Download Epidermal Growth Factor Receptor (EGFR) Mutation Analysis for

Medical Coverage Policy
Genetic Testing: Epidermal Growth Factor
Receptor (EGFR) Mutation Analysis for Patients
with Non-Small Cell Lung Cancer (NSCLC)
Device/Equipment
Effective Date:
Drug
Medical
1/1/2013
Surgery
Policy Last Updated:
Test
Other
3/5/2013
Prospective review is recommended/required. Please check the member
agreement for preauthorization guidelines.
Prospective review is not required.
Description:
Epidermal growth factor receptor (EGFR) is a receptor tyrosine kinase (TK) frequently
over-expressed and activated in non-small cell lung cancer (NSCLC). Mutations in 2
regions of the EGFR gene (exons 18-24)—small deletions in exon 19 and a point
mutation in exon 21 (L858R)—appear to predict tumor response to tyrosine kinase
inhibitors (TKIs) such as erlotinib. This policy summarizes the evidence for using EGFR
mutations to decide which patients with advanced NSCLC should be considered for
erlotinib therapy and which are better suited for alternative therapies.
The test is intended for use in patients with advanced NSCLC. Patients with either small
deletions in exon 19 or a point mutation in exon 21 (L858R) of the tyrosine kinase
domain of the epidermal growth factor gene are considered good candidates for
treatment with erlotinib. Patients found to be wild type are unlikely to respond to erlotinib
and other treatment options should be considered.
Medical Criteria:
Preauthorization is required for BlueCHiP for Medicare and recommended for all other
BCBSRI products.
Medically necessary:
Analysis of 2 types of somatic mutation within the EGFR gene (small deletions in exon
19 and a point mutation in exon 21 (L858R)) may be considered covered and separately
reimbursed to predict treatment response to erlotinib in patients with advanced NSCLC.
Not medically necessary:
Analysis of 2 types of somatic mutation within the EGFR gene (small deletions in exon
19 and a point mutation in exon 21 (L858R)) is considered not medically necessary for
patients with advanced NSCLC of squamous cell-type as it is unlikely to respond to
erlotinib and may be better suited to alternative therapies.
Analysis for other mutations within exons 18-24, or other applications related to NSCLC,
is considered not medically necessary as it is unlikely to respond to erlotinib and may be
better suited to alternative therapies.
Policy:
Epidermal growth factor receptor mutation analysis for patients with non-small cell lung
cancer is considered medically necessary for patients who meet the above-noted
medical criteria.
Prospective medical review is required for BlueCHiP for Medicare and recommended
for all other product lines.
Coverage:
Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage,
Subscriber Agreement, or Benefit Booklet for complete information.
Coding:
81235
Also Known As:
Not applicable.
Related Topics:
Not applicable.
Published:
Provider Update, May 2013
References:
Blue Cross Blue Shield Association (BCBSA), Technology Evaluation Center (TEC).
Epidermal lung volume receptor mutations TEC Assessment Program. Chicago, IL:
BCBSA; March 2011; 25 (6).
Kobayashi S, Boggon TJ, Dayaram T, et al. EGFR Mutation and Resistance of Non–
Small-Cell Lung Cancer to Gefitinib. The New England Journal of Medicine;February
24, 2005; 352;8:786-792.
Non-small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung
cancer: a meta-analysis using updated data on individual patients from 52 randomised
clinical trials. BMJ 1995;311:899.
History:
3/5/13 New policy approved.
This medical policy is made available to you for informational purposes only. It is not a guarantee
of payment or a substitute for your medical judgment in the treatment of your patients. Benefits
and eligibility are determined by the member's subscriber agreement or member certificate and/or
the employer agreement, and those documents will supersede the provisions of this medical
policy. For information on member-specific benefits, call the provider call center. If you provide
services to a member which are determined to not be medically necessary (or in some cases
medically necessary services which are non-covered benefits), you may not charge the member
for the services unless you have informed the member and they have agreed in writing in advance
to continue with the treatment at their own expense. Please refer to your participation
agreement(s) for the applicable provisions. This policy is current at the time of publication;
however, medical practices, technology, and knowledge are constantly changing. BCBSRI
reserves the right to review and revise this policy for any reason and at any time, with or without
notice.