CurrentCignaPolicy N/A

Parkinson's Disease - Carbidopa-Levodopa (Oral) Step Therapy Policy

Defines step therapy requirements for coverage of oral carbidopa-levodopa products (generic immediate- and extended-release, Crexont, Rytary) under Cigna-administered health benefit plans; affects prescribers and pharmacy/utilization reviewers.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Carbidopa-Levodopa (Oral) Step Therapy Policy

Policy CodePolicy N/A

Change TypeMaterial operational revisions to step therapy products and automation

Effective Date

Next Review DateFeb 5, 2025

Key ActionSubmit prior authorization showing Step 1 trial or current use of Crexont/Rytary (brand or authorized generic); approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Authorized generic Rytary capsules added as a Step 2 product.

Criterion revised to approve Crexont or Rytary (brand and authorized generic) when the patient is currently taking the product.

Automation logic revised to exclude patients with a history of one Step 1 or Step 2 product within the 130-day look-back period from step therapy.

2Step levels

3Named Step 2 products

1 yearApproval duration

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Step Therapy Coverage Criteria

Covered when ALL of the following step therapy conditions are met:

Step Therapy Flow

Step 1 trial: Patient has tried at least one Step 1 product: generic immediate-release carbidopa-levodopa tablet or generic extended-release carbidopa-levodopa tablet; a prior trial of brand Sinemet also satisfies this requirement.1 trial
See Step 1 product list.
Current therapy: Patient is currently taking Crexont capsules or Rytary capsules (brand or authorized generic).current use
Allows approval/continuation of the same product.
Automation exclusion: Patient has a history of one Step 1 or one Step 2 product within the 130-day look-back period and is therefore excluded from step therapy enforcement by automation.130 days
Operational automation detail; clinical review may still apply.

The brand product Sinemet is not listed as a Step 1 or Step 2 product in this step therapy program; however, a prior trial of Sinemet (brand) satisfies the Step 1 requirement and may be used to qualify a patient for a Step 2 product. Approvals for Step 2 products are provided for 1 year when the step therapy rule is otherwise met.

Any use of Parkinson's Disease - Carbidopa-Levodopa (Oral) Step Therapy Policy products that does not meet the step therapy criteria outlined in this policy is considered not medically necessary. Coverage for Step 2 products (Crexont and Rytary, including authorized generic Rytary) requires meeting the step therapy conditions before approval; exceptions to the step sequence are limited to the specific allowances described in the policy (for example, a prior trial of brand Sinemet or current use of a Step 2 product).

Covered NDCs / Drug Products

Covered NDCs / Drug ProductsNDCCovered

NDC (various)

Multiple strengths and formulations of carbidopa-levodopa immediate- and extended-release tablets and capsules (generic, Crexont, Rytary)

Prior Authorization, Step Sequence, and Documentation Requirements

Prior Authorization

Step Therapy Prior Authorization — Step 2 products require criteria and 1-year approval

Step 2 products (Crexont capsules and Rytary capsules — brand and authorized generic) require meeting the plan's step therapy criteria for approval. All approvals are provided for a duration of 1 year.

Step Therapy

Required Step Therapy Sequence — Try Step 1 first; Sinemet and current Step 2 use qualify

A Step 1 product must be tried before a Step 2 product unless an exception applies; a prior trial of brand Sinemet satisfies the Step 1 requirement. Patients currently taking Crexont or Rytary (brand or authorized generic) may be approved for that product.

Step 1 includes generic immediate- or extended-release carbidopa-levodopa; Step 2 includes Crexont and Rytary (brand and authorized generic).
Automation excludes patients with a history of one Step 1 or Step 2 product within the 130-day look-back period from step therapy enforcement.

Key Definitions

Carbidopa‑Levodopa — definition

DefinitionCombination of an aromatic amino acid decarboxylation inhibitor (carbidopa) and levodopa used to treat Parkinson's disease, postencephalitic parkinsonism, and parkinsonism following carbon monoxide or manganese intoxication.

Formulations notedIncludes immediate- and extended-release oral formulations; extended-release tablets may be split in half but not crushed; Crexont and Rytary capsules must be swallowed whole.

IndicationsIndicated for treatment of Parkinson's disease and related parkinsonism syndromes.

Mechanism componentsCarbidopa: aromatic amino acid decarboxylation inhibitor; Levodopa: aromatic amino acid (dopamine precursor).

Clinical Background

Carbidopa-levodopa is a combination of an aromatic amino acid decarboxylation inhibitor (carbidopa) and levodopa used to treat Parkinson's disease and related parkinsonism. The policy addresses multiple formulations: immediate-release and extended-release tablets (generic) as Step 1 products, and capsule formulations such as Crexont and Rytary (brand and authorized generic) as Step 2 products. Formulation-specific handling varies by product; dosing regimens differ between immediate- and extended-release products and between tablets and capsules, and certain extended-release tablet products may have administration instructions (for example, tablets that may be split but not crushed) and capsule products that must be swallowed whole per product labeling.