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§
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:
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
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.
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.
*C = Covered, copay amount depends on benefits plan
CS = Covered under Specialty Tier
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.