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Date Printed: August 21, 2017: 07:28 PM

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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-J2000-77

Original Effective Date: 06/15/17

Reviewed: 05/10/17

Revised: 00/00/00

Subject: Niraparib (Zejula®) Capsule

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:

Approximately 22,280 women are predicted to be diagnosed with ovarian cancer in 2016 and 14,240 women are expected to die from the disease. It is estimated that less than 40% of women with ovarian cancer are cured. Many patients relapse following initial therapy and require retreatment with cytotoxic therapy.

Niraparib (Zejula) was approved by the US Food and Drug Administration (FDA) in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Niraparib inhibits poly ADP-ribose polymerase (PARP), which results in cytotoxicity in tumor cell lines with and without the BRCA mutation.

Niraparib was evaluated in 553 patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in a double-blind, placebo-controlled trial. The patients were randomized to receive niraparib or placebo and all had received at least two prior platinum-containing regimens. The patients were in complete or partial response to the most recent regimen and began treatment no later than 8 weeks following the end of the prior platinum treatment. There were two cohorts based on whether the BRCA mutation was present. Niraparib significantly improved the primary endpoint of progression-free survival(PFS) in individuals with and without the BRCA mutation. The median PFS was improved by a greater effect between niraparib and placebo in the patients with the BRCA mutation (21.0 vs 5.5 months; HR 0.26; p<0.0001) as compared to those without the mutation (9.3 vs 3.9 months; HR 0.45; p<0.0001). The most common grade 3 or 4 adverse events were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%).

National Comprehensive Cancer Network (NCCN) Guidelines for Ovarian Cancer recommend niraparib as maintenance therapy in patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with platinum-sensitive disease who have completed two or more lines of platinum-based therapy and are in a complete or partial response.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility does not meet the definition of medical necessity.

I. Initiation of niraparib (Zejula) meets the definition of medical necessity when ALL of the following criteria are met:

1. Epithelial ovarian cancer, Fallopian tube cancer, or Primary peritoneal cancer

a. Member has platinum-sensitive disease and has been treated with two or more lines of platinum-based chemotherapy

b. Niraparib will be used as maintenance therapy following a complete or partial response

c. Niraparib will be used as monotherapy

d. Dose does not exceed 300 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

II. Continuation of niraparib (Zejula) meets the definition of medical necessity for the treatment of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in members meeting the following criteria:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member has previously met all indication-specific initiation criteria

2. Member’s disease has not progressed during treatment with niraparib

3. Dose does not exceed 300 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

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

The recommended dose of niraparib as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily. Patients should start treatment no later than 8 weeks after their most recent platinum-containing regimen. Treatment should be continued until disease progression or unacceptable toxicity.

Dose Adjustments

For adverse reactions, see prescribing information. Consider interruption of treatment, dose reduction, or discontinuation.

Drug Availability

• 100 mg capsule

PRECAUTIONS:

Contraindications

• None

Precautions/Warnings

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed

• Bone Marrow Suppression: Test complete blood counts weekly for the first month, monthly for the next 11 months and periodically thereafter for clinically significant changes.

• Cardiovascular Effects: Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment. Manage with antihypertensive medications as well as adjustment of dose.

• Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals

J8999

Prescription drug, oral, chemotherapeutic, not otherwise specified

ICD-10 Diagnoses Codes That Support Medical Necessity

C48.1 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C56.1 – C56.9

Malignant neoplasm of ovary

C57.00 – C57.9

Malignant neoplasm of other and unspecified female genital organs

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; 2017[cited 2017-04-24]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017-04-24]. Available from: http://www.clinicalpharmacology.com/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017-04-24]. Available from: http://www.thomsonhc.com/.
  4. Mirza MR, Monk BJ, Herrstedt, AM et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016; 375:2154-64.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Ovarian cancer, v. 1.2017 [cited 2017-04-26]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017-04-26]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017-04-24]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  8. Zejula [prescribing information]. Tesaro, Inc. Waltham, MA. March 2017.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

06/15/17

New Medical Coverage Guideline.

Date Printed: August 21, 2017: 07:28 PM