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Prior Authorization Protocol
CHANTIXR (varenicline), ZYBANR (bupropion hydrochloride sustained release), NICOTROLR NS (nicotine nasal spray),
NICOTROL
R INHALER (nicotine inhaler), NICORETTER (nicotine polacrilex), COMMITR (nicotine lozenge)


HNMC
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Chantix is indicated as an aid to smoking cessation treatment
    • Zyban is indicated as an aid to smoking cessation treatment
    • Nicotrol NS and Nicotrol Inhaler are indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms.
    • Nicorette and Commit are indicated for the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms to facilitate smoking cessation in smokers motivated to quit
  2. Health Net Approved Indications and Usage Guidelines:
    • Member has not had smoking cessation treatment for more than two quit attempts of 90 days each in the past 365 days

    AND

    • Member is not currently taking any formulation of bupropion (Wellbutrin) in combination with Zyban
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section unless there is sufficient documentation of efficacy and safety in the published literature
    • Concurrent therapy with other smoking cessation products; member may use only one smoking cessation product at a time.
    • More than one smoking cessation product at a time.
  4. General Information:
    • Members are eligible for two quit attempts of 90 days each per 365 days (180 days/365 days) and may use only one smoking cessation product at a time.
    • In July 2009, the FDA mandated a black box warning alerting providers to observe all patients on Zyban and Chantix for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide related events, including ideation, behavior, and attempted suicide. Patients should stop taking Chantix and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior while taking Chantix or shortly after discontinuing Chantix.
    • Zyban treatment should be initiated while patient is still smoking. Once initiated a "target quit date" should be set for within the first two weeks of treatment.
    • If a patient has not achieved complete abstinence by the seventh week with Zyban, it is unlikely that he or she will quit during this attempt, and treatment should be discontinued.
    • Zyban contains the same active ingredient as WellbutrinR, WellbutrinR SR/XL. It should not be taken concurrently with other bupropion products. Zyban is contraindicated in individuals with a history of seizures, eating disorders, undergoing abrupt discontinuation of alcohol or sedatives, or currently taking monoamine oxidase inhibitors (MAOI).
    • In comparative trials following 12 weeks of treatment, ZybanR naive patients receiving Chantix were more likely to quit smoking than patients on Zyban (OR = 1.90, p < 0.001) or placebo (OR = 3.85, p < 0.001).
    • In one comparative trial, the quit rates for the combination of Zyban and Nicotine were not significantly higher than Zyban alone (p > 0.05). A higher incidence of treatment emergent hypertension was reported in patients treated with combination therapy.
    • Among patients who had stopped smoking after an initial 12 weeks of treatment with Chantix and received a second 12-week course, 70.5% remained smoke-free at 6 months compared to 49.6% who received placebo (OR = 2.48, p < 0.001) and 43.6% remained smoke-free at 1 year compared to 36.9% who received placebo (OR = 1.34, p = 0.02).
    • The safety and efficacy of using Chantix (varenicline) in combination with other smoking cessation therapies (Zyban, Nicotrol) has not been established.
    • All members are eligible for The American Cancer Society and The American Lung Association smoking cessation programs.
    • Health Net Medi-Cal members may enroll in the California Smokers Helpline telephone program by calling 1-800-NO-BUTTS (1-800-662-8887) or the Health Net Member Services Department at (800) 675-6110.
    • The member is responsible for any program fees or copayments when enrolling in a behavioral modification program other than those offered through Health Net.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Nicotine transdermal patches (Nicoderm CQR)

    1 patch changed daily
    >10 cigarettes per day:
    21 mg patch weeks 1-6 then 14 mg weeks 7-8 then 7 mg weeks 9-10
    10 or less cigarettes per day:
    14 mg patch weeks 1-6 then 7 mg weeks 7-8
    1 patch/day
    Total of 180 days of therapy per 365 days
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Nicotrol NS (Nicotine Nasal Spray)
    Initial
    2-4 sprays intranasally per hour (up to a max of 80 sprays per day),
    studies suggest a minimum of 16 sprays per day was most effective.
    Reduction
    Dose may be reduced as nicotine withdrawal subsides

    Total of 180 days of therapy per 365 days

    NicotrolR Inhaler (nicotine Inhaler)

    Initial Treatment (Up to 12 weeks)
    At least 6 cartridges via oral inhalation daily for 3-6 weeks.
    Additional cartridges may be used if needed.
    Maximum of 16 cartridges per day.
    Reduction (Up to 12 weeks)
    Patients should be encouraged to gradually reduce the number of cartridges used.
    Total of 180 days of therapy per 365 days

    Nicotine lozenges (CommitR)

    Slowly dissolve orally as follows:
    1 lozenge every 1-2 hours weeks 1-6 then,
    1 lozenge every 2-4 hours weeks 7-9 then,
    1 lozenge every 4-8 hours weeks 10-12
    Total of 180 days of therapy per 365 days

    bupropion hydrochloride sustained release (ZybanR)

    150 mg PO daily for the first 3 days, then 150 mg PO twice daily for 7-12 weeks.
    Maximum dose is 300 mg/day.

    Total of 180 days of therapy per 365 days

    Nicotine gum (NicoretteR)

    Chew orally as follows:
    1 piece every 1-2 hours week 1-6 then,
    1 piece every 2-4 hours week 7-9 then,
    1 piece every 4-8 hours weeks 10-12
    Max 24 pieces/day
    Total of 180 days of therapy per 365 days

    ChantixR

    Titration schedule:
    0.5 mg PO QD for 3 days, followed by 0.5 mg PO BID for 4 days,
    then 1 mg PO BID to complete 12 weeks of therapy

    Total of 180 days of therapy per 365 days

  7. Product Availability:
    Nicotine Nasal Spray: 10 mg/ml bottle, 0.5 mg/spray; 200 sprays per unit; pkg of 4 x 10 ml
    Nicotine Inhaler: 168 cartridges each containing 10 mg nicotine (4 mg delivered)
    Nicorette gum and lozenge: 2 mg, 4 mg
    Zyban tablet: 150 mg
    Chantix Tablet: 0.5 mg and 1 mg, bottles of 56
    Chantix Starting Month PAK: 53 tablets total (1 card of 0.5 mg x 11 tablets; 3 cards of 1 mg x 14 tablets)
    Chantix Continuing Month PAK: 56 total tablets (4 cards of 1 mg x 14 tablets)
  8. References:
    1. Zyban [package insert]. Glaxo Smith Kline; January 2012.
    2. Nicotrol Nasal Spray [package insert]. Pfizer; June 2010.
    3. Nicotrol Inhaler [package insert]. Pfizer; December 2008.
    4. A clinical practice guideline for treating tobacco use and dependence. JAMA. 2000;283:3244-3254.
    5. Watts SA, Noble SL, Smith PO, and Disco M. First-line Pharmacotherapy for Tobacco Use and Dependence. JABFP. 2002;15(6):489-497.
    6. Anderson JE, Jorenby DE, Scott WJ, and Fiore MC. Treating Tobacco Use and Dependence: An Evidence-Based Clinical Practice Guideline for Tobacco Cessation. Chest. 2002;121:932-941.
    7. Dale LC, Glover EF, Sachs DP, et al. Bupropion for Smoking Cessation: Predictors of Successful Outcome. Chest. 2001;119:1357-1364.
    8. Chantix [package insert]. Pfizer; January 2012
    9. Nicoderm CQ [package insert]. Sanofi Aventis; April 2007.
    10. Nicorette [package insert]. Glaxo Smith Kline; February 2012.
    11. Chantix [Prescribing Information]. New York, NY: Pfizer; October 2014.
    12. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an a4b2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA. 2006;296:56-63.
    13. Gonzales D, Rennard SI, Nides M, et al. Varenicline, an a4b2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation. JAMA. 2006;296:47-55.
    14. Tonstad S, Tonnesen P, Hajek P, et al. Effect of maintenance therapy with varenicline on smoking cessation. JAMA. 2006:296:64-71.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.