CurrentMass General Brigham Health PlanPolicy N/A

Sunosi (solriamfetol) prior authorization and coverage

Defines prior authorization, coverage criteria, and quantity/authorization limits for Sunosi (solriamfetol) for adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicySunosi (solriamfetol) prior authorization and coverage

Policy CodePolicy N/A

Change TypeStep therapy revised

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document either stability for new-to-plan members within 90 days or prior trial/contraindication to one agent (armodafinil or modafinil).

SourceLink

POLICY UPDATE CHANGES

Updated step therapy requirement from two agents to one effective 1/1/2025.

>=18minimum age for coverage

1 agentrequired prior trial

90 daysnew-to-plan allowance

12 moauthorization duration

Coverage Criteria for Sunosi (solriamfetol)

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Initial Authorization

Covered when ONE of the following is met:

Authorization criteria: (1) Member is new to the plan within the last 90 days AND is currently receiving the requested medication and is clinically stable (excluding medication obtained as samples or via manufacturer patient assistance programs).

Prescriber must document member's current receipt of medication and clinical stability.

Authorization criteria: (2) ALL of the following are met: member is 18 years of age or older; the member will use Sunosi to improve wakefulness for excessive daytime sleepiness associated with narcolepsy OR obstructive sleep apnea (OSA); and the member has had a previous trial with, inadequate response to, or contraindication to ONE of the following: armodafinil OR modafinil.

Prescriber must document age, indication, and prior trial/inadequate response/contraindication to one listed agent.

Continuation of Therapy / Reauthorization

Reauthorization is granted when:

Reauthorization: Physician documents improvement in the member’s condition.

Authorizations will be approved for 12 months; documentation of clinical benefit required at each reauthorization.

This policy applies to Sunosi (solriamfetol) dispensed under the pharmacy benefit and is subject to prior authorization as specified by plan type. There are no specialty limitations for coverage noted in the policy (Specialty Limitations: N/A).

Prior authorization may be granted for members who are new to the plan within the last 90 days and are currently receiving the requested medication and are clinically stable. For other members, authorization is granted only when the full coverage criteria are met (see Initial Authorization criteria).

Step therapy and quantity limits apply as described in the policy. Authorizations approved under these criteria are issued per plan rules and durations specified elsewhere in this policy.

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for Sunosi. Members new to the plan (enrolled within the last 90 days) who are currently receiving the requested medication and are clinically stable may be granted an authorization for up to 90 days; this does not apply when the product was obtained as samples or through manufacturer patient assistance programs.

New-to-plan stability allowance: 90 days (member must be currently receiving and stable on therapy)
Excludes medications obtained as samples or via manufacturer's patient assistance programs

Step Therapy

Step Therapy Requirement

Step therapy (prior trial) is required. The member must have had a prior adequate trial, inadequate response, or contraindication to ONE of the following agents before Sunosi will be authorized: armodafinil OR modafinil. This step requirement was updated from two agents to one effective 2025-01-01.

Required prior agent (one of): armodafinil; modafinil
Step updated to require trial of ONE agent (per 11/13/2024 P&T; effective 01/01/2025)

Documentation Required

Required Documentation

Required documentation at reauthorization. Physician documentation must be provided at reauthorization (continuation of therapy) to demonstrate clinical improvement in the member's condition. For new-to-plan members receiving a 90-day stability allowance, documentation that the member is currently on therapy and clinically stable is required. Acceptable evidence includes physician notes, progress assessments, or other clinical records documenting response or stability.

Reauthorization: physician documentation demonstrating improvement
New-to-plan members: documentation that member is currently receiving and stable on therapy (up to 90 days)
Acceptable evidence: physician notes, progress assessments, clinical records

Denial Risk

Denial Risk / Exclusion Conditions

Denial risk: authorization will be denied if the member is under 18 years of age or if required prior trial documentation (trial, inadequate response, or contraindication to ONE required agent) is not provided.

Member must be ≥ 18 years old
Prior trial documentation for ONE agent (armodafinil OR modafinil) must be submitted

Indication and Definitions

inv-09: Indication — Improvement of wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea

IndicationImprovement of wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

Age requirementAdults aged ≥18 years for authorization (unless member is new to plan within 90 days and currently stable on therapy).

Therapy intentTreatment goal is to improve wakefulness in patients with excessive daytime sleepiness due to narcolepsy or OSA.

Reauthorization requirementPhysician must document clinical improvement to qualify for continuation of therapy.

Step therapy notePrior trial, inadequate response, or contraindication to one agent (armodafinil OR modafinil) is required when not eligible under new-to-plan allowance (policy change effective 1/1/2025).

Clinical Background

Sunosi (solriamfetol) is indicated to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). The medication is used when residual excessive sleepiness persists despite treatment of underlying OSA, or to treat sleepiness due to narcolepsy.

Mechanistically, solriamfetol promotes wakefulness through actions on monoamine neurotransmitter systems (see prescribing information). Its use in these indications requires assessment of daytime sleepiness and documentation of clinical benefit at reauthorization.

Reauthorization requires physician documentation demonstrating clinical improvement; authorizations are typically approved for 12 months. Step therapy requires prior trial, inadequate response, or contraindication to one of armodafinil or modafinil (policy updated effective 01/01/2025 to require a trial of one agent rather than two).