OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Breyanzi (lisocabtagene maraleuce l)BENEF IT TYPE Medical ST AT US Prior Authorization Required Breyanzi , approved by the FDA in 2021, is a CD19-directed chimeric antigen receptor (CAR)T-c ell t h e r apy f or the treatment of relapsed or ref ractory large B-cell lymphoma . It has accelerated approval status for relapsed or ref ractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), f ollicular lymphoma (FL) , and mantle cell lymphoma (MCL) . Lymphoma is a cancer of the lymphatic system and white blood cells.Breyanzi (lisocabtagene maraleuce l) will be considered for coverage when the following criteria are met:Large B-Cell Lymphoma (LBCL)For initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Breyanzi REMS ; AND 3. Member has a documented diagnosis of large B-cell lymphoma including an y of the f ollowing: a) Dif f use large B-cell lymphoma (DLBCL) not otherwise specif ied (including DLBCL arising f rom indolent lymphoma) b) High grade B-cell lymphoma (HGBCL) c) Primary mediastinal large B-cell lymphoma (PMBCL) d) Follicular lymphoma (FL) grade 3B e) DLBCL arising f rom f ollicular lymphoma (transf ormation FL; TFL) f) I n t r av as c u lar LBCL g) DLBCL associated with chronic inf lammation h) Fibrin-associated DLBCL i) EBV-positive DLBCL, NOS j) T-cell/histiocyte-rich LBC L; AND 4. Member has been treated with f irst line therapy containing an anthracycline and rituximab (or an other CD20-targeted agent); AND 5. Member meets one of the f ollowing: a) Relapsed or ref ractory disease af ter two or more lines of systemic therapy b) Ref ractory disease to f irst-line chemoimmunotherapy (primary ref ractory) or relapse within 12 months of f irst-line chemoimmunotherapy c) Ref ractory disease to f irst-line chemoimmunotherapy ( p rimar y r e f ract o r y) or relapse af ter f irst-line chemoimmunotherapy an d ineligible f or hematopoietic st e m cell transplant (HSCT) due to comorbidities or age; AND 6. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 7. Member does NOT have an y of the f ollowing: a) Primary central nervous system (CNS) lymphoma OH-MED-P-366685b) Prior CAR T-cell or other genetically-modif ied T-cell therapy ; AND8. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 9. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 10. Dosage allowed/Quantity limit: A f ter 2 or more lines of therapy: A single dose of 50 to 110 10 6 CAR-positive viable Tcells A f ter 1 line of therapy : A single dose of 90 to 110 10 6 CAR-positive viable Tcells If all the above requirements are met , the medication will be approved for 3 months .For reauthorization :1. Breyanzi will not be reauthorized f or continued therapy. Mantle C ell Lymphoma (MCL )For initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Breyanzi REMS ; AND 3. Member has a documented diagnosis of relapsed or ref ractory MCL; AND 4. Member has been treated with 2 or more prior lines of systemic therapy including ALL of the following: a) A lkylating agent b) CD20-targeted drug (e.g., rituximab) c) Covalent Bruton tyrosine kinase inhibitor (BTKi) (i.e., ibrutinib, acalabrutinib, or zanubrutinib) ; AND 5. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 6. Member does NOT have any of the f ollowing: a) Primary central nervous system (CNS) lymphoma b) Prior CAR T-cell or other genetically-modif ied T-cell therapy; AND 7. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 8. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 9. Dosage allowed/Quantity limit: A single dose of 90 to 110 10 6 CAR-positive viable Tcells If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Breyanzi will not be reauthorized f or continued therapy.Follicular Lymphoma (FL)For initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Breyanzi REMS ; AND 3. Member has a documented diagnosis of relapsed or ref ractory FL (grade 1, 2, or 3a [see LBCL section above f or grade 3B] ); AND 4. Member has been treated with 2 or more prior lines of systemic therapy , including an alkylating agent and CD20-targeted drug (e.g., rituximab); AND 5. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 6. Member does NOT have any of the f ollowing: OH-MED-P-366685a) Primary central nervous system (CNS) lymphoma b) Prior CAR T-cell or other genetically-modif ied T-cell therapy; AND 7. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 8. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 9. Dosage allowed/Quantity limit: A single dose of 90 to 110 10 6 CAR-positive viable Tcells If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Breyanzi will not be reauthorized f or continued therapy.Chronic Lymphocytic Leukemia (CL L) or Small Lymphocytic Lymphoma(SLL) For initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Breyanzi REMS ; AND 3. Member has a documented diagnosis of relapsed or ref ractory CLL or SLL; AND 4. Member has been treated with 2 or more prior lines of systemic therapy , including a Bruton tyrosine kinase (BT K) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor (venet oclax); AND 5. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 6. Member does NOT have any of the f ollowing: a) Primary central nervous system (CNS) lymphoma b) Prior gene therapy ; AND 7. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 8. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 9. Dosage allowed/Quantity limit: A single dose of 90 to 110 10 6 CAR-positive viable Tcells If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Breyanzi will not be reauthorized f or continued therapy.CareSource considers Breyanzi (lisocabtagene maraleucel) 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/DESCRIPTION05/20/2021 New policy f or Breyanzi created. 07/2 7/2022 Updates to include 2 nd line use in accordance with recent labeling changes and NCCN guidelines . Updated billing code. 12/12/2024 Updat ed ref s. Changed has been screened to has been or will be screened. Added new sections f or MCL, FL, and CLL/SLL (label update). LBCL: Added more subtypes that would qualif y (per NCCN). OH-ME D-P- 366685 06/05/2025 Added Audaire Health statement. ODM approv ed on 07/15/25. Ref erenc es : 1.B rey anzi (lis o c ab tag ene maraleuc e) [p ac k ag e ins ert]. Bo thell, WA; Juno Therap eutic s , Inc . ; 2024.2. Natio nal Co mp rehens iv e Canc er Netwo rk . B-Cell Ly mp ho mas (Vers io n 3.2024).https://www.nccn.org/prof essionals/physician_gls/pdf /b-cell.pdf . Accessed Dec emb er 12, 2024.3. Natio nal Co mp rehens iv e Canc er Netwo rk . Chro nic Ly mp ho c y tic Leuk emia/ Small Ly mp ho c y tic Ly mp ho m a (V ers io n 1.2025). https://www.nc cn.org/profes sionals/physician_gls/p d f /c ll.p d f . Accessed Dec emb er 13, 2024.4. Ab rams on JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel fo r p atients with relap s ed o r ref rac to ry larg e B-c ell ly mp ho mas (TRANSCEND NHL 001): a multic entre s eamles s d es ig n s tud y . Lanc et . 2020; 396(10254):839-852. d o i:10.1016/S0140-6736(20)31366-05. Ab rams o n JS. Anti-CD 19 CA RT-Cell Therap y f o r B-Cell No n-Hodgkin Lymphoma. Trans fus Med Rev . 2020; 34(1):29-33. d o i:10.1016/j.tmrv .2019.08.0036. Kamd ar M, So lo mo n SR, Arnas o n J , et al. Lis o c ab tag ene maraleuc el v ers us s tand ard o f c are with s alv ag e c hemo therapy followed by autologous s tem c ell transplantation as s ec ond-line treatment in p atients with relapsed o r ref rac t o ry larg e B-c ell ly mp ho ma (TRANSFORM): res ults f ro m an interim analy s is o f an o p en-lab el,rand o mis ed , p has e 3 trial [p ub lis hed c o rrec tio n ap p ears in Lanc et. 2022 Jul 16;400(10347):160]. Lanc et . 2022; 399(10343):2294-2308. d o i:10.1016/S0140-6736(22)00662-67. Sehg al A, Ho da D, Riedell PA, et al. Lis ocabtagene maraleucel as s econd-line therapy in ad ults with relap s ed o r ref rac tory large B-cell lymphoma who were no t intended for haematopoietic s tem c ell transplantatio n (PILOT): an ope n-lab el, p has e 2 s tud y [p ub lis hed o nline ahead o f p rint, 2022 Jul 12]. Lanc et Onc ol . 2022;S1470-2045(22)00339-4. d o i:10.1016/S1470-2045(22)00339-48. Erns t M, Oes er A, Besiroglu B, et al. Chimeric antigen rec eptor (CAR) T-c ell therapy fo r p eo p le with relap s ed o r ref rac tory diffuse large B-c ell ly mphoma. Coc hrane Databas e Sy s t Rev . 2021;9(9):CD 013365. Pub lis hed 2021Sep 13. d o i:10.1002/14651858.CD 013365.p ub 29. Mo rs c hhauser F, Dahiya S, Palomba ML, et al. Lis o c ab tag ene maraleuc el in f o llic ular ly mp ho ma: the p has e 2 T RANSCEND FLs tudy [published correc tion ap p ears in Nat Med . 2024 Aug ;30(8):2374. d o i: 10.1038/s 41591-024-03175-4]. Nat Med. 2024;30(8):2199-2207. d o i:10.1038/s 41591-024-02986-910. Sid d iqi T, Maloney DG, Kenderian SS, et al. Lis o c ab tag ene maraleuc el in c hro nic ly mp ho c y tic leuk aemia and s mall ly mp ho c y tic ly mp ho ma (TRANSCEND CLL 004): a multic entre, o p en-lab el, sing le-arm, p has e 1- 2 s tudy. Lanc et . 2023;402(10402):641-654. d o i:10.1016/S0140-6736(23)01052-811. Ohio Ad minis trativ e Co d e. (2022, Feb ruary 23). 5160-1- 01 (C) Med ic aid med ic al nec es s ity : d ef initio ns and p rinc ip les . Retriev ed Feb ruary 22 2023 f ro m c o d es .o hio .g o v .12. Ohio Ad ministrative Co de. (2022, July 18). 5160-26-03 Managed c are: c overed s ervices. Retriev ed Feb ruary 22,2023 from codes.ohio.gov.13. Ohio Ad minis trativ e Co d e. (2020, January 1). 5160-9- 03 Pharmac y s erv ic es : c o v ered d rug s and as s o c iated limitatio ns . Retriev ed Feb ruary 22, 2023 f ro m c o d es .o hio .g o v .E f f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 06/05/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Aucatzyl (obecabtagene autoleucel)BENEF IT TYPE Medical ST AT US Prior Authorization Required Aucatzyl, approved by the FDA in 2024, is indicated f or the treatment of adults with relapsed or ref ractory B-cell precursor acute lymphoblastic leukemia (ALL) . ALL is a type of cancer of the blood and bone marrow. Aucatzyl is a CD19-directed genetically modified autologous Tcell immunotherapy comprised of the patients Tcells that are transduced with a lentiviral vector to express an anti-CD19 chimeric antigen receptor (CAR). Engagement of anti-CD19 CAR-positive Tcells with CD19 expressed on target cells leads to activation of the an t i-CD19 CAR-positive Tcells and downstream signaling through the CD3-zeta domain. This binding to CD19 results in anti-tumor activity and killing of CD19-expressing target cells. Unlike previously approved CAR-T therapies, Aucatzyl does not have a Risk Evaluation and Mitigation Strategy (REMS) program.Aucatzyl (obecabtagene autoleucel) will be considered for coverage when the following criteria are met:Acute Lymphoblastic Leukemia (ALL) For initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by a hematologist/oncologist ; AND 3. Member has a diagnosis of B-cell ALL ; AND 4. Documentation of one of the f ollowing: a) Relapsed or ref ractory Philadelphia chromosome negative (Ph- ) disease, or b) Relapsed or ref ractory Philadelphia chromosome positive (Ph+) disease f ollowing therapy that has included tyrosine kinase inhibitors (TKI s); AND 5. Documentation of CD19 tumor expression; AND 6. Bone marrow with 5% lymphoblasts by morphologic assessment ; AND 7. Member has an Eastern cooperative oncology group (ECOG) perf ormance status of 0 or 1; AND 8. Member has been or will be screened f or hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 9. Member has NOT had prior CAR-T therapy ; AND 10. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 11. Dosage allowed/Quantity limit: 410 10 6 CD19 CAR-positive viable Tcells as a split dose IV inf usion on day 1 and day 10 (+/ – 2 days). If all the above requirements are met , the medication will be approved for 3 months . For reauthorization :1. Aucatzyl will not be reauthorized f or continued therapy.
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Amvuttra (vutrisiran)BENEF IT TYPE Medical ST AT US Prior Authorization Required Amvuttra, approved by the FDA in 2022, is a transthyretin-directed small interf ering RNA indicated f or the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It is also indicated f or the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart f ailure visit . Amvuttra is a n RNA interf erence (RNAi) drug that causes degradation of mutant and wild-type TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues by delivering t he vutisiran small interf ering RNA ( siRNA) to hepatocytes where TTR protein is synthesized . hATTR is a rare and progressive inherited disorder where misf olded TTR accumulates as amyloid f ibrils in the body. In polyneuropathy of hATTR (hATTR-PN), these fibrils deposit in the peripheral nerves which leads to pain, muscle weakness, and autonomic dysf unction. In the cardiomyopathy f orm of ATTR (ATTR-CM), the amyloid accumulates in the myocardium, resulting in heart f ailure. The hereditary f orm of ATTR (hATTR) is caused by a mutation in the TTR gene, whereas wild type ATTR (ATTRwt) is associated with aging.Amvuttra (vutrisiran) will be considered for coverage when the following criteria are met:Hereditary Transthyretin Amyloidosis (hAT TR Amyloidosis) : PolyneuropathyFor initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of hATTR amyloidosis with documentation of a transthyretin (TTR) mutation conf irmed by genetic testing; AND 4. Member has signs/symptoms of polyneuropathy; AND 5. Member has a polyneuropathy disability (PND) score of IIIb or less (i.e., member is not wheelchair-bound or bedridden) ; AND 6. A mvuttra will NOT be used in combination with another TTR silencer o r a TTR stabilizer . 7. Dosage allowed/Quantity limit: 25 mg subQ every 3 months, administered by a healthcare prof essional . (QL: 1 syringe per 84 days) If all the above requirements are met , the medication will be approved for 9 months . For reauthorization : 1. Chart notes must include documentation of positive clinical response to therapy such as improvement or stabilization of neuropathy impairment, gait speed, nutritional status, disability, or quality of lif e compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months.
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Abecma (idecabtagene vicleucel )BENEF IT TYPE Medical ST AT US Prior Authorization Required Abecma, approved by the FDA in 2021, is a B-cell maturation antigen (BCMA) -directed, autologous chimeric antigen receptor T-cell (CAR-T) immunotherapy. A patients own Tcells are harvested and genetically modif ied outside of the body. The re-engineered cells are injected back into the patient and will recognize the BCMA on the malignant plasma cells to target and kill them. Abecma is indicated f or the treatment of adult s with relapsed or ref ractory multiple myeloma af ter two or more prior lines of therapy including an immunomodulatory agent, a pr oteasome inhibitor, and an anti-CD38 monoclonal antibody . Multiple myeloma is a cancer of the plasma cells in the bone marrow. Abecma is the f irst CAR-T t h e r apy approved f or multiple myeloma and the f irst to target the BCMA protein, whereas existing products target the CD19 protein.Abecma (idecabtagene vicleucel) will be considered for coverage when the following criteria are met:Multiple MyelomaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Healthcare f acility/provider has enrolled in the Abecma REMS program ; AND 3. Member has a diagnosis of relapsed or ref ractory multiple myeloma (RRMM); AND 4. Member has persistent disease af ter treatment with 2 or more prior lines of therapy , including ALL the f ollowing: a) An immunomodulatory agent (e.g. , Revlimid) , b) A proteasome inhibitor (e.g. , Velcade) , an d c) An anti-CD38 monoclonal antibody (e.g. , Dar z ale x ) ; AND 5. Member has an Eastern Cooperative Oncology Group (ECOG) perf ormance status of 0 or 1; AND 6. Member has been or will be screened f or CMV, hepatitis Bvirus (HBV), hepatitis Cvirus (HCV), and human immunodef iciency virus (HIV) ; AND 7. The requesting physician attests to providing clinical outcome inf ormation within the Audaire Health provider portal as requested by CareSource. 8. Dosage allowed/Quantity limit: A single inf usion of 300 to 460 10 6 CAR-positive Tcells . If all the above requirements are met, the medication will be approved for 3 months . For reauthorization :1. Abecma will not be reauthorized f or continued therapy.CareSource considers Abecma (idecabtagene vicleucel) 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.
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Tzield (teplizumab-mzwv)BENEFIT TYPE Medical STATUS Prior Authorization Required Tzield , approved by the FDA in 2022, is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D . It is the first approved drug to delay progression to Stage 3 T1D, the stage at which patients become symptomatic . Tzield is administered by IV infusion once daily for one cycle of 14 consecutive days. Side effects of note include cytokine release syndrome (CRS), lymphopenia, leukopenia, and rash. T1D is a chronic , T-cell-mediated autoimmune condition that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival . It usually develops in children, teenagers, and young adults, at a peak age of 13-14 years, but could occur at any age . Tzield works by binding to CD3 (a cell surface antigen present on Tlymphocytes) . The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive Tcells. In the pivotal Phase 2 clinical trial, TN-10, treatment with Tzield delayed the onset of Stage 3 T1D by approximately 2 years compared to placebo , which is statistically significant. An extended follow-up of this trial demonstrated a delay of 2.7 years.Tzield (teplizumab-mzwv) will be considered for coverage when the following criteria are met:Type 1 Diabetes (T1D)For initial authorization: 1. Member is at least 8 years of age ; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a diagnosis of Stage 2 T1D confirmed by BOTH of the following: a) At least 2 positive pancreatic islet cell autoantibodies (i.e., Glutamic acid decarboxylase 65 (GAD) autoantibodies, Insulin autoantibody (IAA), Insulinoma-associated antigen 2 autoantibody (IA-2A), Zinc transporter 8 autoantibody (ZnT8A)) b) Dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or alternative method; AND 4. Member does NOT have a history suggestive of type 2 diabetes ; AND 5. Member does NOT have any active serious infection or chronic active infection other than localized skin infections ; AND 6. Members baseline lab results do NOT show any of the following: a) Lymphocyte count
OH-MED-P-366685PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Spravato (esketamine)BENEFIT TYPE Pharmacy or Medical BILLIN GCODE S0013 STATUS Prior Authorization Required Spravato is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated in adults for the treatment of treatment-resistant depression (TRD) as monotherapy or in conjunction with an oral antidepressant, and for depressive symptoms with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Spravato (esketamine) will be considered for coverage when the following criteria aremet:Major Depressive Disorder (MDD) With Suicidal IdeationFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is being prescribed by a psychiatrist in a Spravato REMS certified center; AND 3. Member has a diagnosis of MDD with documentation of acute suicidal ideation or behavior requiring immediate intervention; AND 4. Medication must be used in conjunction with an oral antidepressant (e.g., citalopram, duloxetine, venlafaxine, bupropion, trazodone , etc. ). 5. Dosage allowed: 84 mg (1 kit) twice per week for 4 weeks (8 kits total). Note: If member also has concomitant treatment resistant depression (TRD), must meet criteria for TRDin order to qualify for longer approval duration.If member meets all the requirements listed above, the medication will be approved for 1 month.For reauthorization :1. Continuation of Spravato beyond 4 weeks has not been established for the same episode. If this is a new suicidal ideation episode, must follow initial criteria. Treatment Resistant Depression (TRD) For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is being prescribed by a psychiatrist in a Spravato REMS certified center; AND 3. Member has a diagnosis of treatment resistant major depressive disorder; AND 4. Member has tried and failed at least TWO of the following oral antidepressants from different drug classes at optimized doses for at least 8 weeks, at least one of which must be an SSRI or SNRI: a) Selective Serotonin Reuptake Inhibitor (e.g. , citalopram, fluoxetine) b) Selective Norepinephrine Reuptake Inhibitor (e.g. , duloxetine, venlafaxine) c) Tricyclic Antidepressant (e.g. , nortriptyline) d) Monoamine Oxidase Inhibitor (e.g. , tranylcypromine) OH-MED-P – 366685 e) Bupropion f) Mirtazapine; AND5. Documentation of the members baseline depression status using an appropriate rating scale [e.g.,Patient Health Questionnaire (PHQ-9), Beck Depression Inventory (BDI), Quick Inventory ofDepressive Symptomatology (QIDS), Montgomery-sberg Depression Ratin g Scale (MADRS),Hamilton Rating Scale for Depression (HAM-D)].6. Dosage allowed:If member meets all the requirements listed above, the medication will be approved for 2 months. For reauthorization :1. Documented improvement of depressive symptoms as measured by an appropriate rating scale (e.g. ,PHQ-9, BDI, etc.).If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Spravato (esketamine) 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 05/23/2019 New policy for Spravato created. 11/06/2020 New diagnosis of MDD with suicidal ideation added. For TRD: added that medication must be prescribed by psychiatrist in a REMS certified center in accordance with package insert. 01/11/2021 TRD: Changed depression to major depressive disorder. Clarified the dosing. Added dose requirement to step drugs and that one must be an SSRI or SNRI (first line). Removed trazodone. Revised list of severity scales. Reworded renewal criteria. 0 8/14/2023 Updated billing code. 06/07/2024 Annual r eview; no changes needed. 12/13/2024 Added billing code. 02/11/2025 Updated references. TRD: Changed induction dosing in table to match label update . Removed requirement to be used with an oral antidepressant per label update (now approved as monotherapy). ODM approved 4/15/25. OH-MED-P-366685References:1. Spravato [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 202 5.2. Ionescu DF, Fu DJ, Qiu X, et al. Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II). Int JNeuropsychopharmacol . 2021;24(1):22-31. doi:10.1093/ijnp/pyaa068 3. Fu DJ, Ionescu DF, Li X, et al. Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I). JClin Psychiatry . 2020;81(3):19m13191. Published 2020 May 12. doi:10.4088/JCP.19m13191 4. Daly EJ, Trivedi MH, Janik A, et al. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry . 2019;76(9):893-903. 5. Gelenberg A., Freeman M., Markowitz J., et. al. Practice guideline for the treatment of patients with major depressive disorder. Am JPsychiatry . May 2010. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf . 6. Weber AN, Michail M, Thompson A, Fiedorowicz JG. Psychiatric Emergencies: Assessing and Managing Suicidal Ideation. Med Clin North Am . 2017;101(3):553-571. 7. American Psychiatric Association. Practice Guideline for the Assessment and Treatment of Patients With Suicidal Behaviors. 2003. https://psychiatryonline-org.cedarville.ohionet.org/guidelines (Accessed on November 06, 2020). 8. Mithawala PK, Davis DM. Managing treatment-resistant depression. US Pharm . 2020;45(5):15-19. 9. Gaynes BN, Asher G, Gartlehner G, et al. Definition of Treatment-Resistant Depression in the Medicare Population . Rockville (MD): Agency for Healthcare Research and Quality (US); February 9, 2018. 10. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am JPsychiatry . 2006;163(11):1905-1917. doi:10.1176/ajp.2006.163.11.1905 11. McIntyre RS, Rosenblat JD, Nemeroff CB, et al. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am JPsychiatry . 2021;178(5):383-399. doi:10.1176/appi.ajp.2020.20081251 12. Lam RW, Kennedy SH, Adams C, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults. Can JPsychiatry . 2024;69(9):641-687. doi:10.1177/07067437241245384 13. 2021 Georgia Code Title 33 Insurance Chapter 20A – Managed Health Care Plans Article 2 – Patient’s Right to Independent Review 33-20A-31 Definitions. Justia US Law. Accessed April 25, 2023. https://law.justia.com/codes/georgia/2021/title-33/chapter-20a/article-2/section-33-20a-31/ . Effective date: 07/01/2025Revised date: 02/11/2025
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Prevymis (letermovir)BENEFIT TYPE Medical STATUS Prior Authorization Required Prevymis , approved in 2017, is indicated for the prophylaxis of cytomegalovirus (CMV ) infection and disease in adult and pediatric patients 6 months of age and older weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) and prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (d onor CMV seropositive/recipient CMV seronegative). Prevymis works by inhibiting the CMV DNA terminase complex which is required for viral DNA processing and packaging.Prevymis (letermovir) will be considered for coverage when the following criteria are met:HSCT CMV ProphylaxisFor initial authorization: 1. Member is at least 6 months of age and 6 kg ; AND 2. Medication must be prescribed by or in consultation with an infectious disease specialist, hematologist, or transplant specialist; AND 3. Member is the recipient of an allogeneic stem cell transplant; AND 4. Member must be CMV-seropositive; AND 5. Provider attests Prevymis will be initiated within 28 days post-transplant ; AND 6. Provider attests that member is NOT currently taking the following: a) Pimozide ; b) Ergot akaloids (ergotamine, dihydroergotamine) ; c) Pitavastatin or simvastatin with cyclosporine; AND 7. For the IV formulation: documentation must be submitted that the member cannot tolerate or has a contraindication to the oral tablet. 8. Dosage allowed/Quantity limit: Quantity limit: 28 tablet /vials per 28 days or 120 packets per 30 days. a) 6 months to less than 12 years of age or 12 years of age and older and weighing less than 30 kg: dosing based on weight (see below) administered once daily orally or as an IV infusion over 1 hour through 100 days post-HSCT. OH-MED-P-366685b) Adult and pediatric patients 12 years of age and older and weighing at least 30 kg: a dminister 480 mg once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant . NOTE: In patients at risk for late CMV infection and disease, Prevymis may be continued through 200 days post-HSCT. If all the above requirements are met, the medication will be approved for 100 days . For reauthorization :1. Medication will not be reauthorized.Kidney Transplant CMV ProphylaxisFor initial authorization: 1. Member is at least 12 years of age and 40 kg ; AND 2. Medication must be prescribed by or in consultation with an infectious disease specialist, hematologist, or transplant specialist; AND 3. Member is the recipient of a kidney transplant; AND 4. Member must be at high risk (donor CMV-seropositive and recipient CMV seronegative); AND 5. Provider attests Prevymis will be initiated within 7 days post-transplant ; AND 6. Member is unable to use valganciclovir; AND 7. Provider attests that member is NOT currently taking the following: a. Pimozide ; b. Ergot akaloids (ergotamine, dihydroergotamine) ; c. Pitavastatin or simvastatin with cyclosporine; AND 8. For the IV formulation: documentation must be submitted that the member cannot tolerate or has a contraindication to the oral tablet. 9. Dosage allowed/Quantity limit : administer 4 80 mg once daily orally or as an intravenous (IV) infusion over 1 hour through 200 days post-transplant. Quantity limit: 28 tablet /vials per 28 days or 120 packets per 30 days. If all the above requirements are met, the medication will be approved for 200 days. For reauthorization : 1. Medication will not be reauthorized. CareSource considers Prevymis (letermovir) 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/DESCRIPTION02/14/2022 New policy for Prevymis created.07/05/2023 Added kidney transplant indication; added quantity limit; added references; added medical benefit optionOH-MED-P-36668502/05/2025 Updated references; expanded age limit and added weight requirement per PI for both diagnoses ; added pediatric dosing; removed note about coadministration with cyclosporine; added provider attestation for medications member is not taking; added packets to quantity limit; added note for HSCT about continuing through 200 days for patients at risk for late CMV. ODM approved 4/9/25. References: 1. Prevymis [package insert]. County Carlow, Ireland: Merck Sharp & Dohme Corporation; 2024 . 2. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. NEngl JMed. 2017; 377(25):2433-44. 3. Kropeit D, McCormick D, Erb-Zohar K, et al. Pharmacokinetics and safety of the anti-human cytomegalovirus drug letermovir in subjects with hepatic impairment. Br JClin Pharmacol. 2017a;83(12):2678-2686. 4. Malagola M, Radici V, Farina M, et al. Correction: CMV prophylaxis with letermovir significantly improves graft and relapse free survival following allogeneic stem cell transplantation. Bone Marrow Transplant. 2024;59(2):293. doi:10.1038/s41409-023-02158-2 5. Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation . 2018; 102:900. 6. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13512. doi:10.1111/ctr.13512 7. Limaye AP, Budde K, Humar A, et al. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA . 2023;330(1):33-42. doi:10.1001/jama.2023.9106 Effective date: 07/01/2025 Revised date: 02/05/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME MACI ( autologous cultured chondrocytes )BENEFIT TYPE Medical STATUS Prior authorization required MACI (autologous cultured chondrocytes on porcine collagen membrane) , approved by the FDA in 2016, is used for the repair of symptomatic cartilage damage of the knee. It is made up of autologous cells that are collected on biopsy, expanded and proliferated in culture, and seeded onto a collagen membrane that is implanted to the area of d efect and absorbed back into the tissue. The amount of MACI applied depends on the size of the cartilage defect (cm2). The membrane is trimmed by the surgeon to the size and shape of the defect. Implantation is performed via arthrotomy.MACI (autologous cultured chondrocytes) will be considered for coverage when the following criteria are met:Cartilage defect of the knee For initial authorization: 1. Member is 15 (with closed growth plates) to 55 years of age ; AND 2. Medication must be prescribed by or in consultation with an orthopedic surgeon or PM&R (physiatry) specialist; AND 3. Member has a BMI of 35 or less; AND 4. Member has a diagnosis of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement ; AND 5. The defect size is greater than 2 cm2; AND 6. Member has tried and failed conservative therapy such as physical therapy or anti-inflammatory medications; AND 7. The knee has stable alignment with the meniscus intact and normal joint space (per X-ray); AND 8. Documentation that the i mplantation will be followed by an appropriate, physician-prescribed rehabilitation program to which the member is expected to adhere; AND 9. Member does NOT have any of the following: a) Hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin b) Severe osteoarthritis of the knee or degenerative joint disease c) Inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders d) Knee surgery within the past 6 months (except to procure biopsy or to perform a concurrent procedure with MACI) e) Osteochondritis dissecans 10. Dosage allowed/Quantity limit: 1 procedure per defect per lifetime . If all the above requirements are met , the medication will be approved for 3 months. OH-MED-P -366685For reauthorization :1. MACI will not be re-authorized. If the request is for a new defect/injury that has not previously been treated with MACI, all initial criteria apply.CareSource considers MACI (autologous cultured chondrocytes ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION 11/22/2021 New policy created for Maci. 05/24/2022 Annual review; no changes. 01/14/2025 Updated references. Removed disabling knee pain criterion; #4 already specifies that they are symptomatic. Removed duration from trial of conservative therapy. ODM approved 4/9/25. References: 1. MACI. [prescribing information] . Vericel Corporation; 2024. 2. Saris D, Price A, Widuchowski W, et al. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am JSports Med. 2014;42(6):1384-1394. doi:10.1177/0363546514528093 3. Brittberg M, Recker D, Ilgenfritz J, Saris DBF; SUMMIT Extension Study Group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial. Am JSports Med . 2018;46(6):1343-1351. doi:10.1177/0363546518756976 4. National Institute for Health and Care Excellence. (2017). Autologous chondrocyte implantation for treating symptomatic articular cartilage defects of the knee (NICE guideline TA477) Available at https://www.nice.org.uk/guidance/ta477/resources/autologous-chondrocyte-implantation-for-treating-symptomatic-articular-cartilage-defects-of-the-knee-pdf-82604971061701 [Accessed 29 November 2021].5. Mistry H, Connock M, Pink J, et al. Autologous chondrocyte implantation in the knee: systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2017 Feb. (Health Technology Assessment, No. 21.6.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK424075/ doi: 10.3310/hta21060 6. Carey JL, Remmers AE, Flanigan DC. Use of MACI (Autologous Cultured Chondrocytes on Porcine Collagen Membrane) in the United States: Preliminary Experience. Orthop JSports Med. 2020;8(8):2325967120941816. Published 2020 Aug 12. doi:10.1177/2325967120941816 7. Niemeyer P, Albrecht D, Andereya S, et al. Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: A guideline by the working group "Clinical Tissue Regeneration" of the German Society of Orthopaedics and Trauma (DGOU). Knee . 2016;23(3):426-435. doi:10.1016/j.knee.2016.02.001 8. von Keudell A, Han R, Bryant T, Minas T. Autologous Chondrocyte Implantation to Isolated Patella Cartilage Defects. Cartilage . 2017;8(2):146-154. doi:10.1177/1947603516654944 9. Krych AJ, Saris DBF, Stuart MJ, Hacken B. Cartilage Injury in the Knee: Assessment and Treatment Options. JAm Acad Orthop Surg. 2020;28(22):914-922. doi:10.5435/JAAOS-D -20-00266 10. Hinckel BB, Thomas D, Vellios EE, et al. Algorithm for Treatment of Focal Cartilage Defects of the Knee: Classic and New Procedures. Cartilage. 2021;13(1_suppl):473S-495S. doi:10.1177/1947603521993219 Effective date: 07/01/2025 Revised date: 01/14/2025
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Leqembi (lecanemab)BENEFIT TYPE Medical STATUS Prior Authorization Required Leqembi is an amyloid beta-directed antibody indicated for the treatment of Alzheimers disease. Treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease (stage 3 or 4) , the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages. Leqembi was granted accelerated approval by the FDA in January 2023 based on reduction in amyloid beta plaques observed in patients treated with Leqembi in a phase 2 clinical trial . Upon reviewing data from the phase 3 CLARITY AD trial that confirmed a clinical benefit, the FDA converted the accelerated approval to a traditional approval in July 2023. Leqembi is a monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimers disease. Leqembi reduces amyloid beta plaques , with high selectivity for the soluble aggregated species . Alzheimers disease, the most common cause of dementia, is a progressive, irreversible neurodegenerative disease associated with cognitive, functional, and behavioral impairments . Leqembi has a black box warning for a myloid related imaging abnormalities (ARIA). ApoE 4 homozygotes have a higher incidence of ARIA .Leqembi (lecanemab) will be considered for coverage when the following criteria are met:Alzheimers DiseaseFor initial authorization: 1. Member is at least 50 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist or geriatrician; AND 3. Member has a diagnosis of early Alzheimers disease with mild cognitive impairment due to Alzheimers disease OR mild Alzheimers disease related dementia ( on the basis of National Institute on AgingAlzheimers Association criteria (NIA-AA) ); AND 4. Presence of amyloid beta pathology has been confirmed by one of the following: a) Positron-emission tomography ( PET) scan imaging b) Cerebrospinal fluid ( CSF) lumbar puncture; AND 5. Documentation of Mini mental state examination (MMSE) score of 22 to 30; AND 6. Documentation of global Clinical Dementia Rating (CDR) global score of 0.5 or 1.0 and CDR Memory Box score of 0.5 or greater ; AND 7. Member has had a brain MRI in the past 12 months to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA ); AND 8. Members ApoE 4 status has been or will be determined before starting treatment (must provide documentation of results or pending order for testing); AND 9. Member does NOT have any of the following: a) Transient ischemic attacks (TIA), stroke, or seizures within the last 12 months b) Contraindication to MRI c) Inadequately controlled bleeding disorder OH-MED-P-366685d) Taking an anticoagulant.10. Dosage allowed/Quantity limit: 10 mg/kg IV infusion every 2 weeks . After 18 months, may consider 10 mg/kg every 4 weeks. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Member has had a follow up assessment including cognitive test(s) to determine that they have not progressed to moderate/severe dementia; AND 2. Documentation of continued MRI monitoring for amyloid related imaging abnormalities-edema (ARIA-E) and-hemosiderin deposition (ARIA-H) , as per prescribing information. If all the above requirements are met , the medication will be approved for an additional 6 months . CareSource considers Leqembi (lecanemab) 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/DESCRIPTION02/22/2023 New policy for Leqembi created. 07/17/2023 Added reference (Cummings 2023). Added requirement for ApoE 4 testing per updated prescribing information following conversion of accelerated approval to traditional approval status. Removed Wechsler memory score. 01/29/2025 Added new guidelines to references. Updated dosing per drug label update. ODM approved 4/9/2025. References: 1. Leqembi. [prescribing information]. Eisai Inc.; 2025 . 2. Swanson CJ, Zhang Y, Dhadda S, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-A protofibril antibody [published correction appears in Alzheimers Res Ther. 2022 May 21;14(1): 70]. Alzheimers Res Ther . 2021;13(1):80. Published 2021 Apr 17. doi:10.1186/s13195-021-00813-8 3. McDade E, Cummings JL, Dhadda S, et al. Lecanemab in patients with early Alzheimer's disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alzheimers Res Ther . 2022;14(1):191. Published 2022 Dec 21. doi:10.1186/s13195-022-01124-2 4. Reardon S. FDA approves Alzheimer's drug lecanemab amid safety concerns. Nature. 2023;613(7943):227-228. doi:10.1038/d41586-023-00030-3 5. ALZFORUM. Dare We Say Consensus Achieved: Lecanemab Slows the Disease. 09 Dec 2022. https://www.alzforum.org/news/conference-coverage/dare-we-say-consensus-achieved-lecanemab-slows-disease 6. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. NEngl JMed. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948 7. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement . 2011;7(3):270-279. doi:10.1016/j.jalz.2011.03.008 8. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):263-269. doi:10.1016/j.jalz.2011.03.005 9. Porsteinsson AP, Isaacson RS, Knox S, Sabbagh MN, Rubino I. Diagnosis of Early Alzheimer's Disease: Clinical Practice in 2021. JPrev Alzheimers Dis . 2021;8(3):371-386. doi:10.14283/jpad.2021.23 10. Centers for Medicare & Medicaid Services (CMS): Medicare Coverage Database. Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD) . National Coverage Determination (NCD) . 04/07/2022. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=375&ncdver=111. Cummings J, Apostolova L, Rabinovici GD, et al. Lecanemab: Appropriate Use Recommendations. JPrev Alzheimers Dis . 2023;10(3):362-377. doi:10.14283/jpad.2023.30OH-MED-P -36668512. Atri A, Dickerson BC, Clevenger C, et al. The Alzheimer's Association clinical practice guideline for the diagnostic evaluation, testing, counseling, and disclosure of suspected Alzheimer's disease and related disorders (DETeCD-ADRD): Validated clinical as sessment instruments. Alzheimers Dement . 2025;21(1):e14335. doi:10.1002/alz.14335 13. Dickerson BC, Atri A, Clevenger C, et al. The Alzheimer's Association clinical practice guideline for the Diagnostic Evaluation, Testing, Counseling, and Disclosure of Suspected Alzheimer's Disease and Related Disorders (DETeCD-ADRD): Executive summary of recommendations for specialty care. Alzheimers Dement. 2025;21(1):e14337. doi:10.1002/alz.14337 Effective date: 07/01/2025 Revised date: 01/29/2025
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Krystexxa (pegloticase)BENEF IT TYPE Medical ST AT US Prior Authorization Required Krystexxa , approved by the FDA in 2010, is a PEGylated uric acid specif ic enzyme indicated f or the treatment of chronic gout in adult patients ref ractory to conventional therapy . According to the American College of Rheumatology guideline f or management of gout, pegloticase should not be a f irst-line therapy. Pegloticase is recommended f or patients with gout f or whom xanthine oxidase inhibitor treatment, uricosurics, and other int erventions have f ailed to achieve the serum uric acid target, and who continue to have f requent gout flares or who ha ve 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 f lares per year OR with non-resolving subcutaneous tophi associated with gout ; AND 4. Member has had inadequate response (def ined as serum uric acid (sU A) level remains above 6 mg/dL), or contraindication to, at least 3 months of both of the f ollowing: a) A xanthine oxidase inhibitor (e.g., allopurinol (Zyloprim) or f ebuxostat (Uloric)) at maximally appropriate dose. Note: allopurinol is f irst-line (typically 300 to 800 mg/day) an d 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, f ebuxostat, 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 inf usion 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 f rom using medication ( e.g., reduction of f lares, reduction of tophi). If all the above requirements are met , the medication will be approved for an additional 12 months.
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