IN-MED-P-366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Rivfloza (nedosiran)BENEFIT TYPE Medical or Pharmacy STATUS Prior Authorization Required Rivf loza is an LDHA-directed small interf ering RNA indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney f unction, e.g., eGFR 30 mL/min/1.73 m 2. PH1, which is caused by mutations of the AGXT gene, is a rare autosomal recessive disease that mainly af f ects the kidneys. It results f rom buildup of oxalate, which normally is f iltered through the kidneys and excreted in the urine. Stone f ormation (calciu m oxalate) in the kidneys and urinary tract occurs, as well as elevated levels of calcium in the kidneys. Eventually, if kidney f unction declines f ar enough, oxalate can start to accumulate in other body tissues, leading to a variety of problems (systemic oxalosis). Rivfloza (nedosiran) will be considered for coverage when the following criteria aremet:Primary Hyperoxaluria Type 1 (PH1)For initial authorization: 1. Member is at least 9 years of age ; AND 2. Medication must be prescribed by or in consultation with a urologist or nephrologist ; AND 3. Member has a diagnosis of primary hyperoxaluria type 1 conf irmed by g enetic testing that shows a mutation in the AGXT gene ; AND 4. Member has documentation of elevated urinary oxalate levels (24-hour Uox excretion 0.7 mmol (per 1.73 m2 body surf ace area [BSA] in age
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Zilbrysq (zilucoplan)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Zilbrysq, approved by the FDA in 2023, is a C5 complement inhibitor indicated f or the treatment of generalized myasthenia gravis (gMG) in adult patients who are antiacetylcholine receptor (AChR) antibody positive. Approval was based on results of the Phase 3 RAISE study. Myasthenia gravis is an autoimmune disorder af f ecting the neuromuscular junction, characterized by muscle weakness and f atigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junc tion, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AChR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Ocular motility, swallowing, speech, mobility, and respiratory f unction can all be af f ected. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed f or MG. It eases symptoms by slowing the breakdown of acetylcholine. If control is inadequate, immunosuppressive treatment is added, such as prednisone and/or azathioprine. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency.Zilbrysq (zilucoplan) will be considered for coverage when the following criteria are met:Myasthenia GravisFor initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist ; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive f or AChR antibodies; AND 5. Member has tried and f ailed at least 1 conventional therapy: A. Pyridostigmine B. Corticosteroid f or at least 4 weeks C. Non-steroid immunosuppressant (e.g., azathioprine) f or at least 6 months; AND 6. Member has received meningococcal vaccine. 7 . Dosage allowed/Quantity limit: SubQ once daily based on actual body weight: a)
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Yutiq (fluocinolone acetonide)BENEF IT TYPE Medical ST AT US Prior Authorization Required Yutiq is a 0. 18 mg f luocinolone acetonide intravitreal implant that was approved by the FDA in 2018. It is indicated f or the treatment of chronic non-inf ectious uveitis af f ecting the posterior segment of the eye and lasts 36 months. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is af f ected, it can be treated with topical glucocorticoids. If resistant or af fecting the intermediate or posterior segments, more invasive or systemic treatment is needed.Yutiq (fluocinolone acetonide) will be considered for coverage when the following criteria are met:Uveitis For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of chronic (1 year or more) non-inf ectious uveitis af f ecting the posterior segment of the eye; AND 4. Member has tried and f ailed at least one of the f ollowing f or at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mof etil, methotrexate, cyclosporine, tacrolimus); AND 5. Member does not have any active or suspected inf ections in or around the eye. 6. Dosage allowed/Quantity limit: One implant (0.18 mg) per eye Limit: 2 implants (1 per eye) per 36 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or an improved vitreous haze score; AND 2. At least 36 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 3 months . CareSource considers Yutiq (fluocinolone acetonide) 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION11/02/2021 New policy created f or Yutiq . 10/18/2023 Updated ref erences. 04/09/2025 Updated ref erences. Ref erenc es : 1. Yutiq [p res c rib ing inf o rmatio n]. Ey ePo int Pharmac eutic als US, Inc .; 2023. 2. Jaf fe GJ , Pavesio CE; Study Inv estigators . Ef f ec t o f a Fluo c ino lo ne Ac eto nid e Ins ert o n Rec urrenc e Rates in No ninf ectious Intermediate, Po s terio r, o r Panuv eitis : Three-Year Res ults . Ophthalmology . 2020;127(10):1395-1404. d o i:10.1016/j.o p htha.2020.04.001 3. Steep les LR, Poc kar S, Jones NP, Leal I. Ev aluating the Safety, Efficacy and Patient Acc ep tab ility o f Intrav itreal Fluo c inolone Acetonide (0.2mc g/Day) Imp lant in the Treatment of No n-Infectious Uv eitis Af f ec ting the Po s terio r Seg ment. Clin Ophthalmol . 2021;15:1433-1442. Pub lis hed 2021 Ap r 7. d o i:10.2147/OPTH.S216912 4. Red d y A, Liu SH, Brady CJ , Sieving PC, Palestine AG. Corticosteroid implants for c hronic no n-infec tio us uv eitis . Coc hrane Databas e Sy s t Rev . 2023;1(1):CD 010469. Pub lis hed 2023 Jan 16. d o i:10.1002/14651858.CD 010469.p ub 3 5. Tan HY, Ag arwal A, Lee CS, et al. Management of no ninfectious p os terio r uv eitis with intrav itreal d rug therap y . Clin Ophthalmol . 2016;10:1983-2020. Pub lis hed 2016 Oc t 13. d o i:10.2147/OPTH.S89341 6. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectio us uv eitis . Clin Ex p Med. 2023;23(4):1089-1106. d o i:10.1007/s 10238-022-00954-6 7. Ab d ulla D, Ali Y, Menezo V, Tay lo r SRJ . The Us e o f Sus tained Releas e Intrav itreal Stero id Imp lants in No n-Inf ec tio us Uv eitis Af f ec ting the Po s terio r Seg ment o f the Ey e. Ophthalmol Ther . 2022;11(2):479-487. d o i:10.1007/s 40123-022-00456-4 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/09/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Xipere (triamcinolone )BENEF IT TYPE Medical ST AT US Prior Authorization Required Xipere, approved by the FDA in 2021, is an injectable suspension f ormulation of triamcinolone acetonide, indicated f or the treatment of macular edema associated with uveitis. It is injected into the suprachoroidal space to deliver the medication to the choroid and retina at the back of the eye. Xipere is currently the only FDA approved medication administered by this particular route and the f irst specif ically f or macular edema associated with uveitis. It was approved based on results of the phase 3 PEACHTREE trial. Xipere will compete with the intravitreal injectable, Triesence, and with the intravitreal implants, i.e., Retisert, Ozurdex, and Yutiq. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. Approximately one-third of uveitis patients develop uveitic macular edema, a build-up of f luid in the macula, the area of the retina responsible f or central vision. Suprachoroidal administration is a more targeted technique which has shown to lessen the risk of the ocular adverse ef f ects of intravitreal corticosteroids and systemic adverse ef f ects of oral corticosteroids.Xipere (triamcinolone) will be considered for coverage when the following criteria are met:Uveitic Macular Edema For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of non-inf ectious uveitis (pan, anterior, intermediate, or posterior) ; AND 4. Member has a diagnosis of macular edema associated with uveitis; AND 5. Documentation of best corrected visual acuity (BCVA) at baseline; AND 6. Member does not have any active or suspected ocular or periocular inf ections . 7. Dosage allowed/Quantity limit: 4 mg (0.1mL) via suprachoroidal injection every 12 weeks (per eye) QL: 2 vials per 12 weeks If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or reduction f rom baseline in central subf ield thickness (CST) If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Xipere (triamcinolone) 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/DESCRIPTION11/10/2021 New policy f or Xipere created. 10/05/2023 Corrected dosing interval. Added QL. Added ref erences. 04/09/2025 Added ref erence. Ref erenc es : 1. Xip ere [p res c rib ing inf o rmatio n]. Clears id e Bio med ic al, Inc ; 2022. 2. Yeh S, Khurana RN, Shah M, et al. Effic acy and Safety of Suprachoroidal CLS-TA f o r Macular Edema Secondary to No ninf ec tio us Uv eitis : Phas e 3 Rand o mized Trial. Ophthalmology . 2020;127(7):948-955. d o i:10.1016/j.o p htha.2020.01.006 3. Pric e KW, Albini TA, Yeh S. Suprac horoidal Injec tion of Triamc inolone-Rev iew of a No v el Treatment f o r Mac ular Ed ema Caus ed b y Noninfec tious Uv eitis. US Ophthalmic Rev . 2020;13(2):76-79. doi:10.17925/usor.2020.13.2.76 4. Khurana RN, Merrill P, Yeh S, et al. Ex tension s tudy of the s afety and effic acy of CLS-TA for treatment of macular o ed ema as sociated with non-infectious uv eitis (MAGNOLIA) [publis hed online ahead of p rint, 2021 Mar 12]. Br JOphthalmol . 2021;b jo p hthalmo l-2020-317560. d o i:10.1136/b jo p hthalmo l-2020-317560 5. Sing er MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal CLS-TA vers us Res cue Therap ies f o r the Treatment o f Uv eitic Macular Edema: A Post Hoc Analysis of PEACHTREE [publis hed online ahead of print, 2021 No v 6] . Clin Ex p Ophthalmol . 2021;10.1111/c eo .14024. d o i:10.1111/c eo .14024 6. Merrill PT, Henry CR, Ng uy en QD , Red d y A, Kap ik B, Ciulla TA. Sup rac ho ro id al CLS-TA with and witho ut Sy s temic Corticostero id and /o r Stero id-Sp aring Therap y : A Po s t-Ho c Analy s is o f the Phas e 3 PEACHTREE Clinic al Trial [p ub lis hed o nline ahead o f p rint, 2021 Aug 18]. Oc ul Immunol Inflamm . 2021;1-8. d o i:10.1080/09273948.2021.1954199 7. Yeh S, Ciulla T. Sup rac horoidal triamcinolone ac etonide injectable s uspension for macular edema assoc iated with no ninf ectious uveitis : an in-d ep th lo o k at ef f ic ac y and s af ety . Am JManag Care. 2023;29(2 Sup p l):S19-S28. d o i:10.37765/ajmc .2023.89324 8. Yeh S, Henry CR, Kap ik B, Ciulla TA. Triamc inolone Acetonide Suprachoroidal Injectable Sus pens io n f o r Uv eitic Mac ular Ed ema: Integ rated Analy s is o f Two Phas e 3 Stud ies . Ophthalmol Ther . 2023;12(1):577-591. d o i:10.1007/s 40123-022-00603-x 9. So o d G, Patel BC. Uv eitic Macular Edema. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treas ure Is land (FL): StatPearls Pub lis hing ; 2025 Jan- . Av ailab le f ro m: http s ://www.nc b i.nlm.nih.g o v /b o o k s /NBK562158/ Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/09/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vyvgart (efgartigimod alfa-fcab) andVyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) BENEF IT TYPE Vyvgart: Medical Vyvgart Hytrulo: Medical or Pharmacy ST AT US Prior Authorization Required Vyvgart, approved by the FDA in 2021, is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Vyvgart is a f irst-in-class IgG1 antibody Fc f ragment designed to reduce pathogenic IgG autoantibody levels by inhibiting IgG recycling via the neonatal Fc receptor (FcRn) and increasing IgG degradation. Vyvgart Hytrulo is a combination of ef gartigamod and hyaluronidase f or subcutaneous administration. Myasthenia gravis is an autoimmune disorder af f ecting the neuromuscular junction. It is characterized by muscle weakness and f atigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AChR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed f or MG. If control is inadequate, immunosuppressive treatment is added. Other drugs are used in cases of severe or ref ractory MG or myasthenic crisis, which is an e mergency. Vyvgart Hytrulo is also approved f or chronic inf lammatory demyelinating polyneuropathy (CIDP) , a r are autoimmune disorder characterized by progressive peripheral neuropathy with typical and atypical phenotypes. Demyelination manif ests as weakness, numbness, paresthesia, and sensory ataxia .Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be considered for coverage when the following criteria are met:Generalized Myasthenia Gravis (gMG)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive f or AChR antibodies; AND 5. Member has tried and f ailed at le as t 1 conventional therapy: A. pyridostigmine B. corticosteroid f or at least 4 weeks C. non-steroid immunosuppressant (e.g., azathioprine) f or at least 6 months. 6. Dosage allowed/Quantity limit: IV inf usion (Vyvgart) or SubQ injection (Vyvgart Hytrulo) once weekly f or 4 weeks (1 cycle) . Subsequent cycles may take place no sooner than 50 days f rom the start of the previous cycle. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Vyvgart — Weight
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vykat XR (diazoxide choline)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Vykat XR, approved by the FDA in 2025, is indicated f or the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). PWS is a rare genetic disorder that occurs due to the loss of function on chromosome 15 leading to disruption of the hypothalamus. Patients experience hypotonia and f eeding dif f iculties in early lif e f ollowed by hyperphagia and gradual development of obesi ty in early childhood. Hyperphagia of ten begins around 3 years of age and progress until teenage years. It is coupled with f ood-seeking behaviors such as hoarding and stealing f ood as well as attempting to consume inedible items. Thus, patients with PWS ha ve a greater risk of choking and gastric distention. Both patients and caregivers carry a signif icant lif elong psychosocial burden.Vykat XR (diazoxide choline) will be considered for coverage when the following criteria are met:Hyperphagia in Prader-Willi Syndrome (PWS)For initial authorization: 1. Member is at least 4 years of age; AND 2. Medication must be prescribed by or in consultation on with an endocrinologist; AND 3. Member has a diagnosis of PWS conf irmed by genetic testing; AND 4. Provider attests that member has moderate to severe hyperphagia with documentation of associated symptoms such as f ood-seeking behaviors (hoarding, f oraging, stealing, and attempting to consume garbage and inedible objects); AND 5. Member has documentation of a f ood-secure environment (such as locked f ood storage); AND 6. Patient is able to swallow tablets whole; AND 7. Member has documentation of recent weight in chart notes. 8. Dosage allowed/Quantity limit: administer orally once daily per table below. Maximum dose is 5.8 mg/kg/day or 525 mg per day. a) Quantity limit: i) 25 mg: 1 tablet per day ii) 75 mg: 1 tablet per day iii) 150 mg: 3 tablets per day IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023If all the above requirements are met, the medication will be approved for 6 months.For reauthorization :1. Chart notes must have been provided showing improvement or stabilized signs and symptoms of disease such as decrease in f ood-related behaviors, lessened f ood preoccupation that af f ects daily lif e, etc; AND 2. Provider attests that member continues to benef it f rom therapy; AND 3. Member has documentation of recent weight in chart notes. If all the above requirements are met, the medication will be approved for an additional 12 months.CareSource considers Vykat XR (diazoxide choline) 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/DESCRIPTION04/23/2025 New policy f or Vykat XR created. Ref erenc es : 1. Vy k at XR [p res c rib ing inf o rmatio n]. So leno Therap eutic s , Inc .; 2025. 2. Fermin Gutierrez MA, Daley SF, Mend ez MD . Prad er-Willi Synd ro me. In: StatPearls . Treas ure Is land (FL): StatPearls Pub lis hing ; Feb ruary 26, 2024. 3. Mc Cand les s SE; Co mmittee o n Genetic s . Clinic al rep o rt health s up erv is io n f o r c hild ren with Prad er-Willi s y nd ro me. Pediatric s. 2011;127(1):195-204. d o i:10.1542/p ed s .2010-2820 4. Shaik h MG, Barrett TG, Brid g es N, et al. Prad er-Willi s y nd ro me: g uid anc e f o r c hild ren and trans itio n into adulthood. Endoc r Connec t. 2024;13(8):e240091. Pub lis hed 2024 Jul 10. d o i:10.1530/EC-24-0091 5. Bey g o J , Buiting K, Rams den SC, Ellis R, Clay ton-Smith J , Kanber D . Up date of the EMQN/ACGS b es t p rac tic e g uid elines for molecular analys is of Prader-Willi and Angelman sy ndromes . Eur JHum Genet. 2019;27(9):1326-1340. d o i:10.1038/s 41431-019-0435-0 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/23/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vafseo (vadadustat )BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Vaf seo, approved by the FDA in 2024, is a hypoxia-inducible f actor prolyl hydroxylase (HIF PH) inhibitor indicated f or the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis f or at least three months . It has not been shown to improve quality of lif e, f atigue, or patient well-being, and is not indicated f or use as a substitute f or transfusion in patients requiring immediate correction of anemia, or f or patients not on dialysis. Erythropoiesis-stimulating agents (ESAs) are the standard of care f or treating anemia in CKD (especially in dialysis patients). Vaf seo is the second approved HIF inhibitor, f ollowing Jesduvroq (daprodustat). In the Phase 3 INNO2VAT Et r ials, Vaf s e o was noninf erior to darbepoetin alf a in ef f icacy (hemoglobin correction) and cardiovascular (CV) saf ety outcomes. It has a boxed warning f or increased risk of thrombotic vascular events. The lowest dose suf f icient to reduce the need f or red blood cell transf usions should be used.Vafseo (vadadustat) will be considered for coverage when the following criteria are met:Anemia of Chronic Kidney Disease (CKD) For initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with a nephrologist; AND 3. Member has a diagnosis of anemia due to CKD; AND 4. Member has been receiving dialysis f or at least 3 months; AND 5. Members labs show hemoglobin level less than 10 g/dL in the last 30 days; AND 6. Members labs show adequate iron stores with both of the f ollowing: a) Transf errin saturation (T SAT ) is at least 20% b) Ferritin is at least 100 mcg/L; AND 7. Member has tried and f ailed an erythropoiesis stimulating agent (ESA) f or at least 4 weeks; AND 8. Member does NOT have uncontrolled hypertension. 9. Dosage allowed/Quantity limit: St ar t 300 mg orally once daily . Adjust based on hemoglobin levels per prescribing inf ormation; do not target hemoglobin >11 g/dL. Max dose 600 mg once daily. (QL: 60 tablets per 30 days) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show increased hemoglobin compared to baseline; AND 2. Current hemoglobin level does not exceed 11 g/dL. If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Vafseo (vadadustat) 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/DESCRIPTION04/12/2024 New policy f or Vaf s e o created. 04/01/2025 Annual review; no changes. Ref erenc es : 1. Vaf s eo [p res c rib ing inf o rmatio n]. Ak eb ia Therap eutic s , Inc .; 2024. 2. Ec k ard t KU, Agarwal R, Aswad A, et al. Safety and Efficac y o f Vad ad us tat f o r Anemia in Patients Und erg o ing Dialysis. NEngl JMed. 2021;384(17):1601-1612. d o i:10.1056/NEJ Mo a2025956 3. Klig er AS, Foley RN, Goldfarb DS, et al. KDOQI US c ommentary on the 2012 KDIGO Clinic al Prac tic e Guid eline f o r Anemia in CKD . Am JKidney Dis . 2013;62(5):849-859. d o i:10.1053/j.ajk d .2013.06.008 4. Natale P, Palmer SC, Jaure A, et al. Hy p o x ia-ind uc ib le f ac to r s tab ilis ers f o r the anaemia o f c hro nic k id ney d is eas e. Coc hrane Databas e Sy s t Rev . 2022;8(8):CD 013751. Pub lis hed 2022 Aug 25. d o i:10.1002/14651858.CD 013751.p ub 2 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/ 01/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Uplizna (inebilizumab-cdon)BENEF IT TYPE Medical ST AT US Prior Authorization Required Uplizna is a CD19-directed cytolytic antibody indicated f or the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive and the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients. Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease of the central nervous system that primarily attacks the optic nerves and spinal cord leading to blindness and paralysis. Immunoglobulin G4-related disease (IgG4-RD) is a multi-organ inf lammatory disease characterized by high levels of IgG4 and tumor-like masses. It most commonly af f ects the pancreas, kidneys, orbital structures, salivary glands, and retroperitoneum.Uplizna (inebilizumab-cdon) will be considered for coverage when the following criteria are met:Neuromyelitis Optica Spectrum Disorder (NMOSD)For initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of NMOSD and is seropositive f or aquaporin-4 (AQP4) IgG antibodies ; AND 4. Member has had 1 or more relapses within the past year; AND 5. Member has tried and f ailed rituximab f or at least 6 months (requires prior auth); AND 6. Member has tested negative f or hepatitis Band tuberculosis within the past year or there is attestation they will be tested bef ore starting treatment. 7. Dosage allowed/Quantity limit: 300mg IV inf usion f ollowed two weeks later by a second 300 mg inf usion. Subsequently, (starting 6 months f rom the f irst inf usion): 300 mg every 6 months . QL: 3 v ial s every 6 months (maintenance) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must document disease stabilization, symptom improvement, and/or reduced f requency of relapses compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Immunoglobulin G4-related disease (IgG4-RD)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a rheumatologist, immunologist, endocrinologist, hepatologist or nephrologist; AND 3. Member has a diagnosis of IgG4-RD with involvement of at least TWO organ systems; AND 4. Member is experiencing or has recently experienced a f lare requiring initiation or continuation of glucocorticoids; AND 5. Member is ref ractory to glucocorticoids (including glucocorticoid-dependent patients who cannot reduce dose without f lare); AND 6. Member has tested negative f or hepatitis Band tuberculosis within the past year or there is attestation they will be tested bef ore starting treatment. 7. Dosage allowed/Quantity limit: 300 mg IV inf usion f ollowed two weeks later by a second 300 mg inf usion. Subsequently, (starting 6 months f rom the f irst inf usion): 300 mg every 6 months. QL: 3 vials every 6 months (maintenance) If all the above requirements are met, the medication will be approved for 12 months. For reauthorization: 1. Chart notes demonstrate improvement of signs and symptoms such as f ewer f lares and/or decreased steroid use, etc. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Uplizna (inebilizumab-cdon) 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/DESCRIPTION10/02/2020 New policy f or Uplizna created. 07/1 7/2023 Transf erred to new template. Corrected QL. 04/22/2024 Removed azathioprine, mycophenolate trial options (rituximab more ef f ective per guidelines). 05/15/2025 Updated ref erences. Added Immunoglobulin G4-related disease diagnosis. Ref erenc es : 1. Up lizna [p ac k ag e ins ert]. Ho rizo n Therap eutic s ; 2025. 2. Kes s ler RA, Mealy MA, Levy M. Treatment of Neuro myelitis Optica Sp ec trum Dis o rd er: Ac ute, Prev entiv e, and Symptomatic . Curr Treat Options Neurol . 2016;18(1):2. d o i:10.1007/s 11940-015-0387-9 3. Weins henk er B. Neuro myelitis Op tic a Sp ec trum Dis o rd er. NORD (Natio nal Org anizatio n f o r Rare Dis o rd ers ). http s ://raredis eases.org/rare-diseas es/neuromyelitis-optica/. Pub lis hed Aug us t 25, 2020. Ac c es s ed Oc to b er 2, 2020. 4. Mealy MA, Wingerchuk DM, Palac e J, Greenberg BM, Levy M. Comparison of relapse and treatment failure rates amo ng p atients with neuro myelitis o ptica: multic enter s tudy of treatment efficac y . JAMA Neurol. 2014;71(3):324-330. d o i:10.1001/jamaneuro l.2013.5699 5. Cree BAC, Bennett JL, Kim HJ , et al. Ineb ilizumab for the treatment of neuromyelitis optica s pectrum diso rd er (N-MOmentum): a d ouble-blind, rand omised p lac ebo-c ontrolled phase 2/3 trial. Lanc et. 2019;394(10206):1352-1363. d o i:10.1016/S0140-6736(19)31817-3 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20236. Sto ne JH, Khosroshahi A, Zhang W, et al. Ineb ilizumab fo r Treatment o f Ig G4-Related Dis eas e. NEngl JMed. 2025;392(12):1168-1177. d o i:10.1056/NEJ Mo a2409712 7. Wallac e ZS, Katz G, Hernand ez-Barc o YG, Bak er MC. Current and f uture ad v anc es in p rac tic e: Ig G4-related d is eas e. Rheumatol Adv Prac t. 2024;8(2):rk ae020. Pub lis hed 2024 Ap r 10. d o i:10.1093/rap /rk ae020 8. Wallac e ZS, Nad en RP, Chari S, et al. The 2019 Americ an College of Rheumatolo g y /Euro p ean Leag ue Ag ains t Rheumatis m c las s if ic atio n c riteria f o r Ig G4-related d is eas e. Ann Rheum Dis . 2020;79(1):77-87. d o i:10.1136/annrheumd is-2019-216561 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 05/15/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Turalio (pexidartinib)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Turalio , approved by the FDA in 2019, is a kinase inhibitor indicated f or the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or f unctional limitations and not amenable to improvement with surgery. Turalio is the f irst FDA-appr oved systemic treatment for TGCT. It targets colony stimulating f actor 1 receptor (CSF1R) and other tyrosine kinases to inhibit cell prolif eration and accumulation. Turalio has a REMS program and boxed warning f or hepatotoxicity. TGCT, also known as pigmented villonodular synovitis or giant cell tumor of the tendon, is a rare non-malignant tumor that af f ects the synovium and tendon sheath. The tumor causes overgrowth and thickening of the tissues which leads to swelling, pain and r educed range of motion. First-line treatment consists of surgery f or patients who are considered amendable to improvement.Turalio (pexidartinib) will be considered for coverage when the following criteria are met: Tenosynovial Giant Cell TumorFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an oncologist or orthopedic surgeon; AND 3. Member has a diagnosis of symptomatic benign TGCT conf irmed by MRI or histology; AND 4. Disease is associated with severe morbidity or f unctional limitations; AND 5. Prescriber attests that the members disease is not amenable to improvement with surgery; AND 6. Chart notes must document that baseline liver tests have been or will be completed prior to starting therapy . 7. Dosage allowed/Quantity limit: 250 mg orally twice daily with a low-f at me al. Quantity Limit: 120 capsules per 30 days. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Ch ar t notes must show improvement or stabilized signs and symptoms of disease (such as decreased pain and stif f ness , increased range of motion, or reduced tumor volume). If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Turalio (pexidartinib) 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION03/20/2023 New policy f or Turalio created.04/18/2025 Updated ref erences. Added reduced tumor volume to reauth examples. Removed pregnancy and cancer exclusions. Ref erenc es : 1. Turalio (p ex id artinib ) [p ac k ag e ins ert ]. Daiic hi Sank y o , Inc .; 2025 . 2. Stac c hiotti S, Drr HR, Sc haefer IM, et al. Bes t c linical management of tenosy novial g iant c ell tumo ur (TGCT): A c o ns ens us p ap er f ro m the c o mmunity o f ex p erts . Canc er Treat Rev . 2023;112:102491. d o i:10.1016/j.c trv .2022.102491 3. Healey JH, Bernthal NM, van d e Sande M. Manag ement o f Teno s y no v ial Giant Cell Tumo r: A Neo p las tic and Inf lammatory Disease. JAm Acad Orthop Surg Glob Res Rev . 2020;4(11):e20.00028. doi:10.5435/JAAOSGlobal-D -20-00028 4. Tap WD , Geld erblom H, Palmerini E, et al. Pex id artinib v ers us p lac eb o f o r ad v anc ed teno s y no v ial g iant c ell tumo ur (ENLIVEN): a rand o mis ed p has e 3 trial. Lanc et. 2019;394(10197):478-487. d o i:10.1016/S0140-6736(19)30764-0 5. Natio nal Co mp rehens iv e Canc er Netwo rk . So f t Tis s ue Sarc o ma (Vers io n 1.2025). http s ://www.nc c n.o rg /p ro f es s io nals /p hy s ic ian_g ls /p d f /s arc o ma.p d f . Ac c es s ed Ap ril 9, 2025. Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/18/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Syfovre (pegcetacoplan )BENEF IT TYPE Medical ST AT US Prior Authorization Required Syf ovre , approved by the FDA in 2023, is a complement (C3) inhibitor indicated f or the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It was the f irst drug approved f or this indication. There are 2 types of AMD : d ry or wet (neovascular). Syf ovre is approved for dry AMD which is mo r e c o mmo n but progresses more slowly to vision loss than wet AMD . GA can occur in the intermediate and advanced stages of dry AMD and is caused by the breakdown of cells in the macula , resulting in irreversible lesions that can impair vision or lead to blindness . Approval of Syf ovre was based on combined analysis of the Phase 3 DERBY and OAKS trials. It was also studied in the Phase 2 FILLY trial. Although it slows the growth r at e of GA lesions, Syfovre does not preserve visual f unction. It may also accelerate the development of new-onset wet AMD.Syfovre (pegcetacoplan) will be considered for coverage when the following criteria are met:Geographic Atrophy (GA)For initial authorization: 1. Member is at le as t 50 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) ; AND 4. Diagnosis has been conf irmed by f undus autof luorescence (FAF) imaging with both of the f ollowing: a) Total GA area must be 2.5 and 17.5 mm2 (1 and 7 disk areas [DA] respectively) and b) If GA is multif ocal, at least one f ocal lesion must be 1.25 mm2 (0.5 DA); AND 5. Documentation of best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent); AND 6. Member does NOT have any of the f ollowing: a) GA secondary to any condition other than AMD b) History or current evidence of wet AMD. 7. Dosage allowed/Quantity limit: 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each af f ected eye once every 25 to 60 days. (QL: 4 vials per 60 days) If all the above requirements are met , the medication will be approved for 12 months . For reauthorization : 1. GA lesion growth rate has slowed or stabilized. If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Syfovre (pegcetacoplan) 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/DESCRIPTION04/06/2023 New policy f or Syf ovre created. 03/10/2025 Updated ref erences. Ref erenc es : 1. Sy f o v re [p res c rib ing inf o rmatio n]. Ap ellis Pharmac eutic als , Inc . ; 2024. 2. Liao DS, Gro s s i FV, El Mehd i D , et al. Co mp lement C3 Inhib ito r Peg c etac o p lan f o r Geo g rap hic Atro p hy Secondary to Age-Related Mac ular Deg eneratio n: A Rand o mized Phas e 2 Trial. Ophthalmology . 2020;127(2):186-195. d o i:10.1016/j.o p htha.2019.07.011 3. Heier J , et al. Efficac y of intrav itreal pegcetacop lan in g eo g rap hic atro p hy : 24-mo nth res ults f ro m the p has e 3 OAKS and DERBY trials. Presented at: Retina Society 55th Annual Meeting ; No v emb er 2 5, 2022; Pas ad ena, CA. Ac c es s ed Feb ruary 7, 2023. https://investors.apellis.com/static-f iles /78d 1b 209-7324-4c 4c-8b 20-b f 7778493b ae4. Sing h R, et al. Safety of intravitreal p egcetac oplan in g eographic atrophy: 24-mo nth res ults f ro m the OAKS and DERBY phas e 3 trials. Pres ented at: Retina Society 55th Annual Meeting; Nov ember 2 5, 2022; Pas ad ena, CA. Ac c es sed February 7, 2023. https://investors.apellis.com/static-f iles /f aa3ab 29-f ac e-436a-b 19d-4ec 393f 6436e 5. Vemulak o nda GA, Bailey ST, Kim SJ , et al. Ag e-Related Mac ular Deg eneratio n Pref erred Prac tic e Pattern . Ophthalmology . Pub lis hed o nline Feb ruary 7, 2025. d o i:10.1016/j.o p htha.2024.12.018 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 0 3/10/2025
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