Drug Therapy Guidelines

Transcription

1 Drug Therapy Guidelines Applicable Medical Benefit x Effective: 5/1/18 Pharmacy- Frmulary 1 x Next Review: 6/18 Pharmacy- Frmulary 2 x Date f Origin: 11/07 Immune Glbulins Intravenus: Carimune NF, Flebgamma, Flebgamma DIF, Gammagard, Gammagard S/D, Gammaplex, Gamunex-C, Octagam, Gammaked and BIVIGam, Privigen Subcutaneus: Hizentra, Gamunex-C, Gammaked, Gammagard, HyQvia, Cuvitru Pharmacy- Frmulary 3/Exclusive x Review Dates: 11/5/07, 8/7/08, 12/15/08, 12/09, 7/10, 3/11, 3/12, Pharmacy- Frmulary 4/AON x 3/13, 3/14, 6/15, 6/16, 12/16, 6/17, 3/18 I. Medicatin Descriptin Immune glbulins are therapeutic preparatins f pled plyspecific IgG (Immunglbulin G antibdies) btained frm the plasma f a large number f healthy individuals. The riginal use f these immunglbulin preparatins, which cntain a brad range f antibdy specificities, was in antibdy replacement therapy. Hwever, a number f ther clinical benefits f immune glbulin treatment have been demnstrated. Many f these ther uses result frm anti-inflammatry and immunmdulatry effects, which were nt anticipated when these plyclnal preparatins were first develped. Immune glbulins are available as intravenus, subcutaneus and intramuscular dsage frms. II. Psitin Statement All frmulatins f immune glbulin are available under the medical benefit. Subcutaneus frmulatins f immune glbulin are als available under the pharmacy benefit: Hizentra, Gamunex-C, Gammaked, Gammagard Liquid, HyQvia, Cuvitru Cverage is determined thrugh a prir authrizatin prcess with supprting clinical dcumentatin fr all requests. III. Plicy Cverage fr intravenus glbulin prducts (J1459, J1556, J1561, J1566, J1568, J1569, J1572, J1557, J1599) is prvided fr the fllwing: Primary immune and functinal deficiency disrders (including, but nt limited t agammaglbulinemia, hypgammaglbulinemia, cmmn variable immundeficiency, severe cmbined immundeficiencies, Wisktt-Aldrich syndrme) OR B-cell chrnic lymphcytic leukemia (CLL) when: The member has a deficiency in prducing antibdies OR IgG pretreatment lab value is less than 600 mg/dl AND at least 1 bacterial infectin is directly attributed t member's immundeficiency Page 1 f 6

2 Drug Therapy Guideline Immune Glbulins Last Review Date: 3/2018 Infectin prphylaxis in hematpietic cell transplantatin (HCT) recipients OR HIV-infected members when: IgG pretreatment lab value is less than 400 mg/dl Immune thrmbcytpenia/idipathic thrmbcytpenia purpura (ITP) (including HCV and HIVassciated): Fr members unable t receive crticsterids OR wh need a rapid increase in platelet cunt (platelet cunts usually less than 30,000/μl fr newly diagnsed members) T increase platelet cunts prir t invasive majr surgical prcedures(i.e. splenectmy) Pst-splenectmy members with platelet cunts less than 30,000/μl Fetal and nenatal allimmune thrmbcytpenia Chrnic Inflammatry Demyelinating Plyneurpathy (CIDP) Multifcal mtr neurpathy (MMN) Myasthenia gravis exacerbatin Member has had an inadequate respnse t crticsterids (r use is cntraindicated) AND Member is currently receiving r will be starting an immunsuppressive maintenance therapy (i.e. azathiprine, cyclsprine, mycphenlate, methtrexate, tacrlimus, etc.), unless cntraindicated Refractry myasthenia gravis Member has had an inadequate respnse r cntraindicatin t pyridstigmine AND Member has had an inadequate respnse r cntraindicatin t crticsterids AND Member has had an inadequate respnse r cntraindicatin t at least TWO r mre f the fllwing: Azathiprine Cyclsprine Mycphenlate mfetil Tacrlimus Methtrexate Cyclphsphamide Myasthenic crisis (i.e. member is experiencing an acute episde f respiratry muscle weakness) Refractry dermatmysitis Severe disease resistant t a trial f cnventinal therapy ptins (i.e., crticsterids r immunsuppressant agents such as azathiprine, methtrexate, cyclphsphamide, cyclsprine) AND Given in cmbinatin with immunsuppressant therapy Bne Marrw Transplant Slid Organ Transplant: prir t r fllwing a transplant fr preventin r treatment f antibdymediated rejectin Guillian-Barre Syndrme Kawasaki Disease West Nile virus treatment including meningitis and encephalitis Measles prphylaxis: fr severely immune cmprmised r nn-measles immune pregnant members Pst transfusin purpura Page 2 f 6

3 Drug Therapy Guideline Immune Glbulins Last Review Date: 3/2018 Autimmune muccutaneus blistering diseases (including, but nt limited t pemphigus vulgaris): fr members nnrespnsive r intlerant t sterids r immunsuppressant therapy Cverage fr subcutaneus immune glbulin (J1559, J1561, J1562, J1569, J1575) is prvided fr the fllwing diagnses: Primary immundeficiency(including, but nt limited t agammaglbulinemia, hypgammaglbulinemia, cmmn variable immundeficiency, severe cmbined immundeficiencies, Wisktt-Aldrich syndrme) when: The member is 2 years f age r lder if using Hizentra, Gamunex-C, Gammagard Liquid, r Cuvitru OR the member is an adult if using Gammaked r HyQvia AND The member has been receiving intravenus r subcutaneus immune glbulin at regular intervals prir t switching t the requested subcutaneus prduct if using Gamunex-C, Gammagard Liquid, Gammaked, r Cuvitru OR The member has been receiving intravenus immune glbulin at regular intervals fr at least 3 mnths if using Hizentra AND The member has a deficiency in prducing antibdies OR IgG pretreatment lab value is less than 600 mg/dl AND at least 1 bacterial infectin is directly attributed t member's immundeficiency IV. Quantity Limitatins Dependent n diagnsis and prduct Fr myasthenic exacerbatin: ne treatment curse Fr refractry myasthenia gravis: ne treatment curse; repeat dses may be prvided n a case-by-case basis Fr the purpses f Max Unit editing, the dse f 1g/kg every day x 2 days given every 21 days is used fr IVIg: Max units (male): 460 units every 21 days Max units (female): 400 units every 21 days V. Cverage Duratin Initial cverage fr myasthenic exacerbatin will be prvided fr 1 mnth and may nt be renewed. Initial cverage fr refractry myasthenia gravis will be prvided fr up t 3 mnths and may be renewed in up t 6 mnth intervals. Initial cverage fr multifcal mtr neurpathy will be prvided fr 3 mnths t evaluate respnse and may be renewed. Initial cverage fr all ther diagnses is prvided fr 6 mnths and may be renewed. VI. Cverage Renewal Criteria Cverage fr the treatment f refractry myasthenia gravis may be renewed fr up t 6 mnths at a time based upn the fllwing criteria: Page 3 f 6

4 Drug Therapy Guideline Immune Glbulins Last Review Date: 3/2018 Member displays imprvement f symptms r shws stabilizatin f disease AND Cntinuatin f treatment is warranted (medical necessity shwn with prvided dcumentatin) AND Absence f unacceptable txicity frm the drug has been dcumented Cverage fr all ther indicatins can be renewed fr up t 12 mnths at a time based upn the fllwing criteria: Fr multifcal mtr neurpathy: If member is a respnder t initial therapy, renewal may be given. Fr all ther indicatins: Dcumented imprvement f disease symptms AND Dcumentatin f imprvement r stabilizatin f IgG level (if applicable) VII. Billing/Cding Infrmatin J Cdes: J1459- Privigen (500mg per 1 billable unit) J1556- BIVIGam (500mg per 1 billable unit) J1557- Gammaplex (500mg per 1 billable unit) J1559- Hizentra (100mg per 1 billable unit) J1561- Gammaked, Gamunex-C (500mg per 1 billable unit) J1566- IVIg lyphlized: Gammagard S/D, Carimune NF, Panglbulin NF (500mg per 1 billable unit) J1568- Octagam (500mg per 1 billable unit) J1569- Gammagard (500mg per 1 billable unit) J1572- Flebgamma, Flebgamma DIF (500mg per 1 billable unit) J1599- IVIg NOS (500mg per 1 billable unit) J1575- HyQvia (100mg per 1 billable unit) J1555 Cuvitru (100 mg per 1 billable unit) VIII. Summary f Plicy Changes 6/1/11: Gamunex-C (subcutaneus) added t plicy indicatins and cntraindicatins Autpay grid edited fr intravenus prducts nly Criteria added fr specific diagnses (primary immune deficiencies, ITP, CIDP, myasthenic crisis/myasthenia gravis, refractry dermatmysitis, slid rgan transplant, multifcal mtr neurpathy, and preventin f infectin in HIV psitive members. 6/15/12: allw cverage in situatins where the member has a dcumented inability t prduce adequate amunts f antibdy extend cverage duratin fr renewals 12/15/12: Remved requirement fr IVIg use prir t cverage cnsideratin f SCIg based n current practices and dsing capabilities 6/15/13: Additin f IMIg t plicy with criteria fr apprved indicatins Page 4 f 6

5 Drug Therapy Guideline Immune Glbulins Last Review Date: 3/2018 Additin f apprvable diagnses fr SCIg t mirrr IVIg indicatins Additin f dsing limitatins fr all prduct frmulatins Remval f autpay fr Guillain-Barre Syndrme and Kawasaki Disease Additin f Gammaked, BIVIGam, BayGam, and GamaSTAN S/D t the plicy Additin f renewal criteria 1/1/14: BIVIGam cde update dcumented 6/15/14: Clarificatin f West Nile Virus treatment scenari Measles prphylaxis criteria added autimmune muccutaneus blistering diseases criteria added excluded uses updated 1/12/15: HyQvia added t plicy 7/1/15: frmulary distinctins made 9/15/15: n plicy changes 1/1/16: updated HyQvia drug cde 9/15/16: n plicy changes 7/19/16: Update f ITP criteria accrding t guidelines Additin f cverage fr infectin prphylaxis in hematpietic cell transplantatin 1/1/17: Cuvitru added t plicy; Vivaglbin and Baygam remved due t prduct discntinuatin Clarified criteria fr prducts with different rutes f administratin clarified n PA required fr IMIg prducts 6/21/17: remved Gamunex as prduct is ff-market 1/1/18: updated billing/cding infrmatin 5/1/18: updated criteria, quantity limits, and cverage duratin fr myasthenia gravis treatment IX. References 1. Clinical Pharmaclgy Online, retrieved 10/ Facts and Cmparisns Online, retrieved 10/ Carimune NF package insert, Revised June Flebgamma 10% package insert, Revised August Gammagard package insert, Revised June Gammagard S/D package insert, Revised December Octagam package insert, Revised March Privigen package insert, Issued July Gamunex-C package insert, Revised June Gammaplex 5% package insert, Revised December Gammaplex 10% package insert, Revised February Gammaked package insert, Revised September BIVIGam package insert, Revised April Hizentra package insert, September HyQvia package insert, September Page 5 f 6

6 Drug Therapy Guideline Immune Glbulins Last Review Date: 3/ Cuvitru package insert, September Skeie GO, Apstlski S, Evli A, et al. Guidelines fr the treatment f autimmune neurmuscular transmissin disrders. Eur J Neurl. 2006;13(7): Feasby T, Banwell B, Benstead T, et al. Guidelines n the use f intravenus immune glbulin fr neurlgic cnditins. Transfus Med Rev. 2007;21(2 suppl 1):S Gajds P, Tranchant C, Clair B, et al; Myasthenia Gravis Clinical Study Grup. Treatment f myasthenia gravis exacerbatin with intravenus immunglbulin: a randmized duble-blind clinical trial. Arch Neurl. 2005;62(11): Rnager J, Ravnbrg M, Hermansen I, Vrstrup S. Immunglbulin treatment versus plasma exchange in patients with chrnic mderate t severe myasthenia gravis. Artif Organs. 2001;25(12): Wlfe GI, Barhn RJ, Fster BM, et al; Myasthenia Gravis-IVIG Study Grup. Randmized, cntrlled trial f intravenus immunglbulin in myasthenia gravis. Muscle Nerve. 2002;26(4): Zinman L, Ng E, Bril V. IV immunglbulin in patients with myasthenia gravis: a randmized cntrlled trial. Neurlgy. 2007;68(11): Feasby T, Banwell B, Benstead T, et al. Guidelines n the use f intravenus immune glbulin fr neurlgic cnditins. Transfus Med Rev. 2007;21(2 suppl 1):S57-S Hughes RA, Wijdicks EF, Barhn R, et al; Quality Standards Subcmmittee f the American Academy f Neurlgy. Practice parameter: immuntherapy fr Guillain-Barré syndrme: reprt f the Quality Standards Subcmmittee f the American Academy f Neurlgy. Neurlgy. 2003;61(6): Hughes RA, Swan AV, Raphael JC, Annane D, van Kningsveld R, van Drn PA. Immuntherapy fr Guillain- Barré syndrme: a systematic review. Brain. 2007;130(pt 9): Bussel, JB et al. Antenatal management f allimmune thrmbcytpenia with Intravenus Immunglbulin: A randmized trial f he lw dse sterid t intravenus immunglbulin. Am J Obstet Gynecl 1996; UpTDate Online. Subcutaneus and intramuscular immune glbulin therapy. Accessed 5/ Micrmedex. Immune glbulin. DrugDex Evaluatin. Accessed nline 7/ Schmidt E, Zillikens D. The Diagnsis and Treatment f Autimmune Blistering Skin Diseases. Deutsches Ärzteblatt Internatinal. 2011;108(23): di: /arztebl A. Chaudhuri, P.O. Behan. Myastenic crisis. Q J Med 2009; 102: Cindy Neunert, Wendy Lim, Mark Crwther, et all. The American Sciety f Hematlgy 2011 evidencebased practice guideline fr immune thrmbcytpenia. Bld 2011; 117: Patwa HS, Chaudhry V, Katzberg H, et al. Evidence-based guideline: intravenus immunglbulin in the treatment f neurmuscular disrders. Neurlgy 2012; 78(13): Perez EE, Orange JS, Bnilla F, et all. Update n the use f immunglbulin in human disease: a review f evidence. J allergy Clin Immunl, 2017: 139: Sanders DB, Wlfe GI, Benatar M, et al. Internatinal cnsensus guidance fr management f myasthenia gravis: Executive summary. Neurlgy. 2016;87(4): The Plan fully expects that nly apprpriate and medically necessary services will be rendered. The Plan reserves the right t cnduct pre-payment and pst-payment reviews t assess the medical apprpriateness f the abve-referenced therapies. The preceding plicy applies nly t members fr whm the abve named pharmacy benefit medicatins are included n their cvered frmulary. Members with clsed frmulary benefits are subject t trying all apprpriate frmulary alternatives befre a cverage exceptin fr a nn-frmulary medicatin will be cnsidered. The preceding plicy is a guideline t allw fr cverage f the pertinent medicatin/prduct, and is nt meant t serve as a clinical practice guideline. Page 6 f 6