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Prior Authorization Protocol
AMERGER (naratriptan), AXERTR (almotriptan), FROVAR (frovatriptan), IMITREXR (sumatriptan), MAXALTR / MAXALT MLTR (rizatriptan), RELPAXR (eletriptan), TREXIMETR (sumatriptan/naproxen), ZOMIGR (zolmitriptan)


NATL
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:
    • Acute treatment of migraine attacks with or without aura in adults
    • For Axert: Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more and acute treatment of migraine attacks in adults with a history of migraine with or without aura
    • For Maxalt/Maxalt MLT: Acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age
    • For Treximet: Acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older
  2. Health Net Approved Indications and Usage Guidelines:

    Migraines

    • Diagnosis of migraine headaches

      AND
    • For non-preferred triptans (including Axert, Frova, Relpax, Zomig, Treximet):
      • Failure or clinically significant adverse effects to at least two formulary 5HT1-agonist migraine medications (e.g. Amerge, Imitrex or Maxalt/Maxalt MLT)
      • For patients age 12 - 17 years, Axert or Treximet may be approved after failure or clinically significant adverse effects to Maxalt/Maxalt MLT
    AND
    • Requests for monthly quantities greater than the health plan limit but less than or equal to two times the health plan limit:
      • Failure or clinically significant adverse effects to two prophylactic migraine medications unless contraindicated
    OR
      • Patient is being treated by a neurologist or a headache specialist

    AND

    • Requests for monthly quantities greater than two times the health plan limit:
      • Failure or clinically significant adverse effects to two prophylactic migraine medications unless contraindicated

    AND†

      • Patient is being treated by a neurologist or a headache specialist

    AND

    • For all Treximet requests:
      • Medical justification must be provided why individual generic components of sumatriptan and naproxen cannot be used
    Cluster Headaches
    • Diagnosis of cluster headache attacks confirmed by a neurologist or headache specialist (Imitrex Nasal Spray only)
  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.
    • Management of hemiplegic or basilar migraines
    • Concurrent administration with MAO inhibitors or use within 2 weeks of discontinuation of MAO inhibitor therapy (Imitrex, Maxalt and Zomig only)
  4. General Information:
    • The triptans should not be used for hemiplegic or basilar migraines
    • Imitrex, Maxalt, and Zomig are metabolized by monoamine oxidase A (MAO-A), and inhibitors of this enzyme may increase serum concentrations of these triptans. Use of Imitrex, Maxalt, or Zomig concurrently or within 2 weeks of discontinuation of an MAO-A inhibitor or non-selective MAO inhibitor is contraindicated.
    • AAN guidelines for cluster headaches support the use of Imitrex Nasal Spray for acute treatment (Level B). Intranasal sumatriptan at a dose of 20 mg has been shown to be effective in the acute treatment of cluster headache.
    • According to AAN guidelines, verapamil, lithium and melatonin may be considered for the prevention of cluster headaches.
    • The American Academy of Neurology recommends that prophylactic migraine medications should be considered if the patient experiences 2 or more attacks per month that produce aggregate disability of 3 or more days/month.
    Preventive Therapies for Migraine
    (Adopted by the American Academy of Neurology)
    Medication
    Dose
    Level of Evidence**
    Anticonvulsants
    divalproex sodium (DepakoteR)
    500-1000 mg/day PO
    FDA Approved
    divalproex sodium ER (DepakoteR ER)
    500-1000 mg/day PO
    FDA Approved
    gabapentin (NeurontinR)
    900-2400 mg/day PO
    Group II
    topiramate (TopamaxR)
    100 mg/day PO
    FDA Approved
    Beta-Blockers
    atenolol (TenorminR)
    100 mg/day PO
    Group II
    metoprolol (LopressorR)
    200 mg/day PO
    Group II
    nadolol (CorgardR)
    80-240 mg/day PO
    Group II
    propranolol (InderalR)
    80-240 mg/day PO
    Group I
    timolol (BlocadrenR)
    20-30 mg/day PO
    Group I
    Calcium Channel Blockers
    verapamil (CalanR)
    240 mg/day PO
    Group II
    SSRIs
    fluoxetine (ProzacR)
    20 mg QOD - 40 mg/day PO
    Group II
    Tricyclic Antidepressants
    amitriptyline (ElavilR)
    30-150 mg/day PO
    Group I
    imipramine (TofranilR)
    Not Established
    Group III
    nortriptyline (PamelorR)
    Not Established
    Group III
    **Group I = Medium to high efficacy, good strength of evidence, and mild to moderate side effects;
    Group II = Lower efficacy than Group I, or limited strength of evidence, and mild to moderate side effects;
    Group III = Clinically efficacious
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    butalbital/caffeine/APAP

    1 - 2 tablets PO Q4hr

    12 tablets/day (4000 mg APAP)

    butalbital/caffeine/ASA

    1 - 2 tablets PO Q4hr

    6 tablets/day

    ergotamine/caffeine

    1 tablet PO Q 30 min PRN
    up to 6 tablets/attack

    6 tablets/ attack,
    10 tablets/week

    isometheptene/dichloralphenazone/APAP

    2 capsules PO at onset
    then 1 capsule Q 1 hour

    5 capsules/12 hours

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    naratriptan (amerge)

    One tablet PO (1 - 2.5 mg) at onset; can be repeated in 4 hours.
    Maximum dose in 24 hours: 5 mg

    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
    Axert (almotriptan)
    One (6.25 or 12.5 mg) tablet PO at onset of migraine headache; can be repeated in
    2 hours.
    Maximum dose in 24 hours: 25 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
    Frova (frovatriptan)
    One tablet (2.5 mg) PO at onset of migraine.
    If headache recurs despite initial relief, a 2nd tablet may be taken at least 2 hours after 1st dose.
    Maximum dose per 24 hours: 7.5 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy

    sumatriptan (imitrex) tablet

    One tablet (25-100 mg) PO at onset; can be repeated in two hours
    Maximum dose in 24 hours: 200 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy

    sumatriptan nasal spray (imitrex)

    One spray (5-20 mg) intranasally at onset into one nostril; can repeat in 2 hours
    Maximum dose in 24 hours: 40 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy

    rizatriptan (maxalt / maxalt MLT)

    One (5 or 10 mg) tablet PO at onset of migraine headache;
    can be repeated in 2 hours.
    Maximum dose per 24 hours:
    30 mg
    Pediatric patients 6 to 17 years:
    5 mg single dose in patients <40 kg (88 lb);
    10 mg single dose in patients ≥40 kg (88 lb)
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
    Relpax (eletriptan)
    Maximum single dose is 40 mg PO.
    If after initial dose, headache improves but returns; repeat dose may be given but should be at least 2 hours after initial dose.
    Maximum dose per 24 hours: 80 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
    zolmitriptan (zomig and zomig ZMT)

    Zomig nasal (zolmitriptan))
    One tablet (2.5 mg or 5 mg) PO or one nasal spray dose of 5 mg intranasally at onset of migraine headache; can be repeated in 2 hours.
    Maximum dose in 24 hours: 10 mg
    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
    Treximet (sumatriptan / naproxen)
    Adults 18 years of age and older:
    One 85/500 mg tablet PO; efficacy of taking second dose has not been established; however, treatment should not exceed 2 tablets in 24 hours
    Pediatric patients 12 to 17 years of age:
    One 10/60 mg tablet PO. Treatment should not exceed one 85/500 mg tablet in 24 hours

    1 year
    Continued treatment beyond 1 year may be authorized upon a review for prophylactic therapy
  7. Product Availability:
    Amerge tablet: 1 mg, 2.5 mg (package size 9)
    Axert tablet: 6.25 mg (package size 6), 12.5mg (package size 12)
    Frova tablet: 2.5 mg (package size 9)
    Imitrex tablet: 25 mg, 50 mg, 100 mg (package size 9)
    Imitrex nasal: 5 mg, 20 mg (package size 6)
    Maxalt tablet: 5 mg, 10 mg (package size 6, 9, 12, 18)
    Maxalt MLT tablet: 5 mg, 10 mg (package size 3, 6)
    Relpax tablet: 20 mg (package size 6), 40 mg (package size 6, 12)
    Zomig tablet: 2.5 mg (package size 6), 5 mg (package size 3)
    Zomig Nasal Spray: 2.5 mg, 5 mg (package size 6)
    Zomig ZMT tablet: 2.5 mg (package size 6), 5 mg (package size 3)
    Treximet tablet: 85 mg sumatriptan and 500 mg naproxen sodium (package size 9, 12), 10 mg sumatriptan and 60 mg naproxen sodium (package size 9)
  8. References:
    1. Amerge [Prescribing Information] Research Triangle Park, NJ: GlaxoSmithKline; October 2013.
    2. Axert [Prescribing Information] Raritan, NJ: Ortho-Mc-Neil-Janssen; April 2009.
    3. Imitrex Nasal [Prescribing Information] Research Triangle Park, NJ: GlaxoSmithKline; November 2013.
    4. Imitrex [Prescribing Information] Research Triangle Park, NJ: GlaxoSmithKline; November 2013.
    5. Maxalt [Prescribing Information] Whitehouse Station, NJ: Merck; December 2011.
    6. Zomig Nasal [Prescribing Information] Wilmington, DE: AstraZeneca; September 2013.
    7. Zomig [Prescribing Information] Wilmington, DE: Astra Zeneca; September 2012.
    8. Frova [Prescribing Information] Chadds Ford, PA: Endo; October 2013.
    9. Relpax [Prescribing Information] New York, NY: Pfizer; October 2013.
    10. Treximet [Prescribing Information] Morristown, NJ: Pernix Therapeutics; May 2015.
    11. Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review) Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000;55:754-762.
    12. Ferrari MD, Koon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT(1B/1D) agonists) in acute migraine treatment: a meta-analysis of 53 trials. The Lancet 2001;358:1668-1675.
    13. Lewis D, et al. Practice parameter: Pharmacological Treatment of Migraine Headaches in Children and Adolescents. Report of the American Academy of Neurology Quality Standards Subcommittee of the Practice Guidelines of the Child Neurology Society. Neurology 2004;63: 2215-2224.
    14. MICROMEDEXR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July11,2014.
    15. Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology 2010;75:463-73.
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.