IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Promacta (eltrombopag)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Promacta, approved by the FDA in 2008, is a small molecule thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of persistent or chronic immune thrombocytopenia (ITP) , for the treatment of thrombocytopenia in patients with chronic hepatitis Cto allow the initiation and maintenance of interferon-based therapy, and for the treatment of severe aplastic anemia. It is important to take Promacta without a meal or with a meal low in calcium, and separated from any medication or product containing polyvalent cations. Promacta has a boxed warning for risk of hepatic decompensation in patients with chronic hepatitis Cand risk of hepatotoxicity. Dose reductions are needed for patients with hepatic impairment and some patients of East -/SoutheastAsian ancestry . ITP is a rare autoimmune disorder characterized by low levels of platelets due to platelet destruction and insufficient platelet production. Aplastic anemia (AA) is a bone marrow failure syndrome characterized by marrow hypoplasia and hematopoietic stem cell (HSC) deficiency . Most cases of AA are acquired rather than inherited. Acquired AA results from immune-mediated destruction of bone marrow. Empty bone marrow does not produce blood cells, causing pancytopenia.Promacta (eltrombopag) will be considered for coverage when the following criteria are met:Immune Thrombocytopenia (ITP) For initial authorization: 1. Member is at least 1 year of age; AND 2. Medication is prescribed by or in consultation with a hematologist; AND 3. Member has a documented diagnosis of persistent or chronic ITP for at least 3 months; AND 4. Member meets one of the following: a) Current platelet count is 60 years), other clearly identified comorbidity ; AND 5. Member had an inadequate response, intolerance, or contraindication to documented prior therapy with at least one of the following treatments: a) Corticosteroid b) Immunoglobulin c) Splenectomy; AND 6. Members 6 years of age and older requesting oral suspension must provide clinical rationale why tablets cannot be used; AND 7. Member does NOT have any of the following: a) Thromboembolic condition b) Any cause of thrombocytopenia other than primary ITP IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023c) Concurrent use with another TPO-RA or with Tavalisse .. 8. Dosage allowed/Quantity limit: Initiate at 50 mg once daily for most adult and pediatric patients 6 years and older, and at 25 mg once daily for pediatric patients aged 1 to 5 years. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L. Max dose 75 mg per day . QL: 30 tablets per 30 days or 30 packets per 30 days (oral suspension kit). Note: Discontinue if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the maximum dose . If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Chart notes have been provided that show improvement in platelet count from baseline; AND 2. Members platelet count is less than 200 x 10 9/L or the dose is being reduced. If all the above requirements are met, the medication will be approved for an additional 12 months .H epatitis C (HCV) Associated ThrombocytopeniaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is prescribed by or in consultation with a hematologist, gastroenterologist, hepatologist, or infectious disease specialist; AND 3. Member has a documented diagnosis of t hrombocytopenia associated with chronic h epatitis C; AND 4. Members platelet count is less than 75 x 10 9/L ; AND 5. Promacta is being prescribed for use with interferon (IFN)-based therapy for hepatitis C ; AND 6. Members requesting oral suspension must provide clinical rationale why tablets cannot be used; AND 7. Member does NOT have any of the following: a) Decompensated liver disease (Child-Pugh score > 6, class Band C) b) History of ascites c) Hepatic encephalopathy . 8. Dosage allowed/Quantity limit: Initiate at a dose of 25 mg by mouth once daily . Adjust to achieve target platelet count required to start and maintain antiviral therapy . Max dose 100 mg daily. Discontinue when antiviral therapy is discontinued. QL: 60 tablets per 30 days. If all the above requirements are met , the medication will be approved for 6 months. For reauthorization :1. Chart notes have been provided that show the member has achieved and maintained a platelet count necessary to initiate and maintain antiviral therapy ; AND 2. Members platelet count is less than 200 x 10 9/L or the dose is being reduced; AND 3. Member is continuing IFN-based therapy as documented in chart notes and/or pharmacy claims . If all the above requirements are met , the medication will be approved for an additional 6 months . Severe Aplastic AnemiaFor initial authorization: IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20231. Member is at least 2 years of age if using as part of 1 st line therapy OR at least 18 years of age if refractory ; AND 2. Medication is being prescribed by or in consultation with a hematologist; AND 3. Members 6 years of age and older requesting oral suspension must provide clinical rationale why tablets cannot be used; AND 4. Member has a documented diagnosis of severe aplastic anemia defined as a marrow cellularity 200. Hep C : Added GI and hepatology to specialists. Added that they must be starting IFN . For renewal, changed PC
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Doptelet (avatrombopag )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Doptelet , approved by the FDA in 2018, is a small molecule thrombopoietin (TPO) receptor agonist indicated for the treatment of thrombocytopenia in adult s with chronic liver disease (CLD) who are scheduled to undergo a procedure , and for adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment . TPO is important for regulating thrombopoiesis . The agonistic effect of Doptelet upregulates the production of platelets. TPO receptor agonists (TPO-RA) have been associated with thrombotic and thromboembolic complications. Doptelet should not be administered in an attempt to normalize platelet counts. Doptelet was the first TPO receptor agonist approved for the indicated CLD population. Thrombocytopenia is a condition of low platelet counts. It is the most common hematologic complication in patients with CLD, and 1% experience severe thrombocytopenia (platelet count 60 years), other clearly identified comorbidity ); AND 6. Member does NOT have secondary immune thrombocytopenia (i.e., non-idiopathic, due to another condition). 7. Dosage allowed/Quantity limit: Start at 20 mg (1 tablet) once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50 x10 9/L, per tables in prescribing information. Do not exceed 40 mg per day. QL: 60 tablets per 30 days Note : Discontinue if the platelet count does not increase to at least 50 x 10 9/L after 4 weeks at the maximum dose of 40 mg once daily. Discontinue if the platelet count is greater than 400 x10 9/L after 2 weeks of dosing at 20 mg once weekl y. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Chart notes include documentation of achieving and maintaining a platelet count of at least 50 x 10 9/L ; AND 2. Members platelet count is less than 200 x 10 9/L or there is a plan to decrease the dose per prescribing information. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Doptelet (avatrombopag) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION05/06/2019 New policy for Doptelet created. 07/24/2019 New indication of Immune thrombocytopenia (ITP) added. Status changed to preferred . 01/23/2023 Transferred to new template. Updated and added references. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CLD: Added hepatology and GI as accepted specialists. Specified platelet lab must be within past 30 days. Shortened list of exclusions . Added not to be used in combination with another TPO-RA. ITP: Specified duration of chronic disease as at least 6 months. Removed Other medications: cyclosporine A, mycophenolate mofetil, azathioprine, danazol, cyclophosphamide and/or rituximab from list of accepted trials; none of these are initial/first line options per guidelines. Edited criteria under PC of 30,000-50,000. Added exclusion for secondary ITP. Reduced initial approval duration from 12 months to 6 months. For renewal, specified platelet improvement as 50,000 per drug label. For renewal added or plan to decrease dose to criterion for 200,000 ceiling PC. References: 1. Doptelet [ prescribing information]. AkaRx, Inc.; 2021. 2. Terrault N, Chen YC, Izumi N, et al. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology . 2018;155(3):705-718. doi:10.1053/j.gastro.2018.05.025. 3. Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int JHepatol. 2020;2020:5421632. Published 2020 Jan 25. doi:10.1155/2020/5421632 4. Hayashi H, Beppu T, Shirabe K, Maehara Y, Baba H. Management of thrombocytopenia due to liver cirrhosis: a review. World JGastroenterol . 2014;20(10):2595-2605. doi:10.3748/wjg.v20.i10.2595 5. Peck-Radosavljevic M. Thrombocytopenia in chronic liver disease. Liver Int. 2017;37(6):778-793. doi:10.1111/liv.13317 6. Lim HI, Cuker A. Thrombocytopenia and liver disease: pathophysiology and periprocedural management. Hematology Am Soc Hematol Educ Program. 2022;2022(1):296-302. doi:10.1182/hematology.2022000408 7. Miller JB, Figueroa EJ, Haug RM, Shah NL. Thrombocytopenia in Chronic Liver Disease and the Role of Thrombopoietin Agonists. Gastroenterol Hepatol (N Y ). 2019;15(6):326-332. 8. Flisiak R, Antonov K, Drastich P, et al. Practice Guidelines of the Central European Hepatologic Collaboration (CEHC) on the Use of Thrombopoietin Receptor Agonists in Patients with Chronic Liver Disease Undergoing Invasive Procedures. JClin Med. 2021;10(22):5419. Published 2021 Nov 19. doi:10.3390/jcm10225419 9. Markham A. Avatrombopag: A Review in Thrombocytopenia [published correction appears in Drugs. 2021 Dec;81(18):2169]. Drugs . 2021;81(16):1905-1913. doi:10.1007/s40265-021-01613-y 10. Jurczak W, Chojnowski K, Mayer J, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br JHaematol . 2018;183(3):479-490. doi:10.1111/bjh.15573 11. Bussel JB, Kuter DJ, Aledort LM, et al. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood . 2014;123(25):3887-3894. doi:10.1182/blood-2013-07-514398 12. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia [published correction appears in Blood Adv. 2020 Jan 28;4(2):252]. Blood Adv . 2019;3(23):3829-3866. doi:10.1182/bloodadvances.2019000966 13. Wojciechowski P, Wilson K, Nazir J, et al. Efficacy and Safety of Avatrombopag in Patients with Chronic Immune Thrombocytopenia: A Systematic Literature Review and Network Meta-Analysis. Adv Ther. 2021;38(6):3113-3128. doi:10.1007/s12325-021-01752-4 14. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. doi:10.1182/bloodadvances.2019000812 15. Song F, Al-Samkari H. Management of Adult Patients with Immune Thrombocytopenia (ITP): A Review on Current Guidance and Experience from Clinical Practice. JBlood Med. 2021;12:653-664. Published 2021 Jul 26. doi:10.2147/JBM.S259101 Effective date: 08/01/2023 Revised date: 01/23/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Imbruvica (ibrutinib)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Imbruvica is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. GVHD, a common complication following allogenic hematopoietic stem cell transplant (HSCT), occurs in about 50% of HSCT patients. Prednisone is the mainstay of initial therapy but at least half of patients require at least 2 lines of therapy. Clinical guidelines do not come to a consensus regarding optimal 2nd line therapy but describe a variety of options. Imbruvica is a small molecule inhibitor of Brutons tyrosine kinase (BTK). BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. Imbruvica can exert its effects on Bcells and Tcells, both of which are thought to be involved in cGVHD pathogenesis. Initial approval was based on a phase 1b/2 study of 42 adults with cGVHD after failure of first line corticosteroid therapy and requiring additional therapy. Pediatric use was evaluated in the iMAGINE study.Imbruvica (ibrutinib) will be considered for coverage when the following criteria are met: Chronic Graft-Versus-Host Disease (cGVHD)For initial authorization: 1. Member is at least 1 year of age; AND 2. Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist; AND 3. Member has a documented diagnosis of active cGVHD that is steroid-dependent or steroid-refractory; AND 4. Member does NOT have a known bleeding disorder or hemophilia. 5. Dosage allowed/Quantity limit : 12 years and older: 420 mg orally once daily (until progression, recurrence of underlying malignancy, or unacceptable toxicity). QL: 28 tablets per 28 days 1 to less than 12 years of age: 240 mg/m2 orally once daily (up to 420 mg; see chart in prescribing information). QL: 2 bottles per 36 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improvement of signs and symptoms of disease in at least 1 organ/site, without progression in any other organ/site. If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Waldenstroms Macroglobulinemia, Marginal Zone LymphomaAny request for cancer must be submitted through NantHealth/Eviti portal. CareSource considers Imbruvica (ibrutinib) 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/DESCRIPTION10/04/2021 New policy created for Imbruvica. 09/23/2022 Updated age limit from 18 years to 1 year per label change; added pediatric dosing. References: 1. Imbruvica [prescribing information]. Pharmacyclics LLC and Janssen Biotech, Inc.; 2022. 2. Miklos D, Cutler CS, Arora M, et al. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood . 2017;130(21):2243-2250. doi:10.1182/blood-2017-07-793786 3. Waller EK, Miklos D, Cutler C, et al. Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study. Biol Blood Marrow Transplant . 2019;25(10):2002-2007. doi:10.1016/j.bbmt.2019.06.023 4. National Comprehensive Cancer Network. Hematopoietic Cell Transplantation (HCT): Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease. (Version 5 .2021). https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed October 4, 2021. 5. Wolff D, Fatobene G, Rocha V, Krger N, Flowers ME. Steroid-refractory chronic graft-versus-host disease: treatment options and patient management. Bone Marrow Transplant . 2021;56(9):2079-2087. doi:10.1038/s41409-021-01389-5 6. Penack O, Marchetti M, Ruutu T, et al. Prophylaxis and management of graft versus host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. Lancet Haematol . 2020;7(2):e157-e167. doi:10.1016/S2352-3026(19)30256-XEffective date: 04/01/2023 Revised date: 09/23/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Kuvan (sapropterin)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Kuvan, a synthetic form of the cofactor tetrahydrobiopterin, is a phenylalanine hydroxylase (PAH) activator approved by the FDA in 2007 for the treatment of tetrahydrobiopterin- (BH4 -) responsive phenylketonuria (PKU). It is indicated for pediatric and adult patients, and it is supplied as tablets and powder for oral solution. Patients must also maintain a phenylalanine ( Phe) restricted diet as part of treatment. PKU results from a deficiency of PAH, leading to increased concentrations of Phe. If untreated, this excess accumulation causes neuropsychiatric and neuroc ognitive symptoms.Kuvan (sapropterin) will be considered for coverage when the following criteria are met:Phenylketonuria (PKU)For initial authorization: 1. Member is at least 1 month of age ; AND 2. Medication must be prescribed by or in consultation with a specialist experienced in metabolic or genetic diseases ; AND 3. Member has a diagnosis of phenylketonuria; AND 4. Member has documentation of current Phe level sustained above 360 mol/ L; AND 5. Kuvan will be used in conjunction with a compliant Phe-restricted diet; AND 6. Kuvan will not be prescribed in combination with Palynziq. 7. Dosage allowed/Quantity limit: Up to 20 mg/kg once daily . Discontinue after 1 month at this dose if Phe has not decreased. If all the above requirements are met , the medication will be approved for 2 months. For reauthorization : 1. Chart notes must show at least a 30% reduction of Phe, and/or 2. Neuropsychiatric symptoms have improved, and/or 3. Member has shown an increase in Phe tolerance. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Kuvan (sapropterin) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTIONIN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202305/05/2021 New policy for Kuvan created.10/31/2022 Annual review; no updates. References: 1. Kuvan [prescribing information]. Novato, CA: Biomarin Phermaceutical Inc .; February 2021. 2. Vockley J, Andersson HC, Antshel KM, et al. Phenylalanine hydroxylase deficiency: diagnosis and management guideline [published correction appears in Genet Med. 2014 Apr;16(4):356]. Genet Med. 2014;16(2):188-200. doi:10.1038/gim.2013.157 3. van Spronsen FJ, van Wegberg AM, Ahring K, et al. Key European guidelines for the diagnosis and management of patients with phenylketonuria. Lancet Diabetes Endocrinol . 2017;5(9):743-756. doi:10.1016/S2213-8587(16)30320-5 4. Camp KM, Parisi MA, Acosta PB, et al. Phenylketonuria Scientific Review Conference: state of the science and future research needs. Mol Genet Metab. 2014;112(2):87-122. doi:10.1016/j.ymgme.2014.02.013 5. Somaraju UR, Merrin M. Sapropterin dihydrochloride for phenylketonuria. Cochrane Database Syst Rev . 2015;2015(3):CD008005. Published 2015 Mar 27. doi:10.1002/14651858.CD008005.pub4 Effective date: 04/01/2023 Revised date: 10/31/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Ruconest (C1 esterase inhibitor (recombinant))BILLING CODE J0596 or NDC BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Home/Office /Outpatient STATUS Prior Authorization Required Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE) . HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results from excess production of the vasodilator bradykinin. Attacks may be painful and cause funct ional impairment but are not associated with pruritis. The most common types of HAE are caused by deficiency (type 1) or dysfunction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent.Ruconest (C1 esterase inhibitor (recombinant)) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member must be 12 years of age or older; AND 2. Medication must be prescribed by or in consultation with an allergist or immunologist; AND 3. Member has a diagnosis of HAE type I or type II confirmed by both of the following: a) Low C4 level; b) Low (
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Novantrone (mitoxantrone)BILLING CODE J9293 (1 unit = 5 mg) BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office, Outpatient hospital STATUS Prior Authorization Required Mitoxantrone is a synthetic antineoplastic anthracenedione for intravenous use. It indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is s ignificantly abnormal between relapses). It is also used to treat certain cancers. Mitoxantrone is notindicated in the treatment of patients with primary progressive multiple sclerosis . The brand name Novantrone is no longer manufactured and the drug is only available as generic. Mitoxantrone has a black box warning for cardiotoxicity. It is seldom prescribed due to its high risk profile and frequency of severe adverse events. It should only be prescribed if the potential benefits greatly outweigh the risks. Mitoxantrone will be considered for coverage when the following criteria are met:Multiple Sclerosis (MS)For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by, or in consultation with, a neurologist; AND 3. Chart notes have been provided confirming diagnosis of one of the following types of MS: a) Secondary (chronic) progressive b) Progressive relapsing c) Worsening relapsing-remitting (i.e., members neurologic status is significantly abnormal between relapses ); AND 4. Member has had all of the baseline assessments below and does NOT have any of the following: a) Abnormal liver function tests b) LVEF less than 50% c) Neutrophil count less than 1500 cells/mm 3 d) Exceeded m aximum cumulative lifetime dose for mitoxantrone of 140 mg/m 2; AND 5. Members condition continues to decline despite compliant trial and failure of at least 3 prior disease- modifying drugs indicated for MS at the max tolerated doses; AND 6. Member does NOT have primary progressive MS . 7. Dosage allowed/Quantity limit: 12 mg/m 2 infusion every 3 months (Maximum cumulative lifetime dose is 140 mg/m 2) QL: 5 units per 84 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 reduced neurologic disability or reduced frequency of relapses ; AND 2. Members LVEF is being monitored prior to each dose; AND 3. Member has not exceeded the m aximum cumulative lifetime dose of 140 mg/m 2. If all the above requirements are met , the medication will be approved for an additional 12 months. Cancer diagnosisAny request for oncology use must be submitted through NantHealth/Eviti portal. CareSource considers mitoxantrone 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 06/12/2017 New policy for Novantrone created. Not covered diagnosis added. 12/06/2017 Confirmation of diagnosis based on McDonald criteria is no longer required. 07/06/2022 Transferred to new template. Updated all references. Specified and defined worsening relapsing-remitting disease. Added PRMS as a use and PPMS as an exclusion. Added baseline monitori ng assessments. Changed step drugs from 2 to at least 3. Changed QL from per infusion to per 3 months (per label) . Added reduced neurologic disability or reduced frequency of relapses to renewal criteria , split off the max cumulative dose as an additional criterion . References: 1. Mitoxantrone. Hospira, Inc.; 2022. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/. Accessed: July 6, 2022. 2. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol . 2018;17(2):162-173. doi:10.1016/S1474-4422(17)30470-2 3. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology [published corr ection appears in Neurology. 2019 Jan 8;92(2):112]. Neurology. 2018;90(17):777-788 4. National Multiple Sclerosis Society. The Use of Disease-Modifying Therapies in Multiple Sclerosis: Principles and Current Evidence. A Consensus Paper by the Multiple Sclerosis Coalition; 2019. Available from: https://www.nationalmssociety.org/NationalMSSoc iety/media/MSNationalFiles/Brochures/DMT_Consensus_MS_ Coalition.pdf. Accessed July 6, 2022. 5. Martinelli Boneschi F, Vacchi L, Rovaris M, Capra R, Comi G. Mitoxantrone for multiple sclerosis. Cochrane Database Syst Rev . 2013;(5):CD002127. Published 2013 May 31. doi:10.1002/14651858.CD002127.pub3 6. Scott LJ, Figgitt DP. Mitoxantrone: a review of its use in multiple sclerosis. CNS Drugs . 2004;18(6):379-396. doi:10.2165/00023210-200418060-00010 Effective date: 01/01/2023 Revised date: 07/06/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Kalbitor (ecallantide)BILLING CODE J1290 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office /Outpatient STATUS Prior Authorization Required Kalbitor is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older . It must be administered by a healthcare professional because of the risk for anaphylaxis , which is a black box warning for the product . HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results from excess production of the vasodilator bradykinin. Attacks may be painful and cause funct ional impairment but are not associated with pruritis. The most common types of HAE are caused by deficiency (type 1) or dysfunction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent.Kalbitor (ecallantide) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member must be 12 years of age or older; AND 2. Medication must be prescribed by or in consultation with an allergist or immunologist; AND 3. Member has a diagnosis of HAE type I or type II confirmed by both of the following: a) Low C4 level; b) Low (
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tobi, Tobi Pod hal er (tobramycin inhalation solution ) BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Tobi and Tobi Podhaler are an aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa initially approved by the FDA in 1997 and 2013 respectively . Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Tobi and Tobi Podhaler (tobramycin inhalation solution) will be considered for coverage when the following criteria are met:Cystic FibrosisFor initial authorization: 1. Member is at least 6 years of age ; AND 2. Medication must be prescribed by or in consultation with a pulmonologist or an infectious disease specialist ; AND 3. Member has a diagnosis of cystic fibrosis and has a positive culture for Pseudomonas aeruginosa documented in chart notes ; AND 4. Member has documented forced expiratory volume in 1 second (FEV 1) 25% to 80% predicted; AND 5. Member is not colonized with Burkholderia cepacia; AND 6. For Tobi Podhaler or brand name Tobi inhalation solution, member must have trial and failure of generic tobramycin inhalation solution with ineffectiveness, intolerance or contraindication documented in chart notes 7. Dosage allowed/Quantity limit: 300 mg every 12 hours for the solution (280 mL per 56 days) or 112 mg (4 x 28 mg capsules) every 12 hours for Podhaler ( 224 capsules per 56 days); administer in repeated cycles of 28 days on drug followed by 28 days off drug If all the above requirements are met , the medication will be approved for 12 months. For reauthorization :1. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by any of the following: a) Improved FEV1 and/or other lung function tests b) Decrease in pulmonary exacerbations or hospitalization c) Decrease in pulmonary infections 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 Tobi and Tobi Podhaler (tobramycin inhaled solution ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION05/25/2017 New policy for Tobi created. Not covered diagnosis added. 12/30/2020 Reauthorization criteria updated to simplified statement. Diagnosis of cystic fibrosis added to initial criteria. Kitabis removed as preferred option. Exclusion criteria updated. Generic tobramycin and Tobi Podhaler added to policy. 04/28/2022 Policy transferred to new template. Updated references. Corrected Podhaler QL from 228 to 224. Changed FEV1 from 25-75% to 25-80%. Amended renewal criteria to reflect expected treatment response; removed sweat chloride and weight gain . References: 1. Tobi [package insert]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 201 8. 2. Tobi Podhaler [prescribing information]. Mylan; 2020. 3. Mogayzel PJ Jr, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am JRespir Crit Care Med. 2013;187(7):680-689. doi:10.1164/rccm.201207-1160oe 4. Mogayzel PJ Jr, Naureckas ET, Robinson KA, et al. Cystic Fibrosis Foundation pulmonary guideline. pharmacologic approaches to prevention and eradication of initial Pseudomonas aeruginosa infection. Ann Am Thorac Soc . 2014;11(10):1640-1650. doi:10.1513/AnnalsATS.201404-166OC 5. Smith S, Rowbotham NJ, Regan KH. Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis [published online ahead of print, 2018 Mar 30]. Cochrane Database Syst Rev . 2018;3(3):CD001021. doi:10.1002/14651858.CD001021.pub3 Effective date: 10/01/2022 Revised date: 04/28/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Strensiq (asfotase alfa)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Strensiq was approved by the FDA in 2015 as a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP) .HPP is characterized by low serum alkaline-phosphatase (ALP) activity from mutations of the gene for tissue-nonspecific isozyme of alkaline phosphatase (TNSALP) . Natural substrates of TNSALP that accumulate in hypophosphatasia include inorganic pyrophosphate (PPi) , an inhibitor of mineralization, and pyridoxal 5-phosphate (PLP), the principal circulating form of vitamin B 6. High extracellular levels of inorganic pyrophosphate cause rickets or osteomalacia. Pyridoxine-responsive seizures may occur when TNSA LP deficiency is profound. Manifestations of HPP range from neonatal death with almost no skeletal mineralization to dental problems in adults without any bone symptoms. Such differences in expression are explained partly by autosomal recessive and autosomal dominant patterns of inheritance . Strensiq is a TNSALP enzyme replacement therapy (ERT) to reverse the skeletal mineralization defects of HPP. In clinical trials, significant radiographic improvement was observed, as well as significant improvements in patient growth, strength, motor funct ion, agility, pain, disability, and quality of life. Radiographic improvement was noted by 6 weeks and persisted for several years per extension study results. In life-threatening cases, Strensiq improves respiratory function and survival. Strensiq (asfotase alfa) will be considered for coverage when the following criteria are met:Hypophosphatasia (HPP) For initial authorization: 1. Medication must be prescribed by or in consultation with an endocrinologist or other specialist in metabolic bone disease; AND 2. Member has a diagnosis of hypophosphatasia (HPP) with perinatal/infantile-or juvenile-onset (before 18 years of age) with ALL of the following documented: a) Serum alkaline phosphatase (ALP) below age-adjusted normal range b) Plasma pyridoxal 5' -phosphate (PLP) elevation c) Radiographic evidence of skeletal abnormality ( e.g., rickets, osteomalacia) . 3. Dosage allowed/Quantity limit: Perinatal/Infantile-Onset HPP: 2 mg/kg administered subQ three times per week, or 1 mg/kg administered six times per week. The dose may be increased to 3 mg/kg three times per week for insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings). (Max 9 mg/kg/week) . See tables in package insert. Juvenile-Onset HPP : 2 mg/kg administered subQ three times per week, or 1 mg/kg administered six times per week. (Total 6 mg/kg/week). See tables in package insert. 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 document improvement in clinical signs and symptoms of hypophosphatasia, such as respiratory status, growth, or radiographic (skeletal healing) findings. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Strensiq (asfotase alfa) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION09/13/2018 New policy for Strensiq created. 04/23/2021 Updated references. Emphasized disease onset must be before age 18 years. Amended diagnostic criteria to be more simplified: Removed pain, growth components; Removed genetic testing requirement; Added PLP measure. Specified renewal criteria. 03/07/2022 Transferred to new template. Added reference s. Added rickets , osteomalacia as example s in 2c. Clarified max dosing. References: 1. Strensiq [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc.; June 2020. 2. Mornet E, Nunes ME. Hypophophatasia. 2007 Nov 20 [Updated 2016 Feb 4]. In: Adam MP, Ardinger HH, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2018. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1150/ .3. Whyte MP, Greenberg CR, Salman NJ, et al. Enzyme-Replacement Therapy in Life-Threatening Hypophosphatasia. NEngl JMed 2012; 366:904-913. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1106173. 4. Rush ET. Childhood hypophosphatasia: to treat or not to treat. Orphanet JRare Dis. 2018 Jul 16;13 (1):116. 5. Whyte MP, Madson KL, Phillips D, et al. Asfotase alfa therapy for children with hypophosphatasia. JCI Insight . 2016;1(9):e85971. Published 2016 Jun 16. doi:10.1172/jci.insight.85971 6. Whyte MP. Hypophosphatasia-aetiology, nosology, pathogenesis, diagnosis and treatment. Nat Rev Endocrinol . 2016;12(4):233-246. doi:10.1038/nrendo.2016.14 7. Kishnani PS, Rockman-Greenberg C, Rauch F, et al. Five-year efficacy and safety of asfotase alfa therapy for adults and adolescents with hypophosphatasia. Bone. 2019;121:149-162. doi:10.1016/j.bone.2018.12.011 8. Shapiro JR, Lewiecki EM. Hypophosphatasia in Adults: Clinical Assessment and Treatment Considerations. JBone Miner Res . 2017;32(10):1977-1980. doi:10.1002/jbmr.3226 9. Whyte MP, Rockman-Greenberg C, Ozono K, et al. Asfotase Alfa Treatment Improves Survival for Perinatal and Infantile Hypophosphatasia. JClin Endocrinol Metab . 2016;101(1):334-342. doi:10.1210/jc.2015-3462 10. Michigami T, Ohata Y, Fujiwara M, et al. Clinical Practice Guidelines for Hypophosphatasia. Clin Pediatr Endocrinol . 2020;29(1):9-24. doi:10.1297/cpe.29.9 Effective date: 10/01/2022 Revised date: 03/07/2022
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Signifor, Signifor LAR (pasireotide)BILLING CODE Must use valid NDC code (Signifor) or J2502 (Signifor LAR) BENEFIT TYPE Medical (Signifor LAR) or Pharmacy (Signifor) SITE OF SERVICE ALLOWED Home (Signifor), Office/Outpatient (Signifor LAR) STATUS Prior Authorization Required Signifor is a second-generation somatostatin analog indicated for the treatment of adult patients with Cushings disease for whom pituitary surgery is not an option or has not been curative. Signifor LAR has the same indication for Cushings disease, and it is also indicated for patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option.Signifor, Signifor LAR (pasireotide) will be considered for coverage when the following criteria are met:Cushings DiseaseFor 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 diagnosis of Cushings disease, with an elevated urinary free cortisol (UFC) level (lab report required); AND 4. Member had pituitary surgery and it was not curative OR member is not a candidate for surgery (documentation required); AND 5. If the member has uncontrolled diabetes, anti-diabetic therapy must be optimized before starting treatment (as evidenced by consistent fill history); AND 6. Member has tried and failed ketoconazole and/or cabergoline for at least 3 months. 7. Dosage allowed/Quantity limit: Signifor: 0.3 mg to 0.9 mg subQ twice daily (60 ampules per 30 days) Signifor LAR: 10 mg to 40mg IM every 28 days (1 vial per 28 days) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show reduced UFC level from baseline; AND 2. Chart notes must show improved signs and symptoms compared to baseline. 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: 5/16/2023Acromegaly (SIGNIFOR LAR ONLY)For 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 diagnosis of uncontrolled acromegaly confirmed by insulin-like growth factor (IGF-1) elevation above normal (lab report required); AND 4. Member had an inadequate response to surgery or surgery is not an option (documentation required); AND 5. If the member has uncontrolled diabetes, anti-diabetic therapy must be optimized before starting treatment (as evidenced by consistent fill history); AND 6. Member remains uncontrolled (persistent IGF-1 elevation) after optimized treatment with octreotide or lanreotide for at least 3 months 11. 7. Dosage allowed/Quantity limit: 40 mg to 60mg every 28 days (1 vial 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 normalized or improved (decreased) IGF-1. 8,9 If all the above requirements are met, the medication will be approved for an additional 12 months.CareSource considers Signifor, Signifor LAR (pasireotide) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION07/06/2020 New policy for Signifor, Signifor LAR created. 03/28/2022 Transferred to new template. The word second-generation was added to the summary. Cushings: Added new reference. Acromegaly: Added new reference, revised language for octreotide/ lanreotide criterion. References: 1. Signifor [package insert]. Recordati Rare Diseases , Inc; 2020. 2. Signifor LAR [package insert]. Recordati Rare Diseases, Inc; 2020. 3. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. JClin Endocrinol Metab. 2015;100(8):2807-2831. doi:10.1210/jc.2015-1818 4. Pivonello R, Petersenn S, Newell-Price J, et al. Pasireotide treatment significantly improves clinical signs and symptoms in patients with Cushing's disease: results from a Phase III study. Clin Endocrinol (Oxf) . 2014;81(3):408-417. doi:10.1111/cen.12431 5. Colao A, Petersenn S, Newell-Price J, et al. A 12-month phase 3 study of pasireotide in Cushing's disease [published correction appears in NEngl JMed. 2012 Aug 23;367(8):780]. NEngl JMed. 2012;366(10):914-924. doi:10.1056/NEJMoa1105743 6. Lacroix A, Gu F, Gallardo W, et al. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial [published correction appears in Lancet Diabetes Endocrinol. 2018 Jan;6(1):e1]. Lancet Diabetes Endocrinol . 2018;6(1):17-26. doi:10.1016/S2213-8587(17)30326-1 7. 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 8. Colao A, Bronstein MD, Freda P, et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. JClin Endocrinol Metab. 2014;99(3):791-799. doi:10.1210/jc.2013-2480 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20239. Gadelha MR, Bronstein MD, Brue T, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol . 2014;2(11):875-884. doi:10.1016/S2213-8587(14)70169-X 10. Sheppard M, Bronstein MD, Freda P, et al. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study [published correction appears in Pituitary. 2015 Jun;18(3):395-6]. Pituitary . 2015;18(3):385-394. doi:10.1007/s11102-014-0585-6 11. 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 12. Fleseriu M, Auchus R, Bancos I, et al. Consensus on diagnosis and management of Cushing's disease: a guideline update. Lancet Diabetes Endocrinol . 2021;9(12):847-875. doi:10.1016/S2213-8587(21)00235-7 13. 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: 03/28/2022
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