IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Zavesca (miglustat)BENEFIT TYPE Pharmacy 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 glucocerebrosidase (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 m ost 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. Miglustat may also be used off-label for the treatment of Niemann-Pick disease type C, as supported by guidelines . As of 2024, Miplyffa is FDA approved for use with miglustat for NPC.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 documentation 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 2 mutations (biallelic variants) 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 ( QL: 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 If all the above requirements are met, the medication will be approved for an additional 12 months. Niemann-Pick disease type C (NPC)For initial authorization: 1. Medication must be prescribed by or in consultation with a neurologist, metabolic specialist, or geneticist; AND 2. Member has a diagnosis of NPC confirmed by one of the following: a) Genetic testing that shows mutations in both alleles of the NPC1 or NPC2 gene, or b) Mutation in one allele of NPC1 or NPC2 , AND either elevated plasma biomarkers (i.e., cholestane-triol or trihydroxy-cholanoyl-glycine and/or lysoSM-509 with normal or slightly elevated lysoSM) OR positive filipin testing; AND 3. Member has at least 1 neurological sign of disease; AND 4. Member does NOT have advanced neurological disease. 5. Dosage allowed/Quantity limit: Up to 200 mg three times a day. (QL: 180 capsules per 30 days) If all the above requirements are met, the medication will be approved for 12 months. For reauthorization : 1. Chart notes must document improvement or stabilization of neurological signs and symptoms compared to baseline. 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. 05/11/2023 Added references. Clarified that 2 mutations of the GBA gene should be present. Removed bone outcomes from reauth section; was not measured in clinical trials and unlikely to be evident at 12 mo. 10/24/2024 Added criteria for diagnosis of NPC (approved in combination with Miplyffa; off-label as monotherapy or in combination with Aqneursa) . IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023References: 1. Zavesca [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; 2022. 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 7. Stone WL, Basit H, Master SR. Gaucher Disease. [Updated 2022 Jun 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan- . Available from: https://www.ncbi.nlm.nih.gov/books/NBK448080/ 8. Pastores GM, Hughes DA. Gaucher Disease. 2000 Jul 27 [Updated 2023 Mar 9]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1269/9. Dardis A, Michelakakis H, Rozenfeld P, et al. Patient centered guidelines for the laboratory diagnosis of Gaucher disease type 1. Orphanet JRare Dis . 2022;17(1):442. Published 2022 Dec 21. doi:10.1186/s13023-022-02573-6 10. Torralba-Cabeza M, Morado-Arias M, Pijierro-Amador A, Fernndez-Canal MC, Villarrubia-Espinosa J. Recommendations for oral treatment for adult patients with type 1 Gaucher disease [published online ahead of print, 2022 Jun 5]. Rev Clin Esp (Barc ). 2022;S2254-8874(22)00043-1. doi:10.1016/j.rceng.2022.02.008 11. Geberhiwot T, Moro A, Dardis A, et al. Consensus clinical management guidelines for Niemann-Pick disease type C. Orphanet JRare Dis. 2018;13(1):50. Published 2018 Apr 6. doi:10.1186/s13023-018-0785-7 12. Patterson MC, Clayton P, Gissen P, et al. Recommendations for the detection and diagnosis of Niemann-Pick disease type C: An update. Neurol Clin Pract. 2017;7(6):499-511. doi:10.1212/CPJ.0000000000000399 13. Patterson MC, Vecchio D, Prady H, Abel L, Wraith JE. Miglustat for treatment of Niemann-Pick Cdisease: a randomised controlled study. Lancet Neurol. 2007;6(9):765-772. doi:10.1016/S1474-4422(07)70194-1 14. Mengel E, Patterson MC, Da Riol RM, et al. Efficacy and safety of arimoclomol in Niemann-Pick disease type C: Results from a double-blind, randomised, placebo-controlled, multinational phase 2/3 trial of a novel treatment. JInherit Metab Dis. 2021;44(6):1463-1480. doi:10.1002/jimd.12428 Effective date: 06/30/2025 Revised date: 10/24/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Krystexxa (pegloticase)BENEFIT TYPE Medical STATUS Prior Authorization Required Krystexxa , approved by the FDA in 2010, 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 interventions have failed to achieve the serum uric acid target, and who continue to have frequent gout flares or who have non-resolving subcutaneous tophi.Krystexxa (pegloticase) will be considered for coverage when the following criteria are met:Chronic GoutFor 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. 01/15/2025 Consolidated references; no changes to criteria. 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 (H oboken). 2021 Mar;73(3):458]. Arthritis Care Res (Hoboken). 2020;72(6):744-760. 3. 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 4. 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 : 06/30/2025 Revised date: 01/15/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Crenessity (crinecerfont )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Crenessity is a corticotropin-releasing factor type 1 (CRF1) receptor antagonist initially approved by the FDA in 2024. It is indicated as adjunctive treatment for glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH). Congenital Adrenal Hyperplasia (CAH) is an autosomal recessive disorder most commonly caused by 21-hydroxylase deficiency. This enzyme deficiency leads to impaired cortisol and aldosterone production, resulting in adrenal insufficiency, androgen excess, and, in severe cases, life-threatening salt-wasting crises. The condition typically presents in the newborn period, either through newborn screening detecting elevated 17-hydroxyprogesterone levels or by the presence of atypical genitalia in females. Diagnos is is confirmed through hormonal assays, cosyntropin stimulation testing, and genetic analysis of CYP21A2 mutations. Long-term management requires glucocorticoid replacement therapy to prevent adrenal insufficiency and control excess androgen production. Crenessity (crinecerfont) will be considered for coverage when the following criteria are met:Classic Congenital Adrenal Hyperplasia (CAH) For initial authorization: 1. Member is at least 4 years of age; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a diagnosis of classic CAH due to 21-hydroxylas e deficiency confirmed by at least one of the following: a) Elevated 17-hydroxyprogeserone (17OHP) level with or without cosyntropin stim test (e.g., >1,000 ng/dL or >30 nmol/L) b) CYP21A2 mutations through genetic testing,; AND 4. Member requires a supraphy siologic glucocorticoid dose (i.e., >12 mg/m 2/day hydrocortisone equivalents for pediatrics or >13 mg/m 2/day for adults) ; AND 5. Member will continue glucocorticoid replacement. 6. Dosage allowed/Quantity limit: a) Adults ( 18 years ): 100 mg orally twice daily b) Pediatric (4-17 years): weight-based dosing as follows: Weight Range Dose (twice daily) 10 kg to
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Oncology Regimen sBENEFIT TYPE Medical or Pharmacy All oncology treatments must be submitted to Eviti Connect for review via the NantHealth Eviti Connectportal. Eviti Connect is an online platform that connects CareSource with oncology offices for real-time validation of cancer treatment plans. It is the most efficient way to initiate a treatment plan review and reduces the administrative time involved in requesting authorizations at the drug level by assuring accurate reimbursement at the regimen level. Oncology treatment regimens are reviewed in their entirety to include supportive care medications and drugs which otherwise would not require prior authorization (PA). Treatment plans that comply with evidence-based medicine will be issued an Eviti code, meaning that it meets national standards of quality care and the definition of medical necessity. An Eviti code is not a guarantee of payment, however, the code issuance indicates the review process has been completed and an authorization is forwarded to CareSource. For drugs which may have use in the oncology setting as well as other approved indications and which are not being used as a part of an oncology treatment regimen, review under this policy is not necessary. Any existing drug specific clinical review policies will supersede this oncology treatment regimen review policy. Oncology regimens are reviewed based on the following criteria: Cancer (all types )For initial authorization: 1. The oncology drug(s) must be prescribed by an oncologist or hematologist; AND 2. The regimen must have sufficient supporting evidence for use as determined by one or more of the following: a) Food and Drug Administration (FDA) approved indication(s) b) National Comprehensive Cancer Network (NCCN) evidence categories 1, 2a, or 2b c) Other recommendations within the Eviti evidence-based medical library, such as nationally recognized peer-reviewed medical journal articles or professional society oncology treatment standards and guidelines; AND 3. The dose(s) must not exceed the FDA labeled maximum or what is supported by the above compendia or reference guidelines; AND 4. Medical records, applicable lab results, and/or test results such as to detect a genetic mutation must be provided to confirm the diagnosis and provide baseline information; AND 5. Chart notes must document any and all previous treatments for the members cancer; AND 6. The member does not have any contraindications to the requested treatment; AND 7. If the request is for a non-preferred/non-formulary drug and a comparable preferred drug is available as determined by the reviewer ( e.g., a biosimilar or a drug in the same mechanistic class with similar efficacy and safety), then the member must try the alternative preferred regimen first and show a lack of response before requesting a non-preferred drug, unless not tolerated or contraindicated; AND 8. The request is not for experimental or investigational purposes or for use in a clinical trial. If all the above requirements are met, the oncology treatment regimen will be authorized for up to IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20236 months.For reauthorization :1. Chart notes must document improvement or stabilization of disease based on clinical narrative, imaging, or current clinical biomarker/lab results. If all the above requirements are met, the oncology regimen will be authorized for up to an additional 12 months.Scenarios that do not meet the above requirements may be considered on a case-by-case basis if the provider submits timely clinical literature from a nationally recognized peer-reviewed medical journal(s) that presents clear and compelling data for efficacy and safety.DATE ACTION/DESCRIPTION01/19/2021 New policy for Oncology created. 08/16/2022 Eviti code verbiage updated. Changed policy title from Oncology Treatment Regimen Review. 10/03/2024 Annual review; updated references. References: 1. NCCN: Levels of Evidence and Consensus for Recommendations. https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines. Accessed October 3, 2024. 2. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/. Drug Consults: Recommendation, Evidence and Efficacy Ratings. Accessed October 3, 2024. Effective date: 06/30/2025 Revised date: 10/03/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Rituximab (Rituxan, Truxima, Ruxience, Riabni)BENEFIT TYPE Medical STATUS Prior Authorization Required Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Bcells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, Bcells may be acting at multiple sites in the autoimmune/inflammatory process.Rituximab will be considered for coverage when the following criteria are met:Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)For initial authorization: 1. Member is at least 2 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 GPA or MPA ; AND 4. Rituximab will be initiated in combination with glucocorticoids; AND 5. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 6. Dosage allowed/Quantity limit: IV infusion Adult induction: 375 mg/m 2 once weekly for 4 weeks Adult maintenance: Two 500 mg infusions separated by 2 weeks, then 500 mg every 6 months Peds induction: 375 mg/m2 once weekly for 4 weeks Peds Maintenance: Two 250 mg/m 2 infusions separated by 2 weeks, then 250 mg/m 2 every 6 months If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Chart notes demonstrate clinical improvement of disease signs and symptoms. If all the above requirements are met, the medication will be approved for an additional 12 months.Pemphigus Vulgaris (PV)For initial authorization: 1. Member is 18 years old or older; AND 2. Must be prescribed by or in consultation with a dermatologist; AND 3. Member has a documented diagnosis of moderate to severe PV ; AND 4. Rituximab will be initiated in combination with a corticosteroid taper (unless contraindicated); AND IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20235. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 6. Dosage allowed/Quantity limit: Initial: Two 1000mg doses separated by 2 weeks; Maintenance: 500mg infusion at month 12 and every 6 months thereafter or based on clinical evaluation. Relapse: 1000mg infusion. Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion. If all the above requirements are met, the medication will be approved for 12 months. For reauthorization : 1. Chart notes demonstrate clinical improvement of signs and symptoms (e.g. healed lesions, fewer new lesions, etc.) If all the above requirements are met, the medication will be approved for an additional 12 months. Rheumatoid Arthritis (RA)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication is being prescribed by or in consultation with a rheumatologist; AND 3. Member has a documented diagnosis of moderately-to severely-active RA; AND 4. Rituximab is being used in combination with methotrexate, or another non-biologic DMARD if unable to tolerate methotrexate; AND 5. Member must have inadequate response or intolerance to ONE or more tumor necrosis factor (TNF) antagonists (e.g. adalimumab, etanercept, infliximab) for at least 3 months each. Note: TNF antagonists require prior authorization; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: Two 1000mg doses separated by 2 weeks; subsequent courses repeated no sooner than every 16 weeks (every 24 weeks is typical). If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes demonstrate improvement of RA signs and symptoms (e.g. fewer number of painful and swollen joints, achievement of remission, etc.) If all the above requirements are met, the medication will be approved for an additional 12 months. Acquired Thrombotic Thrombocytopenic Purpura (aTTP)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with a hematologist; AND 3. Member has a presumptive or confirmed diagnosis of aTTP including ALL of the following: a) Lab results showing thrombocytopenia (platelet count less than 150,000); b) Microangiopathic hemolytic anemia (MAHA) confirmed by presence of schistocytes on blood smear; IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023c) Documentation of a PLASMIC score between 5 and 7 (intermediate to high risk);1. Testing shows an ADAMTS13 activity level less than 10%, OR test has been ordered and results are pending. 4. Members platelet count has not responded after at least 4 days of plasma exchange and glucocorticoid; AND 5. Rituximab is being used in addition to plasma exchange and glucocorticoid; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: 375mg/m2 once weekly for 4 doses (off label). If all the above requirements are met, the medication will be approved for 30 days. For reauthorization :1. Member is experiencing a relapse of symptoms (thrombocytopenia and MAHA); AND 2. ADAMTS13 activity is less than 20% (lab report required). If all the above requirements are met, the medication will be approved for an additional 30 days.Neuromyelitis Optica Spectrum Disorder (NMOSD)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of NMOSD and is seropositive for aquaporin-4 (AQP4) IgG antibodies (documentation required); AND 4. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 5. Dosage allowed/Quantity limit: 1g on day 1 and day 15, then 1g every 6 months (off label) If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must document disease stabilization, symptom improvement, and/or reduced frequency of relapses. If all the above requirements are met, the medication will be approved for an additional 12 months. Generalized Myasthenia Gravis (gMG)IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For initial authorization:1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member meets ONE of the following: a) Member has a documented diagnosis of gMG that is seropositive for MuSK antibodies AND has tried and failed corticosteroid treatment with or without a non-steroid immunosuppressant b) Member has a documented diagnosis of refractory gMG that is seropositive for AChR antibodies AND has tried and failed ALL of the following: pyridostigmine, corticosteroid, and at least 2 non-steroid immunosuppressives (e.g., azathioprine, mycophenolate mofetil, tacrolimus); AND 4. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 5. Dosage allowed/Quantity limit: Consult updated clinical literature for recommendations. A variety of regimens have shown efficacy. (Off label use) If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must document clinically meaningful improvement in symptom severity and functioning compared to previous treatment. If all the above requirements are met, the medication will be approved for an additional 12 months. Multiple Sclerosis (MS)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of MS, including documentation of baseline relapse rate, lesion count, and/or disability status (e.g., EDSS) ; AND 4. Member has documentation of ONE of the following: a) For primary progressive MS (PPMS): Trial and failure of Ocrevus b) For relapsing forms of MS (RMS): Trial and failure of at least 2 preferred disease-modifying drugs indicated for MS; AND 5. Rituximab will not be used concurrently with another disease-modifying drug for MS; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: Consult updated clinical literature for recommendations. (Off label use) If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Chart notes must indicate a positive clinical response such as lower relapse rate compared to baseline (i.e., for RMS) or overall stability of disease (i.e., for PPMS). If all the above requirements are met, the medication will be approved for an additional 12 months.Immune Thrombocytopenia (ITP)For initial authorization: IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20231. Medication is prescribed by or in consultation with a hematologist; AND2. Member has a documented diagnosis of ITP of at least 6 months duration; AND 3. Members platelet count is
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Vabysmo (faricimab-svoa)BENEFIT TYPE Medical STATUS Prior Authorization Required Vabysmo, initially approved by the FDA in 2022, is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) , Diabetic Macular Edema (DME) , or Macular Edema f ollowing Retinal Vein Occlusion (RVO) . It is administered by intravitreal injection by a physician. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of Ang-2 is thought to promote vascular stability and desens itize blood vessels to the effects of VEGF-A. Vabysmo was approved based on clinical trial results showing achievement of vision gains noninferior to Eylea.Vabysmo (faricimab-svoa) will be considered for coverage when the following criteria are met:Retinal DiseaseFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of one of the following conditions: a) Neovascular (wet) Age-Related Macular Degeneration (AMD) b) Diabetic Macular Edema (DME) c) Macular Edema Following Retinal Vein Occlusion (RVO) ; AND 4. Member has tried and failed bevacizumab intravitreal injection; AND 5. Documentation of best-corrected visual acuity (BCVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated. 7. Dosage allowed/Quantity limit: See package insert for full instructions. AMD : 6 mg every 4 weeks for 4 doses; adjust per clinical evaluation to an interval of every 4 to 16 weeks . Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . DME : 6 mg every 4 weeks for 4 to 6 doses; adjust per clinical evaluation to an interval of every 4 to 8 weeks. Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . RVO : 6 mg every 4 weeks for 6 months. QL: 1 vial or prefilled syringe per eye per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization :1. Chart notes must include documentation of improved or stabilized visual acuity . If all the above requirements are met , the medication will be approved for an additional 12 months.IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CareSource considers Vabysmo (faricimab-svoa) 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 04/05/2022 New policy for Vabysmo created. 05/25/2023 Annual review; no updates. 11/15/2023 Added RVO as an approved indication per label expansion. Clarified dosing for AMD, DME . 11/08/2024 Added prefilled syringe form. References: 1. Vabysmo [prescribing information]. Genentech, Inc.; 2024 . 2. 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 3. 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 4. Holekamp, Nanvy M. Review of Neovascular Age-Related Macular Degeneration Treatment Options. Am JManag Care. July 2019; 25: -S0 5. 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 6. 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 7. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. NEngl JMed. 2015;372(13):1193-1203. doi:10.1056/NEJMoa1414264 8. Flaxel CJ, Adelman RA, Bailey ST, et al. Retinal Vein Occlusions Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology. 2020;127(2):P288-P320. doi:10.1016/j.ophtha.2019.09.029 9. Schmidt-Erfurth U, Garcia-Arumi J, Gerendas BS, et al. Guidelines for the Management of Retinal Vein Occlusion by the European Society of Retina Specialists (EURETINA). Ophthalmologica. 2019;242(3):123-162. doi:10.1159/000502041 Effective date: 06/30/2025 Revised date: 11/08/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Tavneos (avacopan)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Tavneos, approved by the FDA in 2021, is a complement 5a receptor (C5aR) antagonist 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]). It does not eliminate glucocorticoid use. 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 Vasculitis(AAV) For 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 myeloperoxidase (MPO) – or proteinase 3 (PR3)- antineutrophil cytoplasmic antibody (ANCA) ; AND 5. 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 6. Tavneos will be used in combination with standard immunosuppressive therapy (e.g., rituximab or cyclophosphamide) AND glucocorticoids (unless contraindication is documented) ; AND 7. Liver function tests (ALT, AST) have been or will be obtained before starting Tavneos; AND 8. Member does not have severe hepatic impairment (Child-Pugh C); AND 9. Members eGFR is 15 mL/min or greater; AND 10. Member is not currently on dialysis and has not had a kidney transplant. 11. Dosage allowed/Quantity limit: 30 mg (three 10 mg capsules) orally twice daily. QL: 180 capsules per 30 days 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 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. 10/07/2024 Updated references. Removed step requirement (Hellmich 2022). APPENDIX: 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 MeningitisSeizures (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.; 2024. 2. 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 Cyclophosphamide/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 3. 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 4. 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 5. 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 6. 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 7. Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis . 2024;83(1):30-47. Published 2024 Jan 2. doi:10.1136/ard-2022-223764 Effective date: 06/30/2025 Revised date: 10/07/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Xeomin (incobotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Xeomin is a neurotoxin produced from Clostridium botulinum serotype A. Xeomin works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. Blepharospasm is the abnormal contraction of eyelids. Xeomin is indicated for the treatment or improvement of blepharospasm in adults. Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head. Xeomin is indicated for the treatment or improvement of cervical dystonia in adults. Chronic sialorrhea, or excessive drooling, is a common symptom for patients with Parkinsons Disease or other neurological or cognitive impairments. Xeomin is indicated for the treatment or improvement of chronic sialorrhea in patients 2 years of age and older . Xeomin is also indicated for the treatment or improvement of upper limb spasticity in adults and in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy . Xeomin (incobotulinumtoxinA) will be considered for coverage when the following criteria are met:B lepharospasmFor initial authorization: 1. Member has a diagnosis of blepharospasm, characterized by spasms inducing narrowing or closure of the eyelids. 2. Dosage allowed/Quantity limit : Not to exceed 50 units per eye (100 units per treatment session) every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes show improved signs and symptoms (e.g., lessening of involuntary contraction). If all the above requirements are met, the medication will be approved for an additional 12 months. Cervical DystoniaFor initial authorization: 1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed/Quantity limit : Up to 300 units every 12 weeks, divided among affected muscles. If all the above requirements are met, the medication will be approved for 6 months . IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must show improved severity, disability, or pain compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months. C hronic SialorrheaFor initial authorization: 1. Member is at least 2 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has diagnosis of chronic sialorrhea impacting quality of life for at least 3 months; AND 4. Member has tried and failed or has a contraindication to at least one anticholinergic drug (e.g. scopolamine, benztropine, glycopyrrolate, amitriptyline). 5. Dosage allowed/Quantity limit : May repeat no sooner than every 16 weeks . Adult: Pediatric : If all the above requirements are met, the medication will be approved for 16 weeks. For reauthorization : 1. Chart notes have been provided that show the member has improvement of signs and symptoms of disease. If all the above requirements are met, the medication will be approved for an additional 12 months. IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Spasticity (upper limb) For initial authorization: 1. Member is at least 2 years of age; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of UPPER limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try a conservative treatment approach such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed/Quantity limit : (adult and pediatric) Maximum of 400 units per treatment session, every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes show improved signs and symptoms (e.g., decrease in severity of increased muscle tone). If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Xeomin (incobotulinumtoxinA) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION 08/06/2018 New policy for Xeomin created. Age requirement removed for diagnoses of Cervical Dystonia and Upper Limb Spasticity. Criterion no infection at proposed injection site removed from Cervical Dystonia diagnosis; pain and abnormal head position requirements clarified and medications trial added. For Upper Limb Spasticity Ashworth scale requirement removed, post-stroke requirement and chart notes requirement of abnormal muscle tone documentation added. 04/05/2019 New indication of Chronic Sialorrhea added. Dose allowance increased for diagnosis of Cervical Dystonia. Trial of Botox removed form diagnosis of Blepharospasm. 06/09/2020 Edited criteria for Chronic Sialorrhea to more closely align with Myobloc simplified exclusion criteria and added trial of anticholinergics. Changed qty limit at top of document. 08/24/2020 Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing. Added reference. Cervical dystonia: Added age limit and specialist requirement. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Corrected the dose. Extended re-auth duration. Updated references. Spasticity: Added age and specialist. Added trial of conventional treatment. Extended initial auth duration. Corrected the dose. Added references. Label recently expanded to include pediatrics. 12/31/2020 Updated the age limit and dosing for chronic sialorrhea to include pediatric patients, per recent label change. Added a couple references. Changed from try 2 anticholinergics to try 1 anticholinergic. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Allowing higher dose for cervical dystonia. IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202311/14/2023 Cervical dystonia: removed Symptoms affect quality of life and daily functions. Updated references and clarified renewal criteria. 10/02/2024 Removed age and specialist for cervical dystonia and blepharospasm indications. References: 1. Xeomin [package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023. 2. Teasell R, et al. Evidence to practice: botulinum toxin in the treatment of spasticity post stroke. Top Stroke Rehabil. 2012 Mar-Apr;19(2):115-21. 3. Chen R, et al. Botulinum toxin for Post-stroke Limb Spasticity. Ischemic Stroke Therapeutics. 2016; 203-207. 4. Cameron MH, et al. Botulinum toxin for symptomatic therapy in multiple sclerosis. Curr Neurol Neurosci Rep. 2014 Aug;14(8):463. 5. Bavikatte G, Sit PL, Hassoon A. Management of Drooling of Saliva. BJMP. 2012;5(1):a507. [https://www.bjmp.org/content/management-drooling-saliva ]6. Pellegrini A, Lunetta C, et. al. Sialorrhea: How to manage a frequent complication of motor neuron disease. EMJ Neurol . 2015;3[1]:107-113. [ https://emj.emg-health.com/wp-content/uploads/sites/2/2018/02/Sialorrhoea-How-to – Manage-a- Frequent-Complication-of-Motor-Neuron-Disease.pdf ] 7. Jost WH, Friedman A, Michel O, et al. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism & Related Disorders . 2020;70:23-30. doi:10.1016/j.parkreldis.2019.11.024 8. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826. doi:10.1212/wnl.0000000000002560 9. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission . 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 10. Defazio G, Hallett M, Jinnah HA, Berardelli A. Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology . 2013;81(3):236-240. doi:10.1212/WNL.0b013e31829bfdf6 11. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 12. Seppi K, Chaudhuri KR, Coelho M, et al. Update on treatments for nonmotor symptoms of Parkinson's disease an evidence based medicine review. Movement Disorders. 2019;34(2):180-198. doi:10.1002/mds.27602 13. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 14. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 15. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 Effective date: 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 Vijoice (alpelisib)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Vijoice, approved by the FDA in 2022, is a phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy . It was approved under the FDA accelerated approval pathway and is the first approved treatment for PROS . Existing treatment strategies include surgery , interventional radiology , and symptom management. PROS is a group of rare conditions characterized by overgrowth of various parts of the body , caused by mutations in the PIK3CA gene which has a role in regulating cell growth and division. Mutation can result in uncontrolled growth of the affected tissue(s). Some examples of PROS are Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and Spinal syndrome (CLOVES), Megalencephaly-Capillary Malformation Polymicrogyria (MCAP), Klippel-Trenaunay Syndrome (KTS), Facial Infiltrating Lipomatosis (FIL). Vijoice was studied in the EPIK-P1 clinical trial, a retrospective chart review in 37 patients. In the study, 27% had a radiological response at week 24, and 60% had a response lasting at least 12 months. Of note, alpelisib is marketed under the brand name Piqray for the treatment of breast cancer.Vijoice (alpelisib) will be considered for coverage when the following criteria are met:PIK3CA-Related Overgrowth Spectrum (PROS) For initial authorization: 1. Member is at least 2 years of age; AND 2. Medication must be prescribed by or in consultation with an oncologist, geneticist, metabolic specialist, or dermatologist; AND 3. Member has a diagnosis of a PROS disorder confirmed by documentation of both of the following: a) Mutation of the PIK3CA gene* b) At least one measurable target lesion identified on imaging; AND 4. The physician has determined the members condition is severe, life-threatening, or requires surgical intervention. 5. Dosage allowed/Quantity limit: Adults (18+): 250 mg by mouth once daily Age 2 to
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Ofev (nintedanib )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Ofev , approved by the FDA in 2014, is a kinase inhibitor indicated to treat idiopathic pulmonary fibrosis (IPF), to treat chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and to slow the rate of decline in pulmonary function in 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 a UIP pattern on high resolution computed tomography (HRCT) or by a lung biopsy (results must be submitted for review) ; AND 4. Documentation of members baseline forced vital capacity (FVC); 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; AND 7. Ofev will not be prescribed in combination with Esbriet. 8. Dosage allowed/Quantity limit: 300 mg per day (150 mg twice daily) QL: 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 high-resolution computed tomography (HRCT) showing fibrosis affecting at least 10% of the lungs (results must be submitted for review); AND 4. Member has at least 2 of the following: a) Worsening respiratory symptoms b) Physiological evidence of disease progression (i.e., decline in FVC 5% predicted or DLCO 10% predicted within the past year) c) Radiological evidence of disease progression within the past year (e.g., increased traction bronchiectasis, new ground glass opacity or fine reticulation, new/increased honeycombing, increased lobar volume loss) ; 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) QL: 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 baseline forced vital capacity (FVC) ; AND 5. Member meets one of the following: a) Lung disease has progressed despite a trial of mycophenolate mofetil or cyclophosphamide, or b) Initially presents with advanced or aggressive lung disease; 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) QL: 60 capsules per 30 days 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. Member continues to abstain from smoking; AND 2. Chart notes must demonstrate a slowed rate of pulmonary function decline, as evidenced by stabilized FVC or repeat HRCT. If all the above requirements are met, the medication will be approved for an additional 12 months. 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. 10/14/2024 SSc-ILD: Updated refs. Revised reauth wording and added HRCT option. Removed FVC >40 (keep baseline). Added aggressive or advanced lung disease as alternative to CYC/MMF trial requirement (Rahaghi 2023). PF-ILD: Updated refs. Removed FVC >45 and replaced with diagnostic criteria from new guideline (ATS 2022). IPF: Updated refs. Specified UIP presence on HRCT. Removed minimum FVC required. Added to not be used with Esbriet. References: 1. Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 202 4. 2. 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 3. 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 4. 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-gro up trial. Lancet Respir Med. 2020;8(5):453-460. doi:10.1016/S2213-2600(20)30036-9 5. 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 6. 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 [published correction appears in Am JRespir Crit Care Med. 2015 Sep 1;192(5):644. doi: 10.1164/rccm.1925erratum. Dosage error in article text]. Am JRespir Crit Care Med. 2015;192(2):e3-e19. doi:10.1164/rccm.201506-1063ST 7. Raghu G, Remy-Jardin M, Myers JL, et al. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am JRespir Crit Care Med. 2018;198(5):e44-e68. doi:10.1164/rccm.201807-1255ST 8. Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am JRespir Crit Care Med . 2022;205(9):e18-e47. doi:10.1164/rccm.202202-0399ST 9. Distler O, Highland KB, Gahlemann M, et al. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. NEngl JMed. 2019;380(26):2518-2528. doi:10.1056/NEJMoa1903076 10. 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 11. 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 IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202312. Johnson SR, Bernstein EJ, Bolster MB, et al. 2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Treatment of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases. Arthritis Rheumatol. 2024;76(8):1182-1200. doi:10.1002/art.42861 13. Johnson SR, Bernstein EJ, Bolster MB, et al. 2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Screening and Monitoring of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Disea ses. Arthritis Rheumatol . 2024;76(8):1201-1213. doi:10.1002/art.42860 14. Raghu G, Montesi SB, Silver RM, et al. Treatment of Systemic Sclerosis-associated Interstitial Lung Disease: Evidence-based Recommendations. An Official American Thoracic Society Clinical Practice Guideline. Am JRespir Crit Care Med . 2024;209(2):137-152. doi:10.1164/rccm.202306-1113ST 15. Rahaghi FF, Hsu VM, Kaner RJ, et al. Expert consensus on the management of systemic sclerosis-associated interstitial lung disease. Respir Res. 2023;24(1):6. Published 2023 Jan 9. doi:10.1186/s12931-022-02292-3 Effective date: 06/30/2025 Revised date: 10/14/2024
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