Nuplazid (pimavanserin)

POLICY NUMBER

L.5.01.511

Nuplazid (pimavanserin)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Nuplazid (pimavanserin) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The mechanism of action in the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis is unclear. However, the effect could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Nuplazid (pimavanserin) may be considered medically necessary when ALL of the following criteria are met:

1. The individual has a documented diagnosis of Parkinson’s disease psychosis;

2. Hallucinations or delusions associated with Parkinson’s disease psychosis developed after Parkinson’s disease diagnosis and have been present >1 month;

3. ONE of the following:

   1. The individual has tried and failed treatment with clozapine or quetiapine; OR

   2. The individual has a documented intolerance, hypersensitivity, or FDA-labeled contraindication to clozapine or quetiapine;

4. The individual is not and will not be treated with an additional antipsychotic;

5. The individual does not have any FDA labeled contraindications for the requested agent; AND

6. Dose requested is within the FDA approved dosage limits for treatment of the requested indication.

Length of Approval: 12 months

RenewalCriteria

Nuplazid (pimavanserin) may be considered for renewal when ALL of the following criteria are met:

1. The individual was previously approved through BCBSMS PA review process;

2. The individual has documented clinical improvement (i.e., improvement in symptom severity and/or frequency);

3. The individual does not have any FDA-labeled contraindication(s) to the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage range.

Length of Approval: 12 months

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

Medication failure is defined as disease progression despite maximally tolerated dose (>3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

POLICY HISTORY

09/15/2016: New policy added. Policy number L.5.01.511.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding quantity limits. Sources updated.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy description updated to remove quantity limits table. Policy section updated to add statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement revised to state that Nuplazid is considered medically necessary when certain criteria are met. Added quantity limits table. Sources section updated. Effective 01/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding treatment and quantity limits. Medically necessary policy statement updated to add additional criteria. Added renewal criteria. Policy Exceptions updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and to define investigative and medication failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Revised medically necessary criteria regarding a documented diagnosis of Parkinson's disease psychosis, treatment failure, and a documented intolerance, hypersensitivity, or FDA-labeled contraindication to clozapine or quetiapine. Added renewal statement for Nuplazid (pimavanserin) and revised listed criteria. Sources updated.

SOURCE(S)

Nuplazid prescribing information. Acadia Pharmaceuticals Inc. September 2023. Last accessed January 2025.

CODE REFERENCE

None