CurrentNeighborhood Health Plan of Rhode IslandPolicy 3020-D

Combination oral therapies for acute migraine (Symbravo, Treximet)

Policy governs coverage and prior authorization criteria for Symbravo (meloxicam/rizatriptan) and Treximet (sumatriptan/naproxen) for acute treatment of migraine in eligible patients under the payer's pharmacy benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCombination oral therapies for acute migraine (Symbravo, Treximet)

Policy CodePolicy 3020-D

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization when initial step therapy criteria are not met; document trials of three triptans and the two individual components taken together.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval

3Required prior triptan trials

120Lookback period (days)

30Minimum generic supply (days)

Coverage / Medical Necessity Criteria

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Coverage criteria (medical necessity)

Authorization may be granted when the requested drug is being prescribed for the diagnosis of migraine headache when ALL of the following criteria are met:

Primary criteria: The patient has tried and experienced an inadequate treatment response or intolerance to THREE triptan 5-HT1 agonists.three triptans

Document trials and inadequate response or intolerance to three different triptan agents.

Primary criteria: The patient has tried the two individual components of the requested drug taken together (i.e., meloxicam plus rizatriptan OR naproxen plus sumatriptan).

Document trial of the two components given concomitantly prior to approving the fixed‑dose combination.

Both Symbravo (meloxicam/rizatriptan) and Treximet (sumatriptan/naproxen) have explicit limitations of use in their prescribing information. Symbravo is not indicated for the preventive treatment of migraine attacks and is not indicated for the treatment of cluster headache. Similarly, Treximet is not indicated for the prevention of migraine attacks, and its safety and effectiveness have not been established for cluster headache.

Referenced Drugs and Coding Rules

Referenced drugsmixed

Symbravo	meloxicam/rizatriptan (brand and generic names and all strengths/forms unless stated)
Treximet	sumatriptan/naproxen (brand and generic names and all strengths/forms unless stated)

Generic fill lookback

Lookback period≥30-day supply filled within the past 120 days

Products includedGeneric sumatriptan + generic naproxen OR generic meloxicam + generic rizatriptan

Benefit administratorMust be filled under a prescription benefit administered by CVS Caremark

Effect of meeting lookbackRequested combination drug will be paid without prior authorization

Effect of not meeting lookbackClaim will reject with message that prior authorization is required

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization required when initial step therapy criteria are not met. Claims will reject and require prior authorization if the patient does not meet the initial step therapy criteria (i.e., adequate generic fills within the past 120 days). If a PA is submitted, PA approval will be based on the authorization criteria below.

Claims will reject with a message indicating a prior authorization is required when initial step therapy criteria are not met
PA approval criteria applied to requests submitted to the PA unit

Step Therapy

Initial step therapy requirement

Initial step therapy requires that the patient has filled a ≥30-day supply of generic sumatriptan AND either generic naproxen OR generic meloxicam AND generic rizatriptan within the past 120 days under a prescription benefit administered by CVS Caremark. If these fills are present, the requested combination product will be paid under that prescription benefit; if not present, the claim will reject and require PA.

Must include Rx and OTC products unless otherwise stated
Required fills: ≥30-day supply of generic sumatriptan AND (generic naproxen OR generic meloxicam) AND generic rizatriptan within the past 120 days
Fills must be under a prescription benefit administered by CVS Caremark

Documentation Required

Required clinical documentation

Authorization may be granted for the requested drug for migraine when documentation shows the patient has tried and had inadequate response or intolerance to three triptan 5-HT1 agonists, and has tried the two individual components of the requested drug taken together.

Documentation must show failure or intolerance to THREE triptan 5-HT1 agonists
Documentation must show trial of the two individual components taken together (meloxicam + rizatriptan or naproxen + sumatriptan)

Policy Background

Symbravo (meloxicam/rizatriptan) and Treximet (sumatriptan/naproxen) are fixed‑dose oral combination therapies indicated for the acute treatment of migraine. Both products should be used only when a clear diagnosis of migraine has been established, and if a patient does not respond to the first treated migraine attack, the diagnosis should be re-evaluated before further use. Neither product is indicated for migraine prevention; Symbravo is specifically not indicated for cluster headache, and Treximet’s safety and effectiveness for cluster headache have not been established.

Drug Indications and Definitions

Symbravo (meloxicam/rizatriptan) — key facts

IndicationAcute treatment of migraine with or without aura in adults

Not indicated for preventionNot indicated for the preventive treatment of migraine attacks

Not for cluster headacheNot indicated for treatment of cluster headache

Diagnostic cautionUse only where a clear diagnosis of migraine has been established; reassess diagnosis if no response to first treated attack

Treximet (sumatriptan/naproxen) — key facts

IndicationAcute treatment of migraine with or without aura in adults and pediatric patients 12 years and older

Not indicated for preventionNot indicated for the prevention of migraine attacks

Cluster headacheSafety and effectiveness not established for cluster headache

Diagnostic cautionUse only if a clear diagnosis of migraine headache has been established; reconsider diagnosis if no response to first treated attack