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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Anti-Migraine Agents, "Triptans"

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Amerge®  (naratriptan)     X        
C Imitrex®  (sumatriptan)     X        
C Maxalt®, Maxalt MLT  (rizatriptan)     X        
C Relpax®  (eletriptan)     X        
NC Axert®  (almotriptan)     X     X  
NC Frova®  (frovatriptan)     X     X  
NC Zomig®, Zomig ZMT  (zolmitriptan)     X     X  


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Amerge, Axert, Frova, Imitrex, Maxalt/Maxalt MLT, Relpax and Zomig/Zomig ZMT are subject to precertification.   If precertification requirements apply Aetna considers Amerge, Axert, Frova, Imitrex, Maxalt/Maxalt MLT, Relpax and Zomig/Zomig ZMT to be medically necessary for those members who meet the following precertification criteria:

    A. Quantity limits:

    According to the manufacturer, the safety of treating an average of more than the number of headaches listed below in a 30-day period has not been established. Clinical guidelines recommend two treatment days per week for abortive therapy. A quantity of each drug will be considered medically necessary as indicated in the table below.

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Amerge Up to 4 headaches 1 mg, 2.5 mg Up to 9 tablets in 30 days
    Axert Up to 4 headaches 6.25mg, 12.5mg Up to 6 tablets in 30 days
    Frova Up to 4 headaches 2.5 mg Up to 9 tablets in 30 days
    Imitrex Up to 4 headaches 25mg, 50mg, 100mg Up to 18 tablets in 30 days
    Imitrex Up to 4 headaches Nasal spray Up to 6 sprays in 30 days
    Imitrex Up to 4 headaches Injection kits Up to 4 kits (8 syringes) in 30 days
    Imitrex Up to 4 headaches Injection, 6mg/0.5ml vials Up to 10 vials (5ml) in 30 days
    Maxalt, Maxalt MLT Up to 4 headaches 5 mg, 10 mg Up to 12 tablets in 30 days
    Relpax Up to 3 headaches 20 mg Up to 12 tablets in 30 days
    Relpax Up to 3 headaches 40 mg Up to 6 tablets in 30 days
    Zomig, Zomig ZMT Up to 3 headaches 2.5 mg Up to 12 tablets in 30 days
    Zomig, Zomig ZMT Up to 3 headaches 5 mg Up to 6 tablets in 30 days
    Zomig Up to 3 headaches Nasal spray Up to 6 sprays in 30 days


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities of these anti-migraine agents will be considered medically necessary for those members who meet ANY of the following criteria:

    • Documented diagnosis of acute migraine AND member is receiving prophylactic migraine therapy OR
    • Documented diagnosis of acute migraine AND member is being treated by a headache clinic or specialist.


  2. Medical Exception Criteria

    3. Axert, Frova, Zomig and Zomig-ZMT are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*  Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Axert, Frova, Zomig and Zomig-ZMT to be medically necessary for those members who meet the following criteria:

    A documented:

    • Contraindication to two covered anti-migraine "triptan" alternatives OR
    • Intolerance to two covered anti-migraine "triptan" alternatives OR
    • Allergy to two covered anti-migraine "triptan" alternatives OR
    • Failure of an adequate trial of one day each of two covered anti-migraine "triptan" alternatives.
* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.

Place of Service:

Outpatient

The above policy is based on the following references:
  1. Anon. Drugs for migraine. Med Lett 1995; 37: 17-20.
  2. Ferrari MD. Migraine. Lancet 1998; 351: 1043-1051.
  3. Dahlof C, Winter P, Whitehouse H, and Hassani H. Randomized, double-blind placebo-controlled comparison of oral naratriptan and oral sumatriptan in the acute treatment of migraine [abstract]. Neurology 199748:A85.
  4. Klassen A, Elkind A, Asghamejad M, et al Naratriptan is effective and well tolerated in the acute treatment of migraine: Results of a double-blind, placebo-controlled, crossover study. Headache 1997;37(10):640-5.
  5. Mathew NT, Asgharnejad M, Peykamian M, et al. Naratriptan is effective and well tolerated in the acute treatment of migraine: Results of a double-blind, placebo-controlled, crossover study. Neurology 1997;49: 1485-90.
  6. Bomhof M, Paz J, Legg N, et al. Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. Neurology 1999;423:173-9.
  7. Lipton RB. Methodologic issues in acute migraine clinical trials. Neurology 2000;55(Suppl 2):S1-7.
  8. Goadsby PJ and Hargreaves RJ. Mechanisms of action of serotonin 5HT 1B/1D agonists: Insights into migraine pathophysiology using rizatriptan. Neurology 2000;55(Suppl 2):S8-14.
  9. Silberstein SD, Goadsby PJ, and Lipton RB. Management of migraine: An algorithmic approach. Neurology 2000;55(Suppl 2):S46-52.
  10. 5-HT Agonist Comparisons: Clinical. BMMA. 1999;3(2):89.
  11. Jamieson DG. The safety of triptans in the treatment of patients with migraine. Am J Med. 2002;112:135-40.
  12. Jhee SS, Shiovitz T, Crawford AW, Cutler NR. Pharmacokinetics and pharmacodynamics of the triptan antimigraine agents. Clin Pharmacokinet 2001;40:189-205.
  13. Tepper SJ. Safety and rational use of the triptans. Med Clin North Am. 2001;85:959-70.
  14. Salonen R. Drug comparisons: why are they so difficult? Cephalalgia. 2000;29(Suppl 2):25-32.
  15. Rapoport AM, Tepper SJ. All triptans are not the same. J Headache Pain. 2001;2:S87-S92.
  16. Marcus DA. Establishing a standard of speed for assessing the efficacy of the serotonin 1B/1D agonists (triptans). Arch Neurol. 2001;58:1056-8.
  17. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT 1B/1D agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet 2001;358:1668-75.
  18. Ryan Jr RE. Patient treatment preferences and the 5-HT 1B/1D agonists. Arch Intern Med. 2001;161:2545-53.
  19. Pascual J. Clinical benefits of early triptan therapy for migraine. Headache 2002;42(Suppl 1):S10-7.
  20. Goadsby PJ, Lipton RB, Ferrari MD. Migraine - Current understanding and treatment. N Engl J Med. 2002;346:257-70.
  21. Pascual J, Falk RM, Piessens F, et al. Consistent efficacy and tolerability of almotriptan in the acute treatment of multiple migraine attacks: results of a large, randomized, double-blind, placebo-controlled study. Cephalalgia 2000;20:588-96.
  22. Gras J, Cardelus I, Llenas J, Palacios JM. Cardiovascular safety profile of almotriptan, a new indolic derivative for the treatment of migraine. Eur J Pharmacol. 2000;410:53-9.
  23. Goldstein J, Keywood, and Hutchison J. Low 24-hour migraine recurrence during treatment with frovatriptan. Presented at Ninth Congress of the International Headache Society, Barcelona, Spain. June 22-26, 1999.
  24. Spierings ELH, Keywood C on behalf of the VML 251/96/08 investigators. Consistent migraine relief with frovatriptan, a novel 5-HT 1B/1D agonists. Present at the Ninth Congress of the International Headache Society, Barcelona, Spain. June 22-26, 1999.
  25. Elkind A, McDaris HL, Satin L, Keywood C. The cardiovascular safety of frovatriptan in patients at high risk of or with known coronary artery disease during a migraine attack. Presented at the Ninth Congress of the International Headache Society, Barcelona, Spain. June 22-26, 1999.
  26. Easthope SE and Goa KL. Frovatriptan. CNS Drugs 2001:15(12);969-76.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 31, 2006
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