OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Aflibercept ( Eylea , Eylea HD , Pavblu )BENEFIT TYPE Medical STATUS Prior Authorization Required Eylea was originally approved by the FDA in 2011. It is indicated for the treatment of several different ophthalmic conditions. Eylea is a vascular endothelial growth factor (VEGF) inhibitor for intravitreal use. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability . Eylea HD, approved in 2023, is a high-dose, extended-interval version of Eylea, but with fewer indications. There are 2 forms of age-related macular degeneration (AMD), dry and wet (neovascular). Eylea is approved for the treatment of Wet AMD which is less common but progresses more quickly. Neovascular in the context of AMD means growth of new blood vessels under the macula which can lead to loss of central vision. Diabetic eye disease includes diabetic retinopathy (DR) and diabetic macular edema (DME). DR affects blood vessels in the retina at the back of the eye. DME is a consequence of DR that occurs in about half of DR patients. It causes fluid build-up in the macula part of the retina. Retinal Vein Occlusion (RVO) occurs when there is a partial or complete obstruction of a retinal vein. Macular edema is a complication of RVO and can lead to vision loss. It is treated first-line with anti-VEGF drugs. Retinopathy of prematurity (ROP) is a neovascular disorder of the developing retinal blood vessels in preterm infants . The standard treatment has been laser coagulation.Aflibercept (Eylea, Eylea HD, Pavblu) will be considered for coverage when the following criteria are met:Retinal Disease (adults)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 confirmed diagnosis of one of the following conditions: a) Neovascular (Wet) Age-Related Macular Degeneration (AMD) b) Macular Edema Following Retinal Vein Occlusion (RVO ) Eylea , Pavblu o nly c) Diabetic Macular Edema (DME) d) Diabetic Retinopathy (DR) ; AND 4. Member has tried and failed bevacizumab (Avastin) intravitreal injection (Exception: not required for diagnosis of DME when visual acuity is worse than 20/50); AND 5. Documentation of best-corrected visual acuity (B CVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated. 7. Dosage allowed/Quantity limit: Eylea , Pavblu: AMD: 2 mg every 4 weeks for 3 months, then 2 mg every 8 weeks. RVO: 2 mg every 4 weeks. DME or DR: 2 mg every 4 weeks for the first 5 injections, then 2 mg every 8 weeks. Note: Eylea, Pavblu supplied as a 2 mg/0.05 mL single-dose vial or pre-filled syringe. Eylea HD :
OH-MED-P -366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Darzalex Faspro (daratumumab and hyaluronidase-fihj)BENEFIT TYPE Medical STATUS Prior Authorization Required Darzalex Faspro is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase used to increase the dispersion and absorption of co-administered drugs, indicated for the treatment of adult patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone (CyBorD) in newly diagnosed patients. In 2021 it became the first drug approved for treating AL amyloidosis. Approval was based on the ANDROMEDA study in which patients treated with CyBorD plus daratumumab experienced a significantly higher rate of complete hematologic response compared to the CyBorD alone group. There is also evidence to support off label use in relapsed cases.Amyloidosis is a group of protein misfolding disorders characterized by deposition of insoluble protein fibrils in organs and tissues and loss of normal protein function. There are multiple forms of systemic amyloidosis, with AL amyloidosis (also known as light-chain amyloidosis) as the most common type. AL amyloidosis occurs from an abnormality of plasma cells in bone marrow and is closely related to multiple myeloma. Darzalex Faspro (daratumumab and hyaluronidase-fihj) will be considered for coverage when the following criteria are met:Light Chain AmyloidosisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a hematologist/oncologist; AND 3. Member meets ONE of the following: a. Newly diagnosed light chain amyloidosis with one or more organs affected (e.g., heart, kidney) AND medication will be used in combination with bortezomib, cyclophosphamide, and dexamethasone ; b. Relapsed light chain amyloidosis previously treated with at least one prior therapy (note: this is an off-label use) 4. Dosage allowed/Quantity limit : Newly diagnosed: 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously (1 single dose vial), in combination with bortezomib, cyclophosphamide, and dexamethasone as follows:
OH-M ED-P- 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Evkeeza (evinacumab-dgnb ) BENEFIT TYPE Medical STATUS Prior Authorization Required E vkeeza , approved by the FDA in 2021, is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first ANGPTL3 inhibitor to be approved. ANGPTL3 is a protein in the liver that has a role in regulating lipid metabolism. Its inhibition reduces LDL, HDL, and triglycerides. E vkeeza (evinacumab-dgnb) will be considered for coverage when the following criteria are met: H omozygous Familial H ypercholesterolemia (HoFH) For initial authorization: 1.Member is at least 5 years of age ; AND2. Medication must be prescribed by or in consultation with a lipid specialist or cardiologist; AND3. Member has a diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by one of the following:a) Genetic testing confirmation of two mutant alleles in the LDLR, Apo-B, PCSK9, or LDLRAP1 gene l ocus; ORb) LDL-C > 400 mg/dL before any lipid-lowering drug treatment AND at least one of the following:i) Cutaneous or tendon xanthoma before 10 years of age; and/or ii) Evidence of heterozygous FH in both parents ; AND4. Chart notes must include documentation of baseline LDL-C above goal within the past 90 days; AND5. Member is unable to achieve LDL-Cgoal (see Note) after 8-week trials with ALL of the following:a) High-intensity /max-tolerated statin in combination with ezetimibe (unless there is documentati on of clearly established statin intolerance or statin contraindicationsee note* ); andb) PCSK9 inhibitor (e.g., Repatha or Praluent; prior authorization required) unless there is evidenc e of no LDL receptor function (receptor-negative type HoFH ) or the member does not meet thelabeled age of PCSK9 inhibitors ; AND6. Evkeeza will be used as an adjunct to other lipid-lowering treatments (e.g., statin, ezetimibe, PCSK9inhibitor, LDL apheresis), unless contraindicated or intolerant ; AND7. Prescriber attests that the member will adhere to a low-fat diet and exercise regimen; AND8. Evkeeza is not being concomitantly initiated with Juxtapid.9. Dosage allowed/Quantity limit: 15 mg/kg IV infusion once monthly .NO TE: The LDL-Cgoals for adults are
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Pombiliti (c ipaglucosidase alfa-atga ) andOpfolda (miglustat) BENEFIT TYPE Medical STATUS Prior Authorization Required Pombiliti and Opfolda, approved by the FDA in 2023, are indicated to be used in combination for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing 40 kg and who are not improving on their current enzyme replacement therapy (ERT) . Pombiliti provides an exogenous source of the deficient GAA enzyme , and Opfolda is an enzyme stabilizer. Pompe disease is a rare, genetic lysosomal storage disorder that results in the buildup of glycogen in cell lysosomes causing serious and life-threatening muscle damage and weakness . It can be broadly classified as infantile onset within the first few months of life (IOPD) or late onset beyond infancy (LOPD). Classic IOPD is rapidly progressive with severe cardiomyopathy. Non-classic IOPD progresses slower with less severe cardiomyopathy. LO PD does not typically present with cardiomyopathy and has more vari able symptoms, especially skeletal muscle weakness. Pombiliti and Opfolda are only indicated to treat LOPD. Of note, miglustat is also the active ingredient in Zavesca, which is approved for Gaucher disease.Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) will be considered for coverage when the following criteria are met:Pompe DiseaseFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a geneticist, neurologist, pulmonologist, or metabolic specialist ; AND 3. Pombiliti and Opfolda are being prescribed in combination; AND 4. Member has a diagnosis of late onset Pompe disease confirmed by an enzyme activity assay showing GAA deficiency (2% to 40% of normal); AND 5. Molecular genetic testing shows pathogenic mutation of the GAA gene; AND 6. Member is not improving on their current enzyme replacement therapy (i.e., Lumizyme or Nexviazyme); AND 7. Member must show signs or symptoms (i.e., motor weakness, reduced respiratory parameters) ; AND 8. Documentation of baseline percent-predicted forced vital capacity (FVC) and 6-minute walk test (6MWT) ; AND 9. If female, attestation that the member is not pregnant. 10. Dosage allowed/Quantity limit: Starting 2 weeks after the last ERT dose: Pombiliti: 20 mg/kg every other week IV infusion Opfolda: Orally every other week; 260 mg for patients weighing 50 kg or 195 mg for patients weighing 40 kg to
Medical Necessity f or Multi-Source Brands Ohio Medicaid PAD-0005-OH-MCD Ef f ective Date: 03/01/2025 4 Ref er to the p ro d uct p ackag e insert f o r d o sing , ad ministratio n and saf ety g uid elines . E. Con dition s of CoverageAs ab o ve.F. Related Policies/Ru lesMed ical Necessity Of f Lab elG. Review/Revision HistoryDAT ES ACT ION Date Issued 0 8/ 0 1/ 20 18 Date Revised 08/01/2020 Reviewed co ntent, transf erred to new temp late, ad d ed no te ab o ut no n-co verag e o f o f f-lab el/no n-sup p orted use. 10/28/2022 Sectio n D, p art I: Chang ed b ullet A to ad d ress inef f icacy rather than ad verse events, since ad verse events are ad d ressed in p art II. Created criteria to sp ecif y d uratio ns o f ap p ro val and req uirements f o r re-autho rizatio n. Mad e g rammatical/wo rd ing chang es f o r read ab ility. 3/1/2023 Ad d ed no te o n EPSDT. 5/21/2024 Annual review, no up d ates 8/27/2024 8 S G D W H G S R O L F W R 0 H G L F D O 1 H F H V V L W I R U 0 X O W L-so urce % U D Q G V U H P R Y H G U H I H U H Q F H V W R I R U P X O D U $ S S U R Y H G b y ODM 11/28/24) Date Effective 03/01/2025 Date Archived H. Referen ces1. d eShazo RD, Kemp SF. Allerg ic reactio ns to d rug s and b io lo g ic ag ents. JAMA.1997;278:1895 90 6. This guideline contains custom content that has been m odif ied f rom the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The Administrative Po l i c y St a t e m e nt d e t ai l e d a bo v e h a s r ecei v e d due c on si d e ra t i o n a s d e f i n e d i n the Administrative Po li c y St a t e m e nt Po li c y a nd i s a pp r o v e d.
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Xeomin (incobotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Xeomin is a neurotoxin produced from Clostridium botulinum serotype A. Xeomin works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. Blepharospasm is the abnormal contraction of eyelids. Xeomin is indicated for the treatment or improvement of blepharospasm in adults . 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. Xeomin is indicated for the treatment or improvement of cervical dystonia in adults. Chronic sialorrhea, or excessive drooling, is a common symptom for patients with Parkinsons Disease or other neurological or cognitive impairments. Xeomin is indicated for the treatment or improvement of chronic sialorrhea in patients 2 years of age and older . Xeomin is also indicated for the treatment or improvement of upper limb spasticity in adults and in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy . Xeomin (incobotulinumtoxinA) will be considered for coverage when the following criteria are met: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: Not to exceed 50 units per eye (100 units per treatment session) every 12 weeks. 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. , lessening of involuntary contraction). If all the above requirements are met, the medication will be approved for an additional 12 months. Cervical 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 12 weeks, divided among affected muscles. If all the above requirements are met, the medication will be approved for 6 months . OH-MED-P-366685For reauthorization :1. Chart notes must show 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 . C hronic SialorrheaFor initial authorization: 1. Member is at least 2 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). 5. Dosage allowed /Quantity limit : May repeat no sooner than every 16 weeks . Adult : Pediatric : If all the above requirements are met, the medication will be approved for 16 weeks. For reauthorization : 1. Chart notes have been provided that show the member has improvement of signs and symptoms of disease. If all the above requirements are met, the medication will be approved for an additional 12 months . OH-MED-P-366685Spasticity (upper limb)For 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 limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try a conservative treatment approach such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed /Quantity limit: (adult and pediatric) Maximum of 400 units per treatment session, every 12 weeks. 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). If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Xeomin (incobotulinumtoxinA) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION 08/06/2018 New policy for Xeomin created. Age requirement removed for diagnoses of Cervical Dystonia and Upper Limb Spasticity. Criterion no infection at proposed injection site removed from Cervical Dystonia diagnosis; pain and abnormal head position requirements clarified and medications trial added. For Upper Limb Spasticity Ashworth scale requirement removed, post-stroke requirement and chart notes requirement of abnormal muscle tone documentation added. 04/05/2019 New indication of Chronic Sialorrhea added. Dose allowance increased for diagnosis of Cervical Dystonia. Trial of Botox removed form diagnosis of Blepharospasm. 06/09/2020 Edited criteria for Chronic Sialorrhea to more closely align with Myobloc simplified exclusion criteria and added trial of anticholinergics. Changed qty limit at top of document. 08/24/2020 Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing. Added reference. Cervical dystonia : Added age limit and specialist requirement. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Corrected the dose. Extended re-auth duration. Updated references. Spasticity : Added age and specialist. Added trial of conventional treatment. Extended initial auth duration. Corrected the dose. Added references. Label recently expanded to include pediatrics. 12/31/2020 Updated the age limit and dosing for chronic sialorrhea to include pediatric patients, per recent label change. Added a couple references. Changed from try 2 anticholinergics to try 1 anticholinergic. OH-MED-P-36668508/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Allowing higher dose for cervical dystonia. 11/14/2023 Cervical dystonia: removed Symptoms affect quality of life and daily functions. Updated references and clarified renewal criteria. 10/02/2024 Removed age and specialist for cervical dystonia and blepharospasm indications. References: 1. Xeomin [package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023. 2. Teasell R, et al. Evidence to practice: botulinum toxin in the treatment of spasticity post stroke. Top Stroke Rehabil. 2012 Mar-Apr;19(2):115-21. 3. Chen R, et al. Botulinum toxin for Post-stroke Limb Spasticity. Ischemic Stroke Therapeutics. 2016; 203-207. 4. Cameron MH, et al. Botulinum toxin for symptomatic therapy in multiple sclerosis. Curr Neurol Neurosci Rep. 2014 Aug;14(8):463. 5. Bavikatte G, Sit PL, Hassoon A. Management of Drooling of Saliva. BJMP. 2012;5(1):a507. [https://www.bjmp.org/content/management-drooling-saliva ]6. Pellegrini A, Lunetta C, et. al. Sialorrhea: How to manage a frequent complication of motor neuron disease. EMJ Neurol . 2015;3[1]:107-113. [ https://emj.emg-health.com/wp-content/uploads/sites/2/2018/02/Sialorrhoea-How-to – Manage-a- Frequent-Complication-of-Motor-Neuron-Disease.pdf ] 7. Jost WH, Friedman A, Michel O, et al. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism & Related Disorders . 2020;70:23-30. doi:10.1016/j.parkreldis.2019.11.024 8. 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 9. 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 10. Defazio G, Hallett M, Jinnah HA, Berardelli A. Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology . 2013;81(3):236-240. doi:10.1212/WNL.0b013e31829bfdf6 11. 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. 12. Seppi K, Chaudhuri KR, Coelho M, et al. Update on treatments for nonmotor symptoms of Parkinson's disease an evidence based medicine review. Movement Disorders . 2019;34(2):180-198. doi:10.1002/mds.27602 13. 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 14. 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 15. 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 Briumvi (ublituximab-xiiy)BENEFIT TYPE Medical STATUS Prior Authorization Required Briumvi, approved by the FDA in 2022, is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Maintenance doses ar e infused over one hour by the healthcare provider every 24 weeks.Briumvi (ublituximab-xiiy) will be considered for coverage when the following criteria are met:Relapsing forms of Multiple Sclerosis (MS)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 confirmed diagnosis of relapsing multiple sclerosis, including clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), or active secondary progressive disease (SPMS); AND 4. Member has documentation of at least one of the following: a) Inadequate response to at least one preferred disease-modifying MS drug b) Highly active disease (aggressive or rapidly evolving) in the expert opinion of the prescriber; AND 5. Member has tested negative for active hepatitis B, or a hepatologist has been consulted; AND 6. Briumvi will not be used concurrently with another disease-modifying agent for MS. 7. Dosage allowed/Quantity limit: First dose: 150 mg IV infusion Second dose: 450 mg IV infusion 2 weeks after first infusion Maintenance: 450 mg IV infusion 24 weeks after first infusion, and every 24 weeks thereafter. QL: 7 vials for the first 24 weeks, then 3 vials every 24 weeks going forward If all the above requirements are met, the medication will be approved for 12 months. For reauthorization : 1. Chart notes must show a positive clinical response to treatment (e.g., fewer relapses, reduced number or volume of brain lesions on MRI, slowed disability progression) 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 Vabysmo (faricimab-svoa)BENEFIT TYPE Medical STATUS Prior Authorization Required Vabysmo, initially approved by the FDA in 2022, is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) , Diabetic Macular Edema (DME) , or Macular Edema f ollowing Retinal Vein Occlusion (RVO) . It is administered by intravitreal injection by a physician. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of Ang-2 is thought to promote vascular stability and desens itize blood vessels to the effects of VEGF-A. Vabysmo was approved based on clinical trial results showing achievement of vision gains noninferior to Eylea.Vabysmo (faricimab-svoa) will be considered for coverage when the following criteria are met:Retinal DiseaseFor 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 one of the following conditions: a) Neovascular (wet) Age-Related Macular Degeneration (AMD) b) Diabetic Macular Edema (DME) c) Macular Edema Following Retinal Vein Occlusion (RVO) ; AND 4. Member has tried and failed bevacizumab intravitreal injection; AND 5. Documentation of best-corrected visual acuity (BCVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated . 7. Dosage allowed/Quantity limit: See package insert for full instructions. AMD : 6 mg every 4 weeks for 4 doses; adjust per clinical evaluation to an interval of every 4 to 16 weeks . Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . DME : 6 mg every 4 weeks for 4 to 6 doses; adjust per clinical evaluation to an interval of every 4 to 8 weeks. Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . RVO : 6 mg every 4 weeks for 6 months. QL: 1 vial or prefilled syringe per eye per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization :1. Chart notes must include documentation of improved or stabilized visual acuity . If all the above requirements are met , the medication will be approved for an additional 12 months.
OH-MED-P-366685 PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Rituximab (Rituxan, Truxima, Ruxience, Riabni) BENEF IT TYPE Medical ST AT US Prior Authorization Required Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surf ace of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Bcells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, Bcells may be acting at multiple sites in the autoimmune/inf lammatory process.Rituximab will be considered for coverage when the following criteria are met:Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) andMicroscopic Polyangiitis (MPA) For initial authorization: 1. Member is at le as t 2 y e ar s of age; AND 2. Medication mu st be prescribed by or in consultation with a nephrologist or rheumatologist; AND 3. Member h as a diagnosis of GPA or MPA; AND 4. Rituximab will be initiated in combination with glucocorticoids; AND 5. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 6. Dosage allowed/Quantity limit: IV inf usion Adult induction: 375 mg / m 2 once weekly f or 4 weeks Adult maintenance: Two 500 mg inf usions separated by 2 weeks, then 500 mg every 6 months Peds induction: 375 mg/m2 once weekly f or 4 weeks Peds Maintenance: Two 250 mg / m 2 inf usions separated by 2 weeks, then 250 mg / m 2 every 6 months If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization :1. Ch ar t notes demonstrate clinical improvement of disease signs an d symptoms. If all the above req uirement s are met , the medication will be approved for an additional 12 months.Pemphigus Vulgaris (PV)For initial authorization: 1. Member is 18 y e ar s old or older; AND 2. Must be prescribed by or in consultation with a dermatologist; AND 3. Member h as a documented diagnosis of moderate to severe PV; AND 4. Rituximab will be initiated in combination with a corticosteroid taper (unless contraindicated); AND OH-MED-P-366685 5. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 6. Dosage allowed/Quantity limit: Initial: Two 1000mg doses separated by 2 weeks; Maintenance: 500mg inf usion at month 12 and every 6 months thereaf ter or based on clinical evaluation. Relapse: 1000mg inf usion. Subsequent infusions may be administered no sooner t h an 16 weeks following the previous inf usion. If all the above req u iremen t s are met , the medication will be approved for 12 months. For reauthorization : 1. Ch ar t notes demonstrate clinical improvement of signs an d symp t o ms (e.g. healed lesions, f e wer new lesions, etc.) If all the above req uirement s are met , the medication will be approved for an additional 12 months. Rheumatoid Arthritis (RA)For initial authorization: 1. Member is 18 y e ar s old or older; AND 2. Medication is being prescribed by or in consultation with a rheumatologist; AND 3. Member h as a documented diagnosis of moderately-to severely-active RA; AND 4. Rituximab is being used in combination with methotrexate, or another non-biologic DMARD if unable to tolerate methotrexate; AND 5. Member must have inadequate response or intolerance to ONE or mo r e tumor necrosis factor (TNF) antagonists (e.g. adalimumab, etanercept, inf liximab) f or at least 3 months each. Note: TNF antagonists require prior authorization; AND 6. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 7. Dosage allowed/Quantity limit: Two 1000mg doses separated by 2 weeks; subsequent courses repeated no sooner than every 16 weeks (every 24 weeks is typical). If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization : 1. Ch ar t notes demonstrate improvement of RA signs an d symp t o ms (e.g. f e wer number of p ain f ul and swollen joints, achievement of remission, etc.) If all the above req uirement s are met , the medication will be approved for an additional 12 months. Acquired Thrombotic Thrombocytopenic Purpura (aT TP)For initial authorization: 1. Member is 18 y e ar s old or older; AND 2. Medication mu st be prescribed by or in consultation with a hematologist; AND 3. Member h as a presumptive or conf irmed diagnosis of aTTP including ALL of the f ollowing: a) Lab results showing thrombocytopenia (platelet count less t h an 150,000); OH-MED-P-366685 b) Microangiopathic hemolytic anemia (MAHA) conf irmed by p r es e nc e of schistocytes on blood s me ar ; c) Documentation of a PLASMIC score between 5 an d 7 (intermediate to high risk); 1. Testing shows an ADAMT S13 activity level less t h an 10%, OR test h as been ordered an d results are pending. 4. Members platelet count h as not responded af t e r at le as t 4 d ay s of p las ma exchange and glucocorticoid; AND 5. Rituximab is being used in addition to p las ma exchange an d glucocorticoid; AND 6. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 7. Dosage allowed/Quantity limit: 375mg/m2 once weekly f or 4 doses (of f label). If all the above req u iremen t s are met , the medication will be approved for 30 days. For reauthorization : 1. Member is experiencing a relapse of symp t o ms (thrombocytopenia an d MAHA); AND 2. ADAMT S13 activity is less t h an 20% ( lab report required). If all the above req u iremen t s are met , the medication will be approved for an additional 30 days. Neuromyelitis Optica Spectrum Disorder (NMOSD)For initial authorization: 1. Member is 18 y e ar s old or older; AND 2. Medication mu st be prescribed by or in consultation with a neurologist; AND 3. Member h as a diagnosis of NMOSD an d is seropositive f or aquaporin-4 (AQP4) IgG antibodies (documentation required); AND 4. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 5. Dosage allowed/Quantity limit: 1g on d ay 1 an d d ay 15, then 1g every 6 months (of f label) If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization : 1. Ch ar t notes mu st document disease stabilization, symptom improvement, and/or reduced frequency of relapses. If all the above req uirement s are met , the medication will be approved for an additional 12 months. OH-MED-P-366685 Generalized Myasthenia Gravis (gMG)For initial authorization: 1. Member is at le as t 18 y e ar s of age; AND 2. Medication mu st be prescribed by or in consultation with a neurologist; AND 3. Member meets ONE of the f ollowing: a) Member h as a documented diagnosis of gMG t h at is seropositive f or MuSK antibodies AND h as tried and f ailed corticosteroid treatment with or without a non-steroid immunosuppressant b) Member h as a documented diagnosis of refractory gMG t h at is seropositive f or AChR antibodies AND has tried and f ailed ALL of the f ollowing: pyridostigmine, corticosteroid, and at least 2 non-steroid immunosuppressives (e.g., azathioprine, mycophenolate mof etil, tacrolimus); AND 4. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 5. Dosage allowed/Quantity limit: Consult updated clinical literature f or recommendations. A v ar ie t y of regimens have shown ef f icacy. (Of f label use) If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization : 1. Ch ar t notes mu st document clinically meaningf ul improvement in symptom severity an d functioning compared to previous treatment. If all the above req uirement s are met , the medication will be approved for an additional 12 months. Multiple Sclerosis (MS)For initial authorization: 1. Member is at le as t 18 y e ar s of age; AND 2. Medication mu st be prescribed by or in consultation with a neurologist; AND 3. Member h as a diagnosis of MS, including documentation of baseline relapse r at e , lesion count, and/or disability status (e.g., EDSS); AND 4. Member h as documentation of ONE of the f ollowing: a) For primary progressive MS (PPMS): Tr ial an d f ailure of Ocrevus b) For relapsing f o r ms of MS (RMS): Trial an d f ailure of at le as t 2 pref erred d is eas e-modifying drugs indicated f or MS; AND 5. Rituximab will not be used concurrently with another disease-modif ying drug f or MS; AND 6. If the request is f or a non-pref erred product, member has had a trial of a pref erred product where applicable, or acceptable clinical reason mu st be provided as to why it cannot be used. See Appendix A f or named pref erred and non-pref erred products. 7. Dosage allowed/Quantity limit: Consult updated clinical literature f or recommendations. ( Of f label use) If all the above req u iremen t s are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes mu st indicate a positive clinical response such as lower relapse r at e compared to baseline (i.e., f or RMS) or overall stability of disease (i.e., f or PPMS). If all the above req uirement s are met , the medication will be approved for an additional 12 months. OH-MED-P-366685 Immune Thrombocytopenia (IT P)For initial authorization: 1. Medication is prescribed by or in consultation with a hematologist; AND 2. Member h as a documented diagnosis of ITP of at le as t 6 months duration; AND 3. Members platelet count is