CurrentCignaPolicy IP0717

Vyalev (foscarbidopa and foslevodopa) for Parkinson's disease

Defines Cigna's coverage and prior authorization requirements for Vyalev, a continuous subcutaneous infusion for motor fluctuations in adults with advanced Parkinson's disease, and who may prescribe it.

Policy Summary

PayerCigna

PolicyVyalev (foscarbidopa and foslevodopa) for Parkinson's disease

Policy CodePolicy IP0717

Change TypeNew policycoding updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the patient meets all criteria, including diagnosis of advanced Parkinson's disease, presence of 'off' episodes, prior carbidopa/levodopa trial, trial or use of one other 'off' episode treatment, and neurologist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J7356 (Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg) effective 7/1/2025.

Updated J3490 description to note the code is effective until 6/30/2025.

New policy created for Vyalev with criteria and dosing.

1 yearinitial approval duration

3,525 mgmax foslevodopa/day

J7356HCPCS added

J3490temporary code

Coverage Criteria for Vyalev

FDA-Approved Indication (Parkinson's Disease)

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

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

C: Patient has tried an oral carbidopa/levodopa therapy AND meets ONE of the following: (i) patient had significant intolerance, according to the prescriber OR (ii) patient had inadequate efficacy, according to the prescriber

D: Patient has previously tried or is currently receiving ONE other treatment for 'off' episodes (examples: entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, opicapone (Ongentys), safinamide (Xadago))

Policy Summary

PayerCigna

PolicyVyalev (foscarbidopa and foslevodopa) for Parkinson's disease

Policy CodePolicy IP0717

Change TypeNew policycoding updates

Effective Date

Next Review Date

SourceLink

On This Page

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E: Medication is prescribed by or in consultation with a neurologist

Vyalev for any other use is considered not medically necessary.

Use of Vyalev for indications other than treatment of motor fluctuations in adults with advanced Parkinson's disease is considered not medically necessary.

Coding and Dosing Limits

Considered Medically Necessary when criteria metHCPCSCovered

J3490	Unclassified drugs (Effective until 6/30/2025)
J7356	Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg (Effective Date 7/1/2025)

Coding threshold — maximum dose

Maximum daily foslevodopa3,525 mg foslevodopa per day (approve up to this daily dose)

Prescriber Requirements, Prior Authorization, and Billing Rules

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Vyalev. Approval is recommended for patients who meet the policy's Criteria and Dosing for the FDA‑approved indication (advanced Parkinson's disease with 'off' episodes). Initial approval requires Vyalev to be prescribed by or in consultation with a neurologist or a physician who specializes in the condition being treated. Approvals are provided for the duration noted in the policy (e.g., up to 1 year for the FDA‑approved indication) and extended approvals may be allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing described in the policy will be reviewed on a case‑by‑case basis by a clinician (Medical Director or Pharmacist).

Prior authorization required for Vyalev.
Initial approval: prescribed by or in consultation with a neurologist (specialist).
Approve up to duration noted in policy (e.g., 1 year for FDA‑approved indication) if all criteria are met.
Dose deviations reviewed case‑by‑case by clinician.

Denial Risk

Claims Coding Denial Risk

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate diagnosis and procedure/drug codes as of the date of service. Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this Coverage Policy.

Claims without covered codes under this policy will be denied as not covered.
Use the most appropriate and current codes when billing.
Reimbursement not allowed for services billed for non‑covered conditions/diagnoses.

Key Definitions

'Off' episodes (definition)

AssessmentConfirm patient reports or clinician documentation of recurrent "off" periods despite prior oral carbidopa/levodopa therapy or other treatments.

Vyalev (foscarbidopa and foslevodopa)

Drug descriptionVyalev — a combination continuous subcutaneous infusion of foscarbidopa and foslevodopa.

Formulation/routeContinuous subcutaneous infusion.

Background

Vyalev is a continuous subcutaneous infusion combination of foscarbidopa and foslevodopa indicated for treatment of motor fluctuations in adults with advanced Parkinson's disease. Approval is provided for 1 year when all coverage criteria are met, and dosing is permitted up to 3,525 mg foslevodopa per day (approximately 2,500 mg levodopa) administered subcutaneously.

Policy Changes and Revision History

2025-12-15annual_revision

Annual revision performed; no clinical criteria changes noted in the document.

2025-04-15policy_created_and_coding_updateLatest

New policy created for Vyalev (IP0717) and HCPCS coding updated: added J7356 effective 2025-07-01 and J3490 description noted as effective until 2025-06-30.

2025-04-15policy_created

New policy created for Vyalev (IP0717).