1. Precertification Criteria

   Under some plans, including plans that use an open or closed formulary, Migranal is subject to Precertification. If Precertification requirements apply Aetna considers Migranal to be medically necessary for those members who meet the following Precertification criteria:

   A.

   Quantity limits:

   According to the manufacturer, the safety of using a total dose greater than 4 mg in a 7-day period has not been established. Clinical guidelines recommend two treatment days per week for abortive therapy. A quantity of Migranal of up to 4 kits per 30 days will be considered medically necessary.

   For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of Migranal 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

   DHE-45 and Migranal currently are listed on the Aetna Formulary Exclusions List.* DHE-45 and Migranal, therefore, are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted. Aetna considers DHE-45 and Migranal to be medically necessary for those members who meet the following criteria:

   1. A documented:

      • Contraindication to two (2) preferred antimigraine “triptan” alternatives OR
      • Intolerance to two (2) preferred antimigraine “triptan” alternatives OR
      • Allergy to two (2) preferred antimigraine “triptan” alternatives OR
      • Failure of an adequate trial of one (1) day each of two (2) preferred antimigraine “triptan” alternatives.

      OR

   2. Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for non-migraine medical use.

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or if access to the Internet is available, providers may initiate the registration process to use our password-protected provider website. Visit www.aetna.com, select “Doctors & Hospitals” and choose “Physician Self-Service”.

Once registration is completed, health care professionals may utilize our online Precertification/medical exception email request form. The aforementioned lists are subject to change. Not all programs, for example Step-Therapy, Precertification and Quantity Limits, are available in all service areas (for example, Step-Therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a non-preferred drug because (i) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the non-preferred drug, and (ii) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a non-preferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for “preferred” status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than non-preferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (i) the terms of Aetna's arrangements with participating pharmacies; (ii) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (iii) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a non-preferred alternative.

For members in Texas, additions to the 2005 Preferred Drug List will be effective no later than January 1, 2005. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of Precertification is not the same as the definition used by Texas law. Our use of the term, “Precertification” relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or “verification” as defined by Texas Law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: Appropriate use of ergotamine tartrate and dihydroergotamine in the treatment of migraine and status migrainosus. Neurology 1995; 45: 585-587.
2. Winner P et al. A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine. Arch Neurol 1996; 53: 180-184.
3. Anon. Drugs for migraine. Med Lett Drugs Ther. 1995; 37: 17-20.
4. Ferrari MD. Migraine. Lancet 1998; 351: 1043-1051.
5. Lipton RB. Methodologic issues in acute migraine clinical trials. Neurology 2000;55(Suppl 2):S-7.
6. Silberstein SD, Goadsby PJ, and Lipton RB. Management of migraine: An algorithmic approach. Neurology 2000;55(Suppl 2):S46-52.
7. Goadsby PJ, Lipton RB, Ferrari MD. Migraine - Current understanding and treatment. N Engl J Med. 2002;346:257-70.
8. Silberstein SD. The pharmacology of ergotamine and dihydroergotamine. Headache 1997; 37(Suppl 1): S15-S25.
9. Lipton RB. Ergotamine tartrate and dihydroergotamine mesylate: Safety profiles. Headache 1997; 37(suppl 1): S33-S41.
10. Silberstein SD et al. Safety and efficacy of ergotamine tartrate and dihydroergotamine in the treatment of migraine and status migrainosus. Neurology 1995; 45: 577-584.
11. Saper JR. Headache disorders. Med Clin North Am. 1999;83(3):663-90.
12. Kulig J. Advances in medical management of asthma, headaches, and fatigue. Med Clin North Am. 2000 Jul; 84(4): 829-50.
13. Annequin D. Migraine and headache in childhood and adolescence. Pediatr Clin North Am. 2000;47(3): 617-31
14. Andersson PG & Jespersen LT. Dihydroergotamine nasal spray in the treatment of attacks of cluster headache: A double-blind trial versus placebo. Cephalalgia 1986; 6: 51-54.
15. Anon. Vascular headache suppressants, ergot derivative-containing, Systemic. USPDI, 18th edition, Vol. 1, 1998; pp 2935-2948.
16. Lipton RB. Ergotamine tartrate and dihydroergotamine mesylate: Safety profiles. Headache 1997; 37(suppl 1): S33-S41.
17. Touchon J et al. A comparison of subcutaneous sumatriptan and dihydroergotamine nasal spray in the acute treatment of migraine. Neurology 1996; 47: 361-365.
18. Anon. Imitrex intranasal relieves migraine pain 15 - 45 min quicker than oral; more patients respond to Imitrex spray than Migranal. F-D-C Reports. Pharmaceutical Approvals Monthly, June 1, 1997, Volume 2, Issue 6.
19. The Dihydroergotamine Nasal Spray Multicenter Investigators. Efficacy, safety, and tolerability of dihydroergotamine nasal spray as monotherapy in the treatment of acute migraine. Headache 1995; 45(40): 177-184.
20. Gallagher RM. Acute treatment of migraine with dihydroergotamine nasal spray. Arch Neurol 1996; 53: 1285-1291.
21. Migranal Product Insert. Novartis, East Hanover, NJ, December 2000.
22. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
23. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
24. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
25. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.

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.