Yescarta (axicabtagene cilleucel) (Intravenus) Last Review Date: 10/31/2017 Date f Origin: 10/31/2017 Dates Reviewed: 10/2017 Dcument Number: IC-0333 I. Length f Authrizatin Cverage will be prvided fr ne treatment curse (1 dse f Yescarta) and may nt be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: N/A B. Max Units (per dse and ver time) [Medical Benefit]: 1 infusin f Yescarta nly III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient des nt have a clinically significant active systemic infectin r inflammatry disrder; AND Patient has nt received live vaccines within 6 weeks prir t the start f lymphdepleting chemtherapy, during Yescarta treatment, and will nt receive live vaccines until immune recvery fllwing treatment; AND Patient has been screened fr hepatitis B virus (HBV), hepatitis C virus (HCV), and human immundeficiency virus (HIV) in accrdance with clinical guidelines prir t cllectin f cells (leukapheresis); AND Prphylaxis fr infectin has been fllwed accrding t lcal guidelines; AND Healthcare facility has enrlled in the Yescarta REMS and training has been given t prviders n the management f cytkine release syndrme (CRS) and neurlgical txicities; AND Patient des nt have primary central nervus system lymphma; AND Patient did nt receive prir allgeneic hematpietic stem cell transplantatin (HSCT); AND Large B-Cell Lymphma Patient aged 18 years r greater; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5
Patient has CD19-psitive disease; AND Used as single agent therapy (nt applicable t lymphdepleting r additinal chemtherapy while awaiting manufacture); AND Patient has ne f the fllwing aggressive B-cell nn-hdgkin lymphmas: Diffuse large B-cell lymphma (DLBCL) nt therwise specified; OR Primary mediastinal large B-cell lymphma (PMBCL); OR High grade B-cell lymphma; OR DLBCL arising frm fllicular lymphma (TFL); AND Patient s disease is relapsed r refractry defined as ne f the fllwing: Relapse within 1 year after autlgus hematpietic stem cell transplantatin (HSCT); OR Refractry disease t the mst recent therapy; AND Patient must have received tw r mre prir lines f systemic therapy which must have included an anthracycline as well as an anti-cd20 mnclnal antibdy (unless tumr is CD20-negative); AND Patient has an ECOG perfrmance status f 0-1; AND Patient has nt received prir CAR-T therapy FDA Apprved Indicatin(s); Cmpendium Recmmended Indicatin(s) IV. Renewal Criteria Cverage cannt be renewed. V. Dsage/Administratin Indicatin Dse Diffuse Large B- cell Lymphma Fr autlgus use nly. Fr intravenus use nly. Yescarta is prepared frm the patient s peripheral bld mnnuclear cells, which are btained via a standard leukapheresis prcedure One treatment curse cnsists f lymphdepleting chemtherapy fllwed by a single infusin f Yescarta Lymphdepleting chemtherapy: Cnfirm Yescarta availability prir t starting the lymphdepleting regimen Administer cyclphsphamide 500 mg/m 2 and fludarabine 30 mg/m 2 intravenusly n the fifth, furth, and third day befre infusin f Yescarta Yescarta Infusin: Premedicate with 650 mg acetaminphen and 12.5 mg diphenhydramine 1 hur prir t infusin. Avid prphylactic system crticsterids which may interfere with Yescarta activity. Infuse the entire cntents f the Yescarta bag within 30 minutes by either gravity r a peristaltic pump Each single infusin bag f YESCARTA cntains a suspensin f chimeric antigen receptr (CAR)-psitive T cells in apprximately 68 ml. The target dse is 2 10 6 Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5
CAR-psitive viable T cells per kg bdy weight, with a maximum f 2 10 8 CARpsitive viable T cells. Mnitring: Mnitr patients at least daily fr 7 days at the certified healthcare facility fllwing infusin fr signs and symptms f CRS and neurlgic txicities. Instruct patients t remain within prximity f the certified healthcare facility fr at least 4 weeks fllwing infusin. Stre infusin bag in the vapr phase f liquid nitrgen (less than r equal t minus 150 C). Thaw prir t infusin. In case f manufacturing failure, a secnd manufacturing may be attempted. Additinal chemtherapy (nt the lymphdepletin) may be necessary while the patient awaits the prduct. Ensure that 2 dses f tcilizumab and emergency equipment are available prir t infusin and during the recvery perid. YESCARTA cntains human bld cells that are genetically mdified with replicatin incmpetent retrviral vectr. Fllw universal precautins and lcal bisafety guidelines fr handling and dispsal. VI. Billing Cde/Availability Infrmatin Jcde: J9999 - Nt therwise classified, antineplastic drugs NDC: Yescarta suspensin fr intravenus infusin; 1 infusin bag (68 ml): 71287-0119-xx VII. References 1. Yescarta [package insert]. Santa Mnica, CA; Kite Pharma, Inc., Octber 2017. Accessed Octber 2017. 2. Lcke FL, Neelapu SS, Bartlett NL, et al. Phase 1 Results f ZUMA-1: A Multicenter Study f KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractry Aggressive Lymphma. Ml Ther. 2017 Jan 4;25(1):285-295. 3. Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) axicabtagene cilleucel. 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 Octber 2017. Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin C82.20 Fllicular lymphma grade III, unspecified, unspecified site C82.21 Fllicular lymphma grade III, unspecified, lymph ndes f head, face and neck C82.22 Fllicular lymphma, grade III, unspecified, intrathracic lymph ndes C82.23 Fllicular lymphma grade III, unspecified, intra-abdminal lymph ndes C82.24 Fllicular lymphma grade III, unspecified, lymph ndes f axilla and upper limb C82.25 Fllicular lymphma grade III, unspecified, lymph ndes f inguinal regin and lwer limb C82.26 Fllicular lymphma grade III, unspecified, intrapelvic lymph ndes C82.27 Fllicular lymphma grade III, unspecified, spleen C82.28 Fllicular lymphma grade III, unspecified, lymph ndes f multiple sites Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5
C82.29 Fllicular lymphma grade III, unspecified, extrandal and slid rgan sites C82.30 Fllicular lymphma grade IIIa, unspecified site C82.31 Fllicular lymphma grade IIIa, lymph ndes f head, face and neck C82.32 Fllicular lymphma, grade IIIa, intrathracic lymph ndes C82.33 Fllicular lymphma grade IIIa, intra-abdminal lymph ndes C82.34 Fllicular lymphma grade IIIa, lymph ndes f axilla and upper limb C82.35 Fllicular lymphma grade IIIa, lymph ndes f inguinal regin and lwer limb C82.36 Fllicular lymphma grade IIIa, intrapelvic lymph ndes C82.37 Fllicular lymphma grade IIIa, spleen C82.38 Fllicular lymphma grade IIIa, lymph ndes f multiple sites C82.39 Fllicular lymphma grade IIIa, extrandal and slid rgan sites C82.40 Fllicular lymphma grade IIIb, unspecified site C82.41 Fllicular lymphma grade IIIb, lymph ndes f head, face and neck C82.42 Fllicular lymphma, grade IIIb, intrathracic lymph ndes C82.43 Fllicular lymphma grade IIIb, intra-abdminal lymph ndes C82.44 Fllicular lymphma grade IIIb, lymph ndes f axilla and upper limb C82.45 Fllicular lymphma grade IIIb, lymph ndes f inguinal regin and lwer limb C82.46 Fllicular lymphma grade IIIb, intrapelvic lymph ndes C82.47 Fllicular lymphma grade IIIb, spleen C82.48 Fllicular lymphma grade IIIb, lymph ndes f multiple sites C82.49 Fllicular lymphma grade IIIb, extrandal and slid rgan sites C83.30 Diffuse large B-cell lymphma unspecified site C83.31 Diffuse large B-cell lymphma, lymph ndes f head, face, and neck C83.32 Diffuse large B-cell lymphma intrathracic lymph ndes C83.33 Diffuse large B-cell lymphma intra-abdminal lymph ndes C83.34 Diffuse large B-cell lymphma lymph ndes f axilla and upper limb C83.35 Diffuse large B-cell lymphma, lymph ndes f inguinal regin and lwer limb C83.36 Diffuse large B-cell lymphma intrapelvic lymph ndes C83.37 Diffuse large B-cell lymphma, spleen C83.38 Diffuse large B-cell lymphma lymph ndes f multiple sites C83.39 Diffuse large B-cell lymphma extrandal and slid rgan sites C85.20 Mediastinal (thymic) large B-cell lymphma, unspecified site C85.21 Mediastinal (thymic) large B-cell lymphma, lymph ndes f head, face and neck C85.22 Mediastinal (thymic) large B-cell lymphma, intrathracic lymph ndes C85.23 Mediastinal (thymic) large B-cell lymphma, intra-abdminal lymph ndes C85.24 Mediastinal (thymic) large B-cell lymphma, lymph ndes f axilla and upper limb C85.25 Mediastinal (thymic) large B-cell lymphma, lymph ndes f inguinal regin and lwer limb C85.26 Mediastinal (thymic) large B-cell lymphma, intrapelvic lymph ndes C85.27 Mediastinal (thymic) large B-cell lymphma, spleen C85.28 Mediastinal (thymic) large B-cell lymphma, lymph ndes f multiple sites C85.29 Mediastinal (thymic) large B-cell lymphma, extrandal and slid rgan sites Mda Health Plan, Inc. Medical Necessity Criteria Page 4/5
C85.80 Other specified types f nn-hdgkin lymphma, unspecified site C85.81 Other specified types f nn-hdgkin lymphma, lymph ndes f head, face and neck C85.82 Other specified types f nn-hdgkin lymphma, intrathracic lymph ndes C85.83 Other specified types f nn-hdgkin lymphma, intra-abdminal lymph ndes C85.84 Other specified types f nn-hdgkin lymphma, lymph ndes f axilla and upper limb C85.85 Other specified types f nn-hdgkin lymphma, lymph ndes f inguinal regin f lwer limb C85.86 Other specified types f nn-hdgkin lymphma, intrapelvic lymph ndes C85.87 Other specified types f nn-hdgkin lymphma, spleen C85.88 Other specified types f nn-hdgkin lymphma, lymph ndes f multiple sites C85.89 Other specified types f nn-hdgkin lymphma, extrandal and slid rgan sites Z85.72 Persnal histry f nn-hdgkin lymphmas 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): N/A 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 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 5/5