Jakafi (ruxolitinib)

IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Jakafi (ruxolitinib)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Jakafi, a janus kinase inhibitor (JAK1 and JAK2), is approved for use in both acute and chronic graft-versus-host disease (GVHD), myelofibrosis, and polycythemia vera. JAK1 and JAK2 mediate signaling of cytokines and growth factors important for hematopoiesis and immune function. Prominent side effects of Jakafi are thrombocytopenia and anemia. GVHD is a common complication following allogenic hematopoietic stem cell transplant (HSCT). It occurs when immune cells transplanted from a non-identical donor (graft) recognize the transplant recipient (host) as foreign, initiating an immune response. Acute GVHD typically occurs within the first 100 days and mainly affects the skin, gastrointestinal system, and liver. Chronic GVHD affects a wider variety of systems and is less well understood. Steroids are the mainstay of treatment but are only effective for about 50% of patients.Jakafi (ruxolitinib) will be considered for coverage when the following criteria are met:Acute Graft-Versus-Host Disease (aGVHD) For initial authorization: 1. Member is at least 12 years 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 grade II-IV acute graft-versus host disease following allogeneic hematopoietic cell transplantation (HCT); AND 4. Member is refractory to treatment with glucocorticoid (such as methylprednisolone 2mg/kg/day), defined as progression by day 3-5, non-response by day 7, or inability to taper. 5. Dosage allowed/Quantity limit : Starting dose is 5 mg orally twice daily; consider increasing to 10 mg twice daily . (60 tablets per 30 days ). If all the above requirements are met , the medication will be approved for 30 days. For reauthorization : 1. Member is being monitored for side effects (e.g., cytopenias) and has not experienced any life-threatening adverse events; AND 2. Chart notes must demonstrate improved signs and symptoms of disease. If all the above requirements are met, the medication will be approved for an additional 6 months. Chronic Graft-Versus-Host Disease (cGVHD)For initial authorization: 1. Member is at least 12 years of age ; AND IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20232. Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist; AND3. Member has a documented diagnosis of moderate to severe cGVHD; AND 4. Members condition is steroid refractory or dependent (with or without a calcineurin inhibitor): Lack of response or disease progression after at least 1 week (e.g., on prednisone 1mg/kg/day), persistence without improvement after at least 4 weeks, or at least 2 failed taper attempts. 5. Dosage allowed/Quantity limit: 10 mg twice daily. (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 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 . MyelofibrosisAny request for cancer must be submitted through NantHealth/Eviti portal. Polycythemia Vera Any request for cancer must be submitted through NantHealth/Eviti portal. CareSource considers Jakafi (ruxolitinib) 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 06/08/2020 New policy for Jakafi for acute GVHD. 09/30/2021 Transferred to new template. New section added for chronic GVHD. Reviewed aGVHD section: Changed progression by day 3 to progression by day 3-5. References: 1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation; 2021. 2. Chao, NJ. Treatment of acute graft-versus-host disease. UpToDate. https://www.uptodate.com/contents/treatment-of-acute-graft-versus-host-disease. Updated May 15, 2020. Accessed June 5, 2020. 3. Zeiser R, Bubnoff NV, Butler J, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. New England Journal of Medicine. 2020;382(19):1800-1810. doi:10.1056/nejmoa1917635 4. Zeiser R, Burchert A, Lengerke C, et al. Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey. Leukemia. 2015;29(10):2062-2068. doi:10.1038/leu.2015.212 5. Jagasia M, Perales M-A, Schroeder MA, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020;135(20):1739-1749. doi:10.1182/blood.2020004823 6. Zeiser R, Burchert A, Lengerke C, et al. Long-Term Follow-up of Patients with Corticosteroid-Refractory Graft-Versus-Host Disease Treated with Ruxolitinib. Blood. 2016;128(22):4561-4561. doi:10.1182/blood.v128.22.4561.4561 7. Zeiser R, Polverelli N, Ram R, et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. NEngl JMed. 2021;385(3):228-238. doi:10.1056/NEJMoa2033122IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20238. 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. 9. 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 10. 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: 04/01/2022 Revised date: 09/30/2021

Cabenuva (cabotegravir/rilpivirine)

IN-MED-P-366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Cabenuva (cabotegravir/rilpivirine )BILLING CODE J0741 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office STATUS Prior Authorization Required Cabenuva is a co-packaged product consisting of 2 different injectable drugs: cabotegravir, an integrase strand transfer inhibitor (INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). Both are once-monthly intramuscular injections given separately at the same time. Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed. Prior to initiating treatment with Cabenuva, oral lead-in dosing (available at no-charge) should be used for approximately 1 month to assess tolerability of cabotegravir and rilpivirine.Cabenuva (ca botegravir/rilpivirine ) will be considered for coverage when the following criteria are met:HUMAN IMMUNODEFICIENCY VIRUS TYPE-1 (HIV-1)For initial authorization: 1. Member is at least 12 years of age and weigh at least 35 kg ; AND 2. Medication must be prescribed by or in consultation with an HIV specialist; AND 3. Member has a diagnosis of HIV-1; AND 4. Member is currently virologically suppressed (HIV-1 RNA