Triple negative breast cancer Diagnosed at any age with: o

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1 Last Review Date: February 9, 2018 Number: MG.MM.LA.08h Medical Guideline Disclaimer Prperty f EmblemHealth. All rights reserved. The treating physician r primary care prvider must submit t EmblemHealth the clinical evidence that the patient meets the criteria fr the treatment r surgical prcedure. Withut this dcumentatin and infrmatin, EmblemHealth will nt be able t prperly review the request fr prir authrizatin. The clinical review criteria expressed belw reflects hw EmblemHealth determines whether certain services r supplies are medically necessary. EmblemHealth established the clinical review criteria based upn a review f currently available clinical infrmatin (including clinical utcme studies in the peer-reviewed published medical literature, regulatry status f the technlgy, evidence-based guidelines f public health and health research agencies, evidence-based guidelines and psitins f leading natinal health prfessinal rganizatins, views f physicians practicing in relevant clinical areas, and ther relevant factrs). EmblemHealth expressly reserves the right t revise these cnclusins as clinical infrmatin changes, and welcmes further relevant infrmatin. Each benefit prgram defines which services are cvered. The cnclusin that a particular service r supply is medically necessary des nt cnstitute a representatin r warranty that this service r supply is cvered and/r paid fr by EmblemHealth, as sme prgrams exclude cverage fr services r supplies that EmblemHealth cnsiders medically necessary. If there is a discrepancy between this guideline and a member's benefits prgram, the benefits prgram will gvern. In additin, cverage may be mandated by applicable legal requirements f a state, the Federal Gvernment r the Centers fr Medicare & Medicaid Services (CMS) fr Medicare and Medicaid members. All cding and web site links are accurate at time f publicatin. EmblemHealth Services Cmpany LLC, ( EmblemHealth ) has adpted the herein plicy in prviding management, administrative and ther services t HIP Health Plan f New Yrk, HIP Insurance Cmpany f New Yrk, Grup Health Incrprated and GHI HMO Select, related t health benefit plans ffered by these entities. All f the afrementined entities are affiliated cmpanies under cmmn cntrl f EmblemHealth Inc. Definitins Clse bld relative Limited family histry 1 st, 2 nd, r 3 rd degree relative (a parent, full sibling, half sibling, child, grandparent, great-grandparent, grandchild, aunt, great aunt, uncle, great uncle, nephew, niece r first cusin). Fewer than tw first- r secnd-degree female relatives r female relatives surviving beynd 45 years in either lineage (maternal and paternal). Guideline A. BRCA 1 and 2 genetic testing (sequencing analysis, funder mutatins) is cnsidered medically necessary when results will directly impact surveillance r treatment and ne r mre f the fllwing criteria are met: Individual frm a family with a knwn deleterius BRCA1/ BRCA2 gene mutatin Persnal histry f breast cancer (includes invasive and ductal carcinma in situ) + ne r mre f the fllwing: Diagnsed 45 y Diagnsed 50 y with: Diagnsed 60 y with: An additinal breast cancer primary (Nte: Tw breast cancer primaries includes bilateral [cntralateral] disease r tw r mre clearly separate ipsilateral primary tumrs either synchrnusly r asynchrnusly) 1 clse bld relative with breast cancer at any age 1 clse relative with pancreatic cancer 1 relative with prstate cancer (Gleasn scre 7 r metastatic) An unknwn r limited family histry

2 Page 2 f 6 Triple negative breast cancer Diagnsed at any age with: 2 clse bld relatives with breast cancer, pancreatic cancer, r prstate cancer (Gleasn scre 7 r metastatic) at any age 1 clse bld relative with breast cancer diagnsed 50 y 1 clse bld relative with varian carcinma A clse male bld relative with breast cancer Fr an individual f ethnicity assciated with higher mutatin frequency (eg, Ashkenazi Jewish) n additinal family histry may be required (Nte: Testing fr Jewish Ashkenazi funder-specific mutatin[s] shuld be perfrmed first. Cmprehensive genetic testing may be cnsidered if ancestry als includes nn-ashkenazi Jewish relatives r if ther BRCA-related criteria are met. Funder mutatins exist in ther ppulatins) Persnal histry f varian carcinma Persnal histry f male breast cancer Persnal histry f high-grade prstate cancer (Gleasn scre 7) at any age with 1 clse bld relative with varian carcinma at any age r breast cancer 50 y r tw relatives with breast, pancreatic, r prstate cancer (Gleasn scre 7r metastatic) at any age Persnal histry f metastatic prstate cancer (radigraphic evidence f r bipsy-prven disease) Persnal histry f pancreatic cancer at any age with 1 clse bld relative with varian carcinma at any age r breast cancer 50 y r tw relatives with breast, pancreatic cancer, r prstate cancer (Gleasn scre n r metastatic) at any age Persnal histry f pancreatic cancer and Ashkenazi Jewish ancestry BRCA1/2 pathgenic mutatin detected by tumr prfiling n any tumr type in the absence f germline mutatin analysis Family histry nly (significant limitatins f interpreting test results fr an unaffected individual shuld be discussed): First- r secnd-degree bld relative meeting any f the abve criteria Third-degree bld relative wh has breast cancer and/r varian carcinma (includes fallpian tube and primary peritneal cancers) and wh has 2 clse bld relatives with breast cancer (at least ne with breast cancer 50 y) and/r varian carcinma Unaffected/asymptmatic member with psitive family histry f hereditary breast and varian cancer (HBOC) syndrme B. Members are eligible fr BRCA 1 and 2 rearrangement testing if the criteria fr cmprehensive sequence analysis are met and the analysis is negative. Limitatins/Exclusins Authrizatin shuld initially be fr the mutatin(s) specific t the ethnic grup in questin (e.g., Multisite 3 BRACAnalysis [r equivalent testing fr funder mutatins] fr members f Ashkenazi descent). If multisite screening is negative, additinal genetic testing (e.g., cmprehensive sequence analysis) wuld be warranted if the member meets the remainder f the criteria abve. Requests that d nt meet the testing criteria will be reviewed by a Medical Directr.

3 Page 3 f 6 Revisin Histry 2/9/2018 updated cmmensurate with V NCCN criteria. 12/9/2016 expanded cverage t unaffected/asymptmatic members with psitive family histry f HBOC Syndrme. Applicable Prcedure Cdes BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and varian cancer) gene analysis; full sequence analysis and full duplicatin/deletin analysis BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and varian cancer) gene analysis; full sequence analysis and cmmn duplicatin/deletin variants in BRCA1 (ie, exn 13 del 3.835kb, exn 13 dup 6kb, exn del 26kb, exn 22 del 510 bp, exn 8-9 del 7.1kb) BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and varian cancer) gene analysis; 185 delag, 5385insC, 6174delT variants BRCA1, BRCA2 (breast cancer 1 and 2) (eg, hereditary breast and varian cancer) gene analysis; uncmmn duplicatin/deletin variants BRCA1 (breast cancer 1) (eg, hereditary breast and varian cancer) gene analysis; full sequence analysis and cmmn duplicatin/deletin variants (ie, exn 13 del 3.835kb, exn 13 dup 6kb, exn del 26kb, exn 22 del 510 bp, exn 8-9 del 7.1kb) BRCA1 (breast cancer 1) (eg, hereditary breast and varian cancer) gene analysis; knwn familial variant BRCA2 (breast cancer 2) (eg, hereditary breast and varian cancer) gene analysis; full sequence analysis BRCA2 (breast cancer 2) (eg, hereditary breast and varian cancer) gene analysis; knwn familial variant Applicable ICD-10 Diagnsis Cdes C Malignant neplasm f nipple and arela, right female breast C Malignant neplasm f nipple and arela, left female breast C Malignant neplasm f nipple and arela, unspecified female breast C Malignant neplasm f nipple and arela, right male breast C Malignant neplasm f nipple and arela, left male breast C Malignant neplasm f nipple and arela, unspecified male breast C Malignant neplasm f central prtin f right female breast C Malignant neplasm f central prtin f left female breast C Malignant neplasm f central prtin f unspecified female breast C Malignant neplasm f central prtin f right male breast C Malignant neplasm f central prtin f left male breast C Malignant neplasm f central prtin f unspecified male breast C Malignant neplasm f upper-inner quadrant f right female breast C Malignant neplasm f upper-inner quadrant f left female breast C Malignant neplasm f upper-inner quadrant f unspecified female breast C Malignant neplasm f upper-inner quadrant f right male breast

4 Page 4 f 6 C Malignant neplasm f upper-inner quadrant f left male breast C Malignant neplasm f upper-inner quadrant f unspecified male breast C Malignant neplasm f lwer-inner quadrant f right female breast C Malignant neplasm f lwer-inner quadrant f left female breast C Malignant neplasm f lwer-inner quadrant f unspecified female breast C Malignant neplasm f lwer-inner quadrant f right male breast C Malignant neplasm f lwer-inner quadrant f left male breast C Malignant neplasm f lwer-inner quadrant f unspecified male breast C Malignant neplasm f upper-uter quadrant f right female breast C Malignant neplasm f upper-uter quadrant f left female breast C Malignant neplasm f upper-uter quadrant f unspecified female breast C Malignant neplasm f upper-uter quadrant f right male breast C Malignant neplasm f upper-uter quadrant f left male breast C Malignant neplasm f upper-uter quadrant f unspecified male breast C Malignant neplasm f lwer-uter quadrant f right female breast C Malignant neplasm f lwer-uter quadrant f left female breast C Malignant neplasm f lwer-uter quadrant f unspecified female breast C Malignant neplasm f lwer-uter quadrant f right male breast C Malignant neplasm f lwer-uter quadrant f left male breast C Malignant neplasm f lwer-uter quadrant f unspecified male breast C Malignant neplasm f axillary tail f right female breast C Malignant neplasm f axillary tail f left female breast C Malignant neplasm f axillary tail f unspecified female breast C Malignant neplasm f axillary tail f right male breast C Malignant neplasm f axillary tail f left male breast C Malignant neplasm f axillary tail f unspecified male breast C Malignant neplasm f verlapping sites f right female breast C Malignant neplasm f verlapping sites f left female breast C Malignant neplasm f verlapping sites f unspecified female breast C Malignant neplasm f verlapping sites f right male breast C Malignant neplasm f verlapping sites f left male breast C Malignant neplasm f verlapping sites f unspecified male breast

5 Page 5 f 6 C Malignant neplasm f unspecified site f right female breast C Malignant neplasm f unspecified site f left female breast C Malignant neplasm f unspecified site f unspecified female breast C Malignant neplasm f unspecified site f right male breast C Malignant neplasm f unspecified site f left male breast C Malignant neplasm f unspecified site f unspecified male breast C56.1 Malignant neplasm f right vary C56.2 Malignant neplasm f left vary C56.9 Malignant neplasm f unspecified vary D05.10 Intraductal carcinma in situ f unspecified breast D05.11 Intraductal carcinma in situ f right breast D05.12 Intraductal carcinma in situ f left breast D05.80 Other specified type f carcinma in situ f unspecified breast D05.81 Other specified type f carcinma in situ f right breast D05.82 Other specified type f carcinma in situ f left breast D05.90 Unspecified type f carcinma in situ f unspecified breast D05.91 Unspecified type f carcinma in situ f right breast D05.92 Unspecified type f carcinma in situ f left breast Z15.01 Genetic susceptibility t malignant neplasm f breast Z15.02 Genetic susceptibility t malignant neplasm f vary Z80.3 Family histry f malignant neplasm f breast Z80.41 Family histry f malignant neplasm f vary Z85.3 Persnal histry f malignant neplasm f breast Z85.43 Persnal histry f malignant neplasm f vary Z Persnal histry f in-situ neplasm f breast References 1. Natinal Cmprehensive Care Netwrk. Genetic/Familial High-Risk Assessment: Breast Ovarian. Versin Accessed February 2, U. S. Preventive Services Task Frce. Genetic risk assessment and BRCA mutatin testing fr breast and varian cancer susceptibility Sept. accessed at 3. Armstrng K, Eisen A, Weber B. Assessing the risk f breast cancer. N Engl J Med Feb;342(8): Breast Cancer Susceptibility 1 and 2 (BRCA 1/2) Gene Testing fr Hereditary Breast and Ovarian Cancer (HBOC). Hayes GTE Reprt. Winifred S. Hayes, Inc. August 6, 2013.

6 Page 6 f 6 5. Agata S, Viel A, Della Puppa L, et al. Prevalence f BRCA1 genmic rearrangements in a large chrt f Italian breast and breast/varian cancer families withut detectable BRCA1 and BRCA2 pint mutatins. Genes Chrmsmes Cancer Sep;45(9): Engert S, Wappenschmidt B, Betz B, et al. MLPA screening in the BRCA1 gene frm 1,506 German hereditary breast cancer cases: nvel deletins, frequent invlvement f exn 17, and ccurrence in single early-nset cases. Hum Mutat Jul;29(7): Gutierrez-Enriquez S, de la Hya M, Martinez-Buzas C, et al. Screening fr large rearrangements f the BRCA2 gene in Spanish families with breast/varian cancer. Breast Cancer Res Treat May;103(1): Haber D. Prphylactic phrectmy t reduce the risk f varian and breast cancer in carriers f BRCA mutatins. N Engl J Med 2002;346 (21): Hayes GTE Reprt. The Clinical Utility f Genetic Testing fr Hereditary Breast and Ovarian Cancer in Patients with n Persnal Histry f Cancer and a Suggestive Family Histry. December Accessed December 13, Kaback MM, Greendale K, Fnseca LM, et al., American Cllege f Medical Genetics Fundatin. Genetic susceptibility t breast and varian cancer: assessment, cunseling and testing guidelines. Supprted by the New Yrk State Department f Health accessed 10/24/06 at Kauff ND, Satagpan JM, Rbsn ME, et al. Risk-reducing salping-phrectmy in wmen with a BRCA1 r BRCA2 mutatin. N Engl J Med. 2002;346(21): Manguglu E, Guran S, Yamac D, et al. Genmic large rearrangement screening f BRCA1 and BRCA2 genes in high-risk Turkish breast/varian cancer patients by using muliplex ligatin-dependent prbe amplificatin assay. Cancer Invest Jan;29(1): Palma MD, Dmchek SM, Stpfer J, et al. The relative cntributin f pint mutatins and genmic rearrangements in BRCA1 and BRCA2 in high-risk breast cancer families. Cancer Res Sep;68(17): Preisler-Adams S, Schnbuchner I, Fiebig B, et al. Grss rearrangements in BRCA1 but nt BRCA2 play a ntable rle in predispsitin t breast and varian cancer in high-risk families f German rigin. Cancer Genet Cytgenet Jul;168(1): Rebbeck TR, Lynch HT, Neuhausen SL, et al. Prphylactic phrectmy in carriers f BRAC1 r BRCA2 mutatins. N Engl J Med. 2002;346(21): Sluiter MD, van Rensburg EJ. Large genmic rearrangements f the BRCA 1 and BRCA2 genes: review f the literature and reprt f a nvel BRCA 1 mutatin. Breast Cancer Res Treat Jan;125(2): Stadler ZK, Slustrs E, Hansen SA, et al. Absence f genmic BRCA1 and BRCA2 rearrangements in Ashkenazi breast and varian cancer families. Breast Cancer Res Treat Sept;123(2): Specialty-matched clinical peer review. 19. Wdward AM, Davis TA, Silva AG, et al. Large genmic rearrangements f bth BRCA2 and BRCA1 are a feature f the inherited breast/varian cancer phentype in selected families. J Med Genet May;42(5):e31.