CurrentCignaPolicy CNF898

Parkinson’s Disease - Vyalev Prior Authorization Policy - (CNF898)

Defines prior authorization criteria for coverage of Vyalev for treatment of motor fluctuations ('off' episodes) in adults with advanced Parkinson's disease for Cigna-administered health benefit plans. Specifies required prescriber specialty, prior therapy attempts/intolerance, and duration of approval.

Policy Summary

PayerCigna

PolicyParkinson’s Disease - Vyalev Prior Authorization Policy - (CNF898)

Policy CodePolicy CNF898

Change TypeClarified / Revised examples

Effective Date

Next Review DateOct 22, 2026

Key ActionPrior Authorization is recommended; document diagnosis of advanced Parkinson's disease, 'off' episodes, prior carbidopa/levodopa intolerance or inadequate efficacy, trial or current use of one other treatment for 'off' episodes, and ensure prescriber is a neurologist or consults one.

SourceLink

POLICY UPDATE CHANGES

Examples of off episodes were moved to a Note.

The list of examples of treatments for Parkinson's disease off episodes was updated to remove cabergoline and to add Neupro (rotigotine transdermal system), apomorphine, Nourianz (istradefylline tablets), and amantadine.

1Covered Indications (listed)

1 yearApproval Duration

neurologistRequired Prescriber Specialty

Coverage Summary

Scope: Defines prior authorization criteria for coverage of Vyalev (foscarbidopa and foslevodopa) subcutaneous infusion for treatment of motor fluctuations ("off" episodes) in adults with advanced Parkinson's disease for Cigna-administered health benefit plans. Specifies required prescriber specialty, prior therapy attempts/intolerance, and duration of approval (policy number: CNF898).

Coverage stance: Covered with criteria — Vyalev is covered as medically necessary when the FDA‑approved indication criteria are met. Approvals are provided for 1 year and require that the medication be prescribed by or in consultation with a neurologist.

Key Policy Facts

Policy NumberCNF898

Approval Duration1 year

Required Prescriber Specialtyneurologist

Covered Indications (count)1

Coverage Criteria (Medical Necessity)

FDA-Approved Indication - Coverage Criteria

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
Examples of 'off' episodes include muscle stiffness, slow movements, or difficulty starting movements.
C - ONE of
- 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 of treatments include pramipexole, ropinirole, Neupro (rotigotine transdermal system), apomorphine, selegiline, rasagiline, Xadago (safinamide tablets), tolcapone, entacapone, Ongentys (opicapone capsules), Nourianz (istradefylline tablets), or amantadine.
E: The medication is prescribed by or in consultation with a neurologist

Conditions Not Covered

Not medically necessary when any of the following apply:

ANY of the following

Use of Vyalev for ANY other indication(s) not specified in the coverage criteria

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Vyalev; approvals are provided for 1 year and require prescriber specialty (prescribed by or in consultation with a neurologist).

Approvals are provided for 1 year
Requires that Vyalev be prescribed by or in consultation with a neurologist

Documentation Required

Document prior therapies and intolerance/efficacy

Provider must document the following to support coverage:

Diagnosis of advanced Parkinson's disease
Presence of 'off' episodes (e.g., muscle stiffness, slow movements, or difficulty starting movements)
Prior trial of oral carbidopa/levodopa with prescriber-documented significant intolerance or inadequate efficacy
Trial or current use of one other treatment for 'off' episodes

Background & Evidence

Vyalev is a continuous subcutaneous infusion of foscarbidopa and foslevodopa indicated for treatment of motor fluctuations in adults with advanced Parkinson's disease. The International Parkinson and Movement Disorder Society’s 2025 update on motor fluctuations regarded subcutaneous levodopa infusion as likely efficacious for treatment of motor fluctuations (Mov Disord. 2025 May;40(5):776-794).

Source	Citation
FDA Prescribing Information	Vyalev prescribing information, AbbVie; October 2024
Guideline Update	International Parkinson and Movement Disorder Society update on motor fluctuations, Mov Disord. 2025 May;40(5):776-794

'Off' episodes: Episodes characterized by motor symptoms such as muscle stiffness, slow movements, or difficulty starting movements.

Revision History

03/25/2026clarifiedLatest

Operational placement change of examples into a note; not a criteria change.

03/25/2026revisedLatest