ModifiedBlue Cross Blue Shield - IowaPolicy 05.01.47

Antiparkinsons Agents

Prior authorization and medical necessity criteria for multiple antiparkinson agents (including Crexont, Gocovri, Inbrija, Neupro, Nourianz, Onapgo, Ongentys, Osmolex ER, Requip XL, Mirapex ER, Rytary, Tolcapone, Vyalev, Xadago, Zelapar and others) for treatment of Parkinson's disease and related indications; includes initial and continuation approval criteria, quantity limits, documentation and prescriber specialty requirements, and billing codes.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAntiparkinsons Agents

Policy CodePolicy 05.01.47

Change TypeRevised (Jan 2026)

Effective DateJul 24, 2025

Next Review Date

Key ActionSubmit chart notes, medical record documentation, or claims history supporting prior medications tried and response to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised January 2026 with Current Effective Date July 24, 2025.

16Covered Agents with criteria

14Agents with continuation criteria

13Agents with initial approval durations specified

Coverage Summary

This policy covers multiple antiparkinson agents with medical necessity criteria (covered_with_criteria). Covered products include, among others, Crexont, Gocovri, Inbrija, Neupro, Nourianz, Onapgo, Ongentys, Osmolex ER, Rytary, Tolcapone, Vyalev, Xadago, Zelapar and other branded and generic agents. Prior authorization is required and the policy specifies quantity limits and documentation requirements for each product (examples: Crexont 180 caps/30 days; Gocovri 60 caps/30 days; Inbrija 300 caps/30 days; Neupro 30 patches/30 days).

Policy identifiers and dates

Policy Number05.01.47

SubjectAntiparkinsons Agents (multiple agents)

Effective DateJuly 24, 2025

Last ReviewJanuary 2026

StatusMODIFIED

Scope SummaryPrior authorization and medical necessity criteria for multiple antiparkinson agents (including Crexont, Gocovri, Inbrija, Neupro, Nourianz, Onapgo, Ongentys, Osmolex ER, Requip XL, Mirapex ER, Rytary, Tolcapone, Vyalev, Xadago, Zelapar and others); includes initial and continuation criteria, quantity limits, documentation and prescriber specialty requirements, and billing codes.

Initial Therapy Criteria

Initial Approval Criteria Grouping

Covered when ALL of the following are met:

Crexont - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic extended-release carbidopa/levodopa

Gocovri - Dyskinesia Indication Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing dyskinesia despite receiving a stable dosage of carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic immediate-release amantadine
Member has experienced an inadequate response to at least one agent in EACH of the following classes: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) unless there is a clinical reason to avoid therapy
Exception: UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Gocovri - 'Off' Episodes Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing 'off' episodes despite receiving a stable dosage of concurrent carbidopa/levodopa
Member will use Gocovri as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance/contraindication/hypersensitivity to at least one agent in EACH of the following classes: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) AND COMT inhibitor (e.g., entacapone, tolcapone)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Inbrija - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing intermittent 'off' episodes despite receiving a stable dosage of concurrent carbidopa/levodopa
Member will use Inbrija as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in EACH of the following classes used in combination with carbidopa/levodopa: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) unless there is a clinical reason to avoid therapy
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Neupro - Initial Approval (Parkinson's disease)

Member is ≥18 years with Parkinson's disease
Member has tried and failed extended-release ropinirole or pramipexole unless documented intolerance, FDA labeled contraindication, or hypersensitivity
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Neupro - Initial Approval (Restless Legs Syndrome)

Member is ≥18 years with restless legs syndrome
Member has tried and failed extended-release ropinirole unless documented intolerance, FDA labeled contraindication, or hypersensitivity
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Nourianz - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing 'off' episodes despite receiving a stable dosage of concurrent carbidopa/levodopa
Member will use Nourianz as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in EACH of the following classes: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) AND COMT inhibitor (e.g., entacapone, tolcapone)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Onapgo - Initial Approval

Member is levodopa responsive with clearly defined 'on' periods
Member has 'off' periods of at least 2.5 hours per day despite optimization efforts
Refer to policy threshold for on time definition
Member has had an inadequate response or intolerable adverse event with oral carbidopa/levodopa and one of the following anti-Parkinson agents: Dopamine agonist (e.g., pramipexole, ropinirole) OR MAO-B inhibitor (e.g., selegiline, rasagiline) OR COMT inhibitor (e.g., entacapone, tolcapone)

Ongentys - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing intermittent 'off' episodes despite receiving a stable dosage of concurrent carbidopa/levodopa
Member will use Ongentys as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response, despite demonstrated adherence to, a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in EACH of the following classes: Dopamine agonist (e.g., rotigotine, bromocriptine, pramipexole, ropinirole) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) AND another COMT inhibitor (e.g., entacapone, generic Stalevo)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Osmolex ER - Initial Approval (Parkinson's disease)

Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic immediate-release amantadine
Member has experienced an inadequate response to at least one agent in EACH of the following classes: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) unless there is a clinical reason to avoid therapy
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Osmolex ER - Initial Approval (Drug-induced extrapyramidal reactions)

Prescriber has assessed and adjusted, if applicable, any medications known to cause extrapyramidal symptoms
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic immediate-release amantadine
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Extended-release ropinirole / pramipexole - Initial Approval

Member is ≥18 years for management of idiopathic Parkinson's disease
Member has tried and failed immediate-release formulations of ropinirole and pramipexole (patient must try and fail immediate-release product of the extended-release product requested)

Extended-release ropinirole - RLS Initial Approval

Member is ≥18 years with restless legs syndrome
Member has tried and failed the immediate-release formulation of ropinirole

Rytary - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic extended-release carbidopa/levodopa

Tolcapone - Initial Approval

Member has a confirmed diagnosis of idiopathic Parkinson's disease
Member will use tolcapone as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has documented intolerance/contraindication/hypersensitivity to at least one agent in EACH of the following classes: Dopamine agonist (e.g., rotigotine, bromocriptine, pramipexole, ropinirole) AND MAO type B inhibitor (e.g., rasagiline, safinamide, selegiline) AND another COMT inhibitor (e.g., entacapone, generic Stalevo)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Vyalev - Initial Approval

Member is levodopa responsive with clearly defined 'on' periods
Member has 'off' periods of at least 2.5 hours per day despite optimization efforts
Refer to policy threshold for on time definition
Member must have had an inadequate response or intolerable adverse event with oral carbidopa/levodopa and one of the following anti-Parkinson agents: Dopamine agonist (e.g., pramipexole, ropinirole) OR MAO-B inhibitor (e.g., selegiline, rasagiline) OR COMT inhibitor (e.g., entacapone, tolcapone)

Xadago - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and is experiencing 'off' episodes despite receiving a stable dosage of carbidopa/levodopa
Member will use Xadago as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in EACH of the following classes: Dopamine agonist (e.g., rotigotine, pramipexole, ropinirole, bromocriptine) AND another MAO type B inhibitor (e.g., rasagiline, selegiline)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Zelapar - Initial Approval

Member has a confirmed diagnosis of Parkinson's disease and has exhibited deterioration in the quality of their response to carbidopa/levodopa despite an optimized, stable dosage regimen
Member will use Zelapar as an adjunct to carbidopa/levodopa
Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to selegiline capsules or tablets AND at least one agent in EACH of the following classes: Dopamine agonist (e.g., bromocriptine, pramipexole, ropinirole, rotigotine) AND another MAO type B inhibitor (e.g., rasagiline, safinamide)
UNLESS the member is currently receiving treatment with the requested product through insurance (excludes samples or manufacturer's patient assistance programs) and experiencing a positive therapeutic outcome

Continuation Therapy Criteria

Continuation Criteria Grouping

Covered when ALL of the following are met:

Crexont - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy with the requested medication

Gocovri - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit

Inbrija - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit as demonstrated by a reduction in off episodes since initiating therapy with the requested medication

Neupro - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes (Parkinson's) or improvement in quality of life/daytime functioning/sleep (RLS) since initiating therapy

Nourianz - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy

Onapgo - Continuation

Member meets initial criteria
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy

Ongentys - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy

Osmolex ER - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit

Extended-release ropinirole / pramipexole - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit

Rytary - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy

Tolcapone - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit
Member has been evaluated for and is not exhibiting any signs of hepatic injury

Vyalev - Continuation

Member meets initial criteria
Member is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy with the requested medication

Xadago - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit

Zelapar - Continuation

Member meets all initial criteria for approval
Member is experiencing a noticeable symptomatic benefit

Exceptions and Non‑Formulary Criteria

General Non-Formulary Exception Criteria

Non-formulary may be covered when ALL of the following are met:

Requested drug is used for an FDA-approved indication or an indication supported in compendia (AHFS, Micromedex, guidelines). Diagnostic testing/lab results when applicable.
Prescribed dose/quantity falls within FDA labeling or compendia dosing guidelines.
All covered formulary alternative drugs on any tier will be ineffective, have been ineffective, would not be as effective, or would have adverse effects; documentation required (chart notes indicating prior treatment failure, severity, dosage and duration, or contraindication).
See Required Documentation for chart notes and prior medications tried

Applicable Codes

Procedures and billing codes listedmixed

E0781	Vyafuser pump (Vyalev)
J3490	Unclassified drugs
J3590	Unclassified biologics
J7356	Injection, foscarbidopa 0.25mg/foslevodopa 5mg
J7799	Noc drugs, other than inhalation drugs, administered through dme

Provider Actions and Billing Requirements

Prior Authorization

Prior authorization required with documentation

Prior authorization is required. Submit chart notes, medical record documentation, or claims history that show prior medications tried and the member's responses to initiate the prior authorization review.

Chart notes
Medical record documentation
Claims history supporting prior medications tried and responses

Documentation Required

Therapeutic benefit documentation for continuation

For continuation, providers must document a noticeable symptomatic benefit since initiating therapy.

Examples of benefit: reduction in off episodes
Examples of benefit for RLS: improvement in quality of life, daytime functioning, or sleep

Prior Authorization

Prescriber specialty requirement

Medications must be prescribed by or in consultation with a neurologist or a specialist in the treatment of Parkinson's disease; document consultation if not prescribed directly by such a specialist.

Billing Rule

Quantity limits

Product-specific quantity limits per 30 days apply as listed below. Limits are applied per product per 30 days.

Crexont — 180 capsules per 30 days
Gocovri — 60 capsules per 30 days
Inbrija — 300 capsules per 30 days
Neupro — 30 patches per 30 days

Clinical Evidence & References

Policy references multiple FDA package inserts and clinical guideline reviews (including AAN, Movement Disorder Society/MDS, and NICE) as source material. Clinical evidence and guideline sources are used to inform the medical necessity and coverage criteria set forth in the policy.

Definitions and thresholds

Definition - Off episodesPeriods of worsening Parkinson's symptoms when medication effect wears off; used as outcome measure for benefit.

Threshold - On time definition for Onapgo'off' periods of at least 2.5 hours per day

Threshold - On time definition for Vyalev'off' periods of at least 2.5 hours per day

Background

The policy governs appropriate selection of antiparkinson agents based on FDA labeling, clinical guidelines, and clinical studies to promote cost‑effective use. It applies to multiple branded and generic agents across formulations — oral, transdermal patch, inhaled, subcutaneous infusion — and includes initial and continuation approval criteria, prescriber specialty requirements, documentation for prior authorization, and procedure/billing codes.

Revision History

Policy reviewed and revised January 2026 with Current Effective Date July 24, 2025.revisedLatest