CurrentUnitedHealthcarePolicy N/A

Step therapy for carbidopa/levodopa extended-release (Crexont, Rytary)

Defines a step therapy program requiring trial of carbidopa/levodopa immediate-release (or specified alternatives) before approving extended-release formulations Crexont or Rytary for adults with Parkinson's disease and related parkinsonism. Affects prescribers and prior authorization reviewers for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for carbidopa/levodopa extended-release (Crexont, Rytary)

Policy CodePolicy N/A

Change TypeStep therapy program addedfailure definition clarified

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document a trial with suboptimal response, contraindication, or intolerance to immediate-release carbidopa/levodopa or specified alternatives.

SourceLink

POLICY UPDATE CHANGES

New step therapy program established for Crexont and Rytary requiring trial of carbidopa/levodopa immediate-release or specified alternatives.

Updated failure definition to 'suboptimal response' as a reason to approve Crexont or Rytary.

Brand Rytary is typically excluded from coverage.

5/1/2025effective date

3allowed prior therapies

12 moauthorization duration

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

COVERAGE CRITERIA

Covered when ALL of the following are met:

Initial approval conditions

Allowed prior therapies: a. carbidopa/levodopa immediate-release (generic Sinemet) b. carbidopa/levodopa controlled-release (generic Sinemet CR) c. carbidopa/levodopa/entacapone (generic Stalevo)

Brand Rytary is typically excluded from coverage. This exclusion is an operational consideration that may affect prior authorization decisions for the branded product; reviewers should default to the policy’s step-therapy and prior authorization requirements when assessing requests and document any rationale if an exception is considered.

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be granted when there is a documented history of suboptimal response, a contraindication, or intolerance to an alternative therapy.

Approval criteria: documented suboptimal response, contraindication, or intolerance to one of: carbidopa/levodopa immediate-release (generic Sinemet), carbidopa/levodopa controlled-release (generic Sinemet CR), or carbidopa/levodopa/entacapone (generic Stalevo).
Authorization duration: 12 months.
Brand Rytary is typically excluded from coverage; state mandates and member-specific benefit plans may affect coverage.

Step Therapy

Step Therapy Requirement

Step therapy is required before coverage of extended-release carbidopa/levodopa products. The member must have tried and had a suboptimal response, intolerance, or contraindication to immediate-release or other specified alternatives.

Required trial medications: carbidopa/levodopa immediate-release (generic Sinemet) or carbidopa/levodopa controlled-release (generic Sinemet CR) or carbidopa/levodopa/entacapone (generic Stalevo).
This step-therapy requirement supports use of lower-cost alternatives prior to approving extended-release formulations.

Documentation Required

Supporting Documentation

Supporting documentation must be provided with the request. UnitedHealthcare may also use automated checks (previous claim/medication history, diagnosis codes, and claim logic) to approve initial or re-authorization requests.

Acceptable documentation: medication history showing trials of required agents, clinical rationale for intolerance/contraindication/suboptimal response, and relevant ICD-10 diagnosis codes.
Automated approvals: prior claim/medication history and diagnosis codes may be used where applicable.
Supply limits and other utilization management programs may apply.

Denial Risk

Incomplete Prior Trial Documentation May Result in Denial

Requests lacking documentation of a prior trial or documentation of suboptimal response, contraindication, or intolerance to required alternatives may be denied.

If no documented trial of carbidopa/levodopa immediate-release or the specified alternatives is provided, the request may be denied.
Denial risk increases when clinical rationale or ICD-10 diagnosis codes are absent from the submission.

Definitions

Definition — suboptimal response

DefinitionSuboptimal response: patient has not achieved adequate therapeutic benefit with prior carbidopa/levodopa formulations.

Context for useUsed as an approval rationale when considering prior trials of carbidopa/levodopa immediate‑release, controlled‑release, or carbidopa/levodopa/entacapone (Stalevo) before Crexont or Rytary.

Related decision ruleInitial approval requires documented history of suboptimal response, intolerance, or contraindication to one of the listed alternatives.

Documentation to supportProviders should supply medication history and claim/diagnosis (ICD‑10) evidence showing inadequate therapeutic effect on prior formulations.

Operational noteLack of documented prior trial or evidence of suboptimal response may lead to denial of Crexont or Rytary requests.

Initial Therapy Criteria

Initial therapy requirement

Initial approval requires documented trial and suboptimal response, intolerance, or contraindication to listed alternatives.

Initial therapy: Member has history of suboptimal response, intolerance, or contraindication to one of: carbidopa/levodopa immediate-release (generic Sinemet), carbidopa/levodopa controlled-release (generic Sinemet CR), or carbidopa/levodopa/entacapone (generic Stalevo)

Step therapy programs require trial of lower-cost immediate-release formulations prior to extended-release products.

Step	Requirement
1	Trial of one of the following is required prior to approval of Crexont or Rytary: a) carbidopa/levodopa immediate‑release (generic Sinemet); b) carbidopa/levodopa controlled‑release (generic Sinemet CR); or c) carbidopa/levodopa/entacapone (generic Stalevo)

Background

Crexont and Rytary are extended‑release formulations of carbidopa/levodopa indicated for adults with Parkinson’s disease and certain forms of parkinsonism. The program is designed to encourage use of lower‑cost immediate‑release or alternative carbidopa/levodopa formulations prior to covering these extended‑release products.

Prior authorization and step‑therapy rules apply: initial approval requires documented history of suboptimal response, contraindication, or intolerance to one of the listed alternatives (carbidopa/levodopa immediate‑release [generic Sinemet], carbidopa/levodopa controlled‑release [generic Sinemet CR], or carbidopa/levodopa/entacapone [generic Stalevo]). When approved, authorization is issued for 12 months.

Providers seeking coverage should supply medication history, diagnosis codes (ICD‑10), and claim history to support initial or re‑authorization; automated approval logic may use these data. Note that state mandates, federal requirements, and plan‑specific benefit terms may affect coverage.