CurrentMass General Brigham Health PlanPolicy N/A

Carbidopa/Levodopa Extended‑Release Formulations

This policy governs prior authorization for Rytary and Crexont (carbidopa/levodopa extended‑release) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCarbidopa/Levodopa Extended‑Release Formulations

Policy CodePolicy N/A

Change TypeMaterial updates (added Crexontremoved certain trial and paid‑claim requirements)

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization under the pharmacy benefit and document diagnosis plus prior inadequate response or adverse reaction to another oral carbidopa/levodopa product (and for Crexont, prior inadequate response or adverse reaction to Rytary).

SourceLink

POLICY UPDATE CHANGES

Crexont was added to the policy and the title was updated to 'Carbidopa/Levodopa Extended‑Release Formulations.'

The trial requirement with non‑carbidopa/levodopa products was removed.

Requirement for paid claims to document inadequate response with another carbidopa/levodopa product was removed.

12 monthsInitial and reauthorization approval duration

90 daysGrace period for new members

2Named formulations covered

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Coverage and Authorization Criteria

Initial Therapy

Authorization may be granted when ALL the following criteria are met:

Initial Authorization: 1) Member has ONE of the following diagnoses: a. Parkinson disease; b. Postencephalitic parkinsonism; c. Symptomatic parkinsonism following carbon monoxide and/or manganese intoxication.

Therapeutic history: 2) Member has had an inadequate response or adverse reaction to another oral carbidopa/levodopa product (immediate‑release or extended‑release).

Crexont specific: 3) For requests for Crexont: member has had an inadequate response or adverse reaction to Rytary.

New-to-plan allowance: Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication, except when the product was obtained only as samples or via the manufacturer's patient assistance programs.

Continuation of Therapy

Requests for reauthorization will be granted when the following criterion is met:

Reauthorization: Member has demonstrated a positive clinical response to therapy.

Members who are new to the plan within the past 90 days and are currently receiving the requested carbidopa/levodopa extended‑release medication may be authorized without meeting other initial‑use criteria, provided the medication was not obtained solely as samples or through a manufacturer's patient assistance program. This 90‑day allowance does not apply when the drug was supplied only via samples or assistance programs.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members. Submit prior authorization requests to the Pharmacy Benefit contact listed on the policy header; coverage may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication (excluding samples or manufacturer patient assistance programs).

Pharmacy Benefit prior authorization required
Prior authorization phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

No step therapy program is specified for these products under this policy.

Documentation Required

Covered Diagnoses

Covered diagnoses

Parkinson diseaseIndication listed in policy for carbidopa/levodopa extended‑release formulations.

Postencephalitic parkinsonismListed as a covered diagnosis for extended‑release carbidopa/levodopa.

Symptomatic parkinsonism post‑CO or manganese exposureCovered when parkinsonism follows carbon monoxide and/or manganese intoxication.

Background and Scope

Carbidopa/levodopa extended‑release formulations include Rytary and the newer branded product Crexont. These preparations deliver extended‑release carbidopa/levodopa for the management of motor symptoms in patients with Parkinson disease and related parkinsonism syndromes.

Indications covered by this policy are Parkinson disease, postencephalitic parkinsonism, and symptomatic parkinsonism following carbon monoxide or manganese intoxication.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCarbidopa/Levodopa Extended‑Release Formulations

Policy CodePolicy N/A

Change TypeMaterial updates (added Crexontremoved certain trial and paid‑claim requirements)

Effective DateJan 1, 2025

Next Review Date

SourceLink

On This Page

Required Documentation

Providers must document the member's diagnosis and treatment history to support medical necessity. Include: the specific qualifying diagnosis (e.g., Parkinson disease, postencephalitic parkinsonism, symptomatic parkinsonism following CO or manganese intoxication), prior treatment history showing an inadequate response or adverse reaction to another oral carbidopa/levodopa product (immediate‑release or extended‑release), and for Crexont requests, documentation of an inadequate response or adverse reaction to Rytary. For continuation requests, include evidence of a positive clinical response to the requested therapy.

Documented qualifying diagnosis
Record of prior inadequate response or adverse reaction to another oral carbidopa/levodopa product
For Crexont: documentation of inadequate response/adverse reaction to Rytary
For reauthorization: documentation of positive clinical response

Denial Risk

Denial Risk for Missing Criteria

Applications missing required documentation or failing to meet the criteria may be denied. Common reasons for denial include: no documented qualifying diagnosis, absence of documentation showing an inadequate response or adverse reaction to prior carbidopa/levodopa therapy (or to Rytary when Crexont is requested), lack of evidence of current therapy when a new-to-plan exception is claimed, or insufficient documentation of positive clinical response for reauthorization.