CurrentCareSourcePolicy N/A

Vyalev (foscarbidopa/foslevodopa) — Prior Authorization and Coverage Criteria

Defines prior authorization, coverage criteria, dosing limits, and prescriber requirements for Vyalev subcutaneous infusion to treat motor fluctuations in adults with advanced Parkinson's disease for CareSource members.

Policy Summary

PayerCareSource

PolicyVyalev (foscarbidopa/foslevodopa) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 30, 2024

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with a neurologist; approvals are for up to 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard approval duration

3,525 mg/daymax foslevodopa dose

neurologistprescriber requirement

adult ≥30trial population

Recommended Authorization Criteria

FDA-Approved Indication — Parkinson's Disease

Policy Summary

PayerCareSource

PolicyVyalev (foscarbidopa/foslevodopa) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 30, 2024

Key ActionObtain prior authorization and ensure the medication is prescribed by or in consultation with a neurologist; approvals are for up to 1 year when criteria are met.

SourceLink

On This Page

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Initial FDA-approved indication criteria

A) Diagnosis: Patient is diagnosed with advanced Parkinson's disease.
B) Symptoms: Patient is experiencing 'off' episodes such as muscle stiffness, slow movements, or difficulty starting movements.
C) Prior oral carbidopa/levodopa therapy
- ONE of the following (prescriber assessment)
  - i: Patient had significant intolerance to oral carbidopa/levodopa, according to the prescriber.
  - ii: Patient had inadequate efficacy with oral carbidopa/levodopa, according to the prescriber.
D) Other 'off' episode treatment: Patient has previously tried or is currently receiving ONE other treatment for 'off' episodes (examples include entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, opicapone [Ongentys], or safinamide [Xadago]).
E) Prescriber specialty: Medication is prescribed by or in consultation with a neurologist.
Authorization duration and dosing: Approve for up to 1 year; dosing up to 3,525 mg foslevodopa per day (approximately 2,500 mg levodopa).<= 3,525 mg/day
Dose equivalence and approval duration per policy.

Operational note: Prior authorization is required; requests that do not meet these criteria or are for circumstances not listed may be denied.

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required; approvals up to 1 year

Prior authorization is required for Vyalev. When the patient meets all listed criteria, approvals are recommended for up to 1 year. Requests for doses outside the dosing documented in this policy will be reviewed on a case‑by‑case basis by a clinician; extended approvals are allowed if the patient continues to meet criteria.

Approvals provided for 1 year when ALL criteria are met.
Dose-exception requests reviewed case-by-case by a clinician (Medical Director or Pharmacist).

Step Therapy

Prior therapies required before approval

Patient must have tried an oral carbidopa/levodopa therapy and, per the prescriber, either had significant intolerance or experienced inadequate efficacy. In addition, the patient must have previously tried or currently be receiving one other treatment for 'off' episodes (examples listed in policy).

Tried oral carbidopa/levodopa and met ONE of: significant intolerance (per prescriber) OR inadequate efficacy (per prescriber).
Tried or currently receiving ONE other treatment for 'off' episodes (e.g., entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, opicapone, safinamide).

Documentation Required

Prescriber specialty / consultation required for initial approval

Initial approval requires the medication to be prescribed by or in consultation with a neurologist (a physician who specializes in Parkinson's disease). Consultation or documentation of the specialist involvement should be included with the request.

Vyalev must be prescribed by or in consultation with a physician who specializes in the condition being treated (neurologist).
Specialist consultation or prescribing documentation should be submitted with the prior authorization request.

Denial Risk

Denial risk if criteria not met

Requests that do not meet the Recommended Authorization Criteria or that are for circumstances not listed in the criteria may be denied.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Drug and Symptom Definitions

Vyalev

DefinitionVyalev is a continuous subcutaneous infusion combination of foscarbidopa and foslevodopa indicated for motor fluctuations in adults with advanced Parkinson's disease.

FormulationContinuous subcutaneous infusion combination product (foscarbidopa/foslevodopa)

Indication contextUsed to treat motor fluctuations ('off' episodes) in advanced Parkinson's disease patients

'Off' episodes

Definition of 'Off' episodesMotor fluctuations such as muscle stiffness, slow movements (bradykinesia), or difficulty initiating/starting movements (akinesia)

Clinical relevance'Off' episodes are the target symptom cluster for Vyalev therapy in advanced Parkinson's disease

ExamplesMuscle stiffness; slow or reduced movement speed; difficulty starting movements

OpenPayer

Vyalev (foscarbidopa/foslevodopa) — Prior Authorization and Coverage Criteria

Recommended Authorization Criteria

Authorization, Documentation, and Prescriber Requirements

Dosing Limits and Coding Notes

Drug and Symptom Definitions

Clinical Background