OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Bylvay (odevixibat) BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Bylvay, approved by the FDA in July 2021, is indicated f or the treatment of pruritus in patients 3 months of age and older with progressive f amilial intrahepatic cholestasis (PFIC). It is the f irst drug approved f or PFIC and is available as oral pellets or capsules , taken once daily. PFIC is an ultra-rare group of genetic disorders that disrupt bile f ormation in the liver . It usually presents during inf ancy and is characterized by cholestasis, jaundice, and intense itching. Most patients will eventually require biliary diversion surgery or liver transplant. PFIC types 1, 2, and 3 are the most common and types 1 and 2 are t he most severe. PFIC1 involves extrahepatic manif estations while PFIC2 does not. However, PFIC2 can be complicated by hepatocellular carcinoma. As of June 2023, Bylvay is also approved f or the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille Syndrome ( ALGS ) , a rare genetic disorder that can af f ect multiple organ systems, most commonly the liver , with a paucity of interlobular ducts . In cholestatic liver disease, biliary substances arent eliminated f rom the liver , thus they re-enter circulation. Cholestatic itch is thought to be related to the accumulation of bile acids in the skin. Bylvay is a reversible inhibitor of the ileal bile acid transporter (IBAT). Inhibiting IBAT decreases reuptake of bile salts . Bylvay (odevixibat) will be considered for coverage when the following criteria are met: Progressive familial intrahepatic cholestasis (PFIC)For initial authorization: 1. Member is at least 3 months of age; AND2. Medication must be prescribed by or in consultation with a gastroenterologist or hepatologist ; AND3. Member has a diagnosis of PFIC type 1 or 2 conf irmed by genetic testing identif ying pathogenic mutations of the ATP8B1 or ABCB11 genes (results must be provided f or review); AND4. Member has signif icant pruritis not attributed to another cause; AND5. Documentation of serum bile acid level 100 mol/L ; AND6. Documentation of baseline liver f unction tests ( e.g., ALT, AST, bilirubin , INR ); AND7. Trial and f ailure of ursodiol ( may also continue concurrently ); AND8. Member does NOT have any of the f ollowing:a) Decompensated c irrhosis b) Varia nts of the ABCB11 gene (PFIC type 2) that code f or non-f unctional or complete absence of the bile salt export pump (BSEP-3 ) protein (per submitted genetic test result)c) Biliary diversion surgery in the past 6 months d) Liver transplant9. Dosage allowed/Quantity limit: 40 mcg/kg orally once daily. If no improvement af ter 3 months, may increase in 40 mcg/kg increments up to 120 mcg/kg. Max dose per day 6 mg.If all the above requirements are met , the medication will be approved for 6 months . OH-MED-P-366685For reauthorization : 1. Chart notes must show improvement o f pruritis compared to baseline; AND 2. Chart notes must show reduced serum bile acid f rom baseline ; AND 3. Member has NOT experienced portal hypertension or a hepatic decompensation event (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) while being treated with Bylvay . If all the above requirements are met , the medication will be approved for an additional 12 months .Alagille Syndrome (ALGS)For initial authorization: 1. Member is at least 12 months of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist or hepatologist ; AND 3. Member has a diagnosis of Alagille syndrome (ALGS) conf irmed by the involvement of at least 3 of the f ollowing major clinical f eatures : a) Hepatic (e.g., hyperbilirubinemia , cholestasis, xanthomas ) b) Cardiac (e.g., heart murmur, peripheral pulmonic stenosis ) c) Facial (e.g., inverted triangular f ace) d) Ocular (e.g., embryotoxon, optic disk drusen) e) Skeletal (e.g., butterf ly vertebrae) f) Renal (e.g., renal dysplasia, renal tubular acidosis) g) Vascular (e.g., neurovascular accident, moyamoya disease) NOTE: Member also meets criterion if has one or more clinical f eatures and an af f ected f irst-degree relative; AND 4. Member must have liver biopsy demonstrating reduced number of the interlobular bile ducts OR conf irmed f inding of JAG1 or NOTCH2 gene mutation; AND 5. Member has moderate to severe pruritus; AND 6. Members serum bile acid (sBA) level is elevated; AND 7. Member does NOT have any of the f ollowing: a) Previous liver transplant b) Decompensated cirrhosis ; AND 8. Member must have a trial and f ailure of at least 2 of the f ollowing: a) Cholestyramine b) Ursodiol c) Rif ampin d) Naltrexone ; AND 9. Documented rationale why Livmarli cannot be used instead of Bylvay; AND 10. Documentation of baseline liver f unction tests (e.g., ALT, AST, bilirubin, INR). 11. Dosage allowed/Quantity limit: 120 mcg/kg taken orally once daily . If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Pruritis has improved in response to therapy with Bylvay ; AND2. Member has NOT experienced portal hypertension or a hepatic decompensation event (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) while being treated with Bylvay If all the above requirements are met , the medication will be approved for an additional 12 months .OH-MED-P – 366685 CareSource considers Bylvay (odevixibat) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. DATE ACTION/DESCRIPTION 11/17/2021 New policy f or created f or Bylvay . 06/27/2023 Added indication f or Alagille Syndrome. 08/02/2024 Updated ref erence. 11/19/24 Approved by ODMRef erences: 1. Bylvay [p rescrib ing inf o rmatio n]. Alb ireo Pharma, Inc.; 202 4 .2. Baumann U, Sturm E, Lacaille F, et al. Effects of o devixibat on p ruritus and bile acids in child ren with cho lestatic liver d isease: Phase 2 stud y. Clin Res Hepatol Gastroenterol . 2021;45(5):101751. d o i:10.1016/j.clinre.2021.1017513. Deeks ED. Od evixib at: First Ap p ro val [p ub lished co rrectio n ap p ears in Drug s. 2021 Sep 23;:]. Drugs .2021;81(15):1781-1786. d o i:10.1007/s40265-021-01594-y4. Kamath BM, Stein P, Houwen RHJ, Verkade HJ. Potential of ileal bile acid transporter inhibitio n as a therap eutic targ et in Alag ille syndrome and p ro g ressive f amilial intrahep atic cho lestasis. Liver Int . 2020;40(8):1812-1822. d o i:10.1111/liv.145535. Gunayd in M, Bo zkurter Cil AT. Pro g ressive f amilial intrahep atic cho lestasis: d iag no sis, manag ement, and treatment. Hepat Med . 2018;10:95-104. Pub lished 2018 Sep 10. d o i:10.2147/HMER.S1372096. Sid d iqi I, Tad i P. Progressive Familial Intrahepatic Cholestasis. [Updated 2021 Sep 29]. In: StatPearls [Internet].Treasure Island (FL): StatPearls Pub lishing ; 2021 Jan – . Availab le f ro m:http s://www.ncb i.nlm.nih.g o v/b o o ks/NBK559317/7. Baker A, Kerkar N, To dorova L, Kamath BM, Houwen RHJ. Systematic review of p rogressive familial intrahep atic cho lestasis [p ub lished co rrectio n ap p ears in Clin Res Hep ato l Gastro entero l. 2020 Feb ;44(1):115]. Clin ResHepatol Gastroenterol . 2019;43(1):20-36. d o i:10.1016/j.clinre.2018.07.0108. Srivastava A. Pro g ressive f amilial intrahep atic cho lestasis. JClin Exp Hepatol . 2014;4(1):25-36. d o i:10.1016/j.jceh.2013.10.0059. Ovchinsky N, Aumar M, Baker A, et al. Ef f icacy and saf ety o f o d evixib at in p atients with Alag ille synd ro me(ASSERT): a p hase 3, d o ub le-b lind , rand o mised , p laceb o-co ntro lled trial. Lancet Gastroenterol Hepatol .2024;9(7):632-645. d o i:10.1016/S2468-1253(24)00074-810. Ayo ub MD and Kamath BM. Alag ille Synd ro me: Diag no stic Challeng es and Ad vances in Manag ement.Diagnostics . 2020; 10(11):907. http s://d o i.o rg /10.3390/d iag no stics1011090711. Lin, Henry. Alag ille Syndrome. National Org anization for Rare Disorders; Updated May 25, 202 3 . Accessed June27, 2023 . http s://rared iseases.o rg /rare-d iseases/alag ille-synd ro me/12. Diaz-Frias J, Kondamudi NP. Alagille Syndrome. [Updated 2022 Aug 14]. In: StatPearls [Internet]. Treasure Island(FL): StatPearls Pub lishing ; 2023 Jan – . Availab le f ro m: http s://www.ncb i.nlm.nih.g o v/b o o ks/NBK507827/13. Fawaz R, Baumann U, Eko ng U, et al. Guid eline f o r the Evaluatio n o f Cho lestatic Jaund ice in Inf ants: Jo intReco mmendations of the North American Society for Pediatric Gastroenterology, Hepato lo g y, and Nutritio n and the Euro p ean Society for Pediatric Gastro entero lo g y, Hep ato lo g y, and Nutritio n. JPediatr Gastroenterol Nutr .2017;64(1):154-168. d o i:10.1097/MPG.000000000000133414. Sp inner NB, Gilbert MA, Lo omes KM, et al. Alagille Syndrome. 2000 May 19 [Up d ated 2019 Dec 12]. In: Ad amMP, Mirzaa GM, Pagon RA, et al., ed ito rs. GeneReviews [Internet]. Seattle (WA): University o f Washing to n,Seattle; 1993-2023. Availab le f ro m: http s://www.ncb i.nlm.nih.g o v/b o o ks/NBK1273/15. Muntaha HST, Munir M, Sajid SH, et al. Ileal Bile Acid Transp o rter Blo ckers f o r Cho lestatic Liver Disease inPed iatric Patients with Alag ille Synd ro me: A Systematic Review and Meta-Analysis. JClin Med .2022;11(24):7526. Pub lished 2022 Dec 19. d o i:10.3390/jcm1124752616. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.17. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.18. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o v. OH-MED-P-366685Ef f ective d ate: 01/0 1/2025Revised d ate: 08/02/2024
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Immune globulin (IVIG and SCIG): Intravenous (IVIG ): Alyglo, Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen , Yimmugo Subcutaneous (SCIG): Cutaquig, Cuvitru, Hizentra, HyQvia, Xembif y BENEFIT TYPE Medical STATUS Prior Authorization Required Human immune globulin or immunoglobulin (IG) products are used to treat a wide range of conditions f rom autoimmune or inf lammatory disorders to infections and idiopathic diseases. IG functions as antibodies in the immune system. IgG is the most common type. They are derived f rom human plasma, so product availability varies based on the supply dependency on the donor pool . There is not substantial evidence that one product is more ef f ective than another. IVIG and SCIG products are not interchangeable. SCIG can allow f or patient self-administration but requires a larger quantity than IVIG due to bioavailability dif f erences. Primary Immunodef iciency (PI) was the f irst FDA-approved indication f or immunoglobulin therapy . There are hundreds of types of PIs , not all of which require IG replacement. * Dosing should be based on ideal body weight (IBW) or adjusted body weight (adjBW) rather than actual/total body weight (TBW) *Immune globulin will be considered for coverage when the following criteria are met: Autoimmune Bullous DiseaseFor initial authorization: 1. Medication is prescribed by or in consultation with a dermatologist or immunologist ; AND2. Member has tried and f ailed systemic corticosteroids and/ or immunosuppressive treatment (e.g.,azathioprine, cyclophosphamide, mycophenolate mof etil); AND3. Member has a documented , conf irmed diagnosis of one of the f ollowing :a) Bullous pemphigoid b) Epidermolysis bullosa acquisita c) Linear IgA bullous dermatosis d) Mucous membrane (cicatricial) pemphigoid e) Pemphigoid gestationis f ) Pemphigus f oliaceus g) Pemphigus vulgari s4. Dosage allowed/Quantity limit: Consult clinical literature (off-label use) . For example, 2g/kg divided over 5 consecutive days, repeated every 4 weeks if needed.If all the above requirements are met , the medication will be approved for 4 months . OH-MED-P-366685For reauthorization : 1. Chart notes must show documentation of improvement of signs and symptoms of disease (i.e., blistering or corticosteroid dose reduction) ; AND 2. Documentation of titration to the minimum dose and f requency needed to maintain a sustained clinical ef f ect . If all the above requirements are met , the medication will be approved for an additional 12 months .Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)For initial authorization: 1. Medication must be prescribed by or in consultation with a neurologist; AND 2. Member has a documented diagnosis of CIDP conf irmed by electrodiagnostic studies ( motor and sensory nerve conduction studies) ; AND 3. Symptoms of motor weakness and/or sensory disturbances have been present f or at least 2 months; AND 4. Member has impairment of activities of daily living due to disabling symptoms; AND 5. Member must meet at least one of the f ollowing:a) Trial and f ailure of or contraindication to a steroid regimen (oral or IV) f or at least 12 weeks b) Rapidly progressive disease c) Motor CIDP (no sensory involvement ). 6. Dosage allowed/Quantity limit: See dosing inf ormation in individual drug package insert (Gammaked, Gamunex-C, Privigen, Hizentr a, Panzyga, HyQvia, Gammagard liquid ). Note: SCIG is not recommended f or induction treatment but is recommended f or maintenance. If all the above requirements are met , the medication will be approved for 4 months .For reauthorization :1. Member has improvement of neuromuscular disability and impairment, with sustained stability since initiation of therapy; AND 2. Members who are stable on maintenance IVIG should be assessed periodically to determine if the dose and/or f requency can be reduced to the lowest ef f ective and establish the need f or continued treatment . If all the above requirements are met , the medication will be approved for an additional 12 months .Dermatomyositis or Polymyositis For initial authorization: 1. Medication must be prescribed by a neurologist, rheumatologist, or dermatologist; AND 2. Member has a diagnosis of dermatomyositis or polymyositis conf irmed by muscle biopsy; AND 3. Member has tried and f ailed a systemic corticosteroid and/or non-steroid immunosuppressant (e.g., azathioprine, methotrexate, cyclosporine , mycophenolate mof etil ) f or at least 4 weeks ; AND 4. Member has active disease (e.g., myositis, dysphagia, ref ractory skin disease). 5. Dosage allowed/Quantity limit: 2g/kg IV divided in equal doses given over 2-5 consecutive days every 4 weeks in adults (per Octagam 10% labeling f or dermatomyositis ). If all the above requirements are met , the medication will be approved for 3 months . OH-MED-P-366685For reauthorization : 1. Member has signif icantly improved muscle strength sustained since initiation of IG therapy . If all the above requirements are met , the medication will be approved for an additional 12 months .Fetal/Neonatal Alloimmune Thrombocytopenia (F/NAIT )For initial authorization: 1. Member is a newborn, and thrombocytopenia persists af ter transf usion of antigen-negative compatible platelet; OR 2. Member is pregnant and has diagnosis of F/NAIT with one or more of the f ollowing: a) Family history of disease b) Platelet alloantibodies f ound on screening c) Previously af f ected pregnancy . 3. Dosage allowed/Quantity limit: See dosage and administration inf ormation in individual drug package insert . If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Medication will not be reauthorized f or continuous use . Guillain-Barre Syndrome (GBS)For initial authorization: 1. Medication is prescribed by or in consultation with a neurologist; AND 2. Member has a documented diagnosis of Guillain-Barre Syndrome with bilateral weakness of limbs ; AND 3. Member meets one or more of the f ollowing: a) Unable to walk independently beyond 10 meters b) Rapidly progressive weakness c) Severe autonomic or swallowing dif f iculty d) Respiratory insuf f iciency ; AND 4. IG therapy is being initiated within 2 weeks of symptom onset . 5. Dosage allowed/Quantity limit: Consult clinical literature. For example, 0.4g/kg/day x 5 days in adults . If all the above requirements are met , the medication will be approved for 1 month (1 course) .For reauthorization :1. Member responded to initial course of therapy, as evidenced by improved/stabilized disability or weakness; AND 2. Member is experiencing deterioration f ollowing initial response to treatment . If all the above requirements are met , the medication will be approved for an additional 1 month (1course). Further renewal will NOT be considered after a total of 2 courses. Immune Thrombocytopenia (IT P) For initial authorization: OH-MED-P-3666851. Initial therapy (Member diagnosed with ITP within the past 3 months): a) Children (2 serious bacterial inf ections in a 1 – year period) ii) Member is not able to take combination antiretroviral therapy iii) Member has tried and f ailed antibiotic prophylaxis(e.g., trimethoprim-sulf amethoxazole). 4. Dosage allowed/Quantity limit: Consult clinical literature (off-label use). For example: IVIG 400 mg/kg every 2 4 weeks. . If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes must show improvement of signs and symptoms of disease (ex. reduction in the f requency of bacterial inf ections or increased IgG) If all the above requirements are met , the medication will be approved for an additional 6 months.Prophylaxis of Bacterial Infections in BMT /HSCT RecipientsFor initial authorization: 1. Member is an allogenic BMT/HSCT recipient; AND 2. IVIG is prescribed f or prophylaxis of bacterial inf ections; AND 3. Member has a pretreatment serum IgG 60 to appendix A and changed comorbidity (e.g., peptic ulcer disease, OH-MED-P – 366685 hypertension) to c omorbidities that predispose the patient to bleeding . Changed all initial auth durations to 1 month since it should not be used chronically. Kawasaki : Removed pediatrician as specialist and added rheumatologist. Added that the member has f ever, elevated inf lammatory markers, or CAA. HIV : Specif ied increase IgG could be used as improvement in renewal criteria . BMT/HSCT: Specif ied allogenic transplant requirement. Removed requirement f or request needing to be within the f irst 100 days of transplant to be in line with guidelines. Changed dosing section to ref er to clinical lit rather than package inserts since it is of f la bel and provided an example. Specif ied increase IgG could be used as improvement in renewal criteria . 02/01/2024 Updated ref erences. Removed billing code appendix. Removed Carimune NF f rom policy (discontinued). Added Alyglo to policy (new product). CIDP : Added Panzyga, HyQvia, Gammagard liquid to product list . DM/PM : In reauth, changed IVIG to IG. GBS : #4 changed IVIG to IG. PID : Removed appendix f or impaired vaccine response levels . Added requirement f or immunology specialist. Reduced initial auth duration f rom 12 months to 6 months. Simplif ied trough monitoring requirement f or reauth. Changed reduction of inf ections to absence or reduction f or reauth. Updated SCID criteria ( PIDTC 2022 ) . Created separate bullet and criteria f or X-Linked Agammaglobulinemia (was grouped with SCID) . Changed CVID criteria to align with ICON 2016 def inition. Removed selective IgA def iciency and selective IgM def iciency (unlikely benef icial; Perez 2017) ; separated IGGSD, SAD. Separated WAS, DGS, AT. Removed Other predominant antibody def iciency disorders and Other combined immunodeficiency and added the most applicable of the specif ic disorders ; added THI, Hyper-IgE, WHIM, NEMO, XLP, Hyper IgM. Prophylaxis of bacterial inf ections in B-cell CLL: replaced sinopulmonary recurrent inf ections with bacterial inf ections, adding that reauthorization criteria must be documented in chart notes, adding diagnosis, and adding specialist. Kidney transplant: removing consulting PI f or dosing and adding consulting clinical literature with example of f-label dosing, adding that medication cannot be reauthorized, adding that member has had or is scheduled f or a kidney transplant, adding prescriber specialty, specifying type of treatment or prophylaxis that medication i s being used f or, removing that concomitant immunosuppressive therapy must be used . 06/26/2024 Added Yimmugo to policy. 11/19/24 Approved by ODMAPPENDICES Ap p end ix A: Examp les o f Risk Facto rs f o r Bleed ing (no t all inclusive) Und erg o ing a med ical o r d ental p ro ced ure where b lo o d lo ss is anticip atedCo mo rb id ities that p red isp o se the p atient to b leed ingMand ated antico ag ulatio n therap yPro f ession or lifestyle predisposes patient to trauma (e.g ., co nstructio n wo rker, f ireman, p ro f essio nal athlete)Ag e >60 yearsRef erences: 1. Bivig am [p ackag e insert]. Bo ca Rato n, FL: Bio test Pharmaceuticals Co rp o ratio n; 2023.2. Fleb o g amma 10% DIF [p ackag e insert]. Lo s Ang eles, CA: Grif o ls Bio lo g icals, Inc.; January 2016.3. Fleb o g amma 5% DIF [p ackag e insert]. Lo s Ang eles, CA: Grif o ls Bio lo g icals, Inc.; Ap ril 2015.4. Gammag ard Liq uid [p ackag e insert]. Taked a Pharmaceuticals U.S.A., Inc.; 2024.5. Gammag ard S/D [p ackag e insert]. Westlake Villag e, CA: Baxter Healthcare Co rp o ratio n; Ap ril 2014. OH-MED-P – 366685 6. Gammag ard S/D Ig A less than 1 mcg/mL [p ackag e insert]. Westlake Villag e, CA: Baxter Healthcare Co rp o ratio n;Sep temb er 2013.7. Gammaked [p ackag e insert]. Fo rt Lee, NJ: Ked rio n Bio p harma, Inc.; Sep temb er 2013.8. Gammap lex [p ackag e insert]. Hertf o rd shire, United King d o m: Bio Pro d ucts Lab o rato ry; July 2015.9. Gamunex-C[p ackag e insert]. Research Triang le Park, NC: Grif o ls Therap eutics Inc.; July 2014.10. Octag am 10% [p ackag e insert]. Ho b o ken, NJ: Octap harma USA, Inc.; 2022.11. Octag am 5% [p ackag e insert]. Ho b o ken, NJ: Octap harma USA, Inc.; Octo b er 2014.12. Privig en [p ackag e insert]. Kankakee, IL: CSL Behring LLC; No vemb er 2013.13. Cuvitru [p ackag e insert]. Westlake Villag e, CA: Baxalta US Inc.; Sep temb er 2016.14. Hizentra [p ackag e insert]. Kankakee, IL: CSL Behring LLC; Octo b er 2016.15. HyQvia [p ackag e insert]. Taked a Pharmaceuticals U.S.A., Inc.; 2024.16. Xemb if y [p rescrib ing inf o rmatio n]. Research Triang le Park, NC: Grif o ls Therap eutics LLC; July 2019.17. Cutaq uig [p rescrib ing inf o rmatio n]. Paramus, NJ: Octap harma USA, Inc.; 2021.18. Panzyg a [p rescrib ing inf o rmatio n]. Paramus, NJ: Octap harma USA, Inc.; 2021.19. Asceniv [p rescrib ing inf o rmatio n]. Bo ca Rato n, FL: ADMA Bio lo g ics; Ap ril 2019.20. Alyg lo [p rescrib ing inf o rmatio n]. GC Bio p harma Co rp .; 2023.21. Yimmug o [p rescrib ing inf o rmatio n ]. Bio test AG; 2024.22. Amag ai M, Ikeda S, Shimizu H, et al. A rand omized d ouble-blind trial of intravenous immunoglobulin for p emphigus. JAm Acad Dermato l 2009; 60(4):595-603.23. Kirtschig G, Middleton P, Bennett C, Murrell DF, Wo jnarowska F, Khumalo NP. Interventions for bullous pemp hig o id .Co chrane Datab ase o f Systematic Reviews 2010, Issue 10. Art. No .: CD002292.24. Orang e JS, Ho ssny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human d isease: a review of evidence b y memb ers o f the Primary Immuno d ef iciency Co mmittee o f the American Acad emy o f Allerg y, Asthma, andImmuno lo g y. JAllerg y Clin Immuno l. 2006;417(4 Sup p l):S525-553.25. Panel o n Op portunistic Inf ections in Child ren with and Exposed to HIV. Guidelines fo r the Preventio n and Treatment o f Op portunistic Infections in Children with and Exposed to HIV. Department of Health and Human Services. Available at http s://clinicalinf o .hiv.g o v/en/g uid elines/p ed iatric-o p p o rtunistic-inf ectio n. Accessed March 22 , 2023.26. To mb lyn M, Chiller T, Einsele H, et al. Guidelines for p reventing infectious complicatio ns amo ng hemato p o ietic cell transp lant recip ients: a g lo b al p ersp ective. Bio l Blo o d Marro w Transp lant. 2009;15(10):1143-1238.27. Feasb y T, Banwell B, Bernstead T, et al. Guid elines o n the use o f intraveno us immune g lo b ulin f o r neuro lo g ic co nd itio ns. Transf us Med Rev. 2007;21(2):S57-S107.28. Do nofrio PD, Berger A, Brannagan TH 3rd , et al. Co nsensus statement: the use of intravenous immunoglobulin in the treatment o f neuromuscular conditions report of the AANEM ad hoc co mmittee. Muscle Nerve. 2009;40(5):890-900.29. Elo vaara I, Apostolski S, van Doorn P, et al. EFNS g uidelines for the use of intravenous immunoglob ulin in treatment o f neuro logical d iseases: EFNS task force on the use o f intraveno us immuno g lo b ulin in treatment o f neuro lo g ical d iseases. Eur JNeuro l. 2008;15(9):893-908.30. Patwa HS, Chaud hry V, Katzberg H, et al. Evidence-based g uideline: intravenous immunoglobulin in the treatment o f neuro muscular disorders: rep ort of the Therap eutics and Techno lo g y Assessment Sub co mmittee o f the AmericanAcad emy o f Neuro lo g y. Neuro lo g y. 2012;78(13);1009-1015.31. And erso n D, Kaiser A, Blanchette V, et al. Guidelines o n the use o f intraveno us immune g lo b ulin f o r hemato lo g ic co nd itio ns. Transf us Med Rev. 2007;21(2):S9-S56.32. Picard C, Al-Herz W, Bousfiha A, et al. Primary immunodeficiency d iseases: an update on the classificatio n f ro m theInternatio nal Unio n of Immunological Societies Exp ert Co mmittee f o r Primary Immuno d ef iciency. JClin Immuno l.2015; 35(8):696-726.33. Bo nilla FA, Khan DA, Ballas ZK, et al. Practice p arameter f o r the d iag no sis and manag ement o f p rimary immuno d ef iciency. JAllerg y Clin Immuno l. 2015;136(5):1186-205.e1-78.34. Orang e JS, Ballow M, Stiehm ER, et al. Use and interpretation of diagnostic vaccination in p rimary immunodeficiency:a wo rking g roup report of the Basic and Clinical Immunology Interest sectio n o f the American Acad emy o f Allerg y,Asthma and Immuno lo g y. JA llerg y Clin Immuno l. 2012;130:S1-S24.35. Ameratung a R, Woon ST, Gillis D, Koo p mans W, Steele R. New d iag no stic criteria f o r co mmo n variab le immune d ef iciency (CVID), which may assist with d ecisions to treat with intraveno us o r sub cutaneo us immuno g lo b ulin. ClinExp Immuno l. 2013;174(2):203-11.36. Immune Def iciency Fo und atio n. Ab o ut p rimary immuno d ef iciencies. Sp ecif ic d isease typ es.http ://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-typ es/. Accessed Feb ruary 12, 2024 .37. Immune Def iciency Foundation. Diagnostic and Clinical Care Guidelines for Primary Immunodeficiency Diseases. 3rd ed itio n. To wso n, MD: Immune Def iciency Fo und atio n; 2015. http ://p rimaryimmune.o rg /wp co ntent/up lo ad s/2015/03/2015-Diag no stic-and-Clinical-Care-Guid elines-f o r-PI.p d f .Accessed No vemb er 8, 2017. OH-MED-P – 366685 38. Jo int Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve So ciety g uid eline on management of multifocal motor neuro pathy. Report of a joint task force of the Euro p ean Fed eratio n o fNeuro lo g ical Societies and t he Peripheral Nerve So ciety — f irst revisio n. JPerip her Nerv Syst. 2010;15(4):295-301. d o i:10.1111/j.1529-8027.2010.00290.x39. Dalakas MC. Inflammatory muscle d iseases. NEngl JMed . 2015;372(18):1734-1747.d o i:10.1056/NEJMra140222540. Neunert C, Lim W, Cro wther M, et al. The American Society of Hematology 2011 evidence-b ased p ractice g uid eline f o r immune thro mb o cyto p enia. Blo o d . 2011;117(16):4190-4207.41. Pro van D, Stasi R, Newland AC, et al. International consensus rep ort o n the investigation and management of p rimary immune thro mb o cyto p enia. Blo o d . 2010;115(2):168-186.42. Sand ers DB, Wolfe GI, Benatar M, et al. International consensus g uid ance f o r manag ement o f myasthenia g ravis:Executive summary. Neuro lo g y. 2016;87(4):419-425. d o i:10.1212/WNL.000000000000279043. Sussman J, Farrug ia ME, Maddison P, Hill M, Leite MI, Hilto n-Jo nes D. Myasthenia g ravis: Asso ciatio n o f BritishNeuro lo g ists’ manag ement g uid elines. Pract Neuro l. 2015;15(3):199-206. d o i:10.1136/p ractneuro l-2015-00112644. Gajd o s P, Chevret S, To yka KV. Intravenous immunoglobulin for myasthenia gravis. Co chrane Datab ase Syst Rev.2012;12(12):CD002277. Pub lished 2012 Dec 12. d o i:10.1002/14651858.CD002277.p ub 445. Balasub ramanian SK, Sad ap s M, Tho ta S, et al. Ratio nal manag ement ap p ro ach to p ure red cell ap lasia.Haemato lo g ica. 2018;103(2):221-230. d o i:10.3324/haemato l.2017.17581046. Crab o l Y, Terrier B, Ro zenb erg F, et al. Intraveno us immuno g lo b ulin therap y f o r p ure red cell ap lasia related to human p arvo virus b 19 infectio n: a retro sp ective stud y o f 10 p atients and review o f the literature. Clin Inf ect Dis.2013;56(7):968-977. d o i:10.1093/cid /cis104647. Bro wn KE, Young NS. Parvovirus B19 infection and hematopoiesis. Blood Rev. 1995;9(3):176-182. doi:10.1016/0268-960x(95)90023-348. Dalakas MC. The ro le of IVIg in the treatment of patients with stiff person syndrome and other neuro lo g ical d iseases asso ciated with anti-GAD antib o d ies. JNeuro l. 2005;252 Sup p l 1:I19-I25. d o i:10.1007/s00415-005-1105-449. Dalakas MC, Fujii M, Li M, Lutfi B, Kyho s J, McElro y B. Hig h-d o se intraveno us immune g lo b ulin f o r stif f-p erso n synd ro me. NEng l JMed . 2001;345(26):1870-1876. d o i:10.1056/NEJMo a0116750. McCrind le BW, Ro wley AH, Newb urg er JW, et al. Diagnosis, Treatment, and Lo ng-Term Manag ement o f KawasakiDisease: A Scientific Statement for Health Professionals From the American Heart Association [pub lished co rrectio n ap p ears in Circulatio n. 2019 Jul 30; 140(5):e181-e184]. Circulatio n. 2017;135(17):e927-e999. d o i:10.1161/CIR.000000000000048451. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strateg ies. Lancet Neuro l. 2011;10(12):1098-1107. d o i:10.1016/S1474-4422(11)70245-952. Keo g h M, Sedehizadeh S, Maddison P. Treatment f o r Lamb ert-Eato n myasthenic synd ro me. Co chrane Datab aseSyst Rev. 2011;2011(2):CD003279. Pub lished 2011 Feb 16. d o i:10.1002/14651858.CD003279.p ub 353. Williso n HJ, Jaco b s BC, van Do o rn PA. Guillain-Barr synd ro me. Lancet. 2016;388(10045):717-727. d o i:10.1016/S0140-6736(16)00339-154. van Schaik IN, Bril V, van Gelo ven N, et al. Sub cutaneo us immuno g lo b ulin f o r maintenance treatment in chro nic inf lammatory demyelinating p olyneuropathy (PATH): a rand o mised, d o ub le-b lind , p laceb o-co ntro lled , p hase 3 trial[p ub lished correction ap pears in Lancet Neuro l. 2018 Jan;17 (1):26] [published correctio n ap p ears in Lancet Neuro l.2018 Aug ;17(8):661]. Lancet Neuro l. 2018;17(1):35-46. d o i:10.1016/S1474-4422(17)30378-255. Ef timov F, Winer JB, Vermeulen M, d e Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inf lammato ry d emyelinating p olyradiculoneuropathy. Co chrane Database Syst Rev. 2013;(12):CD001797. Published 2013 Dec 30. d o i:10.1002/14651858.CD001797.p ub 356. Oakland er AL, Lunn MP, Hug hes RA, van Schaik IN, Fro st C, Chalk CH. Treatments f o r chro nic inf lammato ry d emyelinating p olyradiculoneuropathy (CIDP): an o verview o f systematic reviews. Co chrane Datab ase Syst Rev.2017;1(1):CD010369. Pub lished 2017 Jan 13. d o i:10.1002/14651858.CD010369.p ub 257. Ryan M, Ryan SJ. Chronic inflammatory d emyelinating polyneuropathy: considerations f o r d iag no sis, manag ement,and p o p ulatio n health. Am JManag Care. 2018;24(17 Sup p l):S371-S379.58. Hameed S, Cascella M. Multifocal Motor Neuropathy. [Updated 2021 Feb 7]. In: StatPearls [Internet]. Treasure Island(FL): StatPearls Pub lishing ; 2021 Jan – . Availab le f ro m: http s://www-ncb i-nlm-nihg o v.ced arville.o hio net.o rg /b o o ks/NBK554524/59. Lund b erg IE, Tjrnlund A, Bo ttai M, et al. 2017 Euro p ean Leag ue Ag ainst Rheumatism/American Co lleg e o fRheumato lo g y classif icatio n criteria f o r ad ult and juvenile id io p athic inf lammato ry myo p athies and their majo r sub g ro up s [p ub lished co rrectio n ap p ears in Ann Rheum Dis. 2018 Sep ;77(9):e64]. Ann Rheum Dis.2017;76(12):1955-1964. d o i:10.1136/annrheumd is-2017-21146860. Neunert C, Terrell DR, Arno ld DM, et al. American So ciety o f Hemato lo g y 2019 g uid elines f o r immune thro mb ocytopenia [published correction ap pears in Blood Ad v. 2020 Jan 28;4(2):252]. Blood Adv . 2019;3(23):3829-3866. d o i:10.1182/b lo o d ad vances.2019000966 OH-MED-P – 366685 61. Pro van D, Arnold DM, Bussel JB, et al. Updated international consensus rep ort o n the investigation and management o f p rimary immune thro mbocytopenia. Blood Adv . 2019;3(22):3780-3817. d o i:10.1182/b lo o d ad vances.201900081262. Eg ami S, Yamagami J, Amagai M. Autoimmune bullous skin d iseases, p emp hig us and p emp hig o id . JAllergy ClinImmunol . 2020;145(4):1031-1047. d o i:10.1016/j.jaci.2020.02.01363. Harman KE, Black MM. High-dose intravenous immune g lobulin for the treatment of autoimmune b listering d iseases:an evaluatio n o f its use in 14 cases. Br JDermatol . 1999;140(5):865-874. d o i:10.1046/j.1365-2133.1999.02817.x64. Murrell DF, Pea S, Joly P, et al. Diagnosis and management of p emphigus: Reco mmend atio ns o f an internatio nal p anel o f exp erts. JAm Acad Dermatol . 2020;82(3):575-585.e1. d o i:10.1016/j.jaad .2018.02.02165. Van d en Berg h PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve So ciety g uid eline on d iagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a jo intTask Fo rce-Seco nd revisio n [p ub l ished co rrectio n ap p ears in Eur JNeuro l. 2022 Ap r;29(4):1288]. Eur JNeurol .2021;28(11):3556-3583. d o i:10.1111/ene.1495966. Old ro yd AGS, Lilleker JB, Amin T, et al. British Society fo r Rheumato lo g y g uid eline o n manag ement o f p aed iatric,ad o lescent and adult p atients with id iopathic inflammatory myopathy. Rheumatology (Oxford). 2022;61(5):1760-1768. d o i:10.1093/rheumato lo g y/keac11567. Dalakas MC. Inflammatory myopathies: update o n d iag no sis, p atho g enesis and therap ies, and COVID-19-related imp licatio ns. Acta Myol . 2020;39(4):289-301. Pub lished 2020 Dec 1. d o i:10.36185/2532-1900-03270. Natio nalInstitute o f Child Health and Human Developments Intravenous Immunoglob ulin Stud y Gro up . Intraveno us immune g lo b ulin f o r the p reventio n o f b acterial inf ectio ns in child ren w ith symp to matic human immuno d ef iciency virus inf ectio n. NEng l JMed . 1991;325(2):73-80. d o i:10.1056/NEJM19910711325020168. Leo nhard SE, Mandarakas MR, Gondim FAA, et al. Diagno sis and manag ement o f Guillain-Barr synd ro me in ten step s. Nat Rev Neurol . 2019;15(11):671-683. d o i:10.1038/s41582-019-0250-969. Go relik M, Chung SA, Ardalan K, et al. 2021 American College of Rheumatology/Vasculitis Foundatio n Guid eline f o r the Manag ement of Kawasaki Disease. Arthritis Care Res (Hoboken) . 2022;74(4):538-548. d o i:10.1002/acr.2483870. d e Graef f N, Groot N, Ozen S, et al. European consensus-based recommendations for the diagnosis and treatment ofKawasaki d isease-the SHARE initiative. Rheumatology (Oxford) . 2019;58(4):672-682. d o i:10.1093/rheumato lo g y/key34471. Bro d erick C, Kobayashi S, Suto M, Ito S, Kobayashi T. Intraveno us immuno g lo b ulin f o r the treatment o f Kawasaki d isease. Cochrane Database Syst Rev . 2023;1(1):CD014884. Pub lished 2023 Jan 25. d o i:10.1002/14651858.CD014884.p ub 272. Dykewicz CA; Centers for Disease Control and Prevention (U.S.); Infectious Diseases Society o f America; AmericanSo ciety of Blood and Marro w Transplantation. Summary o f the Guid elines f o r Preventing Op p o rtunistic Inf ectio ns amo ng Hematopo ietic Stem Cell Tr ansp lant Recip ients. Clin Inf ect Dis. 2001;33(2):139-144. d o i:10.1086/32180573. Centers f o r Disease Co ntrol and Prevention; Inf ectious Disease Society of America; American So ciety o f Blo o d andMarro w Transp lantation. Guidelines for p reventing o pportunistic infections among hematopoietic stem cell transp lant recip ients [published corre ction ap pears in MMWR Recomm Rep. 2004 May 14;53(19):396]. MMWR Reco mm Rep .2000;49(RR-10):1-CE7.74. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: A review of evidence. JAllergy Clin Immunol . 2017;139(3S):S1-S46. doi:10.1016/j.jaci.2016.09.02375. Euro p ean Society for Immunodeficiencies (ESID) . Diagnostic criteria for PID. Availab le at http s://esid .o rg /Wo rking-Parties/Clinical-Wo rking-Party/Reso urces/Diag no stic-criteria-f o r-PID2 . Accessed Feb ruary 5, 2024.76. Dvorak CC, Haddad E, Heimall J, et al. The diagnosis of severe combined immunodeficiency (SCID): The PrimaryImmune Deficiency Treatment Consortium (PIDTC) 2022 Definitions. JAllergy Clin Immunol . 2023;151(2):539-546. doi:10.1016/j.jaci.2022.10.02277. Bo nilla FA, Barlan I, Chap el H, et al. Internatio nal Co nsensus Do cument (ICON): Co mmo n Variab leImmuno d ef iciency Diso rd ers. JAllergy Clin Immunol Pract . 2016;4(1):38-59. d o i:10.1016/j.jaip .2015.07.02578. Picard C, Bo b b y Gasp ar H, Al-Herz W, et al. Internatio nal Unio n o f Immuno lo g ical So cieties: 2017 PrimaryImmuno d eficiency Diseases Committee Rep o rt o n Inb o rn Erro rs o f Immunity. JClin Immunol . 2018;38(1):96-128. d o i:10.1007/s10875-017-0464-979. Tang ye SG, Al-Herz W, Bousfiha A, et al. Human Inb orn Errors of Immunity: 2022 Up date o n the Classif icatio n f ro m the Internatio nal Unio n o f Immuno lo g ical So cieties Exp ert Co mmittee . JClin Immunol . 2022;42(7):1473-1507. d o i:10.1007/s10875-022-01289-380. Natio nal Blood Authority. Criteria for the clinical use of immunoglobulin in Australia (the Criteria). BloodSTAR v.3. 11 .0. Availab le f ro m: http s://www.criteria.b lo o d .g o v.au/Med icalCo nd itio n/View/2685 (accessed 22 Feb 202 4 ).81. Justiz-Vaillant AA, Ho yte T, Davis N, et al. A Systematic Review o f the Clinical Diag no sis o f TransientHyp o g ammag lo b ulinemia o f Inf ancy. Children (Basel ). 2023;10(8):1358. Pub lished 2023 Aug 8. d o i:10.3390/child ren10081358 OH-MED-P – 366685 82. Perez E, Bo nilla FA, Orang e JS, Ballo w M. Sp ecif ic Antib o d y Def iciency: Co ntro versies in Diag no sis andManag ement [p ub lished co rrectio n ap p ears in Fro nt Immuno l. 2018 Mar 15;9:450]. Front Immunol . 2017;8:586. Pub lished 2017 May 22. d o i:10.3389/f immu.2017.0058683. Mustillo PJ, Sullivan KE, Chinn IK, et al. Clinical Practice Guid elines f o r the Immuno lo g ical Manag ement o fChro mo some 22q11.2 Deletion Syndrome and Other Defects in Thymic Development [published co rrectio n ap p ears in JClin Immuno l. 2024 Jan 22;44(2):53]. JClin Immunol . 2023;43(2):247-270. d o i:10.1007/s10875-022-01418-y84. AT So ciety. Ataxia-telangiectasia in children Guidance o n diagnosis and clinical care . Octob er 2014. Availab le f ro m:http s://atsociety.org.uk/wp-content/uploads/2017/10/A-T_Clinical_Guidance_Document_Final.pdf . Accessed February22, 2024. 85. Co o p erative Gro up for the Study of Immunoglobulin in Chronic Lympho cytic Leukemia, Gale RP, Chap el HM, et al.Intraveno us immunoglobulin for the p revention of infection in chronic lymphocytic leukemia. A randomized, contro lled clinical trial. NEng l JMed . 1988;319(14):902-907. d o i:10.1056/NEJM19881006319140386. Natio nal Co mprehensive Cancer Netwo rk. Chro nic Lymphocytic Leukemia/Small Lymp ho cytic Lymp ho ma (Versio n1.2024). http s://www.nccn.o rg /p ro f essio nals/p hysician_g ls/p d f /cll.p d f . Accessed Feb ruary 7 , 2024.87. Shehata N, Pald a VA, Meyer RM, et al. The use o f immuno g lo b ulin therap y f o r p atients und erg o ing so lid o rg an transp lantatio n: an evid ence-b ased p ractice g uid eline. Transfus Med Rev. 2010;24 Sup p l 1:S7-S27. d o i:10.1016/j.tmrv.2009.09.01088. Kid ney Disease: Imp roving Global Outcomes (KDIGO) Transplant Wo rk Group. KDIGO clinical p ractice g uid eline f o r the care o f kid ney transp lant recip ients. Am JTransplant. 2009;9 Sup p l 3:S1-S155. d o i:10.1111/j.1600-6143.2009.02834.x .89. Ohio Ad ministrative Co de. (2022, February 23). 5160-1 – 01 (C) Med icaid medical necessity: definitions and p rincip les.Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.90. Ohio Ad ministrative Code. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved February 22, 2023f ro m co d es.o hio .g o v.91. Ohio Ad ministrative Code. (2020, January 1). 5160-9 – 03 Pharmacy services: covered d rugs and associated limitations.Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o v.Ef f ective d ate: 01/01/2025 Revised d ate: 0 6/26/2024
OH-MED-P – 366685 dc PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Kisunla ( donanemab ) BENEFIT TYPE Medical STATUS Prior Authorization Required Kisunla , approved by the FDA in 2024, is an amyloid beta-directed antibody indicated f or the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease (stage 3 or 4) , the population in which treatment was initiated in clinical trials. Alzheimers disease is a neurodegenerative disease associated with cognitive, f unctional, and behavioral impairments. It is thought to be caused by the increasing accumulation of amyloid beta (A) plaques and neurof ibrillary tangles (NFTs) f ormed by aggregated tau protein. Kisunla targets deposited amyloid plaque and has been shown to lead to plaque clearance in treated patients. Kisunla has a black box warning f or amyloid related imaging abnormalities (ARIA). ApoE 4 homozygotes have a higher incidence of ARIA. Kisunla ( donanemab ) will be considered for coverage when the following criteria are met: Alzheimer’s DiseaseFor initial authorization: 1. Member is at least 60 of age ; AND2. Medication must be prescribed by or in consultation with a neurologist or geriatricia n ; AND3. Member has a diagnosis of early Alzheimers disease with mild cognitive impairment due toAlzheimers disease OR mild Alzheimers disease related dementia ; AND4. Presence of amyloid beta pathology has been conf irmed by ONE of the f ollowing:a) Positron-emission tomography (PET) scan imaging ;b) Cerebrospinal f luid (CSF) lumbar puncture; AND5. Member has had a progressive change in memory f unction f or at least 6 months ; AND6. Documentation of Mini Mental State Examination (MMSE) score of 2 0 to 28 ; AND7. Member has had a brain MRI in the past 12 months to evaluate f or pre-existing Amyloid RelatedImaging Abnormalities (ARIA); AN D8. Members ApoE 4 status has been or will be determined bef ore starting treatment (must provide documentation of results or pending order f or testing); AND9. If member is on an anticoagulant, provider attests that saf ety risks f or ARIA have been discussed and member is on a stable dose; AND10. Member does NOT have ANY of the f ollowing:a) Transient ischemic attacks (TIA), stroke, or seizures within the last 12 months ;b) Contraindication to MRI ;c) Inadequately controlled bleeding disorder .11. Dosage allowed/Quantity limit: administer 700 mg intravenously every f our weeks f or three doses,then 1400 mg intravenously every f our weeks . Quantity limit: 4 vials per 28 days af ter induction dosing.If all the above requirements are met , the medication will be approved for 6 months . OH-MED-P – 366685 For reauthorization : 1. Member has had a f ollow up assessment including cognitive test(s) to determine that they have not progressed to moderate/severe dementia; AND2. Documentation of continued MRI monitoring f or amyloid related imaging abnormalities with edema(ARIA-E) and with hemosiderin deposition (ARIA-H), as per prescribing inf ormation.If all the above requirements are met , the medication will be approved for an additional 6 months . CareSource considers Kisunla (donanemab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. DATE ACTION/DESCRIPTION 07/23/2024 New policy for Kisunla created. 11/19/24 Approved by ODMRef erences: 1. Kisunla [p rescrib ing inf o rmatio n] . Eli Lilly and Co mp any; 2024.2. Alb ert MS, DeKosky ST, Dickson D, et al. The d iagnosis of mild cognitive impairment due to Alzheimer’s disease:reco mmend atio ns f ro m the Natio nal Institute o n Ag ing-Alzheimer’s Asso ciatio n wo rkg ro up s o n d iag no stic g uid elines f o r Alzheimer’s d isease. Alzheimers Dement. 2011;7(3):270-279. d o i:10.1016/j.jalz.2011.03.0083. McKhann GM, Kno p man DS, Chertko w H, et al. The d iag no sis o f d ementia d ue to Alzheimer’s d isease:reco mmend atio ns f ro m the Natio nal Institute o n Ag ing-Alzheimer’s Asso ciatio n wo rkg ro up s o n d iag no stic g uid elines f o r Alzheimer’s d isease. Alzheimers Dement. 2011;7(3):263-269. d o i:10.1016/j.jalz.2011.03.0054. Po rsteinsson AP, Isaacson RS, Knox S, Sabbagh MN, Rubino I. Diagnosis of Early Alzheimer’s Disease: ClinicalPractice in 2021. JPrev Alzheimers Dis. 2021;8(3):371-386. d o i:10.14283/jp ad .2021.235. Centers f o r Medicare & Medicaid Services (CMS): Medicare Co verage Database. Monoclonal Antibodies DirectedAg ainst Amylo id f o r the Treatment o f Alzheimer’s Disease (AD). Natio nal Co verag e Determinatio n (NCD).04/07/2022. http s://www.cms.g o v/med icare-co verag e-d atab ase/view/ncd .asp x?ncd id =375&ncd ver=16. Jack CR Jr, Andrews JS, Beach TG, et al. Revised criteria f o r d iag no sis and stag ing o f Alzheimer’s d isease:Alzheimer’s Association Workgroup. Alzheimers Dement. Published online June 27, 2024. doi:10.1002/alz.138597. Jack CR Jr, Bennett DA, Blenno w K, et al. NIA-AA Research Framewo rk: To ward a b io lo g ical d ef initio n o fAlzheimer’s d isease. Alzheimers Dement. 2018;14(4):535-562. d o i:10.1016/j.jalz.2018.02.0188. Sims JR, Zimmer JA, Evans CD, et al. Do nanemab in Early Symp to matic Alzheimer Disease: TheTRAILBLAZER-ALZ 2 Rand o mized Clinical Trial. JAMA. 2023;330(6):512-527. d o i:10.1001/jama.2023.132399. Ramanan VK, Armstro ng MJ, Cho ud hury P, et al. Antiamylo id Mo no clo nal Antib o d y Therap y f o r AlzheimerDisease: Emerg ing Issues in Neuro lo g y. Neurology . 2023;101(19):842-852. d o i:10.1212/WNL.000000000020775710. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.11. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.12. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o v.Ef f ective d ate: 0 1/01/2025 Revised d ate: 0 7/23/2024
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Livmarli (maralixibat) BENEFIT TYPE Pharmacy Coverage Requirements Prior Authorization Required Livmarli , approved by the FDA in 2021, is an ileal bile acid transport (IBAT) inhibitor indicated f or the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS) or progressive f amilial intrahepatic cholestasis (PFIC) . In cholestatic liver disease, biliary substances arent eliminated f rom the liver, thus they re-enter circulation. Cholestatic itch is thought to be related to the accumulation of bile acids in the skin. Inhibiting IBAT decreases reuptake of bile salts to reduce serum bile acids and pruritis. ALGS is a rare genetic disorder that can af f ect multiple organ systems, most commonly the liver, with a paucity of interlobular ducts. PFIC is an ultra-rare group of genetic disorders that disrupt bile f ormation in the liver. It usually presents during inf ancy with cholestasis, jaundice, and intense itching. Most patients will eventually require biliary diversion surgery or liver transplant. PFIC1 involves extrahepatic manif estations while PFIC2 does not. However, PFIC2 can be complicated by hepatocellular carcinoma . Livmarli (maralixibat) will be considered for coverage when the following criteria are met: Alagille Syndrome (ALGS) For initial authorization: 1. Member is at least 3 months of age; AND2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND3. Member has a diagnosis of Alagille syndrome (ALGS) conf irmed by the involvement of at least 3 of the f ollowing major clinical f eatures :a) Hepatic Features (e.g., hyperbilirubinemia or scleral icterus)b) Cardiac Features (e.g., lesions conf irmed on imaging or murmur)c) Facial Features (e.g., inverted triangular f ace, straight nose with bulbous tip)d) Ocular Features (e.g., embryotoxon, optic disk drusen)e) Skeletal Features (e.g., vertebral anomalies, osteopenia f) Renal Features (e.g., renal dysplasia, renal tubular acidosis)g) Vascular Features (e.g., narrowing of internal carotid artery, moyamoya disease)NOTE: Member also meets criterion if has one or more clinical f eatures and an af f ected f irst-degree relative; AND 4. Member must have liver biopsy demonstrating reduced number of the interlobular bile ducts ORconf irmed f inding of JAG1 or NOTCH2 gene mutation; AND5. Member has symptoms of moderate to severe pruritus ; AND6. Member does NOT have any of the f ollowing:a) Previous liver transplant b) Previous surgical disruption of enterohepatic circulation (partial external bile diversion or ileal exclusion) OH-MED-P-366685c) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) d) History or presence of other concomitant liver disease 7. Member must have a trial and f ailure of at least 2 of the f ollowing: a) Cholestyramine b) Ursodiol c) Rif ampin d) Naltrexone 8. Dosage allowed/Quantity limit: Starting dose is 190mcg/kg orally once daily, titrating up to 380 mcg/kg once daily. Max dose 28.5 mg (3 mL) per day. QL: 3 bottles (90 mL) per 30 days. Note: Use the 9.5 mg/mL oral solution for treatment of ALGS . If all the above requirements are met , the medication will be approved for 6 months.For reauthorization :1. Pruritis has improved in response to therapy with Livmarli ; AND2. Member has not had a hepatic decompensation event. If all the above requirements are met, the medication will be approved for an additional 12 months.Progressive Familial Intrahepatic C holestasis (PFIC )For initial authorization: 1. Member is at least 12 months of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND 3. Member has a diagnosis of PFIC conf irmed by genetic testing results: PFIC 1 (ATP8B1 mutation), PFIC2 (ABCB11 mutation), PFIC3 (ABCB4 mutation), PFIC4 (TJP2 mutation) , or PFIC6 (MYO5B mutation) ; AND 4. Member has signif icant pruritis not attributed to another cause; AND 5. Documentation of total serum bile acid (sBA) 3 ULN ; AND 6. Documentation of baseline liver f unction tests (e.g., ALT, AST, bilirubin, INR); AND 7. Trial and f ailure of ursodiol (may also continue concurrently); AND 8. Member does NOT have any of the f ollowing: a) Variants of the ABCB11 gene (PFIC type 2) that code f or non-f unctional or complete absence of the bile salt export pump (BSEP-3) protein (per submitted genetic test result) b) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) c) Liver transplant . 9. Dosage allowed/Quantity limit: Starting dose is 285 mcg/kg orally once daily, titrating up to recommended dose of 570 mcg/kg twice daily. Max dose 38 mg ( 2 mL) per day. QL: 2 bottles ( 60 mL) per 30 days. Note: Use the 19 mg/mL oral solution for treatment of PFIC. If all the above requirements are met , the medication will be approved for 6 months.For reauthorization :1. Pruritis has improved in response to therapy with Livmarl i; AND2. Member has not had a hepatic decompensation event. If all the above requirements are met, the medication will be approved for an additional 12 months.OH-MED-P – 366685 CareSource considers Livmarli ( maralixibat ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. DATE ACTION/DESCRIPTION 10/15/2021 New policy f or Livmarli created. 03/28/2023 Updated/added ref erences. Changed lower age limit f rom 1 year to 3 months per updated drug label. Added QL. Added naltrexone to list of trial options and removed specif ic trial duration. 03/28/2024 Added criteria f or new PFIC indication. Expanded description of hepatic decompensation contraindication in ALGS section (to match label). 08/02/2024 Added note about strengths to dosing sections. Added no hepatic decompensation to renewal sections. ALGS: Added note to diagnostic f eatures criterion. PFIC: Changed at least 5 years of age to at least 12 months of age (label update); updated max qty. 11/19/24 Approved by ODMRef erences: 1. Livmarli. [Prescrib ing inf o rmatio n]. Mirum Pharmaceuticals, Inc.; 202 4 .2. Shneid er BL, Sp ino C, Kamatha BM, et al. Placeb o-Co ntro lled Rand o mized Trial o f an Intestinal Bile SaltTransp o rt Inhib ito r f o r Pruritus in Alag ille Synd ro me. Hepatol Commun. 2018 Oct; 2(10): 1184-1198. Do i10.1002/hep 4.12443. Ayo ub MD and Kamath BM. Alag ille Synd ro me: Diag no stic Challeng es and Ad vances in Manag ement.Diagnostics . 2020; 10(11):907. http s://d o i.o rg /10.3390/d iag no stics101109074. Lin, Henry. Alag ille Syndrome. National Org anization for Rare Disorders; up d ated 2020. Accessed Octo b er 12,2021. http s://rared iseases.o rg /rare-d iseases/alag ille-synd ro me/5. Kamath BM, Goldstein A, Ho ward R, et al. Maralixibat Treatment Response in Alag ille Synd ro me is Asso ciated with Imp ro ved Health-Related Quality o f Lif e. JPediatr . 2023;252:68-75.e5. d o i:10.1016/j.jp ed s.2022.09.0016. Diaz-Frias J, Kondamudi NP. Alagille Syndrome. [Updated 2022 Aug 14]. In: StatPearls [Internet]. Treasure Island(FL): StatPearls Pub lishing ; 2023 Jan – . Availab le f ro m: http s://www.ncb i.nlm.nih.g o v/b o o ks/NBK507827/7. Shirley M. Maralixib at: First Ap p ro val [p ub lished co rrectio n ap p ears in Drug s. 2021 Dec 6;:]. Drugs .2022;82(1):71-76. d o i:10.1007/s40265-021-01649-08. Shneid er BL, Spino CA, Kamath BM, et al. Imp act o f lo ng-term ad ministratio n o f maralixib at o n child ren with cho lestasis second ary to Alag ille synd ro me. Hepatol Commun . 2022;6(8):1922-1933. d o i:10.1002/hep 4.19929. Lo o mes KM, Squires RH, Kelly D, et al. Maralixibat f o r the treatment o f PFIC: Lo ng-term, IBAT inhib itio n in an o p en-lab el, Phase 2 stud y. Hepatol Commun . 2022;6(9):2379-2390. d o i:10.1002/hep 4.198010. Gunayd in M, Bo zkurter Cil AT. Pro g ressive f amilial intrahep atic cho lestasis: d iag no sis, manag ement, and treatment. Hepat Med . 2018;10:95-104. Pub lished 2018 Sep 10. d o i:10.2147/HMER.S13720911. Srivastava A. Pro g ressive f amilial intrahep atic cho lestasis. JClin Exp Hepatol . 2014;4(1):25-36. d o i:10.1016/j.jceh.2013.10.00512. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.13. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.14. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o vEf f ective d ate: 01/01/2025 Revised d ate: 08/02/2024
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Lupron Depot and Lupron Depot-PED(leuprolide acetate) BENEFIT TYPE Medical STATUS Prior Authorization Required Lupron Depot and Lupron Depot-PED , initially approved by the FDA in 1985, are gonadotropin-releasing hormone (GnRH) agonist s. Lupron Depot is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions and concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. Lupron Depot-PED is indicated for the treatment of pediatric patients with central precocious puberty .Lupron Depot and Lupron Depot-PED (leuprolide acetate) will be considered for coverage when the following criteria are met:Central Precocious Puberty (C PP ) (Lupron Depot Ped Only )For initial authorization: 1. Member is 1 year old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has early onset of puberty symptoms before the age of 8 years for females or 9 years for male s; AND 4. Member has a confirmed diagnosis of central precocious puberty, as evidenced by BOTH of the following: a. Pubertal response to a gonadotropin releasing hormone (GnRH) stimulation test OR pubertal levels of basal luteinizing hormone (LH); b. Advanced bone age for chronological age; AND 5. Members baseline LH level, sex steroid level (estradiol or testosterone) weight and height are submitted with chart notes. 6. Dosage allowed/Quantity limit: a. Inject 11.25 mg or 30 mg intramuscularly once every three months; OR b. Inject 45 mg intramuscularly once every six months ; OR c. Inject intramuscularly once monthly (see table below). Body Weight Recommended Monthly Dosage Less than or equal to 25 kg 7.5 mg Greater than 25 kg up to 37.5 kg 11.25 mg Greater than 37.5 kg 15 mg If all the above requirements are met , the medication will be approved for 6 months .
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME PiaSky (crovalimab-akkz) BENEFIT TYPE Medical STATUS Prior Authorization Required PiaSky is a complement C5 inhibitor indicated f or the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg . PNH is a hematopoietic stem cell disorder in which activation of the complement system destroys red blood cells because of an acquired mutation in the PIGA gene. Common manif estations can include hemolytic anemia and f atigue. Thrombosis and bone marrow suppression may also occur. Standard of care has been the existing C5 inhibitors Soliris and Ultomiris. PiaSky (crovalimab-akkz) will be considered for coverage when the following criteria are met: Paroxysmal Nocturnal Hemoglobinuria (PNH)For initial authorization: 1. Member is at least 13 years of age and weighs at least 40 kg ; AND2. Medication must be prescribed by or in consultation with a hematologist ; AND3. Member has a diagnosis of PNH conf irmed by high sensitivity f low cytometry ; AND4. Member has a lactate dehydrogenase (LDH) level >1.5x upper limit of normal (ULN ); AND5. Member has at least one PNH-related sign/symptom e.g., f atigue, hemoglobin
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Scenesse ( a famelanotide) BENEFIT TYPE Medical STATUS Prior Authorization Required Scenesse , approved by the FDA in 2019, is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain f ree light exposure in adult patients with a history of phototoxic reactions f rom erythropoietic protoporphyria (EPP) . It was the f irst drug approved for the treatment of EPP. Scenesse is a structural analog of alpha-melanocyte stimulating hormone (alpha-MSH). It increases production of photoprotective eumelanin (a type of melanin pigment) in the ski n to help reduce sensitivity to light. EPP , a subtype of a broader group of disorders known as porphyrias, is a rare inherited metabolic disorder caused by def iciency of the enzyme ferrochelatase (FECH) due to mutations in the FECH gene. FECH has a role in the biosynthesis of heme. Low levels of FECH cause excess protoporphyrin to accumulate in certain tissues, which leads to the characteristic symptoms of EPP . The major symptom is skin hypersensitivity to sunlight and some types of artif icial light. Complications may include gallbladder dysf unction and liver damage. Less commonly, EPP can be caused by a mutation in the ALAS2 gene. In these cases, it is referred to as X-linked protoporphyria (XLP). Scenesse ( a famelanotide) will be considered for coverage when the following criteria are met: Erythropoietic Protoporphyria (EPP)For initial authorization: 1. Member is at least 18 years of age ; AND2. Medication must be prescribed by or in consultation with a dermatologist , hepatologist,gastroenterologist , or hematologist ; AND3. Member has a documented diagnosis of EPP conf irmed with biochemical testing that shows elevated total erythrocyte protoporphyrin concentration > 3x ULN and majority (>50%) metal-f ree vs. zinc-bound ; AND4. Member exhibits characteristic symptoms of EPP phototoxicity (e.g., intolerance to light including pain,swelling, burning, itching, and redness of the skin during or af ter exposure to sunlight) which interferes with their quality of lif e (i.e., interference with work, activities of daily living, lif estyle choices, etc.); AND5. Sun avoidance and use of protective measures ( i.e., sunscreen, protective clothing, etc. ) have been inadequate in controlling EPP phototoxic reactions; AND6. Member does NOT have any of the f ollowing:a) EPP with severe hepatic involvement b) Untreated malignant or premalignant skin lesions .7. Dosage allowed/Quantity limit: One 16 mg subcutaneous implant every 2 months (medical justif ication is required f or requests beyond 3 implants a year f or seasonal coverage) .QL: 1 implant per 60 days; 3 implants per year.If all the above requirements are met , the medication will be approved for 6 months . OH-MED-P – 366685 For reauthorization : 1. Chart notes must document improvement of signs and symptoms of disease: Increased tolerance to sunlight exposure and/or decreased phototoxic pain; AND2. Member is receiving skin exams as recommended in the prescribing inf ormation.If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Scenesse ( a famelanotide) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. DATE ACTION/DESCRIPTION 06/17/2020 New policy f or Scenesse created. 10/24/2022 Updated/added ref erences. Added GI, hepatology, hematology to specialists. Removed pain medications f rom criteria. Reworded renewal criteria and added skin exam. 07/02/2024 Updated ref erences. Changed elevated f ree protoporphyrin in peripheral erythrocytes to t otal erythrocyte protoporphyrin concentration > 3x ULN and majority (>50%) metal-f ree vs. zinc-bound. Removed genetic testing option as it is not recommended in the absence of biochemical testing (Dickey 2023)11/19/24 Approved by ODMRef erences: 1. Scenesse [p ackag e insert]. Clinuvel, Inc.; 202 3 .2. Lang end o nk JG, Balwani M, Anderson KE, et al. Afamelanotide for Erythropoietic Protoporp hyria . NEngl JMed .2015;373(1):48 59. d o i:10.1056/NEJMo a14114813. Wensink D, Wagenmakers MAEM, Lang endonk JG. Afamelanotide for prevention of phototoxicity in erythropoietic p ro to p o rp hyria. Expert Rev Clin Pharmacol . 2021;14(2):151-160. d o i:10.1080/17512433.2021.18796384. American Po rp hyria Fo und atio n. Erythro p o ietic p ro to p o rp hyria (EPP) and X-Linked Pro to p o rp hyria (XLP),http s://p o rp hyriaf o und atio n.o rg /f o r-p atients/typ es-of-p o rp hyria/ep p-xlp /5. Balwani M. Erythrop o ietic Pro to p o rp hyria and X-Linked Pro to p o rp hyria: p atho p hysio lo g y, g enetics, clinical manif estations, and management. Mol Genet Metab . 2019;128(3):298-303. d o i:10.1016/j.ymg me.2019.01.0206. Ahmed jan N, Maso o d S. Erythro p o ietic Pro to p o rp hyria. [Up d ated 2023 Feb 16]. In: StatPearls [Internet].Treasure Island (FL): StatPearls Pub lishing ; 2024 Jan – . Availab le f ro m:http s://www.ncb i.nlm.nih.g o v/b o o ks/NBK563141/7. Leaf RK, Dickey AK. Ho w I treat erythro p o ietic p ro to p o rp hyria and X-linked p ro to p o rp hyria. Blood .2023;141(24):2921-2931. d o i:10.1182/b lo o d .20220186888. Dickey AK, Naik H, Keel SB, et al. Evidence-based consensus guidelines for the d iag no sis and manag ement o f erythro p o ietic p ro to p o rp hyria and X-linked p ro to p o rp hyria. JAm Acad Dermatol . 2023;89(6):1227-1237. d o i:10.1016/j.jaad .2022.08.0369. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.10. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.11. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o v.Ef f ective d ate: 01/01/2025 Revised d ate: 07/02/2024
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Simponi Aria (golimumab) BENEFIT TYPE Medical STATUS Prior Authorization Required Simponi Aria is a tumor necrosis f actor (TNF) alpha-inhibitor initially approved by the FDA in 2017 for rheumatoid arthritis . Since that time, Simponi Aria has been approved f o r three additional indications: p soriatic a rthritis, a nkylosing s pondylitis and p olyarticular j uvenile i diopathic a rthritis . This medication is given as an intravenous inf usion. Simponi Aria (golimumab) will be considered for coverage when the following criteria are met: Ankylosing Spondylitis (AS)For initial authorization: 1. Member must be 18 years of age or older; AND2. Medication must be prescribed by or in consultation with a rheumatologist; AND3. Member has a documented diagnosis of active AS; AND4. Member shows at least ONE of the f ollowing signs or symptoms of inf lammation:a) Elevated serum C-reactive protein (CRP);b) Sacroiliitis on magnetic resonance imaging (MRI); AND5. Member has had a trial and f ailure of TWO NSAIDs f or 14 days each, taken at the maximum recommended dosages; AND6. Member has tried and f ailed TWO pref erred biologic DMARDs f or 3 months each, one of which must be a TNF inhibitor; AND7. Member has had a negative tuberculosis test within the past 12 months.8. Dosage allowed/Quantity limit: 2 mg/kg intravenous inf usion at weeks 0 and 4, and every 8 weeks thereaf ter.If all the above requirements are met , the medication will be approved for 12 months . For reauthorization : 1. Chart notes have been provided show ing improvement of signs and symptoms of disease such as decreased morning stif f ness, tenderness or inf lammatory back pai n, improved quality of lif e, etc .If all the above requirements are met , the medication will be approved for an additional 12 months . Polyarticular Juvenile Idiopathic Arthritis (pJIA)For initial authorization: 1. Member must be 2 years of age or older; AND2. Medication must be prescribed by or in consultation with a rheumatologist; AND3. Member has a conf irmed diagnosis of active pJIA; AND OH-MED-P-3666854. Member has had an adequate trial and f ailure of a conventional DMARD (e.g., methotrexate, lef lunomide, etc.) f or 8 weeks, unless not tolerated or contraindicated; AND 5. Member has tried and f ailed TWO pref erred biologic DMARDs f or 3 months each, one of which must be a TNF inhibitor; AND 6. Member has had a negative tuberculosis test within the past 12 months. 7. Dosage allowed/Quantity limit: 80 mg/m 2 (body surface area) intravenous inf usion at week 0 and 4, and every 8 weeks thereaf ter. If all the above requirements are met , the medication will be approved for 12 months .For reauthorization :1. Chart notes have been provided showing improvement of signs and symptoms of disease such as decreased joint swelling and pain and improved quality of lif e. If all the above requirements are met , the medication will be approved for an additional 12 months.Psoriatic Arthritis (PsA)For initial authorization: 1. Member must be 2 years of age or older; AND 2. Medication must be prescribed by or in consultation with a rheumatologist or a dermatologist; AND 3. Member has a documented diagnosis of active PsA; AND 4. Member has met a 4-week trial of an NSAID taken at maximally tolerated dose AND a 3-month trial of a conventional DMARD agent (e.g., methotrexate, sulfasalazine, cyclosporine, etc.) unless ONE of the f ollowing situations is met: a) Conventional DMARD is NOT required f or: i) Concomitant axial disease (i.e., involving sacroiliac joint and spine) or enthesitis; OR b) NSAID and conventional DMARD are NOT required f or: i) Severe PsA (def ined as having at least one of the f ollowing: erosive disease, active PsA at many sites including dactylitis or enthesitis, elevated levels of ESR or CRP, joint def ormities, or major impairment in quality of lif e); AND 5. Member has tried and f ailed TWO pref erred biologic DMARDs f or 3 months each, one of which must be a TNF inhibitor ; AND 6. Member has had a negative tuberculosis test within the past 12 months. 7. Dosage allowed/Quantity limit: Adults : 2 mg/kg intravenous inf usion at weeks 0 and 4, and every 8 weeks thereaf ter. Pediatrics : 80 mg/m2 ( body surf ace area ) intravenous inf usion at weeks 0 and 4, and every 8 weeks thereaf ter. If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes have been provided showing improvement of signs and symptoms of disease such as decreased joint swelling and pain, improved skin appearance, improved quality of lif e, etc . If all the above requirements are met , the medication will be approved for an additional 12 months.Rheumatoid Arthritis (RA)For initial authorization: 1. Member must be 18 years of age or older ; AND 2. Medication must be prescribed by or in consultation with a rheumatologist; AND OH-MED-P-3666853. Member has a documented diagnosis of moderately to severely active RA; AND 4. Member must have a trial and f ailure of , or intolerance to methotrexate f or at least 3 months; Note : If methotrexate is contraindicated, one of the f ollowing conventional DMARDs must be trialed instead: lef lunomide, sulf asalazine, or hydroxychloroquine . 5. Simponi Aria will be given in combination with methotrexate or with another conventional DMARD if member is unable to tolerate methotrexate; AND 6. Member has tried and f ailed TWO pref erred biologic DMARDs f or 3 months each, one of which must be a TNF inhibitor; AND 7. Member has had a negative tuberculosis test within the past 12 months. 8. Dosage allowed/Quantity limit: 2 mg/kg intravenous inf usion at weeks 0 and 4, and every 8 weeks thereaf ter. If all the above requirements are met , the medication will be approved for 12 months.For reauthorization :1. Chart notes demonstrate improvement of RA signs and symptoms such as f ewer number of painf ul and swollen joints, achievement of remission, slowed progression of joint damage, etc. If all the above requirements are met , the medication will be approved for an additional 12 months.CareSource considers Simponi Aria (golimumab) not medically necessary for thetreatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION05/10/2017 New policy f or Simponi Aria created. Policy SRx-0042 archived. List of diagnoses considered not medically necessary was added. 11/13/2017 New indications of AS and PsA added. 02/26/2019 Dosing inf ormation corrected. Humira was removed f rom criteria; Actemra, Cimzia, Cosentyx, Kevzara, Olumiant, Otezla and Xeljanz added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Ref erences added. Symptoms of back pain f or AS ex tended till bef ore age of 50. Other drugs options allowed f or PsA if there is an intolerance or contraindication to methotrexate. 10/12/2020 New diagnosis of pJIA added. Replaced list of excluded diagnoses with the generic statement. Updated ref erences. For all diagnoses: Removed repeat TB in reauth f or all diagnoses. For AS : Removed list of symptoms of spondyloarthritis because imaging result should be suf f icient. Removed peripheral arthritis requirement not relevant f or this diagnosis. For PsA : Age requirement expanded to 2 years or older. Updated dosing and biologic trials ref lective of age label change. Added requirement of diagnosis of PsA. Changed the trial section to be 4 weeks of an NSAID AND 3 months of a DMARD unless other circumstances apply (e.g., concomitant axial disease, severe PsA, etc.). For RA : Changed the trials to require methotrexate as one of the non-biologic DMARD trials; only one trial is needed if member has poor prognostic f actors. 01/24/2022 Transf erred to new template. RA: Added new ref erence. Edited the terminology non-biologic DMARD to conventional DMARD. Changed f rom requiring 2 csDMARD to just 1. Removed Xeljanz, Olumiant f rom try f irst options per recent JAK inhibitor label changes; also OH-MED-P – 366685 changed f rom other specific drug names to say 2 pref erred biologics one of which is a TNF inhibitor. Added pref erred biologic trial with TNFi and Clarif ied reauth criteria f or PsA and AS . 08/09/2024 AS: changed trial of each NSAID f rom 4 weeks to 2 weeks f or a total of 4 weeks of treatment per EULAR 22 guidelines; removed criteria requiring back pain f or 3 or more months bef ore the age of 50 and inf lammation of one or both of the sacroiliac joints and added that member must have elevated CRP or sacroiliitis on MRI per EULAR 2 2 guidelines pJIA: added examples of improvement in reauthorization criteria; changed non-biologic DMARD to conventional DMARD ; changed trial of Enbrel and Actemra to trial of two pref erred biologic DMARDs f or 3 months each, one of which must be a TNF inhibitor . 11/19/2024 Approved by ODMRef erences: 1. Simp o ni Aria [p rescrib ing inf o rmatio n]. Ho rsham, PA; Janssen Bio tech, Inc. ; 2021 .2. Ward MM, Deodhar A, Gensler LS, et al. 2019 Up d ate o f the American Co lleg e o f Rheumato lo g y/Sp o nd ylitisAsso ciation of America/Spondyloarthritis Research and Treatment Network Recommendations f o r the Treatment o f Ankylo sing Sp o nd ylitis and No nrad io g rap hic Axial Sp o nd ylo art hritis. Arthritis Rheumatol . 2019Oct;71(10):1599-1613. d o i: 10.1002/art.41042. Ep ub 2019 Aug 22.3. Ramiro S, Nikip ho ro u E, Sep riano A, et al. ASAS-EULAR reco mmend atio ns f o r the manag ement o f axial sp o nd ylo arthritis: 2022 up d ate. Ann Rheum Dis. 2023;82(1):19-34. d o i:10.1136/ard-2022-2232964. Deo d har A, Reveille JD, Harrison DD, et al. Safety and Ef f icacy o f Go limumab Ad ministered Intraveno usly inAd ults with Ankylo sing Sp o nd ylitis: Results thro ug h Week 28 o f the GO-ALIVE Stud y [p ub lished co rrectio n ap p ears in JRheumato l. 2018 Feb ;45(2):291]. JRheumatol . 2018;45(3):341-348.5. Ring o ld S, Angeles-Han ST, Beukelman T, et al. 2019 American College o f Rheumato lo g y/Arthritis Fo und atio n g uid elines for the treatment of juvenile idiopathic arthritis: therapeutic approaches for no n-systemic p o lyarthritis,sacro iliitis, and enthesitis. Arthritis Care Res (Ho b o ken). 2019 Jun;71(6):717-734.6. Rup erto N, Brunner HI, Pacheco-Tena C, et al. Open-label phase 3 study of intraveno us g o limumab in p atients with p o lyarticular juvenile id io p athic arthritis. Rheumatology (Oxford). 2021;60(10):4495-4507. d o i:10.1093/rheumato lo g y/keab 0217. Kavanaug h A, et al. Golimumab in p soriatic arthritis: one-year clinical eff icacy, rad io g rap hic, and saf ety results f ro m a p hase III, rand o mized , p laceb o-co ntro lled trial. Arthritis Rheum . 2012 Aug ;64(8):2504-17.8. Michelo n MA, et al. Ro le o f g o limumab , a TNF-alp ha inhib ito r, in the treatment o f the p so riatic arthritis. ClinCosmet Investig Dermatol . 2010;3:79-84.9. Co ates LC, Soriano ER, Co rp N, et al. Group for Research and Assessment o f Pso riasis and Pso riatic Arthritis(GRAPPA): updated treatment recommendations for psoriatic arthritis 2021 [published correctio n ap p ears in NatRev Rheumato l. 2022 Dec;18(12):734. d oi: 10.1038/s41584-022-00861-w]. Nat Rev Rheumatol. 2022;18(8):465-479. d o i:10.1038/s41584-022-00798-010. Co ates LC, Kavanaugh A, Mease PJ, et al. Gro up f o r Research and Assessment o f Pso riasis and Pso riaticArthritis 2015 Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol . 2016 May;68(5):1060-71.11. Go ssec L, Kerschb aumer A, Ferreira RJO, et al. EULAR reco mmend atio ns f o r the manag ement o f p so riatic arthritis with p harmacological therapies: 2023 update. Ann Rheum Dis . 2024;83(6):706-719. Published 2024 May15. d o i:10.1136/ard-2024-22553112. Sing h JA, Saag KG, Bridges SL Jr, et al. 2015 American Co llege of Rheumatology Guideline for the Treatment o fRheumato id Arthritis. Arthritis Rheumatol . 2016;68(1):1-26.13. Smo len JS, Landew RBM, Bijlsma JWJ, et al. EULAR reco mmend atio ns f o r the manag ement o f rheumato id arthritis with synthetic and b io lo g ical d isease-mo d if ying antirheumatic d rug s: 2019 up d ate. Ann Rheum Dis .2020;79(6):685-699.14. Smo len JS. Insights into the efficacy of golimumab p lus methotrexate in p atients with active rheumato id arthritis who d iscontinued prior anti-tumour necro sis factor therapy: p ost-ho c analyses f ro m the GO-AFTER stud y. AnnRheum Dis . 2014 Oct;73(10):1811-8.15. Fraenkel L, Batho n JM, England BR, et al. 2021 American College of Rheumatology Guideline f o r the Treatment o f Rheumato id Arthritis. Arthritis Rheumatol . 2021;73(7):1108-1123. d o i:10.1002/art.41752PsA: changed non-biologic DMARD to conventional DMARD OH-MED-P – 366685 16. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.17. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.18. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o vEf f ective d ate: 0 1/01/2025 Revised d ate: 0 8/09/2024
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Xgeva (denosumab) BENEFIT TYPE Medical STATUS Prior Authorization Required Xgeva (denosumab) was initially approved by the FDA in 201 0 and is a monoclonal antibody that inhibits the RANK ligand (RANKL) . It is indicated f or the prevention of skeletal-related events in patients with multiple myeloma or bone metastases f rom solid tumors , and f or the treatment of hypercalcemia of malignancy. It is also indicated f or the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe mo rbidity . Giant cell tumor of bone is an intermediate, locally aggressive primary bone tumor , most commonly occurring in long bones . At presentation, 15% 20% of patients have a pathologic f racture . Malignant transf ormation is uncommon but possible . The main problem in the management of GCTB is local recurrence af ter surgical treatment. The clinical challenge in GCTB treatment is to improve local control and broaden indications for intralesional surgery, providing optimal f unctional and oncological results. This may b e aided by targeted therapy with denosumab . Xgeva (denosumab ) will be considered for coverage when the following criteria are met: Giant Cell Tumor of Bone (GCT B)For initial authorization: 1. Member is at least 18 years of age OR at least 12 years of age and skeletally mature (at least 1mature long bone) ; AND2. Xgeva is prescribed by or in consult with an oncologist; AND3. Member has a conf irmed diagnosis of GCTB (radiographs , CT, MRI , or histology ); AND4. Members tumor is either recurrent (came back af ter surgery), unresectable ( cannot be removed by surgery ) , or surgery is likely to result in severe morbidity (i.e., limb amputation or joint resection ).5. Dosage allowed/Quantity limit: 120 mg (1 injection) subQ every 28 days , with additional 120mg doses on days 8 and 15 of the f irst month of therapy .QL: 3 vials f or the initial 28 days, f ollowed by 1 vial (1.7 mL) per 28 days thereaf terIf all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must document reduction of tumor size or lack of tumor progression f rom baseline.If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months . OH-MED-P – 366685 Multiple Myeloma , Bone Metastasis from Solid Tumors , and Hypercalcemia of MalignancyAny request f or cancer or hypercalcemia of malignancy must be submitted through NantHealth/Eviti portal. CareSource considers Xgeva (denosumab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. DATE ACTION/DESCRIPTION 08/ 13 /20 20 New policy f or Xgeva created 04/26/2022 Transf erred to new template. Added QL. Updated ref erence s . Added specialist and diagnostic conf irmation. Modif ied wording of renewal criteria. Shortened initial approval duration f rom 12 mo to 6 mo. 06/07/2024 Updated ref erences. Clarif ied the member must be skeletally mature. Added CT to diagnostic conf irmation options. 11/19/24 Approved by ODMRef erences: 1. Xg eva [p rescrib ing inf o rmatio n]. Tho usand Oaks, CA: Amg en Inc.; June, 2020.2. van d er Heijd en L, Dijkstra S, van de Sande M, Gelderblom H. Current concepts in the treatment of g iant cell tumo ur o f b o ne. Curr Opin Oncol . 2020;32(4):332-338. d o i:10.1097/CCO.00000000000006453. Natio nal Co mp rehensive Cancer Netwo rk. Bo ne Cancer (Versio n2.20 24 ). http s://www.nccn.o rg /p ro f essio nals/p hysician_g ls/p d f /b o ne.p d f . Accessed June 7, 2024 .4. Tsukamo to S, Mavrogenis AF, Masunaga T, et al. Current Co ncepts in the Treatment of Giant Cell Tumo r o fBo ne: An Up date. Curr Oncol . 2024;31(4):2112-2132. Published 2024 Apr 8. d oi:10.3390/curronco l310401575. Ohio Ad ministrative Co de. (2022, February 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.6. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary22, 2023 f ro m co d es.o hio .g o v.7. Ohio Ad ministrative Co de. (2020, January 1). 5160-9 – 03 Pharmacy services: covered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o v.Ef f ective d ate: 01/01/2025 Revised d ate: 06/07/2024
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Supprelin LA (histrelin acetate)BENEFIT TYPE Medical STATUS Prior Authorization Required Supprelin LA , initially approved by the FDA in 1991, is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP) . CPP refers to early activation of the hypothalamic pituitary gonadal axis which results in premature development of secondary sexual characteristics. Most cases are seen in girls without an identifiable cause. In contrast, about half of cases in boys do have an identifiable cause. When left u ntreated, CPP can result in early epiphyseal fusion and a substantial compromise in adul t height. The goal of treatment is preservation of height therefore GnRH agonists are the standard of treatment.Supprelin LA (histrelin acetate) will be considered for coverage when the following criteria are met:Central Precocious Puberty (CPP)For initial authorization: 1. Member is 2 years old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has early onset of pubertal symptoms before age of 8 years for females or 9 years for males; AND 4. Member has confirmed diagnosis of central precocious puberty, as evidenced by BOTH of the following: a. Pubertal response to a gonadotropin releasing hormone (GnRH) stimulation test OR pubertal levels of basal luteinizing hormone (LH); b. Advanced bone age for chronological age; AND 5. Members baseline LH level, sex steroid level (estradiol or testosterone), and height are submitted with chart notes. 6. Dosage allowed/Quantity limit: Insert one implant (50 mg) every 12 months. Quantity Limit: 1 implant per 12 months. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes have been provided showing efficacy of response (e.g., slowed growth rate, slowed bone age advancement, LH and sex steroid hormone levels have been suppressed or reduced from baseline) ; AND 2. If member is 11 years or older for females or 12 years or older for males, prescriber must provide a clinical reason for continuing medication beyond the recommended age for resuming puberty . If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. OH-MED-P -366685 CareSource considers Supprelin LA (histrelin acetate ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION07/22 /2020 New Policy for Supprelin LA created. 03/1 9/2024 Updated references ; reduced initial approval length to 6 months; removed requirement of estradiol/testosterone level from LH testing; simplified bone age requirement from 1 year or greater to advanced. 8/15/2024 Approved by ODM References: 1. Supprelin LA [package insert]. Malvern, PA: Endo Pharmaceuticals, Inc.; 2022. 2. Silverman LA, Neely EK, Kletter GB, et al. Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial. JClin Endocrinol Metab. 2015;100(6):2354-2363. doi:10.1210/jc.2014-3031 3. Chen M, Eugster EA. Central Precocious Puberty: Update on Diagnosis and Treatment. Paediatr Drugs. 2015;17(4):273-281. 4. Carel JC, Eugster EA, Rogol A, et al; ESPE-LWPES GnRH Analogs Consensus Conference Group. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123(4). 5. Kletter GB, Klein KO, Wong YY. A pediatrician's guide to central precocious puberty. Clin Pediatr (Phila). 2015;54(5):414-424. doi:10.1177/0009922814541807 6. Zevin EL, Eugster EA. Central precocious puberty: a review of diagnosis, treatment, and outcomes. Lancet Child Adolesc Health. 2023;7(12):886-896. doi:10.1016/S2352-4642(23)00237-7 Effective date: 10/01/2024 Revised date: 03/19/2024
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