Myltarg (gemtuzumab zgamicin) (Intravenus) Last Review Date: 09/19/2017 Date f Origin: 09/19/2017 Dates Reviewed: 09/2017 Dcument Number: IC-0320 I. Length f Authrizatin Newly-Diagnsed AML De nv disease in cmbinatin with daunrubicin and cytarabine: cverage will be prvided fr 6 mnths cnsisting f 3 cycles (1 inductin and 2 cnslidatin) and may nt be renewed. Single-agent use: Cverage will be prvided fr 6 mnths and may be renewed. Cverage is prvided fr 1 cycle f inductin and up t a maximum f 8 cycles f cntinuatin. Relapsed r Refractry AML Cverage will be prvided fr 6 mnths cnsisting f ne cycle (3 dses) and may nt be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Myltarg 4.5 mg vial: 5 vials per initial 28 days; 1 vial per 28 days thereafter (up t a maximum f 8 cycles) B. Max Units (per dse and ver time) [Medical Benefit]: Cycle 1 135 billable units n Day 1 & 9 mg (2 vials) n Day 8 f a 28-day cycle; OR 45 billable units n Days 1, 4, & 7 f a 28-day cycle Subsequent Cycles (up t a maximum f 8 cycles) 45 billable units n Day 1 f a 28-day cycle III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient has CD33-psitive disease; AND Patients with a histry f r predispsitin fr QTc prlngatin have a baseline electrcardigram (ECG); AND Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5
Patients with hyperleukcytsis (leukcyte cunt 30 x 10 9 /L) have had cytreductin; AND Patient has nt previusly received gemtuzumab zgamicin; AND Acute Myelid Leukemia (AML) Patient has newly-diagnsed disease; AND Patient is 18 years r lder; AND Used in cmbinatin with daunrubicin and cytarabine; AND Patient has de nv disease; AND Patient des nt have adverse-risk cytgenetics OR cytgenetic results are nt yet knwn; OR Used as a single agent; OR Patient has relapsed r refractry disease; AND Patient is 2 years r lder; AND Must be used as a single agent FDA Apprved Indicatin(s); Cmpendium Recmmended Indicatin(s) IV. Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Patient cntinues t meet the 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. Examples f unacceptable txicity include the fllwing: severe infusin-related reactins, hemrrhage, hepattxicity including hepatic ven-cclusive disease (VOD)/sinusidal bstructin syndrme (SOS), tumr lysis syndrme, symptmatic QTc prlngatin, etc.; AND Patients with newly-diagnsed AML have nt exceeded the maximum f 8 cycles f cntinuatin Nte: treatment f newly diagnsed de nv AML as well as relapsed r refractry AML are nt renewable V. Dsage/Administratin Indicatin Dse Acute Myelid Leukemia Newly Diagnsed AML Cmbinatin regimen (De Nv AML): Inductin Therapy (1 cycle nly): 3 mg/m 2 (up t ne 4.5 mg vial) n Days 1, 4, and 7 in cmbinatin with daunrubicin and cytarabine Fr patients requiring a secnd inductin cycle, d nt administer gemtuzumab zgamicin during the secnd inductin cycle Cnslidatin Therapy (maximum f 2 cycles): Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5
Single-agent regimen: 3 mg/m 2 (up t ne 4.5 mg vial) n Day 1 in cmbinatin with daunrubicin and cytarabine Inductin Therapy (1 cycle nly): 6 mg/m 2 as a single agent n Day 1, and 3 mg/m 2 n Day 8 Cntinuatin Therapy (maximum f 8 cycles): 2 mg/m 2 as a single agent n Day 1 every 4 weeks Relapsed r Refractry AML (single agent) 3 mg/m 2 (up t ne 4.5 mg vial) n Days 1, 4, and 7 (1 cycle nly) Nte: cycle length is 28 days Refrigerate (2-8 C; 36-46 F) and stre in the riginal cartn t prtect frm light. D nt freeze VI. Billing Cde/Availability Infrmatin Jcde: J9999 - Nt therwise classified, antineplastic drugs J9203 Injectin, gemtuzumab zgamicin, 0.1 mg: 1 billable unit = 0.1 mg (Effective 1/1/2018) NDC: Myltarg 4.5 mg single-dse vial: 00008-4510-xx VII. References 1. Myltarg [package insert]. Philadelphia, PA; Pfizer Inc., September 2017. Accessed September 2017. 2. Castaigne S, Pautas C, Terré C, et al. Effect f gemtuzumab zgamicin n survival f adult patients with de-nv acute myelid leukaemia (ALFA-0701): a randmised, pen-label, phase 3 study. Lancet. 2012 Apr 21;379(9825):1508-16 3. Amadri S, Suciu S, Selleslag D, et al. Gemtuzumab Ozgamicin Versus Best Supprtive Care in Older Patients With Newly Diagnsed Acute Myelid Leukemia Unsuitable fr Intensive Chemtherapy: Results f the Randmized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncl. 2016 Mar 20;34(9):972-9. 4. Taksin AL, Legrand O, Raffux E, et al. High efficacy and safety prfile f fractinated dses f Myltarg as inductin therapy in patients with relapsed acute myelblastic leukemia: A prspective study f the ALFA grup. Leukemia 2007;21:66 71. 5. Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) Acute Myelid Leukemia. Versin 3.2017. 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. Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5
Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin C92.00 Acute myelblastic leukemia nt having achieved remissin C92.01 Acute myelblastic leukemia in remissin C92.50 Acute myelmncytic leukemia nt having achieved remissin C92.51 Acute myelmncytic leukemia in remissin C92.60 Acute myelid leukemia with 11q23-abnrmality nt having achieved remissin C92.61 Acute myelid leukemia with 11q23-abnrmality in remissin C92.A0 C92.A1 Acute myelid leukemia with multilineage dysplasia nt having achieved remissin Acute myelid leukemia with multilineage dysplasia in remissin C93.00 Acute mnblastic/mncytic leukemia nt having achieved remissin C93.01 Acute mnblastic/mncytic leukemia in remissin C94.00 Acute erythrid leukemia nt having achieved remissin C94.01 Acute erythrid leukemia in remissin C94.20 Acute megakaryblastic leukemia nt having achieved remissin C94.21 Acute megakaryblastic leukemia in remissin 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 Mda Health Plan, Inc. Medical Necessity Criteria Page 4/5
Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr 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