Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling documentused to make the determination. Administrative Policy StatementOHIO MEDICAIDPolicy Name Policy Number Date Effective Lost, Stolen, Damaged, Vacation and School Supply of Medication PAD-0005-OH-MCD 10/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ………………………………………………………………………………………. 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………….. 2 E. Conditions of Coverage ……………………………………………………………………………………………. 2 F. Related Policies/Rules ……………………………………………………………………………………………… 3 G. Review/Revision History …………………………………………………………………………………………… 3 H. References …………………………………………………………………………………………………………….. 32 A. Subject Lost, Stolen, Damag ed, Vacation, School Supply of MedicationOhio MEDICAIDPAD-0005-OH-MCD Effective Date: 10/1/2025 Early refill override requests due to reports of additional medication needed beyond initial dispensing.B. Background The CareSource pharmacy benefit design places limits on how early a member can refill a prescription. This limit is intended to ensure appropriate and cost-effective use of medications. A pharmacy may request an exception to the refill-too-soon threshold on behalf of a member by calling the pharmacy help desk. This policy serves as guidance for the Pharmacy Help Desk and CareSource operations team member processing of member and pharmacy requests for an override for an early refill resulting from:Lost medication Stolen medication Damaged medication Out of state or out of country travel Separate supply for separated households, school or daycare C. Definitions I. Refill-Too-Soon An early refill; additional medication that is requested following an earlier-dispensed medication request but sooner than allowed by the members coverage benefits. II. Override Authorization for early refill that allows the claim to process at the point of sale (at the pharmacy) III. Refill-Too-Soon Threshold The date before which a claim for a medication refill will reject at the point-of-sale. When a pharmacy attempts to fill a medication refill before this threshold, the rejection message at the point of sale will provide the refill-too-soon threshold date. D. Policy I. The pharmacy help desk will provide a refill-too-soon override in the following circumstances: A. For a lost medication override, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months. The days supply allowed by the refill-too-soon override will be subject to standard days supply restrictions (limited to a 30-day supply). B. For a stolen medication override, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months 3 when member attests that the theft has been reported to the police. Note: Attestation can be relayed through the pharmacy. Documentation is not required. C. For a refill-too-soon override related to damaged medication, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months when the medication was not damaged as a result of pharmacy action or in the process of shipment to the member. a. If the request is for a blood glucose or continuous glucose monitor that is malfunctioning, the member should confirm the manufacturer has been contacted for assistance and was unable to resolve the issue. b. If medication damage occurs as a result of pharmacy action or in the process of shipment to the member, the pharmacy is responsible for replacing the damaged medication. D. For a refill-too-soon override related to member travel, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months when ALL of the following are met: a. The member is traveling to a location where a network, rostered pharmacy is not available, AND b. The days supply of the refill-too-soon request is subject to the plans benefit limits. E. For a refill-too-soon override related to additional medication supply to be provided to a separate household, school or daycare, the pharmacy help desk may place refill-too-soon overrides for medications that are in unbreakable packaging (such as inhalers or epinephrine injectors) when needed. F. For members requesting a refill-too-soon supply due to permanent relocation to a new address out-of-state, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) for up to a 30-day supply. II. The pharmacy help desk will NOT provide a refill-too-soon override when ANY of the following circumstances is true: A. The requested medication is an opioid, B. The total cost of the damaged medication is greater than $8,000, C. The loss or damage is a result of an action on the part of the pharmacy or shipping company, D. The member has already received a refill-too-soon override for the requested medication for any reason in the previous rolling twelve (12) months, E. The requested days supply of the medication exceeds plan benefit limits (30-day supply), OR F. The requested medication is not a Covered product under the plan (including products that are not CMS rebateable). III. All requests for refill-too-soon overrides not permitted by the pharmacy help desk are subject to review and approval or denial by the CareSource Pharmacy Operations team. Any overrides not permitted by the pharmacy help desk will be considered at the discretion of the CareSource Pharmacy Operations team in consultation with the Markets when appropriate. 4 E. Related Policies/Rules F. Review/Revision History Lost, Stolen, Damag ed, Vacation, School Supply of Medication OHIO MEDICAID PLANS PA D-0005-OH-MCD Effective Date: 10-1-2025 DATES ACTIONDate Issued 01/22/2022 Date Revised 06/28/2024 Complete review with updated criteria and restrictions 5/22/2025 Annual review, no updates . OD Mapproved on07/23/25. Date Effective 10/01/2025 Date Archived G. ReferencesThe Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved.
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Kymriah (tisagenlecleucel)BENEF IT TYPE Medical ST AT US Prior Authorization Required Ky mr iah , approved by the FDA in 2017, is a n intravenously administered CD19-directed genetically modified autologous Tcell immunotherapy indicated f or the treatment of : 1) Patients up to 25 years of age with B-c e ll precursor acute lymphoblastic leukemia (ALL) that is ref ractory or in second or later relapse; and 2) Adult s with relapsed or ref ractory (r/r) large B-cell lymphoma af ter two or more lines of systemic therapy, including dif f use large B-cell lymphoma (DLBCL) not otherwise specif ied, high grade B-cell lymphoma and DLBCL arising f rom f ollicular lymphoma; and 3) Adult s with relapsed or ref ractory f ollicular lymphoma (FL) af ter two or more lines of systemic therapy (accelerated approval).Kymriah (tisagenlecleucel) will be considered for coverage when the following criteria are met:Acute Lymphoblastic Leukemia (ALL)For initial authorization: 1. Member is up to 25 years of age; AND 2. Member has a documented diagnosis of B-cell ALL; AND 3. Documentation of one of the f ollowing: a) Philadelphia chromosome negative (Ph-) disease that is ref ractory or in second or later relapse, or b) Philadelphia chromosome positive (Ph+) disease that is ref ractory or in second or later relapse AND f ollowing therapy that has included 2 tyrosine kinase inhibitors (T KI) ; AND 4. Member has a Karnof sky (age 16 years) or Lansky (age
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Izervay (avacincaptad pegol)BENEF IT TYPE Medical ST AT US Prior Authorization Required Izervay, approved by the FDA in 2023, is a complement C5 inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is the second drug approved f or this indication f ollowing C3 inhibitor pegcetacoplan. There are 2 types of AMD: dry or wet (neovascular). Izervay is approved for dry AMD which is more common 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 t h at can impair vision or lead to blindness. Approval of Izervay was based the GAT HER studies . Although it slows the growth rate of GA lesions, Izervay does not appear to preserve visual f unction. It may also accelerate the development of new-onset wet AMD .Izervay (avacincaptad pegol) 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 showing all 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) c) The GA lesion must be, in part, within 1.5 mm f r o m, but NOT involving the f oveal center ; AND 5. Documentation of best corrected visual acuity (BCVA) between 20/25 and 20/320 in the af f ected eye(s) ; 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: Intravitreal injection to each af f ected eye once monthly . QL: 2 vials per 28 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 .
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Imaavy (nipocalimab-aahu)BENEF IT TYPE Medical ST AT US Prior Authorization Required I maav y is a neonatal Fc receptor blocker indicated for the treatment of generalized my as t h e n ia g r av is ( gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specif ic tyrosine kinase (MuSK) antibody positive. 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 in myasthenic crisis, which is an emergency .Imaavy (nipocalimab-aahu) will be considered for coverage when the following criteria are met:Myasthenia Gravis For initial authorization: 1. Member is at le as t 12 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 or MuSK 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 6. Dosage allowed/Quantity limit: Initial: 30 mg/kg once via IV inf usion Maintenance: two weeks af ter initial dose, administer 15 mg/kg IV inf usion every two weeks thereafter If all the above requirements are met , the medication will be approved for 6 months .
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Iluvien (fluocinolone acetonide )BENEF IT TYPE Medical ST AT US Prior Authorization Required Iluvien , approved by the FDA in 2014, is an intravitreal implant containing 0.19 mg (190 mcg) f luocinolone acetonide in a 36-month sustained-release drug delivery system . It is indicated f or the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically signif icant rise in intraocular pressure. DME is a common complication of diabetic retinopathy. Iluvien is also indicated f or the treatment of chronic non-inf ectious uveitis af f ecting the posterior segment of the eye. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-in f ec t ious. Noninf 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 f ecting the intermediate or posterior segments, more invasive or systemic treatment is needed.Iluvien (fluocinolone acetonide) will be considered for coverage when the following criteria are met:D iabetic Macular Edema (DME)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 conf irmed diagnosis of diabetic macular edema; AND 4. Member has been previously treated with a course of corticosteroids and did not have a clinically signif icant increase in intraocular pressure; AND 5. Member has tried and f ailed Ozurdex or an an t i-VEGF drug ( bevacizumab pref erred); AND 6. Member does not have active or suspected ocular or periocular inf ection; AND 7. Member does not have glaucoma with a cup to disc ratio greater than 0.8. 8. Dosage allowed/Quantity limit: One implant (0.19 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 2. At least 36 months have elapsed since the prior treatment (of the same eye). If all the above requirements are met , the medication will be approved for an additional 3 months.OH-MED-P-366685UveitisFor 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 active or suspected ocular or periocular inf ection; AND 6. Dosage allowed/Quantity limit: One implant (0.19 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 Iluvien (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.DATE ACTION/DESCRIPTION10/27/2021 New policy created f or Iluvien. 10/16/2023 Ref erences updated . Added an t i-VEGF as trial option. 04/02/2025 Added criteria f or new indication: Uveitis. Ref erenc es : 1. Iluv ien [p res c rib ing inf o rmatio n]. Alimera Sc ienc es , Inc .; 2025. 2. Flax el CJ , Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [pub lis hed c o rrec tio n ap p ears in Op hthalmo lo g y . 2020 Sep ;127(9):1279]. Ophthalmology . 2020;127(1):P66-P145. d o i:10.1016/j.o p htha.2019.09.025 3. Virg ili G, Parrav ano M, Evans JR, Gordon I, Luc enteforte E. Anti-vas cular endo thelial g ro wth f ac to r f o r d iab etic mac ular o ed ema: a network meta-analy s is . Coc hrane Databas e Sy s t Rev . 2018;10(10):CD 007419. Pub lis hed 2018 Oc t 16. d o i:10.1002/14651858.CD 007419.p ub 6 4. Rittip hairoj T, Mir TA, Li T, Virg ili G. Intrav itreal steroids for macular edema in diabetes . Coc hrane Databas e Sy s t Rev . 2020;11(11):CD 005656. Pub lis hed 2020 No v 17. d o i:10.1002/14651858.CD 005656.p ub 3 5. Zur D , Ig lic k i M, Loewenstein A. The Ro le of Steroids in the Management of Diabetic Macular Edema. Ophthalmic Res . 2019;62(4):231-236. d o i:10.1159/000499540 6. Sc hmid t-Erfurth U, Garcia-Arumi J , Bandello F, et al. Guidelines for the Management of Diabetic Mac ular Ed ema b y the Euro p ean So c iety o f Retina Sp ec ialis ts (EURETINA). Ophthalmologic a. 2017;237(4):185-222. d o i:10.1159/000458539 7. Bailey C, Chak rav arthy U, Lotery A, Menon G, Talk s J ; Medis o f t Aud it Gro up . Ex tend ed real-wo rld ex p erienc e with the ILUVIEN (f luocinolone acetonide) implant in the United King d o m: 3-y ear res ults f ro m the Med is o f t aud it s tudy [published online ahead of print, 2021 May 10]. Eye (Lond) . 2021;1-7. d oi:10.1038/s41433-021-01542-wOH-MED-P -3666858. Yuen YS, Gilho tra JS, Dalto n M, et al. Diab etic Mac ular Oed ema Guid elines : An Aus tralian Pers p ec tiv e. JOphthalmol . 2023;2023:6329819. Pub lis hed 2023 Feb 14. d o i:10.1155/2023/6329819 9. 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 10. 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 11. 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 12. 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 13. 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 14. 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 . 15. 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. 16. 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 . Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/02/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Enzyme Replacement Therapy (ERT ) for Fabry Disease: Fabrazyme (agalsidase beta) and Elfabrio (pegunigalsidase alfa-iwxj ) BENEF IT TYPE Medical ST AT US Prior Authorization Required Fabrazyme, approved by the FDA in 2003, is an enzyme replacement therapy (ERT) indicated f or the treatment of conf irmed Fabry disease, to replace the enzyme alpha-galactosidase A (alpha-G al A) . Fabry disease, a lysosomal storage disorder, is a rare genetic disease caused by certain mutations of the GLA gene resulting in def icient alpha-Gal A. Normally this enzyme breaks down certain lipids in lysosomes, such as globotriaosylceramide (GL-3). Without it, GL-3 accumulates in blood vessels, the kidneys, heart, nerves, and other organs. The continuous build-up of GL-3 results in progressive cell damage and subsequent symptoms and manif estations in the af f ected organ systems. Elf abrio is a biobetter of Fabrazyme and was designed to have an increased half-lif e and reduced immunogenicity.ERT for Fabry Disease will be considered for coverage when the following criteria are met:Fabry DiseaseFor initial authorization: 1. For Fabrazyme: Member is at least 2 years of age OR f or Elf abrio: Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a medical geneticist, nephrologist, cardiologist, neurologist, or metabolic specialist ; AND 3. Member has a diagnosis of Fabry disease conf irmed by genetic testing which identif ies a pathogenic mutation of the GLA gene; AND 4. Member displays symptoms of Fabry disease (i.e., neuropathic pain, renal disease, cardiac disease, abdominal pain, impaired sweating) NOTE: Exception — Males with "classic" gene variants do not need to be symptomatic to qualif y f or treatment. Males with "non-classic" gene variants and asymptomatic f emales may be treated if there is evidence of injury to the heart, kidney, or central nervous system (CNS) ; AND 5. ERT will NOT be used in combination with Galaf old. 6. Dosage allowed/Quantity limit: 1 mg/kg every 2 weeks as an IV inf usion. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Chart notes must show positive clinical response such as stabilized kidney f unction (e.g., GFR, proteinuria), reduced plasma or tissue GL-3 levels, or other improved Fabry symptoms (such as neuropathic pain) .
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Enzyme Replacement Therapy (ERT ) forGaucher Disease : Cerezyme (imiglucerase), Elelyso (taliglucerase alfa), Vpriv ( velaglucerase alfa ) BENEF IT TYPE Medical ST AT US Prior Authorization Required Gaucher disease is a rare, inherited, lysosomal storage disorder. In Gaucher disease, mutations of t he GBA gene cause def iciency of the enzyme glucocerebrosidase ( ac id beta-glucosidase) , resulting in the accumulation of glucocerebroside ( glucosylceramide [GLC ]) in the lysosomes of macrophages to f orm Gaucher cells, especially in the bone marrow, spleen, and liver. Prominent symptoms include hepatosplenomegaly, anemia, thrombocytopenia, and skeletal problems (e.g., bone pain, osteopenia, osteonecrosis, f racture, def ormity) . Type 1 Gaucher disease is the most common f orm and does not af f ect the central nervous system. Type 2 and 3 Gaucher disease are characterized by the presence of primary neurologic disease. Type 2 has an onset bef ore age two years and is rapidly progressive with death by age two to f our years. Individuals with type 3 of ten have a more slowly progressive course. Available treatments are indicated f or Type 1 Gaucher disease and include enzyme replacement therapy (ERT) or substrate reduction therapy (SRT). Individuals with type 2 Gaucher disease are not likely to respond to ERT or SRT. This policy f ocuses on ERT . Cerezyme was the f irst ERT product approved by the FDA f or Gaucher disease, approved in 1994. Notably, Gaucher disease was the f irst lysosomal storage disorder f or which an ef f ective ERT was developed.Enzyme replacement therapy for Gaucher disease will be considered for coverage when the following criteria are met:Gaucher DiseaseFor initial authorization: 1. Member meets the labeled age requirement: a) Cerezyme: At least 2 years of age b) Elelyso: At least 4 years of age c) Vpriv : At least 4 years of age; AND 2. Medication must be prescribed by or in consultation with a geneticist , hematologist , or metabolic specialist ; AND 3. Member has a diagnosis of Gaucher disease Type 1 or Type 3 confirmed by documentation of at le as t one of the f ollowing: a) Reduced activity of glucocerebrosidase via enzyme assay (0 to 15% of normal) , and/or b) Molecular genetic test documenting 2 mutations (biallelic variants) of the GBA gene; AND 4. Member has at least one of the f ollowing as a result of Gaucher disease: a) Anemia b) Thrombocytopenia c) Bone symptoms d) Enlarged spleen or liver; AND 5. Member does NO Th av e an y of the f ollowing:
OH-ME D-P- 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Encelto (revakinagene taroretcel-lwey) BENEF IT TYPE Medical ST AT US Prior Authorization Required E ncelto, approved by the FDA in 2025, is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel) . MacTel is a macular neurodegenerative disease. The non-proliferative phase is primarily driven by neurodegenerative processes , which leads to decreased photoreceptor f unction and subsequent slow progressive vision loss . Patients typically present with dif f iculty reading, metamorphopsia (distorted vision) , and paracentral scotomas (blind spots) . Visual acuity is preserved until late in the disease. Fluorescein a ngiography (FA) is the gold standard f or diagnosis. The Encelto implant is surgically anchored with a titanium loop and secretes recombinant human ciliary neurotrophic f actor (rhCNTF), an endogenously produced neurotrophic f actor. CNTF has been shown to slow p hotoreceptor loss as measured in the area of ellipsoid zone disruption. E ncelto (revakinagene taroretcel-lwey) will be considered for coverage when the following criteria are met: M acular telangiectasia type 2 (MacT el) For initial authorization: 1. Member is at le as t 18 years of age; AND2. Medication must be prescribed by an ophthalmologist; AND3. Member has a diagnosis of Mac Te l with evidence of f luorescein leakage and at least one of t he f ollowing f eatures:a) hyperpigmentation that is outside of a 500 micron radius f rom the center of the f ovea b) retinal opacif ication c) crystalline deposits d) right-angle vessels e) inner/outer lamellar cavities ; AND4. Chart notes show photoreceptor inner segment/outer segment (IS/OS PR) break (loss) in ellipsoi d z one (EZ) between 0.16 mm 2 and 2.00 mm 2 as measured by spectral-domain optical coherenc e t omography (SD-OCT) ; AND5. Chart notes show best corrected visual acuity (BCVA) of 20/80 or better; AND6. Chart notes show whether one or both eyes is to be treated; AND7. Member does NOT have evidence of neovascularization; AND8. Member does NOT have active or suspected ocular or periocular inf ection.9. Dosage allowed/Quantity limit: One implant per af f ected eye containing 200,000 to 440, 000 a llogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic f actor(rhCNTF) , by surgical intravitreal implantation. QL: 1 implant per af f ected eye If all the above requirements are met , the medication will be approved for 3 months . OH-ME D-P- 366685 For reauthorization : 1. Encelto will not be reauthorized. CareSource considers Encelto (revakinagene taroretcel-lwey) 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 03/18/2025 New policy for Encelto created. ODM approved on 07/23/25. R ef erenc es : 1.E nc elto [p res c rib ing inf o rmatio n]. Neuro tec h Pharmac eutic als , Inc . ; 2025.2. Chew EY, Clemo ns TE, Jaffe GJ, et al. Ef f ec t o f Ciliary Neuro tro p hic Fac to r o n Retinal Neuro d eg eneratio n i n P atients with Macular Telangiectasia Ty pe 2: A Randomized Clinic al Trial. Ophthalmology . 2019;126(4):540-549. d o i:10.1016/j.o p htha.2018.09.0413. Ked aris etti KC, Naray anan R, Stewart MW, Red d y Gurram N, Khanani AM. Mac ular Telang iec tas ia Ty p e 2: ACo mp rehens iv e Rev iew. Clin Ophthalmol . 2022;16:3297-3309. Pub lis hed 2022 Oc t 10. d o i:10.2147/OPTH.S3735384. Kho d ab and e A, Ro o hip o o r R, Zamani J , et al. Manag ement o f Id io p athic Mac ular Telang iec tas ia Ty p e 2. Ophthalmol Ther . 2019;8(2):155-175. d o i:10.1007/s 40123-019-0170-15. 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: 03/18/2025
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Eculizumab (Soliris, Epysqli, Bkemv) BENEFIT TYPE Medical STATUS Prior Authorization Required Soliris is a C5 Complement inhibitor initially approved by the FDA in 2007. It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AchR) antibody positive, and neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. PNH is a rare hematopoietic stem cell disorder in which activation of the complement system destroys red blood cells. aHUS is a type of thrombotic microangiopathy (TMA), a group of syndromes defined by the presence of hemolytic anemia, low platelets and organ damage due to microscopic blood clots in the capillaries. Unlike typical HUS, aHUS is usually genetic. The three main signs of aHUS are hemolytic anemia, thrombocytopenia, and acute kidney failure. Of note, the other type of TMA is called thrombotic thrombocytopenic purpura (TTP); Soliris is not used to treat TTP. Epysqli and Bkemv are biosimilars of Soliris.Eculizumab (Soliris, Epysqli, Bkemv) will be considered for coverage when the following criteria are met:Paroxysmal Nocturnal Hemoglobinuria (PNH)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is prescribed by or in consultation with a hematologist; AND 3. Member has a diagnosis of PNH as confirmed by flow cytometry; AND 4. Member has a lactate dehydrogenase (LDH) level >1.5x upper limit of normal (ULN); AND 5. Member has at least one PNH-related sign/symptom e.g., fatigue, hemoglobin 10% (to rule out TTP); AND 5. Member has tried and failed or is unable to try Ultomiris or Epysqli, and Bkemv; AND 6. Member has received meningococcal vaccine. 7. Dosage allowed/Quantity limit: Pediatrics: See weight-based dosing in package insert. Adults: 900mg IV weekly x 4 weeks, then 1200mg 1 week later, then 1200mg every 2 weeks thereafter. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must demonstrate hematologic normalization as evidenced by increased platelet count or LDH maintained below upper limit of normal; AND 2. Improved or preserved kidney function. If all the above requirements are met, the medication will be approved for an additional 12 months. Generalized Myasthenia Gravis (gMG)For initial authorization: 1. Member is at least 6 years of age; AND 2. Medication is 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; AND 6. If an adult, member has tried and failed or is unable to try Ultomiris (requires trial of IV Vyvgart) or Epysqli, and Bkemv; AND 7. Member has received meningococcal vaccine. 8. Dosage allowed/Quantity limit: Pediatrics: See weight-based dosing in package insert. OH-MED-P-366685 Adults: 900 mg IV weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later,then 1200 mg every 2 weeks thereafter. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Chart notes must demonstrate improvement in activities of daily living, muscle strength, and/or health related quality of life; fewer exacerbations or hospitalizations, or reduced use of rescue medication. If all the above requirements are met, the medication will be approved for an additional 12 months.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 had 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 tried and failed or is unable to try Ultomiris; AND 7. Member has received meningococcal vaccine. 8. Dosage allowed/Quantity limit: 900 mg IV weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter. 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. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Eculizumab (Soliris, Epysqli, Bkemv) 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 11/14/2017 New policy for Soliris created. 10/26/2019 New diagnosis of Neuromyelitis optica spectrum disorder (NMOSD) added. 10/15/2020 Revised criteria for NMOSD to align with other products. Only require at least 1 relapse in past year. Added trial of a standard therapy. Added trial of Enspryng. Reworded the criteria for meningitis vaccine. Removed the part about stable immunosuppressive therapy (just assessed for study purpose). Removed restrictions on prior Rituxan, mitoxantrone, IVIG (only applicable to the study design). Changed initial auth duration to 6 months. Edited the renewal criteria to be more appropriate. Also corrected the dose information error. Changed to nonpreferred drug status. 02/08/2021 gMG: Updated references. Added specialist requirement. Removed MG-ADL score. Amended prerequisite drugs to more closely match guidelines and literature. OH-MED-P-366685 Removed clinical trial exclusion criteria. Reduced initial auth duration to 6 months. Revised renewal criteria06/02/2021 aHUS: Updated references. Added specialist requirement. Revised diagnostic parameters. Removed list of restrictions from clinical trials. Stated Ultomiris as preferred. Amended dosing information. Revised renewal criteria. PNH: Updated references. Added age limit. Removed nephrology as specialist. Removed transfusion and organ damage requirements. Preference for Ultomiris. Amended dosing information. Reduced initial auth duration from 12 months to 6 months. Revised renewal criteria. 07/25/2023 Transferred to new template. PNH: Updated references. Added that they must be symptomatic. aHUS: Updated and added references. Corrected ADAMTS13 level cutoff. Changed evidence of hemolysis to evidence of MAHA. NMOSD: Added references. Removed requirement for trial of Enspryng. MG: Added reference. Removed severe, refractory and added MGFA class II-IV. Added MGFA appendix. Added trial of Ultomiris. Shortened and simplified list of conventional therapy trials. 04/10/2024 NMOSD: Added trial of Ultomiris. Removed azathioprine, mycophenolate trial options. 04/07/2025 MG: Age limit changed from at least 18 to at least 6 years per label update; updated dosing info, added reference, added that Ultomiris/Vyvgart trial only applies to adults. Changed steroid trial duration from 3 months to 4 weeks (Sanders, Alhaidar). 06/25/2025 Edited policy title to include biosimilars. Added biosimilar step edits. ODM approved on 07/23/25. APPENDIX: 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. Soliris [prescribing inf ormation]. Boston, MA: Alexion Pharmaceuticals Inc; 2025. 3. Epysqli [prescribing information]. Samsung Bioepis Co., Ltd.; 2025. 4. Bkemv [prescribing inf ormation]. Amgen Inc.; 2025. 5. Hillmen P, Young NS, Schubert J, et. al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. NEng JMed. 2006;355:1233-1243. Doi: 10.1056/NEJMMoa061648. 6. Brodsky RA, Young NS, Antonioli E, et. al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobulinemia. Blood. 2008;111:1840-1847. Doi: 10.1182/blood-2007-06-094136. 7. Sahin F, Akay OM, Ayer M, et al. Pesg PNH diagnosis, follow-up and treatment guidelines. Am JBlood Res. 2016;6(2):19-27. Published 2016 Aug 5. 8. Parker CJ. Update on the diagnosis and management of paroxysmal nocturnal hemoglobinuria. Hematology Am Soc Hematol Educ Program . 2016;2016(1):208-216. doi:10.1182/asheducation-2016.1.208 9. Devos T, Meers S, Boeckx N, et al. Diagnosis and management of PNH: Review and recommendations f rom a Belgian expert panel. Eur JHaematol . 2018;101(6):737-749. doi:10.1111/ejh.13166 OH-MED-P-366685 10. Patriquin CJ, Kiss T, Caplan S, et al. How we treat paroxysmal nocturnal hemoglobinuria: A consensus statement of the Canadian PNH Network and review of the national registry. Eur JHaematol . 2019;102(1):36-52. doi:10.1111/ejh.1317611. Bod I, Amine I, Boban A, et al. Complement Inhibition in Paroxysmal Nocturnal Hemoglobinuria (PNH): A Systematic Review and Expert Opinion f rom Central Europe on Special Patient Populations. Adv Ther. 2023;40(6):2752-2772. doi:10.1007/s12325-023-02510-4 12. Legendre CM, Licht C, Muus P, et. al. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. NEng JMed. 2013;368:2169-2181. Doi: 10.1056/NEJMMoa1208981. 13. Kato H, Nangaku M, Hataya H, et al. Clinical guides for atypical hemolytic uremic syndrome in Japan. Clin Exp Nephrol . 2016;20(4):536-543. doi:10.1007/s10157-016-1276-6 14. Loirat C, Fakhouri F, Ariceta G, et al. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. Pediatr Nephrol . 2016;31(1):15-39. doi:10.1007/s00467-015-3076-8 15. Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev . 2021;3(3):CD012862. Published 2021 Mar 23. doi:10.1002/14651858.CD012862.pub2 16. Tseng MH, Lin SH, Tsai JD, et al. Atypical hemolytic uremic syndrome: Consensus of diagnosis and treatment in Taiwan. JFormos Med Assoc . 2023;122(5):366-375. doi:10.1016/j.jf ma.2022.10.006 17. Lee H, Kang E, Kang HG, et al. Consensus regarding diagnosis and management of atypical hemolytic uremic syndrome. Korean JIntern Med. 2020;35(1):25-40. doi:10.3904/kjim.2019.388 18. Scully M, Goodship T. How I treat thrombotic thrombocytopenic purpura and atypical haemolytic uraemic syndrome. Br JHaematol . 2014;164(6):759-766. doi:10.1111/bjh.12718 19. Howard Jr, James F., et al. "Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive ref ractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study." The Lancet Neurology 16.12 (2017): 976-986. 20. Dhillon, Sohita. "Eculizumab: A Review in Generalized Myasthenia Gravis." Drugs 78.3 (2018): 367-376. 21. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425. doi:10.1212/WNL.0000000000002790 22. Narayanaswami P, Sanders DB, Wolfe G, et al. International Consensus Guidance for Management of Myasthenia Gravis: 2020 Update. Neurology . 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 23. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. JClin Med. 2022;11(6):1597. Published 2022 Mar 14. doi:10.3390/jcm11061597 24. O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol . 2020;11:743. Published 2020 Jul 24. doi:10.3389/f neur.2020.00743 25. 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. 26. 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 27. 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 28. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. NEngl JMed. 2019;381(7):614-625. doi:10.1056/NEJMoa1900866 29. Pardo S, Giovannoni G, Hawkes C, Lechner-Scott J, Waubant E, Levy M. Editorial on: Eculizumab in aquaporin4-positive neuromyelitis optica spectrum disorder. Mult Scler Relat Disord. 2019;33:A1-A2. doi:10.1016/j.msard.2019.07.001 30. Frampton JE. Eculizumab: A Review in Neuromyelitis Optica Spectrum Disorder [published correction appears in Drugs. 2020 Apr 21;:] [published correction appears in Drugs. 2020 Apr 22;:]. Drugs . 2020;80(7):719-727. doi:10.1007/s40265-020-01297-w 31. Pittock SJ, Fujihara K, Palace J, et al. Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension. Mult Scler . 2022;28(3):480-486. doi:10.1177/13524585211038291 32. Aungsumart S, Youngkong S, Dejthevaporn C, et al. Efficacy and saf ety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis. Front Neurol . 2023;14:1166490. Published 2023 Apr 4. doi:10.3389/f neur.2023.1166490 33. Wingerchuk DM, Zhang I, Kielhorn A, et al. Network Meta-analysis of Food and Drug Administration-approved Treatment Options for Adults with Aquaporin-4 Immunoglobulin G-positive Neuromyelitis Optica Spectrum Disorder. Neurol Ther. 2022;11(1):123-135. doi:10.1007/s40120-021-00295-8 34. 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. OH-MED-P-366685 35. Ohio Administrative Code. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved February 22, 2023 f rom codes.ohio.gov.36. 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: 04/07/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Carvykti (ciltacabtagene autoleucel)BENEF IT TYPE Medical ST AT US Prior Authorization Required Carvykti, approved by the FDA in 2022, is a B-cell maturation antigen (BCMA) -directed genetically modified autologous Tcell immunotherapy . A patients own Tcells are harvested and genetically modif ied outside of the body. The re-engineered cells are injected back into the patient and will recognize the BCMA on the malignant plasma cells to target and kill them. Carvykti is indicated f or the treatment of adult patients with relapsed or ref ractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibit or and an immunomodulatory agent, and are ref ractory to lenalidomide. Multiple myeloma is a cancer of the plasma cells in the bone marrow . Abecma (idecabtagene vicleucel) w as the f irst chimeric antigen receptor (CAR) T-cell therapy approved f or RRMM.Carvykti (ciltacabtagene autoleucel) will be considered for coverage when the following criteria are met:Multiple MyelomaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Carvykti REMS program; AND 3. Member has a diagnosis of relapsed or ref ractory multiple myeloma ; AND 4. Member s disease has progressed af ter receiving at least 1 prior line of therapy including ALL of the f ollowing: a) Proteasome inhibitor b) Immunomodulatory agent c) Ref ractory to lenalidomide; AND 5. Member has an Eastern Cooperative Oncology Group (ECOG) perf ormance status of 0 or 1; AND 6. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 7. Dosage allowed/Quantity limit: 0.5-1. 0 10 6 CAR-positive viable Tcells per kg of body weight, with a maximum dose of 110 8 CAR-positive viable Tcells per single inf usion If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Carvykti will not be reauthorized.CareSource considers Carvykti (ciltacabtagene autoleucel) 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.
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