Soliris (eculizumab) (Intravenous)

Transcription

1 Sliris (eculizumab) (Intravenus) Last Review Date: 02/04/2019 Date f Origin: 06/21/2011 Dcument Number: MODA-0114 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, 10/2017, 03/2018, 06/2018, 10/2018, 02/2019 I. Length f Authrizatin PNH and ahus: Cverage will be prvided fr twelve mnths and may be renewed. gmg: Initial cverage will be prvided fr 6 mnths and may be renewed annually thereafter. 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 billable units every 14 days ahus, gmg 90 billable units Days 1, 8, 15, & 22; then 120 billable units Day 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). Cverage is prvided in the fllwing cnditins: Patient des nt have a systemic infectin; AND Patients must be administered a meningcccal vaccine at least tw weeks prir t initiatin f 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 Mda Health Plan, Inc. Medical Necessity Criteria Page 1/6

2 Will nt be used in cmbinatin with ther cmplement-inhibitr therapy (i.e., ravulizumab); AND Parxysmal Ncturnal Hemglbinuria (PNH) Patient is 18 years r lder; AND Diagnsis must be accmpanied by detectin f PNH clnes f at least 10% by flw cytmetry diagnstic testing; AND Demnstrate the presence f at least 2 different glycsylphsphatidylinsitl (GPI) prtein deficiencies (e.g. CD55, CD59, etc.) within at least 2 different cell lines (granulcytes, mncytes, erythrcytes); 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 (ADAMTS-13 activity level > 10%); AND Shiga txin E. cli related hemlytic uremic syndrme (STEC-HUS) has been ruled ut; AND Other causes have been ruled ut such as cexisting diseases r cnditins (e.g. bne marrw transplantatin, slid rgan transplantatin, malignancy, autimmune disrder, druginduced, malignant hypertensin, HIV infectin, etc.), Streptcccus pneumniae r Influenza A (H1N1) infectin, r cbalamin deficiency; 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 Generalized Myasthenia Gravis (gmg) Patient is 18 years r lder; AND Patient has Myasthenia Gravis Fundatin f America (MGFA) Clinical Classificatin f Class II t IV disease; AND Patient has a psitive serlgic test fr anti-acetylchline receptr (AchR) antibdies; AND Physician has assessed the baseline Quantitative Myasthenia Gravis (QMG) scre; AND Patient has a MG-Activities f Daily Living (MG-ADL) ttal scre f 6; AND Patient has failed treatment ver at least 1 year with at least 2 immunsuppressive therapies (e.g. azathiprine, cyclsprine, mycphenlate, etc), r has failed at least 1 Mda Health Plan, Inc. Medical Necessity Criteria Page 2/6

3 immunsuppressive therapy and required chrnic plasmapheresis r plasma exchange (PE) r intravenus immunglbulin (IVIG); AND Patient had an inadequate respnse, r has a cntraindicatin r intlerance, t rituximab 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. Examples f unacceptable txicity include the fllwing: serius meningcccal infectins (septicemia and/r meningitis), infusin reactins, serius infectins, thrmbtic micrangipathy cmplicatins (TMA), 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 gmg Imprvement f at least 3-pints frm baseline in the Myasthenia Gravis-Specific Activities f Daily Living scale (MG-ADL) ttal scre Imprvement f at least 5-pints frm baseline in the Quantitative Myasthenia Gravis (QMG) ttal scre V. Dsage/Administratin Indicatin Parxysmal ncturnal hemglbinuria (PNH) Atypical hemlytic uremic Dse* 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: Adults Lading dse: 900 mg intravenusly every 14 days 900 mg intravenusly every 7 days fr the first 4 weeks, fllwed by 1,200 mg intravenusly fr the fifth dse 7 days later Mda Health Plan, Inc. Medical Necessity Criteria Page 3/6

4 syndrme (ahus) Generalized Myasthenia Gravis (gmg) 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: Lading dse: 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 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 Dse Adjustment fr ahus (adult and pediatric patients) and gmg (adult patients) in case f Plasmapheresis, Plasma Exchange r Fresh Frzen Plasma Infusin Type f Plasma Interventin Mst Recent Sliris Dse Supplemental Sliris With Each Plasma Interventin Timing f Supplemental Sliris Dse Plasmapheresis r plasma exchange (PE) 300 mg 600 mg 300 mg per each plasmapheresis r PE 600 mg per each plasmapheresis r PE Within 60 minutes after each plasmapheresis r PE Fresh frzen plasma infusin (FFP) 300 mg 300 mg per each infusin f FFP 60 minutes prir t each infusin f FFP *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; July Accessed January Guidelines fr the diagnsis and mnitring f parxysmal ncturnal hemglbinuria and related disrders by flw cytmetry. Brwitz MJ, Craig FE, DiGiuseppe JA, Illingwrth AJ, Mda Health Plan, Inc. Medical Necessity Criteria Page 4/6

5 Rsse W, Sutherland DR, Wittwer CT, Richards SJ. Cytmetry B Clin Cytm Jul;78(4): di: /cyt.b 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): Sanders DB, Wlfe GI, Benatar M, et al. Internatinal cnsensus guidance fr management f myasthenia gravis-executive Summary. Neurlgy Jul 26; 87(4): Hward JF. REGAIN: A Phase 3 Randmized, Duble-Blind, Placeb-Cntrlled, Multi- Center Study t Evaluate the Safety and Efficacy f Eculizumab in Subjects With Refractry Generalized Myasthenia Gravis (gmg). Presented at the 14th Internatinal Cngress n Neurmuscular Diseases (ICNMD), Trnt, July 7, Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD): Drugs and Bilgics (Nn-chemtherapy) (L34741). Centers fr Medicare & Medicaid Services, Inc. Updated n 05/24/2018 with effective date 06/01/2018. Accessed January Natinal Gvernment Services, Inc. Lcal Cverage Article: Eculizumab (Sliris ) - Related t LCD L33394 (A54548). Centers fr Medicare & Medicaid Services, Inc. Updated 11/22/2017 with effective dates 12/01/2017. Accessed January Appendix 1 Cvered Diagnsis Cdes ICD-10 ICD-10 Descriptin D59.3 Hemlytic-uremic syndrme Mda Health Plan, Inc. Medical Necessity Criteria Page 5/6

6 ICD-10 ICD-10 Descriptin D59.5 Parxysmal ncturnal hemglbinuria [Marchiafava-Micheli] G70.00 Myasthenia gravis withut (acute) exacerbatin G70.01 Myasthenia gravis with (acute) exacerbatin 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 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) 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 6/6