CurrentCentenePolicy CP PMN.140

Pimavanserin (Nuplazid) coverage

Defines medical necessity and prior authorization criteria for pimavanserin (Nuplazid) for treatment of hallucinations and delusions associated with Parkinson's disease psychosis for Centene lines of business.

Policy Summary

PayerCentene

PolicyPimavanserin (Nuplazid) coverage

Policy CodePolicy CP PMN.140

Change TypeNo material change

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation (e.g., office chart notes, lab results) supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

34 mg/daymaximum daily dose

>18minimum age

12 moHIM/Medicaid approval

12 moCommercial approval

Coverage Criteria

inv-01: Initial Therapy

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Initial Approval - Parkinson's Disease Psychosis: 1. Diagnosis of hallucinations and delusions associated with Parkinson's disease psychosis; 2. Age > 18 years; 3. Dose does not exceed 34 mg per day.

Provider must submit documentation (e.g., office chart notes, lab results) supporting that the member has met all approval criteria.

inv-02: Continued Therapy

Covered for continued therapy when ALL of the following are met

Continued Therapy - Parkinson's Disease Psychosis: a. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is in a state/product with continuity of care regulations; b. Member is responding positively to therapy; c. If request is for a dose increase, new dose does not exceed 34 mg per day.

Approval duration: HIM/Medicaid 12 months; Commercial 12 months or duration of request, whichever is less. Provider must submit documentation supporting continued benefit.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies. Refer to CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP PMN.53 (Medicaid), or the member's evidence of coverage, for required supporting evidence and review standards.

Nuplazid (pimavanserin) is not approved for the treatment of dementia‑related psychosis that is unrelated to hallucinations and delusions associated with Parkinson's disease psychosis. The product carries a boxed warning for increased mortality in elderly patients with dementia‑related psychosis and is contraindicated in individuals with hypersensitivity to Nuplazid or any of its components.

Provider Actions and Administrative Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) that the member meets ALL approval criteria, including a diagnosis of hallucinations and delusions associated with Parkinson's disease psychosis and age > 18 years. Requests for dose increase must show new dose does not exceed 34 mg per day. Approval durations: HIM/Medicaid — 12 months; Commercial — 12 months or duration of request, whichever is less.

Required documentation: office notes, diagnostics, prior medication history, dosing rationale
Dose limit for approval: ≤ 34 mg/day for dose increases
Approval durations: HIM/Medicaid 12 months; Commercial 12 months or duration requested, whichever is less

Documentation Required

Medical Necessity and Coverage Administration

Coverage determinations follow this clinical policy as a guide to medical necessity and are subject to the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance), state and federal requirements, and Health Plan-level administrative policies and procedures. Providers must exercise professional medical judgment; this policy does not replace clinician decision-making.

Medical necessity decisions use this policy as guidance but are subject to plan terms, exclusions, and limitations
Providers remain responsible for clinical care and treatment decisions

Step Therapy

Formulary and Step-Therapy Considerations

Follow applicable formulary, non‑formulary, or no‑coverage policies for other diagnoses/indications or formulary status. For formulary and PDL status, refer to the line-of-business specific policies listed below when applicable.

Commercial formulary/no-coverage: CP.CPA.190
Health Insurance Marketplace formulary/no-coverage: HIM.PA.33 (or HIM.PA.103 for non-formulary as noted)
Medicaid formulary/no-coverage/PDL references: CP PMN.255, CP PMN.16, CP PMN.53
Non‑FDA/off‑label indications require documentation per off-label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53) or may be denied

Denial Risk

Provider Responsibilities and Denial Risk

Providers must follow Health Plan-level administrative policies and procedures. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law. Requests for non‑FDA approved indications without sufficient supporting evidence may be denied.

Adhere to state-specific continuity of care regulations where applicable
Non‑FDA indications require sufficient documentation of efficacy and safety per off-label policies or will be denied

Definitions

Parkinson's disease psychosis

DefinitionPresence of hallucinations and delusions associated with Parkinson's disease.

FDA-approved indicationNuplazid is indicated for treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Related safety noteNot approved for dementia-related psychosis unrelated to Parkinson's disease psychosis (boxed warning).

Clinical policy

PurposeA guide to medical necessity developed from professional standards, literature, and guidelines; not a substitute for provider judgment.

Use in coverage decisionsAssists in making coverage decisions and administering benefits; subject to coverage documents and regulatory requirements.

Provider responsibilityProviders must exercise professional medical judgment; the policy does not dictate clinical care.

Medication and Treatment Modalities

inv-20: Medication (pimavanserin)

Medication (pimavanserin): Boxed warning: increased mortality in elderly patients with dementia-related psychosis; Nuplazid is not approved for treatment of dementia-related psychosis unrelated to Parkinson's disease psychosis. Contraindication: hypersensitivity to Nuplazid or any of its components.

Indication: Nuplazid is FDA‑approved for treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

Background

Pimavanserin (Nuplazid) is an atypical antipsychotic FDA‑approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Clinicians should note the boxed warning for increased mortality in elderly patients with dementia‑related psychosis and the contraindication for hypersensitivity to the drug or its components. This clinical policy is intended to guide medical necessity determinations and does not replace individualized provider clinical judgment.