Soliris (eculizumab) Document Number: MODA-0114
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1 Sliris (eculizumab) Dcument Number: MODA-0114 Last Review Date: 9/19/2017 Date f Origin: 06/21/2011 Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017 I. Length f Authrizatin Cverage will be prvided fr twelve mnths and may be renewed. II. Dsing Limits A. Quantity Limit (max daily dse) [Pharmacy Benefit]: Lading Dses: 3 vials Days 1, 8, 15, & 22; then 4 vials Day 29 Maintenance Dse: 4 vials every 14 days B. Max Units (per dse and ver time) [Medical Benefit]: Indicatin Lading Dses Maintenance Dse PNH 60 billable units Days 1, 8, 15, & 22; then 90 billable units Day 29 ahus 90 billable units Days 1, 8, 15, & 22; then 120 billable units Day billable units every 14 days 120 billable units every 14 days III. Initial Apprval Criteria Site f care specialty infusin prgram requirements are met (refer t Mda Site f Care Plicy). Patient des nt have a systemic infectin; AND Patients must be administered a meningcccal vaccine at least tw weeks prir t initiatin f Sliris therapy and revaccinated accrding t current medical guidelines fr vaccine use; AND Prescriber is enrlled in the Sliris Risk Evaluatin and Mitigatin Strategy (REMS) prgram; AND Cverage is prvided in the fllwing cnditins: Parxysmal Ncturnal Hemglbinuria (PNH) Patient is 18 years r lder; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 1/5
2 Diagnsis must be accmpanied by detectin f PNH clnes by flw cytmetry diagnstic test; AND Patient has ne f the fllwing indicatins fr therapy: Presence f a thrmbtic event Presence f rgan damage secndary t chrnic hemlysis Patient is pregnant and ptential benefit utweighs ptential fetal risk Patient is transfusin dependent Patient has high LDH activity (defined as 1.5 x ULN) with clinical symptms Dcumented baseline values fr ne r mre f the fllwing (necessary fr renewal): serum lactate dehydrgenase (LDH), hemglbin level, and packed RBC transfusin requirement Atypical Hemlytic Uremic Syndrme (ahus) Patient is 2 mnths r lder; AND Thrmbtic Thrmbcytpenic Purpura (TTP) has been ruled ut by evaluating ADAMTS- 13 level; AND Shiga txin E. cli related hemlytic uremic syndrme (STEC-HUS) has been ruled ut; AND Dcumented baseline values fr ne r mre f the fllwing (necessary fr renewal): serum lactate dehydrgenase (LDH), serum creatinine/egfr, platelet cunt, and plasma exchange/infusin requirement FDA Apprved Indicatin(s) IV. Renewal Criteria Cverage may be renewed based upn the fllwing criteria: Patient cntinues t meet the criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug (e.g., infusin reactins, serius infectins, etc.); AND Disease respnse indicated by ne r mre f the fllwing: PNH Decrease in serum LDH frm pretreatment baseline Stabilizatin/imprvement in hemglbin level frm pretreatment baseline Decrease in packed RBC transfusin requirement frm pretreatment baseline ahus Decrease in serum LDH frm pretreatment baseline Stabilizatin/imprvement in serum creatinine/egfr frm pretreatment baseline Increase in platelet cunt frm pretreatment baseline Decrease in plasma exchange/infusin requirement frm pretreatment baseline Mda Health Plan, Inc. Medical Necessity Criteria Page 2/5
3 V. Dsage/Administratin Indicatin Dse Parxysmal ncturnal hemglbinuria (PNH) Atypical hemlytic uremic syndrme (ahus) Lading dse: 600 mg intravenusly every 7 days fr the first 4 weeks, fllwed by 900 mg intravenusly fr the fifth dse 7 days later Maintenance dse: 900 mg intravenusly every 14 days Adults Lading dse: 900 mg intravenusly every 7 days fr the first 4 weeks, fllwed by 1,200 mg intravenusly fr the fifth dse 7 days later Maintenance dse: 1200 mg intravenusly every 14 days Patients < 18 years 5 kg - <10 kg: 300 mg weekly x 1 dse, 300 mg at week 2, then 300 mg every 3 weeks 10 kg - <20 kg: 600 mg weekly x 1 dse, 300 mg at week 2, then 300 mg every 2 weeks 20 kg -<30 kg: 600 mg weekly x 2 dses, 600 mg at week 3, then 600 mg every 2 weeks 30 kg - <40 kg: 40 kg: 600 mg weekly x 2 dses, 900 mg at week 3, then 900 mg every 2 weeks 900 mg weekly x 4 dses, 1200 mg at week 5, then 1200 mg every 2 weeks Dses shuld be administered at the abve intervals, r within tw days f these time pints. VI. Billing Cde/Availability Infrmatin Jcde: J1300 Injectin, eculizumab, 10 mg; 1 billable unit = 10 mg NDC: Sliris 300 mg/30 ml single-use vials fr injectin: xx VII. References 1. Sliris [package insert]. New Haven, CT; Alexin Pharmaceuticals, Inc; January Accessed July Guidelines fr the diagnsis and mnitring f parxysmal ncturnal hemglbinuria and related disrders by flw cytmetry. Brwitz MJ, Craig FE, DiGiuseppe JA, Illingwrth AJ, Rsse W, Sutherland DR, Wittwer CT, Richards SJ. Cytmetry B Clin Cytm Jul;78(4): di: /cyt.b Mda Health Plan, Inc. Medical Necessity Criteria Page 3/5
4 3. Effect f eculizumab n hemlysis and transfusin requirements in patients with parxysmal ncturnal hemglbinuria. Hillmen P; Hall C; Marsh JC; Elebute M; Bmbara MP; Petr BE; Cullen MJ; Richards SJ; Rllins SA; Mjcik CF; Rther RP. N Engl J Med 2004 Feb 5;350(6): The cmplement inhibitr eculizumab in parxysmal ncturnal hemglbinuria. Hillmen P; Yung NS; Schubert J; Brdsky RA; Scie G; Muus P; Rth A; Szer J; Elebute MO; Nakamura R; Brwne P; Risitan AM; Hill A; Schrezenmeier H; Fu CL; Maciejewski J; Rllins SA; Mjcik CF; Rther RP; Luzzatt L. N Engl J Med Sep 21;355(12): Multicenter phase 3 study f the cmplement inhibitr eculizumab fr the treatment f patients with parxysmal ncturnal hemglbinuria. Brdsky RA; Yung NS; Antnili E; Risitan AM; Schrezenmeier H; Schubert J; Gaya A; Cyle L; de Castr C; Fu CL; Maciejewski JP; Bessler M; Krn HA; Rther RP; Hillmen P. Bld Feb 15;111(4): Epub 2007 Nv Parker C, Omine M, Richards S, et al. Diagnsis and management f parxysmal ncturnal hemglbinuria. Bld Dec (12): Lirat C, Fakhuri F, Ariceta G, et al. An internatinal cnsensus apprach t the management f atypical hemlytic uremic syndrme in children. Pediatr Nephrl Jan;31(1): Taylr CM, Machin S, Wigmre SJ, et al. Clinical practice guidelines fr the management f atypical haemlytic uraemic syndrme in the United Kingdm. Br J Haematl Jan;148(1): Sahin F, Akay OM, Ayer M, et al. Pesg PNH diagnsis, fllw-up and treatment guidelines. Am J Bld Res. 2016;6(2): Cheng HI, Kyung J S, Yn SS, et al. Clinical Practice Guidelines fr the Management f Atypical Hemlytic Uremic Syndrme in Krea. J Krean Med Sci Oct;31(10): Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD): Drugs and Bilgics (Nn-chemtherapy) (L34741). Centers fr Medicare & Medicaid Services, Inc. Updated n 06/21/2017 with effective date 07/01/2017. Accessed July Natinal Gvernment Services, Inc. Lcal Cverage Article: Eculizumab (Sliris ) - Related t LCD L33394 (A54548). Centers fr Medicare & Medicaid Services, Inc. Updated 07/24/2015 with effective dates 10/01/2015. Accessed July Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin D59.3 Hemlytic-uremic syndrme D59.5 Parxysmal ncturnal hemglbinuria [Marchiafava-Micheli] 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): Jurisdictin(s): 5, 8 NCD/LCD Dcument (s): L34741 Jurisdictin(s): 6; K NCD/LCD r Article 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) K (13 & 14) NY, CT, MA, RI, VT, ME, NH Nvitas Slutins, Inc. Natinal Gvernment Services, Inc. (NGS) 15 KY, OH CGS Administratrs, LLC Mda Health Plan, Inc. Medical Necessity Criteria Page 5/5
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