OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Zevaskyn (p rademagene zamikeracel )BENEF IT TYPE Medical ST AT US Prior Authorization Required Zevaskyn is an autologous cell sheet-based gene therapy indicated f or the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB ). DEB is one of f our types of epidermolysis bullosa (EB). It is a rare genetic disease with skin f ragility and mechanically induced blistering that can lead to inf ections, scarring, disfigurement , and pain. DEB is caused by mutations in COL7A1, the gene that codes collagen type VII (C7), the major component of anchoring f ibrils in part of the skin. DEB can be autosomal dominant (DDEB) and have lower than normal f unctional anchoring f ibrils, or less of ten (a nd more severe), recessive (RDEB) with no f unctional anchoring f ibrils. Zevaskyn consists of a patient's own cells that have been gene modif ied to express the COL7A1 gene to produce the C7 protein. These cells are f ormed into cellular sheets f or topical application onto wounds .Zevaskyn (prademagene zamikeracel) will be considered for coverage when the following criteria are met:R ecessive D ystrophic Epidermolysis B ullosa (RDEB )For initial authorization: 1. Member is at le as t 6 years of age; AND 2. Medication must be prescribed by or in consultation with a dermatologist; AND 3. Member has a documented diagnosis of RDEB conf irmed by 2 mutations in the COL7A1 gene with recessive inheritance patterns per genetic test report ; AND 4. Member has positive expression of the non-collagenous region 1 of the type 7 collagen protein (NC1+) in the skin ; AND 5. Member s wound(s) to be treated ar e at least 20 cm 2 and ha ve been present f or at least 6 months . 6. Dosage allowed/Quantity limit: Dose is based on surf ace area of wound(s). One sheet covers 41.25 cm 2. Up to 12 sheets may be manuf actured f rom the patient biopsies and supplied f or potential use. Apply in a single surgical session. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Zevaskyn will not be reauthorized. It is a one-time surgical application.CareSource considers Zevaskyn (prademagene zamikeracel) 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.
OH-ME D-P- 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Yutiq (fluocinolone acetonide) BENEF IT TYPE Medical ST AT US Prior Authorization Required Y utiq 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: UveitisFor initial authorization:1. Member is at least 18 years of age; AND2. Medication must be prescribed by or in consultation with an ophthalmologist; AND3. Member has a diagnosis of chronic (1 year or more) non-inf ectious uveitis af f ecting the posterior segment of the eye; AND4. 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); AND5. 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 eyeLimit: 2 implants (1 per eye) per 36 monthsIf 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 improv ed v itreous haze score; AND2. At least 36 months have elapsed since the prior treatment (of the same eye) ; AND3. 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. OH-ME D-P- 366685 DATE ACTION/DESCRIPTION 11/02/2021 New policy created f or Yutiq . 10/18/2023 Updated ref erences. 04/09/2025 Updated references. ODM approved on 07/23/25. Ref erenc es : 1.Y utiq [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 i n N o 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.2020.04.0013. Steep les LR, Poc kar S, Jones NP, Leal I. Ev aluating the Safety, Efficacy and Patient Acc ep tab ility o f Intrav itrealFluo 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 rSeg ment. Clin Ophthalmol . 2021;15:1433-1442. Pub lis hed 2021 Ap r 7. d o i:10.2147/OPTH.S2169124. 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 35. 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.S893416. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectio us uv eitis . Clin Ex p M ed. 2023;23(4):1089-1106. d o i:10.1007/s 10238-022-00954-67. 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 40123-022-00456-48. Ohio Ad minis trativ e Co d e. (2022, Feb ruary 23). 5160-1- 01 (C) Med ic aid med ic al nec es s ity : d ef initio ns and p rinc ip les . Retriev ed Feb ruary 22 2023 f ro m c o d es .o hio .g o v .9. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed c are: c overed s ervices. Retriev ed Feb ruary 22,2023 from codes.ohio.gov.10. Ohio Ad minis trativ e Co d e. (2020, January 1). 5160-9- 03 Pharmac y s erv ic es : c o v ered d rug s and as s o c iated limitatio ns . Retriev ed Feb ruary 22, 2023 f ro m c o d es .o hio .g o v .E f f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/09/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Yescarta (axicabtagene ciloleucel)BENEF IT TYPE Medical ST AT US Prior Authorization Required Yescarta , approved by the FDA in 2017, is a CD19-directed genetically modif ied autologous Tcell immunotherapy indicated f or the treatment of adults with : 1) Large B-cell lymphoma that is ref ractory to f irst-line chemoimmunotherapy or that relapses within 12 months of f irst-line chemoimmunotherapy , 2) Re lapsed or ref ractory large B-cell lymphoma af ter two or more lines of systemic therapy, including dif fuse large B-c ell lymphoma (DLBCL) not otherwise specif ied, primary mediastinal large B-cell lymphoma, high grade B-c e ll lymphoma, and DLBCL arising f rom f ollicular lymphoma; and 3) Relapsed or ref ractory f ollicular lymphoma (FL) af ter two or more lines of systemic therapy (accelerated approval) . NCCN supports of f label use of Ye s c ar t a f o r marginal zone lymphoma as a third or subsequent line of therapy per the ZUMA-5 study.Yescarta (axicabtagene ciloleucel) will be considered for coverage when the following criteria are met:Large B-Cell Lymphoma (LBCL) For initial authorization: 1. Member is at least 18 years of age; AND 2. Member has a documented diagnosis of large B-cell lymphoma including any of the f ollowing: a) Dif f use large B-cell lymphoma (DLBCL) not otherwise specif ied (NOS) b) Primary mediastinal large B-cell lymphoma (PMBCL) c) High grade B-cell lymphoma (HGBCL) d) DLBCL arising f rom f ollicular lymphoma (transf ormation FL; TFL) e) I n t r av as c u lar LBCL f) DLBCL associated with chronic inf lammation g) Fibrin-associated DLBCL h) EBV-positive DLBCL, NOS i) T-cell/histiocyte-rich LBCL ; AND 3. Member s condition meets one of the f ollowing: a) Ref ractory to f irst-line chemoimmunotherapy (primary ref ractory) b) Relapse d within 12 months of f irst-line chemoimmunotherapy c) Relapsed or ref ractory af ter 2 or more lines of systemic therapy ; AND 4. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 5. Member does NOT have an y of the f ollowing: a) Prior allogeneic HSCT b) History or presence of primary central nervous system (CNS) lymphoma c) Prior CAR-T therapy; AND 6. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) prior to collection of cells ; AND 7. Healthcare f acility/provider has enrolled in the Yescarta and Tecartus REMS program ; AND 8. Members weight is documented f or dose calculation ; AND OH-MED-P -3666859. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 10. Dosage allowed/Quantity limit: 2 10 6 CAR-positive viable Tcells per kg body weight, with a maximum of 2 10 8 CAR-positive viable Tcells. If al ,3 . For reauthorization :1. Yescarta will not be reauthorized f or continued therapy.Follicular Lymphoma (FL)For initial authorization: 1. Member is at least 18 years of age; AND 2. Member has a documented diagnosis of relapsed or ref ractory f ollicular lymphoma; AND 3. Member s disease has progressed af t e r 2 or more lines of systemic therapy ; AND 4. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 5. Member does NOT have an y of the f ollowing: a) Prior allogeneic HSCT b) History or presence of primary central nervous system (CNS) lymphoma c) Prior CAR-T therapy; AND 6. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) prior to collection of cells ; AND 7. Healthcare f acility/provider has enrolled in the Yescarta and Tecartus REMS program ; AND 8. Members weight is documented f or dose calculation; AND 9. The requesting physician attests to providing clinical outcome information within the Audaire Health provider portal as requested by CareSource. 10. Dosage allowed/Quantity limit: 2 10 6 CAR-positive viable Tcells per kg body weight, with a maximum of 2 10 8 CAR-positive viable Tcells . If al ,3 . For reauthorization :1. Yescarta will not be reauthorized f or continued therapy .Marginal Zone Lymphoma (MZL) [off-label]For initial authorization: 1. Member is at least 18 years of age; AND 2. Member has a diagnosis of marginal zone lymphoma ; AND 3. Member s disease has progressed af ter 2 or more lines of systemic therapy; AND 4. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 5. Member does NOT have an y of the f ollowing: a) Prior allogeneic HSCT b) History or presence of primary central nervous system (CNS) lymphoma c) Prior CAR-T therapy; AND 6. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) prior to collection of cells; AND 7. Healthcare f acility/provider has enrolled in the Yescarta and Tecartus REMS program ; AND
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio 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 .
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) BENEFIT TYPE Medical STATUS 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 first-in-class IgG1 antibody Fc fragment 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 efgartigamod and hyaluronidase for subcutaneous administration. Myasthenia gravis is an autoimmune disorder affecting the neuromuscular junction. It is characterized by muscle weakness and fatigue. 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 for MG. If control is inadequate, immunosuppressive treatment is added. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency. Vyvgart Hytrulo is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive peripheral neuropathy with typical and atypical phenotypes. Demyelination manifests 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 for AChR antibodies; AND 5. Member has tried and failed at least 1 conventional therapy: A. pyridostigmine B. corticosteroid for at least 4 weeks C. non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months. 6. Dosage allowed/Quantity limit: IV infusion (Vyvgart) or SubQ injection (Vyvgart Hytrulo) once weekly for 4 weeks (1 cycle). Subsequent cycles may take place no sooner than 50 days from the start of the previous cycle. Vyvgart — Weight
OH-ME D-P- 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Vyjuvek ( beremagene geperpavec-svdt ) BENEF IT TYPE Medical ST AT US Prior Authorization Required V yjuvek, approved by the FDA in 2023, is a herpes-simplex virus type 1 (HSV-1) vector-based topical g ene therapy indicated f or the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. DEB is one of f our types of epidermolysis bullosa (EB). It is a rare genetic disease with skin f ragility and mechanically induced blistering that can lead to inf ections, scarring, and disf igurement . DEB is caused by mutations in COL7A1, the gene that codes collagen type VII (C7) , the major component of anchoring f ibrils in part of the skin. DEB can be autosomal dominant (DDEB) and have lower than normal f unctional anchoring f ibrils, or less of ten (and more severe) , recessive ( RDEB) with no f unctional anchoring f ibrils . Vyjuvek gel addresses the underlying cause of DEB by delivering f unctional copies of the COL7A1 gene to restore C7. In the GEM-3 clinical trial, c omplete wound healing at 3 and 6 months in DEB patients was mo re likely with Vyjuvek than placebo. V yjuvek (beremagene geperpavec-s vd t) will be considered for coverage when the following criteria are met: D ystrophic Epidermolysis B ullosa (DEB) For initial authorization: 1. Member is at le as t 6 months of age; AND2. Medication must be prescribed by or in consultation with a dermatologist; AND3. Member has a diagnosis of DEB conf irmed by mutation(s) in the COL7A1 gene; AND4. Member has at least 1 open wound to be treated, that is clean and does not appear inf ected; AND5. Member will continue standard wound care.6. Dosage allowed/Quantity limit: Apply topically once a week to open wound(s). Q L: 4 vials per 28 days. If all the above requirements are met , the medication will be approved for 6 months . OH-ME D-P- 366685 For reauthorization : 1. Chart notes must show successf ul wound healing with Vyjuvek treatment; AND2. Reopening of previously treated wound and/or a dif f erent open wound is to be treated.If all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Vyjuvek (beremagene geperpavec-svdt) 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 07/10/2023 New policy f or Vyjuvek created. 05/19/2025 Annual review; no updates. ODM approved on 07/23/25. Ref erenc es : 1.V y juv ek [p res c rib ing inf o rmatio n]. Kry s tal Bio tec h, Inc .; 2023.2. Guid e SV, Gonzalez ME, Bac IS, et al. Trial of Beremagene Gep erp avec (B-VEC) for Dystrophic Epidermoly s isBullo s a. NEngl JMed. 2022;387(24):2211-2219. d o i:10.1056/NEJ Mo a22066633. Has C, Liu L, Bo lling MC, et al. Clinical prac tice g uidelines for laboratory d iagnosis of ep idermolysis b ullo s a. Br JDermatol . 2020;182(3):574-592. d o i:10.1111/b jd .181284. Has C, Bauer JW, Bo demer C, et al. Cons ens us rec las s if ic atio n o f inherited ep id ermo ly s is b ullo s a and o ther d iso rd ers with skin f rag ility. Br JDermatol . 2020;183(4):614-627. d o i:10.1111/b jd .189215. Ohio Ad minis trativ e Co d e. (2022, Feb ruary 23). 5160-1- 01 (C) Med ic aid med ic al nec es s ity : d ef initio ns and p rinc ip les . Retriev ed Feb ruary 22 2023 f ro m c o d es .o hio .g o v .6. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed c are: c overed s ervices. Retriev ed Feb ruary 22,2023 from codes.ohio.gov.7. Ohio Ad minis trativ e Co d e. (2020, January 1). 5160-9- 03 Pharmac y s erv ic es : c o v ered d rug s and as s o c iated limitatio ns . Retriev ed Feb ruary 22, 2023 f ro m c o d es .o hio .g o v .E f f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 0 5/19/2025
OH-MED-P-366685 PHARMACYPOLICY STATEMENTOhio MedicaidDRUG NAME Uplizna (inebilizumab-cdon) BENEFIT TYPE Medical STATUS Prior Authorization Required Uplizna is a CD19-directed cytolytic antibody indicated for 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 inflammatory disease characterized by high levels of IgG4 and tumor-like masses. It most commonly affects 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 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 NMOSD and is seropositive for aquaporin-4 (AQP4) IgG antibodies; AND 4. Member has had 1 or more relapses within the past year; AND 5. Member has tried and failed rituximab for at least 6 months (requires prior auth); AND 6. Member has tested negative for hepatitis Band tuberculosis within the past year or there is attestation they will be tested before starting treatment. 7. Dosage allowed/Quantity limit: 300mg IV infusion followed two weeks later by a second 300 mg infusion. Subsequently, (starting 6 months from the first infusion): 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 6 months. For reauthorization : 1. Chart notes must document disease stabilization, symptom improvement, and/or reduced frequency of relapses compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months. OH-MED-P-366685 Immunoglobulin 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 flare requiring initiation or continuation of glucocorticoids; AND 5. Member is refractory to glucocorticoids (including glucocorticoid-dependent patients who cannot reduce dose without flare); AND 6. Member has tested negative for hepatitis Band tuberculosis within the past year or there is attestation they will be tested before starting treatment. 7. Dosage allowed/Quantity limit: 300 mg IV infusion followed two weeks later by a second 300 mg infusion. Subsequently, (starting 6 months from the first infusion): 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 fewer flares 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 for Uplizna created. 07/17/2023 Transferred to new template. Corrected QL. 04/22/2024 Removed azathioprine, mycophenolate trial options (rituximab more effective per guidelines). 05/15/2025 Updated references. Added Immunoglobulin G4-related disease diagnosis. ODM approved on 07/23/25. Ref erences: 1. 2021 Georgia Code Title 33 Insurance Chapter 20A-Managed Health Care Plans Article 2-Patient's Right to Independent Review 33-20A-31 Def initions. Justia US Law. Accessed April 25, 2023. https://law.justia.com/codes/georgia/2021/title-33/chapter-20a/article-2/section-33-20a-31/. 2. Uplizna [package insert]. Horizon Therapeutics; 2025. 3. Kessler RA, Mealy MA, Levy M. Treatment of Neuromyelitis Optica Spectrum Disorder: Acute, Preventive, and Symptomatic . Curr Treat Options Neurol . 2016;18(1):2. doi:10.1007/s11940-015-0387-9 4. Weinshenker B. Neuromyelitis Optica Spectrum Disorder. NORD (National Organization for Rare Disorders). https://rarediseases.org/rare-diseases/neuromyelitis-optica/. Published August 25, 2020. Accessed October 2, 2020. 5. Mealy MA, Wingerchuk DM, Palace J, Greenberg BM, Levy M. Comparison of relapse and treatment failure rates among patients with neuromyelitis optica: multicenter study of treatment efficacy. JAMA Neurol. 2014;71(3):324-330. doi:10.1001/jamaneurol.2013.5699 OH-MED-P-366685 6. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-37. Stone JH, Khosroshahi A, Zhang W, et al. Inebilizumab for Treatment of IgG4-Related Disease. NEngl JMed. 2025;392(12):1168-1177. doi:10.1056/NEJMoa2409712 8. Wallace ZS, Katz G, Hernandez-Barco YG, Baker MC. Current and f uture advances in practice: IgG4-related disease. Rheumatol Adv Pract. 2024;8(2):rkae020. Published 2024 Apr 10. doi:10.1093/rap/rkae020 9. Wallace ZS, Naden RP, Chari S, et al. The 2019 American College of Rheumatology/European League Against Rheumatism classif ication criteria for IgG4-related disease. Ann Rheum Dis. 2020;79(1):77-87. doi:10.1136/annrheumdis-2019-216561 10. Ohio Administrative Code. (2022, February 23). 5160-1-01 (C) Medicaid medical necessity: def initions and principles. Retrieved February 22 2023 f rom codes.ohio.gov. 11. Ohio Administrative Code. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved February 22, 2023 f rom codes.ohio.gov. 12. Ohio Administrative Code. (2020, January 1). 5160-9-03 Pharmacy services: covered drugs and associated limitations. Retrieved February 22, 2023 f rom codes.ohio.gov. Eff ective date: 10/01/2025 Revised date: 05/15/2025
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Ultomiris (ravulizumab-cwvz) BENEFIT TYPE Medical STATUS Prior Authorization Required Ultomiris was originally approved by the FDA in 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). It is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the membrane attack complex [MAC or C5b-9]) thus preventing MAC formation. Ultomiris was engineered from an earlier product, Soliris, to have a longer half-life allowing for extended dosing intervals (every 2 weeks vs. every 8 weeks). Ultomiris and Soliris are virtually identical aside from Ultomiris having the longer half-life. Ultomiris is also approved for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA), for the treatment of anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG), and for anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).Ultomiris (ravulizumab-cwvz) will be considered for coverage when the following criteria are met:Atypical Hemolytic Uremic Syndrome (aHUS)For initial authorization: 1. Medication is prescribed by or in consultation with a hematologist or nephrologist; AND 2. Member has a diagnosis of aHUS supported by ALL of the following: a) Thrombocytopenia (platelet count 10% (to rule out TTP); AND 5. Member has received meningococcal vaccine. 6. Dosage allowed/Quantity limit: IV infusion: loading dose followed by maintenance doses starting 2 weeks later, based on body weight, per prescribing information. See appendix 1. Subcutaneous (adults only): 490 mg once weekly (8 cartons per 28 days) If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : OH-MED-P-366685 1. Chart notes must demonstrate hematologic normalization as evidenced by increased platelet count or LDH maintained below upper limit of normal; AND2. Improved or preserved kidney function. If all the above requirements are met, the medication will be approved for an additional 12 months.Paroxysmal Nocturnal Hemoglobinuria (PNH) For initial authorization: 1. Medication is prescribed by or in consultation with a hematologist; AND 2. Member has a documented diagnosis of PNH as confirmed by flow cytometry; AND 3. Member has a lactate dehydrogenase (LDH) level >1.5x upper limit of normal (ULN); AND 4. Member has at least one PNH-related sign/symptom e.g., fatigue, hemoglobin
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Tecartus ( brexucabtagene autoleucel)BENEF IT TYPE Medical ST AT US Prior Authorization Required Tecartus , approved by the FDA in 2020, is a CD19-directed genetically modif ied autologous Tcell immunotherapy. It is indicated f or adult s with relapsed or ref ractory B-cell precursor acute lymphoblastic leukemia (ALL). It is also indicated (by accelerated approval) f or adults with relapsed or refractory mantle cell lymphoma (MCL) based on overall response rate (ORR) and durability of response (DOR). To prepare the product , a patients own Tcells are harvested and genetically modif ied ex vivo to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-c hain v ar iab le f r ag me n t ( s c Fv ) linked to CD28 and CD3-zeta co-stimulatory domains. The anti-CD19 CAR Tcells are expanded and inf used back into the patient, where they can recognize and eliminate CD19-expressing target cells.Tecartus (brexucabtagene autoleucel) will be considered for coverage when the following criteria are met:Mantle Cell Lymphoma (MCL)For initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Yescarta and Tecartus REMS program ; AND 3. Member has a documented diagnosis of relapsed or refractory MCL, def ined as disease progression af ter last regimen or f ailure to achieve a partial response or complete response to the last regimen; AND 4. Member has had prior treatment with ALL of the f ollowing: a) Anthracycline or bendamustine-containing chemotherapy b) Anti-CD20 monoclonal antibody ( e.g., rituximab) c) Covalent Bruton tyrosine kinase inhibitor (BTKi) (i.e., ibrutinib, acalabrutinib, or zanubrutinib); AND 5. Member has at least one measurable lesion; AND 6. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 7. Member does NOT have an y of the f ollowing: a) Central nervous system (CNS) lymphoma b) History of allogeneic stem cell transplantation c) Prior chimeric antigen receptor (CAR) therapy or other genetically modif ied T-cell therapy; AND 8. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 9. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 10. Dosage allowed/Quantity limit: 2 x 10 6 chimeric antigen receptor (CAR) -positive viable Tcells per kg body weight (maximum of 2 x 10 8 CAR-positive viable Tcells ) If all the above requirements are met , the medication will be approved for 3 months.
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Synagis (palivizumab)BENEFIT TYPE Medical STATUS Prior Authorization Required Synagis is a respiratory syncytial virus (RSV) Fprotein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in certain high-risk groups of qualifying pediatric patients. The safety and efficacy of Synagis have not been established for treatment of RSV disease. The safety and effectiveness of Synagis in children older than 24 months of age at the start of dosing have not been established. Synagis is not a vaccine; it delivers antibodies to fight RSV. Synagis is administered by intramuscular injection once monthly for up to 5 consecutive months during RSV season, providing 6 months of protection.Synagis (palivizumab) will be considered for coverage when the following criteria are met:Respiratory Syncytial Virus (RSV): Prevention of serious respiratory diseaseFor initial authorization: 1. Medication will be administered during the RSV season ( October 1st through March 3rd*) AND initiation of injections should be timed with the onset of laboratory confirmed cases of RSV activity in the community, no earlier than October 1*; AND 2. Member is 21% oxygen for at least the first 28 days after birth) c) Member has hemodynamically significant c ongenital heart d isease (CHD) with ONE or more of the following: i) Acyanotic heart disease (e.g., atrial septal defect (ASD), ventricular septal defect (VSD), etc.), AND member is receiving medication to control congestive heart failure (CHF) AND will require cardiac surgical procedures ii) Moderate to severe pulmonary hypertension iii) Cyanotic heart disease and referr al by a pediatric cardiologist (e.g., coarctation of aorta, Ebsteins anomaly, hypoplastic left heart syndrome, t etralogy of Fallot (TOF), total anomalous pulmonary venous connection (TAPVC), etc.) d) Member has pulmonary abnormalities or a neuromuscular disorder that impairs the ability to clear secretions from the upper airways e) Member is profoundly immunocompromised during the RSV season (e.g., concurrent chemotherapy, stem cell transplantation, organ transplantation, etc.) f) Member undergoes cardiac transplantation during the RSV season g) Member has c ystic fibrosis with clinical evidence of CLD and/or nutritional compromise in the first year of life; OR OH-MED-P-3666853. Member is 12 24 months of age at the beginning of the RSV season AND meets ONE of the following (chart notes must be provided as supporting evidence): a) Member was born
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