IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana 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. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CareSource considers Niktimvo (axatilimab) 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 09/19/2024 New policy for Niktimvo created. References: 1. Niktimvo. [prescribing information]. Incyte Corporation; 2024. 2. National Comprehensive Cancer Network. Hematopoietic Cell Transplantation (HCT). Version 2.2024. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed September 20, 2024. Effective date: 06/30/2025 Revised date: 09/19/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana 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. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023References: 1. Daxxify [prescribing information] . Revance Therapeutics, Inc. ; 2023. 2. 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 3. 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: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-1826. doi:10.1212/WNL.0000000000002560 4. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia [published correction appears in JNeural Transm (Vienna). 2016 Mar;123(3):259]. JNeural Transm (Vienna) . 2016;123(3):251-258. doi:10.1007/s00702-015-1453-x 5. 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 6. 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 7. Solish N, Carruthers J, Kaufman J, Rubio RG, Gross TM, Gallagher CJ. Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs. 2021;81(18):2091-2101. doi:10.1007/s40265-021-01631-w Effective date: 06/30/2025 Revised date: 10/02/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Beovu (brolucizumab)BENEFIT TYPE Medical STATUS Prior Authorization Required Beovu was approved by the FDA in 2019 for the treatment of neovascular (wet) age-related macular degeneration (AMD). There are 2 forms of AMD, dry and wet (neovascular). Wet AMD 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. The goal of AMD treatment is to preserve visual function. Beovu is a vascular endothelial growth factor (VEGF) inhibitor administered by intravitreal injection. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability . In the Phase 3 studies HAWK and HARRIER, Beovu was noninferior to another VEGF inhibitor, Eylea (aflibercept), in the primary endpoint measuring change in best corrected visual acuity (BCVA). In 2022, Beovu gained an additional indication for diabetic macular edema (DME). DME occurs in many patients with diabetic retinopathy and causes fluid build-up in the macula part of the retina. In the KITE and KESTREL clinical trials, Beovu was noninferior to Eylea.Beovu (brolucizumab) will be considered for coverage when the following criteria are met:Retinal Disease For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of one of the following conditions: a) Neovascular (wet) age-related macular degeneration (AMD) b) Diabetic Macular Edema (DME) ; 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 any of the following: a) Active infection or inflammation around or in the affected eye(s) b) Uncontrolled glaucoma c) Recent eye surgery d) Concurrent use with another vascular endothelial growth factor (e.g., Eylea, Avastin, Lucentis) 7. Dosage allowed/Quantity limit: AMD: 6 mg by intravitreal injection monthly for the first 3 doses, then 6 mg once every 8-12 weeks. DME: 6 mg by intravitreal injection every 6 weeks for the first 5 doses, then 6 mg every 8-12 weeks. (Note: Each single dose vial provides 6 mg of drug). If all the above requirements are met , the medication will be approved for 6 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For 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. CareSource considers Beovu (brolucizumab) 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/DESCRIPTION04/24/2020 New policy for Beovu created. 10/20/2021 Transferred to new template. Updated references. Added baseline BCVA. Specified visual acuity in renewal criteria. 06/13/2022 Added new indication DME. 11/07/2024 Annual review; no updates. References: 1. Beovu [ prescribing information ]. Novartis Pharmaceuticals Corporation; 2024 . 2. Dugel , Pravin U. et al. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology, Volume 127, Issue 1, 72 84 3. Holekamp, Nanvy M. Review of Neovascular Age-Related Macular Degeneration Treatment Options. Am JManag Care. July 2019; 25: -S0 4. Flaxel CJ, Adelman RA, Bailey ST, et al. Age-Related Macular Degeneration Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(1):P1-P65. doi:10.1016/j.ophtha.2019.09.024 5. Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev . 2019;3(3):CD005139. Published 2019 Mar 4. doi:10.1002/14651858.CD005139.pub4 6. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology. 2020;127(1):P66-P145. doi:10.1016/j.ophtha.2019.09.025 7. Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev . 2018;10(10):CD007419. Published 2018 Oct 16. doi:10.1002/14651858.CD007419.pub6 Effective date: 06/30/2025 Revised date: 11/07/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Hyaluron ic Acid ViscosupplementsBENEFIT TYPE Medical STATUS Prior Authorization Required Osteoarthritis is a common chronic joint disorder involving cartilage degradation, bone remodeling, osteophyte formation, and synovial inflammation. These changes lead to pain, stiffness, swelling, and compromised functional capacity of the affected joint. The goal of treatment is to improve pain and mobility. Viscosupplementation is an intra-articular therapy that leverages the physiology of hyaluronic acid, a major component of normal synovial fluid, 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 variety of properties. They are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed 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 have been incongruent in their recommendations , but overall they are considered a safe and effective 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 for coverage when the following criteria are met:Osteoarthritis (OA) of the K neeFor initial authorization: 1. Member is at least 18 years of age; AND 2. Member has 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 interferes with normal daily activity such as walking, standing, or stair climbing; AND 4. Member has tried and failed ALL of the following conservative therapies for at least 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-articular corticosteroid injection (unless contraindicated); AND 5. Chart notes must indicate if the request is for the treatment of one or both knees; AND 6. Member has NOT had a total knee replacement (arthroplasty) and knee replacement is not anticipated for at least the next 6 months; AND 7. If the request is for a non-preferred product, trial and failure of at least 1 preferred product is required (see Appendix). 8. Dosage allowed/Quantity limit: Intra-articular injection to the affected knee(s) at weekly intervals. Euflexxa: 2 mL weekly for 3 weeks Durolane: 3 mL one time Gel-One: 3 mL one time Gelsyn-3: 2 mL weekly for 3 weeks Gen-Visc: 2.5 mL weekly for 3 to 5 weeks Hyalgan: 2 mL weekly for 3 to 5 weeks Hymovis: 3 mL weekly for 2 weeks IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Monovisc: 4 mL one timeOrthovisc: 2 mL weekly for 3 to 4 weeks Supartz FX: 2.5 mL weekly for 3 to 5 weeks Synvisc: 2 mL weekly for 3 weeks Synvisc-One: 6 mL one time TriVisc: 2.5 mL weekly for 3 weeks TriLuron: 2 mL weekly for 3 weeks Visco-3: 2.5 mL weekly for 3 weeks If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Chart notes must show clinically significant improvement of signs and symptoms such as documentation of improved pain scores, improved functional abilities, and/or reduced use of analgesic medications as a result of the treatment to the affected knee; AND 2. Symptoms have recurred and at least 6 months have elapsed since completion of the previous course of viscosupplementation; AND 3. Member has NOT had a total knee replacement (arthroplasty) and knee replacement is not anticipated for at least the next 6 months. If all the above requirements are met , the medication will be approved for an additional 6 months.CareSource considers h yaluronic 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 for hyaluron ic acid viscosupplements created ; combination and comprehensive update of past individual policies. 11/07/2022 Removed specialist requirement. 10/24/2024 Reviewed and updated references. No changes to criteria. APPENDIX: List of products and status (Y = preferred; N = non-preferred)Euflexxa sodium hyaluronate NDurolane hyaluronic acid Y Gel-One cross-linked hyaluronate N Gelsyn-3 sodium hyaluronate Y GenVisc 850 sodium hyaluronate N Hyalgan sodium hyaluronate N Hymovis high molecular weight viscoelastic hyaluronan N Monovisc high molecular weight hyaluronan N Orthovisc high molecular weight hyaluronan N Supartz FX sodium hyaluronate Y Synvisc hylan G-F 20 N Synvisc-One hylan G-F 20 N TriVisc sodium hyaluronate N TriLuron sodium hyaluronate N Visco-3 sodium hyaluronate N IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023References: 1. Euflexxa [package insert]. Ferring Pharmaceuticals, Inc.; 2016. 2. Durolane [package insert]. Bioventus LLC; 2017. 3. Gel-One [package insert]. Zimmer, Inc.; 2011. 4. Gelsyn-3 [package insert]. Bioventus; 2017 . 5. GenVisc 850 [package insert]. OrthogenRx. N.D . 6. Hyalgan [package insert]. Fidia Pharma USA Inc.; 2014. 7. Hymovis [package insert]. Fidia Pharma USA Inc.; 2017. 8. Monovisc [package insert]. Anika Therapuetics Inc. ; 2013. 9. Orthovisc [package insert]. Anika Therapeutics. N.d. 10. Supartz FX [package insert]. Bioventus LLC; 2015 11. Synvisc [package insert]. Genzyme Biosurgery; 2014. 12. Synvisc-One [package insert]. Genzyme Biosurgery; 2014. 13. TriVisc. [package insert]. OrthogenRx, Inc. 14. TriLuron. [package insert]. Fidia Pharma USA Inc.; 2019. 15. Visco-3. [package insert]. Bioventus LLC. 16. American Academy of Orthopaedic Surgeons Management of Osteoarthritis of the Knee (NonArthroplasty) Evidence-Based Clinical Practice Guideline. https://www.aaos.org/oak3cpg Published 08/31/2021 17. Uson J, Rodriguez-Garca SC, Castellanos-Moreira R, et al. EULAR recommendations for intra-articular therapies. Ann Rheum Dis . 2021;80(10):1299-1305. doi:10.1136/annrheumdis-2021-220266 18. Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee [published correction appears in Arthritis Care Res (Hoboken). 2021 May;73(5):764]. Arthritis Care Res (Hoboken) . 2020;72(2):149-162. doi:10.1002/acr.24131 19. Bellamy N, Campbell J, Robinson V, Gee T, Bourne R, Wells G. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev . 2006;2006(2):CD005321. Published 2006 Apr 19. doi:10.1002/14651858.CD005321.pub2 20. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578-1589. doi:10.1016/j.joca.2019.06.011 21. Trojian TH, Concoff AL, Joy SM, Hatzenbuehler JR, Saulsberry WJ, Coleman CI. AMSSM Scientific Statement Concerning Viscosupplementation Injections for Knee Osteoarthritis: Importance for Individual Patient Outcomes. Clin JSport Med . 2016;26(1):1-11. doi:10.1097/JSM.0000000000000274 22. Bruyre O, Honvo G, Veronese N, et al. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019;49(3):337-350. doi:10.1016/j.semarthrit.2019.04.008 23. Local Coverage Determination (LCD): Intraarticular Knee Injections of Hyaluronan (L39529). Centers for Medicare and Medicaid Services. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39529&ver=3&keywordtype=starts&keyword=hyaluron&bc=0. Accessed October 25, 2024. 24. Conrozier T, Diraogl D, Monfort J, et al. EUROVISCO Good Practice Recommendations for a First Viscosupplementation in Patients with Knee Osteoarthritis. Cartilage. 2023;14(2):125-135. doi:10.1177/19476035221138958 Effective date: 06/30/2025 Revised date: 10/24/2024
Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy StatementINDIANA MEDICAIDPolicy Name Policy Number Date Effective Medicaid Drug Rebate Program (MDRP) Coverage Rules-AC Reject PAD-0100-IN-MCD 01/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ………………………………………………………………………………………. 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ……………………………………………………………………………………………. 3 F. Related Policies/Rules …………………………………………………………………………………………….. 5 G. Review/Revision History …………………………………………………………………………………………… 5 H. References …………………………………………………………………………………………………………….. 5 AC Reject/Covered Outpatient Drug Under the Medicaid Drug Rebate Program (MDRP) INDIANA MEDICAID PAD-0100-IN-MCD Effective Date: 01/01/2025 A. Subject Medicaid Drug Rebate Programs (MDRP) agreement requirements, covered outpatient 2 drugs and the AC pharmacy claims reject code B. Background This policy serves as guidance for CareSource pharmacy staff on the Medicaid Drug Rebate Program as it relates to the definition of covered outpatient drugs and conditions for claims payment. C. DefinitionsI. Covered Outpatient Drug (COD) – A drug which may be dispensed only upon a prescription and is treated as a prescribed drug for the purposes of section 1905(12) of the Social Security Act , (with the exception of those defined in paragraphs II and III, Section E. [Conditions of Coverage] below). II. Medicaid Drug Rebate Program (MDRP) – A program that includes Centers forMedicare & Medicaid Services (CMS), state Medicaid agencies, and participating drug manufacturers to help offset the Federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. III. National Drug Rebate Agreement (NDRA) – An agreement entered into by a drug manufacturer with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturers drugs . IV. Section 340B Drug Pricing Program-A discount drug pricing program underSection 340B of the Public Health Service Act that requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. V. Federal Supply Schedule (FSS) – Also known as General Services AdministrationSchedule (GSA), and Multiple Award Schedule (MAS), is a long-term governmentwide contract with commercial companies that provides access to millions of commercial products and services at fair and reasonable prices to the government. VI. National Council for Prescription Drug Programs (NCPDP) Reject Code-A type of reject error code received by a pharmacy upon processing a prescription. VII. Manufacturer-Any entity that is engaged in:-AC Reject/Covered Outpatient Drug Under the Medicaid Drug Rebate Program (MDRP) INDIANA MEDICAID PAD-0100-IN-MCD Effective Date: 01/01/2025 (A) The production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by 3 extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, or (B) The packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. Such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law.D. Policy I. In order for a drug to be eligible for coverage by Medicaid under the Medicaid Drug Rebate Program (MDRP) it has to meet two requirements: A. It has to meet the definition of a covered outpatient drug (COD) under Section 1927 of the Social Security Act which states the requirements for rebate agreements. B. The manufacturer must have entered into and have in effect, on the date of service dispensed, the following agreements: i. A National Drug Rebate Agreement (NDRA); ii. A pricing agreement for the Section 340B Drug Pricing Program administered by the Health Resources and Services Administration; AND iii. A master agreement with the Secretary of Veterans Affairs for the Federal Supply Schedule (FSS). II. AC Reject Code a. Pharmacy claims not eligible for reimbursement due to not meeting CMS MDRP requirements will reject at the pharmacy with the following Pharmacy NCPDP Reject Code and Reject Code Description: AC-Product Not Covered Non-Participating Manufacturer; Manufacturer is not participating in drug rebate on date of service dispensed. E. Conditions of Coverage I. A drug can only be considered a covered outpatient drug if it: A. Is approved for safety and effectiveness as a prescription drug by the FDA under section 505 or 507 of the FFDCA or under section 505(j) of the FFDCA; B. Was commercially used or sold in the United States before the enactment of the Drug Amendments of 1962 or which is identical, similar, or related (within the AC Reject/Covered Outpatient Drug Under the Medicaid Drug Rebate Program (MDRP) INDIANA MEDICAID PAD-0100-IN-MCD Effective Date: 01/01/2025 4 meaning described in FDA regulations at 21 CFR 310.6(b)(1)) to such a drug, and which has not been the subject of a final determination by the Secretary that it is a new drug (within the meaning of section 201(p) of the FFDCA) or an action brought by the Secretary under sections 301, 302(a), or 304(a) of FFDCA to enforce section 502(f) or 505(a) of the FFDCA; C. Is described in section 107(c)(3) of the Drug Amendments of 1962 and for which the Secretary has determined there is a compelling justification for its medical need or is identical, similar, or related (within the meaning described in FDA regulations at 21 CFR 310.6(b)(1)) to such a drug or for which the Secretary has not issued a notice for an opportunity for a hearing under section 505(e) of the FFDCA on a proposed order of the Secretary to withdraw approval of an application for such drug under section 505(e) of the FFDCA because the Secretary has determined that the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling; D. Is a biological product other than a vaccine that may only be dispensed upon a prescription and is licensed under section 351 of the Public Health Service Act (PHSA) and is produced at an establishment licensed under section 351 of the PHSA to produce such product; or E. Is insulin certified under section 506 of the FFDCA. II. A covered outpatient drugdoes not include:A. Any drug product, prescription or over-the-counter (OTC), for which an NDC number is not required by the FDA ; B. Any drug product for which a manufacturer has not submitted to CMS evidence to demonstrate that the drug product satisfies the criteria in paragraph I, Section E. Conditions of Coverage above; C. Any drug product or biological used for a medical indication which is not a medically accepted indication; D. Over-the-counter products that are not drugs. III. A covered outpatient drug does not include any drug, biological product, orinsulin provided as part of or incident to and in the same setting as any of the following services (and for which payment may be made as part of that service instead of as a direct reimbursement for the drug): A. Inpatient Services; B. Hospice Services; C. Dental Services, except that drugs for which the State plan authorizes direct reimbursement to the dispensing dentist are covered outpatient drugs; AC Reject/Covered Outpatient Drug Under the Medicaid Drug Rebate Program (MDRP) INDIANA MEDICAID PAD-0100-IN-MCD Effective Date: 01/01/2025 5 F. Nursing facility and services provided by an intermediate care facility for individuals with intellectual disabilities; G. Other laboratory and x-ray services; or H. Renal dialysis. IV. In exchange for state Medicaid coverage of most of a manufacturers drugs, rebates are paid by these drug manufacturers on a quarterly basis to states and are shared between the states and the Federal government to offset the overall cost of prescription drugs under the Medicaid Program.F. Related Policies/Rules G. Review/Revision HistoryDATES ACTIONDate Issued 01/22/2022 Date Revised 01/01/2025 No updates Date Effective 01/01/2025 Date Archived H. References1. Legal Information Institute. 42 CFR 447.502 Definitions. Retrieved June 8, 2022 from www.law.cornell.edu2. Social Security. Compilation of The Social Security Laws. Payment for Covered Outpatient Drugs. Retrieved June 7, 2022 from www.ssa.gov3. Medicaid Drug Rebate Program (MDRP). Retrieved June 8, 2022 from www.medicaid.gov4. American Hospital Association. Fact Sheet: The 340B Drug Pricing Program. Retrieved June 8, 2022 from www.aha.org 5. U.S. General Services Administration. About GSA Schedule. Retrieved June 8, 2022 from www.gsa.govThis 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 Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved. IN-MED-P-3546051 ; Issued Date: 04/14/2025 OMPP Approval Date: 03/06/2025D. E. Physician services; Outpatient hospital services;
Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy StatementINDIANA MEDICAIDPolicy Name Policy Number Date Effective Medical Necessity Off Label PAD-0060-IN-MCD 01/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ………………………………………………………………………………………. 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ……………………………………………………………………………………………. 3 F. Related Policies/Rules …………………………………………………………………………………………….. 3 G. Review/Revision History …………………………………………………………………………………………… 3 H. References …………………………………………………………………………………………………………….. 3 2 A. Subject Medical Necessity Off Label Medical Necessity Off Label Indiana Medicaid PAD-0060-IN-MCD Effective Date: 01/01/2025B. BackgroundThe U.S. Food and Drug Administration (FDA) approves drugs for specific indications included in the drugs product information label. Off-label or unlabeled drug use is the utilization of an FDA approved drug for uses other than those listed in the FDA approved labeling or in treatment regimens or populations that are not included in approved labeling. Many off-label uses are effective, well documented in the peer-reviewed literature, and widely used even though the manufacturer has not pursued the additional indications. The FDA advises physicians use of off-label or unlabeled drugs must be done in a well-informed manner in conjunction with firm scientific rationale and medical evidence. CareSource will employ, at its discretion, drug utilization management programs (i.e., prior authorization) to ensure appropriate and safe use of medications. 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. C. Definitions FDA Approved medication: Is the official description of a drug product which includes indication; who should take it; adverse events; instructions for uses in pregnancy; children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging. Off-label or unlabeled drug use : Is the use of a drug approved by the U.S. Food and Drug Administration (FDA) for other uses that are not included in approved labeling. The FDA approves drugs for specific indications that are included in the drugs labeling. When a drug is used for an indication other than those specifically included in the labeling, it is referred to as an off-label use. Many off-label uses are effective, well documented in the literature, and widely used. D. Policy CareSource will review prior authorization requests for coverage based on medical necessity. This policy will not supersede drug-specific criteria developed and approved by the CareSource Pharmacy and therapeutics Committee (P&T). Requests for off-label uses of a drug will be considered for approval according to the following criteria: I. Documentation must be submitted showing the member has tried and failed the existing FDA approved and/or clinical guideline recommended therapies unless contraindicated or not tolerated; AND II. The prescribed use must be supported by one or more of the following: a. Narrative information from American Hospital Formulary Service Drug Information (AHFS) or Clinical Pharmacology 3 Lexicomp: Evidence level A Micromedex: Recommendation class I, IIa, or IIb Medical Necessity Off Label Indiana Medicaid PAD-0060-IN-MCD Effective Date: 01/01/2025 Evidence from at least two published studies from major scientific or medical peer reviewed journals demonstrates safety and efficacy for the specified condition in a comparable population (i.e., age group, level of disease severity, etc.) If applicable clinical trial is yet to be published but interim results are supportive, this may be taken into consideration by the clinician reviewer . III. Requests for members less than 21 years old are reviewed for coverage for Early and Periodic Screening, Diagnosis, and Treatment (ESPDT) on a case-by-case basis in addition to the criteria above. NOTE: For off-label use of oncology drugs, please refer to the policy titled Oncology Regimens accessible from the CareSource website. E. Conditions of CoverageAUTHORIZATION PERIOD Approved authorizations are designated an appropriate authorization period. Continued treatment may be considered when the member has shown tolerability and a positive clinical response. F. Related Policies/Rules Oncology Regimens G. Review/Revision History DATES ACTIONDate Issued 06/06/2013Date Revised 10/30/2014 Added definition to excluded indications 05/05/2015 Removed indications in reference of plan specific member handbooks, EOC, etc. Removed specialty and subspecialty associations and combined with no determinations policy12/15/2015 Revised class/category and defined evidence criteria for article submissions 01/11/2018 Updated format02/12/2021 Updated format, copied to new template. General edits for clarity. Added note about clinical trials in progress. Removed content related to orphan drugs and compassionate use. Removed cancer drug section and refer to separate policy. Added component that member must try and fail available FDA approved on label drugs first. Amended list of acceptable compendia to include Lexicomp. Updated reference section. 11/02/2022 Updated the title of the oncology policy that isreferenced. No other changes.2/24/2023 Added note on EPSDT.5/21/2024 Annual review, no updatesDate Effective 01/01/2025 Date Archived b. c. d. 4 H. References Medical Necessity Off Label Indiana Medicaid PAD-0060-IN-MCD Effective Date: 01/01/2025 1. Medical Benefit Policy Manual. CMS website. Updated August 7, 2020. Accessed February 12, 2021. https://www.cms.gov/Regulations-and – Guidance/Guidance/Manuals/Downloads/bp102c15.pdfThis 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 Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved. IN-MED-P-354604 7; Issued Date: 04/14/2025 OMPP Approval Date: 03/06/2025
IN-MED-P-366647a; Issued Date : 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Crysvita (burosumab-twza) BILLING CODE J0584 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see dosage allowed sections LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Crysvita (burosumab-twza) will be considered for coverage when the following criteria are met:X-LINKED HYPOPHOSPHATEMIA (XLH)For initial authorization: 1. Member is 6 months old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist, nephrologist, or rheumatologist; AND 3. Member has a diagnosis of XLH confirmed by at least one of the following: a) PHEX (Phosphate regulating gene with homology to endopeptidases located on the Xchromosome ) mutation per genetic testing; b) Family history positive for XLH (first-degree relative); c) Elevated plasma levels of intact fibroblast growth factor 23 (FGF23) ; AND 4. Lab results show fasting serum phosphorus level BELOW the reference range for age; AND 5. Member has chart notes documenting the following : a) Pediatric: Radiographic evidence of active bone disease including rickets and/or lower extremity bowing; b) Adult: Persistent bone and/or joint pain due to XLH and/or osteomalacia that limits daily activities; pseudofractures or osteomalacia-related fractures; AND 6. Member is refractory to or develops complications from conventional treatment with phosphate and active vitamin D (e .g., calcitriol, paricalcitol, doxercalciferol, calcifediol) ; AND 7. Member does not have ANY of the following: a) Concurrent use of oral phosphate and active vitamin Danalogs ; b) Severe renal impairment or ESRD . 8. Dosage allowed: Adult XLH (18 years of age and older): 1 mg/kg to the nearest 10 mg up to a maximum dose of 90 mg subQ every four weeks. Pediatric XLH (6 months to 17 years ): For member s who weigh
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Berinert (C1 esterase inhibitor (human))BILLING CODE J0597 or NDC BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Home/Office /Outpatient STATUS Prior Authorization Required Berinert is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients . HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results from excess production of the vasodilator bradykinin. Attacks may be painful and cause functional impairment but are not associated with pruritis. The most common types of HAE are caused by deficiency (type 1) or dysfunction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent.Berinert (C1 esterase inhibitor (human)) will be considered for coverage when the following criteria are met:Hereditary AngioedemaFor initial authorization: 1. Medication must be prescribed by or in consultation with an allergist or immunologist; AND 2. Member has a diagnosis of HAE type I or type II confirmed by both of the following: 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 Zokinvy (lonafarnib )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Zokinvy is a n oral farnesyltransferase inhibitor initially approved by the FDA in 2020. It is used for the treatment of certain mutations in processing-deficient Progeroid Laminopathies and to reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome. These are rare and fatal diseases of premature aging. Cardiovascular complications are the primary cause of mortality. Zokinvy is the first FDA approved disease-modifying treatment for these patients. Farnesyltransferase inhibit ion prevents farnesylation and subsequent accumulation of aberrant progerin and progerin-like proteins in the inner nuclear membrane.Zokinvy (lonafarnib ) will be considered for coverage when the following criteria are met:Hutchinson-Gilford Progeria Syndrome For initial authorization: 1. Member is at least 12 months of age; AND 2. Member has a body surface area (BSA) of 0.39 m 2 or greater; AND 3. Medication must be prescribed by or in consultation with a pediatrician, geneticist, cardiologist, or metabolic specialist ; AND 4. Member has a diagnosis of Hutchinson-Gilford Progeria Syndrome confirmed by a known causative variant mutation in the LMNA gene (documentation required); AND 5. Provider attests that m ember is NOT taking the following : a) Strong or moderate CYP3A4 inhibitors or inducers ; b) Midazolam; c) Lovastatin, simvastatin, or atorvastatin . 6. Dosage allowed/Quantity limit: Start at 115 mg/m2 twice daily . After 4 months, increase to 150 mg/m 2 twice daily. Round all total doses to nearest 25 mg increment. If all the above requirements are met , the medication will be approved for 12 months. For reauthorization :1. Member is tolerating therapy and is taking an appropriate dose. If all the above requirements are met , the medication will be approved for an additional 12 months .Processing-deficient Progeroid LaminopathiesFor initial authorization: 1. Member is at least 12 months of age; AND 2. Member has a body surface area (BSA) of 0.39 m 2 or greater; AND 3. Medication must be prescribed by or in consultation with a pediatrician, geneticist, cardiologist, or metabolic specialist ; AND IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20234. Member has a diagnosis of processing-deficient progeroid laminopathies confirmed by a known causative variant mutation in the LMNA gene (documentation required) with either: a) Heterozygous LMNA mutation with progerin-like protein accumulation , or b) Homozygous or compound heterozygous ZMPSTE24 mutations 5. Provider attests that m ember is NOT taking the following : a) Strong or moderate CYP3A4 inhibitors or inducers ; b) Midazolam; c) Lovastatin, simvastatin, or atorvastatin . 6. Dosage allowed/Quantity limit: Start at 115 mg/m 2 twice daily . After 4 months, increase to 150 mg/m 2 twice daily. Round all total doses to nearest 25 mg increment. If all the above requirements are met , the medication will be approved for 12 months. For reauthorization :1. Member is tolerating therapy and is taking an appropriate dose. If all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Zokinvy (lonafarnib) 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/DESCRIPTION07/01/2021 New policy for Zokinvy created. 06/19/2024 Added references; a dded provider attestation for drug contraindications . References: 1. Zokinvy (lonafarnib) [package insert]. Palo Alto, CA; Eiger BioPharmaceuticals, Inc. 2020. 2. Gordon LB, Kleinman ME, Miller DT, et al. Clinical trial of a farnesyltransferase inhibitor in children with Hutchinson-Gilford progeria syndrome. Proc Natl Acad Sci US A. 2012;109(41):16666-16671. doi:10.1073/pnas.1202529109 3. Harhouri K, Frankel D, Bartoli C, Roll P, De Sandre-Giovannoli A, Lvy N. An overview of treatment strategies for Hutchinson-Gilford Progeria syndrome. Nucleus. 2018;9(1):246-257. doi:10.1080/19491034.2018.1460045 Effective date: 01/01/2025 Revised date: 06/19/2024
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Oxlumo (lumasiran)BENEFIT TYPE Medical STATUS Prior Authorization Required Oxlumo is an HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. 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 (calcium 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).Oxlumo (lumasiran) will be considered for coverage when the following criteria are met:Primary Hyperoxaluria Type 1 (PH1)For initial authorization: 1. Medication must be prescribed by or in consultation with a urologist or nephrologist; AND 2. Member has a diagnosis of primary hyperoxaluria type 1 confirmed by g enetic testing that shows a mutation in the AGXT gene; AND 3. Member has documentation of elevated urinary or plasma oxalate levels (UOx or POx) ; AND 4. Member has had an inadequate response to vitamin B6 (pyridoxine) after at least 3 months on optimal dose; AND 5. Member does not receive peritoneal dialysis (hemodialysis allowed) ; AND 6. Member has not received a liver transplant ; AND 7. Oxlumo will not be used in combination with Rivfloza. 8. Dosage allowed/Quantity limit: SubQ as below: Body Weight* Loading Dose Maintenance Dose (begin 1 month after the last loading dose) Less than 10 kg 6 mg/kg once monthly for 3 doses 3 mg/kg once monthly 10 kg to less than 20 kg 6 mg/kg once monthly for 3 doses 6 mg/kg once every 3 months (quarterly) 20 kg and above 3 mg/kg once monthly for 3 doses 3 mg/kg once every 3 months (quarterly) If all the above requirements are met , the medication will be approved for 6 months .IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must show reduced level of urinary or plasma oxalate compared to baseline; AND 2. Member has maintained s table kidney function (i.e., no clinically significant decline of eGFR ); AND 3. Member has not received a liver transplant and is not on peritoneal dialysis. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Oxlumo (lumasiran) 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/DESCRIPTION12/08/2020 New policy for Oxlumo created. 05/27/2022 Transferred to new template. Updated billing code. Updated references. Added increased fluid intake. In renewal, changed or stable kidney function to and stable kidney function and revised description. 10/18/2022 Changed initial approval duration from 12 months to 6 months. Updated and added references; updated criteria per expanded product labeling which addresses plasma oxalate and use in severe renal disease and hemo dialysis populations; peritoneal dialysis remains excluded . 10/18/2023 Added reference. Removed biopsy option for diagnosis confirmation. Removed urinary alkalinization trial requirement. Defined non-response to vitamin B6. Added no concurrent use with Rivfloza. 02/13/2024 Removed hyperhydration requirement. 06/25/2024 Removed specific level of oxalate reduction from B6 trial. References: 1. Oxlumo (lumasiran) [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals Inc; 2023 . 2. Cochat P, Hulton S, Acquaviva C, et al: Primary hyperoxaluria Type 1: indications for screening and guidance for diagnosis and treatment. Nephrol Dial Transplant 2012;27:1729-1736 doi: 10.1093/ndt/gfs078. 3. Milliner DS, Harris PC, Sas DJ, et al. Primary Hyperoxaluria Type 1. 2002 Jun 19 [Updated 2022 Feb 10]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1283/4. Gupta A, Somers MJG, Baum MA. Treatment of primary hyperoxaluria type 1. Clin Kidney J. 2022;15(Suppl 1):i9-i13. Published 2022 May 17. doi:10.1093/ckj/sfab232 5. Hulton SA, Groothoff JW, Frishberg Y, et al. Randomized Clinical Trial on the Long-Term Efficacy and Safety of Lumasiran in Patients With Primary Hyperoxaluria Type 1. Kidney Int Rep. 2021;7(3):494-506. Published 2021 Dec 11. doi:10.1016/j.ekir.2021.12.001 6. Hayes W, Sas DJ, Magen D, et al. Efficacy and safety of lumasiran for infants and young children with primary hyperoxaluria type 1: 12-month analysis of the phase 3 ILLUMINATE-B trial [published online ahead of print, 2022 Aug 1]. Pediatr Nephrol . 2022;10.1007/s00467-022-05684-1. doi:10.1007/s00467-022-05684-1 7. Michael M, Groothoff JW, Shasha-Lavsky H, et al. Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial [published online ahead of print, 2022 Jul 14]. Am JKidney Dis . 2022;S0272-6386(22)00771-5. doi:10.1053/j.ajkd.2022.05.012 8. Groothoff JW, Metry E, Deesker L, et al. Clinical practice recommendations for primary hyperoxaluria: an expert consensus statement from ERKNet and OxalEurope. Nat Rev Nephrol. 2023;19(3):194-211. doi:10.1038/s41581-022-00661-1 Effective date: 10/01/2024 Revised date: 06/25/2024
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