OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Niktimvo (axatilimab)BENEFIT TYPE Medical STATUS Prior Authorization Required Niktimvo is a colony stimulating factor-1 receptor (CSF-1R) -blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. GVHD is a complication following allogeneic hematopoietic stem cell transplant (HSCT). It occurs when immune cells transplanted from a non-identical donor (graft) recognize the transplant recipient (host) as foreign, initiating an immune response. Chronic GVHD typically occurs more than 100 days posttransplant and involves multiple organ systems. Steroids are the mainstay of treatment but many patients require 2 or more lines of therapy. Niktimvo is a first-in-class drug to target CSF-1R expressed on monocytes and macrophages. Blocking CSF-1R reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages and inhibits the activity of pathogenic macrophages in tissues .Niktimvo (axatilimab) will be considered for coverage when the following criteria are met:C hronic graft-versus-host disease (cGVHD ) For initial authorization: 1. Member weighs at least 40 kg; AND 2. Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist; AND 3. Member has a documented diagnosis of cGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) ; AND 4. Member has failed at least 2 prior lines of systemic therapy, i.e., systemic corticosteroid and another systemic treatment ( calcineurin inhibitor, Jakafi, mycophenolate mofetil, sirolimus, methotrexate, Imbruvica ). 5. Dosage allowed/Quantity limit: IV infusion; 0.3 mg/kg over 30 minutes every 2 weeks until progression or unacceptable toxicity . Max dose 35 mg. QL: 2 vials (2 mL) per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improvement of signs and symptoms of disease in at least 1 organ/site, without progression in any other organ/site. 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 Myobloc (rimabotulinumtoxinB)BENEFIT TYPE Medical STATUS Prior Authorization Required Myobloc is a neurotoxin produced from Clostridium botulinum. Myobloc works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. It is the first and only botulinum toxin type B. Myobloc was initially approved by the FDA in 2000 for the treatment of adults with cervical dystonia. Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head. Chronic sialorrhea, or excessive drooling, is a common symptom for patients with Parkinsons Disease or other neurological or cognitive impairments. Clinical trials showed a decrease in salivary production and improvement in symptoms from baseline with Myobloc.Myobloc (rimabotulinumtoxinB) will be considered for coverage when the following criteria are met:C ervical DystoniaFor initial authorization:1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed /Quantity limit: Up to 5000 or 10,000 units every 12 to 16 weeks, divided among affected muscles. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improved severity, disability, or pain compared to baseline. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. C hronic Sialorrhea 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 diagnosis of chronic sialorrhea impacting quality of life for at least 3 months; AND 4. Member has tried and failed or has a contraindication to at least one anticholinergic drug (e.g. scopolamine, benztropine, glycopyrrolate, amitriptyline).
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Luxturna (voretigene neparvovec-rzyl) BENEF IT TYPE Medical ST AT US Prior Authorization Required Luxturna, approved by the FDA in 2017, is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with conf irmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells. Mutations in t he RPE65 gene le ad to reduced or absent levels of RPE65 isomerohydrolase activity, blocking the visual cycle and resulting in impairment of vision. Luxturna is designed to deliver a normal copy of the gene encoding RPE65 to persons with reduced or absent levels of biologically active RPE65 so t h at f unctional RPE65 protein can be produced to help restore the visual cycle and potentially improve vision. With time, untreated patients lose the ability to detect any intensity of light. In clinical trials, the eff icacy of Luxturna was established based on multi-luminance mobility testing (MLMT) score c h an ge f ro m Baseline to Ye ar 1. Th e MLMT was designed to measure changes in f unctional vision , asassessed by the ability of a subject to navigate a course accurately and at a reasonable pace at diff erent levels of environmental illumination. Response was rapid and sustained, with improvement noted by day 30, durable overall for at least 4 years. Some degree of numerical improvement in visual acuity was shown, but it was not statistically signif icant. Luxturna (voretigene neparvovec-rzyl) will be considered for coverage when the following criteria are met:Biallelic RPE65 Mutation-Associated Retinal DystrophyFor initial authorization: 1. Member is 12 months of ag e or older; AND 2. Medication mu st be prescribed by an ophthalmologist or retinal surgeon; AND 3. Member has a documented diagnosis of biallelic RPE65 mutation-associated retinal dystrophy (e.g., Lebers congenital amau r o s is [LCA], Retinitis pigmentosa [RP], Ear ly Onset Severe Re t inal Dystrophy [EOSRD]); AND 4. Biallelic mutations of the RPE65 gene ar e conf irmed by genetic testing (results required); AND 5. Member h as suf f icient viable retinal cells as determined by optical coherence tomography (OCT) showing an area of the retina within the posterior pole of >100 m thickness; AND 6. Member was NOT previously treated with RPE65 gene therapy. 7. Dosage allowed/Quantity limit: 1.5 x 10 11 vector genomes (vg), administered by subretinal injection in a total volume of 0.3 mL f or e ac h eye. Administration of Luxturna to e ac h eye must be performed on separate days within a close interval, but no f ewer than 6 days apart. If all the above req u iremen t s are met , the medication will be approved for 3 months. For reauthorization :1. Luxturna will not be re-authorized.OH-MED-P-366685 CareSource considers Luxturna (voretigene neparvovec-rzyl) 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/DESCRIPTION08/27/2018 New policy f or Luxturna created. 12/22/2021 Transf erred to new template. Added references. Changed ag e limit f rom 3 y e ar s to 12 months and removed baseline MLMT test. Clarif ied the wording of some of the other criteria without changing the ac t u al requirements. 05/14/2024 Updated ref erences. Separated diagnosis an d genetic testing into s e p ar at e criteria (f or readability) and added types of RD. 11/19/2024 Removed requirement f or signif icant vision impairment (visual acuity, visual f ield). Approv ed by ODM 2/ 6/2025. Ref erenc es : 1. Lux turna [p ac k ag e ins ert]. Philad elp hia, PA; Sp ark Therap eutic s , Inc . : 2022. 2. Rus s ell S, Bennett J , Wellman JA, at el. Efficacy and s afety of voretigene nep arvov ec (AAV2-hRPE65v 2) in p atients wi th RP E65-mediated inherited retinal dys trophy: a randomis ed, controlled, open-label, phase 3 trial. Lanc et . 2017 Aug 26;390(10097):849-860. d o i: 10.1016/S0140-6736(17)31868-8. Ep ub 2017 Jul 14. 3. Mag uire AM, Russ ell S, Chung DC, et al. Durability of Voretigene Neparv ovec for Biallelic RPE 65-Mediated Inherited Retinal Dis eas e: Phas e 3 Res ults at 3 and 4 Years . Ophthalmology . 2021;128(10):1460-1468. d o i:10.1016/j.o p htha.2021.03.031 4. A meri H. Pro spec t of retinal gene therapy following commerc ialization of voretigene nep arv ovec-rzy l f or retinal d y s tro p hy med iated b y RPE65 mutatio n. JCurr Op hthalmo l. 2018 Feb 16;30(1):1-2. 5. Ao un M, Pass erini I, Chiurazzi P, et al. Inherited Retinal Dis eases Due to RP E65 Variants: From Genetic Diag no s tic Manag ement to Therap y . Int JMol Sc i . 2021;22(13):7207. Pub lis hed 2021 Jul 5. d o i:10.3390/ijms 22137207 6. So d i A, Banfi S, Tes ta F, et al. RPE65-associated inherited retinal d iseas es : c o ns ens us rec o mmend atio ns f o r elig ib ility to gene therapy . Orphanet JRare Dis . 2021;16(1):257. Published 2021 Jun 4. doi:10.1186/s 13023-021-01868-4 7. Han J, Joo K, Ki m US , et al. Voretigene Neparvovec for the Treatment of RP E65-ass ociated Retinal Dystrophy: Co ns ens us and Rec o mmend atio ns f ro m the Ko rea RPE65-IRD Co ns ens us Pap er Co mmittee. Korean JOphthalmol . 2023;37(2):166-186. d o i:10.3341/k jo .2023.0008 8. Te s t a F, Bacci G, Falsini B, et al. Voretigene neparvovec for inherited retinal dy strophy due to RPE 65 mutations: a s c o p ing review of eligibility and treatment c hallenges from c linical trials to real p ractice. Eye (Lond). Publis hed o nline Ap ril 16, 2024. d o i:10.1038/s 41433-024-03065-6 Ef f ective d ate: 04/01/2025 Rev is ed d ate: 11/19/2024
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Hyaluronic Acid Viscosupplements BENEF IT TYPE Medical ST AT US Prior Authorization Required Osteoarthritis is a common chronic joint disorder involving cartilage degradation, bone remodeling, osteophyte f ormation, and synovial inf lammation. These changes lead to pain, stiffness, swelling, and compromised functional capacity of the aff ected joint. The goal of treatment is to improve pain and mobility. Viscosupplementation is an intra-ar t ic u lar t he r ap y th at le v er ag e s t h e p hy s io log y of hy alu r o n ic ac id , a majo r component of normal synovial f luid, to restore viscoelasticity and natural protective properties like shock absorption and lubrication of the joint. A multitude of different hyaluronic acid products are available with a v ar ie t y of properties. They ar e ind ic at e d for t he treatment of p ain in osteoarthritis (OA) of the k n ee in p at ien t s who have f ailed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. They have a slower but more durable response than intra-articular steroid injections. Over the years, treatment guidelines h av e been incongruent in their recommendations, but overall they ar e considered a s af e and eff ective option in certain situations. It is important to rule out other causes of joint pain such as rheumatoid arthritis, gout, or malignancy.Hyaluronic acid viscosupplements will be considered fo r coverage when the following criteria are met:Osteoarthritis (OA) of the KneeFor initial authorization: 1. Member is at le as t 18 y e ar s of age; AND 2. Member h as a diagnosis of osteoarthritis of the knee confirmed by radiographic evidence such as joint space narrowing, subchondral sclerosis, osteophytes, and subchondral cysts; AND 3. Pain interf eres with normal daily activity such as walking, standing, or s t air climbing; AND 4. Member h as tried an d f ailed ALL of the f ollowing conservative therapies f or at le as t 3 months: a) Non-pharmacologic strategies such as exercise, physical therapy, bracing, weight loss (if overweight or obese) b) Simple analgesics such as acetaminophen or NSAIDs (oral or topical) c) Intra-ar t ic u lar corticosteroid injection (unless contraindicated); AND 5. Ch ar t notes mu st indicate if the request is f or the treatment of one or both knees; AND 6. Member h as NOT h ad a total knee replacement (arthroplasty) an d knee replacement is not anticipated f or at least the next 6 months; AND 7. If the request is f o r a non-preferred product, t r ial an d f ailure o f at le as t 1 pref erred product is required (see Appendix). 8. Dosage allowed/Quantity limit: Intra-ar t ic u lar injection to t he af fected knee(s) at weekly intervals. Euf lexxa: 2 mL weekly f or 3 weeks Durolane: 3 mL one t ime Gel-One: 3 mL one time Gelsyn-3: 2 mL weekly f or 3 weeks Gen-Visc: 2.5 mL weekly f or 3 to 5 weeks Hy alg an : 2 mL weekly f or 3 to 5 weeks OH-MED-P-366685 Hymovis: 3 mL weekly f or 2 weeksMonovisc: 4 mL one time Orthovisc: 2 mL weekly f or 3 to 4 weeks Supartz FX: 2.5 mL weekly f or 3 to 5 weeks Synvisc: 2 mL weekly f or 3 weeks Synvisc-One: 6 mL one time TriVisc: 2.5 mL weekly f or 3 weeks TriLuron: 2 mL weekly f or 3 weeks Visco-3: 2.5 mL weekly f or 3 weeks If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show clinically signif icant improvement of signs and symptoms such as documentation of improved p ain scores, improved f un c t ion al abilities, and/or reduced use of analgesic medications as a result of the treatment to the af f ected knee; AND 2. Symp t o ms h av e recurred an d at le as t 6 months h av e elapsed since completion of the p r ev io us course of viscosupplementation; AND 3. Member h as NOT h ad a total knee replacement (arthroplasty) an d knee replacement is not anticipated f or at least the next 6 months. If all the above req uirement s are met , the medication will be approved for an additional 6 months. CareSource considers hyaluronic acid viscosupplements 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/DESCRIPTION04/20/2022 New policy f or hyaluronic ac id viscosupplements created; combination and comprehensive update of past individual policies. 11/07/2022 Removed specialist requirement. 10/24/2024 Reviewed an d updated references. No changes to crit e ria. Approved by ODM 2/13/25. APPENDIX: Lis t of products and s tatus (Y = p ref erred ; N = no n-p ref erred ) Euf lex x a sodium hy aluro nate N Duro lane hy aluro nic ac id Y Gel-One cross-link ed hy aluro nate N Gelsyn-3 sodium hy aluro nate Y GenVis c 850 sodium hy aluro nate N Hy alg an sodium hy aluro nate N Hymovis hig h mo lecular weig ht v is c oelastic hy aluro nan N Monovisc hig h mo lec ular weig ht hy aluro nan N Orthovisc hig h mo lec ular weig ht hy aluro nan N Sup artz FX sodium hy aluro nate Y Synvisc hy lan G-F 20 N Synvisc-One hy lan G-F 20 N TriVisc sodium hy aluro nate N OH-MED-P-366685 TriLuro n sodium hy aluro nate NVisco-3 sodium hy aluro nate N Ref erenc es :1. Euf lex x a [p ac k ag e ins ert]. Ferring Pharmac eutic als , Inc . ; 2016.2. Duro lane [p ac k ag e ins ert]. Bio v entus LLC; 2017. 3. Gel-One [p ac k ag e ins ert]. Zimmer, Inc . ; 2011. 4. Gelsyn-3 [p ac k ag e ins ert]. Bio v entus ; 2017. 5. GenVis c 850 [p ac k ag e ins ert]. Ortho g enRx . N. D . 6. Hy alg an [p ac k ag e ins ert]. Fid ia Pharma US A Inc . ; 2014. 7. Hymovis [p ac k ag e ins ert]. Fid ia Pharma US A Inc . ; 2017. 8. Monovisc [p ac k ag e ins ert]. Anik a Therap uetic s Inc . ; 2013. 9. Orthovisc [p ac k ag e ins ert]. Anik a Therap eutic s . N. d . 1 0. Sup artz FX [p ac k ag e ins ert]. Bio v entus LLC; 2015 1 1. Synvisc [p ac k ag e ins ert]. Genzy me Bio s urg ery ; 2014. 1 2. Synvisc-One [p ac k ag e ins ert]. Genzy me Bio s urg ery ; 2014. 1 3. TriVisc. [p ac k ag e ins ert]. Ortho g enRx , Inc . 1 4. TriLuro n. [p ac k ag e ins ert]. Fid ia Pharma US A Inc . ; 2019. 1 5. Visco-3. [p ac k ag e ins ert]. Bio v entus LLC. 1 6. Americ an Ac ademy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (NonArthroplasty) Ev id enc e-Bas ed Clinic al Prac tic e Guid eline. http s :// www.aaos.org/oak3cpg Pub lis hed 08/31/2021 1 7. Us o n J, Rodriguez-Garca SC, Castellanos-Moreira R, et al. EULA Rrecommendations for i ntra-artic ular therap ies . Ann Rheum Dis . 2021;80(10):1299-1305. d o i:10.1136/annrheumd is-2021-220266 1 8. Ko las inski SL, Neogi T, Ho chberg MC, et al. 2019 American Co llege of Rheumatology/Arthritis Fo und atio n Guid eline for the Management of Osteoarthritis of the Hand, Hip, and Knee [published c orrection appears in Arthritis Care Res (Ho b o k en). 2021 May ;73(5):764]. Arthritis Care Res (Hobok en) . 2020;72(2):149-162. d o i:10.1002/ac r.24131 1 9. Bellamy N, Campb ell J, Robinso n V , Gee T, Bo urne R, We l ls G. Viscos upp lementatio n for the treatment of os teo arthritis of the k nee. Coc hrane Databas e Sys t Rev . 2006;2006(2):CD 005321. Pub l is h ed 2006 Ap r 19 . d o i:10.1002/14651858.CD 005321.p ub 2 2 0. Bannuru RR, Os ani MC, Vaysbrot EE , et al. OARSI g uidelines for the non-s urgical management of knee, hip , and p o ly artic ular o s teo arthritis . Os teoarthritis Cartilage. 2019;27(11):1578-1589. d o i:10.1016/j.jo c a.2019.06.011 2 1. Tro jian TH, Co nc o ff AL, Joy SM, Hatzenbuehler JR, Saulsberry WJ , Co leman CI. AMSSM Sc ientif ic Statement Co nc erning Vis cosupplementation Injec tions for Knee Osteoarthritis: Importanc e for Ind ividual Patient Outcomes. Clin JSport Med. 2016;26(1):1-11. d o i:10.1097/J SM.0000000000000274 2 2. Bruy re O, Ho nv o G, Vero nes e N, et al. An updated algorithm recommendation f o r the manag ement o f k nee o s teo arthritis from t he European Society for Clinical and Ec onomic A spect s of Os teoporosis, Osteoarthritis and Mus c ulo s k eletal Dis eas es (ESCEO). Semin Arthritis Rheum. 2019;49(3):337-350. d o i:10.1016/j.s emarthrit.2019.04.008 2 3. Lo c al Co verage Determination (LCD ): Intraarticular Knee Injections of Hy aluronan (L39529). Centers for Medicare and Med ic aid Serv ic es . Av ailab le at: http s :// www.cms.gov/medicare-c o v erag e-d atab ase/view/lcd.aspx?lcdid=39529&v er=3&k ey wordtype=starts&keyword=hy aluron&bc =0. Ac c es s ed Oc to b er 25, 2024. 2 4. Co nro zier T, Dira ogl D, Monfort J, et al. EUROVIS CO Go od Pract ice Recommendations for a Fi rs t Vis c o s up p lementatio n in Patients with Knee Os teo arthritis . Cartilage. 2023;14(2):125-135. d o i:10.1177/19476035221138958 Ef f ective d ate: 04/01/2025 Rev is ed d ate: 10/24/2024
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Dysport (abobotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Dysport is a neurotoxin produced from Clostridium botulinum serotype A. It works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. Dysport was initially approved by the FDA in 2009 and is approved for the treatment of adults with cervical dystonia and for the treatment of spasticity in patients 2 years of age and older . Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head.Dysport (abobotulinumtoxinA) will be considered for coverage when the following criteria are met:C ervical DystoniaFor initial authorization: 1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed /Quantity limit: Up to 1000 units every 12 weeks, divided among affected muscles. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show improved severity, disability, or pain compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months . SpasticityFor initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try one conventional treatment modality such as physical therapy or oral medication (e.g. baclofen, tizanidine). OH-MED-P -36668511. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-706. 12. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 70:1707-14. 13. Keam SJ, Muir VJ, Deeks ED. Botulinum toxin A (Dysport): in dystonias and focal spasticity. Drugs 2011;71(8):1043-58. 14. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826. doi:10.1212/wnl.0000000000002560 15. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission. 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 16. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 17. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 18. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 19. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 Effective date: 04/01/2025 Revised date: 10/02/2024
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Daxxify (DaxibotulinumtoxinA-lanm )BENEFIT TYPE Medical STATUS Prior Authorization Required Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia in adult patients . It was designed to have a longer duration of effect than other botulinum neurotoxin products and may also have a lower incidence of dysphagia side effects . Cervical dystonia, also known as spasmodic torticollis, is a painful , chronic neurological condition characterized by involuntary contractions of neck muscles, leading to abnormal movements and awkward postures of the head, neck, and shoulders . Botulinum toxin products are first line treatment. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -total score is used to assess the severity and treatment success of cervical dystonia, and its change from baseline was the primary outcome in the Phase 3 ASPEN-1 clinical trial, in which Daxxify was superior to placebo.Daxxify (DaxibotulinumtoxinA-lanm) will be considered for coverage when the following criteria are met:Cervical DystoniaFor initial authorization: 1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed/Quantity limit: 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles no more frequently than every three months . If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improv ed severity, disability, or pain compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Daxxify (DaxibotulinumtoxinA-lanm ) 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/DESCRIPTION10/20/2023 New policy for Daxxify created. 10/02/2024 Removed age limit and specialist. References:
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Botox (onabotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Botox is a neurotoxin produced from Clostridium botulinum serotype A. It works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. There are seven types of botulinum toxin serotypes. Only serotypes A and Bare used for medicinal purposes. Botox was initially approved in 1989 by the FDA for the treatment of b lepharospasm. Since then, Botox has gained additional therapeutic indications for overactive bladder, neurogenic detrusor overactivity , chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, and s trabismus.Botox (onabotulinumtoxinA) will be considered for coverage when the following criteria are met:Primary Axillary HyperhidrosisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a dermatologist; AND 3. Member has a diagnosis of severe axillary hyperhidrosis, including documentation in the chart notes of visible, excessive sweating of at least 6 months duration which significantly impairs daily activities; AND 4. Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been ruled out; AND 5. Member has tried and failed topical prescription-strength aluminum chloride (e.g. Xerac) for at least 3 0 days. 6. Dosage allowed / Quantity limit: 50 Units per axilla. Note: Medication will not be covered for treatment of hyperhidrosis in body areas other than axillary. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes have been provided that show improvement of signs and symptoms (i.e. , reduced axillary sweat production). If all the above requirements are met, the medication will be approved for an additional 12 months . B lepharospasmFor initial authorization: 1. Member has a diagnosis of blepharospasm, characterized by spasms inducing narrowing or closure of the eyelids. 2. Dosage allowed /Quantity limit: The cumulative dose of Botox treatment for blepharospasm in a 30- day period should not exceed 200 Units. Treatment may be repeated every 3 months. OH-MED-P-366685If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , lessening of involuntary contraction). If all the above requirements are met, the medication will be approved for an additional 12 months . C ervical DystoniaFor initial authorization: 1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed /Quantity limit: Up to 300 units every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , severity of abnormal head position, neck pain). If all the above requirements are met, the medication will be approved for an additional 12 months . Esophageal AchalasiaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist; AND 3. Member has a diagnosis of achalasia confirmed by high resolution esophageal manometry; AND 4. Chart notes must document that the member is NOT a candidate for ALL of the following: Laparoscopic Heller myotomy, pneumatic dilation, and peroral endoscopic myotomy (POEM); AND 5. Other esophageal motility disorders and malignancy have been ruled out. 6. Dosage allowed /Quantity limit: 100 units every 6 months (off label). If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show the member had symptomatic improvement of dysphagia and/or regurgitation. If all the above requirements are met, the medication will be approved for an additional 12 months . OH-MED-P-366685M igraine Headache ProphylaxisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is being prescribed for the prevention of chronic migraine, with both of the following documented in chart notes: a) 15 headache days per month for at least 3 months; b) 8 migraine days per month for at least 3 months; AND 3. Medication must be prescribed by a neurologist or a headache specialist; AND 4. Member has tried and failed at least 1 of the following prophylactic medications for 8 weeks : a) Beta-blockers (e.g., metoprolol, timolol, or propranolol) b) Calcium channel blockers (e.g., verapamil) c) Antidepressants (e.g., amitriptyline or venlafaxine) d) Anticonvulsant (e.g., topiramate or valproic acid) e) Candesartan ; AND 5. Medication is NOT being used in combination with a prophylactic CGRP product (e.g., Emgality, Aimovig, Ajovy, or Vyepti); AND 6. Member does not have medication-overuse headaches. 7. Dosage allowed /Quantity limit: 155 Units every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Member has improvement in prevention of migraines documented in chart notes (e.g., reduced migraine frequency, reduced use of medication for acute migraines attacks). If all the above requirements are met, the medication will be approved for an additional 12 months . O veractive Bladder (OAB) For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a urologist or gynecologist; AND 3. Member has a diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency; AND 4. Member has tried and failed at least TWO prior pharmacologic therapies for at least 30 days each (e.g. oxybutynin, solifenacin, Myrbetriq); AND 5. Member does not have a urinary tract infection. 6. Dosage allowed /Quantity limit: 100 Units every 12 weeks. If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Chart notes have been provided that show decreased symptoms of urge urinary incontinence, urgency, and frequency. If all the above requirements are met, the medication will be approved for an additional 12 months . OH-MED-P-366685SpasticityFor initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try one conventional treatment modality such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed /Quantity limit: Adult: Not to exceed 400 total units every 12 weeks (given intramuscularly as a divided dose among affected muscles). Pediatric: Not to exceed 340 total units or 10 units per kg (whichever is lower) every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , decrease in severity of increased muscle tone, increased functional ability or range of motion). If all the above requirements are met, the medication will be approved for an additional 12 months . StrabismusFor initial authorization: 1. Member has a diagnosis of a strabismus type with binocular potential, unlikely to spontaneously resolve. 2. Dosage allowed: See package insert. 1 If all the above requirements are met, the medication will be approved for 6 months . For reauthorization :1. Chart notes have been provided showing that the members ocular alignment has improved. If all the above requirements are met, the medication will be approved for an additional 6 months.U rinary Incontinence (associated with neurologic condition)For initial authorization: 1. Member is at least 5 years of age ; AND 2. Medication is prescribed by or in consultation with a urologist, neurologist, or gynecologist; AND 3. Member has a diagnosis of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. brain or spinal cord injury, stroke, multiple sclerosis, Parkinsons, spina bifida); AND 4. Member has tried and failed at least one anticholinergic medication for 30 days (e.g. oxybutynin, solifenacin, tolterodine); AND 5. Member does not have a urinary tract infection. OH-MED-P-3666856. Dosage allowed /Quantity limit : For adults and pediatric patients weighing 34kg or more: 200 units per treatment, no sooner than every 12 weeks. If weight is less than 34kg: 6mg/kg, no sooner than every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization :1. Chart notes have been provided that show decreased frequency of urinary incontinence. If all the above requirements are met, the medication will be approved for an additional 12 months .Anal FissureFor initial authorization: 1. Medication must be prescribed by or in consultation with a gastroenterologist or colorectal surgeon; AND 2. Member has a diagnosis of chronic anal fissure, present for at least 6 weeks ; AND 3. Member has tried and failed one of the following: a) Topical calcium channel blocker (nifedipine or diltiazem) for 8 weeks OR b) Topical nitr ate for 3 weeks . 4. Dosage allowed /Quantity limit: 20-50 units single injection. May repeat after 2 months if healing is incomplete or fissure recurs (off label). If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Medication will not be re-authorized for this indication. CareSource considers Botox (onabotulinumtoxinA) 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/DESCRIPTION08/03/2018 Criterion no infection at proposed injection site removed from Blepharospasm and Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. On diagnosis of Urinary Incontinence criterion Surgical treatment or balloon sphincter dilatation is not indicated, has been refused, or has failed was removed. On diagnosis of Spasticity rehabilitation program is not required anymore. Strabismus diagnosis got criter ia expanded. Lower Limb Spasticity is combined into Spasticity diagnosis. For diagnosis of Migraine Headache Prophylaxis trial length for abortive therapeutic options decreased. 01/19/2020 Updated Overactive Bladder criteria from three to two trials of an adequately titrated overactive bladder medication. 08/17/2020 Removed criteria for upper extremity focal dystonia/writers cramp (off label). Hyperhidrosis: added specialist requirement, changed re-auth duration, changed dx title to match drug label, changed the ordering, removed sweat quantification requirement and changed diagnostic phrase to match guidelines. Added reference. Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing.
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Suboxone (buprenorphine and naloxone sublingual film ), Zubsolv (buprenorphine and naloxone sublingual tablets ) BENEFIT TYPE Medical STATUS Prior Authorization Required Suboxone and Zubsolv are mixed opioid agonist-antagonist s , containing buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. They were initially approved by the FDA in 2002 and indicated for the treatment of opioid dependence. Suboxone and Zubsolv should be used as part of a complete treatment plan that includes counseling and psychosocial support. Suboxone , Zubsolv ( buprenorphine and naloxone ) will be considered for coverage when the following criteria are met: Opioid DependenceFor initial authorization: 1. All of the following:a) The individual has failed an adequate trial of generic buprenorphine/naloxone within the previous120 days (Note: Adequate trial is defined as at least 28 days of treatment); ANDb) One of the following:i) The member experienced therapeutic failure with generic buprenorphine/naloxone (Note:Brand agents will not be approved for members who report lesser efficacy as compared to the preferred generic buprenorphine sublingual tablets unless it would be clinical ly inappropriate to address efficacy with dose adjustment); ORii) Generic caused adverse outcome; ANDc) The prescriber has provided a copy and confirmation of a MedWatch form submission to the FDAdocumenting the therapeutic failure or adverse outcome experienced by the member (Note: TheMedWatch form is available at:https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdfOR 2. Both of the following:a) The individual has a hypersensitivity reaction to an inactive ingredient in the generic buprenorphine product ; ANDb) The hypersensitivity reaction(s) is clearly documented in the member’s medical record.3. Dosage allowed/Quantity limit: 14 days supply during the first 90 days of treatment, one month supply after the first day 90 days.a) Suboxone : The maintenance dose of Suboxone is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day. The recommended target dosage during maintenance is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose. Dosages higher than 24 mg /6 mg daily have not been demonstrated to provide a clinical advantage .Strength Quantity Limit OH-MED-P-3666852 mg 0.5 mg 1 film per day4 mg 1 mg 1 film per day 8 mg 2 mg 2 films per day 12 mg 3 mg 2 films per day b) Zubsolv : The maintenance dose of Zubsolv sublingual tablet is generally in the range of 2.9mg/0.71 mg buprenorphine/naloxone to 17.2 mg/4.2 mg buprenorphine/naloxone per day. The recommended target dose is 11.4 mg/2.9 mg as a single daily dose. Dosages higher th an 17.2 mg/4.2 mg buprenorphine/naloxone have not been demonstrated to provide any clinical advantage. Strength Quantity Limit0.7 mg – 0.18 mg 1 tab per day 2.9 mg – 0.7 mg 1 tab per day 11.4 mg – 2.9 mg 1 tab per day 1.4 mg – 0.36 mg 1 tab per day 5.7 mg – 1.4 mg 1 tab per day 8.6 mg – 2.1 mg 2 tabs per day Additional Notes:GI upset or irritation is not generally considered an allergy or failed treatment. Members should be referred to their physician or pharmacist for advice on dose adjustment, and/or other options to reduce GI upset/irritation. Common documented side effects attributed to the drug (i.e., headache, nausea, blurred vision, fatigue, muscle aches) are not considered an allergy and would be expected to occur at the same level in both the generic and brand agent. Drug hypersensitivity symptoms may include skin rash, hives, itching, fever, swelling, shortness of breath, wheezing, runny nose, itchy and/or watery eyes, and in severe cases, anaphylaxis. If all the above requirements are met, the medication will be approved for 12 months.For reauthorization :1. Chart notes must document positive response to therapyIf all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Suboxone , Zubsolv (buprenorphine and naloxone ) notmedically 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/DESCRIPTION04/03/2019New policy for Suboxone and Zubsolv created. 08/24/2022 Annual Review. Transferred to new template. Updated references. Updated approval duration to 12 months. Combined Suboxone and Zubsolv policies.8/2 6/2024 Added or for clarity between trials and hypersensitivity reaction requiremen t. Updated dosage allowed/QL to 14 days supply during the first 90 days of treatment, one month supply after the first day 90 day and added 5122-40-06 Ohio Administrative code citation. OH-MED-P – 366685 References: 1. Suboxone [package insert]. Richmond, VA: Indivior Inc.; June 20 22 .2. Zubsolv [package insert]. Morristown, NJ: Orexo US, Inc.; June , 20 22 .3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Available at http://www.fda.gov/safety/medwatch/default.htm .4. White L, et al. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 FocusedUpdate. JAddict Med. 2020 Mar/Apr;14(2S Suppl 1):1-91.5. Center for Substance Abuse Treatment. Clinical guidelines for the Use of Buprenorphine in the Treatment ofOpioid Addiction. Treatment Improvement Protocol (TIP) series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Healt h Services Administration, 2004.6. Ohio Administrative Code. (2022, February 23). 5160-1 – 01 (C) Medicaid medical necessity: definitions and principles. Retrieved February 22 2023 from codes.ohio.gov.7. Ohio Administrative Code. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved February 22,2023 from codes.ohio.gov.8. Ohio Administrative Code. (2020, January 1). 5160-9 – 03 Pharmacy services: covered drugs and associated limitations. Retrieved February 22, 2023 from codes.ohio.gov.9. Ohio Administrative Code. ( 2022, June 10 ). 5122-40-06 Medication assisted treatment administration . RetrievedAugust 26 th, 2024 from codes.ohio.gov.Effective date: 1/1/2025 Revised date: 08/26/2024
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Benlysta (belimumab) BENEFIT TYPE Medical STATUS Prior Authorization Required Benlysta is a B-lymphocyte stimulator (BLyS) – specific inhibitor indicated f or the treatment of patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy and for patients aged 5 years and older with active lupus nephritis who are receiving standard therapy . Benlysta is not recommended in patients with severe active central nervous system lupus. SLE is the most common type of lupus. It is a chronic autoimmune disease with periods of f lares and remissions that causes inf lammation and damage throughout the body. LN is a complication of SLE and can progress to end stage renal disease (ESRD). Proteinuria is of ten the f irst sig n of LN. Benlysta (belimumab) will be considered for coverage when the following criteria are met: Systemic Lupus Erythematosus (SLE)For initial authorization: 1. Member is at least 5 years of age ; AND2. Medication must be prescribed by or in consultation with a rheumatologist; AND3. Member has a documented diagnosis of active, autoantibody-positive SLE as conf irmed by documentation of at least one of the f ollowing:a) A nti-nuclear antibody (ANA) titer 1:80b) Elevated (above normal) anti-double-stranded DNA (anti-dsDNA)c) Elevated (above normal) anti-Smith (anti-Sm) antibody ; AND4. Member has tried and f ailed hydroxychloroquine OR is unable to reduce steroid to an acceptable dose f or chronic use ( 5 mg prednisone per day or less) ; AND5. Standard therapy (e.g., hydroxychloroquine) will be continued unless contraindicated ; AND6. Member does NOT have severe active central nervous system (CNS) lupus .7. Benlysta will NOT be used with other biologic therapies .8. Dosage allowed/Quantity limit:IV (Adult or Pediatric): 10mg/kg every 2 weeks f or 3 doses and every 4 weeks thereaf ter SubQ (Adult): 200 mg once weeklySubQ (Pediatric; autoinjector only): 200 mg once weekly if 40 kg or greater; 200 mg every 2 weeks if15 to
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Brineura (cerliponase alfa) BENEFIT TYPE Medical STATUS Prior Authorization Required Brineura is an enzyme replacement therapy (ERT); specif ically, it is a recombinant f orm of human tripeptidyl peptidase 1 (TPP1), which is def icient in patients with neuronal ceroid lipof uscinosis type 2 (CLN2) disease. Def iciency of TPP1 enzyme activity re sults in accumulation of waste that it usually metabolizes in cell lysosomes , particularly in the brain . This build up causes cell death and leads to progressive motor f unction decline , as well as loss of cognitive and visual f unctions . CLN2 is a rare, inherited , neurodegenerative lysosomal storage disease , and one of the more common forms of Batten disease. It is caused by mutation of the CLN2 gene (which produces the TPP1 lysosomal enzyme and is also known as the TPP1 gene ) . Seizures are commonly the initial symptom , typically with late inf antile onset . There is rapid progression to dementia, blindness, and loss of ability to walk or talk , with a greatly shortened lif e expectancy of about 8-12 years. Brineura was approved in 2017 and is indicated to slow the loss of ambulation in CLN2 patients. It works by helping to replace the def icient TPP1 enzyme. Brineura must be administered into the cerebrospinal f luid (CSF) by inf usion via a surgically implanted intraventricular access device . In clinical trials, patients treated with Brineura had less decline in motor and language f unction when compared with historical cohorts. There is no cure f or the disease itself . Brineura (cerliponase alfa) will be considered for coverage when the following criteria are met: Late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (T PP1) deficiencyFor initial authorization: 1. Member weighs at least 2.5 kg; AND2. Brineura is prescribed by or in consultation with a pediatric neurologist or a geneticist; AND3. Me mber has a diagnosis of late inf antile neuronal ceroid lipof uscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) def iciency , conf irmed by BOTH of the f ollowing:a) Demonstration of def icient TPP1 enzyme activity (in leukocytes, f ibroblasts, or dried blood spots)b) Identif ication of causative mutations in each allele of the TPP1/CLN2 gene; AND4. Member has mild to moderate disease documented by a two-domain score of 3-6 on motor and language domains of the Hamburg Scale, with a score of at least 1 in each of these two domains .5. Dosage allowed/Quantity limit: Based on weight, administer 100-300 mg (see prescribing inf ormation) once every other week as an intraventricular inf usion f ollowed by inf usion of i ntraventricular e lectrolytes .QL: 2 packages per 28 days; each package contains 2 vials of 150 mg/5 mLIf all the above requirements are met , the medication will be approved for 12 months. OH-MED-P – 366685 For reauthorization : 1. Documentation of slowed loss of ambulation; AND2. Member does not have an unreversed (sustained) score of 0 on the motor domain of the CLN2 clinical rating scale .If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Brineura (cerliponase alfa) 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 05/17/2017 New policy f or Brineura created. 01/05/2022 Transf erred to new template. Updated the Jcode (ef f ective 1/2019). Updated ref erences. Added specialist requirement. Added diagnostic conf irmation criteria. Removed redundancy of not having score of 0. Removed exclusions f or other neuro illness, ventilation support, status epilepticus. In renewal section, r emoved meeting initial criteria (would not all apply) , reworded slowed loss of ambulation requirement, added that they cant have score of 0 (patient can no longer walk). 04/17/2024 Removed upper age limit. 08/02/2024 Removed age limit, updated dosing inf o, added minimum weight (label update). 11/19/24 Approved by ODMRef erences: 1. Brineura [p ackag e insert]. No vato , CA: Bio Marin Pharmaceutical Inc.; 2024 .2. Mo le SE, Schulz A, Bad o e E, et al. Guid elines o n the d iag no sis, clinical assessments, treatment and manag ement f o r CLN2 d isease p atients. Orphanet JRare Dis . 2021;16(1):185. Pub lished 2021 Ap r 21. d o i:10.1186/s13023-021-01813-53. Fietz M, AlSayed M, Burke D, et al. Diagnosis of neuronal ceroid lip o f uscino sis typ e 2 (CLN2 d isease): Exp ert reco mmend atio ns f o r early d etectio n and lab o rato ry d iag no sis. Mol Genet Metab . 2016;119(1-2):160-167. d o i:10.1016/j.ymg me.2016.07.0114. Schulz A, Ajayi T, Sp ecchio N, et al. Study of Intraventricular Cerliponase Alfa for CLN2 Disease. NEngl JMed .2018;378(20):1898-1907. d o i:10.1056/NEJMo a17126495. Ohio Ad ministrative Co d e. (2022, Feb ruary 23). 5160-1 – 01 (C) Med icaid med ical necessity: d ef initio ns and p rincip les. Retrieved Feb ruary 22 2023 f ro m co d es.o hio .g o v.6. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed care: covered services. Retrieved Feb ruary 22,2023 f ro m co d es.o hio .g o v.7. Ohio Ad ministrative Co d e. (2020, January 1). 5160-9 – 03 Pharmacy services: co vered d rug s and asso ciated limitatio ns. Retrieved Feb ruary 22, 2023 f ro m co d es.o hio .g o vEf f ective d ate: 01/01/2025 Revised d ate: 08/02/2024
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