CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pimavanserin (Nuplazid) for Parkinson's disease psychosis — Coverage Criteria

Covers use of Nuplazid (pimavanserin) for treatment of hallucinations and delusions associated with Parkinson's disease psychosis for members of Neighborhood Health Plan of Rhode Island (Medicaid) when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPimavanserin (Nuplazid) for Parkinson's disease psychosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/201

Next Review DateN/A

Key ActionObtain prior authorization from a board-certified neurologist (or consult with one) and document trials of quetiapine and clozapine or reasons they are not appropriate.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moAuth duration

1/dayDaily quantity

NeurologistPrescriber

Quetiapine, clozapinePrior trials

Coverage Criteria for Pimavanserin (Nuplazid)

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Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria: Documented diagnosis of Parkinson's disease and documented diagnosis of Parkinson's disease psychosis.

Timing of psychosis: Onset of psychosis must be after the Parkinson's disease diagnosis (psychosis diagnosis was not present prior to PD diagnosis).

Severity and duration: Recent history of frequent moderate-to-severe hallucinations and/or delusions for at least one month in duration; 'frequent' defined as psychotic events occurring at least once weekly.>=1 month; >=1/week

Cognitive status: Member has mild or no cognitive impairment as determined by physician clinical assessment and/or screening tests (e.g., MMSE, MoCA).

Medication management: Prescriber has attempted to decrease the member's dose of Parkinson's disease medications to address medication-related causes of psychosis.

Dementia-related psychosis: Member has been evaluated for, and does not have, a diagnosis of dementia-related psychosis.

QT interval and interactions: Member does not have evidence of a prolonged QT interval and is not taking medication(s) that may prolong the QT interval.

Prior antipsychotic trial: Member has experienced inadequate response, intolerance, or has a contraindication to quetiapine and clozapine prior to initiation.

Continuation Therapy

Covered when the following are met for continuation:

Continuation criteria: Member has experienced improvement in psychotic symptoms (hallucinations and/or delusions) since starting therapy.

Authorization of up to 12 months may be granted when criteria are met.

Use of Nuplazid (pimavanserin) is limited to the FDA-approved indication: treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Coverage is granted only when the plan's approval criteria for this indication are met, including prescriber, diagnostic, safety, and prior‑treatment requirements.

Treatment of conditions other than the FDA‑approved indication (Parkinson's disease psychosis) is considered experimental/investigational and not a covered benefit.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for treatment. The prescriber must be a board-certified neurologist or the prescriber must consult with a board-certified neurologist and document the consultation. Approvals may be granted for up to 12 months.

Approval duration: up to 12 months
Prescriber: board-certified neurologist or documented consultation with one

Step Therapy

Required Prior Antipsychotic Trials

Step therapy: Member must have experienced an inadequate treatment response, intolerance, or a contraindication to both quetiapine and clozapine prior to approval.

Required prior antipsychotic trials: quetiapine and clozapine (inadequate response, intolerance, or contraindication)

Documentation Required

Required Documentation

Documentation must include a confirmed diagnosis of Parkinson's disease and Parkinson's disease psychosis, timing showing psychosis onset occurred after the Parkinson's disease diagnosis, recent history of frequent moderate-to-severe hallucinations and delusions (at least one month duration; frequent defined as events occurring at least once weekly), assessment of cognitive status (for example MMSE or MOCA) showing mild or no impairment, evaluation for dementia-related psychosis, attempts to reduce dose of Parkinson's medications to address psychosis, and evidence that the member does not have prolonged QT interval or is not taking medications that may prolong QT interval.

Confirm diagnosis: Parkinson's disease and Parkinson's disease psychosis
Psychosis onset after Parkinson's disease diagnosis
Frequency/duration: frequent moderate-to-severe hallucinations/delusions ≥1 month (≥ once weekly)
Cognitive assessment: MMSE or MOCA showing mild or no impairment
Evaluation excluding dementia-related psychosis
Documentation of attempt to decrease Parkinson's disease medication dose to mitigate psychosis
Assessment for prolonged QT or concomitant QT-prolonging medications

Denial Risk

Denial Triggers / Not Covered Indications

Use for indications other than hallucinations and delusions associated with Parkinson's disease psychosis is considered experimental/investigational and is not a covered benefit. Requests that do not meet the specified diagnostic, trial, or documentation requirements should be denied.

Only FDA-approved indication covered: hallucinations and delusions associated with Parkinson's disease psychosis
All other indications = experimental/investigational = not covered
Denial triggers: lack of required prior antipsychotic trials, missing documentation of diagnosis/timing/frequency, evidence of dementia-related psychosis, or unresolved QT interval concerns

Background

Pimavanserin (brand name Nuplazid) is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. Before initiating therapy, clinicians should confirm the diagnosis of Parkinson's disease psychosis and consider cognitive status assessment and cardiac safety (QT interval and concomitant QT‑prolonging medications) as part of the evaluation.

Definitions

Frequent hallucinations and delusions — definition

DefinitionPsychotic events (hallucinations and/or delusions) occurring at least once weekly and present for a duration of at least one month.

Minimum frequency>= once per week

Minimum duration>= 1 month

Context of useApplies when assessing recent history of moderate-to-severe hallucinations and delusions for initial approval of pimavanserin (Nuplazid).