Perjeta (pertuzumab) Document Number: IC I. Length of Authorization. Dosing Limits. Initial Approval Criteria

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1 Perjeta (pertuzumab) Last Review Date: 11/21/2017 Date f Origin: 11/01/2012 Dcument Number: IC-0096 Dates Reviewed: 12/2012, 3/2013, 6/2013, 9/2013, 11/2013, 12/2013, 3/2014, 6/2014, 9/2014, 12/2014, 3/2015, 5/2015, 8/2015, 11/2015, 2/2016, 5/2016, 8/2016, 11/2016, 2/2017, 5/2017, 8/2017, 11/2017 I. Length f Authrizatin Cverage is prvided fr 6 mnths and may be renewed fr metastatic r recurrent disease. Cverage is prvided fr 6 mnths and may NOT be renewed fr adjuvant and ne-adjuvant use. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Perjeta 420 mg/14ml slutin fr injectin: Lading Dse: 2 vials Maintenance Dses: 1 vial every 21 days B. Max Units (per dse and ver time) [Medical Benefit]: Lading Dse 840 billable units x 1 dse Maintenance Dse 420 billable units every 21 days III. Initial Apprval Criteria Cverage is prvided in the fllwing cnditins: Patient is 18 years r lder; AND Baseline Left ventricular ejectin fractin (LVEF) within nrmal limits; AND Patient has human epidermal grwth factr receptr 2 (HER2)-psitive* disease; AND Breast cancer Used as adjuvant treatment ; AND Patient has early stage r lcally advanced disease; AND Used in cmbinatin with a trastuzumab-based regimen; AND Pertuzumab was nt used as part f neadjuvant therapy; OR Used as neadjuvant treatment fr breast preservatin; AND Patient has lcally advanced, inflammatry r early stage disease; AND Used in cmbinatin with a trastuzumab-based regimen; OR Used fr recurrent r metastatic disease; AND Used as first line therapy in cmbinatin with trastuzumab and paclitaxel r dcetaxel; OR Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5

2 Used as secnd-line therapy in cmbinatin with trastuzumab: AND Previusly treated with trastuzumab-based therapy; AND Patient has nt previusly received pertuzumab *HER2-psitive verexpressin criteria: Immunhistchemistry (IHC) assay 3+ ; OR Flurescence in situ hybridizatin (FISH) assay 2.0 (HER2/CEP17 rati); OR 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 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: carditxicity (i.e. left ventricular dysfunctin, cardimypathy); neutrpenia; neurtxicity; infusin-related and hypersensitivity reactins; 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); AND Use fr adjuvant OR ne-adjuvant Breast Cancer treatment cannt be renewed. V. Dsage/Administratin Indicatin Breast Cancer Dse 840 mg x 1 dse, then 420 mg every 21 days thereafter until disease prgressin r unmanageable txicity* *Fr ne-adjuvant/adjuvant treatment, cntinued use fr greater than 6 cycles is nt recmmended. VI. Billing Cde/Availability Infrmatin JCde: J Injectin, pertuzumab, 1 mg; 1 mg = 1 billable unit NDC(s): Perjeta 420 mg/14 ml slutin fr injectin: xx VII. References 1. Perjeta [package insert]. Suth San Francisc, CA; Genentech; May Accessed Octber Referenced with permissin frm the NCCN Drugs & Bilgics Cmpendium (NCCN Cmpendium ) pertuzumab. Natinal Cmprehensive Cancer Netwrk, The NCCN Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5

3 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 Baselga J, Crtes J, Kim SB, et al. Pertuzumab plus trastuzumab plus dcetaxel fr metastatic breast cancer. N Engl J Med 2012;366(2): Gianni L, Pienkwski T, Im YH, et al. Efficacy and safety f neadjuvant pertuzumab and trastuzumab in wmen with lcally advanced, inflammatry, r early HER2-psitive breast cancer (NeSphere): a randmised multicentre, pen-label, phase 2 trial. Lancet Oncl Jan;13(1): Baselga J, Crtes J, Kim SB, et al. CLEOPATRA Study Grup. Pertuzumab plus trastuzumab plus dcetaxel fr metastatic breast cancer. N Engl J Med. 2012;366: Schneeweiss A., Chia S., Hickish T., et al; Pertuzumab plus trastuzumab in cmbinatin with standard neadjuvant anthracycline-cntaining and anthracycline-free chemtherapy regimens in patients with HER2-psitive early breast cancer: a randmized phase II cardiac safety study (TRYPHAENA). Ann Oncl 2013; 24 (9): Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin 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 Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5

4 ICD-10 ICD-10 Descriptin 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 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 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