as aids for smoking cessation treatment and to help reduce
withdrawal symptoms, including nicotine craving.
Guidelines for Approval
The following criteria apply to AHCCCS members choosing to receive a tobacco cessation
product.
a. Members are encouraged to enroll in a tobacco cessation program through ADHS. To enroll in an ADHS cessation program the member must call 1-800-55-66-222. b. Members must contact their primary care provider (PCP) to obtain a prescription for a tobacco cessation product. The PCP will identify an appropriate tobacco cessation product. In order to be covered by AHCCCS all tobacco use medications require a prescription. This includes all tobacco cessation products, including those that are available over-the-counter. c. The maximum supply a member may receive of a tobacco cessation product is a 12-week supply in a six month time period. The six month time period begins the date the first prescription is filled for the tobacco cessation product. Draft Prepared 5.7.09 Approved by AHCCCS Prior authorization will be required for the following:
a. Members under the age of 18 years old
b. Brand name medications when a generic product is available
c. Bupropion 24 hour / Wellbutrin XL
Coverage is Not Authorized For:
a. Non-Title XIX Members
b. Indications other than for as an aid for smoking cessation
c. Doses greater than the FDA Maximum Allowable
d. Combination treatment with more than one of the above agents
e. Specific drug-disease condition contraindications
Coverage for Dual Eligibles:
a. Medications that are available by prescription only and bear the federal legend, “Federal Law
Prohibits Dispensing Without a Prescription” are to be obtained from and covered by the Medicare Part D Plan. b. Medication that are available over-the-counter are to be covered by the AHCCCS Contracted Health Plans and ordered in accordance with Section II- Guidelines for Approval. Therapeutic Alternatives
Smoking Cessation
Dosing Regimen
Maximum Daily Dose
Product
Nicotine Nasal Spray
(Zyban / Wellbutrin SR ) days, may increase to 150mg twice a Draft Prepared 5.9.09 Approved by AHCCCS General Information
a. Nicotine (NRT)
i. Dependence has been recognized as a chronic, relapsing disease ii. Any form is can be toxic and addictive iii. Smoking-Drug interactions are costly to the health care system b. Bupropion (Wellbutrin, Wellbutrin XL & Zyban) ii. In comparative data trials, efficacy is superior to NRT iii. Reduces weight gain after smoking cessation iv. Has several contraindications, precautions and warnings v. The study, A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both For Smoking Cessation. 1999, found that sustained release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation as compared to the use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone but the difference was not statistically significant. i. Represents a new class for smoking cessation therapy and acts as a nicotinic partial ii. Dose dependent nausea has been reported in up to 40% of utilizing patients. iv. Does not reduce weight gain after smoking cessation. v. Efficacy of Verenicline as compared to NRT is currently unknown. vi. In comparative trials following 12 weeks of treatment, bupropion naïve patients receiving Verenicline were more likely to quit smoking than patients on bupropion. vii. In one Verenicline study, an additional 12-week course of therapy was given to abstinent patients immediately after the first 12-week course had elapsed. There is currently no data to support the efficacy of re-starting Verenicline after a lapse in therapy following the initial 12-week course. viii. No contraindications (other than drug allergy) ix. Extreme caution should be taken when evaluating a person with serious mental illness for d. Abstinence rates were consistently higher with all products when combined with a behavioral e. Based on the clinical trials of all of the products, an assumption can be drawn that Verenicline is superior over Bupropion over NRT.
References:

• AHCCCS Smoking Cessation Policy, October 2009 • Chantix Prescribing Information, Pfizer Labs, May 2006. • Vernicline Monograph, Drug Facts and Comparisons, May 2009 • Bupropion Monograph, Drug Facts and Comparisons, May 2009 • Zyban Prescribing Information, GlaxoSmithKline, December 2008. • Central Nervous system Agents, Smoking Deterrants, Nicotine, Drug Facts and Comparisons, May 2009
• Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an α4β2 nicotinic acetylcholine
receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA. 2006;296:56-63. Draft Prepared 5.9.09 Approved by AHCCCS

Source: http://www.bridgewayhs.com/files/2011/11/Smoking-Cessation-PA-Protocol-.pdf

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