Administrative Policy StatementINDIANA MEDICAID Policy Name Policy Number Date Effective Medical Necessity for DAW PAD-00 07-IN-MCD 03/16/2026 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Administrative Policy Statement s 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 document used to make the determination. Table of Contents Administrative Policy Statement ……………………………………………………………………………………… 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 2 E. Conditions of Coverage …………………………………………………………………………………………… 3 F. Related Policies/Rules …………………………………………………………………………………………….. 4 G. Review/Revision History ………………………………………………………………………………………….. 4 H. References ……………………………………………………………………………………………………………. 4 Medical Necessity for DAW Indiana MedicaidPAD-0007-IN-MCD Effective Date: 03/16/2026 2 1. Subject CareSource uses a state unified preferred drug list (SUPDL) medication list that is established by the Indiana Health Coverage Program (IHCP) Pharmacy Services program and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee. The SUPDL is reviewed routinely by the Indiana Drug Utilization Review Committee and the Therapeutics Committee. A drug may be added or removed from the preferred list as determined by those committees. For new drugs or new indications for drugs, the P&T Committee generally reviews for clinical decisions after 180 days from market release. CareSource will follow the guidance of the state Medicaid programs in the states that it services to enforce clinical ly appropriate lower cost agents as first line therapy for preferred agents. 2. Background The intent of CareSource Pharmacy Policy Statements is to encourage appropriate selection of members for therapy according to product labeling, clinical guidelines, and/or clinical studies as well as to encourage use of preferred agents. The CareSource Pharmacy Policy Statement is a guideline for determining health care coverage for our members with benefit plans covering prescription drugs. Pharmacy Policy Statements are written on selected prescription drugs requiring prior authorization or step therapy. The Pharmacy Policy Statement is used as a tool to be interpreted in conjunction with the member's specific benefit plan. NOTE : The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic or lab. This policy informs providers about when a service may be covered.3. Definitions Allergic Reaction: an allergic reaction, as defined by the American Academy of Allergy Asthma & Immunology, occurs when the immune system overreacts to a harmless substance. Types of allergic symptoms to medications range from skin rashes or hives, itching , respiratory problems, and swelling to anaphylaxis. All medications have the potential to cause side effects, but only about 5 to 10% of adverse reactions to drugs are allergic.1 Clinical Judgment: decisions made within the scope of the expertise of a pharmacist following the review of subjective and objective medical data for a member. A pharmacist can use Clinical Judgment for a benefit determination for an exception request for a Non-Preferred Drug. If the request is outside the scope of a pharmacists expertise, a benefit determination will be made in collaboration with a medical director. DAW: dispense as written. Drug: a medication or substance which induces a physiologic effect on the body of a member (i.e., medication, agent, drug therapy, treatment, product, biosimilar drugs, etc.). Preferred Drug List: a list of prescription drugs which includes a group of selected generic and brand-name drugs which are covered by CareSource. Medical Necessity: health care services, supplies, or drugs needed to diagnose, treat or prevent illness, injury, conditions, diseases or the associated symptoms in accordance with accepted standards in the practice of medicine. Medical necessity will be e valuated based on the overall health and well-being of the member and when the members day to day health would be impacted. Non-Preferred Drug: a drug requiring trial of the preferred drug(s). Medical Necessity for DAW Indiana MedicaidPAD-0007-IN-MCD Effective Date: 03/16/2026 3 4. Policy CareSource will approve the use of DAW medications and consider their use as medically necessary when the following criteria have been met. This policy will not supersede drug-specific criteria developed and approved by the CareSource P&T Committee, the SUPDL, nor drug or therapeutic category benefit exclusions. Prior authorization requests should be submitted for each non-preferred medication with chart notes and documentation supporting medical necessity. I. The member had a serious adverse event with the generic version(s) and the prescriber has provided a copy and confirmation of a MedWatch form submission to the FDA documenting the adverse outcome experienced by the member that includes one of the following (Note: The MedWatch form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf ): A. Was life threatening B. Required hospitalization C. Caused disability or permanent damage D. Required intervention to prevent permanent impairment/damage OR II. Member has a history of allergic reaction to an inactive ingredient in the generic product and the prescriber has documented the inactive ingredient, the reaction (dates and clinical details), and the manufacturer of the generic product. III. Initial approval duration for DAW product request: up to 6 months IV. Subsequent approvals may be renewed for up to 12-month durations, such that chart notes are submitted with the request which clearly document all of the following: A. Initial criteria were previously met B. Positive clinical response to therapy with the requested brand name product C. No toxicities or serious adverse reactions have been experienced with the brand name product All other uses of Brand Name Medications are considered not medically necessary. Requests will not be approved for treatment of non-FDA approved diagnoses or conditions not supported by compendia evidence. Please refer to the Medical Necessity Off-Label policy. Notes: If the requested medication has a Medication Specific Policy, the member will need to meet those requirements in addition to the DAW policy. The start date and duration of the trial must be provided. There must be paid claims if the member was enrolled with CareSource when a trial of a medication occurred. Documented diagnoses must be confirmed by portions of the individuals medical record which need to be supplied with prior authorization requests. These medical records may include, but are not limited to test reports, chart notes from providers office, or hospital admission notes. Refer to the product package insert for dosing, administration and safety guidelines . 5. Conditions of Coverage As above. Medical Necessity for DAW Indiana MedicaidPAD-0007-IN-MCD Effective Date: 03/16/2026 4 6. Related Policies/Rules Medical Necessity Off Label 7. Review/Revision History DATES ACTIONDate Issued 08/01/20 18Date Revised 08/01/2020 Reviewed content, transferred to new template, added note about non-coverage of off-label/non-supported use. 10/28/2022 Section D, part I: Changed bullet A to address inefficacy rather than adverse events, since adverse events are addressed in part II. Created criteria to specify durations of approval and requirements for re-authorization. Made grammatical/wording changes f or readability.5/21/2024 Updated definition of non-preferred, added reference to state SUPDL. 12/1/2025 Removed trial of two generics and preferred alternatives. Added reference to 405 IAC 5-24-8.Date Effective 03/16/2026Date Archived 8. References 1. deShazo RD, Kemp SF. Allergic reactions to drugs and biologic agents. JAMA. 1997;278:1895906. 2. 405 AC 5-24-8 Prior authorization; brand name drugs. Accessed December 1, 2025. https://iar.iga.in.gov/code/2026/405/5#405-5- 24-8. This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The Administrative Policy Stateme nt detai led above has r eceived due consi deration as defined in the AdministrativePolicy Stateme nt Po licy a nd is a pprove d.
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Bevacizumab (Alymsys, Avastin, Mvasi, Zirabev)BILLING CODE See below BENEFIT TYPE Medical STATUS Prior Authorization Required Bevacizumab was initially approved by the FDA in 2004 as Avastin. Since then, the FDA approved Mvasi (2017), Zirabev (2019), Alymsys (2022), and Vegzelma (2022) as biosimilars to Avastin. Bevacizumab is approved for use in the treatment of metastatic color ectal cancer. All oncology treatments, including bevacizumab, must be submitted to Eviti Connect for review via the NantHealth Eviti Connect portal . For additional information and details, please refer to the CareSource policystatement Oncology Treatment Regimen Review. Approval of Avastin, Alymsys, or Vegzelma requires trial of Mvasi and Zirabev. The off-label use of Avastin (bevacizumab) for intravitreal use is considered safe and efficacious by the ophthalmologic community as reported by the American Academy of Ophthalmology (AOO). While Avastin (bevacizumab) has not been FDA approved for ophthalmic indications, compelling evidence has been published of its widespread clinical use for the following conditions: Choroidal neovascularization (CNV) in age-related macular degeneration (AMD) Proliferative diabetic retinopathy Neovascular glaucoma Diabetic macular edema Retinal and iris neovascularization Macular edema following branch and central retinal vein occlusions CareSource considers the use of Avastin (bevacizumab) in Ophthalmology medically reasonable and necessary only when furnished by a qualified Ophthalmologist. Reimbursement under this policy is dependent on, but not limited to meeting the following: Billing codes J3490 and J3590 will be reimbursed as follows, when billed with NDC 50242-0061-01 or 50242-0060-01: 1. For units 1 to 1.25 (billed in mg), reimbursement is up to $70.00 per eye, per calendar month 2. For units 2 to 2.50 (billed in mg), reimbursement is up to $140.00 for both eyes, per calendar month No prior authorization is required for claims less than $8,000 It is the responsibility of the submitting provider to submit accurate documentation of services performed. Providers are expected to use the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion o f a code in a policy does not imply any right to reimbursement or guarantee claims payment. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION12/13/ 2022 New policy for Avastin (bevacizumab) use in ophthalmology billing guidance 10/5/2023 Added trial of Mvasi and Zirabev . Added link to Eviti Connect portal. 1/9/2025 Removed billing code J7999 (not covered). 12/1/2025 Clarified billing units and cost threshold. References: 1. Alymsys. Package insert . Amneal Pharmaceuticals LLC; 2022. 2. Avastin. Package insert. Genentech; 2004. 3. Mvasi. Package insert. Amgen Inc; 2017. 4. Zirabev . Package insert. Pfizer Inc; 2019. 5. What is Avastin https://www.aao.org/eye-health/drugs/avastin 6. “Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices-Information Sheet. (2018, July 12). Retrieved October 29, 2018, from https://www.fda.gov/regulatoryinformation/guidances/ucm126486.htm 7. Avastin Prescribing Information https://www.gene.com/download/pdf/avastin_prescribing.pdf 8. CMS Billing and Coding: Bevacizumab and biosimilars https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52370&keyword=&areaId=all&docType=6,3,5,1,F,P&contractOption=all&hcp csOption=code&hcpcsStartCode=J9035&hcpcsEndCode=J9035&sortBy= title&bc=1#:~:text=Bevacizumab%20sh ould%20be%20reported%20with,MVASI)%2C%2010%20mg). 9. CMS Intraocular Bevacizumab Billing and Coding Guidelines https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53008&ver=35& Effective date: 0 4/01/2024 Revised date: 12/01/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Ap proved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Yeztugo (lenacapavir)BENEF IT TYPE Medical ST AT US Prior Authorization Required Yeztugo is a human immunodef iciency virus type 1 (HIV-1) capsid inhibitor indicated f or pre exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk f or HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo.Yeztugo (lenacapavir) will be considered for coverage when the following criteria are met:Pre exposure Prophylaxis (PrEP) of HIV InfectionFor initial authorization: 1. Member is at least 16 years of age and 35 kg or more; AND 2. Provider attests member is at risk f or HIV inf ection; AND 3. Member has had or will have a negative HIV RNA test bef ore initial and subsequent injections ; AND 4. Member is not a candidate f or oral PrEP therapy (ex. dif f iculty with adherence, signif icant renal disease, trouble swallowing pills etc.) . 5. Dosage allowed/Quantity limit: Maintenance quantity limit: 2 injections per 6 months. If all the above requirements are met, the medication will be approved for 12 months. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Ap proved: 5/16/2023For reauthorization :1. Member has had or will have a negative HIV RNA test bef ore injections. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Yeztugo (lenacapavir) 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/DESCRIPTION07/08/2025 New policy f or Yeztugo (lenacapavir) created. 09/19/2025 Added requirement that member is not a candidate f or oral PrEP with examples. Ref erenc es : 1. Yeztg uo [p res c rib ing inf o rmatio n]. Gilead Sc ienc es , Inc .; 2025. 2. Cho u R, Sp enc er H, Bougatsos C, Blazina I, Ahmed A, Selph S. Preexpos ure Prophy lax is f o r the Prev entio n o f HIV: Up d ated Evidence Report and Sys tematic Rev iew f o r the US Prev entiv e Serv ic es Tas k Fo rc e [p ub lis hed c o rrec tio n ap p ears in JAMA. 2023 No v 14;330(18):1805. d o i: 10.1001/jama.2023.19501.]. JAMA . 2023;330(8):746-763. d o i:10.1001/jama.2023.9865 3. Centers f o r Dis eas e Co ntro l and Prev entio n. Clinic al Guid anc e f o r PrEP. http s ://www.c d c .g o v /hiv nex us /hc p /p rep /ind ex .html. Ac c es s ed July 8, 2025. 4. Bek k er LG, Das M, Ab d o o l Karim Q, et al. Twic e-Yearly Lenac ap av ir o r Daily F/TAF f o r HIV Prev entio n in Cis g end er Wo men. NEngl JMed. 2024;391(13):1179-1192. d o i:10.1056/NEJ Mo a2407001 5. Kelley CF, Ac ev ed o-Quio nes M, Ag wu AL, et al. Twic e-Yearly Lenac ap av ir f o r HIV Prev entio n in Men and Gend er-D iv ers e Pers o ns . NEngl JMed. 2025;392(13):1261-1276. d o i:10.1056/NEJ Mo a2411858 6. Gand hi RT, Land o vitz RJ , Sax PE, et al. Antiretroviral Drug s for Treatment and Prev ention of HIV in Ad ults : 2024 Rec o mmend atio ns o f the Internatio nal Antiv iral So c iety-USA Panel. JAMA . 2025;333(7):609-628. d o i:10.1001/jama.2024.24543 Ef f ec tiv e d ate: 01/01/2026 Rev is ed d ate: 09/19/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP A pproved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tavalisse (fostamatinib disodium hexahydrate)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Tavalisse , approved by the FDA in 2018, is a kinase inhibitor indicated f or the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insuf f icient response to a previous treatment . It has demonstrated activity against spleen tyrosine kinase (SYK), and the active metabolite (R406) reduces antibody-mediated destruction of platelets. Approval was based on the FIT clinical trial program. Immune thrombocytopenia (ITP) is a rare autoimmune disorder characterized by low levels of platelets due to platelet destruction and insuf ficient platelet production. ITP duration of less than 3 months is ref erred to as newly diagnosed, 3-12 months as persistent, and greater than 12 months is considered chronic.Tavalisse (fostamatinib disodium hexahydrate) will be considered for coverage when the following criteria are met:C hronic Immune Thrombocytopenia (IT P)For initial authorization: 1. Member is at le as t 1 8 years of age; AND 2. Medication must be prescribed by or in consultation with a hematologist; AND 3. Member has a documented diagnosis of chronic ITP of at least 6 months duration; AND 4. Member had an inadequate response, intolerance, or contraindication to documented prior therapy with at least one of the f ollowing treatments: a) Corticosteroids ( i.e., prednisone, prednisolone, methylprednisolone, dexamethasone) b) Immunoglobulins c) Splenectomy; AND 5. Member has tried and f ailed treatment with a thrombopoietin receptor agonist (T PO-RA) ( e.g., Promacta, Nplate, Doptelet ); AND 6. Member meets one of the f ollowing: a) Current platelet count is 60 years), other clearly identif ied comorbidity). 7. Dosage allowed/Quantity limit: Initiate at 100 mg orally twice daily . Af ter 4 weeks, increase to 150 mg twice daily, if needed, to achieve platelet counts of at least 50 x 10 9 /L as necessary to reduce the risk of bleeding. QL: 60 tablets/30 days IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP A pproved: 5/16/2023Note : Discontinue Tavalisse af ter 12 weeks of treatment if the platelet count does not increase to a level suf f icient to avoid clinically important bleeding. If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes include documentation of achieving and maintaining a platelet count of at least 50 x 10 9/L. If all the above requirements are met , the medication will be approved for an additional 12 months.CareSource considers Tavalisse (fostamatinib disodium hexahydrate) 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 08/31/2018 New policy f or Tavalisse created. 02/02/2023 Transf erred policy to new template. Updated and added ref erences. Changed disease duration of at least 3 months to at least 6 months to match def inition of chronic disease more closely. Added Doptelet as a TPO-RA option with Promacta, Nplate. Changed platelet count of
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Sylvant (siltuximab)BENEF IT TYPE Medical ST AT US Prior Authorization Required Sylvant, approved by the FDA in 2014, is an interleukin 6 (IL-6) antagonist indicated f or the t r e at me nt of patients with multicentric Castlemans disease (MCD) who are human immunodef iciency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Castleman Disease (CD) is a rare lymphoprolif erative disorder in which benign growths f orm in lymph node tissue. It is also associated with a number of malignancies. It c an be unicentric or multicentric; MCD is f urther subtyped as human herpesvirus-8 (HHV-8) positive or as idiopathic. Symp t o ms r ange f rom mild to severe to lif e-threatening and involve systemic inf lammatory symptoms, polyclonal lymphoprolif eration, cytopenias, and multiple organ system dysf unction. Sylvant is a f irst line treatment f or CD per NCCN (cat egory 2a) and is the pref erred treatment per international guidelines (cat egory 1 ).Sylvant (siltuximab) will be considered for coverage when the following criteria are met:Multicentric Castlemans Disease (MCD)For initial authorization: 1. Medication must be prescribed by or in consultation with a hematologist or oncologist; AND 2. Member has a documented diagnosis of multicentric Castlemans Disease ; AND 3. Member has active disease, with presence of signs/symptoms ; AND 4. Member is human immunodef iciency virus (HIV) negative (lab report required); AND 5. Member is human herpesvirus-8 (HHV-8) negative (lab report required). 6. Dosage allowed/Quantity limit: 11 mg/kg by IV inf usion every 3 weeks until treatment f ailure. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes indicate that disease has not progressed (based on labs, symptoms, and tumor response). If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Sylvant (siltuximab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION06/06/2025 New policy f or Sylvant created. Ref erenc es : 1. Sy lv ant [p res c rib ing inf o rmatio n]. Rec o rd ati Rare Dis eas es Inc . ; 2024. 2. Natio nal Co mp rehens iv e Canc er Netwo rk . Cas tleman Dis eas e. (V ers io n 2.2025). http s ://www.nc c n.o rg /p ro f es s io nals /p hy s ic ian_g ls /p d f /c as tleman.p d f . Ac c es s ed June 6, 2025. 3. v an Rhee F, Ro s enthal A, Kanhai K, et al. Siltuximab is as s o c iated with imp ro v ed p ro g res s io n-f ree s urv iv al in id io p athic multic entric Cas tleman d is eas e. Blood Adv . 2022;6(16):4773-4781. d o i:10.1182/b lo o d ad v anc es .2022007112 4. Fajg enb aum DC, Uld rick TS, Bagg A, et al. International, ev idence-based c onsensus d iagnos tic c riteria f o r HHV-8 -neg ativ e/idiopathic multicentric Cas tleman disease. Blood. 2017;129(12):1646-1657. d o i:10.1182/b lo o d-2016-10-746933 5. v an Rhee F, Vo o rhees P, Dispenzieri A, et al. International, ev idence-based c onsensus treatment g uid elines f o r id io pathic multicentric Cas tleman disease. Blood. 2018;132(20):2115-2124. d o i:10.1182/b lo o d-2018-07-862334 Ef f ec tiv e d ate: 01/01/2026 Rev is ed d ate: 06/06/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Appr oved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Rivfloza (nedosiran)BENEFIT TYPE Medical or Pharmacy STATUS Prior Authorization Required Rivfloza , approved by the FDA in 202 3, is an LDHA-directed small interfering RNA indicated to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR 30 mL/min/1.73 m 2. PH1, which is caused by mutations of the AGXT gene, is a rare autosomal recessive disease that mainly affects the kidneys. It results from buildup of oxalate, which normally is filtered through the kidneys and excreted in the urine. Stone formation (calciu m oxalate) in the kidneys and urinary tract occurs, as well as elevated levels of calcium in the kidneys. Eventually, if kidney function declines far enough, oxalate can start to accumulate in other body tissues, leading to a variety of problems (systemic oxalosis). Rivfloza (nedosiran) will be considered for coverage when the following criteria aremet:Primary Hyperoxaluria Type 1 (PH1)For initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication must be prescribed by or in consultation with a urologist or nephrologist ; AND 3. Member has a diagnosis of primary hyperoxaluria type 1 confirmed by g enetic testing that shows a mutation in the AGXT gene ; AND 4. Member has documentation of elevated urinary oxalate levels (24-hour Uox excretion 0.7 mmol (per 1.73 m2 body surface area [BSA] in age
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP App roved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Radicava (edaravone injection); Radicava ORS (edaravone oral suspension)BENEFIT TYPE Medic al : injec tion; Pharm ac y : suspension STATUS Prior Authorization Required Rad ic av a is a pyrazolone f ree radical scavenger initially approved by the FDA in 2017 as an IV f ormulation. It is the second drug to be approved f or the treatment of patients with Amyotrophic Lateral Sclerosis (ALS) behind Riluzole. In 2022, the FDA approved a new oral suspension f ormulation, Radicava ORS.ALS, also known as Lou Gehrigs disease, is a f atal, progressive neurodegenerative disorder in which motor neuron loss leads to muscle weakness, with most patients succumbing to respiratory failure. Although the exact mechanism of action is unknown, it is hypothesized Radicava works via a mechanism involving antioxidants, which nullif ies the oxidative stress believed to be involved in ALS. Radicava (edaravone) will be considered for coverage when the following criteria are met: Amyotrophic Lateral Sclerosis (ALS) 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 or neuromuscular specialist; AND 3. Member must have detailed chart notes conf irming diagnosis of Definite or Probable ALS based on El Escorial revised criteria (see appendix) ; AND 4. Member s diagnosis of ALS has been present f or a duration of 2 years or less ; AND 5. Member must have a baseline percent f orced vital capacity (FVC%) of 80% or greater; AND 6. Member must have a baseline score of 2 points or greater f or each individual item of the ALS Functional Rating Scale-Revised (ALSFRS-R) , i.e., a total score of at least 24. 7. Dosage allowed/Quantity limit: Rad ic av a: 60 mg (two 30 mg bags) administered as an IV inf usion as f ollows: Initial treatment cycle: daily dosing f or 14 days f ollowed by a 14-day drug-f ree period; Subsequent treatment cycles: daily dosing f or 10 days out of 14-day periods, f ollowed by 14-day drug-f ree periods. Quantity Limit: 20 bags per 28 days Rad ic av a ORS :105 mg (5 mL) orally or via f eeding tube as f ollows: Initial treatment cycle: daily f or 14 days f ollowed by a 14-day drug-f ree period; Subsequent treatment cycles: daily dosing f or 10 days out of 14-day periods, f ollowed by 14-day drug-free periods. Quantity limit: 50mL per 28 daysIf all the above requirements are met, the medication will be approved for 6 months.IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP App roved: 5/16/2023For reauthorization :1. Member has documentation of disease stability or clinical benef it f rom therapy, such as improved ALS f unctional rating scale score or no rapid disease progression while on therapy; AND 2. Member does not require invasive ventilation. If all the above requirements are met, the medication will be approved for an additional 12 months. Appendix : CareSource considers Radicava (edaravone) 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/DESCRIPTIONIN-MED-P-366647a; Issued Date: 6/1/2023 OMPP App roved: 5/16/202305/16/2017 New policy f or Radicava created.09/15/2017Disease duration and percent-predicted f orced vital capacity (%FVC) requirements were removed. ALSFRS-R score requirement was modif ied. 08/23/2022Annual Review. Transf erred to new f ormat. Added Jcode Added new oral f ormulation dosing. Clarif ied reauthorization criteria. Added neurology specialty prescriber. Added age requirement. Reduced initial authorization duration to 6 months. Removed exclusion criteria. Removed daily f unction requirement and clarif ied ALSFRS-R criteria. Updated ref erences. 06/17/2025 Updated and added ref erences. Removed physician specializing in ALS; added neuromuscular specialist . Specif ied which product goes under which benef it type. Ref erenc es : 1. Rad ic av a [p ac k ag e ins ert]. Mits ub is hi Tanab e Pharma Americ a, Inc .; 2022. 2. ALS Func tio nal Rating Sc ale. Av ailab le at: http://www.outcomes-umas s med .o rg /als /als s c ale.as p x.3. ALS As s o c iatio n. El Es c o rial Wo rld Fed eratio n o f Neuro lo g y c riteria f o r the d iag no s is o f ALS. www.als a.o rg /as s ets /p d f s /f y i/c riteria_f o r_d iag no s is-1.pdf . 4. Ab e, K., Ao k i, M., et al. Saf ety and ef f ic ac y o f ed arav o ne in well-d ef ined p atients with amy o tro p hic lateral s c lero s is : a rand omised, do ub le-blind, placebo-c o ntro lled trial. The Lanc et Neuro lo g y . 2017; 16(7), 505-512. 5. Witzel S, Maier A, Steinb ac h R, et al. Saf ety and Ef f ec tiv enes s o f Lo ng-term Intrav eno us Ad minis tratio n o f Ed arav o ne for Treatment o f Patients with Amy o tro p hic Lateral Sc lero s is . JAMA Neurol. 2022;79(2):121 130. 6. Shimizu H, Nis himura Y, Shiide Y, et al. Bioequivalence s tudy of oral s uspension and intravenous f o rmulatio n o f ed arav o ne in healthy ad ult s ub jec ts . Clin Pharmac ol Drug Dev . 2021;10(10):1188-1197 7. Van Damme P, Al-Chalab i A, And ers en PM, et al. Euro p ean Ac ad emy o f Neuro lo g y (EAN) g uid eline o n the manag ement o f amy o tro p hic lateral s c lero s is in c o llab o ratio n with Euro p ean Ref erenc e Netwo rk f o r Neuro mus c ular Dis eas es (ERN EURO-NMD ). Eur JNeurol . 2024;31(6):e16264. d o i:10.1111/ene.16264 8. EFNS Tas k Fo rce o n Diagnosis and Management of Amyotrophic Lateral Scleros is :, Anders en PM, Abrahams S, et al. EFNS g uidelines on the c linical management of amyotrophic lateral s clerosis (MALS) –rev is ed rep o rt o f an EFNS task f orce. Eur JNeurol . 2012;19(3):360-375. d o i:10.1111/j.1468-1331.2011.03501.x 9. Sho es mith C, Abrahao A, Benstead T, et al. Canad ian b est p rac tic e rec o mmend atio ns f o r the manag ement o f amy o tro p hic lateral s c lero s is . CMA J . 2020;192(46):E1453-E1468. d o i:10.1503/c maj.191721 10. Huang SL, Shen YL, Peng WY, Ye K, Zheng H. Ed arav o ne f o r p atients with amy o tro p hic lateral s c lero s is : a s y s tematic rev iew and meta-analys is . Acta Neurol Belg. 2024;124(3):895-904. d o i:10.1007/s 13760-024-02476-2 Ef f ec tiv e d ate: 01/01/2026 Rev is ed d ate: 06/17/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP A pproved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Gamifant (emapalumab-lzsg )BENEF IT TYPE Medical ST AT US Prior Authorization Required Gamif ant, approved by the FDA in 2018, is an interferon gamma (IFN) neutralizing antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with ref ractory, recurrent or progressive disease or intolerance with conventional HLH therapy. It is the f irst FDA approved drug indicated f or primary HLH. Gamif ant is also indicated to treat HLH/macrophage activation syndrome (MAS) in known or suspected Stills disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS . HLH is a r ar e , multi-organ syndrome characterized by immune dysregulation (of NK cells , CD8+ cytotoxic Tcells , and macrophages ) leading to hyperinf lammation. Primary HLH is caused by genetic def ects and typically manif ests during inf ancy or early childhood. It is f atal if lef t untreated. The mainstay of treatment f ocuses on immunosuppression and cytotoxic therapy. The objective is to suppress inflammation to allow for stem cell transplant. MAS is a secondary f orm of HLH, and is a severe, lif e-threatening complication of rheumatic diseases, most f requently in Stills disease (i.e., systemic juvenile idiopathic arthritis (sJIA) and adult-onset Stills disease (AOSD )). High-dose glucocorticoids are the main treatment.Gamifant (emapalumab-lzsg) will be considered for coverage when the following criteria are met:Primary H emophagocytic Lymphohistiocytosis (HLH)For initial authorization: 1. Medication must be prescribed by or in consultation with a hematologist; AND 2. Member has diagnosis of primary HLH with either ref ractory, recurrent, or progressive disease during conventional HLH therapy (e.g., dexamethasone with etoposide, cyclosporine A) or intolerance to conventional HLH therapy (Documentation required); AND 3. HLH diagnosis conf irmed by ONE of the f ollowing: a) Genetic testing b ) 5 out of 8 criteria f ulf illed: i) Fever ii) Splenomegaly iii) Cytopenias af f ecting at le as t 2 of 3 peripheral cell lines (hemoglobin 684 ng/mL, and b ) 2 of the f ollowing: i) Platelet count 181 x10 9/L ii) AST >48 U/L iii) Triglycerides > 156 mg/dL iv) Fibrinogen level 360 mg/dL; AND 4. Member meets one of the f ollowing: a) inadequate response or intolerance to high dose glucocorticoids b) recurrent MAS c) severe MAS with rapid worsening or lif e-threatening MAS; AND 5. Member does NOT have any of the f ollowing: a) Diagnosis of Primary HLH b ) Presence of malignanc y; AND 6. Member must have a negative TB test within 12 months prior to starting therapy . 7. Dosage allowed/Quantity limit: IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP A pproved: 5/16/2023M ay increase based on clinical and laboratory criteria , per prescribing information, up to a cumulative max of 10 mg/kg over 3 days. If all the above requirements are met , the medication will be approved for 8 weeks.For reauthorization :1. Chart notes must show response to treatment such as clinical resolution of MAS signs and symptoms and laboratory parameter endpoints . If all the above requirements are met , the medication will be approved for an additional 8 weeks.CareSource considers Gamifant (emapalumab-lzsg) 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/DESCRIPTION09/23/2019 New policy f or Gamif an t created. 09/21/2023 Updated template. Revised ref erences. Rearranged numbering. Added starting dose. Removed MTX, hydrocortisone f rom conventional therapy since they are not always used; added cyclosporine. Shortened renewal duration f rom 12 months to 6 months. Removed concomitant disease exclusion. Removed f amily history as diagnostic verif ication. 07/22/2025 Primary HLH: Added ref erence (La Rosee 2019). Removed vaccine requirement. Removed body weight f rom list of exclusions. Removed malignancy f rom exclusion list (redundancy). Simplif ied renewal criteria. Added new indication of HLH/MAS. Ref erenc es : 1. 2021 Geo rg ia Co de Title 33 Ins uranc e Chap ter 20A-Managed Health Care Plans A rt ic le 2-Patient' s Rig ht to Ind ep end ent Rev iew 33-20A-31 Def initio ns . Jus tia US Law. Ac c es s ed Ap ril 25, 2023. https://law.justia.com/codes/georgia/2021/title-33/c hap ter-20a/artic le-2/s ec tio n-33-20a-31/.2. Gamif ant [p res c rib ing inf o rmatio n]. Waltham, MA: So b i Inc .; 2025. 3. Lo c atelli F, Jo rd an MB, Allen C, et al. Emap alumab in Child ren with Primary Hemo p hag o c y tic Lymphohistiocytosis. NEngl JMed. 2020;382(19):1811-1822. d o i:10.1056/NEJ Mo a1911326 4. Henter JI, Ho rne A, Aric M, et al. HLH-2004: Diag no s tic and therap eutic g uid elines f o r hemo p hag o c y tic lymphohistiocytosis. Pediatr Blood Canc er. 2007;48(2):124-131. d o i:10.1002/p b c .21039 5. Ko nk ol S, Rai M. Ly mphohistio c y to s is . [Up d ated 2023 Mar 27]. In: StatPearls [Internet]. Treas ure Is land (FL): StatPearls Pub lis hing ; 2023 Jan- . Av ailab le f ro m: http s ://www.nc b i.nlm.nih.g o v /b o o k s /NBK557776/ IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP A pproved: 5/16/20236. Jo rd an MB, Allen CE, Greenb erg J, et al. Challenges in the diagnosis of hemo p hag o c y tic ly mp ho his tio c y to s is : Recommendations f rom the North American Consortium f or Histiocytosis (NACHO). Pediatr Blood Canc er . 2019;66(11):e27929. d o i:10.1002/p b c .27929 7. La Ro s e P, Ho rne A, Hines M, et al. Rec o mmend atio ns f o r the manag ement o f hemo p hag o c y tic lymp ho histio cyto sis in ad ults . Blood. 2019;133(23):2465-2477. d o i:10.1182/b lo o d .2018894618 8. De Bened etti F, Gro m AA, Bro g an PA, et al. Ef f ic ac y and s af ety o f emap alumab in mac ro p hag e ac tiv atio n s y nd ro me. Ann Rheum Dis . 2023;82(6):857-865. d o i:10.1136/ard-2022-223739 9. Fautrel B, Mitrov ic S, De Matteis A, et al. EULAR/PReS rec ommendations for the d iagnosis and manag ement o f Still' s disease, comprising sy stemic juvenile idiopathic arthritis and ad ult-o ns et Still' s d is eas e. Ann Rheum Dis . 2024;83(12):1614-1627. Pub lis hed 2024 No v 14. d o i:10.1136/ard-2024-225851 10. Shakoory B, Geerlinks A, Wilejto M, et al. The 2022 EULAR/ACR points to consider at the early stages of d iag no sis and management of s uspec ted haemophagoc ytic ly mphohistioc ytos is /mac rophage ac tiv ation sy ndrome (HLH/ MA S ). Ann Rheum Dis . 2023;82(10):1271-1285. d o i:10.1136/ard-2023-224123 Ef f ec tiv e d ate: 0 1/01/2026 Rev is ed d ate: 0 7/22/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Firazyr or Sajazir (icatibant)BENEF IT TYPE Medical or Pharmacy ST AT US Prior Authorization Required Firazyr , approved by the FDA in 2011, is a bradykinin B2 receptor antagonist indicated f or treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older . HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results f rom excess production of the vasodilator bradykinin. Attacks may be painf ul and cause f unct ional impairment but are not associated with pruritis. The most common types of HAE are caused by def iciency (type 1) or dysf unction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent. Firazyr is available as generic icatibant. Another brand name of icatibant is Sajazir.Icatibant will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by or in consultation with an allergist or immunologist; AND 3. Member has a diagnosis of HAE type I or type II conf irmed by both of the f ollowing: a) Low C4 level; b) Low (
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Ekterly (sebetralstat)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Ekterly , approved by the FDA in 2025, is a plasma kallikrein inhibitor indicated f or the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older . It is the f irst oral option f or treatment of acute HAE attacks. HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results f rom excess production of the vasodilator bradykinin. Attacks may be painf ul and cause f unct ional impairment but are not associated with pruritis. The most common types of HAE are caused by def iciency (type 1) or dysf unction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent.Ekterly (sebetralstat) will be considered for coverage when the following criteria are met:Hereditary AngioedemaFor initial authorization: 1. Member is at le as t 12 years of age; AND 2. Medication must be prescribed by or in consultation with an allergist or immunologist ; AND 3. HAE type I or type II conf irmed by both of the f ollowing: a) Low C4 level; b) Low (
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