CurrentCignaPolicy N/A

Nuplazid (pimavanserin) — Coverage Criteria (Parkinson's disease psychosis)

This policy governs prior authorization and coverage criteria for Nuplazid (pimavanserin) for treatment of hallucinations and delusions associated with Parkinson's disease psychosis for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyNuplazid (pimavanserin) — Coverage Criteria (Parkinson's disease psychosis)

Policy CodePolicy N/A

Change TypeMaterial clinical updates (exclusion addedpreferred-product criteria revised)

Effective DateN/A

Next Review DateApr 10, 2026

Key ActionObtain prior authorization and document neurologist prescribing or consultation; approvals are for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Patient does not have dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.

Preferred product criteria updated to include inability to use quetiapine or clozapine and current or prior use of Nuplazid as acceptable criteria.

1 yearauthorization duration

Increased mortalityboxed warning

3preferred-product options

PD psychosisFDA-approved use

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Coverage and Medical Necessity Criteria

FDA-Approved Indication

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

A: Patient has hallucinations and delusions associated with Parkinson's disease psychosis
B: Patient does not have dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis
Boxed warning context
C: The medication is prescribed by or in consultation with a neurologist
Specialist requirement
D: Preferred product criteria is met for the product(s) as listed in the preferred product criteria block
See preferred-product options

A: Patient has hallucinations and delusions associated with Parkinson's disease psychosis

B: Patient does not have dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis

Boxed warning context

C: The medication is prescribed by or in consultation with a neurologist

Specialist requirement

D: Preferred product criteria is met for the product(s) as listed in the preferred product criteria block

See preferred-product options

Preferred Product Criteria

Preferred product criteria: Approve if ONE of the following is met:

Preferred-product options

Option 1: Failure, contraindication, or intolerance to quetiapine or clozapine
Option 2: Per prescriber, patient is unable to use either quetiapine or clozapine
Includes inability as documented by prescriber
Option 3: Patient is currently taking Nuplazid or has taken Nuplazid at any time in the past
Prior or current use qualifies

Option 1: Failure, contraindication, or intolerance to quetiapine or clozapine

Nuplazid (pimavanserin) is not medically necessary for treatment of Dementia-Related Psychosis that is unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis. The Nuplazid prescribing information includes a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis; elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Claims for Nuplazid submitted for dementia-related psychosis (unrelated to PD psychosis) will be denied as not covered under this policy.

Nuplazid for any use other than the FDA-approved indication for hallucinations and delusions associated with Parkinson's disease psychosis is considered not medically necessary. This includes, but is not limited to, use for Dementia-Related Psychosis; such uses are not approved and carry safety risks documented in the product labeling.

Coding Guidance

Coding guidancemixed

affected codes

Providers must use the most appropriate codes as of the effective date; claims without covered diagnosis/procedure codes will be denied.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals are provided for 1 year when criteria are met, including a diagnosis of hallucinations and delusions associated with Parkinson's disease psychosis, absence of dementia-related psychosis unrelated to PD psychosis, and that the medication is prescribed by or in consultation with a neurologist.

Prior authorization required for Nuplazid (pimavanserin).
Approve for 1 year if initial criteria are met (see FDA-Approved Indication).

Step Therapy

Step / Preferred-Product Requirement

Preferred product (step) requirement: one of the following must be met for coverage of Nuplazid — 1) failure, contraindication, or intolerance to quetiapine or clozapine; 2) prescriber documents the patient is unable to use quetiapine or clozapine; OR 3) the patient is currently taking, or has previously taken, Nuplazid.

Applies to Employer Plans and Individual & Family Plans.
Receipt of sample product does not satisfy step requirement.

Key Definitions

Definition — Parkinson's disease psychosis

TermParkinson's disease psychosis

DefinitionHallucinations and delusions associated with Parkinson's disease.

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

Prior authorization noteApprovals are for 1 year when all coverage criteria are met, including this diagnosis.

Definition — Dementia-related psychosis (unrelated to PD psychosis)

TermDementia-related psychosis (unrelated to PD psychosis)

Definition

Background

Nuplazid (pimavanserin) is a selective serotonin 5-HT2A receptor inverse agonist approved to treat hallucinations and delusions associated with Parkinson's disease psychosis. The drug carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis and is not approved for treatment of dementia-related psychosis unrelated to PD psychosis. When covered for the approved indication, prior authorization is required and approvals are provided for the duration specified by the plan.

Policy Revision History

2026-05-01effective_dateLatest

Policy effective date updated (policy remains in force until updated or retired).

2025-06-15effective_date

Policy effective date updated with no criteria changes noted.

2024-07-01material_change

Policy Summary

PayerCigna

PolicyNuplazid (pimavanserin) — Coverage Criteria (Parkinson's disease psychosis)

Policy CodePolicy N/A

Change TypeMaterial clinical updates (exclusion addedpreferred-product criteria revised)

Effective DateN/A

Next Review DateApr 10, 2026

Key ActionObtain prior authorization and document neurologist prescribing or consultation; approvals are for 1 year when criteria are met.

SourceLink

On This Page

Option 2: Per prescriber, patient is unable to use either quetiapine or clozapine

Includes inability as documented by prescriber

Option 3: Patient is currently taking Nuplazid or has taken Nuplazid at any time in the past

Prior or current use qualifies

Documentation Required

Required Documentation and Prescriber

Documentation and prescriber requirements must be submitted with the prior authorization request. Nuplazid must be prescribed by or in consultation with a neurologist (physician who specializes in the condition being treated). Include clinical rationale supporting the preferred-product criteria (e.g., records of failure, intolerance, contraindication, or inability to use quetiapine or clozapine).

Prescriber requirement: neurologist or consult with neurologist.
Document prior treatment history or current/past use of Nuplazid as applicable.

Denial Risk

Denial Triggers

Claims submitted without a covered diagnosis (hallucinations and delusions associated with Parkinson's disease psychosis) or without meeting the required criteria will be denied. Services billed for non-covered indications (including dementia-related psychosis and other non‑PD psychosis uses) will be denied as not medically necessary.

Dementia-related psychosis is not a covered indication (Boxed Warning: increased mortality).
Claims lacking supporting documentation or appropriate diagnosis codes will be denied.

Psychosis associated with dementia that is unrelated to the hallucinations and delusions of Parkinson's disease psychosis.

Regulatory/safety noteNuplazid has a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis and is not approved for this condition.

Coverage implicationPresence of dementia-related psychosis unrelated to PD psychosis excludes coverage for Nuplazid under this policy.

Added exclusion: patient must not have dementia-related psychosis unrelated to Parkinson's disease psychosis; step-through criteria moved into preferred product table and preferred-product options expanded to include inability to use quetiapine or clozapine and current/prior use of Nuplazid.

2024-04-11review

Clinical review documenting addition of dementia-related psychosis exclusion and updates to preferred-product/step criteria.