CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Duopa (carbidopa/levodopa) Enteral suspension

Defines medical benefit coverage and prior authorization criteria for Duopa enteral suspension for members of Neighborhood Health Plan of Rhode Island (Medicaid, Commercial, Medicare-Medicaid Plan). Applies to use via enteral infusion for advanced Parkinson's disease.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDuopa (carbidopa/levodopa) Enteral suspension

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization requests demonstrating diagnosis, specialist involvement, PEG‑J tube in place, required prior oral therapy trials, and documented ≥3 hours/day off time.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial coverage duration

12 monthscontinuation coverage duration

2000 mgmax daily dose

J7340HCPCS

>=18min age

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Coverage and Medical Necessity Criteria

Initial and continuation coverage criteria

Coverage is provided under the medical benefit when ALL of the following initial or continuation criteria are met. Prior authorization is required.

ALL of the following

ALL of the following
- ALL of the following
  - Patient is 18 years of age and older
    Documented birth date must be provided
- ALL of the following
  - Documented diagnosis of levodopa-responsive advanced Parkinson's Disease with clearly defined 'on' periods and presence of complicated motor fluctuations
    Clinical notes should describe motor fluctuations and levodopa responsiveness
ALL of the following
- ALL of the following
  - Drug prescribed by or in consultation with a neurologist or a specialist in movement disorders
    Consultation documentation required if prescribed by non-specialist
ALL of the following
- ALL of the following
  - Oral levodopa/carbidopa trial
  - Trial of a dopamine agonist
  - ONE of
    Trial of a catechol-O-methyl transferase (COMT) inhibitor
    Trial of a monoamine oxidase B (MAO-B) inhibitor
ALL of the following
- Patient experiences 'off' periods of at least 3 hours per day on current regimen>= 3 hours/day
ALL of the following
- Percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube is in place
- Duopa is administered by a CADD-legacy 1400 portable infusion pump
Step therapy exception: MMP members who have received this medication within the past 365 days are not subject to Step Therapy Requirements
ALL of the following
- Maximum recommended daily dose: 2000 mg levodopa OR 100 ml (one 100 ml cassette) administered over 16 hours<= 2000 mg levodopa / <= 100 ml per day
  Billing limit: 1 billable unit = 100 ml; maximum 28 billable units per 28 days

ALL of the following

ALL of the following
- Drug continues to be prescribed by or in consultation with a neurologist or a specialist in movement disorders
ALL of the following
- Patient is tolerating and responding to medication (stabilization or absence of disease progression) and there continues to be a medical need for the medication
  Provide clinical documentation of benefit and tolerability
ALL of the following
- Continue to adhere to maximum recommended daily dose: 2000 mg levodopa OR 100 ml per day<= 2000 mg levodopa / <= 100 ml per day
  Billing limit: maximum 28 billable units per 28 days

ALL of the following

ALL of the following
- Initial coverage authorized for 12 months
ALL of the following
- Continuation of therapy coverage authorized for 12 months

ALL of the following

Uses at doses or for conditions other than recognized medically accepted indications are investigational and not covered
Determination based on standard reference compendia or peer-reviewed literature

ALL of the following

Requests for Duopa will be reviewed prospectively via the prior authorization process and must meet the above initial or continuation criteria to be approved

Billing Codes and Units

HCPCS for DuopaHCPCSCovered

J7340

Carbidopa 5 mg/levodopa 20 mg enteral suspension

Maximum billable units per 28 days

Unit definition1 billable unit = 100 ml cassette (maximum recommended daily dose = 100 ml per day)

Maximum units per 28 days28 billable units per 28 days

Dosing schedule contextMaximum recommended daily dose corresponds to 2000 mg levodopa administered over 16 hours (1 cassette/day)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Coverage of Duopa (carbidopa/levodopa) is reviewed prospectively via prior authorization. Requests must include clinical documentation demonstrating diagnosis and prior therapies; prescriptions should be by or in consultation with a neurologist or movement disorders specialist.

Affected product: Duopa (carbidopa/levodopa)
Prescriber requirement: Neurologist or movement disorders specialist involvement
Required documentation: Diagnosis of levodopa‑responsive advanced Parkinson’s disease, details of 'on'/'off' periods, prior medication history, PEG‑J tube placement, pump type

Denial Risk

Denial Risk for Use Outside Guidelines

Use of Duopa outside the criteria (e.g., non‑levodopa‑responsive Parkinson’s, insufficient prior therapy, lack of specialist involvement, or missing required documentation) may result in denial or non‑payment unless an exception is approved.

Key Terms and Device Definitions

Drug definition

Drug nameCombination carbidopa and levodopa enteral suspension (Duopa)

Indication summaryIndicated for treatment of motor fluctuations in patients with advanced Parkinson's disease

Clinical effectShown to decrease mean 'Off' time and increase 'On' time without troublesome dyskinesia compared with immediate‑release oral therapy

levodopa-responsive advanced Parkinson's Disease

DefinitionLevodopa‑responsive advanced Parkinson's Disease: advanced Parkinson's disease with levodopa‑responsive symptoms and clearly defined 'on' periods and complicated motor fluctuations

Required symptom severityPatient experiences 'off' periods of at least 3 hours per day on current regimen