CurrentMass General Brigham Health PlanPolicy N/A

Journavx (suzetrigine) — Coverage Criteria for Acute Pain

Defines prior authorization, quantity limits, dosing, and coverage criteria for Journavx (suzetrigine) for treatment of moderate to severe acute pain in adults under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyJournavx (suzetrigine) — Coverage Criteria for Acute Pain

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document patient age (≥18), new acute pain episode, prior medication history showing trial or contraindication to both an NSAID and acetaminophen when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 daysmaximum studied/treatment duration per acute pain occurrence

18+minimum patient age (years)

twice dailydosing frequency limit

29quantity limit for Journavx 50 mg

1 per 60dapproval frequency limit

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Coverage Criteria

Initial therapy criteria

Authorizations will be granted when ALL of the following criteria are met:

Primary enrollment criteria: Member is 18 years of age or older>=18

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Diagnosis: Member is experiencing a new episode of moderate to severe acute pain

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Dosing and duration limits: Initial dosing: 100 mg first dose then 50 mg every 12 hours; therapy limited to 14 days for one acute pain occurrence; dosing frequency limited to twice daily14 days; twice daily

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Concomitant opioid restriction: Requested medication will not be used in combination with opioid products unless specific exception applies

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Prior therapy requirement: Member has history of inadequate response, adverse reaction, or contraindication to BOTH: (1) a NSAID (e.g., ibuprofen, naproxen) AND (2) acetaminophen OR Member meets alternate condition where an acute pain event requires opioid for pain management AND member has history of opioid use disorder

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Journavx will not be approved for the treatment of headache or migraine.

Members receiving Journavx through samples or patient assistance programs will not be approved for continuation of therapy under the benefit.

Requests for treatment beyond 14 days, or more than one approval within a 60-day period for the same acute pain episode, are not supported by this policy and will be denied.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Quantity and duration limits apply; approvals are limited to 14 days. Requests exceeding limits or not meeting criteria may be denied.

Approval limited to 14 days
One approval per 60-day period
Journavx 50 mg tablet — limit 29 tablets per 14 days

Step Therapy

Step Therapy / Prior Therapies

Member must fail, have an adverse reaction to, or have a contraindication to BOTH an NSAID (e.g., ibuprofen, naproxen) AND acetaminophen before approval. Alternatively, acute pain requiring an opioid for pain management with a history of opioid use disorder also satisfies step therapy.

Required prior therapies: NSAID AND acetaminophen
Exception: acute pain requiring opioid + history of opioid use disorder

Conservative Treatment Requirements

Trial or contraindication to NSAID and acetaminophen

Covered when ONE of the following conservative treatment conditions is met:

Conservative treatment requirement: Member has history of inadequate response, adverse reaction, or contraindication to BOTH a NSAID (e.g., ibuprofen, naproxen) AND acetaminophen

Require documented trial/failure or contraindication to both agents

Alternate condition: Acute pain event requires opioid for pain management AND member has history of opioid use disorder

Allows bypass of NSAID/acetaminophen trial when opioids are clinically required and opioid use disorder is present

Frequency and Quantity Limits

Journavx course for acute pain (up to 14 days)

Allowed course lengthUp to 14 days per acute pain occurrence

Approval frequencyOne approval per 60 days

Repeat approvals for same episodeNot approved more than once for the same acute pain episode

Review of new episodesRequests for a new pain episode will be reviewed against initial criteria

Quantity limit (50 mg)29 tablets per 14 days

Definitions

Journavx (suzetrigine) — description and dosing

Generic name / classSuzetrigine; sodium channel blocker indicated for moderate to severe acute pain in adults

Formulation50 mg tablets

Initial dosing100 mg for the first dose

Maintenance dosing50 mg every 12 hours starting 12 hours after the initial dose (twice daily)

Studied durationTreatment beyond 14 days has not been studied

New episode of acute pain — definition and policy implication

Definition

Background

Journavx (suzetrigine) is a sodium channel blocker indicated for the treatment of moderate to severe acute pain in adults. It is available as 50 mg tablets with the recommended initial dosing regimen described in the policy; treatment beyond 14 days has not been studied. Prior authorization is required and quantity/duration limits apply.

Not Covered

Treatment of headache or migraine with Journavx is explicitly not covered under this policy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyJournavx (suzetrigine) — Coverage Criteria for Acute Pain

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required Documentation

Provider must document member age, diagnosis of a new episode of moderate to severe acute pain, dosing frequency (limited to twice daily), prior medication history including trials of NSAID and acetaminophen or reasons they are not appropriate, and rationale if opioid-level pain management is required (including history of opioid use disorder).

Document member age (>=18)
Document new acute pain episode and diagnosis
Document prior medication history and reasons for failures/contraindications
Document dosing frequency (twice daily) and planned duration

Denial Risk

Denial Triggers / Limits

Requests that exceed duration or quantity limits, are for repeat approval for the same acute pain episode, are for headache/migraine, or request continuation for members on samples/patient assistance are denial risks.

Treatment > 14 days
More than one approval per 60 days
Repeat approval for the same acute pain episode
Requests for continuation when member is on samples or patient assistance
Requests for treatment of headache or migraine

An occurrence of moderate to severe acute pain for which treatment with Journavx is being requested

Policy implication — number of approvalsPolicy limits to one approval per 60 days for a new episode

Policy implication — episode-specific repeat approvalsJournavx will not be approved more than once for the same acute pain episode

Review requirementRequests for a new pain episode will be reviewed against initial coverage criteria (age, prior therapy, dosing limits)