CurrentCignaPolicy IP0523

Parkinson's Disease - Carbidopa

Defines prior authorization and coverage criteria for carbidopa (Lodosyn and generic carbidopa tablets) for Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism for Cigna-administered health benefit plans; includes preferred product rules for Employer and Individual/Family plans and prescriber specialty requirement.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Carbidopa

Policy CodePolicy IP0523

Change TypeClarified; Revised preferred product criteria

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior Authorization is required for carbidopa; approvals are for 1 year and require prescription by or consultation with a neurologist.

POLICY UPDATE CHANGES

Updated wording from 'Currently receiving levodopa-based treatment' to 'Patient is currently receiving carbidopa/levodopa therapy'.

Updated preferred product table language to require trial of bioequivalent generic carbidopa tablet and inability to take it due to inactive ingredient differences causing significant allergy or serious adverse reaction.

3Covered Indications (FDA-listed)

1 yearApproval Duration

Coverage Summary

Defines prior authorization and coverage criteria for carbidopa (Lodosyn and generic carbidopa tablets) for Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism. Approvals are provided for 1 year and require that carbidopa be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist). Coverage includes preferred product rules for Employer and Individual/Family plans regarding brand versus bioequivalent generic products.

Initial Therapy Criteria (FDA-Approved Indications)

FDA-Approved Indications (Approval for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is currently receiving carbidopa/levodopa therapy
B: The medication is prescribed by or in consultation with a neurologist
C: Preferred product criteria is met for the product as listed in the preferred product tables

Preferred Product Criteria — Employer Plans (Brand Exception)

Preferred Product Criteria — Employer Plans (Lodosyn brand exception)

Approve brand Lodosyn when ALL of the following are met:

ALL of the following

1: Patient has tried the bioequivalent generic product carbidopa tablet
2: Patient cannot take the bioequivalent generic product due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the brand and the bioequivalent generic product which would result, per the prescriber, in a significant allergy or serious adverse reaction
Prescriber must attest that the formulation difference would result in significant allergy or serious adverse reaction

Preferred Product Criteria — Individual & Family Plans (Brand Exception)

Preferred Product Criteria — Individual and Family Plans (Lodosyn brand exception)

Approve brand Lodosyn when ALL of the following are met:

ALL of the following

1: Patient has tried the bioequivalent generic product carbidopa tablet
2: Patient cannot take the bioequivalent generic product due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the brand and the bioequivalent generic product which would result, per the prescriber, in a significant allergy or serious adverse reaction
Prescriber must attest that the formulation difference would result in significant allergy or serious adverse reaction

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior Authorization is required for prescription benefit coverage of carbidopa. All approvals are provided for 1 year. Approval requires that carbidopa be prescribed by or in consultation with a physician who specializes in the condition being treated (neurologist).

Approval duration = 1 year
Prescriber specialty = neurologist

Documentation Required

Documentation of trial and intolerance to generic

For coverage of brand Lodosyn under Employer and Individual/Family plans, the provider must document a trial of the bioequivalent generic carbidopa tablet and that the patient cannot take the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction. The prescriber must attest to the intolerance related to the inactive ingredient difference.

Employer plan applicability: trial of bioequivalent generic required; brand exception only if generic cannot be taken due to inactive ingredient difference causing significant allergy or serious adverse reaction
Individual/Family plan applicability: trial of bioequivalent generic required; brand exception only if generic cannot be taken due to inactive ingredient difference causing significant allergy or serious adverse reaction

To request a brand exception for Lodosyn, submit prior authorization documentation including a prescriber attestation and clinical documentation showing the patient has tried the bioequivalent generic carbidopa tablet and cannot take it due to a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that the prescriber states would cause a significant allergy or serious adverse reaction. Prior authorization approvals are issued for 1 year and require the drug to be prescribed by or in consultation with a specialist (neurologist).

Clinical Evidence & References

Prescribing information: Lodosyn tablets prescribing information, Bausch Health; July 2020. Coverage aligns with FDA-approved indications and approves therapy for patients meeting the listed criteria for the approved indications.

Preferred product criteria definition: plan-specific requirement that defines when a brand product is covered instead of the bioequivalent generic, requiring trial of the bioequivalent generic carbidopa tablet and documented inability to take the generic due to inactive ingredient differences causing a significant allergy or serious adverse reaction.

Background

Carbidopa is an aromatic amino acid decarboxylation inhibitor indicated for use with levodopa for idiopathic Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism. Coverage policies guide the administration of benefits and require adherence to plan terms, including prior authorization and specialty prescriber requirements.

Revision History

2024-07-01annual_review

Annual Review dated 7/1/2024 updated wording from 'Currently receiving levodopa-based treatment' to 'Patient is currently receiving carbidopa/levodopa therapy' and moved step-through generic language to preferred product tables.

2025-06-01annual_revisionLatest

Annual Revision dated 6/1/2025 updated preferred product table language to require trial of the bioequivalent generic carbidopa tablet and documentation that the patient cannot take the generic due to formulation differences in inactive ingredients (e.g., dyes, fillers, preservatives) causing a significant allergy or serious adverse reaction.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Carbidopa

Policy CodePolicy IP0523

Change TypeClarified; Revised preferred product criteria

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior Authorization is required for carbidopa; approvals are for 1 year and require prescription by or consultation with a neurologist.

On This Page

OpenPayer

Parkinson's Disease - Carbidopa

Coverage Summary

Initial Therapy Criteria (FDA-Approved Indications)

Preferred Product Criteria — Employer Plans (Brand Exception)

Preferred Product Criteria — Individual & Family Plans (Brand Exception)

Not Medically Necessary / Exclusions

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History