IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Recorlev (levoketoconazole)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Recorlev is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushings syndrome for whom surgery is not an option or has not been curative. It is an enantiomer derived from racemic ketoconazole and is a cortisol synthesis inhibitor . Recorlev has black box warnings for hepatotoxicity and QT prolongation. Cushings Syndrome is a disorder of excess cortisol which can be of an exogenous cause, for example from taking glucocorticoids, or it can be endogenous. Endogenous Cushings Syndrome is rare, with the most common type being Cushings Disease, which is caused by a pituitary adenoma that secretes excess adrenocorticotropic hormone (ACTH) , a hormone responsible for cortisol production. Cortisol is a hormone made by the adrenal glands and has a role in many body functions. First-line treatment is surgical resection of the adenoma.Recorlev (levoketoconazole) will be considered for coverage when the following criteria are met:Cushings SyndromeFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a diagnosis of endogenous Cushings Syndrome (e.g., pituitary adenoma) ; AND 4. Chart notes must include documentation of elevated baseline urinary free cortisol (UFC); AND 5. Documentation must show the member is NOT a candidate for surgery, or previous surgery was not curative; AND 6. A trial of ketoconazole at max tolerated dose for at least 3 months was ineffective; AND 7. The following have been or will be assessed prior to treatment (and monitored during treatment): a) Liver enzymes b) ECG c) Potassium, magnesium 8. Member does NOT have any of the following: a) Malignant etiology (i.e., pituitary or adrenal carcinoma) b) Non-endogenous (exogenous) hypercortisolism (e.g., caused by corticosteroids) c) Known inherited syndrome as the cause of hypercortisolism (e.g., multiple endocrine neoplasia syndrome, Carney Complex) d) Pre-existing hepatic disease or history of drug-induced liver injury from azoles. 9. Dosage allowed/Quantity limit: Initiate at 150 mg twice daily; titrate according to package insert up to a max dose of 600 mg twice daily . (QL 240 tablets 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 document positive response to therapy including a decrease in UFC compared to baseline; AND 2. Chart notes must show the member has improved signs and symptoms of disease (e.g. weight, fasting glucose, blood pressure, or tumor size). If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Recorlev (levoketoconazole) 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/DESCRIPTION03/23/2022 New policy for Recorlev created. References: 1. Recorlev. [prescribing information]. Xeris Pharmaceuticals, Inc.; 2021. 2. Fleseriu M, Pivonello R, Elenkova A, et al. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial [published correction appears in Lancet Diabetes Endocrinol. 2019 Nov;7(11):e22]. Lancet Diabetes Endocrinol . 2019;7(11):855-865. doi:10.1016/S2213-8587(19)30313-4 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. 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 5. Castinetti F, Nieman LK, Reincke M, Newell-Price J. Approach to the Patient Treated with Steroidogenesis Inhibitors. JClin Endocrinol Metab. 2021;106(7):2114-2123. doi:10.1210/clinem/dgab122 6. Castinetti F, Guignat L, Giraud P, et al. Ketoconazole in Cushing's disease: is it worth a try?. JClin Endocrinol Metab. 2014;99(5):1623-1630. doi:10.1210/jc.2013-3628 Effective date: 10/01/2022 Revised date: 03/23/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Pulmozyme (dornase alfa inhalation solution ) BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Pulmozyme is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis patients to improve pulmonary function, initially approved by the FDA in 1993. Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Pulmozyme (dornase alfa inhalation solution ) will be considered for coverage when the following criteria are met:Cystic FibrosisFor initial authorization: 1. Member is at least 3 months 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. 4. Dosage allowed/Quantity limit : 2 .5 mg (1 ampule) inhaled once daily using a recommended jet nebulizer/compressor system, or eRapid Nebulizer System ( 30 ampules per 30 days) . 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) Improvement in sweat chloride c) Decrease in pulmonary exacerbations d) Decrease in pulmonary infections e) Increase in weight-gain f) Decrease in hospitalizations If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Pulmozyme ( dornase alfa inhalation 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION05/25/2017 New policy for Pulmozyme created. Not covered diagnosis added. 12/31/2020 Updated verbiage of approved nebulizers. Diagnosis of cystic fibrosis added to initial criteria. 04/28/2022 Policy transferred to new template. Changed age limit from 5 years to 3 months. Removed FVC requirement . Updated references. References: 1. Pulmozyme [package insert]. South San Francisco, CA: Genentech Inc; 2021. 2. 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. 3. Yang C, Montgomery M. Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev . 2021;3(3):CD001127. Published 2021 Mar 18. doi:10.1002/14651858.CD001127.pub5 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 Korlym (mifepristone)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Korlym is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushings syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery . It is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Korlym does not reduce cortisol levels. Glucose intolerance is common in Cushings syndrome, primarily due to stimulation of gluconeogenesis by excess cortisol. Controlling hypercortisolism is the first step taken to improve glucose metabolism in these patients , before the addition of antidiabetic medication such as metformin. Impaired glucose metabolism is generally resolved once cortisol levels have normalized, however, patients with diabetes should continue antidiabetic therapy.Korlym (mifepristone) will be considered for coverage when the following criteria are met:Cushings SyndromeFor 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 diagnoses of endogenous Cushings syndrome AND type 2 diabetes or glucose intolerance secondary to hypercortisolism (baseline labs required); AND 4. Member failed surgery or is not a candidate for surgery (documentation required); AND 5. Member has tried and failed ketoconazole and/or cabergoline for at least 3 months 2,5; AND 6. Female members with reproductive potential must have a negative pregnancy test. 7. Dosage allowed/Quantity limit: Start 300 mg orally once daily; titrate as needed per package insert u p to 20mg/kg or 1200mg (4 tablets) once daily . (QL 120 tablets per 30 days) If all the above requirements are met , the medication will be approved for 6 months. For reauthorization :1. Chart notes documenting sustained improvement of glucose control compared to pre-treatment (i.e. decreased HbA1c and/or fasting glucose from baseline, reduced use of antidiabetic medications) 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 Korlym (mifepristone) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION07/01/2020 New policy for Korlym created. 03/28/2022 Transferred to new template. Added new reference. Elaborated dosing information. References: 1. Korlym [package insert]. Menlo Park, CA: Corcept Therapeutics Incorporated; 20 19. 2. 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 3. Fleseriu M, Biller BM, Findling JW, et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. JClin Endocrinol Metab . 2012;97(6):2039-2049. doi:10.1210/jc.2011-3350 4. Mazziotti G, Gazzaruso C, Giustina A. Diabetes in Cushing syndrome: basic and clinical aspects. Trends Endocrinol Metab. 2011;22(12):499-506. doi:10.1016/j.tem.2011.09.001 5. Scaroni C, Zilio M, Foti M, Boscaro M. Glucose Metabolism Abnormalities in Cushing Syndrome: From Molecular Basis to Clinical Management. Endocrine Reviews. 2017;38(3):189-219. doi:10.1210/er.2016-1105 6. 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 Effective date: 10/01/2022 Revised date: 03/28/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Kitabis Pak (tobramycin inhalation solution ) BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Kitabis Pak is an aminoglycoside antibacterial dru g indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa initially approved by the FDA in 2014. Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Kitabis Pak (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 with 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 75% predicted; AND 5. Member is not colonized with Burkholderia cepacia; AND 6. Member has tried and failed generic tobramycin inhalation solution, and ineffectiveness, intolerance or contraindication is documented in chart notes . 7. Dosage allowed/Quantity limit: 300 mg every 12 hours; administer in repeated cycles of 28 days on drug followed by 28 days off drug ( 280 mL per 56 days). 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 Kitabis Pak (tobramycin inhalation 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/DESCRIPTION06/12/2017 New policy for Kitabis Pak created. Not covered diagnosis added. 12/30/2020 Quantity limit changed to 56 days from 28 days. Corrected status to non-preferred. Reauthorization criteria updated to ask for evidence of disease stability or improvement. Diagnosis of cystic fibrosis added to initial criteria. Exclusion criteria updated to a simplified statement. 04/27/2022 Policy transferred to new policy. Added references. Amended renewal criteria to reflect expected treatment response; removed sweat chloride and weight gain . References: 1. Kitabis Pak [package insert]. Midlothian, VA: Catalent Pharma Solutions LLC; 2014. 2. 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 3. 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 4. 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: 04/27/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Isturisa (osilodrostat)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Isturisa is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushings disease for whom pituitary surgery is not an option or has not been curative. It inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. Cushings Syndrome is a disorder of excess cortisol which can be of an exogenous cause, for example from taking glucocorticoids, or it can be endogenous. Endogenous Cushings Syndrome is rare, with the most common type being Cushings Disease, which is caused by a pituitary adenoma that secretes excess adrenocorticotropic hormone (ACTH), a hormone responsible for cortisol production. Cortisol is a hormone made by the adrenal glands and has a role in many body functions. First-line treatment is surgical resection of the adenoma.Isturisa (osilodrostat) 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. Member has tried ketoconazole or metyrapone for at least 3 months with inadequate response. 6. Dosage allowed/Quantity limit: Initiate 2 mg orally twice daily; titrate per package insert; m ax recommended dose is 30mg (as three 10mg tablets), twice daily. (QL: 180 tablets per 30 days ). Note: The maintenance dosage varied between 2 mg and 7 mg twice daily in clinical trials . If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Labs must show an improved UFC level compared to pre-treatment ; AND 2. Chart notes must show the member has improved signs and symptoms of disease ( e.g., weight, fasting glucose, blood pressure, or tumor size). 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 Isturisa (osilodrostat) 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/DESCRIPTION06/30/2020 New policy for Isturisa created. 03/28/2022 Transferred to new template. Added new references. Elaborated on dosing information. Added metyrapone as a trial option. In renewal, changed UFC normal range to improved UFC. References: 1. Isturisa [package insert]. Lebanon, NJ: Recordati Rare Diseases Inc; 2020. 2. Recordati Rare Diseases: Isturisa(R) (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease. Barron’s. https://www.barrons.com/press-release/recordati-rare-diseases-isturisa-r-osilodrostat-phase-iii-linc-4 -trial-meets-its-pri mary-endpoint-in-cushing-s-disease-01592380982?tesla=y. Published June 17, 2020. Accessed June 30, 2020. 3. Nieman, LK. Medical therapy of hypercortisolism (Cushing’s syndrome). UpToDate. https://www.uptodate.com. Updated 6/29/20. Accessed 6/30/20. 4. IPD analytics. Accessed 6/30/20. 5. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline. JClin En docrinol Metab. 2015;100(8):2807-2831. doi:10.1210/jc.2015-1818 6. Fleseriu M, Pivonello R, Young J, et al. Osilodrostat, a potent oral 11-hydroxylase inhibitor: 22-week, prospective, Phase II study in Cushings disease. Pituitary . 2015;19(2):138-148. doi:10.1007/s11102-015-0692-z 7. Biller BM, Newell-Price J, Fleseriu M, et al. OR16-2 Osilodrostat Treatment in Cushing's Disease (CD): Results from a Phase III, Multicenter, Double-Blind, Randomized Withdrawal Study (LINC 3). Journal of the Endocrine Society . 2019;3(Supplement_1). 8. 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 9. Castinetti F, Nieman LK, Reincke M, Newell-Price J. Approach to the Patient Treated with Steroidogenesis Inhibitors. JClin Endocrinol Metab. 2021;106(7):2114-2123. doi:10.1210/clinem/dgab122 10. Castinetti F, Guignat L, Giraud P, et al. Ketoconazole in Cushing's disease: is it worth a try?. JClin Endocrinol Metab. 2014;99(5):1623-1630. doi:10.1210/jc.2013-3628 Effective date: 10/01/2022 Revised date: 03/28/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Cayston (aztreonam inhalation solution )BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Cayston (aztreonam inhalation solution) is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa, initially approved by the FDA in 2010. Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Cayston (aztreonam inhalation solution ) will be considered for coverage when the following criteria are met:Cystic FibrosisFor initial authorization: 1. Member is at least 7 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 a documented trial and failure of or contraindication to generic tobramycin inhalation solution; AND 5. Member has documented forced expiratory volume in 1 second (FEV 1) 25% to 75% predicted ( d ocumented in chart notes and submitted with prior authorization request) ; AND 6. Member is not colonized with Burkholderia cepacia. 7. Dosage allowed/Quantity limit: 75 mg 3 times daily for 28 days in repeated cycles of 28 days on drug, followed by 28 days off drug (84 vials per 56 days ). 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 .CareSource considers Cayston (aztreonam inhalation 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION06/12/2017 New policy for Cayston created. Not covered diagnosis added. 12/30/2020 Quantity limit changed to 56 days from 28 days. Reauthorization criteria updated to ask for evidence of disease stability or improvement. Diagnosis of cystic fibrosis added to initial criteria. Exclusion criteria updated to a simplified statement. 04/27/2022 Policy transferred to new template. Adde d references . Amended renewal criteria to reflect expected treatment response; removed sweat chloride and weight gain. Added preference for generic tobra soln. References: 1. Cayston [package insert]. Foster City, CA: Gilead Sciences , Inc; 2019 . 2. 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 3. 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 4. 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: 04/27/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME B ronchitol (mannitol )BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Bronchitol (mannitol) is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis , initially approved by the FDA in 2020 . Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Bronchitol (mannitol ) will be considered for coverage when the following criteria are met:Cystic FibrosisFor 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 an infectious disease specialist ; AND 3. Member has a diagnosis of cystic fibrosis; AND 4. Member had an inadequate response, intolerance, or contraindication to documented prior therapy with nebulized hypertonic saline (7%); AND 5. Documentation showing member has passed the Bronchitol tolerance test (BTT) . 6. Dosage allowed/Quantity limit: 400 mg (10 capsules) twice daily, inhaled ( 560 capsules per 28 days) 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 defined as any of the following: a) Improved FEV1 and/or other lung function tests b) Decrease in pulmonary exacerbations c) Decrease in pulmonary infections d) Increase in weight-gain e) Decrease in hospitalizations If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Bronchitol ( mannitol ) 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION01/13/2021 New policy for Bronchitol created. 04/26/2022 Policy transferred to new template. Annual review; no updates. References: 1. Bronchitol (mannitol) [prescribing information]. Cary, NC: Chiesi USA Inc; October 2020. 2. Flume PA, Aitken ML, Bilton D, et al. Optimising inhaled mannitol for cystic fibrosis in an adult population. Breathe Sheff Engl 2015;11:39-48. 3. Castellani C, Duff AJA, Bell SC, et al. ECFS best practice guidelines: the 2018 revision. JCyst Fibros. 2018;17(2):153-178. doi:10.1016/j.jcf.2018.02.006 4. Smyth AR, Bell SC, Bojcin S, et al. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. JCyst Fibros. 2014;13 Suppl 1:S23-S42. doi:10.1016/j.jcf.2014.03.010 5. Teper A, Jaques A, Charlton B. Inhaled mannitol in patients with cystic fibrosis: a randomised open label dose response trial. Journal of Cystic Fibrosis. 2011 Jan 1;10(1):1-8. 6. Patrick J. Moore & Robert Tarran (2018) The epithelial sodium channel (ENaC) as a therapeutic target for cystic fibrosis lung disease, Expert Opinion on Therapeutic Targets, 22:8, 687-701, DOI: 10.1080/14728222.2018.1501361. 7. Tildy BE, Rogers DF. Therapeutic options for hydrating airway mucus in cystic fibrosis. Pharmacology. 2015;95(3-4):117-32. 8. Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am JRespir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28. PMID: 22198974. 9. Agent P, Parrott H. Inhaled therapy in cystic fibrosis: agents, devices and regimens. Breathe. 2015 Jun 1;11(2):110-8. Effective date: 10/01/2022 Revised date: 04/26/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Bethkis (tobramycin inhalation solution)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Bethkis (tobramycin inhalation solution) is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa initially approved by the FDA in 2012. Cystic fibrosis is an autosomal recessive disease in which patients can have abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction.Bethkis (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 is prescribed by a pulmonologist or an infectious disease specialist; AND 3. Member has a diagnosis of cystic fibrosis with a positive culture for Pseudomonas aeruginosa documented in chart notes; AND 4. Member has documented forced expiratory volume in 1 second (FEV 1) of 40% to 80% predicted; AND 5. Member is not colonized with Burkholderia cepacia; AND 6. Member has tried and failed generic tobramycin inhalation solution and ineffectiveness, intolerance or contraindication is documented in chart notes . 7. Dosage allowed/Quantity limit: 300 mg twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug (224 mL per 56 days). 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 defined as 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 . CareSource considers Bethkis ( tobramycin inhalation 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. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION06/12/2017 New policy for Bethkis created. Not covered diagnosis added . 12/29/2020 Quantity limit changed to 56 days from 28 days. Reauthorization criteria updated to ask for evidence of disease stability or improvement. Diagnosis of cystic fibrosis added to initial criteria. Kitabis removed as preferred option. Exclusion criteria updated to a simplified statement. 4/26/2022 Policy transferred to new template. Added references. Amended renewal criteria to reflect expected treatment response; removed sweat chloride and weight gain . References: 1. Bethkis [package insert]. Woodstock, IL: Cornerstone Therapeutics, Inc.; 2012. 2. 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 3. 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 4. 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: 04/26/2022
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Livtencity (maribavir )BILLING CODE Must use valid NDC code BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Livtencity is a cytomegalovirus pUL97 kinsae inhibitor initially approved by the FDA in November 2021. It is the first medication for the treatment of refractory post-transplant CMV with or without genotypic resistance.Livtencity was evaluated in the SOLSTICE Phase 3 clinical trial, where 56% [95% CI 2280 4274]; p
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Cytogam (cytomegalovirus immune globulin ) BILLING CODE J0850 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office/Outpatient STATUS Prior Authorization Required Cytogam is an immunoglobulin G (IgG) containing a standardized amount of antibody to Cytomegalovirus (CMV) initially approved by the FDA in 1987. The globulin contains a relatively high concentration of antibodies directed against Cytomegalovirus (CMV). In the case of persons who may be exposed to CMV, Cytogam can raise the relevant antibodies to levels sufficient to attenuate or reduce the incidenc e of serious CMV disease. Cytomegalovirus Immune Globulin Intravenous (Human) is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir and valganciclovir . Because efficacy data are limited, many experts do not favor the addition of CMV immunoglobulin to treatment regimens; this approach is no longer recommended in the 2013 international consensus guidelines.Cytogam (cytomegalovirus immune globulin ) will be considered for coverage when the following criteria are met:CMV ProphylaxisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an infectious disease specialist or transplant specialist ; AND 3. Member is the recipient of a solid organ transplant ( i. e . kidney, lung, liver, pancreas, heart transplant ); 4. Member or donor must be CMV-seropositive; 5. Pr escrib er attests Cytogam will be used with other antiviral therapy (i.e. ganciclovir, valganciclovir) ; AND 6. Dosage allowed/Quantity limit: The maximum recommended total dosage per infusion is 150 mg I g/kg, administered according to the following schedule: Type of transplant Kidney Liver, Pancreas, Lung, HeartWithin 72 hours of transplant: 150 mg/kg 150 mg/kg2 weeks post-transplant: 100 mg/kg 150 mg/kg 4 weeks post-transplant: 100 mg/kg 150 mg/kg 6 weeks post-transplant: 100 mg/kg 150 mg/kg 8 weeks post-transplant: 100 mg/kg 150 mg/kg 12 weeks post-transplant: 50 mg/kg 100 mg/kg 16 weeks post-transplant: 50 mg/kg 100 mg/kg If all the above requirements are met , the medication will be approved for 16 weeks .IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Medication will not be reauthorized. CareSource considers Cytogam (cytomegalovirus immune globulin) 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/DESCRIPTION02/15/2022 New policy for Cytogam created. References: 1. Cytogam [prescribing information]. Roswell , GA :Saol Therapeutics, Inc ; August 2020. 2. Alexander BT, Hladnik LM, Augustin KM, et al, Use of Cytomegalovirus Intravenous Immune Globulin for the Adjunctive Treatment of Cytomegalovirus in Hematopoietic Stem Cell Transplant Recipients, Pharmacotherapy, 2010, 30(6):554-61. 3. Snydman DR, Werner BG, Heinze-Lacey BH, et al. Use of cytomegalovirus immune globulin to prevent cytomegalovirus disease in renal transplant recipients. NEngl JMed 1987;317:1049-1054. 4. Snydman DR, Werner BG, Dougherty NN, et al. Cytomegalovirus Immune Globulin prophylaxis in liver transplantation. A randomized, double-blind, placebo-controlled trial. Ann Int Med 1993;119:984-991. 5. Falagas ME, Snydman DR, Ruthazer R, et al. Cytomegalovirus Immune Globulin (CMVIG) prophylaxis is associated with increased survival after orthotopic liver transplantation. Clin Transplant 1997;11:432-437. 6. Snydman DR, Werner BG, Tilney NL, et al. A final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with a cytomegalovirus immune globulin: Comparison of randomized and open-label trials. Transplant Proc 1991;23:1357-1360. Effective date: 07/01/2022 Revised date: 02/15/2022
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