CurrentCentenePolicy CP PMN.267

Levodopa Inhalation Powder (Inbrija)

Policy governing medical necessity and prior authorization criteria for Inbrija (levodopa inhalation powder) for treatment of OFF episodes in Parkinson's disease for Centene lines of business.

Policy Summary

PayerCentene

PolicyLevodopa Inhalation Powder (Inbrija)

Policy CodePolicy CP PMN.267

Change TypeNo material change

Effective DateDec 1, 2021

Next Review Date

Key ActionObtain prior authorization with documentation that the member meets initial or continued therapy criteria; approvals are granted for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

420 mg/daymaximum daily dose

84 mg/doseper inhalation dose

12 monthsapproval duration

>= 18minimum age

Coverage Criteria for Inbrija (levodopa inhalation powder)

inv-01: Initial Therapy

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Initial Approval Criteria: 1) Diagnosis of Parkinson's disease; 2) Prescribed by or in consultation with a neurologist; 3) Age >= 18 years; 4) Inbrija (levodopa inhalation powder) will be used as intermittent treatment for OFF episodes; 5) Prescribed concurrently with carbidopa/levodopa at a dose not exceeding 1,600 mg levodopa per day; 6) Member is experiencing motor fluctuations with a minimum of 2 hours of average daily 'off' time per waking day (excluding early morning 'off' time) while on carbidopa/levodopa therapy; 7) Failure of at least two anti-Parkinson agents from different therapeutic classes unless clinically significant adverse effects are experienced or all are contraindicated; 8) Dose does not exceed both of the following: a) 84 mg (two capsules) per inhalation; and b) five inhalations (420 mg) per day.see text

Approval duration: 12 months

inv-02: Continuation Therapy

Continued therapy — Covered when ANY of the following apply:

Continued Therapy Criteria: a) Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; b) Member is responding positively to therapy; c) Member continues concurrent treatment with carbidopa/levodopa; d) Dose does not exceed 84 mg (two capsules) per inhalation and five inhalations (420 mg) per day. If the request is for a dose increase, the new dose must not exceed these limits.see text

Approval duration: 12 months

Non‑FDA approved indications for Inbrija are not authorized under this policy unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies. See off‑label use policies CP CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP PMN.53 (Medicaid) for required evidence and review standards.

Coverage and administration of benefits for Inbrija are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance) and to applicable state and federal requirements and Health Plan administrative policies and procedures. This clinical policy is a guide to medical necessity and does not guarantee payment.

Uses that are not FDA‑approved and that are not supported by the referenced off‑label use policies are considered not authorized by this policy. Providers seeking coverage for such uses must provide documentation per the off‑label policies cited to justify medical necessity; absent that documentation, coverage will not be approved.

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inbrija (levodopa inhalation powder). Approvals, when granted, are valid for 12 months.

Prior authorization required
Approval duration: 12 months

Prior Authorization

Follow Health Plan Policies

Follow the Health Plan's applicable prior authorization policies and administrative procedures when submitting requests for Inbrija.

Submit requests according to Health Plan prior authorization processes

Note

Coverage Dependent on Benefit Documents

Coverage decisions are subject to the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy or contract) and applicable state and federal laws and regulations. This clinical policy is a guide to medical necessity and does not guarantee payment.

Coverage depends on member's plan terms, exclusions, and limitations
State and federal requirements supersede policy if discrepancies exist

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to provide adequate supporting documentation may result in denial of the request.

Required documentation: office notes, medication history, laboratory or diagnostic testing, and any documentation of therapeutic failures or contraindications
Incomplete documentation may lead to denial

Documentation Required

Documentation and Benefit Alignment

Providers are responsible for ensuring documentation aligns with applicable coverage documents and for maintaining records that support medical necessity. Providers should follow the Health Plan's documentation and submission requirements.

Providers must ensure documentation supports medical necessity per plan policies
Adhere to Health Plan administrative procedures for submissions

Step Therapy

Therapeutic Failure Requirement

For initial approval, the member must have failed at least two anti-Parkinson agents from different therapeutic classes unless clinically significant adverse effects occurred or the agents are contraindicated.

Therapeutic failure: ≥2 anti-Parkinson agents from different classes required unless contraindicated/intolerant
Examples of classes: MAO-B inhibitor (e.g., rasagiline), dopamine agonists (e.g., ropinirole, pramipexole), COMT inhibitors (e.g., entacapone, tolcapone)

Documentation Required

Provider Documentation Responsibilities

Providers must adhere to applicable coverage documents and are responsible for documentation supporting medical necessity. Use clinical judgment and consult the Health Plan policy for any state-specific continuity of care provisions.

Provider responsibility to supply documentation for medical necessity
Refer to state addendums for continuity of care where applicable

Background on Inbrija and Indication

Inbrija (levodopa inhalation powder, also referenced as CVT‑301 in clinical trials) is indicated as an inhaled formulation of levodopa for the intermittent treatment of OFF episodes in patients with Parkinson’s disease who are receiving carbidopa/levodopa. The product is administered as two capsules per inhalation (one capsule = 42 mg levodopa; 84 mg per inhalation) with a maximum of 5 inhalations (420 mg) per day. Prescribing information and pivotal CVT‑301 studies are primary references for efficacy and safety in this indication.

Key Definitions

inv-17: OFF episodes — OFF time/episodes definition

DefinitionOFF episodes represent a return of Parkinson's disease motor symptoms (bradykinesia, resting tremor, or rigidity) when the levodopa treatment effect wears off after each dosing interval.

Clinical contextOFF time/episodes occur as motor fluctuations when L-dopa effect declines between doses.

Relation to therapyIntermittent treatment (e.g., inhaled levodopa) targets these episodic returns of motor symptoms.

inv-18: Dyskinesia vs OFF time — distinction between dyskinesia and OFF episodes

Core distinctionDyskinesia typically results from excessive levodopa exposure; OFF episodes result from insufficient levodopa effect.

PhenomenologyDyskinesia manifests as involuntary, often choreiform movements occurring at peak-dose; OFF episodes manifest as bradykinesia, tremor, or rigidity when medication effect wanes.

Implication for treatmentManagement differs: dyskinesia may require reducing peak levodopa exposure or adjunctive agents; OFF episodes may be treated with rescue or adjunctive dopaminergic therapies to restore levodopa effect.

inv-19: Inbrija / CVT-301 — prescribing information and clinical trial references

Primary referencesInbrija prescribing information (Acorda Therapeutics, Dec 2022) and clinical trial CVT-301 are cited as primary sources for efficacy and safety in treating OFF episodes.

Key trial referenceClinicalTrials.gov: Efficacy and safety study of CVT-301 (levodopa inhalation powder) in Parkinson's disease patients with OFF episodes (NCT02240030).

Dosing referenceDosage and administration: inhale contents of two capsules (84 mg) per inhalation; maximum 84 mg per dose and 420 mg per day.

Policy Summary

PayerCentene

PolicyLevodopa Inhalation Powder (Inbrija)

Policy CodePolicy CP PMN.267

Change TypeNo material change

Effective DateDec 1, 2021

Next Review Date

Key ActionObtain prior authorization with documentation that the member meets initial or continued therapy criteria; approvals are granted for 12 months.

SourceLink

On This Page

OpenPayer

Levodopa Inhalation Powder (Inbrija)

Coverage Criteria for Inbrija (levodopa inhalation powder)

Product Codes and Dosing Limits

Prior Authorization, Documentation, and Provider Responsibilities

Background on Inbrija and Indication

Key Definitions