Kadcyla (ado-trastuzumab emtansine) Document Number: IC-0092

Transcription

1 Kadcyla (ad-trastuzumab emtansine) Dcument Number: IC-0092 Last Review Date: 2/6/2018 Date f Origin: 05/16/2013 Dates Reviewed: 7/2013, 11/2013, 12/2013, 3/2014, 6/2014, 9/2014, 12/2014, 5/2015, 8/2015, 11/2015, 2/2016, 5/2016, 8/2016, 11/2016, 2/2017, 5/2017, 8/2017, 11/2017, 2/2018 I. Length f Authrizatin Cverage will be prvided fr six mnths and may be renewed. II. III. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Kadcyla 100 mg vial 1 vial every 21 days Kadcyla 160 mg vial 3 vials every 21 days B. Max Units (per dse and ver time) [Medical Benefit]: 480 billable units every 21 days Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient at least 18 years ld; AND Patient s disease is human epidermal grwth factr receptr 2 (HER2)-psitive*; AND Baseline left ventricular ejectin fractin (LVEF) within nrmal limits; AND Breast cancer Must be used as single agent therapy; AND Patient s cancer is metastatic r recurrent; AND 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; OR Patient was previusly treated with trastuzumab and a taxane (separately r in cmbinatin) Nn-Small Cell Lung Cancer Must be used as single agent therapy *HER2 psitive verexpressin criteria: Immunhistchemistry (IHC) assay 3+; OR Flurescence in situ hybridizatin (FISH) assay 2.0 (HER2/CEP17 rati); OR Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5

2 Average HER2 cpy number 6 signals/cell FDA apprved indicatin(s), Cmpendia Recmmended Indicatin(s) IV. Renewal Criteria Cverage can be renewed based upn the fllwing criteria: Patient cntinues t meet the criteria nted in sectin III; AND Tumr respnse with stabilizatin f disease r decrease in size f tumr; AND Absence f unacceptable txicity frm the drug. Examples f unacceptable txicity include the fllwing: hepattxicity; left ventricular dysfunctin; pulmnary txicity (i.e. pneumnitis); thrmbcytpenia; neurtxicity; infusin-related and hypersensitivity reactins; hemrrhage; extravasatin at infusin site; etc.; AND Left ventricular ejectin fractin (LVEF) is >45% OR LVEF is 40% and abslute decrease is <10% frm baseline (results must be less than 3 mnths ld) V. Dsage/Administratin Indicatin All indicatins Dse 3.6 mg/kg given as an intravenus infusin every 3 weeks (21-day cycle) VI. Billing Cde/Availability Infrmatin Jcde: J Injectin, ad-trastuzumab emtansine, 1 mg; 1 billable unit = 1 mg NDC: Kadcyla 100 mg single-use vial: xx Kadcyla 160 mg single-use vial: xx VII. References 1. Kadcyla [package insert]. Suth San Francisc, CA; Genentech, Inc; July Accessed January Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) ad-trastuzumab emtansine. 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 January Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine fr HER2-psitive advanced breast cancer. N Engl J Med Nv 8; 367(19): Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5

3 4. Li BT, Shen R, Buncre D, et al. Ad-trastuzumab emtansine in patients with HER2 mutant lung cancers: Results frm a phase II basket trial. J Clin Oncl 2017, 35: Abstract Appendix 1 Cvered Diagnsis Cdes ICD-10 C33 ICD-10 Descriptin 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 C34.92 Malignant neplasm f unspecified part f left brnchus r lung 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 Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5

4 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 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 Z Persnal histry f ther malignant neplasm f brnchus and lung Z85.3 Persnal histry f malignant neplasm f breast Mda Health Plan, Inc. Medical Necessity Criteria Page 4/5

5 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): 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 Palmett GBA, 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