CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyalev (foscarbidopa/foslevodopa) Subcutaneous infusion

Clinical coverage policy for Vyalev subcutaneous infusion for advanced, levodopa-responsive Parkinson's disease for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyalev (foscarbidopa/foslevodopa) Subcutaneous infusion

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date07/01/2025

Next Review DateMar 24, 2026

Key ActionObtain prior authorization demonstrating the member meets initial criteria including specialist prescriber, ≥2.5 hours 'Off' time/day, and ≥400 mg levodopa/day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2.72 hrsmean increase in 'On' time

1.79 hrsreduction in 'Off' time

62%infusion site reactions

6 moinitial coverage

J7356HCPCS code

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Initial Therapy

Covered when ALL of the following are met:

Initial Criteria: Prescribed by, or in consultation with, a neurologist or specialist in movement disorders; member is 18 years of age or older; diagnosis of idiopathic, levodopa-responsive advanced Parkinson's disease with clearly defined 'On' periods; member experiences 'Off' periods of at least 2.5 hours per day on their current drug regimen; persistent motor fluctuations despite optimization efforts; taking ≥400 mg of levodopa per day; inadequate response or intolerable adverse event with at least two drugs from different therapeutic classes (examples: dopamine agonist such as pramipexole or ropinirole; COMT inhibitor such as entacapone or tolcapone; MAO-B inhibitor such as selegiline or rasagiline); Vyalev will be administered by a portable Vyafuser pump; Medicare members who have received this medication within the past 365 days are exempt from step therapy requirements.See thresholds (≥2.5 hours 'Off' time/day; ≥400 mg levodopa/day)

All elements required

Continuation Therapy

Continuation of therapy covered when ALL of the following are met:

Continuation Criteria: Prescribed by, or in consultation with, a neurologist or specialist in movement disorders; patient is tolerating and responding to medication (stabilization or absence of disease progression) and there continues to be a medical need for the medication.

All elements required

Use of Vyalev for dosing regimens or clinical indications that are not recognized as medically accepted (per standard compendia or peer‑reviewed literature) is considered investigational and is not covered. Requests for coverage must conform to the approved indication and dosing guidance; therapies administered at doses or for conditions outside those recognized in reference compendia will be denied as investigational.

Prior authorization is required for Vyalev and will be reviewed to confirm the request meets the policy's coverage criteria, including approved dosing limits and indication. Noncompliant use may result in non‑payment unless an exception is approved.

Coding and Dosing Parameters

Applicable HCPCS/CPT CodesHCPCS

J7356

Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg

Minimum 'Off' time

Minimum daily 'Off' time>= 2.5 hours per day

Source assessment methodAs assessed by Parkinson's Disease (PD) diaries and normalized to a daily awake period

Applies toMembers with idiopathic, levodopa-responsive advanced Parkinson's disease on current regimen

Minimum levodopa daily dose

Minimum levodopa dose/day>= 400 mg levodopa/day

Role in eligibilityRequired element of Initial Criteria to qualify for Vyalev therapy

DocumentationTotal daily levodopa dose must be recorded to calculate infusion rate

Maximum recommended daily foslevodopa

Maximum foslevodopa/day3,525 mg foslevodopa per day

Levodopa equivalenceApproximately equivalent to 2,500 mg levodopa per day

Billing unit note1 billable unit = 5.25 mg foslevodopa

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required for Vyalev

Prior authorization is required for Vyalev. Requests must demonstrate the member meets all Initial Criteria including that the drug is prescribed by or in consultation with a neurologist or movement disorders specialist, the member is ≥18 years old, has idiopathic levodopa‑responsive advanced Parkinson's disease with ≥2.5 hours/day 'Off' time, persistent motor fluctuations despite optimization, is taking ≥400 mg levodopa/day, has inadequate response or intolerance to at least two different classes of adjunctive therapies, and that Vyalev will be administered by a portable Vyafuser pump.

Provider must be a neurologist or specialist in movement disorders (prescribing or consulting).
Documentation must show all Initial Criteria elements are met prior to approval.

Step Therapy

Step therapy exemption for recent Medicare users

Medicare members who have received Vyalev within the prior 365 days are exempt from Step Therapy requirements and are not subject to the step therapy rule.

Documentation Required

Required clinical documentation and specialist involvement

Prescriber (or consulting neurologist/movement disorders specialist) must document the diagnosis of idiopathic, levodopa‑responsive advanced Parkinson's disease and that the member meets numeric thresholds and prior-treatment requirements for coverage.

Daily 'Off' time of at least 2.5 hours as assessed on current regimen.
Current total levodopa dose ≥400 mg/day (Total Levodopa Dosage used to calculate infusion rate).
Evidence of persistent motor fluctuations despite optimization and inadequate response/intolerance to at least two different classes (dopamine agonist, COMT inhibitor, MAO‑B inhibitor).
Documentation that Vyalev will be administered using a portable Vyafuser pump and dosing calculations including that maximum foslevodopa/day is 3,525 mg.

Denial Risk

Noncompliant use may be denied

Use outside the listed guidelines may result in non‑payment unless an exception is approved; coverage is reviewed prospectively via the prior authorization process.

Off‑label or investigational dosing/indications (per listed compendia) are considered investigational and not covered without an approved exception.

Background

Vyalev is a fixed‑combination of foscarbidopa and foslevodopa formulated for continuous subcutaneous infusion to treat motor fluctuations in adults with advanced, levodopa‑responsive Parkinson's disease. The foscarbidopa component acts as an aromatic amino acid decarboxylase inhibitor while foslevodopa provides levodopa replacement to reduce 'Off' time.

Efficacy was established in randomized controlled trial data demonstrating increased mean daily “On” time without troublesome dyskinesia and a reduction in mean daily “Off” time versus oral immediate‑release carbidopa‑levodopa. Common adverse events observed in studies include infusion‑site reactions and infections, hallucinations, and dyskinesias.

Dosing is individualized using the patient’s Total Levodopa Dosage (TLD) to calculate an hourly base continuous infusion rate; the product can be administered during waking hours or continuously for 24 hours and should be programmed and adjusted only by a healthcare professional. The maximum recommended daily foslevodopa dose is 3,525 mg.

Definitions and Calculations

Advanced Parkinson's disease (levodopa-responsive)

DefinitionIdiopathic Parkinson's disease in adults who respond to levodopa but have motor fluctuations inadequately controlled by current medications

Minimum 'Off' time criterionAt least 2.5 hours of 'Off' time per day as assessed by PD diaries

Age requirementAdults aged 18 years and older

Treatment contextPatients with persistent motor fluctuations despite optimization of therapy

Total levodopa dosage (TLD)

DefinitionTotal levodopa dosage (TLD) is the patient's total levodopa dose used to calculate the continuous infusion rate for Vyalev

Role in dosing formulaHourly base continuous infusion rate (mL/hr) = [(TLD x 1.3) / 240] / (number of waking hours, e.g., 16)

Use in programming pumpPrescribed dose based on TLD is programmed into the Vyalev pump by a healthcare professional; adjustments only by HCP