CurrentCignaPolicy N/A

Duopa (carbidopa and levodopa enteral suspension) patient prior authorization

This form governs prior authorization and clinical information collection for Cigna members when requesting Duopa (carbidopa and levodopa enteral suspension) and affects prescribers, dispensing facilities, and specialty pharmacies submitting requests to Cigna.

Policy Summary

PayerCigna

PolicyDuopa (carbidopa and levodopa enteral suspension) patient prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and submit a prior authorization form (fax or electronic) with documentation of ≥3 hours of 'Off' time and prior trials of oral carbidopa/levodopa plus two alternatives.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

855-840-1678fax number to submit completed form

800-882-4462phone contact for carbidopa and levodopa enteral suspension

AccredoCigna's nationally preferred specialty pharmacy

Coverage Criteria for Duopa

Initial or continued therapy coverage criteria

Covered when ALL of the following are met:

Diagnosis related to use: advanced Parkinson's disease (or other specified) must be provided.

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Symptom burden ('Off' time): Patient is experiencing 3 or more hours of 'Off' time on their current Parkinson's disease drug treatment ('Off' time is a return of parkinsonian symptoms before the onset of the next dose).>= 3 hours

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Prior response to oral levodopa: Patient has had a previous positive clinical response to treatment with oral levodopa (e.g., Rytary, Sinemet, Sinemet CR, Stalevo) OR documentation explaining why oral carbidopa/levodopa was not tried (including reasons, contraindications, or intolerance).

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Policy Summary

PayerCigna

PolicyDuopa (carbidopa and levodopa enteral suspension) patient prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Trials of alternative therapies: Patient has tried oral carbidopa/levodopa (immediate or controlled release) and TWO other listed adjunctive alternatives (examples: entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, oral selegiline) with documentation of drug name/strength, dates taken, duration, outcomes, and any intolerances OR has documented contraindications/reasons these alternatives cannot be tried.

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The prior authorization form does not list specific population exclusions. Instead, coverage is governed by the documentation requirements on the form: confirm whether the request is a new start or continued therapy, provide evidence of prior response to oral levodopa if available, and document trials of the covered oral carbidopa/levodopa alternative and two other adjunctive therapies (or explain why these cannot be tried). Absence of these required items on the submitted form may prevent approval even though no explicit exclusion language appears on the form.

If the submitted request lacks the required clinical documentation it may be denied. Required items include documentation of ≥3 hours of 'Off' time, evidence of a prior beneficial response to levodopa for continuation requests (when applicable), and detailed records of trials of the covered oral carbidopa/levodopa and two other listed alternatives (dates, doses, durations, outcomes, and intolerances). For any alternative not tried, the form must state why it cannot be used (e.g., contraindication, intolerance, or inability to administer). Failure to provide these elements or an adequate clinical justification increases the risk of denial.

Requested Medication, Diagnosis, and Coding

Requested medication and diagnosismixed

Duopa	Duopa
ICD10	Diagnosis code field for indication (e.g., advanced Parkinson's disease)

Off time threshold — 3 or more hours

Off time thresholdPatient is experiencing 3 or more hours of 'Off' time on current Parkinson's disease drug treatment.

Threshold context'Off' time quantified as ≥ 3 hours per day while on current therapy.

Role in coverage decisionMeeting the ≥3-hour 'Off' time threshold is a required criterion for coverage approval (initial or continued therapy).

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Duopa. The prescriber must complete and submit the Cigna prior authorization form (fax) or submit via CoverMyMeds / SureScripts from the prescriber's EHR with all required clinical information.

Submit via fax with all asterisked patient/physician identifiers completed
Submit online: www.covermymeds.com or via SureScripts in EHR

Denial Risk

Documentation and Denial Risk

For continuation of therapy, documentation of a beneficial clinical response to Duopa must be provided. Lack of documentation that the patient had a beneficial response or failure to document ≥3 hours per day of 'Off' time increases risk of denial.

For continued therapy: indicate Yes/No to documented beneficial response
Document amount of daily 'Off' time (must show ≥3 hours/day) and description of symptomatic improvement

Documentation Required

Completed Prior Authorization Form Required

The prescriber must complete the prior authorization form in full. The form must include physician and patient identifiers and the clinical justification for Duopa use (diagnosis, start vs continuation, response to prior therapy, and dispensing facility information). Incomplete forms or missing identifiers may delay or prevent review.

Required patient identifiers: Cigna ID, patient name, DOB, address, phone
Required prescriber identifiers: Physician name, specialty, DEA/NPI/TIN, office contact, phone, fax
Facility/dispensing info when applicable: facility name, tax ID, address

Step Therapy

Step Therapy / Documented Trials of Alternatives

Step therapy / documented trials of alternatives are required. Provide detailed documentation of prior trials of oral carbidopa/levodopa (examples: Rytary, Sinemet, Sinemet CR, Stalevo) and of at least two other covered alternatives for 'Off' episodes, including dates, doses, duration, outcomes, and intolerances.

Documented trial of oral carbidopa/levodopa: drug name, strength, dates taken, duration, clinical outcome, and intolerances if any
Document trials of TWO alternatives (e.g., entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, oral selegiline): include drug name/strength, dates/duration, outcomes, and reasons for discontinuation/intolerance
If alternatives were not tried, provide clinical rationale or contraindication details per FDA labeling or other clinical factors

Background

Duopa (carbidopa and levodopa enteral suspension) is intended for patients with advanced Parkinson's disease who experience motor fluctuations and clinically significant "Off" time. The form asks whether the request is a new start or continued therapy, whether the patient has had a prior positive response to oral levodopa (examples: Rytary, Sinemet, Sinemet CR, Stalevo), and whether the patient is experiencing 3 or more hours of 'Off' time. It also requires documentation of trials of the covered oral carbidopa/levodopa formulation and two other adjunctive therapies (entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, oral selegiline, etc.) including dates, doses, durations, results, and any intolerances—information used to support medical necessity for Duopa.

Definitions

'Off' time definition

Definition'Off' time is defined as a return of parkinsonian symptoms before the onset of the next dose.

Assessment timingAssessed on current Parkinson's disease drug treatment to determine if ≥3 hours of 'Off' time occur.

Use in documentationProviders must document presence and duration of 'Off' time when completing the prior authorization form.