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Date Printed: June 23, 2017: 06:33 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-J2000-44

Original Effective Date: 09/15/15

Reviewed: 08/10/16

Revised: 09/15/16

Next Review: 08/09/17

Subject: Gefitinib (Iressa)

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  

Previous Version

           

DESCRIPTION:

Gefitinib (Iressa), an oral selective epidermal growth factor receptor (EGFR)-inhibitor, was approved by the U.S. Food and Drug Administration (FDA) in July 2015 for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Efficacy has not been established in patients with whose tumors have other EGFR mutations.

The efficacy and safety of gefitinib for the first-line treatment of patients with metastatic NSCLC containing EGFR exon 19 deletions or L858R substitution mutations was demonstrated in a multicenter, single-arm, open-label clinical study (Study 1). A total of 106 treatment-naive patients with metastatic EGFR mutation positive NSCLC received gefitinib 250 mg once daily until disease progression or intolerable toxicity. The major efficacy outcome measure was objective response rate (ORR) according to RECIST v1.1 as evaluated by both blinded independent review and investigators. Duration of response (DOR) was an additional outcome measure.

Eligible patients were required to have a deletion in EGFR exon 19 or L858R, L861Q, or G719X substitution mutation and no T790M or S768I mutation or exon 20 insertion in tumor specimens as prospectively determined by a clinical trial assay. Tumor samples from 87 patients were tested retrospectively using the therascreen® EGFR RGQ PCR Kit. Sixty patients had exon 19 deletions (65%), 29 patients had L858R substitution (31%), while two patients each had tumors harboring L861Q or G719X substitution mutation.

The median duration of treatment was 8.0 months. Efficacy results from Study 1 are summarized below:

Efficacy Parameter

Blinded Independent

Assessment (n=106)

Investigator

Assessment (n=106)

ORR (95% CI)

50% (41, 59)

70% (61, 78)

Complete Response Rate

0.9%

1.9%

Median DOR (months) (95% CI)

6.0 (5.6, 11.1)

8.3 (7.6, 11.3)

The response rates were similar in patients whose tumors had EGFR exon 19 deletions and exon 21 L858R substitution mutations. Two partial responses were observed in both patients whose tumors had G719X substitution mutation with duration of response of at least 2.8 months and 5.6 months, respectively. One of two patients whose tumors had L861Q substitution mutation also achieved a partial response with duration of response of at least 2.8 months.

National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 4.2016) recommend gefitinib be used in place of erlotinib for EGFR mutation positive NSCLC; however, this was based on gefitinib’s availability worldwide and not based on the recent FDA-approval in the US.

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 is not considered medically necessary.

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

1. Member is diagnosed with non-small cell lung cancer (NSCLC)

2. Member’s disease is recurrent or metastatic

3. Member has a documented epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation as detected by an FDA-approved test – laboratory documentation must be provided

4. Dose does not exceed 250 mg daily with the following exception:

a. Dose does not exceed 500 mg daily AND member is receiving a concomitant strong CYP3A4 enzyme inducer (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifapentin)

5. Member is age 18 years or older

Approval duration: 6 months

Continuation of gefitinib (Iressa) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member was previously approved by Florida Blue or another health plan in the past 2 years for the treatment of NSCLC with an EGFR exon 19 deletion or exon 21 substitution as detected by an FDA-approved test, OR the member previously met ALL indication-specific initiation criteria

2. Member’s disease has not progressed during treatment with gefitiinib OR member has asymptomatic disease, symptomatic brain lesions, or isolated symptomatic systemic lesions

3. Dose does not exceed 250 mg daily with the following exception:

a. Dose does not exceed 500 mg daily AND member is receiving a concomitant strong CYP3A4 enzyme inducer (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifabutin, rifampin, rifapentin)

4. Member is age 18 years or older

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

• 250 mg orally, once daily with or without food

Dose Adjustments

• Refer to prescribing information

Drug Availability

• Tablets: 250 mg

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• Interstitial lung disease

• Hepatotoxicity: Obtain periodic liver function testing

• Gastrointestinal perforation

• Diarrhea

• Ocular disorders including keratitis

• Bullous and exfoliative skin disorders

• Embryo-fetal toxicity

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8565

Gefitinib, oral, 250 mg

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

C34.0

Malignant neoplasm of main bronchus

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.1

Malignant neoplasm of upper lobe, bronchus or lung

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.3

Malignant neoplasm of lower lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.8

Malignant neoplasm of overlapping sites of bronchus and lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.9

Malignant neoplasm of unspecified part of bronchus or lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

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; 2015 [cited 2016-07-23]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. AstraZeneca. Iressa (gefitinib) tablet, coated. 2015 [cited 2016-07-23]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41#section-1/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016-07-23]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016-07-23]. Available from: http://clinicaltrials.gov/.
  5. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-07-23]. Available from: http://www.thomsonhc.com/.
  6. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-small cell lung cancer, v. 4.2016 [cited 2016-07-21]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016-07-23]. 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 08/10/16.

GUIDELINE UPDATE INFORMATION:

09/15/15

New Medical Coverage Guideline.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/16

Review and revision to guideline, consisting of updating position statement and references

Date Printed: June 23, 2017: 06:33 PM