Erbitux (cetuximab) Dcument Number: IC-0038 Last Review Date: 11/21/2017 Date f Origin: 12/22/2009 Dates Reviewed: 07/2010, 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017 I. Length f Authrizatin Cverage will be prvided fr six mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Erbitux 100 mg slutin fr injectin Erbitux 200 mg slutin fr injectin Weekly Every tw weeks 1 vial every 7 days 1 vial every 14 days 3 vials every 7 days (5 vials fr first dse nly) 6 vials every 14 days B. Max Units (per dse and ver time) [Medical Benefit]: Weekly Lad: 100 billable units x 1 dse Maintenance Dse: 60 billable units every 7 days Every tw weeks 120 billable units every 14 days III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Clrectal Cancer Patient is bth KRAS and NRAS mutatin negative (wild-type) as determined by FDAapprved tests; AND Patient has nt been previusly treated with cetuximab r panitumumab; AND Patient must have prgressive, metastatic, r unresectable advanced disease; AND Used in cmbinatin with irintecan- r xaliplatin-based regimens ; OR Used as a single agent therapy fr metastatic disease ; AND Patient has previusly failed n an xaliplatin- and irintecan-based regimen; OR Patient is unable t tlerate irintecan Mda Health Plan, Inc. Medical Necessity Criteria Page 1/9
Squamus Cell Carcinma f the Head and Neck (SCCHN) Used in ne f the fllwing regimens: In cmbinatin with radiatin therapy fr reginally r lcally advanced disease; OR As a single agent in recurrent r metastatic disease after failure n platinum-based therapy; OR In cmbinatin with platinum-based therapy fr first-line treatment f recurrent, lcreginal, r metastatic disease; AND Patient has ne f the fllwing types: Cancer f the Glttic Larynx Cancer f the Hyppharynx Cetuximab may als be used as a single agent fr sequential chemradiatin Cancer f the Lip Cancer f the Naspharynx Cancer f the Orpharynx Cetuximab may als be used as a single agent fr sequential chemradiatin Cancer f the Supraglttic Larynx Ethmid Sinus Tumrs Maxillary Sinus Tumrs Very advanced and recurrent/persistent head and neck cancer Cetuximab may als be used as a single agent fr very advanced and recurrent persistent head and neck cancer Occult Primary Head and Neck Cancers Must be used as initial treatment as a single agent with sequential chemradiatin Nn-melanma Skin Cancer (squamus cell cancers) Fr reginal recurrence r distant metastases Penile Cancer Patient must have metastatic disease; AND Must be used fr subsequent treatment; AND Must be used as a single agent Nn-Small Cell Lung Cancer (NSCLC) Patient must have metastatic disease; AND Must be used in cmbinatin with afatinib; AND Must be used as subsequent therapy fr sensitizing EGFR mutatin-psitive tumrs; AND Patient is T790M negative; AND Patient has prgressed n EGFR tyrsine kinase inhibitr therapy; AND Patient has multiple symptmatic systemic lesins FDA Apprved Indicatin(s); Cmpendia Recmmended Indicatin(s) Mda Health Plan, Inc. Medical Necessity Criteria Page 2/9
IV. Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Patient cntinues t meet criteria identified in sectin III; AND Tumr respnse with stabilizatin f disease r decrease in size f tumr r tumr spread; AND Absence f unacceptable txicity frm the drug (e.g., severe infusin reactins, cardipulmnary arrest, pulmnary txicity/interstitial lung disease, dermatlgic txicity, electrlyte abnrmalities, etc.). V. Dsage/Administratin Indicatin Clrectal Cancer All ther indicatins Dse 400 mg/m² lading dse, then 250 mg/m² every 7 days; OR 500 mg/m² every 14 days 400 mg/m² lading dse, then 250 mg/m² every 7 days VI. Billing Cde/Availability Infrmatin Jcde: J9055 Injectin, cetuximab, 10 mg; 1 billable unit = 10 mg NDC: Erbitux 100 mg/50 ml single-use vial; slutin fr injectin: 66733-0948-xx Erbitux 200 mg/100 ml single-use vial; slutin fr injectin: 66733-0958-xx VII. References 1. Erbitux [package insert]. Branchburg, NJ; ImClne LLC; Octber 2016; Accessed September 2017. 2. Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) cetuximab. Natinal Cmprehensive Cancer Netwrk, 2017. The NCCN Cmpendium is a derivative wrk f the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks wned by the Natinal Cmprehensive Cancer Netwrk, Inc. T view the mst recent and cmplete versin f the Cmpendium, g nline t NCCN.rg. Accessed September 2017. 3. Buchahda M, Macarulla G, Lled F, et al. Efficacy and safety f cetuximab (C) given with a simplified, every ther week (q2w), schedule in patients (pts) with advanced clrectal cancer (acrc): a multicenter, retrspective study. J Clin Oncl. 2008; 26(15S): Abstract 15118. Presented at: The 44th American Sciety f Clinical Onclgy Annual Meeting (ASCO). May 30 June 3, 2008. Chicag, Illinis. 4. Mrabti H, La Fuchardiere C, Desseigne F, Dussart S, Negrier S, Errihani H. Irintecan assciated with cetuximab given every 2 weeks versus cetuximab weekly in metastatic clrectal cancer. J Can Res Ther. 2009; 5:272-6. Mda Health Plan, Inc. Medical Necessity Criteria Page 3/9
5. Shitara K, Yuki S, Yshida M, et al. Phase II study f cmbinatin chemtherapy with biweekly cetuximab and irintecan fr wild-type KRAS metastatic clrectal cancer refractry t irintecan, xaliplatin, and flurpyrimidines Wrld J Gastrenterl, 2011, April 14; 17(14): 1879-1888 6. Pfeiffer P, Bjerregarrd JK, Qvrtrup C, et al, Simplificatin f Cetuximab (Cet) Administratin: Duble Dse Every Secnd Week as a 60 Minute Infusin, J Clin Oncl, 2007, 25(18S):4133 [abstract 4133 frm 2007 ASCO Annual Meeting Prceedings, Part I]. 7. Pfeiffer P, Nielsen D, Bjerregaard J, et al, Biweekly Cetuximab and Irintecan as Third- Line Therapy in Patients with Advanced Clrectal Cancer after Failure t Irintecan, Oxaliplatin and 5-Flururacil, Ann Oncl, 2008, 19(6):1141-5. 8. Carneir BA, Ramanathan RK, Fakih MG, et al. Phase II study f irintecan and cetuximab given every 2 weeks as secnd-line therapy fr advanced clrectal cancer. Clin Clrectal Cancer. 2012 Mar; 11(1):53-9. 9. First Cast Service Optins, Inc. Lcal Cverage Determinatin (LCD): Cetuximab (Erbitux ) (L33278). Centers fr Medicare & Medicaid Services, Inc. Updated n 7/1/2014 with effective date 10/1/2015. Accessed September 2017. 10. Palmett GBA. Lcal Cverage Determinatin (LCD): K-ras Testing Required befre Epidermal Grwth Factr Receptr Antibdy Use in Clrectal Cancer (L33434). Centers fr Medicare & Medicaid Services, Inc. Updated n 4/28/2017 with effective date 5/4/2017. Accessed September 2017. 11. Cahaba Gvernment Benefit Administratrs, LLC. Lcal Cverage Article fr Drugs and Bilgicals - Chemtherapeutic Agents (A52701). Centers fr Medicare & Medicaid Services, Inc. Updated n 9/20/2017 with effective date 10/01/2017. Accessed September 2017. Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin C00.0 Malignant neplasm f external upper lip C00.1 Malignant neplasm f external lwer lip C00.2 Malignant neplasm f external lip, unspecified C00.3 Malignant neplasm f upper lip, inner aspect C00.4 Malignant neplasm f lwer lip, inner aspect C00.5 Malignant neplasm f lip, unspecified, inner aspect C00.6 Malignant neplasm f cmmissure f lip, unspecified C00.8 Malignant neplasm f verlapping sites f lip C00.9 Malignant neplasm f lip, unspecified C01 Malignant neplasm f base f tngue C02.0 Malignant neplasm f drsal surface f tngue C02.1 Malignant neplasm f brder f tngue C02.2 Malignant neplasm f ventral surface f tngue C02.3 Malignant neplasm f anterir tw-thirds f tngue, part unspecified C02.4 Malignant neplasm f lingual tnsil C02.8 Malignant neplasm f verlapping sites f tngue Mda Health Plan, Inc. Medical Necessity Criteria Page 4/9
ICD-10 ICD-10 Descriptin C02.9 Malignant neplasm f tngue, unspecified C03.0 Malignant neplasm f upper gum C03.1 Malignant neplasm f lwer gum C03.9 Malignant neplasm f gum, unspecified C04.0 Malignant neplasm f anterir flr f muth C04.1 Malignant neplasm f lateral flr f muth C04.8 Malignant neplasm f verlapping sites f flr f muth C04.9 Malignant neplasm f flr f muth, unspecified C05.0 Malignant neplasm f hard palate C05.1 Malignant neplasm f sft palate C06.0 Malignant neplasm f cheek mucsa C06.2 Malignant neplasm f retrmlar area C06.80 Malignant neplasm f verlapping sites f unspecified parts f muth C06.89 Malignant neplasm f verlapping sites f ther parts f muth C06.9 Malignant neplasm f muth, unspecified C09.0 Malignant neplasm f tnsillar fssa C09.1 Malignant neplasm f tnsillar pillar (anterir) (psterir) C09.8 Malignant neplasm f verlapping sites f tnsil C09.9 Malignant neplasm f tnsil, unspecified C10.3 Malignant neplasm f psterir wall f rpharynx C11.0 Malignant neplasm f superir wall f naspharynx C11.1 Malignant neplasm f psterir wall f naspharynx C11.2 Malignant neplasm f lateral wall f naspharynx C11.3 Malignant neplasm f anterir wall f naspharynx C11.8 Malignant neplasm f verlapping sites f naspharynx C11.9 Malignant neplasm f naspharynx, unspecified C12 Malignant neplasm f pyrifrm sinus C13.0 Malignant neplasm f pstcricid regin C13.1 Malignant neplasm f aryepiglttic fid, hyppharyngeal aspect C13.2 Malignant neplasm f psterir wall f hyppharynx C13.8 Malignant neplasm f verlapping sites f hyppharynx C13.9 Malignant neplasm f hyppharynx, unspecified C14.0 Malignant neplasm f pharynx, unspecified C14.2 Malignant neplasm f Waldeyer's ring C14.8 Malignant neplasm f verlapping sites f lip, ral cavity and pharynx C17.0 Malignant neplasm dudenum C17.1 Malignant neplasm jejunum C17.2 Malignant neplasm ileum C17.8 Malignant neplasm f verlapping sites f small intestines Mda Health Plan, Inc. Medical Necessity Criteria Page 5/9
ICD-10 ICD-10 Descriptin C17.9 Malignant neplasm f small intestine, unspecified C18.0 Malignant neplasm f cecum C18.1 Malignant neplasm f appendix C18.2 Malignant neplasm f ascending cln C18.3 Malignant neplasm f hepatic flexure C18.4 Malignant neplasm f transverse cln C18.5 Malignant neplasm f splenic flexure C18.6 Malignant neplasm f descending cln C18.7 Malignant neplasm f sigmid cln C18.8 Malignant neplasm f verlapping sites f large intestines C18.9 Malignant neplasm f cln, unspecified C19 Malignant neplasm f rectsigmid junctin C20 Malignant neplasm f rectum C21.8 Malignant neplasm f verlapping sites f rectum, anus and anal canal C30.0 Malignant neplasm f nasal cavity C31.0 Malignant neplasm f maxillary sinus C31.1 Malignant neplasm f ethmidal sinus C32.0 Malignant neplasm f glttis C32.1 Malignant neplasm f supraglttis C32.2 Malignant neplasm f subglttis C32.3 Malignant neplasm f laryngeal cartilage C32.8 Malignant neplasm f verlapping sites f larynx C32.9 Malignant neplasm f larynx, unspecified C33 Malignant neplasm f trachea C34.00 Malignant neplasm f unspecified main brnchus C34.01 Malignant neplasm f right main brnchus C34.02 Malignant neplasm f left main brnchus C34.10 Malignant neplasm f upper lbe, unspecified brnchus r lung C34.11 Malignant neplasm f upper lbe, right brnchus r lung C34.12 Malignant neplasm f upper lbe, left brnchus r lung C34.2 Malignant neplasm f middle lbe, brnchus r lung C34.30 Malignant neplasm f lwer lbe, unspecified brnchus r lung C34.31 Malignant neplasm f lwer lbe, right brnchus r lung C34.32 Malignant neplasm f lwer lbe, left brnchus r lung C34.80 Malignant neplasm f verlapping sites f unspecified brnchus and lung C34.81 Malignant neplasm f verlapping sites f right brnchus and lung C34.82 Malignant neplasm f verlapping sites f left brnchus and lung C34.90 Malignant neplasm f unspecified part f unspecified brnchus r lung C34.91 Malignant neplasm f unspecified part f right brnchus r lung Mda Health Plan, Inc. Medical Necessity Criteria Page 6/9
ICD-10 ICD-10 Descriptin C34.92 Malignant neplasm f unspecified part f left brnchus r lung C44.00 Unspecified malignant neplasm f skin f lip C44.02 Squamus cell carcinma f skin f lip C44.09 Other specified malignant neplasm f skin f lip C44.121 Squamus cell carcinma f skin f unspecified eyelid, including canthus C44.122 Squamus cell carcinma f skin f right eyelid, including canthus C44.129 Squamus cell carcinma f skin f left eyelid, including canthus C44.221 Squamus cell carcinma f skin f unspecified ear and external auricular canal C44.222 Squamus cell carcinma f skin f right ear and external auricular canal C44.229 Squamus cell carcinma f skin f left ear and external auricular canal C44.320 Squamus cell carcinma f skin f unspecified parts f face C44.321 Squamus cell carcinma f skin f nse C44.329 Squamus cell carcinma f skin f ther parts f face C44.42 Squamus cell carcinma f skin f scalp and neck C44.520 Squamus cell carcinma f anal skin C44.521 Squamus cell carcinma f skin f breast C44.529 Squamus cell carcinma f skin f ther part f trunk C44.621 Squamus cell carcinma f skin f unspecified upper limb, including shulder C44.622 Squamus cell carcinma f skin f right upper limb, including shulder C44.629 Squamus cell carcinma f skin f left upper limb, including shulder C44.721 Squamus cell carcinma f skin f unspecified lwer limb, including hip C44.722 Squamus cell carcinma f skin f right lwer limb, including hip C44.729 Squamus cell carcinma f skin f left lwer limb, including hip C44.82 Squamus cell carcinma f verlapping sites f skin C44.92 Squamus cell carcinma f skin, unspecified C60.0 Malignant neplasm f prepuce C60.1 Malignant neplasm f glans penis C60.2 Malignant neplasm f bdy f penis C60.8 Malignant neplasm f verlapping sites f penis C60.9 Malignant neplasm f penis, unspecified C63.7 Malignant neplasm f ther specified male genital rgans C63.8 Malignant neplasm f verlapping sites f male genital rgans C76.0 Malignant neplasm f head, face and neck C77.0 Secndary and unspecified malignant neplasm f lymph ndes f head, face and neck C78.00 Secndary malignant neplasm f unspecified lung C78.01 Secndary malignant neplasm f right lung C78.02 Secndary malignant neplasm f left lung C78.6 Secndary malignant neplasm f retrperitneum and peritneum C78.7 Secndary malignant neplasm f liver and intrahepatic bile duct Mda Health Plan, Inc. Medical Necessity Criteria Page 7/9
ICD-10 ICD-10 Descriptin C78.89 Secndary malignant neplasm f ther digestive rgans D37.01 Neplasm f uncertain behavir f lip D37.02 Neplasm f uncertain behavir f tngue D37.05 Neplasm f uncertain behavir f pharynx D37.09 Neplasm f uncertain behavir f ther specified sites f the ral cavity D38.0 Neplasm f uncertain behavir f larynx D38.5 Neplasm f uncertain behavir f ther respiratry rgans D38.6 Neplasm f uncertain behavir f respiratry rgan, unspecified Z85.038 Persnal histry f ther malignant neplasm f large intestine Z85.118 Persnal histry f ther malignant neplasm f brnchus and lung Z85.21 Persnal histry f malignant neplasm f larynx Z85.22 Persnal histry f malignant neplasm f nasal cavities, middle ear, and accessry sinuses Z85.810 Persnal histry f malignant neplasm f tngue Z85.818 Persnal histry f malignant neplasm f ther sites f lip, ral cavity and pharynx Z85.819 Persnal histry f malignant neplasm f unspecified site f lip, ral cavity and pharynx Z85.828 Persnal histry f ther malignant neplasm f skin Appendix 2 Centers fr Medicare and Medicaid Services (CMS) Medicare cverage fr utpatient (Part B) drugs is utlined in the Medicare Benefit Plicy Manual (Pub. 100-2), Chapter 15, 50 Drugs and Bilgicals. In additin, Natinal Cverage Determinatin (NCD) and Lcal Cverage Determinatins (LCDs) may exist and cmpliance with these plicies is required where applicable. They can be fund at: http://www.cms.gv/medicarecverage-database/search/advanced-search.aspx. Additinal indicatins may be cvered at the discretin f the health plan. Medicare Part B Cvered Diagnsis Cdes (applicable t existing NCD/LCD): Jurisdictin(s): N NCD/LCD Dcument (s): L33278 Jurisdictin(s): M NCD/LCD Dcument (s): L33434 Jurisdictin(s): J NCD/LCD Dcument (s): A52701 https://www.cms.gv/medicare-cverage-database/search/lcd-datesearch.aspx?dcid=l33278&bc=gaaaaaaaaaaaaa== https://www.cms.gv/medicare-cverage-database/search/lcd-datesearch.aspx?dcid=l33434&bc=gaaaaaaaaaaaaa== https://www.cms.gv/medicare-cverage-database/search/article-datesearch.aspx?dcid=a52701&bc=gaaaaaaaaaaaaa== Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr E (1) CA, HI, NV, AS, GU, CNMI Nridian Healthcare Slutins, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 8/9
Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Nridian Healthcare Slutins, LLC 5 KS, NE, IA, MO Wiscnsin Physicians Service Insurance Crp (WPS) 6 MN, WI, IL Natinal Gvernment Services, Inc. (NGS) H (4 & 7) LA, AR, MS, TX, OK, CO, NM Nvitas Slutins, Inc. 8 MI, IN Wiscnsin Physicians Service Insurance Crp (WPS) N (9) FL, PR, VI First Cast Service Optins, Inc. J (10) TN, GA, AL Cahaba Gvernment Benefit Administratrs, LLC M (11) NC, SC, WV, VA (excluding belw) Palmett GBA, LLC L (12) DE, MD, PA, NJ, DC (includes Arlingtn & Fairfax cunties and the city f Alexandria in VA) Nvitas Slutins, Inc. K (13 & 14) NY, CT, MA, RI, VT, ME, NH Natinal Gvernment Services, Inc. (NGS) 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 9/9