IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Radicava (edaravone injection); Radicava ORS (edaravone oral suspension)BILLING CODE J1301 or must use valid NDC code BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Home/Office/Outpatient STATUS Prior Authorization Required Radicava is a pyrazolone free radical scavenger initially approved by the FDA in 2017 as an IV formulation. It is the second drug to be approved for the treatment of patients with Amyotrophic Lateral Sclerosis (ALS) behind Riluzole . In May of 2022, the FDA approved a new oral suspension formulation, Radicava ORS. ALS is a progressive neurodegenerative disease characterized by the weakness of voluntary muscles due to the loss of motor neurons. Although the exact mechanism of action is unknown, it is hypothesized Radicava works via a mechanism involving antioxidants, which nullifies 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 must be at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist or a physician specializing in ALS; AND 3. Member must have detailed chart notes confirming members Definite or Probable ALS based on EL Escorial revised criteria 3; AND 4. Member must have had the diagnosis of ALS for a duration of 2 years or less; AND 5. Member must have a baseline percent forced vital capacity (FVC%) of 80% or greater; AND 6. Member must have a baseline score of 2 points or greater for each individual item of the ALS Functional Rating Scale-Revised (ALSFRS-R), *Note: Should be a minimum score of 24 4. 7. Dosage allowed/Quantity limit: a. Radicava: 60 mg (two 30mg bags) administered as an IV infusion over 60 minutes as follows: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period; Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. Quantity Limit: 20 bags per 28 days b. R adicava ORS: Initial treatment cycle: 105 mg (5 mL) taken orally or via feeding tube daily for 14 days followed by a 14-day drug-free period; Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. Quantity limit: 50mL per 28 days IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Member has documentation of disease stability or clinical benefit from therapy, such as improved ALS functional 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:Diagnostic Criteria for ALS.Diagnosis El Escorial Revised Airlie House CriteriaDefinite ALS UMN (clinical exam) and LMN (clinical, electrophysiological or neuropathological exam) signs: Bulbar region and > two spinal regions OR Three spinal regions Probable ALS UMN and LMN signs in > two regions and UMN signs rostral to LMN signs Probable ALS laboratory-supported UMN + LMN signs in one region OR UMN signs alone in one region and LMN signs via electrophysiological criteria of LMN loss > two regions Possible ALS UMN and LMN signs in one region OR UMN signs alone in > two regions OR LMN rostral to UMN and unable to prove clinically probably ALS UMN Upper motor neuron; LMN Lower motor neuron. 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/DESCRIPTION05/16/2017 New policy for Radicava created. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202309/15/2017 Disease duration and percent-predicted forced vital capacity (%FVC) requirements were removed. ALSFRS-R score requirement was modified. 08/23/2022Annual Review. Transferred to new format. Added Jcode Added new oral formulation dosing. Clarified reauthorization criteria. Added neurology specialty prescriber. Added age requirement. Reduced initial authorization duration to 6 months. Removed exclusion criteria. Removed daily function requirement and clarified ALSFRS-R criteria. Updated references. References: 1. Radicava [package insert]. Jersey City, NJ: MT Pharma America, Inc.; May 2022. 2. Cedarbaum JM, Stambler N, Malta E, at el. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. Journal of the Neurological Sciences, 169 (1999) 13 21. 3. ALS Association. El Escorial World Federation of Neurology criteria for the diagnosis of ALS. www.alsa.org/assets/pdfs/fyi/criteria_for_diagnosis-1.pdf.4. ALS Functional Rating Scale. Available at: http://www.outcomes-umassmed.org/als/alsscale.aspx . 5. Abe, K., Aoki, M., et al. Safety and efficacy of edaravone in well-defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. The Lancet Neurology. 2017; 16(7), 505-512. 6. Witzel S, Maier A, Steinbach R, et al. Safety and Effectiveness of Long-term Intravenous Administration of Edaravone for Treatment of Patients with Amyotrophic Lateral Sclerosis. JAMA Neurol. 2022;79(2):121 130. 7. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197 Effective date: 04/01/2023 Revised date: 08/23/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Nitisinone (Orfadin and Nityr)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is supplied as generic nitisinone capsules, brand name Orfadin capsules or oral suspension, and brand name Nityr tablets. Nitisinone in combination with prescribed diet leads to far greater survival and clinical outcomes compared to untreated HT-1 patients. Strict adherence to therapy is crucial. HT-1 is a genetic metabolic disorder that usually presents before 6 months of age. Fumarylacetoacetate hydrolase (FAH) is the deficient enzyme responsible for HT-1. It is the terminal step in the tyrosine catabolic pathway . Mutations in the FAH gene lead to HT-1. Nitisinone inhibits an enzyme in the normal catabolic pathway of tyrosine to prevent accumulation of catabolic intermediates that convert to the toxic metabolites succinylacetone (SA) and succinylacetoacetate (SAA) responsible for the liver and kidney symptoms of HT-1. Neurologic porphyric-like crises may also occur . SA is the primary marker used to screen for HT-1.Nitisinone will be considered for coverage when the following criteria are met:Hereditary Tyrosinemia Type 1 (HT-1)For initial authorization: 1. Member has a diagnosis of hereditary tyrosinemia type 1 (HT-1) confirmed by at least one of the following: a) Biochemical testing ( i.e., presence of succinylacetone in the urine or blood) b) Genetic test results showing pathogenic mutation of the FAH gene; AND 2. Member has a baseline succinylacetone level documented in chart notes; AND 3. Member is using medication in combination with dietary restriction of tyrosine and phenylalanine (commonly found in high-protein food); AND 4. Chart notes must document that the member has had or will have a slit-lamp ophthalmic exam completed prior to initiating treatment; AND 5. If the request is for brand name Orfadin capsules or suspension or Nityr tablets, clinical justification must be provided why generic nitisinone capsules cannot be used. 6. Dosage allowed/Quantity limit: Max total daily dosage of 2 mg/kg (orally), based on evaluation of biochemical and/or clinical response. See prescribing info for details. 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 Approved: 5/16/2023For reauthorization :1. Member must continue dietary restriction of tyrosine and phenylalanine; AND 2. Chart notes must show a reduc ed succinylacetone level compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers nitisinone 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/DESCRIPTION04/30/2020 New policy for Orfadin created.11/01/2022 Transferred to new template. Renamed policy to generic name and added Nityr brand name. Amended dosing section. Split diagnostic confirmation into 2 parts and added name of mutated gene. Changed wording of slit-lamp exam requirement. Updated references. Ad ded criterion requiring generic caps.References: 1. Orfadin [ prescribing information] . Sobi, Inc ; 2021. 2. Nityr [prescribing information]. Cycle Pharmaceuticals Ltd; 2021. 3. Jack RM, Scott CR. Validation of a therapeutic range for nitisinone in patients treated for tyrosinemia type 1 based on reduction of succinylacetone excretion. JIMD reports. 2019;46(1)75-78. 4. Chinsky JM, Singh R, Ficicioglu C, et al. Diagnosis and treatment of tyrosinemia type I: a US and Canadian consensus group review and recommendations. Genet Med. 2017;19(12):. doi:10.1038/gim.2017.101. 5. Sniderman King L, Trahms C, Scott CR. Tyrosinemia Type I. 2006 Jul 24 [Updated 2017 May 25]. In: Adam MP, Everman DB, Mirzaa GM, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://w ww.ncbi.nlm.nih.gov/books/NBK1515/ Effective date: 04/01/2023 Revised date: 11/01/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Galafold (migalastat)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Galafold is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. It is estimated that the amenable variants are present in 35-50% of the Fabry disease patient population. Galafold is an alternative to enzyme replacement therapy (ERT) and is taken orally. It increases activity of the deficient enzyme instead of replacing it. Fabry disease is an X-linked lysosomal storage disorder caused by mutations in the GLA gene that cause deficiency of the alpha-galactosidase A (alpha-Gal A) lysosomal enzyme. Normally this enzyme breaks down certain lipids in lysosomes, such as globotriaosylcer amide (GL-3). Without it, GL-3 accumulates in blood vessels, the kidneys, heart, nerves, and other organs.Galafold (migalastat) will be considered for coverage when the following criteria are met:Fabry DiseaseFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a medical geneticist, nephrologist, cardiologist, neurologist, or metabolic specialist; AND 3. Member has a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant (refer to package insert) based on in vitro assay data documented in chart notes; AND 4. Member does NOT have severe renal impairment or end-stage renal disease requiring dialysis; AND 5. Galafold will NOT be used in combination with Fabrazyme. 6. Dosage allowed/Quantity limit: 123 mg (1 capsule) orally every other day. (QL: 14 capsules 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 positive clinical response such as stabilized kidney function (e.g., GFR, proteinuria), reduced plasma or tissue GL-3 levels, reduced left ventricular mass index, or other Fabry symptom improvement. 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: 5/16/2023 CareSource considers Galafold (migalastat) 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/DESCRIPTION05/20/2019 New policy for Galafold created.06/18/2021 Transferred to new template. Updated references. Added neurology to specialists.Removed baseline GL-3 level. Removed exclusions except renal impairment and combination therapy. Increased initial approval duration to 6 months and renewal to 12 months. Revised renewal criteria; removed % reductions. 11/22/2022 Annual review. Reorganized summary and added reference. References: 1. Galafold [prescribing information]. Philadelphia, PA: Amicus Therapeutics US, LLC; February 2021. 2. Desnick R, et al. Fabry disease, an under-recognized multisystemic disorder: expert recommendations for diagnosis,management, and enzyme replacement therapy. Annals of internal medicine. 2003 Feb 18;138(4):338 46. 3. Ellaway C. Paediatric fabry disease. Transl pediatr. 2016; 5(1): 37-42. 4. Hopkin R, et al. The management and treatment of children with Fabry disease: A United States-based perspective. Molecular genetics and metabolism. 2016 Feb 1;117(2):104-13. 5. Ortiz A, et al. Fabry disease revisited: management and treatment recommendations for adult patients. Molecular genetics and metabolism. 2018 Apr 1;123(4):416-27. 6. Wang R, et al. Lysosomal storage diseases: diagnostic confirmation and management of presymptomatic individuals. Genetics in Medicine. 2011 May;13(5):457. 7. Wanner C, et al. European expert consensus statement on therapeutic goals in Fabry disease. Molecular genetics and metabolism. 2018 Jun 12. 8. Germain D, et al. Treatment of Fabrys disease with the pharmacologic chaperone migalastat. New England Journal of Medicine. 2016 Aug 11;375(6):545-55. 9. Hughes D, et al. Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study. Journal of medical genetics. 2017 Apr 1;54(4):288-96. 10. National institute for health and care excellence. Migalastat for treating Fabry disease. 2017 Feb. Available from: nice.org.uk/guidance/hst4/chapter/1-Recommendations. 11. Laney DA, Bennett RL, Clarke V, et al. Fabry disease practice guidelines: recommendations of the National Society of Genetic Counselors. JGenet Couns . 2013;22(5):555-564. doi:10.1007/s10897-013-9613-3 12. Feldt-Rasmussen U, Hughes D, Sunder-Plassmann G, et al. Long-term efficacy and safety of migalastat treatment in Fabry disease: 30-month results from the open-label extension of the randomized, phase 3 ATTRACT study. Mol Genet Metab. 2020;131(1-2):219-228. doi:10.1016/j.ymgme.2020.07.00713. Germain DP, Fouilhoux A, Decramer S, et al. Consensus recommendations for diagnosis, management and treatment of Fabry disease in paediatric patients. Clin Genet. 2019;96(2):107-117. doi:10.1111/cge.13546 Effective date: 04/01/2023 Revised date: 11/22/2022
IN-MED-P-366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Hyaluron ic Acid ViscosupplementsBILLING CODE See table in appendix for list of products and codes BENEFIT 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 recommendat ions, 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 IN-MED-P-366647 OMPP Approved Template on: 01/22/2021Hymovis: 3 mL weekly for 2 weeksMonovisc: 4 mL one time Orthovisc: 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 hyaluron ic 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. APPENDIX: List of products, codes , and status (Y = preferred; N = non-preferred)Euflexxa sodium hyaluronate J7323 NDurolane hyaluronic acid J7318 Y Gel-One cross-linked hyaluronate J7326 N Gelsyn-3 sodium hyaluronate J7328 Y GenVisc 850 sodium hyaluronate J7320 N Hyalgan sodium hyaluronate J7321 N Hymovis high molecular weight viscoelastic hyaluronan J7322 N Monovisc high molecular weight hyaluronan J7327 N Orthovisc high molecular weight hyaluronan J7324 N Supartz FX sodium hyaluronate J7321 Y Synvisc hylan G-F 20 J7325 N Synvisc-One hylan G-F 20 J7325 N TriVisc sodium hyaluronate J7329 N TriLuron sodium hyaluronate J7332 N Visco-3 sodium hyaluronate J7321 N IN-MED-P-366647 OMPP Approved Template on: 01/22/2021 References: 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; 201 7. 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. Jordan, KM et al. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Annals of the rheumatic diseases vol. 62,12 (2003): 1145-55. doi:10.1136/ard.2003.011742 19. 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 20. 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 21. Evaniew N, Simunovic N, Karlsson J. Cochrane in CORR: Viscosupplementation for the treatment of osteoarthritis of the knee. Clin Orthop Relat Res . 2014;472(7):2028-2034. doi:10.1007/s11999-013-3378-8 22. 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 23. National Institute for Health and Care Excellence (NICE). Osteoarthritis: care and management . Clinical guideline [CG177] . Published: 12 February 2014 Last updated: 11 December 2020. https://www.nice.org.uk/guidance/cg17724. Local Coverage Determination (LCD): Hyaluronan Acid Therapies for Osteoarthritis of the Knee (L35427). Centers for Medicare and Medicaid Services. Available at: https://www.cms.gov/medicare-coverage- database/view/lcd.aspx?LCDId=35427 . Accessed April 26, 2022. 25. Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021;325(6):568-578. doi:10.1001/jama.2020.22171 26. 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 27. 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 Effective date: 04/01/2023 Revised date: 11/07/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Orladeyo (berotralstat)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Orladeyo is a plasma kallikrein inhibitor approved in December 2020 for the prevention of hereditary angioedema (HAE) attacks. It is the first FDA approved oral drug for HAE attack prophylaxis, taken once daily for long term use. It is not for on-demand use to manage acute attacks. Approval was based on clinical trials showing that Orladeyo reduced the frequency of HAE attacks compared to placebo. Although it may not have the same level of effectiveness as competitor products, the advantage of oral administration m ay compensate for this difference, depending on patient specific factors such as disease severity. Patients with type 1 or type 2 HAE have deficient or dysfunctional C1 esterase inhibitor, respectively. This leads to an uncontrolled increase in plasma kall ikrein activity, which generates excess bradykinin, causing greater vascular permeability that results in angioedema attacks. Type I HAE is the most common.Orladeyo (berotralstat) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member is at least 12 years of age; 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 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 Krystexxa (pegloticase)BILLING CODE J2507 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient STATUS Prior Authorization Required Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy . According to the American College of Rheumatology guideline for management of gout, pegloticase should not be a first-line therapy. Pegloticase is recommended for patients with gout for whom xanthine oxidase inhibitor treatment, uricosurics, and other int erventions have failed to achieve the serum uric acid target, and who continue to have frequent gout flares or who have non-resolving subc utaneous tophi.Krystexxa (pegloticase ) will be considered for coverage when the following criteria are met:Chronic Gout For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is prescribed by or in consultation with a rheumatologist; AND 3. Member has a diagnosis of chronic gout with 2 or more flares per year OR with non-resolving subcutaneous tophi associated with gout ; AND 4. Member has had inadequate response ( defined as serum uric acid (sU A) level remains above 6 mg/dL), or contraindication to , at least 3 months of both of the following: a) A xanthine oxidase inhibitor (e.g., allopurinol (Zyloprim) or febuxostat (Uloric)) at maximally appropriate dose. Note: allopurinol is first-line (typically 300 to 800 mg/day) and b) A uricosuric agent (e.g., probenecid) ; AND 5. Krystexxa will be co-administered with methotrexate unless contraindicated or not tolerated; AND 6. Other urate lowering therapy (i.e., allopurinol, febuxostat, probenecid, lesinurad) will be discontinued; AND 7. Member does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency per screening result. 8. Dosage allowed/Quantity limit: 1 single-dose vial (8 mg) given as an intravenous infusion every 2 weeks , co-administered with weekly methotrexate 15 mg. QL: 2 vials per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Members serum uric acid (sU A) level has maintained below 6 mg/dL ; AND 2. Chart notes demonstrate a positive clinical outcome from using medication (e.g., reduction of flares, reduction of tophi). 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: 5/16/2023 CareSource considers Krystexxa (pegloticase) 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/DESCRIPTION04/06 /2021 New policy for Krystexxa (pegloticase ) created. 07/28/2022 Transferred to new template. Updated and added references. Removed nephrology, podiatry specialists. Corrected sUC to sUA. Added QL. Added must be given with methotrexate (new labeling). Added not to be used with other urate lowering drugs. Added example dosing to first line allopurinol. References: 1. Krystexxa [package insert]. Dublin, Ireland; Horizon Therapeutics Ireland DA C; 2022. 2. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for the Management of Gout [published correction appears in Arthritis Care Res (Hoboken). 2020 Aug;72(8):1187] [published correction appears in Arthritis Care Res (Hoboken). 2021 Mar;73(3):458]. Arthritis Care Res (Hoboken) . 2020;72(6):744-760. 3. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis . 2017;76(1):29-42. doi:10.1136/annrheumdis-2016-209707 4. Sundy JS, Baraf HS, Yood RA, et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA . 2011;306(7):711-720. doi:10.1001/jama.2011.1169 5. Study of KRYSTEXXA (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout (MIRROR RCT) . ClinicalTrials.gov Identifier: NCT03994731. https://clinicaltrials.gov/ct2/show/NCT03994731. Accessed July 28,2022. 6. Botson JK, Tesser JRP, Bennett R, et al. Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR). JRheumatol . 2021;48(5):767-774. doi:10.3899/jrheum.200460 Effective date: 01/01/2023 Revised date: 07/28/2022
IN-MED-P -366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Haegarda (C1 esterase inhibitor (human))BILLING CODE NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Haegarda i s a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 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 from excess production of the vasodilator bradykinin. Attacks may be painful and cause funct ional 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 .Haegarda (C1 esterase inhibitor (human)) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member must be 6 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 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 Firazyr or Sajazir (icatibant)BILLING CODE J1744 or NDC BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Home/Office STATUS Prior Authorization Required Firazyr is a bradykinin B2 receptor antagonist indicated for 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 from excess production of the vasodilator bradykinin. Attacks may be painful and cause funct ional 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. 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 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 Cinryze (C1 esterase inhibitor (human))BILLING CODE J0598 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office STATUS Prior Authorization Required Cinryze is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years of age and older) with Hereditary Angioedema (HAE ). 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 funct ional 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.Cinryze (C1 esterase inhibitor (human)) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member must be 6 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 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 Beovu (brolucizumab)BILLING CODE J0179 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient Hospital 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. References: 1. Beovu [ prescribing information]. Novartis Pharmaceuticals Corporation; 2022. 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: 01/01/2023 Revised date: 06/13/2022
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