DraftNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyalev (foscarbidopa/foslevodopa) Subcutaneous infusion

Clinical coverage policy governing prior authorization and medical necessity 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 TypeAdministrative — no material clinical changes

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Vyalev including documentation that initial and continuation criteria are met and include billing code J7356.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2.5 hrsminimum daily 'off' time required for eligibility

18+minimum patient age (years)

6 moinitial coverage duration

J7356applicable HCPCS/CPT code

3,525 mgmaximum daily foslevodopa dose

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Vyalev (foscarbidopa/foslevodopa)

inv-01: Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initial Criteria: The drug is being prescribed by, or in consultation with, a neurologist or a specialist in movement disorders; patient is 18 years of age or older; diagnosis of idiopathic, levodopa-responsive advanced Parkinson's Disease with clearly defined 'on' periods; patient experiences 'off' periods of at least 2.5 hours per day on their current drug regimen; persistent motor fluctuations despite optimization efforts; patient is taking ≥400 mg of levodopa per day; inadequate response or intolerable adverse event with at least two of the following drugs from different therapeutic classes: dopamine agonist (e.g., pramipexole, ropinirole), COMT inhibitor (e.g., entacapone, tolcapone), MAO-B inhibitor (e.g., selegiline, rasagiline); Vyalev is administered by a portable Vyafuser pump; Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy requirements.

All bullets in Initial Criteria must be satisfied as listed in chunk 5.

inv-02: Continuation of Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

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

See chunk 6 for exact language.

Investigational use: Therapies are considered investigational and are not covered when used at a dose or for a condition other than those recognized as medically accepted indications in standard reference compendia (e.g., AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) or supported by peer‑reviewed literature. Neighborhood does not provide coverage for drugs when used for investigational purposes.

Use of Vyalev outside the stated policy guidelines, including investigational or unapproved indications or dosing, is not covered and may be denied. Vyalev is covered under the Medical Benefit only when used within the criteria described in this policy; requests that do not meet these criteria 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

inv-06: Minimum daily 'off' time and maximum dose

Minimum daily 'off' timeOff time >= 2.5 hours per day as assessed by PD diaries

Maximum foslevodopa dose3,525 mg foslevodopa per day (maximum recommended daily dose)

Levodopa equivalent note3,525 mg foslevodopa is approximately equivalent to 2,500 mg levodopa

inv-07: Levodopa daily dose

ContextRequirement is part of initial therapy eligibility for advanced, levodopa-responsive PD

Assessment sourceDose should be documented in prior authorization request and clinical records

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for Vyalev; requests will be reviewed prospectively against the policy's initial and continuation criteria. Include the submitted billing code J7356 when requesting authorization.

Requests are reviewed via the prior authorization process.
Authorization review checks all initial and continuation criteria in the policy.
Include applicable HCPCS/CPT code (J7356) on the request.

Step Therapy

Step therapy exception for prior Medicare users

Medicare members who have previously received Vyalev within the past 365 days are exempt from the policy's Step Therapy requirements.

Prior receipt within 365 days removes Step Therapy requirement for Medicare members.

Background

Vyalev is a proprietary combination of foscarbidopa and foslevodopa indicated for treatment of motor fluctuations in adults with idiopathic, levodopa‑responsive advanced Parkinson’s disease. Efficacy was demonstrated in randomized trials showing increased daily "on" time without troublesome dyskinesia and reduced "off" time compared with oral carbidopa/levodopa. The medication is delivered as a continuous subcutaneous infusion via a portable pump; dosing is individualized using the Total Levodopa Dosage (TLD) formula and must be programmed into the Vyalev pump by a healthcare professional. The maximum recommended daily foslevodopa dose is 3,525 mg (equivalent to approximately 2,500 mg levodopa).

Definitions and Dosing Calculations

inv-13: Definition

Definition (term)Idiopathic, levodopa-responsive advanced Parkinson’s Disease with motor fluctuations

Key featuresDiagnosis of advanced PD that responds to levodopa and has clearly defined 'on' periods

Clinical trial populationEfficacy established in adults responsive to levodopa with motor fluctuations (Study 1, NCT04380142)

inv-14: TLD and infusion rate calculation

Total levodopa dosage (TLD)TLD = total daily levodopa amount used to calculate infusion rate

Hourly base continuous infusion rate formulaHourly rate (mL/hr) = [(TLD x 1.3) / 240] / (number of hours patient is typically awake, e.g., 16 hours)