SCIG: Hizentra, Gammagard Liquid, Gamunex -C, Gammaked, Hyqvia, Cuvitru (immune globulin SQ)

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1 SCIG: Hizentra, Gammagard Liquid, Gamunex -C, Gammaked, Hyqvia, Cuvitru (immune glbulin SQ) Dcument Number: IC-0059 Last Review Date: 04/03/2018 Date f Origin: 7/20/2010 Dates Reviewed: 9/2010, 12/2010, 3/2011, 6/2011, 9/2011, 12/2011, 3/2012, 6/2012, 9/2012, 12/2012, 3/2013, 6/2013, 9/2013, 12/2013, 3/2014, 9/2014, 12/2014, 3/2015, 6/2015, 9/2015, 12/2015, 3/2016, 6/2016, 9/2016, 12/2016, 3/2017, 6/2017, 9/2017, 12/2017, 03/2018, 04/2018 I. Length f Authrizatin 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]: Drug Name Dse/ week Dse/28 days Hizentra 46 g 184 g Gamunex-C & Gammaked 24 g 96 g Gammagard liquid 24 g 96 g HyQvia 17.5 g 69 g Cuvitru 23 g 92 g B. Max Units (per dse and ver time) [Medical Benefit]: Drug Name Billable units/28 days Hizentra 960 (PID) 1840 (CIDP) Gamunex-C & Gammaked 192 Gammagard liquid 192 HyQvia 690 Cuvitru 920 III. Initial Apprval Criteria Baseline values fr BUN and serum creatinine btained within 30 days f request; AND Cverage is prvided in the fllwing cnditins: Primary immundeficiency (PID)/Wisktt -Aldrich syndrme Such as: x-linked agammaglbulinemia, cmmn variable immundeficiency, transient hypgammaglbulinemia f infancy, IgG subclass deficiency with r withut IgA deficiency, antibdy deficiency with near nrmal immunglbulin levels) and cmbined deficiencies (severe Mda Health Plan, Inc. Medical Necessity Criteria Page 1/8

2 cmbined immundeficiencies, ataxia-telangiectasia, x-linked lymphprliferative syndrme) [list nt all inclusive] Fr HyQvia ONLY: Patient must be 18 years ld; AND Patient s IgG level is <200 mg/dl OR bth f the fllwing Patient has a histry f multiple hard t treat infectins as indicated by at least ne f the fllwing: Fur r mre ear infectins within 1 year Tw r mre serius sinus infectins within 1 year Tw r mre mnths f antibitics with little effect Tw r mre pneumnias within 1 year Recurrent r deep skin abscesses Need fr intravenus antibitics t clear infectins Tw r mre deep-seated infectins including septicemia; AND The patient has a deficiency in prducing antibdies in respnse t vaccinatin; AND Titers were drawn befre challenging with vaccinatin; AND Titers were drawn between 4 and 8 weeks f vaccinatin Chrnic Inflammatry Demyelinating Plyneurpathy (CIDP) [Hizentra ONLY] Patient must be 18 years ld; AND Physician has assessed baseline disease severity utilizing an bjective measure/tl; AND Used as initial maintenance therapy fr preventin f disease relapses after treatment and stabilizatin with intravenus immunglbulin (IVIG) ; OR Used fr re-initiatin f maintenance therapy after experiencing a relapse and requiring re-inductin therapy with IVIG (see Sectin IV fr criteria) Initial IVIG criteria used fr determinatin f cverage: (Reference Use Only) Patient s disease curse is prgressive r relapsing and remitting fr 2 mnths r lnger; AND Patient has abnrmal r absent deep tendn reflexes in upper r lwer limbs; AND Electrdiagnstic testing indicating demyelinatin: Partial mtr cnductin blck in at least tw mtr nerves r in 1 nerve plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Distal CMAP duratin increase in at least 1 nerve plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Abnrmal tempral dispersin cnductin must be present in at least 2 mtr nerves; OR Reduced cnductin velcity in at least 2 mtr nerves; OR Prlnged distal mtr latency in at least 2 mtr nerves; OR Absent F wave in at least tw mtr nerves plus ne ther demyelinatin criterin listed here in at least 1 ther nerve; OR Prlnged F wave latency in at least 2 mtr nerves; AND Cerebrspinal fluid analysis indicates the fllwing: CSF white cell cunt f <10 cells/mm 3 ; AND CSF prtein is elevated; AND Mda Health Plan, Inc. Medical Necessity Criteria Page 2/8

3 Patient is refractry r intlerant t crticsterids (e.g., prednislne, prednisne, etc.) given in therapeutic dses ver at least three mnths; AND Baseline in strength/weakness has been dcumented using an bjective clinical measuring tl (e.g., INCAT, Medical Research Cuncil (MRC) muscle strength, 6-MWT, Rankin, Mdified Rankin, etc.) FDA Apprved Indicatin(s) IV. Renewal Criteria Cverage can be renewed fr 1 year based upn the fllwing criteria: Patient cntinues t meet criteria identified in sectin III; AND Absence f unacceptable txicity frm the drug; AND BUN and serum creatinine btained within the last 6 mnths and the cncentratin and rate f infusin have been adjusted accrdingly; AND Primary immundeficiency (PID)/Wisktt -Aldrich syndrme Disease respnse as evidenced by ne r mre f the fllwing: Decrease in the frequency f infectin Decrease in the severity f infectin Chrnic Inflammatry Demyelinating Plyneurpathy (CIDP) Renewals will be authrized fr patients that have demnstrated a beneficial clinical respnse t maintenance therapy, withut relapses, based n an bjective clinical measuring tl; OR Patient is re-initiating maintenance therapy after experiencing a relapse while n Hizentra; AND V. Dsage/Administratin Patient imprved and stabilized n IVIG treatment: AND Patient was NOT receiving maximum dsing f Hizentra prir relapse Dsing shuld be calculated using adjusted bdy weight if ne r mre f the fllwing criteria are met: Patient s bdy mass index (BMI) is 30 kg/m 2 r mre; OR Patient s actual bdy weight is 20% higher than his r her ideal bdy weight (IBW) Use the fllwing dsing frmulas t calculate the adjusted bdy weight (rund dse t nearest 5 gram increment in adult patients) BMI = 703 x (weight in punds/height in inches 2 ) IBW(kg) fr males = 50 + [2.3 (height in inches 60)] Dsing frmulas IBW(kg) fr females = [2.3 x (height in inches 60)] Adjusted bdy weight = IBW (actual bdy weight IBW) This infrmatin is nt meant t replace clinical decisin making when initiating r mdifying medicatin therapy and shuld nly be used as a guide. Patient-specific variables shuld be taken int accunt. Mda Health Plan, Inc. Medical Necessity Criteria Page 3/8

4 Indicatin Dse Chrnic Inflammatry Demyelinating Plyneurpathy Primary immune deficiency including Wisktt-Aldrich Syndrme Hizentra ONLY: Initiate therapy 1 week after the last IVIG dse The recmmended subcutaneus dse is 0.2 g/kg (1 ml/kg) bdy weight per week, administered in 1 r 2 sessins ver 1 r 2 cnsecutive days. If CIDP symptms wrsen, cnsider re-initiating treatment with an IVIG while discntinuing Hizentra. Hizentra: If imprvement and stabilizatin are bserved during IVIG treatment, cnsider reinitiating Hizentra at the dse f 0.4 g/kg bdy weight per week, administered in 2 sessins per week ver 1 r 2 cnsecutive days, while discntinuing IVIG. If CIDP symptms wrsen n the 0.4 g/kg bdy weight per week dse, cnsider reinitiating therapy with an IVIG while discntinuing Hizentra. Weekly dse: 1.37*(previus IVIG dse(g)/number f weeks between IVIG dses) Biweekly dse: twice the weekly dse (using calculatin abve) Gamunex-C/Gammaked/Gammagard Liquid: Weekly dse: 1.37*(previus IVIG dse(g)/number f weeks between IVIG dses) HyQvia: Naïve t IgG r switching frm SCIG: 300 t 600 mg/kg at 3 t 4 week intervals after initial ramp-up* Switching frm IGIV: use the same dse and frequency as the previus IV treatment after initial ramp-up* Cuvitru: Switching frm IVIG r HyQvia: Weekly dse: 1.30*(previus IVIG r HyQvia dse (g)/number f weeks between IVIG r HyQvia dses) May be administered frm daily up t every tw weeks (biweekly) Biweekly dse: twice the weekly dse (using calculatin abve) Frequent dsing (2-7 times per week): divide the calculated weekly dse by the desired number f times per week Switching frm SCIG Weekly dse (in grams) shuld be same as the weekly dse f prir SCIG treatment (in grams) Biweekly dse: multiply the calculated weekly dse by 2 Frequent dsing (2-7 times per week): divide the calculated weekly dse by the desired number f times per week Dsing fr immunglbulin prducts is highly variable depending n numerus patient specific factrs, indicatin(s), and the specific prduct selected. Fr specific dsing regimens refer t current prescribing literature. *HyQvia initial treatment interval/dsage ramp-up schedule Week Infusin Number 3-week treatment interval 4-week treatment interval 1 1 st infusin Dse in Grams X 0.33 Dse in Grams X 0.25 Mda Health Plan, Inc. Medical Necessity Criteria Page 4/8

5 Week Infusin Number 3-week treatment interval 4-week treatment interval 2 2 nd infusin Dse in Grams X 0.67 Dse in Grams X rd infusin Ttal Dse in Grams Dse in Grams X th infusin N/A Ttal Dse in Grams VI. Billing Cde/Availability Infrmatin HCPCS cde & NDC: Drug Name Manufacturer HCPCS Cde 1 Billable NDC IgG Vlume unit (grams) (ml) Hizentra 20% CSL Behring AG J1559 Injectin, immune glbulin (Hizentra), 100 mg 100 mg Gammaked 10% Kedrin Bipharma, Inc. J1561 Injectin, immune glbulin, (Gamunex-C/Gammaked), nn-lyphilized (e.g. liquid), 500 mg 500 mg Gamunex-C 10% Grifls Therapeutics J1561 Injectin, immune glbulin, (Gamunex-C/Gammaked), nn-lyphilized (e.g. liquid), 500 mg 500 mg Gammagard Liquid 10% Baxter Healthcare Crpratin J1569 Injectin, immune glbulin, (Gammagard liquid), nnlyphilized, (e.g. liquid), 500 mg 500 mg HyQvia 10% (with Recmbinant Human Hyalurnidase 160 U/mL) Baxter Healthcare Crpratin J1575 Injectin, immune glbulin/hyalurnidase, (Hyqvia), 100 mg immune glbulin 100 mg Cuvitru 20% Baxalta US Inc. J1555 Injectin, immune glbulin (Cuvitru), 100 mg 100 mg Immune Glbulin, Human, Subcutaneus N/A J3590 unclassified bilgic immune glbulin (SCIg), human, fr use in subcutaneus infusins N/A N/A N/A N/A Mda Health Plan, Inc. Medical Necessity Criteria Page 5/8

6 VII. References 1. Hizentra [package insert]. Bern, Switzerland; CSL Behring AG; March Accessed March HyQvia [package insert]. Westlake Village, CA; Baxter Healthcare Crpratin; September Accessed January Cuvitru [package insert]. Westlake Village, CA; Baxalta US Inc.; September Accessed January Gammagard Liquid [package insert]. Westlake Village, CA; Baxter Healthcare Crpratin; June Accessed January Gamunex -C [package insert]. Research Triangle, NC; Grifls Therapeutics, Inc.; March Accessed January Gammaked [package insert]. Research Triangle, NC; Grifls Therapeutics, Inc.; September Accessed January Jeffrey Mdell Fundatin Medical Advisry Bard, Warning Signs f Primary Immundeficiency. Jeffrey Mdell Fundatin, New Yrk, NY 8. Orange J, Hssny E, Weiler C, et al. Use f intravenus immunglbulin in human disease: A review f evidence by members f the Primary Immundeficiency Cmmittee f the American Academy f Allergy, Asthma and Immunlgy. J Allergy Clin Immunl 2006;117(4 Suppl): S Orange JS, Ballw M, Stiehm, et al. Use and interpretatin f diagnstic vaccinatin in primary immundeficiency: A wrking grup reprt f the Basic and Clinical Immunlgy Interest Sectin f the American Academy f Allergy, Asthma & Immunlgy. J Allergy Clin Immunl Vl 130 (3). 10. Bnilla FA, Khan DA, Ballas ZK, et al. Practice Parameter fr the diagnsis and management f primary immundeficiency. J Allergy Clin Immunl 2015 Nv;136(5): e Emersn GG, Herndn CN, Sreih AG. Thrmbtic cmplicatins after intravenus immunglbulin therapy in tw patients. Pharmactherapy. 2002;22: Department f Health (Lndn). Clinical Guidelines fr Immunglbulin Use: Update t Secnd Editin. August, Prvan, Drew, et al. "Clinical guidelines fr immunglbulin use." Department f Health Publicatin, Lndn (2008). 14. Dantal J. Intravenus Immunglbulins: In-Depth Review f Excipients and Acute Kidney Injury Risk. Am J Nephrl 2013;38: Immune Deficiency Fundatin. Diagnstic & Clinical Care Guidelines fr Primary Immundeficiency Diseases. 3 rd Ed Avail at: Guidelines-fr-PI_1.pdf. 16. First Cast Service Optins, Inc. Lcal Cverage Determinatin (LCD): Intravenus Immune Glbulin (L34007). Centers fr Medicare & Medicaid Services, Inc. Updated n 1/5/2018 with effective date 1/1/2018. Accessed March Wiscnsin Physicians Service Insurance Crpratin. Lcal Cverage Determinatin (LCD): Immune Glbulins (L34771). Centers fr Medicare & Medicaid Services, Inc. Updated n 12/19/2017 with effective date 1/1/2018. Accessed March Appendix 1 Cvered Diagnsis Cdes Mda Health Plan, Inc. Medical Necessity Criteria Page 6/8

7 ICD-10 B20 ICD-10 Descriptin Human immundeficiency virus [HIV] disease D80.0 Hereditary hypgammaglbulinemia D80.1 Nnfamilial hypgammaglbulinemia D80.2 Selective deficiency f immunglbulin A [IgA] D80.3 Selective deficiency f immunglbulin G [IgG] subclasses D80.4 Selective deficiency f immunglbulin M [IgM] D80.5 Immundeficiency with increased immunglbulin M [IgM] D80.7 Transient hypgammaglbulinemia f infancy D81.0 Severe cmbined immundeficiency [SCID] with reticular dysgenesis D81.1 Severe cmbined immundeficiency [SCID] with lw T- and B-cell numbers D81.2 Severe cmbined immundeficiency [SCID] with lw r nrmal B-cell numbers D81.6 Majr histcmpatibility cmplex class I deficiency D81.7 Majr histcmpatibility cmplex class II deficiency D81.89 Other cmbined immundeficiencies D81.9 Cmbined immundeficiency, unspecified D82.0 Wisktt-Aldrich syndrme D83.0 Cmmn variable immundeficiency with predminant abnrmalities f B-cell numbers and functin D83.2 Cmmn variable immundeficiency with autantibdies t B- r T-cells D83.8 Other cmmn variable immundeficiencies D83.9 Cmmn variable immundeficiency, unspecified G61.81 Chrnic inflammatry demyelinating plyneuritis G61.89 Other inflammatry plyneurpathies G62.89 Other specified plyneurpathies 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): N NCD/LCD/Article Dcument (s): L Mda Health Plan, Inc. Medical Necessity Criteria Page 7/8

8 Jurisdictin(s): 5, 8 NCD/LCD/Article Dcument (s): L 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 8/8