CurrentCignaPolicy IP0717

Vyalev (foscarbidopa and foslevodopa) for Parkinson's disease

Defines Cigna medical-benefit coverage criteria, prior authorization requirements, dosing limits, and coding for Vyalev (continuous subcutaneous foscarbidopa/foslevodopa) for treatment of motor fluctuations in adults with advanced Parkinson's disease.

Policy Summary

PayerCigna

PolicyVyalev (foscarbidopa and foslevodopa) for Parkinson's disease

Policy CodePolicy IP0717

Change TypeNew policy; coding update (J7356 added)

Effective DateApr 15, 2025

Next Review Date

Key ActionPrior Authorization is required; ensure Vyalev is prescribed by or in consultation with a neurologist and document diagnosis, 'off' episodes, prior carbidopa/levodopa intolerance or inadequate efficacy, and prior/ongoing alternative 'off' therapy.

POLICY UPDATE CHANGES

New policy created for Vyalev

Added HCPCS code J7356 (effective 7/1/2025)

Updated description and effective note for J3490

1Covered Indication (Parkinson's Disease)

1 yearInitial Approval Duration

3,525 mg/dayMax foslevodopa per day

2HCPCS codes referenced

Overview: This policy defines Cigna medical-benefit coverage criteria for Vyalev (continuous subcutaneous foscarbidopa and foslevodopa) for treatment of motor fluctuations in adults with advanced Parkinson's disease. Coverage stance: Covered with criteria — prior authorization is required and approvals are granted when the specified clinical criteria and dosing limits are met. Subject: Vyalev (foscarbidopa and foslevodopa) for Parkinson's disease. Status: CURRENT — policy established as new on 04/15/2025 with updated HCPCS coding (J3490 effective until 6/30/2025; J7356 effective 7/1/2025).

Approval duration and dosing limits

Duration of approval1 year

Maximum daily foslevodopa doseUp to 3,525 mg foslevodopa per day (approx. 2,500 mg levodopa)

Medical‑Necessity Criteria

FDA-Approved Indication (Initial Authorization)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

A: Patient is diagnosed with advanced Parkinson's disease
B: Patient is experiencing 'off' episodes such as muscle stiffness, slow movements, or difficulty starting movements
'Off' episodes defined per policy
C
- i: Patient had significant intolerance to oral carbidopa/levodopa therapy, according to the prescriber
- ii: Patient had inadequate efficacy from oral carbidopa/levodopa therapy, according to the prescriber
D: Patient has previously tried or is currently receiving ONE other treatment for 'off' episodes
Examples include entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, Ongentys (opicapone), or Xadago (safinamide)
E: Medication is prescribed by or in consultation with a neurologist
Initial approval requires prescription by or consultation with a specialist

Dosing and Quantity Limits

Dosing limit for approval period

Approve up to 3,525 mg foslevodopa every day (equivalent to approximately 2,500 mg levodopa)Up to 3,525 mg foslevodopa per day

Dosing limit for approval period

Not Medically Necessary

Conditions where Vyalev is not covered

Vyalev for any use other than the FDA-approved indication described above is considered not medically necessary

Criteria will be updated as new published data are available

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is required for medical benefit coverage of Vyalev; approvals are granted for the duration specified in the policy when all criteria are met (see approval duration below).

J3490
J7356
Approval duration: 1 year

Documentation Required

Specialist involvement required

Initial approval requires Vyalev to be prescribed by or in consultation with a physician who specializes in the condition (neurologist).

Billing Rule

Use appropriate HCPCS code by effective date

Report Vyalev using the most appropriate HCPCS code by the effective date: J3490 is effective through 2025-06-30 and J7356 is effective beginning 2025-07-01.

J3490 — Unclassified drugs (Effective until 2025-06-30)
J7356 — Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg (Effective 2025-07-01)

Documentation Required

Prior treatment and intolerance/inefficacy documentation

Document the diagnosis of advanced Parkinson's disease, presence of 'off' episodes, prior trial and intolerance or inadequate efficacy of oral carbidopa/levodopa, and prior or current use of one other treatment for 'off' episodes.

Examples of other 'off' episode treatments: entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, opicapone (Ongentys), safinamide (Xadago)

Denial Risk

Not covered for off-label uses

Claims for Vyalev billed for indications other than the FDA‑approved Parkinson's Disease criteria described in the policy will be denied as not medically necessary.

Background & Evidence

Background: Vyalev is a continuous subcutaneous infusion combination of foscarbidopa and foslevodopa indicated for motor fluctuations in adults with advanced Parkinson's disease. Efficacy was evaluated in pivotal studies including a randomized, double-blind phase 3 trial and an open-label study with follow-up up to 52 weeks. Current International Parkinson and Movement Disorder Society guidelines do not yet address Vyalev.

Evidence

Definitions

Revision History

2025-04-15policy establishedLatest

Policy established as new on 04/15/2025 — New policy created for Vyalev

2025-07-01coding updateLatest

Updated coding to include HCPCS code J7356 (Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg) effective 7/1/2025 — Added HCPCS code J7356 (effective 7/1/2025)

2025-06-30coding note

J3490 (Unclassified drugs) effective until 6/30/2025 — Updated description and effective note for J3490