HN Logo
Prior Authorization Protocol
ALSUMATM, IMITREXR INJECTION, SUMAVELTM DoseProTM, ZECUITYR (sumatriptan)

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
    • Alsuma, Imitrex Injection, Sumavel DosePro: Acute treatment of cluster headache in adults
  2. Health Net Approved Indications and Usage Guidelines:
    Migraines
    • Diagnosis of migraine attacks with or without an aura
    AND
    • Failure or clinically significant adverse effects to sumatriptan (Imitrex) nasal spray
    AND
    • Failure or clinically significant adverse effects to TWO formulary 5HT1-agonist migraine medications (e.g., AmergeR, ImitrexR or MaxaltR /Maxalt MLTR oral) at maximum tolerable doses
    OR
    • Patient cannot take oral agents due to migraine associated nausea

    AND

    • Requests for monthly quantities greater than 2 kits per month (Alsuma, Imitrex Injection), 1 kit per month (Sumavel DosePro), or 4 patches per month (Zecuity):
      • Failure or clinically significant adverse effects to at least TWO prophylactic migraine medications unless contraindicated
    AND
      • Patient is being treated by a neurologist or a headache specialist
    Cluster Headaches
    • Diagnosis of cluster headache attacks confirmed by a neurologist or headache specialist
  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.
    • Prophylactic therapy of migraine
    • Management of hemiplegic or basilar migraine
  4. General Information:
    Preventative Therapies for Migraine
    Class
    Commonly Used Examples
    Dose/Limit/Maximum Dose
    Anticonvulsants*
    divalproex (DepakoteR), topiramate (TopamaxR)
    Varies according to the agent used
    Beta blockers
    propranolol (InderalR), metoprolol (LopressorR), atenolol (TenorminR)
    Varies according to the agent used
    Antidepressants/
    Tricyclic antidepressants
    amitriptyline (ElavilR), venlafaxine (EffexorR)
    Varies according to the agent used
    Non steroidal anti-inflammatory drugs (NSAIDs)
    Fenoprofen (NalfonR), ibuprofen (MotrinR), ketoprofen (OrudisR), naproxen (NaprosynR)
    Varies according to the agent used

    * Check the member's benefits; some agents may require prior authorization

    • Alsuma, Imitrex and Sumavel are contraindicated in patients with history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
    • Alsuma, Imitrex and Sumavel are not FDA indicated for the prophylactic therapy of migraine.
    • The American Academy of Neurology and the National Headache Foundation recommend that prophylactic migraine medications should be considered if one or more of the following are present: greater than 2 migraine headaches per week; migraines cause significant impairment in daily routine even with abortive treatment; contraindication to, adverse effects, overuse or failure of abortive migraine medications, presence of uncommon migraine condition (e.g., basilar migraine); or patient requesting prophylactic therapy.
    • Sumavel is a needle-free injection system although there is still pain associated with administration. Alsuma is a needle auto-injector dosage form.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    naratriptan (Amerge)

    One tablet (1 or 2.5 mg) PO at onset;
    can be repeated in 4 hours

    Maximum dose of 5 mg per 24 hours

    sumatriptan (Imitrex nasal spray)

    One spray (5 - 20 mg) at onset into one nostril;
    can be repeated in 2 hours

    Maximum dose of 40 mg per 24 hours

    sumatriptan (Imitrex tablets)

    One tablet (25 -100 mg) at onset;
    can be repeated in two hours

    Maximum dose of 200 mg per 24 hours

    rizatriptan (Maxalt, Maxalt MLT )

    One (5 or 10 mg) tablet PO at onset of migraine headache;
    can be repeated in two hours

    Maximum dose of 30 mg per 24 hours

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

    Alsuma Injection

    Migraines
    One subcutaneous injection at onset; maximum of two
    injections in 24 hours separated by at least one hour

    2 kits (4 doses) per month,
    6 months
    Alsuma Injection
    Cluster Headache
    One subcutaneous injection at onset; maximum of two
    injections in 24 hours separated by at least one hour
    6 months
    Imitrex Injection
    Migraine
    One subcutaneous injection at onset; maximum of two
    injections in 24 hours separated by at least one hour.
    2 kits (4 doses) per month,
    6 months

    Imitrex Injection

    Cluster Headache
    One subcutaneous injection at onset; maximum of two
    injections in 24 hours separated by at least one hour

    6 months

    Sumavel DosePro

    Migraine
    One subcutaneous 6 mg dose at onset administered to abdomen or thigh;
    maximum of two injections in 24 hours separated by at least one hour.

    1 kit (6 doses) per month,
    6 months

    Sumavel DosePro

    Cluster Headache
    One subcutaneous 6 mg dose at onset administered to abdomen or thigh; maximum of two injections in 24 hours separated by at least one hour

    6 months
    Zecuity
    Migraine:
    Apply one patch to dry, intact, non-irritated skin of upper arm or thigh; no more than two patches should be used in any 24 hour period; second patch should be used no sooner than 2 hours after the first patch was applied

    4 patches per month, 6 months

  7. Product Availability:
    Alsuma: 2 single dose 6 mg/0.5ml auto injectors per package
    Imitrex STATdose System: Each package containing 1 pen with 2 prefilled 4 mg/0.5 mL single dose syringe cartridges (4 mg dose); 1 pen with 2 prefilled 6 mg/0.5 mL single dose syringe cartridges (6 mg dose)
    Imitrex Injection cartridge: 2 prefilled 4 mg/0.5 ml syringe cartridge for refill (4 mg dose); 2 prefilled 6 mg/0.5 ml syringe cartridges for refill (6 mg dose)
    Imitrex 6 mg single-dose vials: (6 mg/0.5 mL) in cartons of 5 vials
    Sumavel DosePro needle-free delivery system: 4 mg/0.5 mL in a package of six prefilled, single-dosed units, 6 mg/0.5mL in a package of six prefilled, single-dosed units
    Zecuity iontophoretic transdermal system (patch): 6.5 mg/4 hours
  8. References:
    1. Imitrex Injection [Prescribing information] Research Triangle Park, NC: GlaxoSmithKline, September 2012.
    2. 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.
    3. Silberstein SD, Holland S, Freitag F et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Neurology 2012;78:1337-45.
    4. Francis GJ, Becker WJ, Pringsheim TM. Acute and preventive pharmacologic treatment of cluster headache. Neurology 2010;75:463-73.
    5. Alsuma Injection [Prescribing Information] Columbia, MD: Meridian Medical Technologies; April 2014.
    6. Sumavel DosePro [Prescribing Information] San Diego, CA: Zogenix Inc.; November 2013.
    7. MICROMEDEXR Healthcare Series [Internet database]. Greenwood Village, CO.: Thompson Healthcare. Updated periodically. Accessed May 26, 2015.
    8. Zecuity [prescribing information]. NuPathe Inc., Malvern, PA; March 2014.
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.