IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Ofev (nintedanib )BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Ofev is a kinase inhibitor indicated in adults initially approved by the FDA in 2014. It is used to treat multiple diseases affecting the lungs including idiopathic pulmonary fibrosis (IPF) , chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and sl owing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) . Idiopathic pulmonary fibrosis (IPF), the most common of the interstitial lung diseases, is characterized by chronic, progressive scarring of the lungs and the pathological hallmark of usual interstitial pneumonia (UIP). Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune disease associated with vasculopathy, inflammation, and fibrosis of the skin and/or internal organs. ILD is a frequent complication and the leading cause of death in patients with SSc . Progressive fibrosing ILDs encompass a wide range of diseases, including hypersensitivity pneumonitis, occupational diseases, granulomatous diseases, drug-induced diseases, and idiopathic pneumonitis.Ofev (nintedanib ) will be considered for coverage when the following criteria are met:Idiopathic Pulmonary Fibrosis (IPF)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a pulmonologist; AND 3. Member has a diagnosis of IPF confirmed by high resolution computed tomography (HRCT) or lung biopsy (results must be submitted for review) ; AND 4. Documentation of members baseline forced vital capacity (FVC) must be equal to or greater than 50% predicted; AND 5. Member does not have moderate to severe hepatic impairment (Child Pugh Bor C); AND 6. Member is not a current smoker and provider attests the member will not smoke during treatment 7. Dosage allowed/Quantity limit: 300 mg per day (150 mg twice daily) (60 capsules per 30 days). If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Member continues to abstain from smoking; AND 2. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by reduced rate of FVC decline 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: 5/16/2023Chronic Fibrosing Interstitial Lung Diseases (ILD) with a ProgressivePhenotype For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a pulmonologist or rheumatologist; AND 3. Member has a diagnosis of Progressive Fibrosing ILD confirmed by diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) (results must be submitted for review); AND 4. Documentation of members baseline forced vital capacity (FVC) must be equal to or greater than 45% predicted; AND 5. Member does not have moderate to severe hepatic impairment; AND 6. Member is not a current smoker and provider attests the member will not smoke during treatment . 7. Dosage allowed/Quantity limit: 300 mg per day (150 mg twice daily) (60 capsules per 30 days). If all the above requirements are met , the medication will be approved for 6 months .For reauthorization : 1. Member continues to abstain from smoking; AND 2. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by reduced rate of FVC decline If all the above requirements are met, the medication will be approved for an additional 12 months . Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a pulmonologist or rheumatologist; AND 3. Member has a diagnosis of ILD associated with systemic sclerosis confirmed by high-resolution computed tomography (HRCT) showing fibrosis affecting at least 10% of the lungs (results must be submitted for review); AND 4. Documentation of members baseline forced vital capacity (FVC) equal to or greater than 40 % predicted; AND 5. Members lung disease has progressed despite at least a 3-month trial of mycophenolate mofetil or cyclophosphamide, unless contraindicated; AND 6. Member does not have moderate to severe hepatic impairment; AND 7. Member is not a current smoker and provider attests the member will not smoke during treatment . 8. Dosage allowed/Quantity limit: 300 mg per day (150 mg twice daily) (60 capsules per 30 days). If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Member continues to abstain from smoking; AND 2. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by reduced rate of FVC decline 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 Ofev (nintedanib ) 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/DESCRIPTION06/19/2020 New policy for Ofev created. Previously on IPF policy, now splitting from Esbriet, updating references, and adding new indications PF-ILD and SSc-ILD 05/24/2022 Policy transferred to new template. Updated references. Removed azathioprine trial option from SSc-ILD. References: 1. Of ev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 202 2. 2. Raghu G, Rochwerg B, Zhang Y, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine. 2015;192(2). doi:10.1164/rccm.201506-1063st 3. Canestaro WJ, Forrester SH, Raghu G, Ho L, Devine BE. Drug Treatment of Idiopathic Pulmonary Fibrosis. Chest. 2016;149(3):756-766. doi:10.1016/j.chest.2015.11.013 4. Richeldi L, Bois RMD, Raghu G, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. New England Journal of Medicine. 2014;370(22):2071-2082. doi:10.1056/nejmoa1402584 5. Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. New England Journal of Medicine. 2019;381(18):1718-1727. doi:10.1056/nejmoa1908681 6. Cottin V, Hirani NA, Hotchkin DL, et al. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. European Respiratory Review. 2018;27(150):180076. doi:10.1183/16000617.0076-2018 7. Cottin V, Wollin L, Fischer A, Quaresma M, Stowasser S, Harari S. Fibrosing interstitial lung diseases: knowns and unknowns. European Respiratory Review. 2019;28(151):180100. doi:10.1183/16000617.0100-2018 8. Wells AU, Flaherty KR, Brown KK, et al. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020;8(5):453-460. doi:10.1016/S2213-2600(20)30036-9 9. Distler O, Highland KB, Gahlemann M, et al. Nintedanib for Systemic Sclerosis Associated Interstitial Lung Disease. New England Journal of Medicine. 2019;380(26):2518-2528. doi:10.1056/nejmoa1903076 10. Varga J, Montesi S. Treatment and prognosis of interstitial lung disease in systemic sclerosis (scleroderma). UpToDate. https://www.uptodate.com/. Updated March 29, 2022 Accessed May 25, 2022 11. Mirsaeidi M, Barletta P, Glassberg MK. Systemic Sclerosis Associated Interstitial Lung Disease: New Directions in Disease Management. Front Med (Lausanne). 2019;6:248. Published 2019 Oct 31. doi:10.3389/fmed.2019.00248 12. Sharif R. Overview of idiopathic pulmonary fibrosis (IPF) and evidence-based guidelines. Am JManag Care. 2017;23(11 Suppl):S176-S182. 13. Belhassen M, Dalon F, Nolin M, Van Ganse E. Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis. Respir Res . 2021;22(1):135. Published 2021 May 4. doi:10.1186/s12931-021-01714-y 14. Fleetwood K, McCool R, Glanville J, et al. Systematic Review and Network Meta-analysis of Idiopathic Pulmonary Fibrosis Treatments. JManag Care Spec Pharm. 2017;23(3-b Suppl):S5-S16. doi:10.18553/jmcp.2017.23.3-b.s5 15. Hamblin MJ, Kaner RJ, Owens GM. The spectrum of progressive fibrosis interstitial lung disease: clinical and managed care considerations. Am JManag Care. 2021;27(7 Suppl):S147-S154. doi:10.37765/ajmc.2021.88657 16. Bernstein EJ, Huggins JT, Hummers LK, Owens GM. Systemic sclerosis with associated interstitial lung disease: management considerations and future directions. Am JManag Care. 2021;27(7 Suppl):S138-S146. doi:10.37765/ajmc.2021.88656 17. Khanna D, Lescoat A, Roofeh D, et al. Systemic Sclerosis-Associated Interstitial Lung Disease: How to Incorporate Two Food and Drug Administration-Approved Therapies in Clinical Practice. Arthritis Rheumatol. 2022;74(1):13-27. doi:10.1002/art.41933 18. Hoffmann-Vold AM, Maher TM, Philpot EE, Ashrafzadeh A, Distler O. Assessment of recent evidence for the management of patients with systemic sclerosis-associated interstitial lung disease: a systematic review. ERJ Open Res . 2021;7(1):00235-2020. Published 2021 Feb 22. doi:10.1183/23120541.00235-2020 Effective date: 10/01/2022 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 Revised date: 05/24/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Mycapssa (octreotide)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Mycap ssa is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. It is a delayed-release oral capsule formulation of octreotide. Acromegaly is typically the result of a GH-secreting pituitary adenoma, thus surgical resection is the preferred treatment whenever possible as the best chance for a cure. If disease persists after surgery, a first-generation long-acting somatostatin receptor ligand is recommended as first-line therapy .Mycapssa (octreotide) will be considered for coverage when the following criteria are met:AcromegalyFor initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a confirmed diagnosis of acromegaly; AND 4. Member had an inadequate response to surgery or surgery is not an option (documentation required); AND 5. Member has been stabilized on injectable octreotide or lanreotide for at least 3 months, with insulin-like growth factor (IGF-1) lab results demonstrating response to treatment; AND 6. Member has documented rationale for why it is medically necessary to switch to the oral formulation of octreotide ( e.g., injection site reactions, ongoing symptoms despite biochemical control). 7. Dosage allowed/Quantity limit: Initiate at 40mg per day, given as 20mg twice daily. Titrate in 20mg increments, based on IGF-1 levels. Max dose of 80mg per day, given as 40mg twice daily . (QL 1 12 capsules per 28 days) If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes/lab report must show maintained or normalized IGF-1. 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 Mycapssa (octreotide) 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/DESCRIPTION10/19/20 20 New policy for Mycapssa created. 04/01/2022 Transferred to new template. Updated references. References: 1. Mycapssa (octreotide) [package insert] . Amryt Pharmaceuticals, Inc .; 3/2022. 2. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism. 2014;99(11):3933-3951. doi:10.1210/jc.2014-2700 3. Melmed S, Bronstein MD, Chanson P, et al. A Consensus Statement on acromegaly therapeutic outcomes. Nature Reviews Endocrinology . 2018;14(9):552-561. doi:10.1038/s41574-018-0058-5 4. Melmed S, Popovic V, Bidlingmaier M, et al. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial [published correction appears in JClin Endocrinol Metab. 2016 Oct;101(10 ):3863]. JClin Endocrinol Metab. 2015;100(4):1699-1708. doi:10.1210/jc.2014-4113 5. Samson SL, Nachtigall LB, Fleseriu M, et al. Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide. JClin Endocrinol Metab. 2020;105(10):dgaa526. doi:10.1210/clinem/dgaa526 6. Zahr R, Fleseriu M. Updates in Diagnosis and Treatment of Acromegaly. Eur Endocrinol . 2018;14(2):57-61. doi:10.17925/EE.2018.14.2.57 7. Fleseriu M, Biller BMK, Freda PU, et al. A Pituitary Society update to acromegaly management guidelines. Pituitary . 2021;24(1):1-13. doi:10.1007/s11102-020-01091-7 Effective date: 10/01/2022 Revised date: 04/01/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME MACI ( autologous cultured chondrocytes )BILLING CODE J7330 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Inpatient/ Outpatient hospital STATUS Prior authorization required MACI (autologous cultured chondrocytes on porcine collagen membrane) is used for the repair of symptomatic cartilage damage of the knee. It is made up of autologous cells that are collected on biopsy, expanded and proliferated in culture, and seeded onto a collagen membrane that is implanted to the area of d efect and absorbed back into the tissue. The amount of MACI applied depends on the size of the cartilage defect (cm2) . The membrane is trimmed by the surgeon to the size and shape of the defect. Implantation is performed via arthrotomy.MACI (autologous cultured chondrocytes) will be considered for coverage when the following criteria are met:Cartilage defect of the knee For initial authorization: 1. Member is 15 (with closed growth plates) to 55 years of age ; AND 2. Medication must be prescribed by or in consultation with an orthopedic surgeon or PM&R (physiatry) specialist; AND 3. Member has a BMI of 35 or less; AND 4. Member has a diagnosis of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement ; AND 5. The defect size is greater than 2 cm2; AND 6. Documentation of disabling knee pain that limits activities of daily living with symptom onset less than 3 years ago; AND 7. Member has tried and failed conservative therapy for at least 2 months, including physical therapy and anti-inflammatory medications; AND 8. The knee has stable alignment with the meniscus intact and normal joint space (per X-ray); AND 9. Documentation that the i mplantation will be followed by an appropriate, physician-prescribed rehabilitation program to which the member is expected to adhere; AND 10. Member does NOT have any of the following: a) Hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin b) Severe osteoarthritis of the knee or degenerative joint disease c) Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders d) Knee surgery within the past 6 months (except to procure biopsy or to perform a concurrent procedure with MACI) e) Osteochondritis dissecans 11. Dosage allowed/Quantity limit: 1 procedure per defect per lifetime . 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 3 months .For reauthorization :1. MACI will not be re-authorized. If the request is for a new defect/injury that has not previously been treated with MACI, all initial criteria apply.CareSource considers MACI (autologous cultured chondrocytes ) 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/DESCRIPTION11/22/2021 New policy created for Maci. 05/24/2022 Annual review; no changes. References: 1. MACI. [prescribing information] . Vericel Corporation; 2021. 2. Saris D, Price A, Widuchowski W, et al. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am JSports Med. 2014;42(6):1384-1394. doi:10.1177/0363546514528093 3. Brittberg M, Recker D, Ilgenfritz J, Saris DBF; SUMMIT Extension Study Group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Am JSports Med . 2018;46(6):1343-1351. doi:10.1177/0363546518756976 4. National Institute for Health and Care Excellence. (2017). Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee (NICE guideline TA477) Available at https://www.nice.org.uk/guidance/ta477/resources/autologous-chondrocyte-implantation-for-treating-symptomatic-articular-cartilage-defects-of-the-knee-pdf-82604971061701 [Accessed 29 November 2021].5. Mistry H, Connock M, Pink J, et al. Autologous chondrocyte implantation in the knee: systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2017 Feb. (Health Technology Assessment, No. 21.6.) Available from: https://www.ncbi.nl m.nih.gov/books/NBK424075/ doi: 10.3310/hta21060 6. Carey JL, Remmers AE, Flanigan DC. Use of MACI (Autologous Cultured Chondrocytes on Porcine Collagen Membrane) in the United States: Preliminary Experience. Orthop JSports Med. 2020;8(8):2325967120941816. Published 2020 Aug 12. doi:10.1177/2325967120941816 7. Niemeyer P, Albrecht D, Andereya S, et al. Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: A guideline by the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma (DGOU). Knee . 2016;23(3):426-435. doi:10.1016/j.knee.2016.02.001 8. Rosa D, Di Donato SL, Balato G, et al. How to Manage a Failed Cartilage Repair: A Systematic Literature Review. Joints . 2017;5(2):93-106. Published 2017 Jul 28. doi:10.1055/s-0037-1603900 9. von Keudell A, Han R, Bryant T, Minas T. Autologous Chondrocyte Implantation to Isolated Patella Cartilage Defects. Cartilage . 2017;8(2):146-154. doi:10.1177/1947603516654944 Effective date: 10/01/2022 Revised date: 05/24/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Esbriet (pirfenidone )BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Esbriet is a pyrid one oral antifibrotic drug approved by the FDA in 2014 . Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by chronic, progressive scarring of the lungs and the pathological hallmark of usual interstitial pneumonia (UIP).Esbriet (pirfenidone ) will be considered for coverage when the following criteria are met:Idiopathic Pulmonary Fibrosis (IPF)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a pulmonologist ; AND 3. Member has a diagnosis of IPF confirmed by high resolution computed tomography (HRCT) or lung biopsy (results must be submitted for review); AND 4. Documentation of members baseline forced vital capacity (FVC) must be equal to or greater than 50% predicted; AND 5. Member does not have severe hepatic impairment (Child Pugh Class C); AND 6. Member is not a current smoker and provider attests the member will not smoke during treatment . 7. Dosage allowed/Quantity limit: Titrate as follows, to 801 mg three times per day (2403 mg/day total) (90 tablets per 30 days). If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Member continues to abstain from smoking; AND 2. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by reduced rate of FVC decline. 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 Esbriet ( pirfenidone ) 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/DESCRIPTION06/22/2020 New policy for Esbriet created; split off from combined IPF policy with Ofev. 05/24/2022 Policy transferred to new template. Updated references. References: 1. Esbriet [package insert]. South San Francisco, CA: Genentech, Inc; 202 2. 2. Raghu G, Rochwerg B, Zhang Y, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine. 2015;192(2). doi:10.1164/rccm.201506-1063st 3. Canestaro WJ, Forrester SH, Raghu G, Ho L, Devine BE. Drug Treatment of Idiopathic Pulmonary Fibrosis. Chest. 2016;149(3):756-766. doi:10.1016/j.chest.2015.11.013 4. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377(9779):1760-1769. doi:10.1016/S0140-6736(11)60405-4 5. King TE Jr, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis [published correction appears in NEngl JMed. 2014 Sep 18;371(12):1172]. NEngl JMed. 2014;370(22):2083-2092. doi:10.1056/N EJMoa1402582 6. Sharif R. Overview of idiopathic pulmonary fibrosis (IPF) and evidence-based guidelines. Am JManag Care. 2017;23(11 Suppl):S176-S182. 7. Belhassen M, Dalon F, Nolin M, Van Ganse E. Comparative outcomes in patients receiving pirfenidone or nintedanib for idiopathic pulmonary fibrosis. Respir Res . 2021;22(1):135. Published 2021 May 4. doi:10.1186/s12931-021-01714-y 8. Fleetwood K, McCool R, Glanville J, et al. Systematic Review and Network Meta-analysis of Idiopathic Pulmonary Fibrosis Treatments. JManag Care Spec Pharm. 2017;23(3-b Suppl):S5-S16. doi:10.18553/jmcp.2017.23.3-b.s5 Effective date: 10/01/2022 Revised date: 05/24/2022
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tavneos (avacopan)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Tavneos , approved by the FDA in 2021, is indicated as an adjunctive treatment for severe active antineutrophil cytoplasmic autoantibody (ANCA) -associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids . (It is NOT approved for eosinophilic granulomatosis with polyangiitis [EGPA]). ANCA-associated vasculitis (AAV) is thought to be caused by an overactivation of the complement system, leading to excess generation of complement fragment 5a (C5a). C5a is a chemoattractant involved in recruiting inflammatory cells that can cause damage to blood vessels. Tavneos is an oral complement inhibitor that selectively blocks the C5a receptor (CD88). In the phase 3 ADVOCATE clinical trial, Tavneos was noninferior to prednisone taper for remission at 26 weeks, but superior for sustained remission at 52 weeks. Disease activity and remission are measured using the Birmingham Vasculitis Activity Score (BVAS). AAV is a group of progressive autoimmune disease with circulating ANCA autoantibodies, inflammation, and damage to small and sometimes medium sized blood vessels. Multiple organ systems may be affected and most patients have renal involvement . Kidney biopsy is the gold standard for diagnosis but clinical presentation and serology are also used, especially in rapidly progressive cases .Tavneos (avacopan) will be considered for coverage when the following criteria are met:A ntineutrophil C ytoplasmic A utoantibody (ANCA )- Associated VasculitisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a nephrologist or rheumatologist ; AND 3. Member has a diagnosis of severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA); AND 4. Documentation of positive test for autoantibodies against myeloperoxidase (MPO) or proteinase 3 (PR3 ); AND 5. Member meets one of the following: a) Trial and failure of cyclophosphamide (IV or oral) + glucocorticoid b) Trial and failure of rituximab + glucocorticoid; AND 6. Tavneos will be used in combination with standard immunosuppressive therapy (e.g., rituximab or cyclophosphamide) AND glucocorticoids (unless contraindication is documented) ; AND 7. Member has at least 1 major item, 3 non-major items, or 2 renal items of proteinuria and hematuria on the BVAS (see appendix) ; AND 8. Liver function tests (ALT, AST) have been or will be obtained before starting Tavneos; AND 9. Member does not have severe hepatic impairment (Child-Pugh C); AND 10. Members eGFR is 15 mL/min or greater; AND 11. Member is not currently on dialysis and has not had a kidney transplant . 12. Dosage allowed/Quantity limit: 30 mg (three 10 mg capsules) twice daily . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023(180 capsules per 30 days)If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes must show improvement or stabilized signs and symptoms of disease such as decreased BVAS, improved or sustained renal function, or ability to decrease or discontinue corticosteroids. If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Tavneos (avacopan) 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/DESCRIPTION02/04/2022 New policy for Tavneos created. A PPENDIX : Birmingham Vasculitis Activity Score (BVAS) The BVAS organ systems are shown below. Major items are indicated in bold italics . The score is on a scale from 0 to 63, with higher scores indicating greater disease activity. A score of 0 indicates remission. Body Systems: 1. General Myalgia Arthralgia / arthritis Fever 38 CWeight loss 2 kg 2. Cutaneous Infarct Purpura Ulcer Gangrene Other skin vasculitis 3. Mucous membranes / eyes Mouth ulcers Genital ulcers Adnexal inflammation Significant proptosis Scleritis / Episcleritis Conjunctivitis / Blepharitis / Keratitis Blurred vision Sudden visual loss Uveitis Retinal changes (vasculitis / thrombosis / exudate / haemorrhage) 4. Ear Nose & Throat Bloody nasal discharge / crusts / ulcers / granulomata Paranasal sinus involvement Subglottic stenosis Conductive hearing loss Sensorineural hearing loss 5. Chest Wheeze Nodules or cavities Pleural effusion / pleurisy Infiltrate Endobronchial involvement Massive hemoptysis / alveolar hemorrhage Respiratory failure 6. Cardiovascular Loss of pulses Valvular heart disease Pericarditis Ischemic cardiac pain Cardiomyopathy Congestive cardiac failure 7. Abdominal Peritonitis Bloody diarrhea Ischemic abdominal pain 8. RenalIN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 Hypertension Proteinuria >1+ or >0.2 g/g creatinine Hematuria 10 RBCs/hpf Serum creatinine 125-249 mol/L Serum creatinine 250-499 mol/L Serum creatinine 500 mol/L Rise in serum creatinine >30% or fall in creatinine clearance >25% 9. Nervous system Headache Meningitis Seizures (not hypertensive) Cerebrovascular accident Organic confusion Spinal cord lesion Cranial nerve palsy Sensory peripheral neuropathy Mononeuritis multiplex 10. Other RBC casts and/or glomerulonephritis References: 1. Tavneos [prescribing information]. ChemoCentryx, Inc.; 2021. 2. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int . 2021;100(4S):S1-S276. doi:10.1016/j.kint.2021.05.021 3. Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphami de/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc . 2020;9(4):e16664. Published 2020 Apr 7. doi:10.2196/16664 4. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. NEngl JMed. 2021;384(7):599-609. doi:10.1056/NEJMoa2023386 5. Jayne DRW, Bruchfeld AN, Harper L, et al. Randomized Trial of C5a Receptor Inhibitor Avacopan in ANCA-Associated Vasculitis. JAm Soc Nephrol . 2017;28(9):2756-2767. doi:10.1681/ASN.2016111179 6. Yates M, Watts RA, Bajema IM, et al. EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis [published correction appears in Ann Rheum Dis. 2017 Aug;76(8):1480]. Ann Rheum Dis. 2016;75(9):1583-1594. doi:10.1136/annrheumdis-2016-209133 7. Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Care Res (Hoboken) . 2021;73(8):1088-1105. doi:10.1002/acr.24634 8. IPD Analytics; accessed February 4, 2022. Effective date: 07/01/2022 Revised date: 02/04/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tarpeyo (budesonide)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Tarpeyo is a novel formulation of the corticosteroid budesonide that was approved by the FDA in December 2021. It is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) 1.5 g/g . IgA nephropathy is the most common primary glomerular disease. It is an autoimmune condition caused by deposits of immunoglobulin A (IgA) in the kidney, leading to hematuria, proteinuria, and nephropathy (kidney disease) as the kidneys become unable to filter. This can slowly progress to end stage renal disease (ESRD) requiring dialysis or kidney transplant. ACE inhibitors or angiotensin receptor blockers (ARBs ) are used to slow the progression of kidney disease, and immunosuppressive agents are added for those with rapidly progressing disease. Tarpeyo is the first drug approved specifically for IgA nephropathy. As a delayed, sustained release formulation, Tarpeyo is able to be released in a pulse-like manner only once it has reached the small intestine, allowing the drug to be delivered to the Peyers patches in the ileum, which is theorized to be the source of IgA production. Being a targeted-release dosage form, Tarpeyo is subject to high first-pass metabolism resulting in lower systemic exposure and appears to elicit fewer and less severe systemic effects with better tolerability than high-dose systemic corticosteroids in this population.Tarpeyo (budesonide) will be considered for coverage when the following criteria are met:IgA Nephropathy (IgAN)For initial authorization: 1. Member is at least 18 years of age; AND 2. Member has a diagnosis of IgA nephropathy confirmed by renal biopsy; AND 3. Member has a progressively declining glomerular filtration rate (GFR) and/or worsening proteinuria (e.g. UPCR 1.5 g/g or greater); AND 4. Member has been stable on the max tolerated dose of an ACEi or ARB for at least 3 months or has a contraindication to both; AND 5. Member has trialed one generic oral corticosteroid therapy . 6. Dosage allowed/Quantity limit: 16 mg (4 capsules) by mouth once daily for 9 months. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy . QL: 120 capsules per 30 days If all the above requirements are met , the medication will be approved for 10 months. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Tarpeyo will not be reauthorized.In part A of the NefIgArd clinical trial, the basis of accelerated FDA approval, the UPCR improvements continued through 12 months. The confirmatory part Bof this study taking place over 2 years will evaluate long term benefit.CareSource considers Tarpeyo (budesonide) 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 01/27/2022 New policy for Tarpeyo created. References: 1. Tarpeyo [ prescribing information]. Calliditas Therapeutics AB; 2021 . 2. Fellstrm BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet . 2017;389(10084):2117-2127. doi:10.1016/S0140-6736(17)30550-0 3. Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (Nefigard) . ClinicalTrials.gov Identifier: NCT03643965. Updated December 13, 2021. Accessed January 27,2022. https://clinicaltrials.gov/ct2/show/NCT03643965.4. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int . 2021;100(4S):S1-S276. doi:10.1016/j.kint.2021.05.021 Effective date: 07/01/2022 Revised date: 01/27/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Zavesca (miglustat)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Zavesca is a substrate reduction therapy, FDA approved in 2003 for the treatment of Gaucher disease type 1. Gaucher disease is a rare, inherited, lysosomal storage disorder. In Gaucher disease, mutations of the GBA gene cause deficiency of the enzyme glucocerebro sidase (acid beta-glucosidase), resulting in the accumulation of glucocerebroside ( glucosylceramide [GLC]) in the lysosomes of macrophages to form Gaucher cells, especially in the bone marrow, spleen, and liver. Prominent symptoms include hepatosplenomegaly, anemia, thrombocytopenia, and skeletal problems. Type 1 Gaucher disease is the most common form and does not affect the central nervous system. In contrast to standard of care enzyme replacement therapy (ERT), Zavesca reduces synthesis of the accumulating substrate to compensate for its impaired degradation.Zavesca (miglustat) will be considered for coverage when the following criteria are met:Gaucher disease type 1 (GD1)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a geneticist, hematologist, or metabolic specialist ; AND 3. Member has a diagnosis of mild to moderate Gaucher disease type 1, confirmed by document ation of at least one of the following: a) Reduced activity of glucocerebrosidase via enzyme assay (0 to 15% of normal), and/or b) Molecular genetic test documenting mutation of the GBA gene; AND 4. Member is NOT eligible for enzyme replacement therapy ( e.g., hypersensitivity, poor venous access , failed after at least 6 months ); AND 5. Member exhibits at least one of the following disease manifestations: a) Anemia, b) Thrombocytopenia, c) Spleen and/or liver enlargement; AND 6. Member does NOT have any of the following: a) Neurologic symptoms possibly suggestive of type II or III Gaucher disease (i.e., supranuclear gaze palsy, cognitive decline, epilepsy, myoclonus and/or ataxia) , b) Concomitant use with Cerdelga (eliglustat) or ERT. 7. Dosage allowed/Quantity limit: 100 mg three times a day. (Limit: 90 capsules per 30 days). 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. Chart notes must document improvement in one or more of the following parameters compared to baseline: a) Hemoglobin level b) Platelet count c) Spleen and/or liver volumes d) Bone outcomes If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Zavesca (miglustat) 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/DESCRIPTION06/29/2017 New policy for Zavesca created. 08/06/2021 Transferred to new template. Added references. Added specialist requirement. Elaborated on diagnostic requirement. Removed restriction of ERT within last 6 months. Removed baseline measures requirement. Added that they must present with symptoms. Changed renewal criteria. Changed approval durations from 6 months to 12 months. References: 1. Zavesca [package insert]. South San Francisco, CA; Actelion Pharmaceuticals US, Inc: 1/2021. 2. Cox T, Lachmann R, Hollak C, et al. Novel oral treatment of Gaucher’s disease with N-butyldeoxynojirimycin (OGT 918) to decrease substrate biosynthesis. Lancet . 2000;355(9214):1481-1485. doi:10.1016/S0140-6736(00)02161-9 3. Elstein D, Hollak C, Aerts JM, et al. Sustained therapeutic effects of oral miglustat (Zavesca, N-butyldeoxynojirimycin, OGT 918) in type I Gaucher disease. JInherit Metab Dis . 2004;27(6):757-766. doi:10.1023/B:BOLI.0000045756.54006.17 4. Cox TM, Aerts JM, Andria G, et al. The role of the iminosugar N-butyldeoxynojirimycin (miglustat) in the management of type I (non-neuronopathic) Gaucher disease: a position statement. JInherit Metab Dis . 2003;26(6):513-526. doi:10.1023/a:1025902113005 5. Elstein D, Dweck A, Attias D, et al. Oral maintenance clinical trial with miglustat for type I Gaucher disease: switch from or combination with intravenous enzyme replacement. Blood . 2007;110(7):2296-2301. doi:10.1182/blood-2007-02-075960 6. Biegstraaten M, van Schaik IN, Aerts JM, Hollak CE. 'Non-neuronopathic' Gaucher disease reconsidered. Prevalence of neurological manifestations in a Dutch cohort of type I Gaucher disease patients and a systematic review of the literature. JInherit Metab Dis . 2008;31(3):337-349. doi:10.1007/s10545-008-0832-y Effective date: 01/01/2022 Revised date: 08/06/2021
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