Subject: 5-HT1 Agonist Limit 2-H 07-2022
| 5-HT1 AGONISTS, COMBINATIONS (ALL DOSAGE FORMS) |
|
almotriptan
|
|
AMERGE
(naratriptan)
|
|
FROVA
(frovatriptan)
|
|
IMITREX
(sumatriptan)
|
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MAXALT/MAXALT-MLT
(rizatriptan)
|
|
ONZETRA XSAIL
(sumatriptan)
|
|
RELPAX
(eletriptan)
|
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TOSYMRA
(sumatriptan)
|
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TREXIMET
(sumatriptan/naproxen)
|
|
ZEMBRACE SYMTOUCH
(sumatriptan)
|
|
ZOMIG / ZOMIG-ZMT
(zolmitriptan)
|
Policy:
FDA-approved Indications
Almotriptan
Adults: Almotriptan tablets are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.
Adolescents Age 12 to 17 Years: Almotriptan tablets are indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).
Limitations of Use:
Almotriptan tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with almotriptan tablets, the diagnosis of migraine should be reconsidered before almotriptan tablets are administered to treat any subsequent attacks. In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of almotriptan tablets have not been established for cluster headache which is present in an older, predominantly male population.
Amerge
Amerge is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Amerge, reconsider the diagnosis of migraine before Amerge is administered to treat any subsequent attacks. Amerge is not indicated for the prevention of migraine attacks. Safety and effectiveness of Amerge have not been established for cluster headache.
Frova
Frova is indicated for the acute treatment of migraine attacks with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Frova, reconsider the diagnosis of migraine before Frova is administered to treat any subsequent attacks. Frova is not indicated for the prevention of migraine attacks. Safety and effectiveness of Frova have not been established for cluster headache.
Imitrex Injection
Imitrex injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Imitrex injection, reconsider the diagnosis before Imitrex injection is administered to treat any subsequent attacks. Imitrex is not indicated for the prevention of migraine or cluster headache attacks.
Imitrex Nasal Spray and Imitrex Tablets
Imitrex nasal spray and Imitrex tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Imitrex, reconsider the diagnosis of migraine before Imitrex is administered to treat any subsequent attacks. Imitrex is not indicated for the prevention of migraine attacks. Safety and effectiveness of Imitrex nasal spray and Imitrex tablets have not been established for cluster headache.
Maxalt and Maxalt-MLT
Maxalt and Maxalt-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use:
Maxalt should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with Maxalt, the diagnosis of migraine should be reconsidered before Maxalt is administered to treat any subsequent attacks. Maxalt is not indicated for use in the management of hemiplegic or basilar migraine. Maxalt is not indicated for the prevention of migraine attacks. Safety and effectiveness of Maxalt have not been established for cluster headache.
Onzetra Xsail
Onzetra Xsail is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Onzetra Xsail, reconsider the diagnosis of migraine before treatment of subsequent attacks with Onzetra Xsail. Onzetra Xsail is not indicated for the prevention of migraine attacks. Safety and effectiveness of Onzetra Xsail have not been established for the treatment of cluster headache.
Relpax
Relpax is indicated for the acute treatment of migraine attacks with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Relpax, reconsider the diagnosis of migraine before Relpax is administered to treat any subsequent attacks. Relpax is not indicated for the prevention of migraine attacks. Safety and effectiveness of Relpax have not been established for the treatment of cluster headache.
Tosymra
Tosymra is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Tosymra, reconsider the diagnosis before Tosymra is administered to treat any subsequent attacks. Tosymra is not indicated for the preventive treatment of migraine. Tosymra is not indicated for the treatment of cluster headache.
Treximet
Treximet is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Treximet, reconsider the diagnosis of migraine before Treximet is administered to treat any subsequent attacks. Treximet is not indicated for the prevention of migraine attacks. Safety and effectiveness of Treximet have not been established for cluster headache.
Zembrace SymTouch
Zembrace SymTouch is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Zembrace SymTouch, reconsider the diagnosis before Zembrace SymTouch is administered to treat any subsequent attacks. Zembrace SymTouch injection is not indicated for the prevention of migraine attacks.
Zomig Nasal Spray
Zomig nasal spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Limitations of Use:
Only use Zomig if a clear diagnosis of migraine has been established. If a patient has no response to Zomig treatment for the first migraine attack, reconsider the diagnosis of migraine before Zomig is administered to treat any subsequent attacks. Zomig is not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig have not been established for cluster headache. Not recommended in patients with moderate or severe hepatic impairment.
Zomig Tablets and Zomig-ZMT
Zomig is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Only use Zomig if a clear diagnosis of migraine has been established. If a patient has no response to Zomig treatment for the first migraine attack, reconsider the diagnosis of migraine before Zomig is administered to treat any subsequent attacks. Zomig is not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig have not been established for cluster headache.
|
LIMIT CRITERIA
The intent is for the patient to receive only one drug from this drug class at a time.
PLEASE NOTE: Since manufacturer package sizes may vary, it is the discretion of the dispensing pharmacy to fill
quantities per package size up to these quantity limits. In such cases the filling limit and day supply may be less than
what is indicated.
|
|
Medication
|
Strength
|
Dose per
headache
|
Maximum
dose per 24
hours
|
Package
Size
|
1 Month Limit *
3 Months Limit *
|
|
almotriptan
|
6.25 mg
|
1-2
tablets
|
2 tablets**
|
6 tablets
|
12 tablets /
25 days
36 tablets /
75 days
|
|
12.5 mg
|
1-2
tablets
|
2 tablets
25 mg
|
6 tablets
12 tablets
|
|
Amerge
(naratriptan)
|
1 mg
|
1-2
tablets
|
2 tablets**
|
9 tablets
|
12 tablets /25
days
36 tablets / 75
days
|
|
2.5 mg
|
1-2
tablets
|
2 tablets 5 mg
|
|
Frova
(frovatriptan)
|
2.5 mg
|
1-2
tablets
|
3 tablets
7.5 mg
|
9 tablets
|
18 tablets / 25
days
54 tablets / 75
days
|
|
Imitrex Injection
(sumatriptan) vials
|
6 mg
|
1-2
injections
|
2 injections
12 mg
|
5 single
dose vials
0.5mL each
|
12 vials (6mL)
/ 25 days
40 vials (20mL)
/ 75 days
|
|
Imitrex Injection
(sumatriptan) syringes
STATdose / Refill
|
4 mg
|
1-2
injections
|
3 injections
12 mg
|
2 prefilled
syringes
0.5mL each
|
18 syringes
(9mL) / 25
days
54 syringes
(27mL) / 75
days
|
|
6 mg
|
1-2
injections
|
2 injections
12 mg
|
12 syringes
(6mL) / 25
days
36 syringes
(18mL) / 75
days
|
|
Imitrex Nasal Spray
(sumatriptan)
|
5 mg
|
1-4 sprays
|
4 sprays**
|
6 nasal
spray units
|
24 units /
25 days
72 units /
75 days
|
|
20 mg
|
1-2 sprays
|
2 sprays
40 mg
|
12 units /
25 days
36 units /
75 days
|
|
Imitrex Tablets
(sumatriptan)
|
25mg,
50mg
|
1-2
tablets
|
2 tablets**
|
9 tablets
(brand and
generic)
27, 36, 90,
100 tablets
(generic)
|
12 tablets /
25 days
36 tablets /
75 days
|
|
100 mg
|
1-2
tablets
|
2 tablets
200 mg
|
|
Maxalt Maxalt-MLT
(rizatriptan)
|
5 mg
|
1-2
tablets
|
3 tablets**
|
12, 18
tablets
(generic), 3, 9, 12, 18
orally
disintegrating
tablets (generic)
|
18 tablets /
25 days
54 tablets /
75 days
|
|
10 mg
|
1-2
tablets
|
3 tablets
30 mg
|
18 tablets
(brand and
generic)
12 tablets
(generic),
3 orally
disintegrating
tablets
(brand and
generic),9,
12, 18 orally
disintegrating
tablets (generic)
|
|
Onzetra Xsail
(sumatriptan)
|
11mg
|
2
nosepieces
|
4 nosepieces
44mg
|
16
nosepieces
2 nosepieces
per pouch
8 pouches per kit
|
16 nosepieces /
25 days
(1 kit, 8 pouches)
64 nosepieces /
75 days
(4 kits, 32
pouches)
|
|
Relpax
(eletriptan)
|
20 mg
|
1-2
tablets
|
2 tablets**
|
6 tablets
|
12 tablets /
25 days
36 tablets /
75 days
|
|
40 mg
|
1-2
tablets
|
2 tablets
80 mg
|
6 tablets
12 tablets
|
|
Tosymra
(sumatriptan nasal)
|
10 mg
|
1-3
sprays
|
3 sprays
30 mg
|
6 nasal
spray units
|
18 units /
25 days
54 units /
75 days
|
|
Treximet
(sumatriptan/naproxen)
|
85mg/
500mg
|
1-2
tablets
|
1-2 tablets
170mg/1000mg
|
9 tablets
dispense in
original
container
|
9 tablets /
25 days
36 tablets /
75 days
|
|
Zembrace SymTouch|
(sumatriptan)
|
3 mg
|
1-4 injections
|
4 injections
12mg
|
4 autoinjectors
0.5mL each
|
24 injectors
(12mL) /
25 days
72 injectors
(36mL) /
75 days
|
|
Zomig Nasal Spray
(zolmitriptan)
|
2.5 mg
|
1-2
sprays
|
2 sprays**
|
6 nasal
spray units
|
12 units /
25 days
36 units /
75 days
|
|
5 mg
|
1-2
sprays
|
2 sprays
10 mg
|
|
Zomig Tablets Zomig-ZMT
(zolmitriptan)
|
2.5 mg
|
1/2-2
tablets
|
2 tablets**
|
6 tablets
|
12 tablets /
25 days
36 tablets /
75 days
|
|
5 mg
|
1-2
tablets
|
2 tablets
10 mg
|
3 tablets
|
|
* The duration of 25 days is used for a 30-day fill period and 75 days is used for a 90-day fill period to allow time for refill processing.
**Utilize higher strength available.
|
RATIONALE
According to the American Headache Society, all patients with a confirmed diagnosis of migraine should be offered a trial of acute treatment. Use of migraine-specific agents (triptans, dihydroergotamine, small-molecule CGRP receptor antagonists [gepants], or selective serotonin (5-HT1F) receptor agonist [ditan]) for moderate or severe attacks and mild-to-moderate attacks that respond poorly to nonspecific therapy is recommended. Some patients may require additional preventive treatment based on attack frequency or degree of disability. Patients with migraine should be considered for preventive treatment in any of the following situations: attacks significantly interfere with patients’ daily routines despite acute treatment; frequent attacks (≥ 3 migraine headache days per month if associated with severe disability, ≥ 4 migraine headache days per month if associated with some disability or ≥ 6 migraine headache days if associated with no disability); a contraindication to, failure, or overuse of acute treatments; adverse events with acute treatments; or patient preference.17 Based on these recommendations, patients requiring treatment for more than 4 migraine headache days per month should be evaluated further for preventive treatment. The limits are set at a quantity sufficient to treat at least 4 headaches per month and up to 6 headaches per month at maximum recommended daily dosing, based on manufacturer package sizes. Since manufacturer package sizes may vary, it is the discretion of the dispensing pharmacy to fill quantities per package size up to these quantity limits. In such cases the filling limit and day supply may be less than what is indicated in the Limit Criteria chart.
Because their vasospastic effects may be additive, coadministration of another 5-HT1 agonists (triptans) within 24 hours of each other is contraindicated.1-16
If the patient is requesting more than the initial quantity limit the system will reject with a message indicating that a prior authorization is required.
Almotriptan
The recommended dose of almotriptan tablets in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg. The dose may be repeated after 2 hours. The maximum daily dose should not exceed 25 mg.
Amerge
The recommended dose of Amerge is 1 mg or 2.5 mg. The dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.
Frova
The recommended dose is a single tablet of Frova 2.5 mg. A second tablet may be taken providing there is an interval of at least two hours between doses. The total daily dose of Frova should not exceed three tablets (7.5 mg).
Imitrex
Injection
The maximum single recommended adult dose of Imitrex injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, the lower dose of 4 mg may be used. For the treatment of cluster headache, the efficacy of lower doses has not been established. The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6-mg injections separated by at least 1 hour.
Imitrex injection is supplied in systems with 2 prefilled single-dose (4-mg or 6-mg) syringe cartridges.
Nasal Spray
The recommended adult dose of Imitrex nasal spray is 5 mg, 10 mg or 20 mg . The 5-mg and 20-mg doses are given as a single spray in one nostril. The 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. The dose may be repeated once after 2 hours, not to exceed a total daily dose of 40 mg.
Imitrex nasal spray is supplied in boxes of 6 nasal spray (5-mg or 20-mg) devices.
Tablets
The recommended dose of Imitrex tablets is 25 mg, 50 mg or 100 mg. The dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg.
Maxalt and Maxalt-MLT
The recommended starting dose of rizatriptan benzoate is either 5 mg or 10 mg for the acute treatment of migraines in adults. A second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg. Dosing in pediatric patients is based on the patient's body weight. The recommended dose of rizatriptan benzoate is 5 mg in patients weighing less than 40 kg, and 10 mg in patients weighing 40 kg or more. The safety and efficacy of treatment with more than one dose of rizatriptan benzoate within 24 hours in pediatric patients have not been established.
Onzetra Xsail
The recommended dosage of Onzetra Xsail is 22 mg of sumatriptan nasal powder (2 nosepieces). A second dose of 22 mg may be administered at least 2 hours after the first dose. The maximum recommended dose that may be given in 24 hours is two doses of Onzetra Xsail (44 mg/4 nosepieces).
Onzetra Xsail is supplied as a disposable nosepiece containing a capsule with 11 mg sumatriptan base. Onzetra Xsail is available in kits containing 8 doses. 1 kit contains 8 pouches of 2 nosepieces (22 mg sumatriptan) per pouch and 2 breath-powered delivery system bodies. Each pouch delivers one 22-mg dose.
Relpax
Single doses of 20 mg and 40 mg are effective for the acute treatment of migraine in adults. If a second dose is required, it should be taken at least two hours after the initial dose. The maximum daily dose should not exceed 80 mg.
Tosymra
The recommended dosage is 10 mg given as a single spray in one nostril. The maximum cumulative dose that may be given in a 24-hour period is 30 mg, with doses of Tosymra separated by at least 1 hour. Tosymra may also be given at least 1 hour following a dose of another sumatriptan product.
Tosymra is supplied as a ready-to-use, single-dose, disposable unit. Each carton contains 6 units.
Treximet
The recommended dosage for adults is 1 tablet of Treximet 85/500 mg. The maximum recommended dosage of Treximet 85/500mg in a 24-hour period is two tablets, taken at least 2 hours apart.
The recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of Treximet 10/60 mg. The maximum recommended dosage in a 24-hour period is 1 tablet of Treximet 85/500 mg.
Treximet is available in bottles of 9 tablets. Do not repackage; dispense and store in original container with desiccant.
Zembrace SymTouch
The recommended dose of Zembrace SymTouch is 3 mg injected subcutaneously. The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses separated by at least 1 hour.
Zembrace SymTouch is suppled in a pre-filled, ready-to-use, single dose, disposable auto-injector unit. Each carton contains 4 units.
Zomig and Zomig-ZMT
Nasal Spray
The recommended starting dose for Zomig nasal spray in adult and pediatric patients 12 years of age and older is 2.5 mg. The maximum recommended single dose of Zomig is 5 mg. Another dose may be administered at least 2 hours after the previous dose. The maximum daily dose should not exceed 10 mg.
Zomig nasal spray is supplied in boxes of 6 single-use nasal spray units. The nasal spray unit must be discarded after use.
Tablets
The recommended starting dose of Zomig is 1.25 mg or 2.5 mg. The maximum recommended single dose of Zomig is 5 mg. The dose may be repeated after two hours, not to exceed the maximum daily dose of 10 mg within a 24-hour period.
Place of Service:
Outpatient
The above policy is based on the following references:
- Almotriptan [package insert]. Bridgewater, NJ: Ajanta Pharma USA Inc.; November 2021.
- Amerge [package insert]. Research Triangle Park, NC: GlaxoSmithKline; October 2020.
- Frova [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; August 2018.
- Imitrex Injection [package insert]. Research Triangle Park, NC: GlaxoSmithKline; December 2021.
- Imitrex Nasal Spray [package insert]. Research Triangle Park, NC: GlaxoSmithKline; December 2017.
- Imitrex Tablets [package insert]. Research Triangle Park, NC: GlaxoSmithKline; December 2020.
- Maxalt and Maxalt-MLT [package insert]. Jersey City, NJ: Organon LLC; June 2021.
- Onzetra Xsail [package insert]. Morristown, NJ: Currax Pharmaceuticals LLC; December 2019.
- Relpax [package insert]. New York, NY: Pfizer, Inc.; March 2020.
- Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC; February 2021.
- Treximet [package insert]. Morristown, NJ: Currax Therapeutics, LLC; April 2021.
- Zembrace SymTouch [package insert]. Maple Grove, MN: Upsher-Smith Laboratories LLC; February 2021.
- Zomig Nasal Spray [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; May 2019.
- Zomig and Zomig-ZMT [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; May 2019.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, Ohio: UpToDate, Inc.; 2022; Accessed June 1, 2022.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed June 1, 2022.
- American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache 2021;61:1021-1039.
Copyright 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.
December 10, 2022
