CurrentUnitedHealthcarePolicy N/A

Nourianz (istradefylline) prior authorization

Defines UnitedHealthcare Pharmacy prior authorization and medical necessity criteria for Nourianz (istradefylline) as adjunctive therapy to levodopa/carbidopa for adults with Parkinson's disease experiencing off episodes. Affects prescribers and pharmacy benefit adjudication for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyNourianz (istradefylline) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain documentation of diagnosis of Parkinson's disease and trials (or documented intolerance/contraindication) of two different adjunctive anti-Parkinson's therapy classes prior to initial approval; approve for 12 months if criteria met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

2adjunctive classes required

adultpatient population

levodopa/carbidoparequired concomitant therapy

Coverage Criteria for Nourianz (istradefylline)

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Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: a. Diagnosis of Parkinson's disease

source: chunk 2

Initial Authorization: c. History of failure, contraindication, or intolerance to therapies from two different adjunctive anti-Parkinson's pharmacotherapy classes (must include trials from two different classes: dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., rasagiline, selegiline), COMT inhibitors (e.g., entacapone)).two classes

source: chunk 3

Continuation Therapy / Reauthorization

Reauthorization requires BOTH of the following:

Reauthorization: a. Documentation of positive clinical response to Nourianz therapy

source: chunk 4

Reauthorization: b. Patient will continue to receive treatment with a carbidopa/levodopa-containing medication

source: chunk 5

Coverage of Nourianz (istradefylline) may be affected by state mandates, federal regulatory requirements, and the member's specific benefit plan limits. These external requirements can modify or supersede the criteria described in this policy. Additionally, other UnitedHealthcare policies and utilization management programs may apply and influence coverage determinations.

Initial Authorization Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial: Diagnosis of Parkinson's disease

chunk 2

Initial: Adjunctive use with levodopa/carbidopa for off episodes

chunk 3

Initial: Trial, failure, contraindication, or intolerance to therapies from two different adjunctive classes (dopamine agonists, MAO-B inhibitors, COMT inhibitors)two classes

chunk 3

Provider Actions and Documentation Requirements

Prior Authorization

Initial Authorization Requirements

Initial authorization requires documentation that the member has a diagnosis of Parkinson's disease, that Nourianz (istradefylline) is being used as an adjunct to levodopa/carbidopa for patients experiencing motor "off" episodes, and that the member has a history of failure, contraindication, or intolerance to trials of at least two different adjunctive anti-Parkinson's therapy classes (trials must be from two different classes). Authorization will be issued for 12 months.

Diagnosis: Parkinson's disease
Use: Adjunctive to levodopa/carbidopa for patients with motor "off" episodes
Prior therapy: Trial or documented intolerance/contraindication to at least two different adjunctive anti-Parkinson's therapy classes (see examples below)
Authorization duration: 12 months

Step Therapy

Adjunctive Therapy Trials

Adjunctive therapy trials must include trials of therapies from at least two different classes unless there is documentation of contraindication or intolerance. Examples of adjunctive classes include dopamine agonists (e.g., pramipexole, ropinirole), MAO-B inhibitors (e.g., rasagiline, selegiline), and COMT inhibitors (e.g., entacapone). The provider must document specific agents tried, dates of therapy, and reason for discontinuation (lack of efficacy, intolerance, or contraindication).

Required: Trials from two different adjunctive pharmacotherapy classes
Examples: Dopamine agonists (pramipexole, ropinirole); MAO-B inhibitors (rasagiline, selegiline); COMT inhibitors (entacapone)
Documentation: agents tried, treatment dates, and reason for failure/intolerance/contraindication

Documentation Required

Reauthorization Documentation

For reauthorization, the provider must document a positive clinical response to Nourianz and that the patient continues to receive a carbidopa/levodopa-containing medication. Reauthorization will be contingent on these materials being present in the medical record.

Documented positive clinical response to Nourianz
Ongoing concomitant treatment with carbidopa/levodopa-containing medication

Denial Risk

Failure to Meet Prior Therapy Requirement

If the prior therapy requirement is not met — i.e., lack of documentation of trials of two different adjunctive classes or absence of documented contraindication/intolerance — the request may be denied. Providers should include complete prior therapy history and rationale for any deviations to avoid denial risk.

Consequence: Potential denial if trials or documented contraindications/intolerances are not provided
Action: Provide complete prior therapy history and reasons for any exceptions

Requirement	Details
Trial of adjunctive therapy from two different pharmacologic classes
Required classes (must be from two different classes): dopamine agonists (e.g., pramipexole, ropinirole); MAO‑B inhibitors (e.g., rasagiline, selegiline); COMT inhibitors (e.g., entacapone)
Documented outcome acceptable for requirement
Failure, contraindication, or intolerance to therapies in the two required classes must be documented

Background and Drug Information

Istradefylline (Nourianz) is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease who are experiencing off episodes. The policy requires that initial authorization demonstrate a diagnosis of Parkinson's disease, use as an adjunct to levodopa/carbidopa for off episodes, and prior failure, contraindication, or intolerance to therapies from two different adjunctive classes (dopamine agonists, MAO‑B inhibitors, or COMT inhibitors); reauthorization requires documentation of a positive clinical response and continued use of a carbidopa/levodopa‑containing medication.