IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Wainua (eplontersen )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Wainua is a ligand-conjugated antisense oligonucleotide (LICA) 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 ansform clinical trial. hATTR is a rare and progressive inherite d 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 dysfunction. It is a monthly self-administered subcutaneous injection.Wainua (eplontersen ) 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 familiar amyloid polyneuropathy (FAP) Cutinho stage 1 (ambulatory without assistance) or stage 2 (ambulatory with assistance); AND 6. Member has NOT had a liver transplant; AND 7. Wainiua is NOT being used in combination with another hATTR drug (e.g., Amvuttra, Onpattro, Tegsedi, Vyndaqel, Vyndamax). 8. Dosage allowed/Quantity limit: 45 mg injected subQ once monthly. (1 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 Wainua (eplontersen) 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/DESCRIPTION1/26/2024 New policy for Wainua created. References: 1. Wainua [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 202 3. 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.pd 5. BioNews Services, LLC. Stages of familial amyloid polyneuropathy. Available at: https://fapnewstoday.com/stages-of-familial-amyloid-polyneuropathy/ 6. Coelho T, Marques Jr W, Dasgupta NR, et al. Eplontersen for Hereditary Transthyretin Amyloidosis With Polyneuropathy. JAMA. 2023;330(15):1448-1458. doi:10.1001/jama.2023.18688 7. Coelho T, et al. Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen. Neurol Ther. 2023;12:267 287 8. 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 9. Stages of FAP. FAP News Today. Accessed February 1, 2024. https://fapnewstoday.com/stages-of-familial- amyloid-polyneuropathy/ Effective d ate: 07/01/2024 Revised date: 01/26/2024
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: 07/01/2024 Revised date: 02/22/2024
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Retisert (fluocinolone acetonide)BENEFIT TYPE Medical STATUS Prior Authorization Required Retisert is a 0.59 mg fluocinolone acetonide intravitreal implant indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. It is released over a period of 30 months and has been shown to reduce the rate of recurrence and improve visual acuity. Uveitis is an inflammation of the uvea (middle layer of the eye). It can be infectious or non-infectious. Non-infectious uveitis (NIU) is often associated with inflammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is aff ected, it can be treated with topical glucocorticoids. If resistant or affecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Retisert (fluocinolone acetonide) will be considered for coverage when the following criteria are met:Uveitis For initial authorization: 1. Member is at least 12 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of chronic (1 year or more) non-infectious uveitis affecting the posterior segment of the eye ; AND 4. Member has tried and failed at least one of the following for at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus); AND 5. Member has had a failed trial of Ozurdex or Yutiq; AND 6. Member does not have any active infections of the eye. 7. Dosage allowed/Quantity limit: One implant (0.59 mg) per eye Limit: 2 implants (1 per eye) per 30 months If all the above requirements are met , the medication will be approved for 3 months. For reauthorization : 1. Chart notes must show improved or stabilized visual acuity following treatment and/or an improved vitreous haze score ; AND 2. At least 3 0 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 3 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Retisert (fluocinolone acetonide) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION10/28/2021 New policy created for Retisert . 10/18/2023 Updated Cochrane reference. Added references. Added Yutiq as a trial option. References: 1. Retisert [prescribing information]. Bausch & Lomb; 2021. 2. Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Kempen JH, Altaweel MM, et al. Benefits of Systemic Anti-inflammatory Therapy versus Fluocinolone Acetonide Intraocular Implant for Intermediate Uveitis, Posterior Uveitis, and Panuveitis: Fifty-four-Month Results of the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Ophthalmology . 2015;122(10):1967-1975. doi:10.1016/j.ophtha.2015.06.042 3. Writing Committee for the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group, Kempen JH, Altaweel MM, et al. Association Between Long-Lasting Intravitreous Fluocinolone Acetonide Implant vs Systemic Anti-inflammatory Ther apy and Visual Acuity at 7 Years Among Patients With Intermediate, Posterior, or Panuveitis. JAMA . 2017;317(19):1993-2005. doi:10.1001/jama.2017.5103 4. Reddy A, Liu SH, Brady CJ, Sieving PC, Palestine AG. Corticosteroid implants for chronic non-infectious uveitis. Cochrane Database Syst Rev . 2023;1(1):CD010469. Published 2023 Jan 16. doi:10.1002/14651858.CD010469.pub3 5. Tan HY, Agarwal A, Lee CS, et al. Management of noninfectious posterior uveitis with intravitreal drug therapy. Clin Ophthalmol . 2016;10:1983-2020. Published 2016 Oct 13. doi:10.2147/OPTH.S89341 6. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectious uveitis. Clin Exp Med. 2023;23(4):1089-1106. doi:10.1007/s10238-022-00954-6 Effective date: 04/01/2024 Revised date: 10/18/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana 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 is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist or other specialist experienced with treating cervical dystonia; AND 3. Member has a documented diagnosis of moderate to severe cervical dystonia with dystonic symptoms localized to the head, neck, shoulder areas . 4. 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. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023C hronic SialorrheaFor 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). 5. 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. 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 . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20236. 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 9. 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: 04/01/2024 Revised date: 11/13/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vabysmo (faricimab-svoa)BENEFIT TYPE Medical STATUS Prior Authorization Required Vabysmo, initially approved by the FDA in 2022, is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) , Diabetic Macular Edema (DME) , or Macular Edema f ollowing Retinal Vein Occlusion (RVO) . It is administered by intravitreal injection by a physician. VEGF inhibitors suppress endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of Ang-2 is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. Vabysmo was approved based on clinical trial results showing achievement of vision gains noninferior to Eylea.Vabysmo (faricimab-svoa) 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 diagnosis of one of the following conditions: a) Neovascular (wet) Age-Related Macular Degeneration (AMD) b) Diabetic Macular Edema (DME) c) Macular Edema Following Retinal Vein Occlusion (RVO) ; AND 4. Member has tried and failed bevacizumab intravitreal injection; AND 5. Documentation of best-corrected visual acuity (BCVA); AND 6. Member does NOT have active infection or inflammation in or around the eye(s) to be treated . 7. Dosage allowed/Quantity limit: See package insert for full instructions. AMD : 6 mg every 4 weeks for 4 doses; adjust per clinical evaluation to an interval of every 4 to 16 weeks . Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . DME : 6 mg every 4 weeks for 4 to 6 doses; adjust per clinical evaluation to an interval of every 4 to 8 weeks. Note: For most patients, every 4-week dosing did not demonstrate additional efficacy compared to every 8 weeks . RVO : 6 mg every 4 weeks for 6 months. QL: 1 vial per eye per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization :1. Chart notes must include documentation of improved or stabilized visual acuity . If all the above requirements are met , the medication will be approved for an additional 12 months.IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Vabysmo (faricimab-svoa) 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/DESCRIPTION04/05/2022 New policy for Vabysmo created. 05/25/2023 Annual review; no updates. 11/15/2023 Added RVO as an approved indication per label expansion. Clarified dosing for AMD, DME . References: 1. Vabysmo [prescribing information]. Genentech, Inc.; 2023 . 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. 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. 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 6. 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 7. 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 8. 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 9. Schmidt-Erfurth U, Garcia-Arumi J, Gerendas BS, et al. Guidelines for the Management of Retinal Vein Occlusion by the European Society of Retina Specialists (EURETINA). Ophthalmologica . 2019;242(3):123-162. doi:10.1159/000502041 Effective date: 04/01/2024 Revised date: 11/15/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Koselugo (selumetinib)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Koselugo, approved by the FDA in 2020, is a kinase inhibitor indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) . It works by targeting mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK is a component of a pathway that is often activated in certain types of cancer. NF1 is a rare, progressive genetic condition caused by a mutation in the NF1 gene. PNs are histologically benign peripheral-nerve sheath tumor s (PNST) that occur in up to 50% of NF1 patients . For PNs that cannot be completely removed by surgery , systemic therapy may be appropriate. PNs do have a risk of malignant transformation. Koselugo was approved based on data from the phase 2 SPRINT clinical trial in which a majority of children had durable tumor shrinkage and clinical benefit such as pain reduction with treatment.Koselugo (selumetinib) will be considered for coverage when the following criteria are met:Neurofibromatosis Type 1 (NF1)For initial authorization: 1. Member is at least 2 years of age; AND 2. Medication must be prescribed by or in consultation with a pediatric oncologist , neurologist, or geneticist ; AND 3. Member has a confirmed diagnosis of neurofibromatosis type 1 (NF1) with at least 1 of the following: a) Positive genetic test for NF1 b) 6 or more caf-au-lait macules (CALMs) c) Axillary or inguinal freckl ing d) Optic glioma e) 2 or more Lisch nodules f) A distinctive osseous lesion g) First degree relative with NF1; AND 4. Member has at least one measurable plexiform neurofibromas (PN) as evidenced by MRI or PET-CT scan; AND 5. The plexiform neurofibromas (PN) is inoperable and cannot be removed completely by surgery without risk for substantial morbidity due to encasement of , or close proximity to , vital structures, invasiveness, or high vascularity of the PN; AND 6. Member has significant morbidity related to the PN (e.g., disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment, bladder/bowel dysfunction) . 7. Dosage allowed/Quantity limit : 25 mg/m 2 by mouth twice daily until disease progression or unacceptable toxicity . Capsules must be swallowed whole. ( See Table 1 in prescribing information for recommended dosage based on body surface area). QL for 10 mg capsules: 224 per 28 days (8/day) IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023QL for 25 mg capsules: 112 per 28 days (4/day)If all the above requirements are met , the medication will be approved for 6 months.For reauthorization :1. Chart notes have been provided showing that the member has had at least a partial response (defined as 20% reduction in the PN volume) from baseline and no disease progression and/or 2. Clinical improvement such as reduction of tumor pain or increased physical functioning. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Koselugo (selumetinib) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION05/14/2020 New policy for Koselugo created. 09/19/2023 Updated template. Revised references. Added neurology, genetics as specialists. Removed upper age limit. Added criteria to define NF1 diagnosis (only need to fulfill one since PN would count as the second) . Added clinical benefit to reauth. References: 1. Koselugo [Package Insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021. 2. Gross AM, Wolters PL, Dombi E, et al. Selumetinib in Children with Inoperable Plexiform Neurofibromas [published correction appears in NEngl JMed. 2020 Sep 24;383(13):1290]. NEngl JMed. 2020;382(15):1430-1442. doi:10.1056/NEJMoa1912735 . 3. Miller DT, Freedenberg D, Schorry E, et al. Health Supervision for Children With Neurofibromatosis Type 1. Pediatrics . 2019;143(5):e20190660. doi:10.1542/peds.2019-0660. 4. Pellerino A, Verdijk RM, Nichelli L, Andratschke NH, Idbaih A, Goldbrunner R. Diagnosis and Treatment of Peripheral and Cranial Nerve Tumors with Expert Recommendations: An EUropean Network for RAre CANcers (EURACAN) Initiative. Cancers (Basel ). 2023;15(7):1930. Published 2023 Mar 23. doi:10.3390/cancers15071930 5. Armstrong AE, Belzberg AJ, Crawford JR, Hirbe AC, Wang ZJ. Treatment decisions and the use of MEK inhibitors for children with neurofibromatosis type 1-related plexiform neurofibromas. BMC Cancer . 2023;23(1):553. Published 2023 Jun 16. doi:10.1186/s12885-023-10996-y 6. Legius E, Messiaen L, Wolkenstein P, et al. Revised diagnostic criteria for neurofibromatosis type 1 and Legius syndrome: an international consensus recommendation. Genet Med. 2021;23(8):1506-1513. doi:10.1038/s41436-021-01170-5 Effective date: 04/01/2024 Revised date: 09/19/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Izervay (avacincaptad pegol)BENEFIT TYPE Medical STATUS Prior Authorization Required Izervay, approved by the FDA in 2023, is a complement C5 inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is the second drug approved for this indication following C3 inhibitor pegcetacoplan. There are 2 types of AMD: dry or wet (neovascular). Izervay is approved for dry AMD which is more common but progresses more slowly to vision loss than wet AMD. GA can occur in the intermediate and advanced stages of dry AMD and is caused by the breakdown of cells in the macula, resulting in irreversible lesions t hat can impair vision or lead to blindness. Approval of Izervay was based the GATHER studies. Although it slows the growth rate of GA lesions, Izervay does not appear to preserve visual function. It may also accelerate the development of new-onset wet AMD .Izervay (avacincaptad pegol) will be considered for coverage when the following criteria are met:Geographic Atrophy (GA)For initial authorization: 1. Member is at least 50 years of age ; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) ; AND 4. Diagnosis has been confirmed by fundus autofluorescence (FAF) imaging showing all of the following: a) Total GA area must be 2.5 and 17.5 mm2 (1 and 7 disk areas [DA] respectively) and b) If GA is multifocal, at least one focal lesion must be 1.25 mm2 (0.5 DA) c) The GA lesion must be, in part, within 1.5 mm from, but NOT involving the foveal center ; AND 5. Documentation of best corrected visual acuity (BCVA) between 20/25 and 20/320 in the affected eye(s) ; AND 6. Member does NOT have any of the following: a) GA secondary to any condition other than AMD b) History or current evidence of wet AMD 7. Dosage allowed/Quantity limit: Intravitreal injection to each affected eye once monthly . QL: 2 vials per 28 days If all the above requirements are met , the medication will be approved for 12 months. For reauthorization : 1. Izervay will not be reauthorized. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Izervay (avacincaptad pegol) 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/DESCRIPTION09/18/2023 New policy for Izervay created. References: 1. Izervay [prescribing information] . IVERIC bio, Inc.; 2023. 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. Jaffe GJ, Westby K, Csaky KG, et al. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology . 2021;128(4):576-586. doi:10.1016/j.ophtha.2020.08.027 4. Patel SS, Lally DR, Hsu J, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial [published online ahead of print, 2023 Mar 24] [published correction appears in Eye (Lond). 2023 May 26;:]. Eye (Lond). 2023;10.1038/s41433-023-02497-w. doi:10.1038/s41433-023-02497-w 5. Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev . 2023;6(6):CD009300. Published 2023 Jun 14. doi:10.1002/14651858.CD009300.pub3 6. Cruz-Pimentel M, Wu L. Complement Inhibitors for Advanced Dry Age-Related Macular Degeneration (Geographic Atrophy): Some Light at the End of the Tunnel?. JClin Med. 2023;12(15):5131. Published 2023 Aug 4. doi:10.3390/jcm12155131 Effective date: 04/01/2024 Revised date: 09/18/2023
IN-MED-P -366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Iluvien (fluocinolone acetonide )BENEFIT TYPE Medical STATUS Prior Authorization Required Iluvien is an intravitreal implant containing 0.19 mg (190 mcg) fluocinolone acetonide in a 36-month sustained-release drug delivery system . It is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure . DME is a common complication of diabetic retinopathy.Iluvien (fluocinolone acetonide) will be considered for coverage when the following criteria are met:D iabetic Macular Edema (DME) For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a confirmed diagnosis of diabetic macular edema; AND 4. Member has been previously treated with a course of corticosteroids and did not have a clinically significant increase in intraocular pressure; AND 5. Member has tried and failed Ozurdex or an anti-VEGF drug (bevacizumab ); AND 6. Member does not have active or suspected ocular or periocular infection ; AND 7. Member does not have glaucoma with a cup to disc ratio greater than 0.8. 8. Dosage allowed/Quantity limit: One implant (0.19 mg) per eye Limit: 2 implants (1 per eye) per 36 months. If all the above requirements are met , the medication will be approved for 3 months. For reauthorization : 1. Chart notes must show improved or stabilized visual acuity following treatment; AND 2. At least 36 months have elapsed since the prior treatment (of the same eye). If all the above requirements are met , the medication will be approved for an additional 3 months .CareSource considers Iluvien (fluocinolone acetonide ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION 10/27/2021 New policy created for Iluvien. 10/16/2023 References updated . Added anti-VEGF as trial option. IN-MED-P -366647 OMPP Approved Template on: 01/22/2021 References: 1. Iluvien [prescribing information]. Alimera Sciences, Inc.; 2016. 2. 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 3. 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 4. Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev . 2020;11(11):CD005656. Published 2020 Nov 17. doi:10.1002/14651858.CD005656.pub3 5. Zur D, Iglicki M, Loewenstein A. The Role of Steroids in the Management of Diabetic Macular Edema. Ophthalmic Res . 2019;62(4):231-236. doi:10.1159/000499540 6. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica . 2017;237(4):185-222. doi:10.1159/000458539 7. Bailey C, Chakravarthy U, Lotery A, Menon G, Talks J; Medisoft Audit Group. Extended real-world experience with the ILUVIEN (fluocinolone acetonide) implant in the United Kingdom: 3-year results from the Medisoft audit study [published online ahead of pr int, 2021 May 10]. Eye (Lond) . 2021;1-7. doi:10.1038/s41433-021-01542-w 8. Yuen YS, Gilhotra JS, Dalton M, et al. Diabetic Macular Oedema Guidelines: An Australian Perspective. JOphthalmol . 2023;2023:6329819. Published 2023 Feb 14. doi:10.1155/2023/6329819 Effective date: 04/01/2024 Revised date: 10/16/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Gamifant (emapalumab-lzsg )BENEFIT TYPE Medical STATUS Prior Authorization Required Gamifant, approved by the FDA in 2018, is an interferon gamma (IFN ) blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. It is the first FDA approved drug indicated for primary HLH. HLH is a rare, multi-organ syndrome characterized by immune dysregulation (of NK cells, CD8+ cytotoxic Tcells , and macrophages ) leading to hyperinflammation. Primary HLH is caused by genetic defects and typically manifests during infancy or early childhood. It is fatal if left untreated. The mainstay of treatment focuses on immunosuppression and cytotoxic therapy. The objective is to suppress inflammation to allow for stem cell transplant.Gamifant (emapalumab-lzsg) will be considered for coverage when the following criteria are met:Primary H emophagocytic Lymphohistiocytosis (HLH)For initial authorization: 1. Medication must be prescribed by or in consultation with a hematologist; AND 2. Member has diagnosis of primary HLH with either refractory, recurrent, or progressive disease during conventional HLH therapy (e.g., dexamethasone with etoposide, cyclosporine A) or intolerance to conventional HLH therapy (Documentation required); AND 3. HLH diagnosis confirmed by ONE of the following: a) Genetic testing b ) 5 out of 8 criteria fulfilled: i) Fever ii) Splenomegaly iii) Cytopenias affecting at least 2 of 3 peripheral cell lines (hemoglobin 1×10 9 /L, platelets > 100×10 9 /L, ferritin 1.50 g/L, D-dimer 2-fold baseline) b) Partial response, defined as normalization of 3 HLH abnormalities (see above) c) HLH improvement, defined as 3 HLH abnormalities improved by at least 50% from baseline; AND 2. Member has not received a hematopoietic stem cell transplant since initial authorization . If all the above requirements are met , the medication will be approved for an additional 6 months. CareSource considers Gamifant (emapalumab-lzsg) 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/DESCRIPTION09/23/2019 New policy for Gamifant created. 09/21/2023 Updated template. Revised references. Rearranged numbering. Added starting dose. Removed MTX, hydrocortisone from conventional therapy since they are not always used; added cyclosporine. Shortened renewal duration from 12 months to 6 months. Removed concomitant disease exclusion. Removed family history as diagnostic verification. References: 1. Gamifant [prescribing information]. Waltham, MA: Sobi Inc.; 2022. 2. Locatelli F, Jordan MB, Allen C, et al. Emapalumab in Children with Primary Hemophagocytic Lymphohistiocytosis. NEngl JMed. 2020;382(19):1811-1822. doi:10.1056/NEJMoa1911326 3. Henter JI, Horne A, Aric M, et al. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer . 2007;48(2):124-131. doi:10.1002/pbc.21039 4. Konkol S, Rai M. Lymphohistiocytosis. [Updated 2023 Mar 27]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan- . Available from: https://www.ncbi.nlm.nih.gov/books/NBK557776/5. Jordan MB, Allen CE, Greenberg J, et al. Challenges in the diagnosis of hemophagocytic lymphohistiocytosis: Recommendations from the North American Consortium for Histiocytosis (NACHO). Pediatr Blood Cancer . 2019;66(11):e27929. doi:10.1002/pbc.27929 Effective date: 04/01/2024 Revised date: 09/21/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana 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 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). IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 References: 1. Eylea [prescribing information] . Regeneron Pharmaceuticals, Inc.; 202 3. 2. Eylea HD [prescribing information]. Regeneron Pharmaceuticals, Inc.; 2023. 3. 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: 04/01/2024 Revised date: 10/02/2023
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