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


HNMC
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Amerge, Frova, Imitrex, Relpax, Zomig/Zomig-ZMT tablet:
      • Acute treatment of migraine attacks with or without aura in adults.
    • Axert and Zomig nasal spray (ONLY):
      • Acute treatment of migraine attacks in adults with a history of migraine with or without aura.
      • 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.
    • Maxalt,, Maxalt MLT
      • Acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age.
    • 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, Maxalt/Maxalt MLT):
      • Failure or clinically significant adverse effects to two formulary 5HT1-agonist migraine medications (e.g. Amerge and Imitrex)
      • For patients age 6 to 17 years, Maxalt/Maxalt MLT may be approved and for 12 to 17 years, Axert or Treximet may be approved
    AND
    • Requests for monthly quantities greater than 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
    • For all Treximet requests:
      • Medical justification must be provided why individual generic components of sumatriptan and naproxen cannot be used
  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:
    • Black Box Warning for Treximet stating NSAIDs may cause an increased risk of serious cardiovascular events and increased of gastrointestinal events.
    • All Triptans are contraindicated in patients with history of coronary artery disease or coronary vasospasm; symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or hemiplegic or basilar migraine, or peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension. Also with recent (within 24 hours) used of another 5-HT1 agonist (e.g., another triptan), or an ergotamine-containing medication.
    • Relpax (ONLY) is contraindicated within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir.
    • 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/APAP/caffeine(Fioricet)

    1 - 2 tablets PO Q4hr

    6 tablets/day

    butalbital/ASA/caffeine(Fiorinal)

    1 - 2 tablets PO Q 4hr

    6 tablets/day

    ergotamine/caffeine (Cafergot)

    1 - 2 tablets PO Q 30 min PRN

    6 mg/day (ergotamine)
    10 mg/week (ergotamine)
    isometheptene/dichloralphenazone/ APAP (Midrin)

    2 capsules PO at onset then 1 capsule Q 1 hour PRN

    5 capsules/12 hours

    naratriptan (Amerge)

    1 or 2.5 mg PO QD
    May repeat dose in 4 hours

    5 mg/24 hours

    sumatriptan (Imitrex) tablet

    25 to 100 mg PO QD
    May repeat dose in 2 hours

    200 mg/24 hours

    sumatriptan nasal spray (Imitrex)

    One spray (5-20 mg) intranasally at onset into one nostril; can repeat in 2 hours.

    40 mg/24 hours

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

    naratriptan (Amerge)

    1 or 2.5 mg PO QD
    May repeat dose in 4 hours
    Max dose: 5 mg/24 hours
    Length of Benefit (quantity limits apply)
    rizatriptan (Maxalt/ Maxalt MLT)
    5 or 10 mg PO QD
    May repeat dose in 2 hours
    Max dose: 30 mg/24 hours

    Pediatrics:
    <40 kg: 5 mg PO QD (MAX: 1 dose/24 hr)
    ≥40 kg: 10 mg PO QD (MAX: 1 dose/24 hr)
    Length of Benefit (quantity limits apply)
    sumatriptan (Imitrex) tablet
    25 to 100 mg PO QD
    May repeat dose in 2 hours
    Max dose: 200 mg/24 hours
    Length of Benefit (quantity limits apply)
    Axert (almotriptan)
    6.25 to 12.5 mg PO QD
    May repeat dose in 2 hours
    Max dose: 25 mg/24 hours
    Length of Benefit (quantity limits apply)
    Frova (frovatriptan)
    2.5 mg PO QD
    May repeat dose in 2 hours
    Max dose: 7.5 mg/24 hours
    Length of Benefit (quantity limits apply)

    sumatriptan nasal spray (Imitrex)

    One spray (5-20 mg) intranasally at onset into one nostril
    May repeat dose in 2 hours
    Max dose: 40 mg/24 hours
    Length of Benefit (quantity limits apply)
    Relpax (eletriptan)
    20 or 40 mg PO QD
    May repeat dose in 2 hours
    Max single dose: 40 mg
    Max daily dose: 80 mg
    Length of Benefit (quantity limits apply)
    zolmitriptan (Zomig and Zomig ZMT)
    1.25 or 2.5 mg PO QD
    May repeat dose in 2 hours
    Max single dose: 5 mg
    Max daily dose: 10 mg
    Length of Benefit (quantity limits apply)
    Zomig nasal (zolmitriptan)
    2.5 mg intranasally into one nostril
    May repeat dose in 2 hours
    Max single dose: 5 mg
    Max daily dose: 10 mg

    Pediatrics: 12 to 17 years old:
    2.5 mg intranasally into one nostril
    May repeat dose in 2 hours
    Max single dose: 5 mg
    Max daily dose: 10 mg
    Length of Benefit (quantity limits apply)
    Treximet (sumatriptan/naproxen)
    85 mg sumatriptan/500 mg naproxen PO QD
    May repeat dose in 2 hours
    Max dose: 170 mg sumatriptan/1000 mg naproxen /24 hours
    (*safety of treating an average of more than 5 headaches/30 days is not established)

    Pediatrics: 12 to 17 years of age
    10 mg sumatriptan/60 mg naproxen PO QD
    Max dose: 85 mg sumatriptan/500 mg naproxen /24 hours
    (*safety of treating an average of more than 2 headaches/30 days is not established)
    Length of Benefit (quantity limits apply)
  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; August 2014.
    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; September 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 July 6, 2015.
    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.