CurrentmhnPolicy CP.PMN.238

Carbidopa/Levodopa ER (Crexont, Rytary), Duopa, Dhivy, and Foscarbidopa/Foslevodopa (Vyalev) Clinical Policy

Medical necessity and prior authorization criteria for Crexont, Rytary, Duopa, Dhivy, and Vyalev for treatment of Parkinson's disease and related parkinsonism across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyCarbidopa/Levodopa ER (Crexont, Rytary), Duopa, Dhivy, Vyalev — Coverage Criteria

Policy CodePolicy CP.PMN.238

Change TypeAnnual review — no material changes

Effective DateSep 1, 2020

Next Review DateAug 25, 2025

Key ActionProvider must submit clinical documentation demonstrating the member meets product-specific criteria (diagnosis, age ≥18, product requested, dose limits, and prior therapy/intolerance) for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5product-specific initial criteria groups

12 moapproval duration

≥18minimum age

5products described

J7356HCPCS code

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

Initial Approval — Crexont or Rytary

Covered when ALL of the following are met

Crexont/Rytary Initial: 1. Diagnosis of Parkinson disease (PD) or parkinsonism; 2. Request is for Crexont or Rytary; 3. Age ≥ 18 years; 4. Documented intolerance or contraindication to carbidopa-levodopa sustained release tablets (Sinemet CR) that would NOT apply to Crexont or Rytary (examples: inability to swallow tablets, intolerance to excipients); Note: Failure of Sinemet CR alone is NOT an acceptable rationale for use of Crexont or Rytary; 5. Requested dose does not exceed product-specific maximums (Crexont: carbidopa 525 mg / levodopa 2,100 mg per day; Rytary: carbidopa 612.5 mg / levodopa 2,450 mg per day).

Prior authorization required; provider must submit documentation supporting criteria

Initial Approval — Duopa or Vyalev

Covered when ALL of the following are met

Duopa/Vyalev Initial: 1. Diagnosis of Parkinson disease (PD); 2. Request is for Duopa or Vyalev; 3. Prescribed by or in consultation with a neurologist; 4. Age ≥ 18 years; 5. Demonstrated clear responsiveness to levodopa; 6. Member is experiencing required motor fluctuation threshold (Duopa: ≥3 hours of 'off' time per waking day; Vyalev: ≥2 hours of 'off' time per waking day); 7. Failure of at least two anti-Parkinson agents from different therapeutic classes (unless clinically significant adverse effects or contraindications): a) MAO‑B inhibitor (e.g., rasagiline); b) COMT inhibitor (e.g., entacapone, tolcapone); c) Dopamine agonist (e.g., ropinirole, pramipexole); 8. For Duopa requests, placement of a procedurally-placed tube (PEG‑J) has been completed or is planned; 9. Requested dose does not exceed product-specific maximums (Duopa: levodopa 2,000 mg per day; Vyalev: foslevodopa 3,525 mg per day).

Step therapy requirements may be bypassed per state-specific rules (e.g., IL HB 5395)

Initial Approval — Dhivy

Covered when ALL of the following are met

Dhivy Initial: 1. Diagnosis of Parkinson disease (PD) or parkinsonism; 2. Request is for Dhivy; 3. Age ≥ 18 years; 4. Member must use generic carbidopa-levodopa unless contraindicated or clinically significant adverse effects are experienced; 5. Requested dose does not exceed carbidopa 200 mg / levodopa 800 mg per day.

Prior authorization required; known hypersensitivity to product components is a contraindication

Continuation Therapy

Covered when ALL of the following are met

Continuation: 1. Member meets one of the following: a) Currently receiving the medication via the Centene benefit or previously met initial approval criteria; or b) Member is receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If a dose increase is requested, the new dose does not exceed product-specific maximums (Crexont: carbidopa 525 mg/levodopa 2,100 mg/day; Rytary: carbidopa 612.5 mg/levodopa 2,450 mg/day; Duopa: levodopa 2,000 mg/day; Dhivy: carbidopa 200 mg/levodopa 800 mg/day; Vyalev: foslevodopa 3,525 mg/day).

Provider must submit documentation demonstrating continued benefit; prior authorization required for renewal

Product dosing / administration criteria

Product-specific dosing and maximum dose guidance (used to support medical necessity and appropriate administration):

Crexont dosing: Levodopa‑naïve starting dose: 35 mg/140 mg PO twice daily for first 3 days; may be increased as needed to a maximum daily dose of carbidopa 525 mg / levodopa 2,100 mg divided up to 4 times daily.max carbidopa 525 mg / levodopa 2,100 mg/day

See prescriber information for conversion from immediate‑release formulations

Rytary dosing: Levodopa‑naïve starting dose: 23.75 mg/95 mg PO three times daily; may increase (e.g., to 36.25 mg/145 mg TID on day 4) and titrate up to carbidopa 97.5 mg/levodopa 390 mg TID with frequency up to 5 times daily as tolerated; maximum daily dose carbidopa 612.5 mg / levodopa 2,450 mg/day. Dosages are not interchangeable on a 1:1 basis with other formulations.max carbidopa 612.5 mg / levodopa 2,450 mg/day

Duopa dosing: Administered as a 16‑hour enteral infusion composed of a morning dose, a continuous dose, and extra doses; extra dose function initially set at 1 mL (20 mg levodopa) and may be adjusted in 0.2 mL increments; extra dose frequency limited to one extra dose every 2 hours; maximum recommended daily dose is 2,000 mg of the levodopa component (one cassette) per 16‑hour infusion.

Non‑FDA indications that are not specifically addressed by this policy are not authorized for coverage unless the provider supplies sufficient supporting documentation of safety and efficacy and the request is acceptable under the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

The policy lists concomitant use of nonselective monoamine oxidase (MAO) inhibitors (for example, phenelzine or tranylcypromine), or recent use within the prior 2 weeks, as a contraindication.

Requests that do not meet the product‑specific inclusion criteria are considered not medically necessary. Applicable criteria include diagnosis, age (all products require ≥18 years), product requested, required prior therapies or documented intolerances, procedural requirements for enteral therapy (Duopa), and adherence to product‑specific maximum dose limits.

Known hypersensitivity to any component of the product is a contraindication for use of Dhivy. Members with documented allergy or hypersensitivity to Dhivy ingredients should not receive the product.

Coding

Drug codes (NDCs not specified in excerpt)NDC

NDC	Not listed explicitly in this document excerpt

HCPCS Codes (referenced)HCPCS

J7356

Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg (Vyalev)

Maximum daily dose limits

Crexont maximum daily doseCarbidopa 525 mg / Levodopa 2,100 mg per day

Rytary maximum daily doseCarbidopa 612.5 mg / Levodopa 2,450 mg per day

Dhivy maximum daily doseCarbidopa 200 mg / Levodopa 800 mg per day

Duopa maximum daily doseLevodopa 2,000 mg per day (one cassette; 16‑hour infusion)

Off time threshold

Duopa off time thresholdMotor fluctuations: ≥3 hours of 'off' time per waking day

Vyalev off time threshold

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Crexont, Rytary, Duopa, Dhivy, and Vyalev. Submit clinical documentation (office notes, labs, consults) supporting that the member meets all approval criteria. Claims may be denied if required prior authorization is not obtained.

Applies to requests for Crexont, Rytary, Duopa, Dhivy, and Vyalev
Provider must submit supporting documentation (office chart notes, lab results, other clinical information)

Step Therapy

Step Therapy Requirements for Duopa and Vyalev

Step therapy is required for Duopa and Vyalev: member must have failed at least two anti-Parkinson agents from different therapeutic classes unless clinically significant adverse effects are experienced or all are contraindicated. For Duopa, procedural placement of the infusion tube must be completed or planned. Document demonstrated responsiveness to levodopa and the specified minimum daily 'off' time.

Required failures: at least two agents from different classes (example classes: MAO-B inhibitor, COMT inhibitor, dopamine agonist)

Background

Carbidopa‑levodopa combinations and the foscarbidopa/foslevodopa prodrug provide levodopa delivered with a peripheral decarboxylase inhibitor (carbidopa or the foscarbidopa prodrug) to increase central availability of levodopa for treatment of Parkinson disease and related parkinsonism. Formulations described in the policy include extended‑release oral capsules (Crexont, Rytary), immediate‑release tablets (Dhivy), an enteral jejunal suspension delivered via PEG‑J and portable pump (Duopa), and a subcutaneous foscarbidopa/foslevodopa infusion system (Vyalev). Product selection and authorization depend on the clinical indication (general PD versus advanced motor fluctuations), demonstrated levodopa responsiveness, required off‑time thresholds for infusion therapies, and adherence to product‑specific dosing and maximum daily limits.

Definitions

Duopa — definition and administration summary

FormulationDuopa is an enteral suspension of carbidopa/levodopa administered directly into the jejunum

Route and deviceDelivered via percutaneous endoscopic gastrostomy with jejunal tube (PEG‑J) or short‑term naso‑jejunal prior to PEG‑J

Administration scheduleInfused with a portable infusion pump over a 16‑hour daily period (morning, continuous, and extra doses)

Vyalev — definition and prodrug description

CompositionVyalev is a prodrug combination of foscarbidopa and foslevodopa that is converted in vivo to carbidopa and levodopa

IndicationIndicated for motor fluctuations in patients with advanced Parkinson's disease

Policy Summary

Payermhn

PolicyCarbidopa/Levodopa ER (Crexont, Rytary), Duopa, Dhivy, Vyalev — Coverage Criteria

Policy CodePolicy CP.PMN.238

Change TypeAnnual review — no material changes

Effective DateSep 1, 2020

Next Review DateAug 25, 2025

SourceLink

On This Page

max 2,000 mg levodopa/day

Initiation involves conversion to immediate‑release tablets, calculation of starting Duopa doses, and titration per response

Dhivy dosing: Levodopa‑naïve starting dose: 25 mg/100 mg PO three times daily; may increase by one tablet daily or every other day as needed; maximum daily dose carbidopa 200 mg / levodopa 800 mg per day.max carbidopa 200 mg / levodopa 800 mg/day

Vyalev dosing: Initiation requires calculating the total levodopa dose being replaced (convert all levodopa formulations to immediate‑release levodopa), multiply the total levodopa dosage by 1.3 to obtain the Vyalev foslevodopa mg, divide that value by 240 to determine total daily mL, then divide by the number of awake hours to determine the hourly base continuous infusion rate; an optional loading dose may be used; extra dose usage limited (no more than 1 extra dose per hour); maximum recommended daily foslevodopa component is 3,525 mg/day.max foslevodopa 3,525 mg/day

Documentation of calculated total levodopa and infusion parameters is required when initiating Vyalev

Motor fluctuations: ≥2 hours of 'off' time per waking day

Definition source'Off time' = return of PD symptoms (bradykinesia, rest tremor, rigidity) when L‑dopa effect wears off

Maximum daily infusion dosages

Duopa infusion maximumMaximum recommended daily dose: 2,000 mg levodopa per day administered over a 16‑hour infusion (one cassette)

Vyalev infusion maximumMaximum recommended daily dose: 3,525 mg of the foslevodopa component per day

Duopa extra dose limitsExtra dose function initial setting 1 mL (20 mg levodopa); adjust in 0.2 mL increments; limit one extra dose every 2 hours

Duopa-specific: motor fluctuations ≥ 3 hours off per waking day; tube placement completed or planned; max levodopa component 2,000 mg/day

Vyalev-specific: motor fluctuations ≥ 2 hours off per waking day; max foslevodopa component 3,525 mg/day

Document clear responsiveness to levodopa

Note

Step Therapy Bypass Note (Illinois HIM)

Step therapy requirements do not apply to Illinois HIM requests effective 01/01/2026 per IL HB 5395. When requesting an IL HIM review, note the statutory bypass and include relevant jurisdictional information.

IL HIM (Illinois Health Insurance Marketplace) — step therapy bypass effective 01/01/2026 per IL HB 5395
Operational note: include jurisdiction and indication when submitting to ensure the bypass is considered

Billing Rule

Prior Authorization and Coding

Coding implications: when applicable use HCPCS code J7356 for foscarbidopa/foslevodopa (Vyalev). Claims may be denied if correct HCPCS coding is not used.

HCPCS: J7356 — Injection, foscarbidopa 0.25 mg/foslevodopa 5 mg (Vyalev)
Providers should reference up-to-date professional coding guidance prior to claim submission

Documentation Required

Documentation and Denial Risk

Insufficient documentation or requests for non‑FDA indications without adequate off‑label justification may result in denial. Providers must calculate and document the total levodopa dosage (TLD) when initiating Vyalev or Duopa per dosing conversion instructions.

Calculate and document TLD and conversion steps for Vyalev (convert to immediate‑release levodopa equivalent, multiply by 1.3, determine mL and hourly rate)
For Duopa, document starting dose calculation and titration steps and total daily levodopa component
Non‑FDA indications require sufficient documentation per off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Conversion guidanceTotal levodopa replaced should be converted to immediate‑release levodopa equivalents to calculate Vyalev dosing (multiply by 1.3 to get foslevodopa mg)

Off time / motor fluctuations definition

Definition'Off time' or motor fluctuations are periods when Parkinson's disease symptoms (bradykinesia, rest tremor, rigidity) return as the L‑dopa effect wears off

Clinical distinction'Off' episodes result from insufficient levodopa, whereas dyskinesia typically results from excess levodopa

Relation to therapyMotor fluctuations are the alternation between 'on' time (symptom control) and 'off' time and are an indication for Duopa or Vyalev when thresholds met

Duopa administration — PEG-J, pump, 16-hr infusion summary

Route and accessAdministered into the jejunum via PEG‑J (naso‑jejunal possible short term) using a portable infusion pump (CADD®‑Legacy 1400 referenced)

Infusion periodDelivered as a 16‑hour daily infusion composed of a morning dose, continuous base dose, and programmable extra doses

Patient managementPatients disconnect after the 16‑hour infusion and take an oral immediate‑release carbidopa‑levodopa night dose; initiation includes conversion, calculation of starting doses, and titration

Vyalev administration — Vyafuser subcutaneous infusion summary

Delivery systemVyalev is administered subcutaneously using the Vyafuser pump over the patient's waking hours or continuously for 24 hours

Dosing calculationDetermine total levodopa replaced (convert to IR levodopa), multiply by 1.3 to get foslevodopa mg, divide by 240 to get total daily mL, then divide by awake hours for hourly infusion rate

Maximum daily doseMaximum recommended daily dosage is 3,525 mg of the foslevodopa component