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Date Printed: August 18, 2017: 10:35 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-66

Original Effective Date: 09/15/16

Reviewed: 08/10/16

Revised: 09/15/16

Subject: Pimavanserin (Nuplazid®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates    
           

DESCRIPTION:

The Food and Drug Administration (FDA) approved pimavanserin (Nuplazid®) in April 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Pimavanserin (Nuplazid®) is an atypical antipsychotic that works as an inverse agonist and antagonist at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors. Pimavanserin has no binding affinity for dopamine receptors.

Pimavanserin was evaluated in a 6-week randomized, placebo-controlled study. Study participants were aged 40 years or older and had a diagnosis of Parkinson’s disease (PD) established at least 1 year prior to study entry. The participants were on stable PD medications and were required to have a Mini-Mental State Examination (MMSE) score greater than or equal to 21. Participants had severe psychotic symptoms (hallucinations and/or delusions) severe enough to warrant treatment that began after diagnosis of PD. The primary efficacy endpoint of the study was assessed using the Scale for the Assessment of Positive Symptoms adapted for PD (SAPS-PD). Pimavanserin significantly reduced the frequency and/or severity of hallucinations and delusions as compared to placebo in participants with PDP (difference -3.06, p=0.001). Pimavanserin did not show an effect on motor function.

POSITION STATEMENT:

Initiation of pimavanserin (Nuplazid) meets the definition of medical necessity when ALL of the following are met:

1. Member has a diagnosis of Parkinson’s disease

2. Use is for the treatment of hallucinations or delusions associated with Parkinson’s disease psychosis

3. Symptoms of psychosis (hallucinations or delusions) have been present for at least one month and developed after the diagnosis of Parkinson’s disease

4. Other causes of psychosis have been ruled out (e.g., infection, electrolyte disturbances)

5. The member is not receiving treatment with an additional antipsychotic

6. Dose does not exceed 34 mg daily

Approval duration: 1 year

Continuation of pimavanserin (Nuplazid) meets the definition of medical necessity when ALL of the following are met:

1. The member has been previously approved by Florida Blue or another healthplan in the past 2 years, OR the member has previously met all indication-specific criteria

2. Use is for the treatment of hallucinations or delusions associated with Parkinson’s disease psychosis

3. Member has demonstrated a beneficial response to therapy

4. The member is not receiving treatment with an additional antipsychotic

5. Dose does not exceed 34 mg daily

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The recommended dose is 34 mg, taken orally as two 17 mg tablets once daily, without titration, and can be taken with or without food.

Dose Adjustments

Severe renal impairment: Pimavanserin is not recommended and has not been evaluated in patients with severe renal impairment (CrCl < 30 ml/min).

Hepatic impairment: Pimavanserin is not recommended and has not been evaluated in patients with severe hepatic impairment.

Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin, itraconazole): Reduce dose by one-half.

Strong CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): Monitor for reduced efficacy. An increase in dosage may be needed.

Drug Availability

• 17 mg tablets

PRECAUTIONS:

Boxed Warning

• Increased mortality in elderly patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Pimavanserin is not approved for the treatment of patients with dementia –related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

Contraindications

• none

Precautions/Warnings

• QT Interval Prolongation: Increases in QT interval; avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, Not otherwise specified

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

G20

Parkinson’s disease

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the guideline creation.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 2016-07-25]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016-07-25]. Available from: http://www.clinicalpharmacology.com/.
  3. Cummings J, Isaacson S, Mills R et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomized, placebo-controlled phase 3 trial. Lancet 2014; 383: 533-40.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-07-25]. Available from: http://www.thomsonhc.com/
  5. Nuplazid® (pimavanserin) [package insert]. Acadia Pharmaceuticals Inc. San Diego, CA. May 2016.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/10/16.

GUIDELINE UPDATE INFORMATION:

09/15/16

New Medical Coverage Guideline.

Date Printed: August 18, 2017: 10:35 AM