IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Ap proved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Andembry (garadacimab-gxii)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Andembry, approved by the FDA in 2025, is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated f or prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older . HAE is a rare autosomal dominant disease characterized by episodic unpredictable swelling, which can occur in a variety of anatomic locations. The swelling results f rom excess production of the vasodilator bradykinin. Attacks may be painf ul and cause f unct ional impairment but are not associated with pruritis. The most common types of HAE are caused by def iciency (type 1) or dysf unction (type 2) of C1 inhibitor (C1-INH). Type 1 is the most prevalent.Andembry (garadacimab-gxii) will be considered for coverage when the following criteria are met:Hereditary Angioedema (HAE)For initial authorization: 1. Member is at le as t 12 years of age; AND 2. Medication must be prescribed by or in consultation with an allergist or immunologist; AND 3. Member has a diagnosis of HAE type I or type II conf irmed by both of the f ollowing: a) Low C4 level; b) Low (
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vykat XR (diazoxide choline)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Vykat XR, approved by the FDA in 2025, is indicated f or the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). PWS is a rare genetic disorder that occurs due to the loss of function on chromosome 15 leading to disruption of the hypothalamus. Patients experience hypotonia and f eeding dif f iculties in early lif e f ollowed by hyperphagia and gradual development of obesi ty in early childhood. Hyperphagia of ten begins around 3 years of age and progress until teenage years. It is coupled with f ood-seeking behaviors such as hoarding and stealing f ood as well as attempting to consume inedible items. Thus, patients with PWS ha ve a greater risk of choking and gastric distention. Both patients and caregivers carry a signif icant lif elong psychosocial burden.Vykat XR (diazoxide choline) will be considered for coverage when the following criteria are met:Hyperphagia in Prader-Willi Syndrome (PWS)For initial authorization: 1. Member is at least 4 years of age; AND 2. Medication must be prescribed by or in consultation on with an endocrinologist; AND 3. Member has a diagnosis of PWS conf irmed by genetic testing; AND 4. Provider attests that member has moderate to severe hyperphagia with documentation of associated symptoms such as f ood-seeking behaviors (hoarding, f oraging, stealing, and attempting to consume garbage and inedible objects); AND 5. Member has documentation of a f ood-secure environment (such as locked f ood storage); AND 6. Patient is able to swallow tablets whole; AND 7. Member has documentation of recent weight in chart notes. 8. Dosage allowed/Quantity limit: administer orally once daily per table below. Maximum dose is 5.8 mg/kg/day or 525 mg per day. a) Quantity limit: i) 25 mg: 1 tablet per day ii) 75 mg: 1 tablet per day iii) 150 mg: 3 tablets per day IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023If all the above requirements are met, the medication will be approved for 6 months.For reauthorization :1. Chart notes must have been provided showing improvement or stabilized signs and symptoms of disease such as decrease in f ood-related behaviors, lessened f ood preoccupation that af f ects daily lif e, etc; AND 2. Provider attests that member continues to benef it f rom therapy; AND 3. Member has documentation of recent weight in chart notes. If all the above requirements are met, the medication will be approved for an additional 12 months.CareSource considers Vykat XR (diazoxide choline) 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/DESCRIPTION04/23/2025 New policy f or Vykat XR created. Ref erenc es : 1. Vy k at XR [p res c rib ing inf o rmatio n]. So leno Therap eutic s , Inc .; 2025. 2. Fermin Gutierrez MA, Daley SF, Mend ez MD . Prad er-Willi Synd ro me. In: StatPearls . Treas ure Is land (FL): StatPearls Pub lis hing ; Feb ruary 26, 2024. 3. Mc Cand les s SE; Co mmittee o n Genetic s . Clinic al rep o rt health s up erv is io n f o r c hild ren with Prad er-Willi s y nd ro me. Pediatric s. 2011;127(1):195-204. d o i:10.1542/p ed s .2010-2820 4. Shaik h MG, Barrett TG, Brid g es N, et al. Prad er-Willi s y nd ro me: g uid anc e f o r c hild ren and trans itio n into adulthood. Endoc r Connec t. 2024;13(8):e240091. Pub lis hed 2024 Jul 10. d o i:10.1530/EC-24-0091 5. Bey g o J , Buiting K, Rams den SC, Ellis R, Clay ton-Smith J , Kanber D . Up date of the EMQN/ACGS b es t p rac tic e g uid elines for molecular analys is of Prader-Willi and Angelman sy ndromes . Eur JHum Genet. 2019;27(9):1326-1340. d o i:10.1038/s 41431-019-0435-0 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 Vanrafia (atrasentan)BENEF IT TYPE Ph ar mac y ST AT US Prior Authorization Required Vanraf ia, approved by the FDA in 2025, is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether it slows kidney f unction decline. IgA nephropathy is the most common primary glomerular disease. It is an autoimmune condition caused by deposits of immunoglobulin A (IgA) in the kidney, leading to hematuria, proteinuria, and nephropathy (kidney disease) as the kidneys become unable to f il ter. This can slowly progress to end stage renal disease (ESRD) requiring dialysis or kidney transplant. ACE inhibitors or angiotensin receptor blockers (ARBs) are used to slow the progression of kidney disease. Vanrafia (atrasentan) will be considered for coverage when the following criteria are met:Primary Immunoglobulin A Nephropathy (IgAN)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 a nephrologist; AND 3. Member has a diagnosis of IgA nephropathy conf irmed by renal biopsy ; AND 4. Chart notes must indicate risk of rapid disease progression per documentation of UPCR 1.5 g/g or greater despite max tolerated dose of an ACEi or ARB f or at least 3 months ; AND 5. Member has had a trial and f ailure of Tarpeyo or Filspari; AND 6. Members eGFR is at least 30 mL/min/1.73m 2; AND 7. Member will continue ACEi or ARB unless contraindicated or intolerable. 8. Dosage allowed/Quantity limit: 0.75 mg orally once daily . QL: 30 tablets per 30 days. If all the above requirements are met , the medication will be approved for 9 months . For reauthorization :1. Chart notes must show reduced proteinuria (e.g., UPCR) compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Vanrafia (atrasentan) 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/DESCRIPTION04/11/2025 New policy f or Van r af ia created. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202306/25/2025 Added trial of Tarpeyo or Filspari.Ref erenc es : 1. Vanraf ia [p res c rib ing inf o rmatio n]. No v artis Pharmac eutic als Co rp o ratio n; 2025. 2. Kid ney Dis ease: Imp roving Global Outcomes (KDIGO) Glomerular Dis eas es Wo rk Gro up . KD IGO 2021 Clinic al Prac tic e Guid eline f o r the Manag ement o f Glo merular Dis eas es . Kidney Int. 2021;100(4S):S1-S276. d o i:10.1016/j.k int.2021.05.021 3. Heers p ink HJ L, Jardine M, Kohan DE, et al. Study Design and Baseline Charac teris tics of ALIGN, a Rand o mized Co ntro lled Study of Atrasentan in Patients With IgA Nephropathy. Kidney Int Rep. 2024;10(1):217-226. Publis hed 2024 Oc t 10. d o i:10.1016/j.ek ir.2024.10.004 Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/11/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Apretude (cabotegravir extended-release )BENEF IT TYPE Medical ST AT US Prior Authorization Required Apretude is an HIV-1 integrase strand transf er inhibitor (INSTI) initially approved by the FDA in 2021. It is indicated f or the pre-exposure prophylaxis (PrEP) of HIV inf ection in at-risk adults and adolescents weighing at least 35 kg. Apretude is the f irst injectable medication f or the prevention of HIV, taken every two months. The u se of oral cabotegravir (Vocabria) as a lead-in prior to initiating therapy with Apretude is optional.Individuals must have a negative HIV test prior to initiating Apretude to prevent drug resistance. Apretude (cabotegravir extended-release) will be considered for coverage when the following criteria are met:Pre-exposure Prophylaxis of HIV infectionFor initial authorization: 1. Member must be at least 12 years of age and weigh at least 35 kg; AND 2. Member is not a candidate f or oral PrEP (such as member has dif f iculty with adherence, signif icant renal disease, trouble swallowing pills etc.); AND 3. Member has had or will have completed an HIV RNA test bef ore initial and subsequent injections; AND 4. Provider attests member is NOT taking any of the f ollowing concomitantly with Apretude: a) Rif ampin; b) Carbamazepine, oxcarbazepine, phenobarbital or phenytoin; c) Other antiretroviral therapy. 5. Dosage allowed/Quantity limit: Initiate Apretude with a single 600-mg ( 3-mL) injection given 1 month apart f or 2 consecutive months on the last day of an oral lead-in if used or within 3 days and continue with the injections every 2 months thereaf ter. Quantity Limit: 3 mL per 56 days. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Member has had or will have completed an HIV RNA test bef ore injections. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Apretude (cabotegravir extended-release) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION01/12/2022 New policy f or Apretude created. 05/11/2023 Simplif ied HIV RNA testing requirement and removed 7-day window; added quantity limit. 08/16/2023 Rephrased trial of oral PrEP to patient is not a candidate f or oral PrEP and added examples. 04/22/2025 Increased initial auth length to 6 months and reauth length to 12 months; added provider attestation to medications that cannot be administered with Apretude Ref erenc es : 1. Ap retud e [p ac k ag e ins ert]. Glax o SmithKline; 2025.2. Pre-ex p o sure Prophylaxis f o r the Prev entio n o f HIV Inf ec tio n in the United States 2021 Up d ate. Center f o r Dis eas e Co ntrol and Prevention. : Available at : https ://www.cdc.gov /hiv/pdf/ris k/prep/cdc-hiv-p rep-guidelines-2021 . Accessed on January 13, 2022. 3. Land o v itz RJ , Li S, Eron Jr JJ, et al. Tail-p hase s afety , tolerability, and pharmacokinetics of lo ng ac ting injec tab le c ab o teg rav ir in HIV-uninf ec ted ad ults : a s ec o nd ary analy s is o f the HPTN 077 trial. The Lanc et HIV. 2020 4. Land o v itz RJ , Donnell D, Clement ME, et al. Cabotegravir for HIV p revention in c is g end er men and trans g end er wo men. NEng l JMed . 2021;385(7):595-608. 5. Marzink e MA, Grins ztejn B, Fogel JM, et al. Charac terization of human immunodeficienc y v irus (HIV) inf ec tio n in c is g end er men and trans g end er wo men who hav e s ex with men rec eiv ing injec tab le c ab o teg rav ir f o r HIV p rev entio n: HPTN 083. Inf ec t Ds . 2021. Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/22/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tegsedi (inotersen)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Tegsedi is a transthyretin-directed antisense oligonucleotide (ASO) indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults . It inhibits hepatic synthesis of human transthyretin (TTR) protein by causing degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues . Efficacy was demonstrated in the NEURO-TTR clinical trial. hATTR is a rare and progressive inherited disorder where misfolded TTR accumulates as amyloid fibrils in the body. In polyneuropathy of hATTR (hATTR-PN), these fibrils deposit in the peripheral nerves which leads to pain, muscle weakness, and autonomic dys function. Tegsedi has a black box warning for thrombocytopenia and glomerulonephritis and is only available thr ough a REMS program. It is a weekly self-administered subcutaneous injection.Tegsedi (inotersen) will be considered for coverage when the following criteria are met:Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis): PolyneuropathyFor 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 diagnosis of hATTR amyloidosis with documentation of a transthyretin (TTR) mutation confirmed by genetic testing; AND 4. Member has signs/symptoms of polyneuropathy; AND 5. Member must have documentation of familial amyloid polyneuropathy (FAP) stage 1 ( ambulatory) or stage 2 ( ambulatory with assistance ); AND 6. Members platelet count is at least 100 x10 9/L; AND 7. Members eGFR is at least 45 mL/min/1.73 m 2; AND 8. Members urinary protein to creatinine ratio (UPCR) is less than 1000 mg/g; AND 9. Member has NOT had a liver transplant; AND 10. Tegsedi is NOT being used in combination with another hATTR drug (e.g., Amvuttra, Onpattro, Vyndaqel, Vyndamax , Wainua). 11. Dosage allowed/Quantity limit: 284 mg injected subQ once weekly . (4 syringes per 28 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. 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 Tegsedi (inotersen) 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/DESCRIPTION08/07/2019 New policy for Tegsedi created. 07/06/2020 Removed office from site of service allowed. Expanded prescriber to include physicians who specialize in treating amyloidosis. Simplified diagnostic requirement of hATTR to just any method of confirmation by chart notes. Separated genetic testing and FAP staging into their own mandatory requirements. Removed the following exclusions: type 1 or type 2 DM, sensorimotor or autonomic neuropathy, Acute Coronary Syndrome or major surgery, HF Class III, anticipated survival less than 2 years. 08/03/2022 Transferred to new template. Updated and added references. Removed other specialists except neurology. Removed exclusions except liver transplant. Added baseline monitoring (platelets, UPCR, GFR). Simplified FAP stage descriptions. Increased initial auth duration from 6 mo to 9 mo. Edited renewal criteria . 02/22/2024 Simplify reauth criteria and allow stabilization as well as improvement. Added Wainua to list of drugs not to be used in combination with. References: 1. Tegsedi [prescribing information]. Akcea Therapeutics, Inc.; 2024. 2. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet JRare Dis. 2013;8:31. 3. National Institutes of Health (NIH). Transthyretin amyloidosis. Available at: https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis.4. Amyloid transthyretin (ATTR) Amyloidosis: Signs, symptoms, and diagnostic workup. 2018 Akcea Therapeutics, Inc. Available at: https://www.hattrguide.com/wp-content/uploads/2018/04/Diagnostic-Card.pdf 5. BioNews Services, LLC. Stages of familial amyloid polyneuropathy. Available at: https://fapnewstoday.com/stages-of-familial-amyloid-polyneuropathy/ 6. Benson MD, Waddington-Cruz M, Berk JL, et al. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. NEngl JMed . 2018;379(1):22-31. doi:10.1056/NEJMoa1716793 7. Ando Y, Adams D, Benson MD, et al. Guidelines and new directions in the therapy and monitoring of ATTRv amyloidosis [published online ahead of print, 2022 Jun 2]. Amyloid . 2022;1-13. doi:10.1080/13506129.2022.2052838 8. Sekijima Y. Hereditary Transthyretin Amyloidosis. 2001 Nov 5 [Updated 2021 Jun 17]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1194/ 9. Dyck PJB, Gonzlez-Duarte A, Obici L, et al. Development of measures of polyneuropathy impairment in hATTR amyloidosis: From NIS to mNIS+7. JNeurol Sci . 2019;405:116424. doi:10.1016/j.jns.2019.116424 10. Adams D, Ando Y, Beiro JM, et al. Expert consensus recommendations to improve diagnosis of ATTR amyloidosis with polyneuropathy. JNeurol. 2021;268(6):2109-2122. doi:10.1007/s00415-019-09688-0 11. Magrinelli F, Fabrizi GM, Santoro L, et al. Pharmacological treatment for familial amyloid polyneuropathy. Cochrane Database Syst Rev . 2020;4(4):CD012395. Published 2020 Apr 20. doi:10.1002/14651858.CD012395.pub2 Effective date: 06/30/2025 Revised date: 02/22/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Somavert (pegvisomant)BILLING CODE Must use valid NDC BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home STATUS Prior Authorization Required Somavert is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels. Somavert binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of endogenous GH, and thus interferes 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 preferred treatment whenever possible as the best chance for a cure. If disease persists after surgery, a first-generation long-acting somatostatin receptor ligand such as octreotide is recommended as first-line therapy . Somavert 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 diagnosis of uncontrolled acromegaly confirmed by insulin-like growth factor (IGF-1) elevation above normal (lab report required); AND 4. Member had an inadequate response to surgery or radiation, or member is ineligible for these treatments (documentation required); AND 5. Member remains uncontrolled (persistent IGF-1 elevation) after optimized treatment with octreotide or lanreotide for at least 3 months ( NOTE: Somavert may be used in combination with octreotide or lanreotide if member had a partial response (as opposed to no response) after 3 months; cabergoline is another option that may be added instead and does not require prior auth); AND 6. Member has had baseline liver function testing. 7. Dosage allowed/Quantity limit: Loading dose 40mg subQ under provider supervision. Titrate to normalize IGF-1; dosing range 10mg-30mg subQ once daily. (QL 30 vials per 30 days) If all the above requirements are met , the medication will be approved for 3 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes/lab report 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. 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 for Somavert created. 03/31/2022 Transferred to new template. Updated references. References: 1. Somavert [package insert]. NY, NY: Pharmacia and Upjohn Company LLC ; 8/2021. 2. Katznelson L, Laws ER, Melmed S, et al. Acromegaly: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism . 2014;99(11):3933-3951. doi:10.1210/jc.2014-2700 3. Melmed S, Bronstein MD, Chanson P, et al. A Consensus Statement on acromegaly therapeutic outcomes. Nature Reviews Endocrinology . 2018;14(9):552-561. doi:10.1038/s41574-018-0058-5 4. Zahr R, Fleseriu M. Updates in Diagnosis and Treatment of Acromegaly. Eur Endocrinol . 2018;14(2):57-61. doi:10.17925/EE.2018.14.2.57 5. Fleseriu M, Biller BMK, Freda PU, et al. A Pituitary Society update to acromegaly management guidelines. Pituitary . 2021;24(1):1-13. doi:10.1007/s11102-020-01091-7 Effective date: 06/30/2025 Revised date: 03/31/2022
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Nemluvio (nemolizumab-ilto)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Nemluvio, approved in 2024, is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis and the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. It inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemluvio (nemolizumab-ilto) will be considered for coverage when the following criteria are met:Prurigo N odularis (PN) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a dermatologist; AND 3. Member has a documented diagnosis of prurigo nodularis with ALL of the following: a) Chronic pruritis lasting more than 6 weeks; b) Severe itch with repeated scratching; c) At least 20 total lesions present; AND 4. Member has had a trial and failure of a medium to super high potency topical corticosteroid for at least 2 weeks . NOTE: If topical corticosteroids are contraindicated, must alternatively try and fail at least ONE of the following: topical emollient, capsaicin, calcipotriol, calcineurin inhibitor, phototherapy, or oral antihistamine; AND 5. Member has tried and failed Dupixent. 6. Dosage allowed/Quantity limit: quantity limit-2 pens per 4 weeks. a) Less than 90 kg: administer 60 mg (two 30 mg injections) subcutaneously , followed by 30 mg given every 4 weeks. b) 90 kg or m ore: administer 60 mg (two 30 mg injections) subcutaneously , followed by 60 mg given every 4 weeks. If all the above requirements are met , the medication will be approved for 4 months . For reauthorization : 1. Chart notes have been provided documenting clinically significant reduction of itch intensity and/or nodule clearance compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Atopic Dermatitis (AD)For initial authorization: 1. Member is at least 12 years of age; AND 2. Medication must be prescribed by or in consultation with a dermatologist, allergist, or immunologist; AND 3. Member has a diagnosis of moderate to severe AD ; AND 4. Provider attests Nemluvio will be used in combination with topical corticosteroids and/or topical calcineurin inhibitors; AND 5. Members atopic dermatitis involves 10% or more of the body surface area (BSA) OR involves highly visible or functional areas (e.g., neck, face, genitals, palms) and is significantly impairing quality of life; AND 6. Member has a documented trial and failure of ONE of the following: a) Medium to very high potency topical corticosteroids for 2 weeks; b) Topical calcineurin inhibitor (e.g., tacrolimus, pimecrolimus) for 6 weeks. Note: Eucrisa for 4 weeks is also acceptable. 7. Dosage allowed/Quantity limit: inject 60 mg (two 30 mg injections) subcutaneously , followed by 30 mg given every 4 weeks . After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. Quantity limit: 1 pen per 28 days. If all the above requirements are met, the medication will be approved for 4 months. For reauthorization :1. Chart notes have been provided showing an improvement in signs and symptoms of disease such as fewer flares, less itching/erythema, improved quality of life, etc. If all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Nemluvio (nemolizumab-ilto) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION09/10/2024 New policy for Nemluvio created. 02/17/2025 Added AD indication. References: 1. Nemluvio [package insert]. Galderma Laboratories, L.P.; 2024. 2. Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. JAm Acad Dermatol. 2021;84(3):747-760. doi:10.1016/j.jaad.2020.07.025. 3. Stnder S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042. 4. Satoh T, Yokozeki H, Murota H, et al. 2020 guidelines for the diagnosis and treatment of prurigo. JDermatol. 2021;48(9):e414-e431. doi:10.1111/1346-8138.16067. 5. Chisolm SS. A review of the current management and burden of prurigo nodularis in the United States. Am JManag Care. 2023;29(5 Suppl):S63-S72. doi:10.37765/ajmc.2023.89366. 6. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. NEngl JMed. 2023;389(17):1579-1589. doi:10.1056/NEJMoa2301333 7. Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema: part I-systemic therapy. JEur Acad Dermatol Venereol. 2022;36(9):1409-1431. doi:10.1111/jdv.18345 8. Eichenfield LF, Tom WL, Chamlin SL et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. JAm Acad Dermatol. 2014; 70(1):338-51. 9. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. JAm Acad Dermatol. 2014;71(1):116-132. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202310. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: Section 3. Management and treatment with photot herapy and systemic agents. JAm Acad Dermatol. 2014 Aug;71(2):327-49. 11. Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. JAm Acad Dermatol. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102 12. AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel, Chu DK, Schneider L, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE-and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024;132(3):274-312. doi:10.1016/j.anai.2023.11.00 Effective date: 06/30/2025 Revised date: 02/17/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Onpattro (patisiran)BENEFIT TYPE Medical STATUS Prior Authorization Required Onpattro contains a transthyretin-directed small interfering RNA (siRNA) and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. It is an RNA interference (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 targeting the liver where TTR protein is synthesized. In the APOLLO clinical trial , changes from baseline to Month 18 on both the mNIS+7 (primary endpoint) and the Norfolk QoL-DN significantly favored Onpattro, as well as changes in modified body mass index (mBMI) and gait speed (10-meter walk test) . Changes were evident at 9 months. hATTR is a rare and progressive inherited disorder where misfolded TTR accumulates as amyloid fibrils in the body. In polyneuropathy of hATTR (hATTR-PN), these fibrils deposit in the peripheral nerves which leads to pain, muscle weakness, and autonomic dys function. Onpattro is administered by a healthcare professional every 3 weeks via IV infusion.Onpattro (patisiran) will be considered for coverage when the following criteria are met:Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis): PolyneuropathyFor 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 diagnosis of hATTR amyloidosis with documentation of a transthyretin (TTR) mutation confirmed 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. Member has NOT had a liver transplant; AND 7. Onpattro is NOT being used in combination with another hATTR drug (e.g., Amvuttra, Tegsedi, Vyndaqel, Vyndamax ). 8. Dosage allowed/Quantity limit: For members weighting less than 100 kg: 0.3 mg/kg every 3 weeks . For members weighing 100 kg or more, the recommended dosage is 30 mg every 3 weeks . (QL: 3 vials per 21 days) If all the above requirements are met , the medication will be approved for 9 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For 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 life compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Onpattro (patisiran) 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/DESCRIPTION08/05/2019 New policy for Onpattro created.07/02/2020 Simplified diagnostic requirement of hATTR to just any method of confirmation by chart notes. Separated genetic testing and FAP staging into their own mandatory requirements. Expanded prescriber to include physicians who specialize in treating amyloidosis. 08/02/2022 Transferred to new template. Updated and added references. Removed other specialists except neurology. Removed exclusions except liver transplant. Replaced FAP staging with PND score. Added QL. Increased initial auth duration from 6 mo to 9 mo. Edited renewal criteria to be consistent with Amvuttra. 04/19/2023 Added or stabilization to renewal section. References: 1. Onpattro [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals, Inc.; 2022. 2. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet JRare Dis. 2013;8:31. 3. National Institutes of Health (NIH). Transthyretin amyloidosis. Available at: https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis.4. Adams D, Gonzalez-Duarte A, O’Riordan WD, et al. Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis. NEngl JMed . 2018;379(1):11-21. doi:10.1056/NEJMoa1716153 5. Ando Y, Adams D, Benson MD, et al. Guidelines and new directions in the therapy and monitoring of ATTRv amyloidosis [published online ahead of print, 2022 Jun 2]. Amyloid . 2022;1-13. doi:10.1080/13506129.2022.2052838 6. Sekijima Y. Hereditary Transthyretin Amyloidosis. 2001 Nov 5 [Updated 2021 Jun 17]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm .nih.gov/books/NBK1194/ 7. Dyck PJB, Gonzlez-Duarte A, Obici L, et al. Development of measures of polyneuropathy impairment in hATTR amyloidosis: From NIS to mNIS+7. JNeurol Sci . 2019;405:116424. doi:10.1016/j.jns.2019.116424 8. Adams D, Ando Y, Beiro JM, et al. Expert consensus recommendations to improve diagnosis of ATTR amyloidosis with polyneuropathy. JNeurol. 2021;268(6):2109-2122. doi:10.1007/s00415-019-09688-0 9. Magrinelli F, Fabrizi GM, Santoro L, et al. Pharmacological treatment for familial amyloid polyneuropathy. Cochrane Database Syst Rev . 2020;4(4):CD012395. Published 2020 Apr 20. doi:10.1002/14651858.CD012395.pub2 Effective date: 06/30/2025 Revised date: 04/19/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Yorvipath (palopegteriparatide )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Yorvipath, approved by the FDA in 2024, is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults . It has not been studied for acute post-surgical hypoparathyroidism , and should not be used in those with increased risk of osteosarcoma. It is the prodrug of teriparatide, and is identical to the biologically active region of the 84-amino acid human PTH. Hypoparathyroidism is an endocrine disease caused by insufficient or absent production of parathyroid hormone (PTH) leading to hypocalcemia and hyperphosphatemia. Multiple organ systems are affected, including neuromuscular, cardi ovascular, and renal dysfunction. Conventional therapy is calcium and active forms of vitamin Dt o resolve hypocalcemia, but this does not restore normal PTH. Endogenous PTH maintains extracellular calcium and phosphate homeostasis by increasing serum calcium and decreasing serum phosphate.Yorvipath (palopegteriparatide) will be considered for coverage when the following criteria are met:HypoparathyroidismFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has a diagnosis of hypoparathyroidism for at least 26 weeks based on labs that show both of the following: a) Hypocalcemia, and b) Low serum PTH ; AND 4. Member is uncontrolled on conventional therapy with optimized calcium AND active vitamin D (e.g., calcitriol); AND 5. Members current albumin-corrected serum calcium is at least 7.8 mg/dL. 6. Dosage allowed/Quantity limit: Administer as a single subQ injection. Start at 18 mcg once daily. Titrate per prescribing information, based on serum calcium levels. Max dose 30 mcg once daily. QL: 2 pens 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 a positive clinical response such as normalized calcium levels, reduced need for conventional therapy, and improved quality of life. 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: 5/16/2023CareSource considers Yorvipath (palopegteriparatide) 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 09/23/2024 New policy for Yorvipath created. References: 1. Yorvipath [prescribing information]. Ascendis Pharma Bone Diseases A/S ; 2024. 2. Khan AA, Rubin MR, Schwarz P, et al. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. JBone Miner Res. 2023;38(1):14-25. doi:10.1002/jbmr.4726 3. Khan AA, Bilezikian JP, Brandi ML, et al. Evaluation and Management of Hypoparathyroidism Summary Statement and Guidelines from the Second International Workshop. JBone Miner Res. 2022;37(12):2568-2585. doi:10.1002/jbmr.4691 Effective date: 06/30/2025 Revised date: 09/23/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Susvimo (ranibizumab)BENEFIT TYPE Medical STATUS Prior Authorization Required Susvimo , an intravitreal ocular implant, was approved by the FDA in 2021. It is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability . Susvimo was previously referred 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 . After 6 months, the port can be re-filled. Lucentis is approved for other indications aside from just wet AMD. Susvimo has a black box warning for endophthalmitis , an infection inside the eye which is a medical emergency. Approval was based on the phase 3 A rchway trial which demonstrated equivalent visual acuity results between Susvimo and Lucentis.Susvimo (ranibizumab) will be considered for coverage when the following criteria are met:Neovascular (wet) Age-related Macular Degeneration (AMD)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 diagnosis of wet AMD; AND 4. Member has previously responded to at least 2 intravitreal injections of a VEGF inhibitor; bevacizumab is the preferred product (others require prior authorization); AND 5. Documentation of best-corrected visual acuity (BCVA); AND 6. Member does NOT have any ocular or periocular infections or active intraocular inflammation. 7. 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: 5/16/2023CareSource 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/DESCRIPTION 11/09/2021 New policy for Susvimo created.05/19/2023 Added baseline BCVA documentation.11/08/2024 Annual review; no updates. References: 1. SUSVIMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022. 2. Flaxel CJ, Adelman RA, Bailey ST, et al. Age-Related Macular Degeneration Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(1):P1-P65. doi:10.1016/j.ophtha.2019.09.024 3. Solomon SD, Lindsley K, Vedula SS, Krzystolik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev . 2019;3(3):CD005139. Published 2019 Mar 4. doi:10.1002/14651858.CD005139.pub4 4. A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway) . ClinicalTrials.gov Identifier: NCT03677934. Updated October 28, 2021. Accessed November 10, 2021. https://clinicaltrials.gov/ct2/show/NCT03677934Effective date: 06/30/2025 Revised date: 11/08/2024
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