Page: 1 of 5. Sumatriptan Tablets and Nasal Spray (Imitrex) / sumatriptan and naproxen sodium (Treximet tablets)

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Sumatriptan (Imitrex / Treximet) Page: 1 of 5 Last Review Date: September 12, 2014 Sumatriptan (Imitrex / Treximet) Description Sumatriptan Tablets and Nasal Spray (Imitrex) / sumatriptan and naproxen sodium (Treximet tablets) Background Migraine is a chronic, recurrent condition that affects millions of people worldwide. An estimated 10-20% of the US population suffers from migraine headaches (1). Triptans are serotonin (5-HT) receptor agonists that interrupt attacks or episodes of migraine, but do not prevent migraines from happening. Most of these agents are FDA approved for use in patients 18 years of age and above. This class of medications has potentially serious side effects, especially when taken in high doses. Life-threatening disturbances of cardiac rhythm and myocardial infarction have been reported, as well as stroke. Excessive use of triptans can lead to medication overuse headache (MOH). MOH was previously called rebound headache, drug-induced headache and medication-misuse headache (2). Regulatory Status FDA-approved indication: Imitrex Nasal Spray and Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults (1,2).

2 Subject: Sumatriptan (Imitrex / Treximet) Page: 2 of 5 Imitrex Nasal Spray is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of Imitrex Nasal Spray have not been established for cluster headache, which is present in an older, predominantly male population (1,2). Treximet is indicated for the acute treatment of migraine attacks with or without aura in adults. Carefully consider the potential benefits and risks of Treximet and other treatment options when deciding to use Treximet (3). Treximet is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of Treximet have not been established for cluster headache (3). Off Label Use: Triptans have been found to be safe and effective in the pediatric and adolescent population (4). Related policies Alsuma, Amerge, Axert, Frova, Maxalt, Maxalt MLT, Relpax, Sumavel, Zomig and Zomig ZMT Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Sumatriptan and sumatriptan / naproxen may be considered medically necessary for the treatment of migraine (classical, common) in patients 6 years of age or older. Sumatriptan and sumatriptan / naproxen must be prescribed by a neurologist for ages Sumatriptan and sumatriptan / naproxen may be considered investigational for the treatment of basilar or hemiplegic migraine or in patients under the age of 6. Prior-Approval Requirements

3 Subject: Sumatriptan (Imitrex / Treximet) Page: 3 of 5 Age 6 to 11 years of age AND 1. Must be prescribed by a neurologist 12 years of age or older Diagnoses Patient must have ONE of the following 1. Migraine, with aura (classic or classical) 2. Migraine, without aura (common) AND NONE of the following: a. Hemiplegic migraine b. Basilar migraine Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance Age 6-11 years of age No pre- PA allowance Age 12 years of age or older 5 mg nasal spray units per 180 days 20 mg nasal spray - 48 units per 180 days 25 mg tablets tablets per 180 days 50 mg tablets - 90 tablets per 180 days 100 mg tablets - 54 tablets per 180 days Treximet - 63 tablets per 180 days

4 Subject: Sumatriptan (Imitrex / Treximet) Page: 4 of 5 Prior - Approval Limits 5 mg nasal spray units per 180 days 20 mg nasal spray - 72 units per 180 days 25 mg tablets tablets per 180 days 50 mg tablets tablets per 180 days 100 mg tablets - 72 tablets per 180 days Treximet 90 tablets per 180 days Duration 6 months Prior Approval Renewal Limits Duration 5 mg nasal spray units per 180 days 20 mg nasal spray - 72 units per 180 days 25 mg tablets tablets per 180 days 50 mg tablets tablets per 180 days 100 mg tablets - 72 tablets per 180 days Treximet 90 tablets per 180 days 6 months Rationale Summary Migraine is a chronic, recurrent condition that affects millions of people worldwide (1). Triptans are serotonin (5-HT) receptor agonists that interrupt attacks or episodes of migraine, but do not prevent migraines from happening. This class of medications has potentially serious side effects, especially when taken in high doses. Life-threatening disturbances of cardiac rhythm and myocardial infarction have been reported, as well as stroke. Triptans have been found to be safe and effective in the pediatric and adolescent population (4).

5 Subject: Sumatriptan (Imitrex / Treximet) Page: 5 of 5 Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of sumatriptan and sumatriptan / naproxen while maintaining optimal therapeutic outcomes. References 1. Imitrex nasal spray [package insert].research Triangle Park, NC: GlaxoSmithKline; November Imitrex tablets [package insert]. Research Triangle Park, NC.: GlaxoSmithKline; November Treximet [package insert]. Research Triangle Park, NC: GlaxoSmithKline ; October Evers S the Efficacy of Triptans in Childhood and Adolescence Migraine Curr Pain Headache Rep (2013) 17: 342 Policy History Date December 2011 December 2012 April 2013 September 2014 Action New Policy Changed quantity limit to 1.5 x FDA-approved dosage. Annual review and update Revised quantity limits to allow mail order to fill correctly Revision of age to allow pediatric and adolescent use. Annual editorial review and reference update Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 12, 2014 and effective October 1, Signature on File Deborah M. Smith, MD, MPH