IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Tarpeyo (budesonide)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Tarpeyo is a novel formulation of the corticosteroid budesonide that was granted accelerated approval by the FDA in 2021 and converted to a traditional approval in 2023. It is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. 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 filter. 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, and immunosuppressive agents (i.e., steroids ) may be added for those with rapidly progressing disease. Tarpeyo was the first drug approved specifically for IgA N. As a delayed, sustained release formulation, Tarpeyo is released in a pulse-like manner only once it has reached the small intestine, allowing it to be delivered to the Peyers patches in the ileum, which is theorized to be the source of IgA production. Being a targeted-release dosage form, Tarpeyo is subject to high first-pass metabolism resulting in lower systemic exposure and appears to elicit fewer and less severe systemic effects with better tolerability than high-dose systemic corticosteroids.Tarpeyo (budesonide) will be considered for coverage when the following criteria are met:IgA Nephropathy (IgAN)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a nephrologist; AND 3. Member has a diagnosis of primary IgA nephropathy confirmed by renal biopsy; AND 4. Chart notes indicate risk of disease progression per documentation of proteinuria 1g/day or greater despite max tolerated dose of an ACEi or ARB for at least 3 months ; AND 5. Labs/chart notes must show an eGFR of 35 mL/min/1.73m 2 or greater; AND 6. Member has NOT had a kidney transplant. 7. Dosage allowed/Quantity limit: 16 mg (4 capsules) by mouth once daily for 9 months. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy . QL: 120 capsules per 30 days If all the above requirements are met , the medication will be approved for 10 months. For reauthorization :1. Tarpeyo will not be reauthorized for continuous use.IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CareSource considers Tarpeyo (budesonide) 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 01/27/2022 New policy for Tarpeyo created. 01/12/2024 Updated reference s. Removed reauthorization note. Changed UPCR cutoff to match trial criteria instead of that stated in the original labeled indication. Removed rapid from risk of disease progression. Specified primary IgAN. 09/12/2024 Changed UPCR 1g to proteinuria 1g and clarified that this is despite at least 3 mo of ACEi or ARB (KDIGO 2021 ). References: 1. Tarpeyo [ prescribing information]. Calliditas Therapeutics AB; 202 4. 2. Fellstrm BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet . 2017;389(10084):2117-2127. doi:10.1016/S0140-6736(17)30550-0 3. Barratt J, Lafayette R, Kristensen J, et al. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A neph ropathy. Kidney Int . 2023;103(2):391-402. doi:10.1016/j.kint.2022.09.017. 4. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int . 2021;100(4S):S1-S276. doi:10.1016/j.kint.2021.05.021 Effective date: 06/30/2025 Revised date: 09/12/202 4
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Ranibizumab (Lucentis, Byooviz, Cimerli)BENEFIT TYPE Medical STATUS Prior Authorization Required Lucentis was approved by the FDA in 2006. It is indicated for the treatment of several ophthalmic conditions. Lucentis is a vascular endothelial growth factor (VEGF) inhibitor for intravitreal use. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability . There are 2 forms of age-related macular degeneration (AMD), dry and wet (neovascular). Lucentis is approved for the treatment of Wet AMD which is less common but progresses more quickly. Neovascular in the context of AMD means growth of new blood vessels under the macula which can lead to loss of central vision. Diabetic eye disease includes diabetic retinopathy (DR) and diabetic macular edema (DME). DR affects blood vessels in the retina at the back of the eye. DME is a consequence of DR that occurs in about half of DR patients. It causes fluid build-up in the macula part of the retina. Retinal Vein Occlusion (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. It is treated first-line with anti-VEGF drugs. Myopia (nearsightedness) occurs when the eyeball becomes elongated. In pathological myopia, progressive elongation can cause a weakened sclera to bulge at the posterior of the eye which can lead to thinning of the retina and growth of new blood vessels. This can result in vision loss if not treated. Two biosimilar products have also been approved, Byooviz and Cimerli.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 confirmed diagnosis of one of the following conditions: a) Neovascular (Wet) Age-Related Macular Degeneration (AMD) b) Macular Edema Following Retinal Vein Occlusion (RVO ) c) Diabetic Macular Edema (DME) [Lucentis or Cimerli only] d) Diabetic Retinopathy (DR) [Lucentis or Cimerli only] e) Myopic Choroidal Neovascularization (mCNV) ; AND 4. Member has tried and failed bevacizumab intravitreal injection; AND 5. Documentation of best-corrected visual acuity (B CVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated. 7. Dosage allowed/Quantity limit: AMD: 0.5 mg every 28 days (may extend to every 3 months after 4 monthly doses). RVO: 0.5 mg every 28 days DME or DR: 0.3 mg every 28 days CNV: 0.5 mg every 28 days for up to 3 months. Re-treat if needed. If all the above requirements are met , the medication will be approved for 6 months (3 months for mCNV) . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For 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 (3 months for mCNV) . CareSource considers 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/DESCRIPTION10/26/2021 New policy for Lucentis created. 04/07/2023 Changed policy name to Ranibizumab and added biosimilars. 11/08/2024 Annual review; no updates. References: 1. Lucentis [prescribing information]. Genentech, Inc.; 2024. 2. Byooviz [prescribing information]. Biogen, Inc.; 2023 . 3. Cimerli [prescribing information]. Coherus BioSciences, Inc.; 2024. 4. 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 5. 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 6. Holekamp, Nanvy M. Review of Neovascular Age-Related Macular Degeneration Treatment Options. Am JManag Care. July 2019; 25: -S0 7. Flaxel CJ, Adelman RA, Bailey ST, et al. Retinal Vein Occlusions Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(2):P288-P320. doi:10.1016/j.ophtha.2019.09.029 8. Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev . 2020;7(7):CD009510. Published 2020 Jul 7. doi:10.1002/14651858.CD009510.pub3 9. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(1):P66-P145. doi:10.1016/j.ophtha.2019.09.025 10. Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev . 2018;10(10):CD007419. Published 2018 Oct 16. doi:10.1002/14651858.CD007419.pub6 11. Zhu Y, Zhang T, Xu G, Peng L. Anti-vascular endothelial growth factor for choroidal neovascularisation in people with pathological myopia. Cochrane Database Syst Rev . 2016;12(12):CD011160. Published 2016 Dec 15. doi:10.1002/14651858.CD011160.pub2 12. Pham B, Thomas SM, Lillie E, et al. Anti-vascular endothelial growth factor treatment for retinal conditions: a systematic review and meta-analysis. BMJ Open. 2019;9(5):e022031. Published 2019 May 28. doi:10.1136/bmjopen-2018-022031 Effective date: 06/30/2025 Revised date: 11/08/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Nitisinone (Orfadin and Nityr)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Nitisinone, approved by the FDA in 2002, is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is supplied as generic nitisinone capsules, brand name Orfadin capsules or oral suspension, and brand name Nityr tablets. Nitisinone in combination with prescribed diet leads to far greater survival and clinical outcomes compared to untreated HT-1 patients. Strict adherence to therapy is crucial. HT-1 is a genetic metabolic disorder that usually presents before 6 months of age. Fumarylacetoacetate hydrolase (FAH) is the deficient enzyme responsible for HT-1 . It is the terminal step in the tyrosine catabolic pathway . Mutations in the FAH gene lead to HT-1. Nitisinone inhibits an enzyme in the normal catabolic pathway of tyrosine to prevent accumulation of catabolic intermediates that convert to the toxic metabolites succinylacetone (SA) and succinylacetoacetate (SAA) responsible for the liver and kidney symptoms of HT-1. Neurologic porphyric-like crises may also occur. SA is the primary marker used to screen for HT-1.Nitisinone will be considered for coverage when the following criteria are met:Hereditary Tyrosinemia Type 1 (HT-1)For initial authorization: 1. Medication must be prescribed by or in consultation with an endocrinologist, geneticist, dietician, hepatologist, or nephrologist; AND 2. Member has a diagnosis of hereditary tyrosinemia type 1 (HT-1) confirmed by at least one of the following: a) Biochemical testing ( i.e., presence of succinylacetone in the urine or blood) b) Genetic test results showing pathogenic mutation of the FAH gene; AND 3. Member has a baseline succinylacetone level documented in chart notes; AND 4. Member is using medication in combination with dietary restriction of tyrosine and phenylalanine (commonly found in high-protein food); AND 5. Chart notes must document that the member has had or will have a slit-lamp ophthalmic exam completed prior to initiating treatment; AND 6. If the request is for brand name Orfadin capsules or suspension or Nityr tablets, clinical justification must be provided why generic nitisinone capsules cannot be used. 7. Dosage allowed/Quantity limit: Max total daily dosage of 2 mg/kg (orally), based on evaluation of biochemical and/or clinical response. See prescribing info for details. If all the above requirements are met , the medication will be approved for 12 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Member must continue dietary restriction of tyrosine and phenylalanine; AND 2. Chart notes must show a reduc ed succinylacetone (SA) level compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers nitisinone 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/DESCRIPTION04/30/2020 New policy for Orfadin created.11/01/2022 Transferred to new template. Renamed policy to generic name and added Nityr brand name. Amended dosing section. Added specialist requirement. Split diagnostic confirmation into 2 parts and added name of mutated gene. Changed wording of slit-lamp exam requi rement. Updated references. Added criterion requiring generic caps. 10/11/2024 Annual review; no updates to clinical criteria . References: 1. Orfadin [ prescribing information] . Sobi, Inc ; 2021. 2. Nityr [prescribing information]. Cycle Pharmaceuticals Ltd; 2024. 3. Jack RM, Scott CR. Validation of a therapeutic range for nitisinone in patients treated for tyrosinemia type 1 based on reduction of succinylacetone excretion. JIMD reports. 2019;46(1)75-78. 4. Chinsky JM, Singh R, Ficicioglu C, et al. Diagnosis and treatment of tyrosinemia type I: a US and Canadian consensus group review and recommendations. Genet Med. 2017;19(12):. doi:10.1038/gim.2017.101. 5. Sniderman King L, Trahms C, Scott CR. Tyrosinemia Type I. 2006 Jul 24 [Updated 2017 May 25]. In: Adam MP, Everman DB, Mirzaa GM, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2022. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1515/ Effective date: 06/30/2025 Revised date: 10/11/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Livdelzi (seladelpar )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Livdelzi , approved by the FDA in 2024, is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA . PBC is a progressive, autoimmune liver disease that leads to scarring and inflammation of the small bile ducts. It primarily affects women and is characterized by fatigue, pruritis, and jaundice. Activation of PPAR-delta inhibits bile acid synthesis. Ursodiol (ursodeoxycholic acid [UDCA]) is the first-line treatment for PBC. It improves biochemical indices, delays histologic progression, and improves survival . Accelerated approval of Livdelzi for PBC was based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established.Livdelzi (seladelpar) will be considered for coverage when the following criteria are met:Primary Biliary Cholangitis (PBC) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a hepatologist or gastroenterologist; AND 3. Member has a diagnosis of PBC confirmed by at least 2 of the following: a) Biochemical evidence of cholestasis based on ALP elevation b) Presence of AMA or other PBC-specific antibodies, including sp100 or gp210 c) Histologic evidence of nonsuppurative cholangitis and destruction of small or medium-sized bile ducts on biopsy; AND 4. Member had an inadequate response to UDCA after 1 year of treatment OR the member has documentation of intolerance to UDCA ; AND 5. UDCA will be continued in combination with Livdelzi unless documented intolerance; AND 6. Member does NOT have any of the following: a) Decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy) b) Complete biliary obstruction. 7. Dosage allowed/Quantity limit: 10 mg orally once daily . (QL: 30 capsules/30 days) If all the above requirements are met , the medication will be approved for 6 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must show improved (decreased) ALP and/or total bilirubin compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Livdelzi (seladelpar) 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 Livdelzi created. References: 1. Livdelzi. [Prescribing information]. Gilead Sciences, Inc.; 2024. 2. Hirschfield GM, Bowlus CL, Mayo MJ, et al. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. NEngl JMed . 2024;390(9):783-794. doi:10.1056/NEJMoa2312100 3. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases . Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145 4. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2021 practice guidance update from the American Association for the Study of Liver Diseases. Hepatology. 2022;75(4):1012-1013. doi:10.1002/hep.32117 5. Hirschfield GM, Dyson JK, Alexander GJM, et al. The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines. Gut. 2018;67(9):1568-1594. doi:10.1136/gutjnl-2017-315259 6. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. JHepatol. 2017;67(1):145-172. doi:10.1016/j.jhep.2017.03.022 Effective date: 06/30/2025 Revised date: 09/10/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Myobloc (rimabotulinumtoxinB)BENEFIT TYPE Medical STATUS Prior Authorization Required Myobloc is a neurotoxin produced from Clostridium botulinum. Myobloc works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. It is the first and only botulinum toxin type B. Myobloc was initially approved by the FDA in 2000 for the treatment of adults with cervical dystonia. Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head. Chronic sialorrhea, or excessive drooling, is a common symptom for patients with Parkinsons Disease or other neurological or cognitive impairments. Clinical trials showed a decrease in salivary production and improvement in symptoms from baseline with Myobloc.Myobloc (rimabotulinumtoxinB) will be considered for coverage when the following criteria are met:C ervical DystoniaFor initial authorization:1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed/Quantity limit : Up to 5000 or 10,000 units every 12 to 16 weeks, divided among affected muscles. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improved severity, disability, or pain compared to baseline. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. C hronic Sialorrhea For 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 diagnosis of chronic sialorrhea impacting quality of life for at least 3 months; AND 4. Member has tried and failed or has a contraindication to at least one anticholinergic drug (e.g. scopolamine, benztropine, glycopyrrolate, amitriptyline). IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20235. Dosage allowed /Quantity limit : 1,500 Units to 3,500 Units, divided among the parotid and submandibular glands, every 3 months. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization :1. Chart notes have been provided that show the member has improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Myobloc (rimabotulinumtoxinB) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION08/06/2018 New policy for Myobloc created. Age requirement removed. Criterion no infection at proposed injection site removed from Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. 06/09/2020 Added new diagnosis of chronic sialorrhea and its criteria. 08/17/2020 Cervical Dystonia : Added age limit and specialist requirement. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Corrected the dose. Extended re-auth duration. Updated references. 01/04/2021 For sialorrhea, changed try 2 anticholinergics to try 1 anticholinergic. Added a reference. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia indication. 03/04/2022 Annual review; no changes 11/13/2023 Removed Symptoms affect quality of life and daily functions for cervical dystonia ; clarified renewal criteria and updated references. 10/02/2024 Removed age and specialist for cervical dystonia. References: 1. Myobloc [package insert]. San Francisco, CA: Solstice Neurosciences, Inc.; 2021. 2. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin Bfor sialorrhea in Parkinsons disease. Neurology. 2004;62(1):37-40 3. Brashear A, Lew MF, Dykstra DD, et al. Safety and Efficacy of NeuroBloc (Botulinum Toxin Type B) in Type A-Responsive Cervical Dystonia, Neurology, 1999, 53(7):1439-464. Isaacson S, Ondo W, Jackson C, et al. Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea inAdults. JAMA Neurology. 2020;77(4), 461. https://pubmed.ncbi.nlm.nih.gov/31930364/?dopt=Abstract. 5. Dashtipour K, Bhidayasiri, R, Chen J, et al. RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials. Journal of Clinical Movement Disorders. 2017;4(1). https://clinicalmovementdisorders.biomedcentral.com/track/pdf/10.1186/s40734-017-0055-1 . 6. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826. doi:10.1212/wnl.0000000000002560 7. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission . 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 8. Seppi K, Chaudhuri KR, Coelho M, et al. Update on treatments for nonmotor symptoms of Parkinson's disease an evidence based medicine review. Movement Disorders. 2019;34(2):180-198. doi:10.1002/mds.27602 IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20239. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci . 2019;405:116413. doi:10.1016/j.jns.2019.07.031 10. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna ). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z Effective date: 06/30/2025 Revised date: 10/02/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Filspari (sparsentan )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Filspari, approved by the FDA in 2023, is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. It is only available through a REMS program due to risks of hepatotoxicity and teratogenicity. Filspari was originally granted accelerated approval to reduce proteinuria in those at risk of rapid progression. 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 fil 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.Filspari (sparsentan) will be considered for coverage when the following criteria are met:Primary Immunoglobulin A N ephropathy (IgAN)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a nephrologist; AND 3. Member has a diagnosis of primary IgA nephropathy confirmed by renal biopsy; AND 4. Chart notes indicate risk of disease progression per documentation of proteinuria 1g/day or greater despite max tolerated dose of an ACEi or ARB for at least 3 months; AND 5. Members eGFR is at least 3 0 mL/min/1.73m 2; AND 6. Filspari is NOT being prescribed with any renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren; AND 7. Baseline liver function testing has been or will be completed prior to initiation. 8. Dosage allowed/Quantity limit: Initiate with 200 mg orally once a day. After 14 days, increase to the recommended dose of 400 mg once daily, as tolerated. (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 improved proteinuria or slowed rate of eGFR decline 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: 5/16/2023CareSource considers Filspari (sparsentan ) 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 03/31/2023 New policy for Filspari created. 09/09/2024 Drug was converted from accelerated to traditional FDA approval. Changed UPCR 1.5 g/g or greater to proteinuria of 1g/day or greater and clarified that this is despite at least 3 mo of ACEi or ARB (KDIGO 2021) . Removed rapid from disease progression (per label update) . Specified primary IgAN (label) . Added slowing of GFR decline to renewal section (per confirmatory clinical trial data) . References: 1. Filspari. [prescribing information]. Travere Therapeutics, Inc.; 2024. 2. A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT) . ClinicalTrials.gov Identifier: NCT03762850. Updated February 2, 2023. Accessed March 31, 2023. https://clinicaltrials.gov/ct2/show/NCT03762850 3. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276. doi:10.1016/j.kint.2021.05.021 Effective date: 06/30/2025 Revised date: 09/09/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Botox (onabotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Botox is a neurotoxin produced from Clostridium botulinum serotype A. It works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. There are seven types of botulinum toxin serotypes. Only serotypes A and Bare used for medicinal purposes. Botox was initially approved in 1989 by the FDA for the treatment of b lepharospasm. Since then, Botox has gained additional therapeutic indications for overactive bladder, neurogenic detrusor overactivity , chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, and s trabismus.Botox (onabotulinumtoxinA) will be considered for coverage when the following criteria are met:Primary Axillary HyperhidrosisFor 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 diagnosis of severe axillary hyperhidrosis, including documentation in the chart notes of visible, excessive sweating of at least 6 months duration which significantly impairs daily activities; AND 4. Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been ruled out; AND 5. Member has tried and failed topical prescription-strength aluminum chloride (e.g. Xerac) for at least 3 0 days. 6. Dosage allowed/ Quantity limit : 50 Units per axilla. Note: Medication will not be covered for treatment of hyperhidrosis in body areas other than axillary. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes have been provided that show improvement of signs and symptoms (i.e., reduced axillary sweat production). If all the above requirements are met, the medication will be approved for an additional 12 months. B lepharospasmFor initial authorization: 1. Member has a diagnosis of blepharospasm, characterized by spasms inducing narrowing or closure of the eyelids. 2. Dosage allowed/Quantity limit : The cumulative dose of Botox treatment for blepharospasm in a 30-day period should not exceed 200 Units. Treatment may be repeated every 3 months. 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 show improved signs and symptoms (e.g., lessening of involuntary contraction). If all the above requirements are met, the medication will be approved for an additional 12 months.C ervical DystoniaFor initial authorization: 1. Member has a documented diagnosis of moderate to severe cervical dystonia. 2. Dosage allowed/Quantity limit : Up to 300 units every 3 months. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes show improved signs and symptoms (e.g., severity of abnormal head position, neck pain). If all the above requirements are met, the medication will be approved for an additional 12 months. Esophageal AchalasiaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist; AND 3. Member has a diagnosis of achalasia confirmed by high resolution esophageal manometry; AND 4. Chart notes must document that the member is NOT a candidate for ALL of the following: Laparoscopic Heller myotomy, pneumatic dilation, and peroral endoscopic myotomy (POEM); AND 5. Other esophageal motility disorders and malignancy have been ruled out. 6. Dosage allowed/Quantity limit : 100 units every 6 months (off label). If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show the member had symptomatic improvement of dysphagia and/or regurgitation. 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: 5/16/2023M igraine Headache ProphylaxisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is being prescribed for the prevention of chronic migraine, with both of the following documented in chart notes: a) 15 headache days per month for at least 3 months; b) 8 migraine days per month for at least 3 months; AND 3. Medication must be prescribed by a neurologist or a headache specialist; AND 4. Member has tried and failed a t least 1 of the following prophylactic medications for 8 weeks : a) Beta-blockers (e.g., metoprolol, timolol, or propranolol) b) Calcium channel blockers (e.g., verapamil) c) Antidepressants (e.g., amitriptyline or venlafaxine) d) Anticonvulsant (e.g., topiramate or valproic acid) e) Candesartan; AND 5. Medication is NOT being used in combination with a prophylactic CGRP product (e.g., Emgality, Aimovig, Ajovy, or Vyepti); AND 6. Member does not have medication-overuse headaches. 7. Dosage allowed/Quantity limit : 155 Units every 3 months. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Member has improvement in prevention of migraines documented in chart notes (e.g., reduced migraine frequency, reduced use of medication for acute migraines attacks). If all the above requirements are met, the medication will be approved for an additional 12 months. O veractive Bladder (OAB) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a urologist or gynecologist; AND 3. Member has a diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency; AND 4. Member has tried and failed at least TWO prior pharmacologic therapies for at least 30 days each (e.g. oxybutynin, solifenacin, Myrbetriq); AND 5. Member does not have a urinary tract infection. 6. Dosage allowed/Quantity limit : 100 Units every 12 weeks. If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Chart notes have been provided that show decreased symptoms of urge urinary incontinence, urgency, and frequency. 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: 5/16/2023SpasticityFor initial authorization: 1. Member is at least 2 years of age; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try one conventional treatment modality such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed/Quantity limit : Adult: Not to exceed 400 total units every 12 weeks (given intramuscularly as a divided dose among affected muscles). Pediatric: Not to exceed 340 total units or 10 units per kg (whichever is lower) every 3 months. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes show improved signs and symptoms (e.g., decrease in severity of increased muscle tone, increased functional ability or range of motion). If all the above requirements are met, the medication will be approved for an additional 12 months. StrabismusFor initial authorization: 1. Member has a diagnosis of a strabismus type with binocular potential, unlikely to spontaneously resolve. 2. Dosage allowed: See package insert. 1 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 members ocular alignment has improved. If all the above requirements are met, the medication will be approved for an additional 6 months.U rinary Incontinence (associated with neurologic condition)For initial authorization: 1. Member is at least 5 years of age; AND 2. Medication is prescribed by or in consultation with a urologist, neurologist, or gynecologist; AND 3. Member has a diagnosis of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. brain or spinal cord injury, stroke, multiple sclerosis, Parkinsons, spina bifida); AND 4. Member has tried and failed at least one anticholinergic medication for 30 days (e.g. oxybutynin, solifenacin, tolterodine); AND 5. Member does not have a urinary tract infection. 6. Dosage allowed/Quantity limit : For adults and pediatric patients weighing 34kg or more: 200 units per treatment, no sooner than every 12 weeks. If weight is less than 34kg: 6mg/kg, no sooner than every 12 weeks. 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 have been provided that show decreased frequency of urinary incontinence. If all the above requirements are met, the medication will be approved for an additional 12 months. Anal FissureFor initial authorization: 1. Medication must be prescribed by or in consultation with a gastroenterologist or colorectal surgeon; AND 2. Member has a diagnosis of chronic anal fissure, present for at least 6 weeks ; AND 3. Member has tried and failed one of the following: a) Topical calcium channel blocker (nifedipine or diltiazem) for 8 weeks OR b) Topical nitrate for 3 weeks . 4. Dosage allowed/Quantity limit : 20-50 units single injection. May repeat after 2 months if healing is incomplete or fissure recurs (off label). If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Medication will not be re-authorized for this indication. CareSource considers Botox (onabotulinumtoxinA) 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/DESCRIPTION08/03/2018 Criterion no infection at proposed injection site removed from Blepharospasm and Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. On diagnosis of Urinary Incontinence criterion Surgical treatment or balloon sphincter dilatation is not indicated, has been refused, or has failed was removed. On diagnosis of Spasticity rehabilitation program is not required anymore. Strabismus diagnosis got criter ia expanded. Lower Limb Spasticity is combined into Spasticity diagnosis. For diagnosis of Migraine Headache Prophylaxis trial length for abortive therapeutic options decreased. 01/19/2020 Updated Overactive Bladder criteria from three to two trials of an adequately titrated overactive bladder medication. 08/17/2020 Removed criteria for upper extremity focal dystonia/writers cramp (off label). Hyperhidrosis: added specialist requirement, changed re-auth duration, changed dx title to match drug label, changed the ordering, removed sweat quantification requirement and changed diagnostic phrase to match guidelines. Added reference. Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing. Added reference. Strabismus: Added specialist, referred dose to PI, simplified diagnostic wording. Added reference. Cervical dystonia: Added specialist. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Added frequency to dose. Extended re-auth duration. Added references. Achalasia (off label use): added age IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023and specialist, changed initial auth duration from 12 mo to 6mo. Removed requirement for oral therapy (not effective). Specified high resolution manometry per guideline. Included surgical procedures per guideline. Removed redundancy. Simplified other causes. Added frequency to dose. Added references. Migraine: removed symptoms and duration of migraine episode from diagnostic requirement; trial length reduced to 2 months/trial; added one of the abortive trials must be a triptan; added no concurrent use with prophylactic CGRP; removed statement about episodic migraine because not an FDA approved indication. OAB: added frequency to dose. Added specialist. Amended dx per drug label. Specified length of alternate drug trials. Added examples of drugs. Added reference. Urinary incontinence: added specialist, added frequency to dose, edited dx to match fda label wording, changed initial auth duration. Changed order of criteria to match others. Removed statement about urinary retention. Expanded examples of neurologic disease, added examples of anticholinergic, specified length of trial. Added reference. Spasticity: Add age and specialist. Update to match latest drug label. Generalized list of co-existing conditions. Added trial of conventional treatment. Extended initial auth duration. Edited dose allowed. Added reference. All : specified type of symptom improvement to look for at re-auth.11/23/2020 Hyperhidrosis: Replaced Drysol with Xerac and changed trial length to 60 days. 02/15/2021 Per label change: Updated age to 5 yrs old for urinary incontinence due to detrusor overactivity assoc. with neurologic condition; added spina bifida to list of examples; added dosing for peds. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Annual review; no changes 11/14/2023 Cervical dystonia: removed Symptoms affect quality of life and daily functions. Updated references. 07/09/2024 Migraine: Changed from 2 prior prophylactic trials to 1 and added candesartan to list of trial options (per AHS 2024 statement). Removed requirement for trial of abortive drugs. Hyperhidrosis: Reduced topical product trial from 60 days to 30 days. Added section for anal fissure (off label). 09/25/2024 Removed age limits and specialists for blepharospasm, strabismus. Removed specialist for cervical dystonia. References: 1. Botox [package insert]. Madison, NJ: Allergan USA, Inc.; 2023. 2. Clinical use of botulinum toxin. National Institutes of Health Consensus Development Conference Statement, November 12-14, 1990. Arch Neurol . 1991;48(12):1294-1298. 3. Borodic GE and Pearce LB, New Concepts in Botulinum Toxin Therapy, Drug Saf, 1994, 11(3):145-52. 4. Jankovic Jand Brin MF, Therapeutic Uses of Botulinum Toxin, NEngl JMed,1991, 324(17):1186-94. 5. Naumann Mand Jankovic J, "Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis," Curr Med Res Opin, 2004, 20(7):981-90. 6. Russman, BS, Tilton, A, Gormley ME. Jr. Cerebral palsy; a rational approach to a treatment protocol, and the role of botulinum toxin in treatment, Muscle Nerve Suppl 1997; 6:S181. 7. Fishman LM, Anderson C, Rosner B. Botox and physical therapy in the treatment of Piriformis syndrome Am JPhys Med Rehabil. 2002 Dec;81(12):936-42. 8. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-706. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20239. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 70:1707-14. 10. Pasricha, P.J., Ravich, W.J., Hendrix, T.R., et al. M.D. Intrasphincteric Botulinum Toxin for the Treatment of Achalasia. NEngl JMed (1995); 332:774-778. March 23, 1995. DOI: 10.1056/NEJM199503233321203 11. Storr M, Born P, Frimberger E, et al. Treatment of achalasia: the short-term response to botulinum toxin injection seems to be independent of any kind of pretreatment. BMC Gastroenterology. 2002;2:19. doi:10.1186/1471-230X-2 -19. 12. Fock J, Galea MP, Stillman BC, et al. Functional outcome following Botulinum toxin A injection to reduce spastic equinus in adults with traumatic brain injury. Brain Inj. 2004;18(1):57-63. 13. Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989;96(7):935-943. 14. Munksgaard SB, et al. Medication overuse headache. Headache. 2014 Jul-Aug;54(7):1251-7. 15. Gmez-Caravaca MT, et al. The use of botulinum toxin in the treatment of sialorrhea in parkinsonian disorders. Neurol Sci. 2015 Feb;36(2):275-9. 16. Hornberger J, Grimes K, Naumann M, et al. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. JAm Acad Dermatol . 2004;51(2):274-286. doi:10.1016/j.jaad.2003.12.029 17. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology . 2016;86(19):1818-1826. doi:10.1212/WNL.0000000000002560 18. Defazio G, Hallett M, Jinnah HA, Berardelli A. Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology . 2013;81(3):236-240. doi:10.1212/WNL.0b013e31829bfdf6 19. Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD006499. DOI: 10.1002/14651858.CD006499.pub4. 20. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission . 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 21. Khashab MA, Vela MF, Thosani N, et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91(2):213-227.e6. doi:10.1016/j.gie.2019.04.231 22. Zaninotto G, Bennett C, Boeckxstaens G, et al. The 2018 ISDE achalasia guidelines. Dis Esophagus. 2018;31(9):10.1093/dote/doy071. doi:10.1093/dote/doy071 23. Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am JGastroenterol . 2013;108(8):1238-1250. doi:10.1038/ajg.2013.196 24. The American Headache Society Position Statement on Integrating New Migraine Treatments into Clinical Practice. Headache: The Journal of Head and Face Pain. 2019;59: 1-18. 25. Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. JUrol. 2015;193(5):1572-1580. doi:10.1016/j.juro.2015.01.087 26. Groen J, Pannek J, Castro Diaz D, et al. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016;69(2):324-333. doi:10.1016/j.eururo.2015.07.071 27. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 28. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 29. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 30. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 31. Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A; American Headache Society. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024;64(4):333-341. doi:10.1111/head.14692 32. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am JGastroenterol . 2021;116(10):1987-2008. doi:10.14309/ajg.0000000000001507 IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202333. Davids JS, Hawkins AT, Bhama AR, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anal Fissures. Dis Colon Rectum. 2023;66(2):190-199. doi:10.1097/DCR.0000000000002664 34. Cross KLR, Brown SR, Kleijnen J, et al. The Association of Coloproctology of Great Britain and Ireland guideline on the management of anal fissure. Colorectal Dis. 2023;25(12):2423-2457. doi:10.1111/codi.16762 Effective date: 06/30/2025 Revised date: 09/25/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Esbriet (pirfenidone )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Esbriet , approved by the FDA in 2014, is a pyrid one oral antifibrotic drug indicated for the treatment of idiopathic pulmonary fibrosis (IPF) . IPF is an interstitial lung disease characterized by chronic, progressive scarring of the lungs and the pathological hallmark of usual interstitial pneumonia (UIP).Esbriet (pirfenidone) will be considered for coverage when the following criteria are met:Idiopathic Pulmonary Fibrosis (IPF)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a pulmonologist; AND 3. Member has a diagnosis of IPF confirmed by a UIP pattern on high resolution computed tomography (HRCT) or by a lung biopsy (results must be submitted for review); AND 4. Documentation of members baseline forced vital capacity (FVC); AND 5. Member does not have severe hepatic impairment (Child Pugh Class C); AND 6. Member is not a current smoker and provider attests the member will not smoke during treatment; AND 7. Esbriet will not be prescribed in combination with Ofev. 8. Dosage allowed/Quantity limit: Titrate as follows, to 801 mg three times per day (2403 mg/day total) QL: 90 tablets per 30 days OR 270 capsules per 30 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Member continues to abstain from smoking; AND 2. Chart notes must show improvement or stabilized signs and symptoms of disease demonstrated by reduced rate of FVC decline. 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 Esbriet ( pirfenidone ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION06/22/2020 New policy for Esbriet created; split off from combined IPF policy with Ofev. 05/24/2022 Policy transferred to new template. Updated references. 10/17/2024 Updated refs. Specified UIP presence on HRCT. Removed minimum FVC required. Added to not be used with Ofev. Added capsules with QL. References: 1. Esbriet [package insert]. South San Francisco, CA: Genentech, Inc; 2023 . 2. Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011;377(9779):1760-1769. doi:10.1016/S0140-6736(11)60405-4 3. King TE Jr, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis [published correction appears in NEngl JMed. 2014 Sep 18;371(12):1172]. NEngl JMed. 2014;370(22):2083-2092. doi:10.1056/N EJMoa1402582 4. Raghu G, Rochwerg B, Zhang Y, et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline [published correction appears in Am JRespir Crit Care Med. 2015 Sep 1;192(5):644. doi: 10.1164/rccm.1925erratum. Dosage error in article text]. Am JRespir Crit Care Med. 2015;192(2):e3-e19. doi:10.1164/rccm.201506-1063ST 5. Raghu G, Remy-Jardin M, Myers JL, et al. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am JRespir Crit Care Med. 2018;198(5):e44-e68. doi:10.1164/rccm.201807-1255ST 6. Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am JRespir Crit Care Med . 2022;205(9):e18-e47. doi:10.1164/rccm.202202-0399ST Effective date: 06/30/2025 Revised date: 10/17/2024
IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Eylea and Eylea HD (aflibercept)BENEFIT TYPE Medical STATUS Prior Authorization Required Eylea was originally approved by the FDA in 2011. It is indicated for the treatment of several different ophthalmic conditions. Eylea is a vascular endothelial growth factor (VEGF) inhibitor for intravitreal use. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability . Eylea HD, approved in 2023, is a high-dose, extended-interval version of Eylea, but with fewer indications. There are 2 forms of age-related macular degeneration (AMD), dry and wet (neovascular). Eylea is approved for the treatment of Wet AMD which is less common but progresses more quickly. Neovascular in the context of AMD means growth of new blood vessels under the macula which can lead to loss of central vision. Diabetic eye disease includes diabetic retinopathy (DR) and diabetic macular edema (DME). DR affects blood vessels in the retina at the back of the eye. DME is a consequence of DR that occurs in about half of DR patients. It causes fluid build-up in the macula part of the retina. Retinal Vein Occlusion (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. It is treated first-line with anti-VEGF drugs. Retinopathy of prematurity (ROP) is a neovascular disorder of the developing retinal blood vessels in preterm infants . The standard treatment has been laser coagulation.Eylea and Eylea HD (aflibercept) will be considered for coverage when the following criteria are met:Retinal Disease (adults)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 confirmed diagnosis of one of the following conditions: a) Neovascular (Wet) Age-Related Macular Degeneration (AMD) b) Macular Edema Following Retinal Vein Occlusion (RVO ) Eylea Only c) Diabetic Macular Edema (DME) d) Diabetic Retinopathy (DR) ; AND 4. Member has tried and failed bevacizumab (Avastin) intravitreal injection (Exception: not required for diagnosis of DME when visual acuity is worse than 20/50); AND 5. Documentation of best-corrected visual acuity (B CVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated. 7. Dosage allowed/Quantity limit: Eylea: AMD: 2 mg every 4 weeks for 3 months, then 2 mg every 8 weeks. RVO: 2 mg every 4 weeks. DME or DR: 2 mg every 4 weeks for the first 5 injections, then 2 mg every 8 weeks. Note: Eylea is supplied as a 2 mg/0.05 mL single-dose vial or pre-filled syringe. Eylea HD : IN-MED-P- 366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023AMD or DME: 8 mg every 4 weeks for 3 months, then 8 mg every 8 to 16 weeks.DR: 8 mg every 4 weeks for 3 months, then 8 mg every 8 to 12 weeks. 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.Retinopathy of Prematurity (ROP) Eylea OnlyFor initial authorization: 1. Members gestational age at birth was 32 weeks or fewer, or birth weight 1500 g or less; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a confirmed diagnosis of Type 1 ROP (specify one or both eye(s)) defined by any of the following: a) Zone I ROP: any stage with plus disease b) Zone I or posterior zone II ROP: stage 3 without plus disease c) Zone II ROP: stage 2 or 3 with plus disease; AND 4. Member does NOT have any of the following: a) Advanced stages of ROP with partial or complete retinal detachment (stage 4 or 5) b) ROP involving only Zone III 5. Dosage allowed/Quantity limit: 0.4 mg. May be given bilaterally on same day. May repeat after an interval of at least 10 days. If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Member continues to have active ROP; AND 2. Member has not experienced retinal detachment, macular dragging, macular fold, or retrolental opacity. If all the above requirements are met , the medication will be approved for an additional 3 months . CareSource considers Eylea and Eylea HD (aflibercept) 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/DESCRIPTION10/22/2021 New policy for Eylea created. 04/04/2023 Added new indication for ROP. 10/02/2023 Added Eylea HD to policy name. Incorporated Eylea HD into policy. Noted that ROP and RVO indication s are exclusive to Eylea (not HD). 11/08/2024 Annual review; no updates. References: 1. Eylea [prescribing information] . Regeneron Pharmaceuticals, Inc.; 2024. 2. Eylea HD [prescribing information]. Regeneron Pharmaceuticals, Inc.; 2024. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20233. 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 4. Holekamp, Nanvy M. Review of Neovascular Age-Related Macular Degeneration Treatment Options. Am JManag Care. July 2019; 25:-S0 5. Flaxel CJ, Adelman RA, Bailey ST, et al. Retinal Vein Occlusions Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(2):P288-P320. doi:10.1016/j.ophtha.2019.09.029 6. Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev . 2020;7(7):CD009510. Published 2020 Jul 7. doi:10.1002/14651858.CD009510.pub3 7. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(1):P66-P145. doi:10.1016/j.ophtha.2019.09.025 8. Virgili G, Parravano M, Evans JR, Gordon I, Lucenteforte E. Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis. Cochrane Database Syst Rev . 2018;10(10):CD007419. Published 2018 Oct 16. doi:10.1002/14651858.CD007419.pub6 9. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. NEngl JMed . 2015;372(13):1193-1203. doi:10.1056/NEJMoa1414264 10. Stahl A, Sukgen EA, Wu WC, et al. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022;328(4):348-359. doi:10.1001/jama.2022.10564 11. Sankar MJ, Sankar J, Chandra P. Anti-vascular endothelial growth factor (VEGF) drugs for treatment of retinopathy of prematurity. Cochrane Database Syst Rev . 2018;1(1):CD009734. Published 2018 Jan 8. doi:10.1002/14651858.CD009734.pub3 12. Fierson WM; AMERICAN ACADEMY OF PEDIATRICS Section on Ophthalmology; AMERICAN ACADEMY OF OPHTHALMOLOGY; AMERICAN ASSOCIATION FOR PEDIATRIC OPHTHALMOLOGY AND STRABISMUS; AMERICAN ASSOCIATION OF CERTIFIED ORTHOPTISTS. Screening Examination of Premature Infan ts for Retinopathy of Prematurity [published correction appears in Pediatrics. 2019 Mar;143(3):]. Pediatrics. 2018;142(6):e20183061. doi:10.1542/peds.2018-3061 13. Chiang MF, Quinn GE, Fielder AR, et al. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology . 2021;128(10):e51-e68. doi:10.1016/j.ophtha.2021.05.031 Effective date: 06/30/2025 Revised date: 11/08/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Niktimvo (axatilimab)BENEFIT TYPE Medical STATUS Prior Authorization Required Niktimvo is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. GVHD is a complication following allogeneic hematopoietic stem cell transplant (HSCT). It occurs when immune cells transplanted from a non-identical donor (graft) recognize the transplant recipient (host) as foreign, initiating an immune response. Chronic GVHD typically occurs more than 100 days posttransplant and involves multiple organ systems. Steroids are the mainstay of treatment but many patients require 2 or more lines of therapy. Niktimvo is a first-in-class drug to target CSF-1R expressed on monocytes and macrophages. Blocking CSF-1R reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages and inhibits the activity of pathogenic macrophages in tissues .Niktimvo (axatilimab) will be considered for coverage when the following criteria are met:C hronic graft-versus-host disease (cGVHD ) For initial authorization: 1. Member weighs at least 40 kg; AND 2. Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist; AND 3. Member has a documented diagnosis of cGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) ; AND 4. Member has failed at least 2 prior lines of systemic therapy, i.e., systemic corticosteroid and another systemic treatment ( calcineurin inhibitor, Jakafi, mycophenolate mofetil, sirolimus, methotrexate, Imbruvica). 5. Dosage allowed/Quantity limit: IV infusion; 0.3 mg/kg over 30 minutes every 2 weeks until progression or unacceptable toxicity . Max dose 35 mg. QL: 2 vials (2 mL) 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 of signs and symptoms of disease in at least 1 organ/site, without progression in any other organ/site. If all the above requirements are met , the medication will be approved for an additional 12 months. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CareSource considers Niktimvo (axatilimab) 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 09/19/2024 New policy for Niktimvo created. References: 1. Niktimvo. [prescribing information]. Incyte Corporation; 2024. 2. National Comprehensive Cancer Network. Hematopoietic Cell Transplantation (HCT). Version 2.2024. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed September 20, 2024. Effective date: 06/30/2025 Revised date: 09/19/2024
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