Abraxane (paclitaxel protein-bound particles) (Intravenous)

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1 Abraxane (paclitaxel prtein-bund particles) (Intravenus) Last Review Date: 5/30/2017 Date f Origin: 10/17/2008 Dcument Number: IC-0001 Dates Reviewed: 06/2009, 12/2009, 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, 5/2015, 8/2015, 11/2015, 2/2016, 5/2016, 8/2016, 11/2016, 02/2017, 05/2017 I. Length f Authrizatin Cverage is prvided fr 6 mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: 900 mg (9 vials) as a 21 day supply B. Max Units (per dse and ver time) [Medical Benefit]: 900 billable units per 21 days III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient is 18 years f age r lder; AND Breast cancer Patient failed n cmbinatin chemtherapy fr metastatic disease r relapsed within 6 mnths f adjuvant therapy; AND -OR - -OR- Previus chemtherapy included an anthracycline Patient s disease is recurrent r metastatic; AND Patient s disease is: HER2-negative and using this as single agent therapy; OR HER2-psitive and using in cmbinatin with trastuzumab (in patients wh were previusly treated with trastuzumab); AND Patient has ne f the fllwing: Disease is hrmne receptr negative; OR Disease is hrmne receptr psitive and refractry t endcrine therapy; OR Patient has symptmatic visceral disease r visceral crisis Mda Health Plan, Inc. Medical Necessity Criteria Page 1/10

2 May be substituted fr paclitaxel r dcetaxel if patient has experienced hypersensitivity reactins despite premedicatin r the patient has cntraindicatins t standard hypersensitivity premedicatins. Nn-small cell lung cancer -OR- Patient s disease is lcally advanced r metastatic; AND Used in cmbinatin with carbplatin; AND Used as first line therapy in patients wh are nt candidates fr curative surgery r radiatin therapy Patient s disease is recurrent r metastatic; AND Abraxane will be used as ne f the fllwing: -OR- Used as a single agent in patients with a perfrmance status scre f 2; OR Used in cmbinatin with carbplatin in patients with a perfrmance status scre f 0-2; AND Used as first line therapy fr EGFR, ALK, ROS1, and PD-L1 negative r unknwn; OR Subsequent therapy fr sensitizing EGFR mutatin-psitive tumrs and prir erltinib, afatinib, gefitinib, r simertinib therapy; OR Subsequent therapy fr ALK rearrangement-psitive tumrs and prir criztinib, ceritinib, r alectinib therapy; OR Subsequent therapy fr ROS1 rearrangement-psitive tumrs and prir criztinib therapy; OR Subsequent therapy fr PD-L1 expressin-psitive ( 50%) and EGFR, ALK, and ROS1 negative tumrs and prir pembrlizumab therapy May be substituted fr paclitaxel r dcetaxel if patient has experienced hypersensitivity reactins despite premedicatin r the patient has cntraindicatins t standard hypersensitivity premedicatins. Ovarian cancer (Epithelial/Fallpian Tube/Primary Peritneal) Patient s disease is recurrent r persistent; AND Must be used as a single agent; OR Used in cmbinatin with carbplatin if platinum-sensitive with cnfirmed taxane hypersensitivity Pancreatic Adencarcinma Must be used in cmbinatin with gemcitabine; AND Patient s disease is lcally advanced, unresectable, r metastatic; AND Used as first-line therapy; AND Patient has gd perfrmance status (defined as ECOG 0-1 with gd pain management, patent biliary stent, and adequate nutritinal intake.); OR Patient s disease is prgressive r recurrent; AND Used as secnd-line therapy Patient s disease is resectable with high-risk features r brderline resectable; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 2/10

3 Melanma Used fr neadjuvant treatment Must be used as a single agent; AND Patient s disease must be unresectable r metastatic; AND Used as 2 nd line r later treatment; AND Patient has had disease prgressin (r maximum clinical benefit achieved) frm BRAF targeted therapies; AND Patient has perfrmance status 0-2 Bladder Cancer/Urthelial Carcinma Must be used as a single agent; AND Must be used as subsequent therapy; AND Patient has a diagnsis f ne the fllwing: Lcally advanced r metastatic disease fllwing prir treatment with a systemic therapy; OR Disease recurrence pst-cystectmy; OR Recurrent r metastatic Primary Carcinma f the Urethra; OR Metastatic Urthelial Carcinma f the Prstate; OR Metastatic Upper GU Tract Tumrs FDA Apprved Indicatin(s), Cmpendia recmmended indicatin(s) 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., neutrphil cunts f < 1,500 cell/mm 3, sensry neurpathy, sepsis, pneumnitis, severe hypersensitivity reactins, etc.). V. Dsage/Administratin Indicatin All ther indicatins Pancreatic Cancer 260 mg/m² every 21 days OR Dse 100 mg/m² days 1, 8, and 15 f a 21-day cycle 125 mg/m² days 1, 8, and 15 f a 28-day cycle VI. Billing Cde/Availability Infrmatin Jcde: J9264 Injectin, paclitaxel prtein-bund particles, 1 mg; 1 billable unit = 1 mg Mda Health Plan, Inc. Medical Necessity Criteria Page 3/10

4 NDC: Abraxane 100 mg pwder fr injectin; single-use vial: xx VII. References 1. Abraxane [package insert]. Summit, NJ; Celgene Crpratin; July Accessed March Referenced with permissin frm the NCCN Drugs and Bilgics Cmpendium (NCCN Cmpendium ) paclitaxel, albumin bund. Natinal Cmprehensive Cancer Netwrk, 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 March Teneriell, MG et al. Phase II evaluatin f nanparticle albumin-bund paclitaxel in platinum-sensitive patients with recurrent varian, peritneal, r fallpian tube cancer. J Clin Oncl Mar 20; 27(9): Epub 2009 Feb Gradishar WJ, Krasnjn D, Cheprv S, et al, Significantly Lnger Prgressin-Free Survival With nab-paclitaxel Cmpared With Dcetaxel as First-Line Therapy fr Metastatic Breast Cancer, J Clin Oncl, 2009, 27(22): Rizvi NA, Riely GJ, Azzli CG, et al, Phase I/II Trial f Weekly Intravenus 130-nm Albumin-Bund Paclitaxel as Initial Chemtherapy in Patients With Stage IV Nn-Small- Cell Lung Cancer, J Clin Oncl, 2008, 26(4): Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD) fr Chemtherapy Drugs and their Adjuncts (L35053). Centers fr Medicare & Medicaid Services, Inc. Updated n 3/8/2017 with effective date 3/1/2017. Accessed March Natinal Gvernment Services, Inc. Lcal Cverage Article fr Paclitaxel (e.g., Taxl /Abraxane ) related t LCD L33394 (A52450). Centers fr Medicare & Medicaid Services, Inc. Updated n 09/23/2016 with effective date f 10/1/2016. Accessed March Cahaba Gvernment Benefit Administratrs, LLC. Lcal Cverage Article fr Drugs and Bilgicals - Chemtherapeutic Agents (A52701). Centers fr Medicare & Medicaid Services, Inc. Updated n 1/24/2017 with effective date 11/1/2016. Accessed March Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin C25.0 Malignant neplasm f head f pancreas C25.1 Malignant neplasm f bdy f the pancreas C25.2 Malignant neplasm f tail f pancreas C25.3 Malignant neplasm f pancreatic duct C25.7 Malignant neplasm f ther parts f pancreas C25.8 Malignant neplasm f verlapping sites f pancreas Mda Health Plan, Inc. Medical Necessity Criteria Page 4/10

5 ICD-10 ICD-10 Descriptin C25.9 Malignant neplasm f pancreas, 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 r 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 C34.92 Malignant neplasm f unspecified part f left brnchus r lung C43.0 Malignant melanma f lip C43.10 Malignant melanma f unspecified eyelid, including canthus C43.11 Malignant melanma f right eyelid, including canthus C43.12 Malignant melanma f left eyelid, including canthus C43.20 Malignant melanma f unspecified ear and external auricular canal C43.21 Malignant neplasm f right ear and external auricular canal C43.22 Malignant neplasm f left ear and external auricular canal C43.30 Malignant melanma f unspecified parts f face C43.31 Malignant melanma f nse C43.39 Malignant melanma f ther parts f face C43.4 Malignant melanma f scalp and neck C43.51 Malignant melanma f anal skin C43.52 Malignant melanma f skin f breast C43.59 Malignant melanma f ther part f trunk C43.60 Malignant melanma f unspecified upper limb, including shulder C43.61 Malignant melanma f right upper limb, including shulder C43.62 Malignant melanma f left upper limb, including shulder Mda Health Plan, Inc. Medical Necessity Criteria Page 5/10

6 ICD-10 ICD-10 Descriptin C43.70 Malignant melanma f unspecified lwer limb, including hip C43.71 Malignant melanma f right lwer limb, including hip C43.72 Malignant melanma f left lwer limb, including hip C43.8 Malignant melanma f verlapping sites f skin C43.9 Malignant melanma f skin, unspecified C48.1 Malignant neplasm f specified parts f peritneum C48.2 Malignant neplasm f peritneum, unspecified C48.8 Malignant neplasm f verlapping sites f retrperitneum and peritneum 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 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 Mda Health Plan, Inc. Medical Necessity Criteria Page 6/10

7 ICD-10 ICD-10 Descriptin 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 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 C57.00 Malignant neplasm f unspecified fallpian tube C57.01 Malignant neplasm f right fallpian tube C57.02 Malignant neplasm f left fallpian tube C57.10 Malignant neplasm f unspecified brad ligament C57.11 Malignant neplasm f right brad ligament Mda Health Plan, Inc. Medical Necessity Criteria Page 7/10

8 ICD-10 ICD-10 Descriptin C57.12 Malignant neplasm f left brad ligament C57.20 Malignant neplasm f unspecified rund ligament C57.21 Malignant neplasm f right rund ligament C57.22 Malignant neplasm f left rund ligament C57.3 Malignant neplasm f parametrium C57.4 Malignant neplasm f uterine adnexa, unspecified C57.7 Malignant neplasm f ther specified female genital rgans C57.8 Malignant neplasm f verlapping sites f female genital rgans C57.9 Malignant neplasm f female genital rgan, unspecified C61 Malignant neplasm f prstate C65.1 Malignant neplasm f right renal pelvis C65.2 Malignant neplasm f left renal pelvis C65.9 Malignant neplasm f unspecified renal pelvis C66.1 Malignant neplasm f right ureter C66.2 Malignant neplasm f left ureter C66.9 Malignant neplasm f unspecified ureter C67.0 Malignant neplasm f trigne f bladder C67.1 Malignant neplasm f dme f bladder C67.2 Malignant neplasm f lateral wall f bladder C67.3 Malignant neplasm f anterir wall f bladder C67.4 Malignant neplasm f psterir wall f bladder C67.5 Malignant neplasm f bladder neck C67.6 Malignant neplasm f ureteric rifice C67.7 Malignant neplasm f urachus C67.8 Malignant neplasm f verlapping sites f bladder C67.9 Malignant neplasm f bladder, unspecified C68.0 Malignant neplasm f urethra C79.31 Secndary malignant neplasm f brain C80.0 Disseminated malignant neplasm, unspecified C80.1 Malignant (primary) neplasm, unspecified D09.0 Carcinma in situ f bladder Z85.07 Persnal histry f malignant neplasm f pancreas Z Persnal histry f ther malignant neplasm f brnchus and lung Z85.3 Persnal histry f malignant neplasm f breast Z85.43 Persnal histry f malignant neplasm f vary Mda Health Plan, Inc. Medical Necessity Criteria Page 8/10

9 ICD-10 ICD-10 Descriptin Z85.51 Persnal histry f malignant neplasm f bladder Z85.59 Persnal histry f malignant neplasm f ther urinary tract rgan Z Persnal histry f malignant melanma 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 ), 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: 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): 5, 8 NCD/LCD Dcument (s): L35053 Jurisdictin(s): J NCD/LCD Dcument (s): A52701 Jurisdictin(s): 6, K NCD/LCD Dcument (s): 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) Mda Health Plan, Inc. Medical Necessity Criteria Page 9/10

10 Medicare Part B Administrative Cntractr (MAC) Jurisdictins Jurisdictin Applicable State/US Territry Cntractr 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 10/10

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