ModifiedAnthemPolicy CC-0035

Duopa (carbidopa and levodopa enteral suspension)

Defines medical necessity criteria for initial and continuation coverage of Duopa enteral suspension for advanced Parkinson's disease, lists contraindications and relevant billing/coding information (HCPCS J7340, ICD-10 G20.A1-G20.C).

Policy Summary

PayerAnthem

PolicyDuopa (carbidopa and levodopa enteral suspension)

Policy CodePolicy CC-0035

Change TypeRevised (annual review updates)

Effective DateOct 24, 2025

Next Review Date

Key ActionProvide documentation of diagnosis, PEG-J or naso-jejunal administration, prior optimal medical therapy trials (oral levodopa-carbidopa, dopamine agonist, and one agent from COMT inhibitor, MAO-B inhibitor, or adenosine receptor antagonist) and for continuation, document clinically significant improvement (increased on-time and decreased off episodes).

SourceLink

POLICY UPDATE CHANGES

Updated continuation verbiage to align with other Parkinson's agents and administrative update to add documentation; updated HCPCS J7340 description and ICD-10 range from G20 to G20.A1-G20.C.

Added continuation requirements previously in 08/19/2022 and added adenosine receptor antagonist (Nourianz) to initial therapy per meeting amendment.

2Therapy phases covered (Initial, Continuation)

J7340Primary HCPCS code

3Required prior medication classes

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Coverage Summary

Defines medical necessity criteria for both initial and continuation coverage of Duopa (carbidopa/levodopa enteral suspension) for advanced Parkinson's disease. Initial coverage requires: diagnosis of advanced PD with complicated motor fluctuations; administration via PEG-J or naso-jejunal tube; and documentation of inadequate control with optimal medical therapy including oral levodopa-carbidopa, a dopamine agonist, and one agent from COMT inhibitor, MAO-B inhibitor, or adenosine receptor antagonist (Nourianz).

Continuation coverage requires documentation of clinically significant improvement or stabilization defined as an increase of on-time with a decrease in the number of off episodes compared to baseline. Contraindications/exclusions include concurrent use of a nonselective MAO inhibitor (e.g., phenelzine, tranylcypromine), diagnosis of atypical or secondary Parkinson's disease, or failure to meet the listed criteria. Relevant billing/coding information: HCPCS J7340 and ICD-10 range G20.A1-G20.C.

Policy metadata

policy_numberCC-0035

subjectDuopa (carbidopa and levodopa enteral suspension)

coverage_stancecovered_with_criteria

effective_date2025-10-24

last_review2025-09-08

therapy_phases_coveredInitial, Continuation

Initial Therapy Criteria

Initial Therapy

Initial requests for Duopa may be approved if ALL of the following are met:

ALL of the following

Individual has a diagnosis of advanced Parkinson's disease (PD) with complicated motor fluctuations
Individual is using via a percutaneous endoscopic gastrostomy with jejunal tube (PEG-J) or naso-jejunal tube
Optimal medical therapy
- Oral levodopa-carbidopa
- Dopamine agonists
- ONE of the following adjunct agents

Continuation Therapy Criteria

Continuation Therapy

Continuation requests may be approved if ALL of the following are met:

ALL of the following

Documentation is provided that there is clinically significant improvement or stabilization in clinical signs and symptoms of disease
Improvement/stabilization defined as an increase of on-time with a decrease in the number of off episodes compared to baseline
See definitions for on-time and off episodes

On-time refers to periods when medication controls PD symptoms; off episodes refer to periods of reduced symptom control, including end-of-dose wearing off and unpredictable on/off episodes. These measures (on-time increase and decreased number of off episodes) are the basis for assessing clinically significant improvement for continuation requests.

Not Approved / Contraindications / Exclusions

Duopa may not be approved for the following:

ANY of the following

Individual is receiving a nonselective MAO inhibitor (including but not limited to phenelzine or tranylcypromine)
Contraindicated concurrent medications
Individual has a diagnosis of atypical Parkinson's disease or secondary Parkinson's disease
When the above criteria are not met and for all other indications
General not-meeting-criteria exclusion

Applicable Codes

Drug HCPCSHCPCS

J7340

Carbidopa 5 mg/levodopa 20 mg enteral suspension, 100 ml [Duopa]

Relevant Diagnosis Codes (informational)ICD-10

G20.A1-G20.C

Parkinson's disease

Prior Authorization

Prior authorization required based on medical necessity criteria

Initial and continuation prior authorization requests require documentation supporting the medical necessity criteria. For initial requests provide evidence of diagnosis of advanced Parkinson's disease with complicated motor fluctuations, documentation of administration via PEG-J or naso-jejunal tube, and records showing trials of optimal medical therapy (oral levodopa-carbidopa, a dopamine agonist, and one agent from COMT inhibitor, MAO-B inhibitor, or adenosine receptor antagonist). For continuation requests provide documentation of clinically significant improvement or stabilization (increased on-time with decreased number of off episodes compared to baseline).

J7340

Documentation Required

Documentation of administration route

Provider must document that Duopa is administered via a percutaneous endoscopic gastrostomy with jejunal tube (PEG-J) or via a naso-jejunal tube to meet the route requirement for coverage.

Clinical Evidence

Key trial citation: Lancet Neurol. 2014;13(2):141-149 randomized controlled study of continuous intrajejunal infusion.

Background

Duopa is a carbidopa/levodopa enteral suspension administered via PEG-J or naso-jejunal tube for advanced Parkinson's disease with complicated motor fluctuations. It is indicated when motor symptoms are not controlled with optimized oral therapy and adjunct agents and is used to manage increased off periods and motor fluctuations despite prior combination therapy.

Definitions

On-time / Off episodesOn-time refers to periods when medication controls Parkinson's disease symptoms; off episodes refer to periods of reduced symptom control, including end-of-dose wearing off and unpredictable on/off episodes.

Revision History

09/08/2025material_revisionLatest

Annual review updated continuation verbiage to align with other Parkinson's agents, added an administrative documentation requirement, updated the HCPCS J7340 description, and replaced ICD-10 range G20 with G20.A1-G20.C.

08/19/2022material_revision

Annual review added continuation requirements and added the adenosine receptor antagonist (Nourianz) to the initial therapy adjunct options per meeting amendment.

Provider Actions

Prior Authorization

Prior authorization required based on medical necessity criteria

Initial and continuation prior authorization requests require documentation demonstrating diagnosis, PEG-J or naso-jejunal administration route, prior optimal medical therapy trials, and for continuation, documentation of clinically significant improvement (increased on-time and decreased off episodes).

Diagnosis of advanced Parkinson's disease with complicated motor fluctuations
Administration route documented (PEG-J or naso-jejunal tube)
Prior medication trials: oral levodopa-carbidopa; dopamine agonist; and one agent from COMT inhibitor, MAO-B inhibitor, or adenosine receptor antagonist
Continuation evidence: clinically significant improvement or stabilization (increased on-time and decreased off episodes)
J7340

Denial Risk

Contraindicated concurrent medications

Requests should be denied if the member is receiving a nonselective MAO inhibitor due to contraindication.

Use of nonselective MAO inhibitors (including phenelzine or tranylcypromine) is a contraindication and may result in denial.