Subject: Nuplazid SGM 2319-A P2024_R

Drug

NUPLAZID  (pimavanserin)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Nuplazid is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Parkinson’s disease^1-3

Authorization of 6 months may be granted for treatment of hallucinations and delusions associated with Parkinson’s disease psychosis when the member has mild or no cognitive impairment as determined by the physician’s clinical diagnosis and/or cognitive impairment screening tests (e.g., Mini-Mental Status Examination [MMSE], Montreal Cognitive Assessment [MoCA]).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment of hallucinations and delusions associated with Parkinson’s disease psychosis when the member has experienced improvement in psychotic symptoms (hallucinations and/or delusions) since starting therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nuplazid [package insert]. San Diego, CA: Acadia Pharmaceuticals, Inc.; September 2023.
2. Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomized, placebo-controlled phase 3 trial. [published correction appears in Lancet. 2014 Jul 5;384(9937):28]. Lancet. 2014; 383(9916):533-540. doi:10.1016/S0140-6736(13)62106-6
3. Hoops S, Nazem S, Siderowf AD, et al. Validity of the MoCA and MMSE in the detection of MCI and dementia in Parkinson disease. Neurology. 2009; 73 (21): 1738-1745. doi:10.1212/WNL.0b013e3181c34b47

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 23, 2025