CurrentUnitedHealthcarePolicy N/A

Prior authorization for Inbrija and Ongentys (antiparkinson agents)

Defines prior authorization requirements and clinical questions for initial and reauthorization requests for Inbrija (levodopa inhalation) and Ongentys (opicapone) for beneficiaries in North Carolina; intended for prescribers and pharmacists submitting PA requests to UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization for Inbrija and Ongentys (antiparkinson agents)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with beneficiary, prescriber, drug, and clinical information including prescriber signature and documentation of trials/response as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

NCApplicable state

Prescriber signature mandatoryForm requirement

Coverage Criteria for Inbrija and Ongentys

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization for Inbrija and Ongentys (antiparkinson agents)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with beneficiary, prescriber, drug, and clinical information including prescriber signature and documentation of trials/response as required.

SourceLink

On This Page

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Initial therapy criteria for Inbrija and Ongentys

Covered when ALL of the following are met for initial and reauthorization requests as specified:

Inbrija initial: Beneficiary has diagnosis of Parkinson's Disease and is experiencing "off" episodes; beneficiary will be concurrently receiving optimized carbidopa/levodopa therapy; beneficiary is not taking a nonselective monoamine (MAO) inhibitor currently or within the last 2 weeks; beneficiary does not have asthma, COPD, or other chronic lung disease; prescriber signature providedinitial approval up to 6 months

Reauthorization requires documentation of symptom improvement; reauthorization can be approved up to 12 months

Ongentys initial: Beneficiary is age >= 18 years; beneficiary has diagnosis of Parkinson's Disease with "off" episodes averaging at least 1.5 hours/day; beneficiary has no contraindications including ESRD (creatinine clearance <15 mL/min/1.73 m2) and no severe hepatic impairment (Child-Pugh C); beneficiary is not currently taking a nonselective MAO-B inhibitor; beneficiary will be concurrently receiving optimized carbidopa/levodopa therapy; documentation of an adequate trial and subsequent failure of at least 2 preferred adjunctive therapies (e.g., dopamine agonists, MAO-B inhibitors, COMT inhibitors) has been providedinitial approval up to 6 months

Reauthorization requires documentation of clinically meaningful response and assessment of adverse events; reauthorization can be approved up to 12 months

Coding and Clinical Thresholds

No codes listed on formmixed

No codes listed

Minimum off time for Ongentys

Minimum required average daily off timeAt least 1.5 hours per day on average

Applies toOngentys (opicapone) initial authorization requests

Documentation sourceQuestion on prior authorization form asking if beneficiary is experiencing 'off' episodes for at least 1.5 hours/day (Question 8)

Reauthorization clinical response

Required reauthorization evidenceDocumentation that indicates the beneficiary has had an improvement in their symptoms or reduction in time of 'off' episodes

Applies toInbrija and Ongentys reauthorization requests per form questions

Approval window tied to documentationReauthorization requests can be approved for up to 12 months when improvement is documented

Provider Actions, Documentation, and Authorization Timeframes

Prior Authorization

Prior Authorization Timeframe

Prior authorization is required for Inbrija and Ongentys. Initial prior authorization requests may be approved for up to 6 months; reauthorization requests may be approved for up to 12 months.

Initial approval: up to 6 months (Inbrija and Ongentys).
Reauthorization approval: up to 12 months (Inbrija and Ongentys).

Denial Risk

Clinical Eligibility Missing: Denial Risk

Requests may be denied if the beneficiary does not have a diagnosis of Parkinson's disease with documented "off" episodes or if required clinical information demonstrating benefit or ongoing need is not provided.

Clinical eligibility must document Parkinson's disease with "off" episodes (Inbrija and Ongentys).
For Ongentys initial requests, documentation must show "off" episodes averaging ≥1.5 hours/day.
For reauthorization, submit documentation of clinically meaningful response (e.g., reduction in time spent in "off" episodes).

Documentation Required

Required Form Fields and Prescriber Signature

The prior authorization form must be completed with beneficiary, prescriber, drug, and clinical information, and must include the prescriber's signature and date. Incomplete forms or missing prescriber signature may result in denial or delay.

Completed beneficiary, prescriber, drug, and clinical sections are required.
Answer all required clinical questions for initial and reauthorization requests (see clinical question set).
Prescriber signature and date are mandatory on the NC Pharmacy Prior Approval Request form.

Background

Parkinson's disease patients commonly experience "off" episodes, periods when motor symptoms re-emerge due to wearing off of dopaminergic therapy. Inbrija (inhaled levodopa) is intended for treatment of these "off" episodes when used concurrently with optimized carbidopa/levodopa therapy. Ongentys (opicapone) is an adjunctive COMT inhibitor intended to reduce daily "off" time; the form requires documentation of baseline off-time and response to therapy for reauthorization.

Definitions

Off episodes

DefinitionPeriods when Parkinson's motor symptoms re-emerge due to wearing-off of dopaminergic therapy

Captured on formForm asks whether beneficiary is experiencing 'off' episodes and queries duration and change with treatment

Clinical relevanceUsed to determine eligibility for Inbrija (to treat 'off' episodes) and to assess benefit from Ongentys

Assessment pointsForm questions include presence of 'off' episodes, average daily duration (e.g., ≥1.5 hours for Ongentys), and improvement on reauthorization