CurrentColorado Rocky Mountain Health PlansPolicy N/A

Anti-parkinson's Agents [Inbrija, Ongentyx] (North Carolina) Prior Authorization Form - Community Planopen_in_new

A payer prior authorization form capturing required beneficiary, prescriber, drug and clinical information to support initial and reauthorization requests for Inbrija (levodopa inhalation) and Ongentys (opicapone). Defines age, diagnosis, concomitant therapy, contraindications, prior therapy trials, and response/toxicity documentation required for approval durations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAnti-parkinson's Agents [Inbrija, Ongentyx] (North Carolina) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the prior authorization form with beneficiary, prescriber, drug, and clinical information; prescriber signature is mandatory.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Drugs covered by form

6 monthsInitial approval duration

12 monthsReauthorization approval duration

Coverage Summary

A payer prior authorization form capturing required beneficiary, prescriber, drug and clinical information to support initial and reauthorization requests for Inbrija (levodopa inhalation) and Ongentys (opicapone). The form implements a covered_with_criteria stance and defines required items including age, diagnosis of Parkinson's disease with 'off' episodes, concurrent optimized carbidopa/levodopa therapy, contraindications (renal and hepatic limits, chronic lung disease), prior adjunctive therapy trials for Ongentys, and documentation of response/toxicity. Initial approvals are allowed for up to 6 months and reauthorizations for up to 12 months.

Inbrija - Initial Therapy Criteria

Inbrija - Initial Authorization

Initial requests can be approved for up to 6 months. Covered when ALL of the following are met:

Age: Beneficiary age is 18 years or older
Diagnosis of Parkinson's Disease and experiencing 'off' episodes
Concomitant therapy: Beneficiary will be concurrently receiving optimized carbidopa/levodopa therapy
MAO inhibitor: Beneficiary is not currently taking a nonselective monoamine (MAO) inhibitor and has not taken a MAO inhibitor within the last two weeks
Pulmonary disease: Beneficiary does not have asthma, COPD or other chronic lung disease

Initial authorization requests for both Inbrija and Ongentys can be approved for up to 6 months. The form collects baseline clinical items (age, diagnosis, concurrent optimized carbidopa/levodopa therapy, and relevant contraindications) that must be met for initial approval.

Inbrija - Reauthorization Criteria

Inbrija - Reauthorization

Reauthorization requests can be approved for up to 12 months. Covered when ALL of the following are met:

Continuation: Initial authorization criteria continue to be met (questions 1-5)
Response: Documentation submitted shows improvement in symptoms from baseline

Reauthorization requests can be approved for up to 12 months. For reauthorization the provider must submit documentation showing improvement in symptoms from baseline (Inbrija) or documentation indicating a clinically meaningful response to treatment (Ongentys).

Ongentys - Initial Therapy Criteria

Ongentys - Initial Authorization

Initial requests can be approved for up to 6 months. Covered when ALL of the following are met:

Age: Beneficiary age is 18 years or older
Diagnosis and off time: Diagnosis of Parkinson's Disease and experiencing 'off' episodes for at least 1.5 hours/day on average>= 1.5 hours/day
Renal function: No contraindications including ESRD (creatinine clearance <15 ml/min/1.73m2)CrCl >= 15 ml/min/1.73m2
Hepatic impairment: No contraindications including severe hepatic impairment (Child-Pugh C)
Beneficiary must not have severe hepatic impairment
MAO-B inhibitor: Beneficiary is not currently taking a nonselective monoamine oxidase-B (MAO-B) inhibitor
Concomitant therapy: Beneficiary will be concurrently receiving optimized carbidopa/levodopa therapy
Prior adjunctive therapies: Beneficiary has had an adequate trial and subsequent failure of at least 2 preferred adjunctive therapies (e.g., dopamine agonists, MAO-B inhibitors, COMT inhibitors) to control 'off' symptoms>= 2 preferred adjunctive therapies tried and failed

Initial authorization requests (up to 6 months) require all listed criteria to be met. Key numeric thresholds include: beneficiary age ≥ 18 years and, for Ongentys, mean daily 'off' time of >= 1.5 hours/day.

Ongentys - Reauthorization Criteria

Ongentys - Reauthorization

Reauthorization requests can be approved for up to 12 months. Covered when ALL of the following are met:

Continuation of initial criteria: Initial authorization criteria continue to be met (questions 7-13)
Clinically meaningful response: Documentation submitted indicates clinically meaningful response to treatment (e.g., reduction in time of 'off' episodes)
Toxicity reporting: Documentation of whether beneficiary has experienced toxicity or treatment-related adverse events (e.g., dyskinesias, hallucinations/psychotic behavior, impulse control/compulsive behaviors)

Reauthorization (up to 12 months) requires documentation of a clinically meaningful response — for example, a documented reduction in time of 'off' episodes — and reporting of any treatment-related toxicity or adverse events.

Provider Actions & Documentation Requirements

Prior Authorization

Submit prior authorization form

Prescriber must complete and sign the prior authorization form with beneficiary, prescriber, drug, and clinical information. The prescriber signature is mandatory and must be dated on the form to certify the accuracy and completeness of the information submitted.

Prescriber signature is mandatory and must be dated

Documentation Required

Document optimized carbidopa/levodopa therapy

Provider must document that the beneficiary will be or is concurrently receiving optimized carbidopa/levodopa therapy. This concurrent optimized carbidopa/levodopa therapy requirement applies to both Inbrija and Ongentys requests as indicated on the form.

Documentation Required

Document prior therapy trials for Ongentys

For Ongentys initial requests, the provider must document adequate trials and subsequent failures of at least 2 preferred adjunctive therapies (for example: dopamine agonists, MAO-B inhibitors, COMT inhibitors) to control 'off' symptoms before approval.

Documentation Required

Document treatment response for reauthorization

For reauthorization requests, providers must submit documentation showing treatment response: for Inbrija, evidence of improvement in symptoms from baseline; for Ongentys, documentation of a clinically meaningful response (for example, reduction in time spent in 'off' episodes). The provider must also report whether the beneficiary has experienced treatment-related toxicity or adverse events (e.g., dyskinesias, hallucinations/psychotic behavior, impulse control/compulsive behaviors).

Symptom improvement from baseline (Inbrija)
Clinically meaningful response such as reduced time of 'off' episodes (Ongentys)
Documentation of any treatment-related toxicity or adverse events (e.g., dyskinesias, hallucinations, impulse control issues)

Background & Definitions

The prior authorization form is used to determine coverage for Inbrija and Ongentys by collecting beneficiary, prescriber and drug information and specific clinical answers relevant to approval. It captures prescriber identifiers, drug name/strength/quantity and length of therapy choices, and clinical checklist items (age, Parkinson's diagnosis with 'off' episodes, concurrent optimized carbidopa/levodopa therapy, contraindications, prior adjunctive therapy trials for Ongentys, and documentation of response/toxicity). The prescriber must complete and sign the form.

Term	Definition
Optimized carbidopa/levodopa therapy	Concomitant, adjusted levodopa-based therapy managed to best effect prior to initiation of adjunctive agents.
Off episodes	Periods of diminished motor function between doses of levodopa in Parkinson's disease.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAnti-parkinson's Agents [Inbrija, Ongentyx] (North Carolina) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the prior authorization form with beneficiary, prescriber, drug, and clinical information; prescriber signature is mandatory.

SourceLink

On This Page

OpenPayer

Anti-parkinson's Agents [Inbrija, Ongentyx] (North Carolina) Prior Authorization Form - Community Planopen_in_new

Coverage Summary

Inbrija - Initial Therapy Criteria

Inbrija - Reauthorization Criteria

Ongentys - Initial Therapy Criteria

Ongentys - Reauthorization Criteria

Provider Actions & Documentation Requirements

Applicable Codes

Background & Definitions

Clinical Evidence & Thresholds

Revision History