CurrentCentenePolicy CP.PMN.140

Pimavanserin (Nuplazid) (PDF)

Clinical policy defining medical necessity criteria, dosing limits, contraindications, and authorization durations for pimavanserin (Nuplazid) across Centene lines of business (Commercial, HIM, Medicaid). Includes initial and continuation criteria and references to related policies for off-label or non-formulary uses.

Policy Summary

PayerCentene

PolicyPimavanserin (Nuplazid) (PDF)

Policy CodePolicy CP.PMN.140

Change TypeRevised / Annual review / Template / References updated

Effective Date11.16.16

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less. (Change recorded 09.28.21)

Template changes applied to other diagnoses/indications and continued therapy section.

References updated and additional guideline reference added (American Psychiatric Association).

3Q 2025 annual review: no significant changes; references reviewed and updated.

1FDA‑approved Indication

34 mg/dayMaximum Dose

≥18Minimum Age (years)

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Coverage Summary

Pimavanserin (Nuplazid) is covered with criteria for the FDA-approved indication of hallucinations and delusions associated with Parkinson's disease psychosis. Medical necessity requires documentation of the diagnosis, age ≥ 18 years, and that the dose does not exceed 34 mg per day. Approval durations vary by line of business: HIM/Medicaid: 12 months; Commercial: 12 months or duration of request, whichever is less.

Maximum daily dose≤ 34 mg/day

Age≥ 18 years

Typical Approval Duration (Medicaid/HIM)12 months

Typical Approval Duration (Commercial)12 months or duration of request, whichever is less

Initial Therapy Criteria

I. Initial Approval Criteria - Parkinson's Disease Psychosis

Provider must submit documentation supporting that member has met all approval criteria. Nuplazid is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of hallucinations and delusions associated with Parkinson's disease psychosis
Age ≥ 18 years
Dose does not exceed 34 mg per day

I. Initial Approval Criteria - Other diagnoses/indications

If initial approval criteria above are not met and drug label recently changed or indication not listed, follow one of the below:

ANY of the following

If drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business
Commercial/formulary: CP.CPA.190; Medicaid/formulary: CP.PMN.255; HIM/formulary: HIM.PA.33; Commercial/non-formulary: CP.CPA.190; HIM/non-formulary: HIM.PA.103; Medicaid/non-formulary: CP.PMN.16
If requested use is not listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business
Commercial: CP.CPA.09; HIM: HIM.PA.154; Medicaid: CP.PMN.53

Continuation Therapy Criteria

II. Continued Therapy (Renewal) - Parkinson's Disease Psychosis

For continuation, MUST meet all of the following:

ALL of the following

one_of
- Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed 34 mg per day

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Coverage is not authorized for the following:

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Boxed warning: increased mortality in elderly patients with dementia-related psychosis, and 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. When coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) dosing should be adjusted to 10 mg PO once daily.

Applicable Codes & Policy References

Relevant policy references (not billing codes)mixed

CP.PMN.140	Reference number for this clinical policy (Pimavanserin)
CP.CPA.190	Commercial no coverage criteria policy reference
HIM.PA.33	Health insurance marketplace no coverage criteria policy reference
CP.PMN.255	Medicaid no coverage criteria policy reference
HIM.PA.103	Health insurance marketplace non-formulary policy reference
CP.PMN.16	Medicaid non-formulary policy reference
CP.CPA.09	Commercial off-label use policy reference
HIM.PA.154	Health insurance marketplace off-label use policy reference
CP.PMN.53	Medicaid off-label use policy reference
CC.PHARM.03A	State specific addendum for continuity of care

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Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required per Centene clinical policy

Prior authorization is required per Centene clinical policy; approval is subject to meeting the medical necessity criteria in this policy and, when applicable, referenced formulary or off-label use policies should be followed.

Documentation Required

Submit supporting clinical documentation

Provider must submit supporting clinical documentation to show the member meets all approval criteria.

Office chart notes
Laboratory results
Other clinical information

Documentation Required

Clinical Evidence & References

Evidence: Nuplazid Prescribing Information, Acadia Pharmaceuticals, January 2025; and guideline reference added: American Psychiatric Association clinical practice guideline (per policy updates).

Background

Pimavanserin is an atypical antipsychotic approved by the FDA for treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The policy includes a boxed warning regarding increased mortality in elderly patients with dementia-related psychosis, and specifies dosing adjustments when given with strong CYP3A4 inhibitors (example: reduce to 10 mg PO once daily with ketoconazole).

Definitions

FDAFood and Drug Administration

Revision History

09.28.2021change

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less. (material)

02.22P&T approval

P&T Approval for 09.28.2021 change (material)

10.04.2022template update

Template changes applied to other diagnoses/indications and continued therapy section. (non-material)