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Date Printed: August 21, 2017: 07:47 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-J2000-72

Original Effective Date: 03/15/17

Reviewed: 02/08/17

Revised: 00/00/00

Subject: Rucaparib (Rubraca®)

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. BRCA gene mutations are present in an estimated 15 to 20 percent of patients with ovarian cancer. The BRCA genes work to prevent tumor development by repairing damaged DNA, and a mutation in BRCA can cause ovarian cancer. Rucaparib inhibits poly ADP-ribose polymerase (PARP), which results in cytotoxicity in tumor cell lines with the BRCA mutation.

Rucaparib (Rubraca) was approved by the US Food and Drug Administration (FDA) in December 2016 as monotherapy for the treatment of advanced ovarian cancer with deleterious BRCA mutation (germline and/or somatic) as detected by a FDA-approved test (available at http://www.fda.govCompanionDioagnositics) in adults who have been previously treated with 2 or more chemotherapies. Approval is contingent upon confirmation of clinical benefit as part of the accelerated approval process.

Rubraca was evaluated in 106 patients with advanced ovarian cancer in two single-arm, open-label clinical trials. All patients had progressed after 2 or more prior chemotherapies and 96% had confirmed BRCA gene mutations using the FoundationFocus CDxBRCA companion diagnostic test. There was an objective response rate (ORR) of 54% and a duration of response of 9.2 months. The ORR was 66% in platinum-sensitive, 25% in platinum-resistant, and 0% in platinum-refractory patients. The most common adverse reactions were gastrointestinal (nausea, vomiting, constipation, diarrhea), hematological (anemia, thrombocytopenia), and respiratory (dyspnea). The most common reactions leading to dose reduction or interruption were anemia and fatigue.

POSITION STATEMENT:

Initiation of rucaparib (Rubraca) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with advanced ovarian cancer

2. Member has a deleterious BRCA mutation as detected by an FDA-approved test – laboratory documentation must be provided

3. Member ‘s disease has been treated with two or more lines of chemotherapy

4. Rucaparib will be used as monotherapy

5. Dose does not exceed 1200 mg/day – dosage will be achieved using the fewest number of tablets per day

Approval duration: 6 months

Continuation of rucaparib (Rubraca) meets the definition of medical necessity for the treatment of ovarian 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 rucaparib

3. Dose does not exceed 1200 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

Rucaparib is indicated for treatment of deleterious BRCA mutation associated advanced ovarian cancer that has been treated with two or more chemotherapies. Patient selection is based on use of an FDA-approved companion diagnostic test. The dose is 600 mg orally twice a day until disease progression or unacceptable toxicity.

Dose Adjustments

There is no starting dose adjustment for patients with mild to moderate renal impairment or mild hepatic impairment. Data is not available for patients with CrCl less than 30 mL/min, on dialysis, or those with moderate to severe hepatic impairment and dosing cannot be recommended.

Interrupt or reduce dose according to package labeling for adverse reactions.

Drug Availability

200 mg and 300 mg tablets

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported with use, including one fatal event of AML. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

• 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:

09-J2000-32, Olaparib (Lynparza)

OTHER:

None.

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2017. URL www.clinicalpharmacilogy-ip.com Accessed 1/18/17.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2017 - [cited 2017-01-24]. Available from: http://clinicaltrials.gov/.
  3. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 1/18/17.
  4. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Ovarian cancer, v. 1.2016 [cited 2017-01-24]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  5. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017-01-24]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  6. Rubraca (rucaparib) [package insert]. Clovis Oncology, Inc. Boulder (CO): December 2016.
  7. U.S. Food and Drug Administration Website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm Accessed 1/24/17.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 02/08/2017.

GUIDELINE UPDATE INFORMATION:

03/15/17

New Medical Coverage Guideline.

Date Printed: August 21, 2017: 07:47 PM