Subject: Anti-Migraine Agents, "Triptans"

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
Ergotamines/dihydroergotamines:
C	ergotamine/caffeine
C	dihydro-ergotamine injection
NC	Cafergot®  (ergotamine/caffeine)						X
NC	DHE-45®  (dihydro-ergotamine injection)						X
NC	Ergomar®  (ergotamine)						X
NC	Migranal®  (dihydro-ergotamine nasal spray)			X			X
Triptans:
C	sumatriptan inj and spray			X
C	Imitrex®  (sumatriptan inj, nasal spray and tablets)			X
NC	Amerge®  (naratriptan)			X			X
NC	Axert®  (almotriptan)			X			X
NC	Frova®  (frovatriptan)			X			X
NC	Maxalt®, Maxalt MLT®  (rizatriptan)			X			X
NC	Relpax®  (eletriptan)			X			X
NC	Treximet™  (sumatriptan and naproxen sodium)			X			X
NC	Zomig®, Zomig ZMT®  (zolmitriptan)			X			X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Amerge, Axert, Frova, Imitrex, Maxalt/Maxalt MLT, Migranal, Relpax, sumatriptan, Treximet and Zomig/Zomig ZMT are subject to precertification.  If precertification requirements apply Aetna considers Amerge, Axert, Frova, Imitrex, Maxalt/Maxalt MLT, Migranal, Relpax, sumatriptan, Treximet 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 total of all strengths combined in 30 days
Axert	Up to 4 headaches	6.25mg, 12.5mg	Up to 8 tablets total of all strengths combined in 30 days
Frova	Up to 4 headaches	2.5 mg	Up to 12 tablets in 30 days
Imitrex	Up to 4 headaches	25mg, 50mg, 100mg	Up to 18 tablets total of all strengths combined in 30 days
sumatriptan, Imitrex	Up to 4 headaches	Nasal spray	Up to 6 sprays in 30 days
sumatriptan inj, Imitrex	Up to 4 headaches	Injection kits; refill syringes, 4mg/0.5ml; 6mg/0.5ml	Up to 4 kits (8 syringes) total combined in 30 days
sumatriptan, Imitrex	Up to 4 headaches	Injection, 6mg/0.5ml vials	Up to 10 vials (5ml) in 30 days
sumatriptan inj	Up to 4 headaches	Injection, 4mg/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 total of all strengths/dosage forms combined in 30 days
Migranal	Up to 4 headaches	4 mg/ml nasal spray	Up to 1 box (8 units/box) per 30 days
Relpax	Up to 3 headaches	20 mg, 40 mg	Up to 6 tablets total of all strengths combined in 30 days
Treximet	Up to 5 headaches	85 mg sumatriptan+ 500 mg naproxen sodium	Up to 9 tablets in 30 days
Zomig, Zomig ZMT	Up to 3 headaches	2.5 mg, 5 mg	Up to 6 tablets total of all strengths/dosage forms combined 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:

• Member has a documented diagnosis of migraine AND one of the following:

a) Member is receiving prophylactic* migraine therapy (may approve up to 2 times the set qty limit)
b) Member is being treated by a headache clinic or specialist (may approve up to 2 times the set qty limit)
OR

• Member has a documented diagnosis of cluster headaches AND Member is being treated by a headache clinic or specialist (may approve up to 3 times the set qty limit for indefinite period of time)
  OR
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  
  
  



2. Medical Exception Criteria

Amerge, Axert, Cafergot, DHE-45, Ergomar, Frova, Maxalt/Maxalt MLT, Migranal, Relpax, Treximet, 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 Amerge, Axert, Cafergot, DHE-45, Ergomar, Frova, Maxalt/Maxalt MLT, Migranal, Relpax, Treximet, Zomig and Zomig-ZMT to be medically necessary for those members who meet the following criteria:

Cafergot, DHE-45, Ergomar and Migranal

A documented:

• Contraindication to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Intolerance to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Allergy to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Failure of an adequate trial of one day of one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex

OR

B. Member's physician provides documentation from the approved drug labeling or CMS approved compendia for non-migraine medical use.

Amerg, Axert, Frova, Maxalt/Maxalt MLT, Relpax, Treximet, Zomig and Zomig-ZMT

A.   A documented:

• Contraindication to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Intolerance to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Allergy to one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex  OR
• Failure of an adequate trial of one day of one preferred anti-migraine "triptan" alternative, sumatriptan /Imitrex
  

Special Notes:

According to the manufactures, Triptans are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of these agents have not been established for cluster headache, which is present in an older, predominantly male population.

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because there is a theoretical basis that these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and any of these anti-migraine agents within 24 hours is contraindicated. Because their vasospastic effects may be additive, coadministration of more than one of these anti-migraine agents (5-HT₁ agonists) within 24 hours of each other is not recommended

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Tfelt-Hansen P. A review of evidence-based medicine and meta-analytic reviews in migraine. Cephalalgia. 2006;26(11):1265-74.
7. Rapoport A, Winner P. Nasal delivery of antimigraine drugs: clinical rationale and evidence base. Headache. 2006;46 Suppl 4:S192-201.
8. Pascual J, Mateos V, Roig C, Sanchez-Del-Rio M, Jiménez D. Marketed oral triptans in the acute treatment of migraine: a systematic review on efficacy and tolerability. Headache. 2007;47(8):1152-68.
9. Chen LC, Ashcroft DM. Meta-analysis of the efficacy and safety of zolmitriptan in the acute treatment of migraine. Headache. 2008;48(2):236-47.

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.

May 05, 2009