IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Susvimo (ranibizumab)BENEF IT TYPE Medical ST AT US Prior Authorization Required Susvimo , approved by the FDA in 2021, is a v as c u lar endothelial growth factor (VEGF) inhibitor intravitreal ocular implant, indicated f or the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor , and f or diabetic mac u lar edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor . VEGF inhibitors suppress endothelial cell prolif eration, neovascularization, and vascular permeability . Susvimo was previously ref erred to as Lucentis Port Delivery System (PDS) since it is essentially a longer lasting version of Lucentis, releasing ranibizumab over a 6-month period rather than needing to be administered monthly . Af ter 6 months, the port can be re-f illed. Lucentis is approved f or additional indications . Susvimo has a black box warning f or endophthalmitis, an inf ection inside the eye which is a medical emergency.Susvimo (ranibizumab) will be considered for coverage when the following criteria are met:Retinal DiseaseFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a conf irmed diagnosis of one of the f ollowing: a) Neovascular (wet) Age-related Macular Degeneration (AMD) , or b) Diabetic Mac u lar Edema (DME) ; AND 4. Member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor; AND 5. Documentation of medical necessity rationale why a pref erred intravitreal injectable VEFG inhibitor cannot be used; AND 6. Documentation of best-corrected visual acuity (BCVA); AND 7. Member does NOT have any ocular or periocular inf ections or active intraocular inf lammation. 8. Dosage allowed/Quantity limit: 2 mg via surgical administration every 6 months. (1 single dose vial per eye per 6 months) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must include documentation of improved or stabilized visual acuity. If all the above requirements are met , the medication will be approved for an additional 12 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Susvimo (ranibizumab) 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/DESCRIPTION11/09/2021 New policy f or Susvimo created.05/19/2023 Added baseline BCVA documentation.11/08/2024 Annual review; no updates. 03/11/2025 Updated ref erences. Removed note about bevacizumab. Added medical necessity rationale criterion. Added new indication f or DME. Ref erenc es : 1. SUSVIMO [p ac k ag e ins ert]. So uth San Franc is c o , CA: Genentec h, Inc ; 2025 . 2. So lo mon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-v as c ular end o thelial g ro wth f ac to r f o r neo v as c ular ag e-related macular degeneration. Coc hrane Databas e Sy s t Rev . 2019;3(3):CD 005139. Pub lis hed 2019 Mar 4. d o i:10.1002/14651858.CD 005139.p ub 4 3. Vemulak o nda GA, Bailey ST, Kim SJ , et al. Ag e-Related Mac ular Deg eneratio n Pref erred Prac tic e Pattern . Ophthalmology . Pub lis hed o nline Feb ruary 7, 2025. d o i:10.1016/j.o p htha.2024.12.018 4. Flax el CJ , Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [pub lis hed c o rrec tio n ap p ears in Op hthalmo lo g y . 2020 Sep ;127(9):1279]. Ophthalmology . 2020;127(1):P66-P145. d o i:10.1016/j.o p htha.2019.09.025 5. Americ an Diabetes As sociation Profes sional Practice Committee . 12. Retinopathy, Neuro p athy , and Fo o t Care: Stand ard s of Care in Diabetes-2025. Diabetes Care. 2025;48(Supplement_1):S252-S265. doi:10.2337/dc25-S 012 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 03/11/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Somavert (pegvisomant)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Somavert , approved in 2003, is a growth hormone receptor antagonist indicated f or the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or f or whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth f actor-I (IGF-I) levels. Somavert binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of endogenous GH, and thus interf eres with GH signal transduction. Inhibition of GH action results in decreased serum concentrations of IGF-I, as well as other GH-responsive serum proteins . Acromegaly is typically the result of a GH-secreting pituitary adenoma, thus surgical resection is the pref erred treatment whenever possible as the best chance f or a cure. If disease persists af ter surgery, a f ir s t-generation long-acting somatostatin receptor ligand such as octreotide is recommended as f irst-line therapy . So mav ert does not target the tumor.Somavert (pegvisomant) will be considered for coverage when the following criteria are met:AcromegalyFor 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 documented diagnosis of uncontrolled acromegaly conf irmed by insulin-lik e g r o wt h f actor (IGF-1) elevation above normal; AND 4. Documentation of an inadequate response to surgery or radiation, or they are not an option f or the member ; AND 5. Member h as persistent IGF-1 elevation af ter optimized treatment with octreotide or lanreotide ( NOTE: Somavert may be used in combination with octreotide or lanreotide); AND 6. Member has had baseline liver f unction testing. 7. Dosage allowed/Quantity limit: initial dose of 40 mg subcutaneously . Titrate to normalize IGF-1 with a dos ag e range of 10 mg to 30 mg subcutaneously once daily. Quantity limit: 30 vials 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 normalized or improved (decreased) IGF-1. 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 Somavert (pegvisomant) 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/DESCRIPTION11/02/2020 New policy f or Somavert created. 03/31/2022 Transf erred to new template. Updated ref erences. 03/19/2025 Updated ref erences; increased initial authorization length to 6 months; removed three – month trial length ; removed note about cabergoline. Ref erenc es : 1. So mav ert [p ac k ag e ins ert]. NY, NY: Pharmac ia and Up jo hn Co mp any LLC; 2023. 2. Katznels o n L, Laws ER, Melmed S, et al. Ac ro meg aly : An End o c rine So c iety Clinic al Prac tic e Guid eline. The Journal of Clinic al Endoc rinology & Metabolis m . 2014;99(11):3933-3951. d o i:10.1210/jc .2014-2700 3. Melmed S, Bronstein MD , Chans o n P, et al. A Co ns ens us Statement o n ac ro meg aly therap eutic o utc o mes . Nature Rev iews Endoc rinology . 2018;14(9):552-561. d o i:10.1038/s 41574-018-0058-5 4. Zahr R, Fles eriu M. Up d ates in Diag no s is and Treatment o f Ac ro meg aly . Eur Endoc rinol . 2018;14(2):57-61. d o i:10.17925/EE.2018.14.2.57 5. Fles eriu M, Biller BMK, Fred a PU, et al. A Pituitary So c iety up d ate to ac ro meg aly manag ement g uid elines . Pituitary . 2021;24(1):1-13. d o i:10.1007/s 11102-020-01091-7 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 03/ 19/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Rystiggo (rozanolixizumab-noli)BENEF IT TYPE Medical ST AT US Prior Authorization Required Rystiggo is a neonatal Fc receptor blocker indicated f or the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specif ic tyrosine kinase (MuSK) antibody positive. Approval was based on the Phase 3 MycarinG study. It is the second FcRn antagonist to be approved; the f irst was Vyvgart , however, Vyvgart is not approved f or the MuSK population. Myasthenia gravis is an autoimmune disorder af f ecting the neuromuscular junction , characterized by muscle weakness and f atigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AC hR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Ocular motility, swallowing, speech, mobility, and respiratory f unction can all be af f ected. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed f or MG. It eases symptoms by slowing the breakdown of acetylcholine. If control is inadequate, immunosuppressive treatment is added, such as prednisone and/or azathioprine. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency.Rystiggo (rozanolixizumab-noli) will be considered for coverage when the following criteria are met:Myasthenia GravisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive f or AChR or MuSK antibodies; AND 5. Member has tried and f ailed at least 1 conventional therapy: A. pyridostigmine B. corticosteroid f or at least 4 weeks C. non-steroid immunosuppressant (e.g., azathioprine) f or at least 6 months. 6. Dosage allowed/Quantity limit: Subcutaneous inf usion once weekly for 6 weeks as 1 cycle of treatment; subsequent treatment cycles ar e based on clinical evaluation and must be at least 63 days apart. QL: 18 vials per 42 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 clinically meaningf ul improvement in symptom severity and daily f unctioning compared to pre-treatment baseline (e.g., improved MG-ADL or QMG scores) ; AND 2. Treatment cycles are being prescribed at least 63 days apart. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Rystiggo (rozanolixizumab-noli) 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/DESCRIPTION07/05/2023 New policy f or Rystiggo created. 05/19/2025 Changed steroid trial duration f rom 3 months to 4 weeks (Sanders, Alhaidar). Appendix:MG Foundation of Am erica (MGFA) Clinical ClassificationClass I any o c ular weak nes s ; all o ther mus c le s treng th is no rmal Class II mild weak nes s affec ting other than o c ular mus c les ; may als o hav e o c ular weak nes s at any lev el Cl as s III mo d erate weaknes s affecting other than o cular muscles; may also hav e ocular weak nes s at any lev el Class IV s ev ere weak nes s affecting o ther than oc ular mus cles; may als o have o cular weak nes s at any lev el Class V d ef ined b y intub atio n, with o r witho ut mec hanic al v entilatio n Ref erenc es : 1. Ry s tig g o [p res c rib ing inf o rmatio n]. UCB Inc .; 2025 . 2. Naray anas wami P, Sand ers DB, Wo lf e G, et al. Internatio nal Co ns ens us Guid anc e f o r Manag ement o f My as thenia Grav is : 2020 Up d ate. Neuro lo g y . 2021;96(3):114-122. d o i:10.1212/WNL.0000000000011124 3. Sand ers DB, Wolfe GI, Benatar M, et al. International c onsensus g uidance for management of myasthenia g ravis: Ex ec utiv e s ummary . Neuro lo g y . 2016;87(4):419-425. d o i:10.1212/WNL.0000000000002790 4. Alhaid ar MK, Ab umurad S, So liv en B, Rezania K. Current Treatment o f My as thenia Grav is . JClin Med. 2022;11(6):1597. Pub lis hed 2022 Mar 14. d o i:10.3390/jc m11061597 5. Bril V, Drud A, Grosskreutz J, et al. Saf ety and ef f icacy of rozanolixizumab in patients with generalised my as thenia grav is (MycarinG): a rand omised, d ouble-blind, p lac ebo-c ontrolled, ad ap tiv e p has e 3 s tud y . Lanc et Neurol . 2023;22(5):383-394. d o i:10.1016/S1474-4422(23)00077-7 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 05/19/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Romvimza (vimseltinib )BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Ro mvimz a, approved by the FDA in 2025, is a kinase inhibitor indicated f or treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) f or which surgical resection will potentially cause worsening f unctional limitation or severe morbidity. Romvimza is a selective oral inhibitor of the colony-stimulating f actor 1 receptor (CSF1R). It works by blocking CSF1R-driven signaling involved in the prolif eration and accumulation of tumor-associated macrophages in TGCT. TGCT is a rare, typically non-malignant tumor of the synovium, tendon sheath, and bursae that can lead to joint damage, pain, swelling, and f unctional impairment. Surgical resection remains the first-lin e t r eat ment f or TGCT, but in patients f or whom surger y is not f easible or would result in signif icant morbidity, systemic treatment such as Romvimza may be considered.Romvimza (vimseltinib) will be considered for coverage when the following criteria are met: Tenosynovial Giant Cell Tumor (T GCT ) For initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with an oncologist or orthopedic surgeon; AND 3. Member has a documented diagnosis of benign TGCT confirmed by imaging (MRI) or histology ; AND 4. Member is symptomatic (i.e., pain or stif f ness); AND 5. Prescriber attests that surgical resection will potentially cause worsening f unctional limitation or severe morbidity ; AND 6. Chart notes must document that baseline liver tests have been or will be completed prior to starting therapy . 7. Dosage allowed/Quantity limit: a) 30 mg orally twice weekly with at least 72 hours between doses. b) Quantity Limit: 8 capsules per 28 days. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show improvement or stabilized signs and symptoms of disease (such as decreased pain and stif f ness , increased range of motion, or reduced tumor volume). 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 Romvimza (vimseltinib) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION04/7/2025 New policy f or Ro mvimza created. Ref erenc es : 1. Ro mv imza (v ims eltinib ) [p ac k ag e ins ert]. Dec ip hera Pharmac eutic als , LLC; Feb ruary 2025. 2. IPD Analytics. So lid Tumo rs-No n Malig nant . Av ailab le f ro m: http s ://s ec ure.ip d analy tic s .c o m/Us er/Pharma/Rx Strateg y /Pag e/c d 33496c-1413-40a5-8489-c b f b 6c 1eb b c 6#c o mment-groups. Accessed Ap ril 7, 2025. 3. Tap WD , Sharma MG, Vallee M, et al. The MOTIONs tudy : a rand omized , p has e IIIs tud y o f v ims eltinib f o r the treatment o f teno s y no v ial g iant c ell tumo r. Future Onc ol . 2024;20(10):593-601. d o i:10.2217/f o n-2023-0238. 4. Geld erb lo m H, Bhad ri V, Stac c hio tti S, et al. Vims eltinib v ers us p lac eb o f o r teno s y no v ial g iant c ell tumo ur (MOTION): a multic entre, rand o mis ed , d o ub le-blind, placebo-c o ntro lled , p has e 3 trial. Lanc et . 2024;403(10445):2709-2719. d o i:10.1016/S0140-6736(24)00885-7. 5. Stac c hiotti S, Drr HR, Sc haefer IM, et al. Bes t c linical management of tenosy novial g iant c ell tumo ur (TGCT): A c o ns ens us p ap er f ro m the c o mmunity o f ex p erts . Canc er Treat Rev . 2023;112:102491. d o i:10.1016/j.c trv .2022.102491. 6. U.S. Natio nal Lib rary o f Med ic ine. Stud y o f Vims eltinib f o r Teno s y no v ial Giant Cell Tumo r (MOTION ,NCT05059262). Av ailab le from: https ://clinicaltrials.gov /study/NCT05059262?tab=res ults. Ac cessed April 7, 2025 . 7. Natio nal Co mp rehens iv e Canc er Netwo rk . So f t Tis s ue Sarc o ma (Vers io n 1.2025). https://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf . Ac c es s ed Ap ril 9, 2025. Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/07/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Retisert (fluocinolone acetonide)BENEF IT TYPE Medical ST AT US Prior Authorization Required Retisert is a 0.59 mg f luocinolone acetonide intravitreal implant indicated f or the treatment of chronic non-inf ectious uveitis affecting the posterior segment of the eye. It is released over a period of 30 months and has been shown to reduce the rate of recurrence and improve visual acuity. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is af f ected, it can be treated with topical glucocorticoids. If resistant or af fecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Retisert (fluocinolone acetonide) will be considered for coverage when the following criteria are met:Uveitis For initial authorization: 1. Member is at least 12 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of chronic (1 year or more) non-inf ectious uveitis af f ecting the posterior segment of the eye; AND 4. Member has tried and f ailed at least one of the f ollowing f or at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mof etil, methotrexate, cyclosporine, tacrolimus); AND 5. Member has had a f ailed trial of Ozurdex, Yutiq , or Iluvien; AND 6. Member does not have any active inf ections of the eye. 7. Dosage allowed/Quantity limit: One implant (0.59 mg) per eye Limit: 2 implants (1 per eye) per 30 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or an improved vitreous haze score; AND 2. At least 3 0 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 3 months . CareSource considers Retisert (fluocinolone acetonide) 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/DESCRIPTION10/28/2021 New policy created f or Retisert . 10/18/2023 Updated Cochrane ref erence. Added ref erences. Added Yutiq as a trial option. 04/09/2025 Updated ref erences. 06/25/2025 Added Iluvien as a step option. Ref erenc es : 1. Retis ert [p res c rib ing inf o rmatio n]. Baus c h & Lo mb ; 2023. 2. Multic enter Uv eitis Steroid Treatment (MUST) Trial Res earc h Gro up, Kempen JH, Altaweel MM, et al. Benefits o f Systemic Anti-inflammatory Therap y vers us Fluocinolone Acetonide Intrao cular Implant f o r Intermed iate Uv eitis , Po s terior Uv eitis, and Panuv eitis: Fi f ty-four-Month Res ults o f the Multic enter Uv eitis Stero id Treatment (MUST) Trial and Fo llo w-up Stud y . Ophthalmology . 2015;122(10):1967-1975. d o i:10.1016/j.o p htha.2015.06.042 3. Writing Co mmittee fo r the Multic enter Uv eitis Stero id Treatment (MUST) Trial and Fo llo w-up Stud y Res earc h Gro up , Kempen JH, Altaweel MM, et al. As sociation Between Long-Las ting Intrav itreous Fluocinolo ne Ac eto nid e Imp lant v s Systemic Anti-inflammatory Ther ap y and Visual Acuity at 7 Years Among Patients With Intermed iate, Po s terio r, o r Panuv eitis . JAMA . 2017;317(19):1993-2005. d o i:10.1001/jama.2017.5103 4. Red d y A, Liu SH, Brady CJ , Sieving PC, Palestine AG. Corticosteroid implants for c hronic no n-infec tio us uv eitis . Coc hrane Databas e Sy s t Rev . 2023;1(1):CD 010469. Pub lis hed 2023 Jan 16. d o i:10.1002/14651858.CD 010469.p ub 3 5. Tan HY, Ag arwal A, Lee CS, et al. Management of no ninfectious p os terio r uv eitis with intrav itreal d rug therap y . Clin Ophthalmol . 2016;10:1983-2020. Pub lis hed 2016 Oc t 13. d o i:10.2147/OPTH.S89341 6. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectio us uv eitis . Clin Ex p Med. 2023;23(4):1089-1106. d o i:10.1007/s 10238-022-00954-6 7. Ab d ulla D, Ali Y, Menezo V, Tay lo r SRJ . The Us e o f Sus tained Releas e Intrav itreal Stero id Imp lants in No n-Inf ec tio us Uv eitis Af f ec ting the Po s terio r Seg ment o f the Ey e. Ophthalmol Ther . 2022;11(2):479-487. d o i:10.1007/s 40123-022-00456-4 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/09/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Ozurdex (dexamethasone)BENEF IT TYPE Medical ST AT US Prior Authorization Required Ozurdex is an intravitreal implant containing dexamethasone 0.7 mg. It is indicated f or the treatment of r e t in al vein occlusion (RVO), posterior segment uveitis, and diabetic macular edema (DME). RVO occurs when there is a partial or complete obstruction of a retinal vein. Macular edema is a complication of RVO and can lead to vision loss. First-line treatment is with an t i-vascular endothelial growth f actor ( an t i-VEGF) drugs. DME is a common consequence of diabetic retinopathy. It is caused by leakage f rom retinal capillaries and leads to f luid build-up in the macula part of the retina. This can result in loss of central vision. The importance of maintaining glucose control cannot be understated. Uveitis is an inf lammation of the uvea (middle layer of the eye). It can be inf ectious or non-infectious. Non-inf ectious uveitis (NIU) is of ten associated with inf lammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is af f ected, it can be treated with topical glucocorticoids. If resistant or af fecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Ozurdex (dexamethasone) will be considered for coverage when the following criteria are met:Retinal Vein Occlusion (RVO) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of macular edema f ollowing branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO ); AND 4. Trial and f ailure of or contraindication to an an t i-VEGF drug; AND 5. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 4 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must include documentation of improved or stabilized visual acuity; AND 2. At least 4 months have elapsed since the prior treatment (of the same eye) . 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: 5/16/2023UveitisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of non-infectious uveitis af f ecting the posterior segment of the eye ; AND 4. Member has tried and f ailed at least one of the f ollowing f or at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mof etil, methotrexate, cyclosporine, tacrolimus); AND 5. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 6 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment and/or an improved vitreous haze score; AND 2. At least 6 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 12 months . Diabetic Macular Edema (DME) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of diabetic macular edema; AND 4. Member does NOT have any of the f ollowing: a) A ctive or suspected ocular or periocular inf ections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 5. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 3 months If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity f ollowing treatment; AND 2. At least 3 months have elapsed since the prior treatment (of the same eye). If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Ozurdex (dexamethasone) 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/DESCRIPTION11/03/2021 New policy created f or Ozurdex. 10/23/2023 Updated ref erences. Changed treatment interval f rom 6 months to 4 months f or RVO. 07/16/2024 Updated ref erences; changed treatment interval f rom 6 mo to 3 mo f or DME. Extended reauth durations f rom 3 mo to 1 yr. 04/09/2025 Updated ref erences. RVO: Removed note about bevacizumab. Ref erenc es : 1. Ozurd ex [p res c rib ing inf o rmatio n]. Allerg an USA, Inc .; 2024. 2. Tan HY, Ag arwal A, Lee CS, et al. Manag ement o f no ninf ec tio us p o s terio r uv eitis with intrav itreal d rug therap y . Clin Ophthalmol . 2016;10:1983-2020. Pub lis hed 2016 Oc t 13. d o i:10.2147/OPTH.S89341 3. Red d y A, Liu SH, Brady CJ , Sieving PC, Palestine AG. Corticosteroid implants for c hronic no n-infec tio us uv eitis . Coc hrane Databas e Sy s t Rev . 2023;1(1):CD 010469. Pub lis hed 2023 Jan 16. 4. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectio us uv eitis . Clin Ex p Med. 2023;23(4):1089-1106. d o i:10.1007/s 10238-022-00954-6 5. Ab d ulla D, Ali Y, Menezo V, Tay lo r SRJ . The Us e o f Sus tained Releas e Intrav itreal Stero id Imp lants in No n-Inf ec tio us Uv eitis Af f ec ting the Po s terio r Seg ment o f the Ey e. Ophthalmol Ther. 2022;11(2):479-487. d o i:10.1007/s 40123-022-00456-4 6. Lim JI, Kim SJ , Bailey ST, et al. Diab etic Retino p athy Pref erred Prac tic e Pattern . Ophthalmology . 2025;132(4):P75-P162. d o i:10.1016/j.o p htha.2024.12.020 7. Rittip hairoj T, Mir TA, Li T, Virg ili G. Intrav itreal steroids for macular edema in diabetes . Coc hrane Databas e Sy s t Rev . 2020;11(11):CD 005656. Pub lis hed 2020 No v 17. d o i:10.1002/14651858.CD 005656.p ub 3 8. Zur D , Ig lic k i M, Loewenstein A. The Ro le of Steroids in the Management of Diabetic Macular Edema. Ophthalmic Res . 2019;62(4):231-236. d o i:10.1159/000499540 9. Yuen YS, Gilho tra JS, Dalto n M, et al. Diab etic Mac ular Oed ema Guid elines : An Aus tralian Pers p ec tiv e. JOphthalmol . 2023;2023:6329819. Pub lis hed 2023 Feb 14. d o i:10.1155/2023/6329819 10. Ko v ac h JL, Bailey ST, Kim SJ , et al. Retinal Vein Oc c lus io ns Pref erred Prac tic e Pattern . Ophthalmology . 2025;132(4):P303-P343. d o i:10.1016/j.o p htha.2024.12.025 11. Malc les A, Dot C, Voirin N, et al. Safety of intravitreal d examethasone implant (Ozurd ex ): The SAFOD EXs tud y . Inc id enc e and ris k f ac to rs o f o c ular hy p ertens io n. Retina. 2017;37(7):1352-1359. 12. Sp inetta R, Petrillo F, Reibaldi M, et al. Intravitreal DEX Implant for the Treatment of Diabetic Mac ular Ed ema: A Rev iew o f Natio nal Co ns ens us . Pharmac eutic s . 2023;15(10):2461. Pub lis hed 2023 Oc t 13. d o i:10.3390/p harmac eutic s 15102461 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 0 4/09/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Mycapssa (octreotide)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Mycap ssa is a somatostatin analog indicated f or long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. It is a delayed-release oral capsule f ormulation of octreotide. Acromegaly is typically the result of a GH-secreting pituitary adenoma, thus surgical resection is the pref erred treatment whenever possible as the best chance f or a cure. If disease persists af ter surgery, a f ir s t-generation long-acting somatostatin receptor ligand is recommended as f irst-line therapy .Mycapssa (octreotide) will be considered for coverage when the following criteria are met:AcromegalyFor 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 documented diagnosis of acromegaly; AND 4. Member has been stabilized on injectable octreotide or lanreotide f or at least 3 months, with documentation of IGF-1 demonstrating response to treatment ; AND 5. Member has documented rationale f or why it is medically necessary to switch to the oral f ormulation of octreotide ( e.g., injection site reactions, ongoing symptoms despite biochemical control). 6. Dosage allowed/Quantity limit: initial dose of 40 mg orally per day, given as 20 mg orally twice daily. Titrate in 20 mg increments, based on IGF-1 levels. Max dose of 80 mg orally per day, given as 40 mg orally twice daily . Quantity limit: 1 12 capsules per 28 d ay s. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes/lab report must show maintained or normalized IGF-1. If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Mycapssa (octreotide) 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/DESCRIPTION10/19/20 20 New policy f or Mycapssa created. 04/01/2022 Transf erred to new template. Updated ref erences. 03/21/2025 Updated ref erences ; clarif ied dosing ; removed documentation of surgery or surgery not an option . Ref erenc es : 1. My c ap s s a (o c treo tid e) [p ac k ag e ins ert] . Amry t Pharmac eutic als , Inc.; 2024. 2. Katznels o n L, Laws ER, Melmed S, et al. Ac ro meg aly : An End o c rine So c iety Clinic al Prac tic e Guid eline. The Journal of Clinic al Endoc rinology & Metabolis m . 2014;99(11):3933-3951. d o i:10.1210/jc .2014-2700 3. Melmed S, Bronstein MD , Chans o n P, et al. A Co ns ens us Statement o n ac ro meg aly therap eutic o utc o mes . Nature Rev iews Endoc rinology . 2018;14(9):552-561. d o i:10.1038/s 41574-018-0058-5 4. Melmed S, Popov ic V, Bidlingmaier M, et al. Safety and ef f ic ac y o f o ral o c treo tid e in ac ro meg aly : res ults o f a multic enter p has e III trial [p ublished correc tion appears in JClin End o c rino l Metab . 2016 Oc t;101(10 ):3863]. JClin Endoc rinol Metab. 2015;100(4):1699-1708. d o i:10.1210/jc .2014-4113 5. Sams o n SL, Nac htigall LB, Fleseriu M, et al. Maintenanc e o f Ac ro meg aly Co ntro l in Patients Switc hing Fro m Injec tab le Somatostatin Rec eptor Ligands to Oral Oc treo tid e. JClin Endoc rinol Metab. 2020;105(10):d g aa526. d o i:10.1210/c linem/d g aa526 6. Zahr R, Fles eriu M. Up d ates in Diag no s is and Treatment o f Ac ro meg aly . Eur Endoc rinol . 2018;14(2):57-61. d o i:10.17925/EE.2018.14.2.57 7. Fles eriu M, Biller BMK, Fred a PU, et al. A Pituitary So c iety up d ate to ac ro meg aly manag ement g uid elines . Pituitary . 2021;24(1):1-13. d o i:10.1007/s 11102-020-01091-7 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 0 3/21/2025
Administrative Policy StatementINDIANA MEDICAIDPolicy Name Policy Number Date Effective Lost, Stolen, Damaged, Vacation and School Supply of Medication PAD-0091-IN-MCD 10/01/ 2025 Policy Type Medical ADMINISTRATIVE Ph ar mac y Reimbursement Table of ContentsAdministrative Policy St at e men t ……………………………………………………………………………………1 A. Subject ………………………………………………………………………………………………………………2 B. Bac k g r ou nd ………………………………………………………………………………………………………..2 C. Def initions …………………………………………………………………………………………………………..2 D. Policy ………………………………………………………………………………………………………………..2 E. Conditions of Co ve r age …………………………………………………………………………………………2 F. Related Policies/Rules …………………………………………………………………………………………..3 G. Review/Revision History ………………………………………………………………………………………..3 H. Ref er en ce s …………………………………………………………………………………………………………3 Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of d ise a se , illn ess, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Po licy Statements, Provider Manuals, Member Handbooks, a n d/ or other p o licie s and procedures. A d min istra tive Po licy Statements prepared b y CS MG Co . and its a ffilia te s (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the A d min istra tive Po licy Statement. If there is a co n flict between the A d min istra tive Policy Statement and the plan contract (i.e . , Evidence of Coverage), t h en the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. 2 A. Subjec t Lo s t, Stolen, Damag ed , Vac ati o n , School Supply of Med i c ati o n INDIANA MEDICAID PAD-0091-IN-MCD Effec ti v e Date: 10/1/2025Ear ly ref ill override r eq u es t s due to reports of additional medication needed beyond initial dispensing. B. Bac k ground The CareSource pharmacy benef it design places limits on how early a member can ref ill a prescription. This limit is intended to ensure appropriate and cost-ef f ective use of medications. A pharmacy may request an exception to the ref ill-too-soon threshold on behalf of a member by calling the pharmacy help desk. This policy serves as guidance f or the Pharmacy Help Desk and CareSource operations t e am member processing of member and pharmacy requests f or an override f or an early ref ill resulting f rom: Lost medication Stolen medication Damag e d medication Out of state or out of country travel Se p ar at e supply f or separated households, school or d ay c ar e C. Def initionsI. Ref ill-Too-Soon An early ref ill; a dditional medication t h at is requested f ollowing an earlier-dispensed medication request but sooner t h an allowed by the members coverage benef its. II. Override Authorization for e ar ly refill that allows the claim to process at the point of sale (at the pharmacy) III. Ref ill-Too-Soon Threshold The date bef ore which a claim f or a medication ref ill will reject at the point-of-sale. When a pharmacy attempts to f ill a medication ref ill bef ore this threshold, the rejection message at the point of sale will provide the ref ill-too-soon threshold date. D. Polic y I. The pharmacy help desk will provide a ref ill-too-soon override in the f ollowing circumstances: A. For a lost medication override, the pharmacy help desk will place a single ref ill-too-soon override per medication (including strength) per rolling twelve (12) months. The days supply allowed by the ref ill-too-soon override will be subject to standard days supply restrictions (limited to a 30-day supply). B. For a stolen medication override, the pharmacy help desk will place a single ref ill-too-soon override per medication (including strength) per rolling twelve (12) months 3 when member attests that the thef t has been reported to the police. Note: Attestation can be relayed through the pharmacy. Documentation is not required. C. For a ref ill-too-soon override related to damaged medication, the pharmacy help desk will place a single ref ill-too-soon override per medication (including strength) per rolling twelve (12) months when t he medication was not damaged as a result of pharmacy action or in the process of shipment to the member . a. If the request is f or a blood glucose or continuous glucose monitor that is malf unctioning, the member should conf irm the manuf acturer has been contacted f or assistance and was unable to resolve the issue. b. If medication damage occurs as a result of pharmacy action or in the process of shipment to the member, the pharmacy is responsible f or replacing the damaged medication. D. For a ref ill-too-soon override related to member t r av e l, the pharmacy help desk will place a single ref ill-too-soon override per medication (including strength) per rolling twelve (12) months when ALL of the f ollowing are met: a. The member is traveling to a location where a network, rostered p h ar mac y is not available, AND b. The days supply of the ref ill-t oo-soon request is subject to the plans benef it limits. E. For a ref ill-too-soon override related to additional medication supply to be provided t o a separate household, school or daycare, the pharmacy help desk may p lac e ref ill-too-soon overrides for medications that are in unbreakable packaging (such as inhalers or epinephrine injectors) when needed. F. For members requesting a ref ill-too-soon supply due to permanent relocation to a new address out-of-state, the pharmacy help desk will place a single ref ill-too-soon override per medication (including strength) f or up to a 30-day supply. II. The pharmacy help desk will NOT provide a ref ill-too-soon override when ANY of the f ollowing circumstances is true: A. The requested medication is a n opioid, B. The total cost of the damaged medication is greater than $8,000, C. The loss or damage is a result of an action on the part of the pharmacy or shipping company, D. The member has already received a ref ill-too-soon override f or the requested medication f or any reason in the previous rolling twelve (12) months, E. The requested days supply of the medication exceeds plan benef it limits (30-d ay supply) , OR F. The requested medication is not a Covered product under the plan (including products that are not CMS rebateable) . III. All requests f or ref ill-too-soon overrides not permitted by the pharmacy help desk ar e subject to review and approval or denial by the CareSource Pharmacy Operations team. Any overrides not permitted by the pharmacy help desk will be considered at the discretion of the CareSource Pharmacy Operations team in consultation with the Markets when appropriate. 4 E. Related Polic ies/Rules F. Rev iew/Rev ision History Lo s t, Stolen, Damag ed , Vac ati o n , School Supply of Med i c ati o n INDIANA MEDICAID PLANS PAD-0091-IN-MCD Effec ti v e Date: 10-1- 2025 DATES ACTIONDate Issued 01/22/2022Date Revised 06/28/2024 Co mp lete rev iew with up d ated c riteria and res tric tio ns 5/22/2025 Annual rev iew, no up d atesDate Effecti ve 10/01/ 202 5Date Archived G. Ref erenc esThe Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved.
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Livmarli (maralixibat)BENEF IT TYPE Ph ar mac y Coverage Requirements Prior Authorization Required Livmarli, approved by the FDA in 2021, is an ileal bile acid transport (IBAT) inhibitor indicated f or the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS) or progressive f amilial intrahepatic cholestasis (PFIC) . In cholestatic liver disease, biliary substances arent eliminated f rom the liver, thus they re-enter circulation. Cholestatic itch is thought to be related to the accumulation of bile acids in the skin. Inhibiting IBAT decreases reuptake of bile salts to reduce serum bile acids and pruritis. ALGS is a rare genetic disorder that can af f ect multiple organ systems, most commonly the liver, with a paucity of interlobular ducts. PFIC is an ultra-rare group of genetic disorders that disrupt bile f ormation in the liver. It usually presents during inf ancy with cholestasis, jaundice, and intense itching. Most patients will eventually require biliary diversion surgery or liver transplant. PFIC1 involves extrahepatic manif estations while PFIC2 does not. However, PFIC2 can be complicated by hepatocellular carcinoma . Livmarli (maralixibat) will be considered for coverage when the following criteria are met:Alagille Syndrome (ALGS)For initial authorization: 1. Member is at least 3 months of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND 3. Member has a diagnosis of Alagille syndrome (ALGS) conf irmed by the involvement of at le as t 3 of the f ollowing major clinical f eatures : a) Hepatic Features (e.g., hyperbilirubinemia or scleral icterus) b) Cardiac Features (e.g., lesions conf irmed on imaging or murmur) c) Facial Features (e.g., inverted triangular f ace, straight nose with bulbous tip) d) Ocular Features (e.g., embryotoxon, optic disk drusen) e) Skeletal Features (e.g., vertebral anomalies, osteopenia f) Renal Features (e.g., renal dysplasia, renal tubular acidosis) g) Vascular Features (e.g., narrowing of internal carotid artery, moyamoya disease) NOTE: Member also meets criterion if has one or more clinical f eatures an d an af f ected f irst-degree relative; AND 4. Member must have liver biopsy demonstrating reduced number of the interlobular bile ducts OR conf irmed f inding of JAG1 or NOTCH2 gene mutation; AND 5. Member has symptoms of moderate to severe pruritus ; AND 6. Member does NOT have any of the f ollowing: a) Previous liver transplant b) Previous surgical disruption of enterohepatic circulation (partial external bile diversion or ileal exclusion) c) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023d) History or presence of other concomitant liver disease7. Member must have a trial and f ailure of at least 2 of the f ollowing: a) Cholestyramine b) Ursodiol c) Rif ampin d) Naltrexone 8. Dosage allowed/Quantity limit: Starting dose 190 mcg/kg orally once daily, titrating up to 380 mcg/kg once daily. Max dose 28.5 mg (3 mL) per day f or the solution or 30 mg per day f or the tablets . QL: 3 bottles (90 mL) per 30 days or 30 tablets per 30 days . Note: Use the 9.5 mg/mL oral solution for treatment of ALGS . Note: Must weigh at least 25 kg to use tablets. If all the above requirements are met , the medication will be approved for 6 months. For reauthorization: 1. Pruritis has improved in response to therapy with Livmarli ; AND 2. Member has not had a hepatic decompensation event. If all the above requirements are met, the medication will be approved for an additional 12 months.Progressive Familial Intrahepatic C holestasis (PFIC )For initial authorization: 1. Member is at least 12 months of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND 3. Member has a diagnosis of PFIC conf irmed by genetic testing results: PFIC 1 (ATP8B1 mutation), PFIC2 (ABCB11 mutation), PFIC3 (ABCB4 mutation), PFIC4 (TJP2 mutation) , or PF IC6 (MYO5B mutation) ; AND 4. Member has signif icant pruritis not attributed to another cause; AND 5. Documentation of total serum bile acid (sBA) 3 ULN; AND 6. Documentation of baseline liver f unction tests (e.g., ALT, AST, bilirubin, INR); AND 7. Trial and f ailure of ursodiol (may also continue concurrently); AND 8. Member does NOT have any of the f ollowing: a) Variants of the ABCB11 gene (PFIC type 2) that code f or non-f unctional or complete absence of the bile salt export pump (BSEP-3) protein (per submitted genetic test result) b) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) c) Liver transplant . 9. Dosage allowed/Quantity limit: Starting dose 285 mcg/kg orally once daily, titrating up to 570 mcg/kg twice daily. Max dose 38 mg (2 mL) per day f or the solution or 40 mg per day f or the tablets . QL: 2 bottles ( 60 mL) per 30 days or 60 tablets per 30 days . Note: Use the 19 mg/mL oral solution for treatment of PFIC. Note: Must weigh at least 25 kg to use tablets. If all the above requirements are met , the medication will be approved for 6 months. For reauthorization: 1. Pruritis has improved in response to therapy with Livmarl i; AND 2. Member has not had a hepatic decompensation event. 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 Livmarli (maralixibat) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION10/15/2021 New policy f or Livmarli created.03/28/2023 Updated/added ref erences. Changed lower age limit f rom 1 year to 3 months per updated drug label. Added QL. Added naltrexone to list of trial options and removed specif ic trial duration. 03/28/2024 Added criteria f or new PFIC indication. Expanded description of hepatic decompensation contraindication in ALGS section (to match label). 08/02/2024 Added note about strengths to dosing sections. Added no hepatic decompensation to renewal sections. ALGS: Added note to diagnostic f eatures criterion. PFIC: Changed at least 5 years of age to at least 12 months of age (label update); updated max qty. 04/23/2025 Added tablet f ormulation to policy, including QL; added note about minimum weight for tablet use. Ref erenc es : 1. Livmarli. [Pres c rib ing inf o rmatio n]. Mirum Pharmac eutic als , Inc .; 2025 . 2. Shneid er BL, Sp ino C, Kamatha BM, et al. Plac eb o-Co ntro lled Rand o mized Trial o f an Intes tinal Bile Salt Trans p o rt Inhib ito r f o r Pruritus in Alag ille Sy nd ro me. Hepatol Commun. 2018 Oc t; 2(10): 1184-1198. Do i 10.1002/hep 4.1244 3. Ay o ub MD and Kamath BM. Alag ille Sy nd ro me: Diag no s tic Challeng es and Ad v anc es in Manag ement. Diagnos tic s . 2020; 10(11):907. http s ://d o i.o rg /10.3390/d iag no s tic s 101109074. Lin, Henry . Alag ille Syndrome. National Org anization for Rare Disorders; up d ated 2020. Ac c es s ed Oc to b er 12, 2021. http s ://rared is eas es .o rg /rare-d is eas es /alag ille-s y nd ro me/ 5. Kamath BM, Goldstein A, Ho ward R, et al. Maralixibat Treatment Respons e in Alag ille Sy nd ro me is As s o c iated with Imp ro v ed Health-Related Quality o f Lif e. JPediatr . 2023;252:68-75.e5. d o i:10.1016/j.jp ed s .2022.09.001 6. Diaz-Frias J , Kondamudi NP. Alagille Syndrome. [Updated 2022 Aug 14]. In: StatPearls [Internet]. Treas ure Is land (FL): StatPearls Pub lis hing ; 2023 Jan- . Av ailab le f ro m: http s ://www.nc b i.nlm.nih.g o v /b o o k s /NBK507827/7. Shirley M. Maralix ib at: Firs t Ap p ro v al [p ub lis hed c o rrec tio n ap p ears in Drug s . 2021 Dec 6;:]. Drugs . 2022;82(1):71-76. d o i:10.1007/s 40265-021-01649-0 8. Shneid er BL, Spino CA, Kamath BM, et al. Imp ac t o f lo ng-term ad minis tratio n o f maralix ib at o n c hild ren with c ho les tasis s econd ary to Alag ille s y nd ro me. Hepatol Commun. 2022;6(8):1922-1933. d o i:10.1002/hep 4.1992 9. Lo o mes KM, Squires RH, Kelly D, et al. Maralixibat f o r the treatment o f PFIC: Lo ng-term, IBAT inhib itio n in an open-lab el, Phas e 2 s tud y . Hepatol Commun. 2022;6(9):2379-2390. d o i:10.1002/hep 4.1980 10. Gunay d in M, Bo zk urter Cil AT. Pro g res s iv e f amilial intrahep atic c ho les tas is : d iag no s is , manag ement, and treatment. Hepat Med. 2018;10:95-104. Pub lis hed 2018 Sep 10. d o i:10.2147/HMER.S137209 11. Sriv as tav a A. Pro g res s iv e f amilial intrahep atic c ho les tas is . JClin Ex p Hepatol . 2014;4(1):25-36. d o i:10.1016/j.jc eh.2013.10.005 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/23/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Koselugo (selumetinib)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Koselugo, approved by the FDA in 2020, is a kinase inhibitor indicated f or the treatment of p e d iat r ic p at ients 2 years of age and older with neurof ibromatosis type 1 (NF1) who have symptomatic, inoperable plexif orm neurof ibromas (PN) . It works by targeting mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK is a component of a pathway that is of ten activated in certain types of cancer. NF1 is a rare, progressive genetic condition caused by a mutation in the NF1 gene. PNs are histologically benign peripheral-nerve sheath tumor s (PNST) that occur in up to 50% of NF1 patients . For PNs t h at c an not be completely removed by surgery , systemic therapy may be appropriate. PNs do have a risk of malignant transf ormation. Koselugo was approved based on data f rom the phase 2 SPRINT clinical trial in which a majority of children had durable tumor shrinkage and clinical benef it such as pain reduction with treatment.Koselugo (selumetinib) will be considered for coverage when the following criteria are met:Neurofibromatosis Type 1 (NF1)For initial authorization: 1. Member is at le as t 2 years of age; AND 2. Medication must be prescribed by or in consultation with a pediatric oncologist or neurologist ; AND 3. Member has a conf irmed diagnosis of neurofibromatosis type 1 (NF1) with at least 1 of the f ollowing: a) Positive genetic test f or NF1 b) 6 or more caf-au-lait macules (CALMs) c) Axillary or inguinal f reckling d) Optic glioma e) 2 or more Lisch nodules f) A distinctive osseous lesion g) First degree relative with NF1; AND 4. Member has at least one measurable plexif orm neurofibromas (PN) as evidenced by MRI or PET-CT scan; AND 5. The plexif orm neurof ibromas (PN) is inoperable and cannot be removed completely by surgery without risk f or substantial morbidity due to encasement of , or close proximity to, vital structures, invasiveness, or high vascularity of the PN; AND 6. Member has signif icant morbidity related to the PN (e.g., disf igurement, motor dysf unction, pain, air way dysf unction, visual impairment, bladder/bowel dysf unction) . 7. Dosage allowed/Quantity limit : 25 mg / m 2 by mouth twice daily until disease progression or unacceptable toxicity . Capsules must be swallowed whole. ( See Table 1 in prescribing inf ormation f or recommended dosage based on body surf ace area). QL f or 10 mg capsules: 224 per 28 days (8/day) IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023QL f or 25 mg capsules: 112 per 28 days (4/day)If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes have been provided showing that the member has had at least a partial response ( d e f ined as 20% reduction in the PN volume) f rom baseline and no disease progression and/or 2. Clinical improvement such as reduction of tumor pain or increased physical f unctioning. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Koselugo (selumetinib) 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/DESCRIPTION05/14/2020 New policy f or Koselugo created. 09/19/2023 Updated template. Revised ref erences. Added neurology, genetics as specialists. Removed upper age limit. Added criteria to def ine NF1 diagnosis (only need to f ulf ill one since PN would count as the second) . Added clinical benef it to reauth. 05/21/2025 Removed geneticist as prescriber. Ref erenc es : 1. 2021 Geo rg ia Co de Title 33 Ins uranc e Chap ter 20A-Managed Health Care Plans A rt ic le 2-Patient’ s Rig ht to Ind ep end ent Rev iew 33-20A-31 Def initio ns . Jus tia US Law. Ac c es s ed Ap ril 25, 2023. https://law.justia.com/codes/georgia/2021/title-33/c hap ter-20a/artic le-2/s ec tio n-33-20a-31/.2. Ko s elug o [Pac k ag e Ins ert]. Wilming to n, DE: As traZenec a Pharmac eutic als LP; 2024. 3. Gro s s AM, Wo lters PL, Do mb i E, et al. Selumetinib in Child ren with Ino p erab le Plex if o rm Neuro f ib ro mas [p ub lished c orrection ap pears in NEngl JMed. 2020 Sep 24;383(13):1290]. NEngl JMed. 2020;382(15):1430-1442. d o i:10.1056/NEJ Mo a1912735. 4. Miller DT, Freed enb erg D , Sc ho rry E, et al. Health Sup erv is io n f o r Child ren With Neuro f ib ro mato s is Ty p e 1. Pediatric s . 2019;143(5):e20190660. d o i:10.1542/p ed s .2019-0660. 5. Pellerino A, Verd ijk RM, Nic helli L, And rats c hk e NH, Id b aih A, Go ld b runner R. Diag no s is and Treatment o f Perip heral and Cranial Nerv e Tumo rs with Expert Rec ommendations: An EUro p ean Netwo rk f o r RAre CANc ers (E URA CA N) Init iat iv e. Canc ers (Basel ). 2023;15(7):1930. Published 2023 Mar 23. doi:10.3390/c anc ers 15071930 6. Arms tro ng AE, Belzberg AJ, Crawford JR, Hirbe AC, Wang ZJ. Treatment dec is ions and the us e of MEK inhibitors f o r c hild ren with neuro f ib ro mato s is ty p e 1-related p lex if o rm neuro f ib ro mas . BMC Canc er . 2023;23(1):553. Pub lis hed 2023 Jun 16. d o i:10.1186/s 12885-023-10996-y 7. Leg ius E, Messiaen L, Wolkenstein P, et al. Rev ised diagnostic c riteria for neurofib ro mato s is ty p e 1 and Leg ius s y nd ro me: an international c onsensus recommendation. Genet Med. 2021;23(8):1506-1513. doi:10.1038/s 41436-021-01170-5 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 0 5/21/2025
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