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Date Printed: October 21, 2017: 11:30 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-J2000-32

Original Effective Date: 04/01/15

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Olaparib (LynparzaTM)

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. Metastatic disease will account for 61% of these new cases. The five year survival rate for those diagnosed with metastatic ovarian cancer is less than 27%. Current treatment options for recurrent or metastatic disease include single-agent or combination cytotoxic therapies. Treatment for those who fail two consecutive therapy regimens is limited to clinical trials and supportive care. 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.

Olaparib (Lynparza), a polyadenosine 5-diphosphoribose polymerase (PARP) enzyme inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in December 2014 as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Olaparib is also FDA approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

The initial safety and efficacy of olaparib were evaluated in a phase 2, noncomparative, open-label, nonrandomized single-arm study (Study 42) of subjects with heavily pretreated deleterious or suspected deleterious germline BRCA-mutated advanced cancers. Study 42 enrolled 137 patients with measurable, germline BRCA-mutated advanced ovarian cancer treated with three or more prior lines of chemotherapy. This patient subset was referred to as “Study 1” in the FDA-approved package insert and comprised the pivotal data (objective response rate, duration of response) upon which the drug was approved.

All study participants received olaparib 400 mg twice daily as monotherapy until disease progression or intolerable toxicity. Objective response rate (ORR) and duration of response were assessed by the investigators according to RECIST v1.1. ORR was 34% (95% CI, 26 to 42); 2% of subject had a complete response and 32% a partial response. The median duration of response was 7.9 months (95% CI, 5.6 to 9.6).

BRAC Analysis CDx Mutation Kit was approved with olaparib for use as a diagnostic assay to detect germline BRCA mutations and to aid in the selection of patients for treatment with olaparib.

National Comprehensive Cancer Network (NCCN) Guidelines for Ovarian Cancer recommend olaparib as preferred single-agent therapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with BRCA mutated genes for persistent disease or recurrence following three or more lines of therapy. Olaparib is also recommended as maintenance therapy in patients with platinum sensitive disease that have been treated with two or more lines of platinum-based chemotherapy and are in complete or partial response.

POSITION STATEMENT:

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

1. Member is diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

2. ONE of the following:

a. Olaparib will be used for the treatment of persistent or recurrent disease and member meets BOTH of the following:

i. Member has a deleterious (or suspected deleterious) germline BRCA mutation as detected by an FDA-approved test

ii. Member has been treated with three or more lines of chemotherapy

b. Olaparib will be used as maintenance therapy following a complete or partial response and meets BOTH of the following:

i. Member has platinum sensitive disease

ii. Member has been treated with two or more lines of platinum-based chemotherapy

3. Olaparib will be used as monotherapy

4. Dose does not exceed the following:

a. Tablets: 600 mg/day – dosage will be achieved using the fewest number of tablets per day

b. Capsules: 800 mg/day – dosage will be achieved using the fewest number of capsules per day

Approval duration: 6 months

Continuation of olaparib (Lynparza) 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 olaparib

3. Dose does not exceed the following:

a. Tablets: 600 mg/day – dosage will be achieved using the fewest number of tablets per day

b. Capsules: 800 mg/day – dosage will be achieved using the fewest number of capsules 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

Advanced germline BRCA-mutated ovarian cancer after 3 or more lines of chemotherapy: Capsules: 400 mg twice daily; Tablets: 300 mg twice daily

Maintenance treatment of recurrent ovarian cancer who are in a complete or partial response to platinum-based chemotherapy: Tablets: 300 mg twice daily

Continue treatment until disease progression or unacceptable toxicity

Do not substitute tablets and capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation

Swallow whole – do not chew, dissolve, or crush.

Dose Adjustments

Moderate renal impairment (CrCl 31-50 mL/min): Capsules: reduce dose to 300 mg twice daily; Tablets: reduce dose to 200 mg twice daily

CYP3A Inhibitors: Avoid concomitant use, if the inhibitor cannot be avoided refer to prescribing information.

Adverse reactions: Consider dose interruption or dose reduction, refer to prescribing information

Drug Availability

• 50 mg capsule

100mg and 150 mg tablets

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Myelodysplastic syndrome/Acute Myeloid Leukemia

• Pneumonitis

• Embryo-Fetal toxicity

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 Diagnosis Codes That Support Medical Necessity

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C56.1C56.9

Malignant neoplasm of ovary

C57.00C57.02

Malignant neoplasm of fallopian tube

C57.10C57.12

Malignant neoplasm of broad ligament

C57.20C57.22

Malignant neoplasm of round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

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 last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2017[cited 2017-02-14]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. AstraZeneca. Lynparza (olaparib) capsule. 2017 [cited 2017-08-30]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e31a6a9-864f-4aba-8085-37ee1ddcd499/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017-08-30]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016-02-12]. Available from: http://clinicaltrials.gov/.
  5. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017-08-30]. Available from: http://www.thomsonhc.com/.
  6. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Ovarian cancer, v. 3.2017 [cited 2017-08-30]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  7. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017-08-30]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  8. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017-02-21]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 09/13/17.

GUIDELINE UPDATE INFORMATION:

03/15/15

New Medical Coverage Guideline.

11/01/15

Revision: ICD-9 Codes deleted.

04/15/16

Review and revision to guidelines; position statement, coding, references, description.

04/15/17

Review and revision to guidelines; consisting of updating position statement, description, precautions and references.

10/15/17

Review and revision to guideline; consisting of updating position statement, description, dosing and references.

Date Printed: October 21, 2017: 11:30 AM