IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Rebyota (fecal microbiota, live – jslm )BENEFIT TYPE Medical STATUS Prior Authorization Required Background statement: Rebyota is a fecal microbiota suspension for rectal administration approved by the FDA in 2022 for the prevention of Clostridioides difficile infection (CDI) in patients 18 years and older following completion of antibiotic treatment for recurrent CDI . This is the first FDA-approved microbiota-based therapy for prevention of recurrent CDI. Antibiotics including vancomycin and fidaxomicin are effective at treating CDI, however symptoms recur in ~15% of patients. Preceding FDA approval of Rebyota, Fecal Microbiota Transplantation (FMT) from donor stool administered via colonoscopy was used for prevention of recurrent CDI.Rebyota (fecal microbiota, live-jslm) will be considered for coverage when the following criteria are met: Prevention of recurrence of Clostridioides difficile infection (CDI)For initial authorization:1. Member is at least 18 years of age ; AND 2. Medication is prescribed by or in consultation with a gastroenterologist or infectious disease specialist ; AND 3. Member has documentation of one or more recurrences of CDI (two or more episodes); AND 4. Member has a positive stool test for the presence of Clostridioides difficile within the past 30 days; AND 5. Member has had a trial and failure of Zinplava; AND 6. Member has completed or will have completed an appropriate antibiotic treatment regimen for recurrent CDI 24-72 hours prior to administration supported by claims history and/or provider documentation; AND 7. Rebyota is not prescribed for the treatment of CDI; AND 8. Dosage allowed/Quantity limit : Administer a single dose of 150 mL rectally 24-72 hours after the last dose of antibiotics for CDI. If all the above requirements are met , one dose of the medication will be approved. For reauthorization :1. Medication will not be reauthorized. CareSource considers Rebyota (fecal microbiota, live-jslm) 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/DESCRIPTION01/30/2023 New policy for Rebyota created. 07/13/2023 Added trial of Zinplava. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 References: 1. Rebyota . Package Insert. Ferring Pharmaceuticals Inc. ; 2022. Accessed January 30, 2023 . 2. Rebyota . Prescribing information. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2022. 3. McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Feb 15;66(7):1-48. https://doi.org/10.1093/cid/cix10854. Khanna S, Assi M, Lee C, Yoho D, Louie T, Knapple W, et al. Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase III, Randomized, Double-Blind, Placebo-Controlled Trial with a Bayesian Primary Analysis for the Prevention of Recurrent Clostridioides difficile Infection. Drugs. 2022 Oct;82(15):1527-38. https://doi.org/10.1007/s40265-022-01797-x. 5. Orenstein R. The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660. Infect Dis Ther. 2023;12(1):1-7. doi:10.1007/s40121-022-00714-9 6. Orenstein R, Dubberke ER, Khanna S, et al. Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial. BMC Infect Dis. 2022;22(1):245. Publis hed 2022 Mar 12. doi:10.1186/s12879-022-07256-y. 7. Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results from a randomized, placebo-controlled clinical trial of a RBX2660-a microbiota-based drug for the prevention of recurrent Clostridium difficile infection. Clin Infect Dis. 2018;67(8):1198-1204. doi:10.1093/cid/ciy259. Effective date: 10/01/2023 Revised date: 01 /30/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Zinplava ( bezlotoxumab )BENEFIT TYPE Medical STATUS Prior Authorization Required Zinplava is a human monoclonal antibody indicated to reduce recurrence of Clostridioides difficile infection (CDI) in patients 18 years and older who are receiving standard of care antibacterial treatment for CDI and are at high risk for CDI recurrence. Zinplava acts by binding to C. difficile toxin Band neutralizing its effects. Zinplava is administered as a one-time 60-minute intravenous infusion during antibacterial treatment for CDI.Zinplava (bezlotoxumab) will be considered for coverage when the following criteria are met:Reduce recurrence of Clostridioides difficile infection (CDI)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is prescribed by or in consultation with a gastroenterologist or infectious disease specialist ; AND 3. Member has documentation of 3 or more loose stools or liquid stools within 24 hours; AND 4. Member has a positive stool test for the presence of Clostridioides difficile within the past 7 days; AND 5. Member is receiving standard of care antibacterial drug treatment for CDI (i.e., vancomycin, fidaxomicin, or metronidazole); AND 6. Member will receive Zinplava (bezlotoxumab) before completing antibacterial treatment for CDI; AND 7. Member meets one or more of the following criteria: a. Member has documentation of one or more CDI episodes within the last 6 months in addition to the current episode b. Member is 65 years of age c. Member is immunocompromised (i.e., history or use of immunosuppressive therapy) d. Member has documentation of severe CDI (i.e., WBC > 15,000 cells/mL or serum creatinine 1.5 mg/dL); AND 8. Dosage allowed/Quantity limit : Administer a single dose of 10 mg/kg during antibacterial treatment for CDI. If all the above requirements are met, one dose of the medication will be approved. For reauthorization : 1. Medication will not be reauthorized. CareSource considers Zinplava (bezlotoxumab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION04/25/2023 New policy for Zinplava created. References: 1. Zinplava. Package Insert, Merck & Co. Inc.; 2016. Accessed April 25, 2023. 2. Stuart Johnson, Valry Lavergne, Andrew MSkinner, Anne JGonzales-Luna, Kevin WGarey, Ciaran PKelly, Mark HWilcox, Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults, Clinical Infectious Diseases, Volume 73, Issue 5, 1 September 2021, Pages e1029e1044, https://doi.org/10.1093/cid/ciab549 3. Wilcox MH, Gerding DN, Poxton IR, et al. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection. NEngl JMed. 2017;376(4):305-317. doi:10.1056/NEJMoa1602615 4. Gerding DN, Kelly CP, Rahav G, et al. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence. Clin Infect Dis. 2018;67(5):649-656. doi:10.1093/cid/ciy171 5. de la Villa S, Herrero S, Muoz P, et al. Real-world Use of Bezlotoxumab and Fecal Microbiota Transplantation for the Treatment of Clostridioides difficile Infection. Open Forum Infect Dis. 2023;10(2):ofad028. Published 2023 Jan 25. doi:10.1093/ofid/ofad02 8 6. Birch T, Golan Y, Rizzardini G, et al. Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection. JAntimicrob Chemother. 2018;73(9):2524-2528. doi:10.1093/jac/dky182 7. Basu A, Prabhu VS, Dorr MB, et al. Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials. Open Forum Infect Dis. 2018;5(11):ofy218. Published 2018 Nov 15. doi :10.1093/ofid/ofy218 8. Kelly CR, Fischer M, Allegretti JR, et al. ACG Clinical Guidelines: Prevention, Diagnosis, and Treatment of Clostridioides difficile Infections [published correction appears in Am JGastroenterol. 2022 Feb 1;117(2):358]. Am JGastroenterol. 2021;116(6):112 4-1147. doi:10.14309/ajg.0000000000001278 Effective date: 10/01/2023 Revised date: 04/25/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vowst (fecal microbiota spores, live-brpk)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Vowst is a capsule for oral administration indicated to prevent recurrence of Clostridioides difficile infection (CDI) in patients 18 years and older following antibacterial treatment for recurrent CDI. Vowst is the first FDA approved fecal microbiota product for oral administration. Antibiotics including vancomycin and fidaxomicin are effective at treating CDI, however symptoms recur in ~15% of patients. Preceding FDA approval of Vowst and Rebyota, Fecal Microbiota Transplantation (FMT) from donor stool adminis tered via colonoscopy was used for prevention of recurrent CDI.Vowst (fecal microbiota spores, live-brpk) will be considered for coverage when the following criteria are met:Prevention of recurrence of Clostridioides difficile infection (CDI)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is prescribed by or in consultation with a gastroenterologist or infectious disease specialist ; AND 3. Member has documentation of one or more recurrences of CDI (two or more episodes) ; AND 4. Member has a positive stool test for the presence of Clostridioides difficile within the past 30 days; AND 5. Member has had a trial and failure of Rebyota; AND 6. Member has completed or will have completed an appropriate antibiotic treatment regimen (i.e., vancomycin, fidaxomicin, or metronidazole) for recurrent CDI 2-4 days prior to initiating treatment supported by claims history and/or provider documentation; AN D 7. Vowst is not prescribed for the treatment of CDI. 8. Dosage allowed/Quantity limit : 4 capsules orally once daily for 3 days. QL: 12 capsules. If all the above requirements are met, one course of the medication will be approved. For reauthorization : 1. Medication will not be reauthorized. CareSource considers Vowst (fecal microbiota spores, live-brpk) 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/DESCRIPTION05/09/2023 New policy for Vowst created.07/13/2023 Added trial of Rebyota.IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 References: 1. Vowst. Package Insert. Seres Therapeutics, Inc.; 2023. Accessed May 11, 2023. 2. McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of Am erica (SHEA). Clin Infect Dis. 2018 Feb 15;66(7):1-48. https://doi.org/10.1093/cid/cix1085 3. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. NEngl JMed. 2022;386(3):220-229. doi:10.1056/NEJMoa2106516 4. Cohen SH, Louie TJ, Sims M, et al. Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile Infection in a Randomized Clinical Trial. JAMA. 2022;328(20):2062-2064. doi:10.1001/jama.2022.16476 5. Sims MD, Khanna S, Feuerstadt P, et al. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Netw Open. 2023;6(2):e2255758. Published 2023 Feb 1. doi:10.1001/jamanetworkopen.2022.55758 Effective date: 10/01/2023 Revised date: 04/25/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Tepezza (teprotumumab-trbw)BENEFIT TYPE Medical STATUS Prior Authorization Required Tepezza is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease (TED), also known as Graves orbitopathy (GO) . It binds to IGF-1R and blocks its activation and signaling. Tepezza was the first drug approved by the FDA for TED, approved in 2020. Hyperthyroidism of autoimmune origin is referred to as Graves disease. TED occurs in some of these patients, causing inflammation and tissue expansion behind the eye leading to proptosis (bulging eyes), often accompanied by diplopia. Most cases are classified as mild; however, blindness is possible in severe cases. The mainstay medical therapy for moderate to severe TED is glucocorticoids.Tepezza (teprotumumab-trbw) will be considered for coverage when the following criteria are met:Thyroid Eye Disease (TED)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 or endocrinologist; AND 3. Member has a documented diagnosis of moderate to severe thyroid eye disease (TED) with at least one of the following: a) Proptosis 3 mm above normal for race and gender b) Moderate or severe soft tissue involvement c) Diplopia d) Orbital pain and/or pressure e) Lid retraction 2mm ; AND 4. Chart notes must show the member is euthyroid or mildly hypo-or hyper-thyroid (defined as having free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the reference normal limits) prior to starting therapy; AND 5. Member does NOT have sight-threatening TED such as severe optic neuropathy or corneal breakdown. 6. Dosage allowed/Quantity limit: 10mg/kg initial dose intravenously followed by seven 20mg/kg infusions every 3 weeks (total of 8 infusions). If all the above requirements are met , the medication will be approved for 24 weeks. For reauthorization : Retreatment will not be authorized due to a lack of robust literature available to support the use of Tepezza beyond 24 weeks. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Tepezza (teprotumumab-trbw) 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/DESCRIPTION04/22/2020 New policy for Tepezza created. 02/24/2022 Transferred to new template. Updated references. Added definition of moderate to severe disease, made CAS a separate point. Added endocrine as a specialist. Removed high dose from steroid trial; regimen may vary. 04/20/2023 Updated references. Updated policy to allow treatment of TED regardless of disease activity or duration (per phase 4 study and label update); previously only allowed for active disease. Removed CAS score requirement, added exclusion of sight-threatening TED , added orbital pain/pressure as qualifier, removed steroid trial . References: 1. Tepezza Prescribing Information. Lake Forest, IL: Horizon Therapeutics USA, Inc.; 2023. 2. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. NEngl JMed. 2020;382(4):341-352. doi:10.1056/NEJMoa1910434 3. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. NEngl JMed. 2017;376(18):1748-1761. doi:10.1056/NEJMoa1614949 4. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur JEndocrinol . 2021;185(4):G43-G67. Published 2021 Aug 27. doi:10.1530/EJE-21-0479 5. Winn BJ, Kersten RC. Teprotumumab: Interpreting the Clinical Trials in the Context of Thyroid Eye Disease Pathogenesis and Current Therapies. Ophthalmology . 2021;128(11):1627-1651. doi:10.1016/j.ophtha.2021.04.024 6. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study. Ophthalmology . 2022;129(4):438-449. doi:10.1016/j.ophtha.2021.10.017 7. IPD Analytics; Accessed April 20, 2023. 8. A Study Evaluating TEPEZZA Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease. ClinicalTrials.gov Identifier: NCT04583735. Updated April 11, 2023. Accessed April 19, 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT04583735?cond=tepezza&draw=2&rank=19. Burch HB, Perros P, Bednarczuk T, et al. Management of Thyroid Eye Disease: A Consensus Statement by the American Thyroid Association and the European Thyroid Association. Thyroid . 2022;32(12):1439-1470. doi:10.1089/thy.2022.0251 10. Nie T, Lamb YN. Teprotumumab: A Review in Thyroid Eye Disease [published correction appears in Drugs. 2022 Dec 2;:]. Drugs. 2022;82(17):1663-1670. doi:10.1007/s40265-022-01804-1 11. Douglas RS, Kossler AL, Abrams J, et al. Expert Consensus on the Use of Teprotumumab for the Management of Thyroid Eye Disease Using a Modified-Delphi Approach. JNeuroophthalmol. 2022;42(3):334-339. doi:10.1097/WNO.0000000000001560 12. Douglas RS, Dailey R, Subramanian PS, et al. Proptosis and Diplopia Response With Teprotumumab and Placebo vs the Recommended Treatment Regimen With Intravenous Methylprednisolone in Moderate to Severe Thyroid Eye Disease: A Meta-analysis and Matching-Adjusted Indirect Comparison. JAMA Ophthalmol . 2022;140(4):328-335. doi:10.1001/jamaophthalmol.2021.6284 Effective date: 10/01/2023 Revised date: 04/20/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Qalsody (tofersen)BENEFIT TYPE Medical STATUS Prior Authorization Required Qalsody , approved by the FDA in 2023, is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilamentlight chain (NfL) observed in patients treated with Qalsody. There is literature to support the use of NfL as a prognostic marker of ALS disease progression. It is a biomarker of nerve injury and neurodegeneration, reasonably believed to predict clinical benefit in SOD1-ALS. ALS, also known as Lou Gehrigs disease, is a fatal, progressive neurodegenerative disorder in which motor neuron loss leads to muscle weakness, with most patients succumbing to respiratory failure . SOD1-ALS is a rare genetic form of ALS, accounting for approximately 2% of ALS cases . Qalsody binds to SOD1 mRNA to cause its degradation, resulting in a reduction of SOD1 protein synthesis. Efficacy was assessed in the Phase 3 VALOR study in which Qalsody did not meet the primary endpoint for clinical function (ALS Functional Rating Scale Revised [ALSFRS-R] score change over 24 weeks ). Confirmatory clinical trials are pending. Qalsody (tofersen) will be considered for coverage when the following criteria are met:A myotrophic Lateral Sclerosis (ALS)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 or neuromuscular specialist ; AND 3. Member has a documented diagnosis of ALS with signs/symptoms of weakness ; AND 4. Member has genetic test results showing mutation in the SOD1 gene; AND 5. Documentation of baseline ALSFRS-R score. 6. Dosage allowed/Quantity limit: 100 mg (15 mL) intrathecally every 14 days for 3 loading doses, then every 28 days thereafter for maintenance. (QL: 1 vial per 28 days maintenance) If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must document positive clinical response, such as reduced plasma NfL level or reduced rate of disease progression/functional decline. If all the above requirements are met , the medication will be approved for an additional 6 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Qalsody (tofersen) 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/DESCRIPTION05/08/2023 New policy for Qalsody created. References: 1. Qalsody [prescribing information]. Biogen MA Inc.; 2023. 2. Miller TM, Cudkowicz ME, Genge A, et al. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. NEngl JMed. 2022;387(12):1099-1110. doi:10.1056/NEJMoa2204705 3. van den Berg LH, Sorenson E, Gronseth G, et al. Revised Airlie House consensus guidelines for design and implementation of ALS clinical trials. Neurology . 2019;92(14):e1610-e1623. doi:10.1212/WNL.0000000000007242 4. ALS Functional Rating Scale. Available at: http://www.outcomes-umassmed.org/als/alsscale.aspx .Effective date: 10/01/2023 Revised date: 05/08/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Nulibry (fosdenopterin )BENEFIT TYPE Medical or Pharmacy STATUS Prior Authorization Required Nulibry , approved by the FDA in 2021, is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A . MoCD Type A is an ultra-rare autosomal recessive, inborn error of metabolism that results in accumulation of a neurotoxic metabolite of sulfite (SSC) which causes rapid and progressive neurological damage that usually presents shortly after birth . Mutations in the molybdenum cofactor synthesis 1 gene (MOCS1) lead to deficient synthesis of cPMP . Nulibry provides a synthetic exogenous source of cPMP as substrate replac ement therapy. Nulibry is the first drug to target the underlying etiology of MoCD Type A and reduce the risk of mortality. Prior to Nulibry, treatment had been strictly supportive , such as anticonvulsants for seizures.Nulibry ( fosdenopterin ) will be considered for coverage when the following criteria are met:M olybdenum C ofactor D eficiency (MoCD) T ype A For initial authorization: 1. Medication must be prescribed by or in consultation with a neonatologist , geneticist , metabolic specialist, or pediatric neurologist; AND 2. ONE of the following: a) Member has a diagnosis of MoCD Type A confirmed by genetic testing (must show mutation in the MOSC1 gene) , OR b) Member has a presumptive diagnosis of MoCD Type A with e arly presenting characteristics such as seizures of unknown origin, exaggerated startle response, axial hypotonia, strongly positive sulfite dipstick, etc AND genetic testing is to be immediately complet ed. NOTE: If genetic testing does not confirm the diagnosis, Nulibry must be discontinued; AND 3. Documentation of baseline S-sulfocysteine (SSC) level; AND 4. Documentation of members weight . 5. Dosage allowed/Quantity limit: Less than 1 year of age: Dosing based on weight per package insert Age 1 year or older: 0.9 mg/kg IV once daily If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. If not provided for initial authorization, genetic test result confirming MoCD Type A must be submitted ; AND 2. Chart notes must show positive clinical response such as reduced convulsions, normalized biomarkers (urinary S-sulphocysteine (SSC), xanthine, urate), improved neurological or motor function, or achievement of developmental milestones. 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 Nulibry (fosdenopterin ) 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/DESCRIPTION6/24/2021 New policy for Nulibry (fosdenopterin) created. 04/28/2023 Added reference. Added more examples of presenting characteristics and clarified criterion. Added requirement for weight documentation. References: 1. Nulibry (fosdenopterin) [package insert]. Charleston SC; Alcami Carolinas Corporation;2022. 2. Molybdenum cofactor deficiency. Genetics Home Reference. Accessed June 24, 2021. https://medlineplus.gov/genetics/condition/molybdenum-cofactor-deficiency/3. Study of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A . ClinicalTrials.gov Identifier: NCT02629393 . Updated February 26, 2021. Accessed June 30, 2021. https://clinicaltrials.gov/ct2/show/NCT02629393?term=NCT02629393&draw=2&rank=1 4. Atwal PS, Scaglia F. Molybdenum cofactor deficiency. Mol Genet Metab. 2016;117(1):1-4. doi:10.1016/j.ymgme.2015.11.010 5. Schwahn BC, Van Spronsen FJ, Belaidi AA, et al. Efficacy and safety of cyclic pyranopterin monophosphate substitution in severe molybdenum cofactor deficiency type A: a prospective cohort study. Lancet . 2015;386(10007):1955-1963. doi:10.1016/S0140-6736(15)00124-5 6. IPD Analytics. Accessed 4/28/2023. 7. Misko A, Mahtani K, Abbott J, et al. Molybdenum Cofactor Deficiency. 2021 Dec 2 [Updated 2023 Feb 2]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available from: https:/ /www.ncbi.nlm.nih.gov/books/NBK575630/ Effective date: 10/01/2023 Revised date: 04/28/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Gamastan (immune globulin (human) )BILLING CODE J1460; J1560 BENEFIT TYPE Medical STATUS Prior Authorization Required Background statement: Gamastan is a human immune globulin solution for intramuscular injection, initially approved by the FDA in 1944 with prescribing information updated in 2018. Indications for Gamastan include preexposure and postexposure prophylaxis for hepatitis A, prevention or modification of measles (Rubeola) following exposure, modification of varicella following exposure, and modification of rubella in exposed women not considering therapeutic abortion. Gamastan is a polyclonal antibody which acts as a passive immunizing agent to neutralize viruses and remedy disease. Gamastan is made from human blood and carries the potential risk of transmitting infection.Gamastan (immune globulin (human) ) will be considered for coverage when the following criteria are met: Hepatitis AFor initial authorization: 1. Medication is prescribed by or in consultation with an infectious disease specialist ; AND 2. Member meets one of the following: a) Has been exposed to hepatitis A within the past 2 weeks b) Traveling to an area with endemic hepatitis A and Gamastan will be administered prior to departure; AND 3. Member does not have clinical manifestations of hepatitis A; AND 4. Dosage allowed/Quantity limit : Administer within two weeks of prior exposure 0.1 mL/kg IM (0.05 mL/lb.) Administer before travel to areas with endemic hepatitis A: Length of stay up to 1 month Length of stay up to 2 months 0.1 mL/kg IM 0.2 mL/kg IMIf all the above requirements are met , one dose of the medication will be approved for 7 days. For reauthorization :1. If Gamastan was previously approved for travel to an area with endemic hepatitis A, medication will be reauthorized if member length of stay will be longer than 2 months. Length of stay longer than 2 months 0.2 mL/kg IM ; repeat every 2 months If all the above requirements are met , the medication will be approved for member length of stay up to 12 months .IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Measles (Rubeola)For initial authorization: 1. Medication is prescribed by or in consultation with an infectious disease specialist ; AND 2. Member has not been vaccinated against measles; AND 3. Member has not had measles previously; AND 4. Member was exposed to measles within the last 6 days ; AND 5. Member meets one or more of the below criteria a) Member is an immunocompromised child b) Me mber is pregnant and lacks evidence for immunity to measles ; AND 6. Gamastan is not administered at the same time as the measles vaccine ; AND 7. Dosage allowed/Quantity limit : Administer to a susceptible person within 6 days of measles exposure 0.25 mL/kg IM (0.11 mL/lb.) Administer to an immunocompromised child within 6 days of measles exposure 0.5 mL/kg IM (max dose 15 mL)If all the above requirements are met , one dose of the medication will be approved for 7 days. For reauthorization :1. Medication will not be reauthorized. VaricellaFor initial authorization: 1. Medication is prescribed by or in consultation with an infectious disease specialist ; AND 2. Member is immunocompromised; AND 3. Member was exposed to varicella within the last 72 hours ; AND 4. Member is unable to access Varicella Zoster Immune Globulin (Human) ; AND 5. Dosage allowed/Quantity limit : 0.6 mL/kg to 1.2 mL/kg IM If all the above requirements are met , one dose of the medication will be approved for 7 days. For reauthorization : 1. Medication will not be reauthorized. RubellaFor initial authorization: 1. Medication is prescribed by or in consultation with an infectious disease specialist ; AND 2. Member is pregnant; AND 3. Member was exposed to rubella within the last 72 hours ; AND 4. Member will not consider therapeutic abortion; AND 5. Dosage allowed/Quantity limit : 0.55 mL/kg IM If all the above requirements are met , one dose of the medication will be approved for 7 days . For reauthorization : 1. Medication will not be reauthorized. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Gamastan (immune globulin (human)) 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/DESCRIPTION01/31/2023 New policy for Gamastan created. References: 1. Gamastan . Prescribing information. Grifols Therapeutics LLC; 20 18. Accessed January 31, 2023. 2. Immune Globulin. Lexi-Drugs. Lexicomp Online. Wolters Kluwer Health Inc. January 31, 2023. Accessed January 31, 2023. http://online.lexi.com3. Gamastan S/D Immune Globulin (Human). U.S. FDA. Current as of January 26, 2023. Accessed January 31, 2023. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/gamastan-sd-immune-globulin- human 4. Grifols. Gamastan Immune Globulin (Human). Accessed January 31, 2022. https://www.gamastan.com/en/hcp 5. CDC. Update: prevention of hepatitis A after exposure to hepatitis A virus and in international travelers. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2007;56:1080 4. 6. Tejada-Strop A, Costafreda MI, Dimitrova Z, Kaplan GG, Teo CG. Evaluation of potencies of immune globulin products against hepatitis A. JAMA Intern Med 2017; 177:430 2. 7. Nelson NP. Updated Dosing Instructions for Immune Globulin (Human) Gamastan S/D for Hepatitis A Virus Prophylaxis. MMWR. 2017. 66(36): 959-960. doi: 10.15585/mmwr.mm6636a5 8. Nelson NP, Weng MK, Hofmeister MG, et al. Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020. MMWR Recomm Rep 2020;69(No. RR-5):1 38. DOI: http://dx.doi.org/10.15585/mmwr.rr6905a1 9. Krow-Lucal E, Marin M, Shepersky L, Bahta L, Loehr J, Dooling K. Measles, Mumps, Rubella Vaccine (PRIORIX): Recommendations of the Advisory Committee on Immunization Practices United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1465 1470. DOI: http://dx.doi.org/10.15585/mmwr.mm7146a1 Effective date: 10/01/2023 Revised date: 01/31/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Enjaymo (sutimlimab )BENEFIT TYPE Medical STATUS Prior Authorization Required Enjaymo is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD) . It is an immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specifically binds to complement protein component 1, s subcomponent (C1s), a serine protease which cleaves C4. Inhibition of t he classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of RBCs, resulting in inhibition of hemolysis in patients with CAD. CAD is a form of autoimmune hemolytic anemia (AIHA) in which cold agglutinins can cause clinical symptoms related to RBC agglutination in cooler parts of the body and hemolytic anemia. Cold agglutinins are IgM autoantibodies against red blood cell antigens that bind at cold temperatures. Primary CAD (also called idiopathic CAD) is used to refer to cold agglutinins that cause RBC agglutination and extravascular hemolysis in the absence of an underlying disorder.Enjaymo ( sutimlimab ) will be considered for coverage when the following criteria are met:Cold Agglutinin Disease (CAD)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with hematologist or CAD specialist ; AND 3. Member has a diagnosis of primary CAD confirmed by ALL of the following: a) Cold agglutinin titer of 64; b) Positive polyspecific direct antiglobin test (DAT); c) Positive monospecific DAT for C3d; d) Immunogloulin G (IgG) DAT 1+; e) Evidence of chronic hemolysis (such as elevated reticulocyte count or increased lactate dehydrogenase (LDH)); AND 4. Member has documentation of one or more of the following symptoms: symptomatic anemia, acrocyanosis, Raynauds phenomenon, hemoglobinuria, disabling circulatory symptoms, or a major adverse vascular event ; AND 5. Member has a documented hemoglobulin level 10.0 g/dL; AND 6. Member has a documented bilirubin level above normal reference range; AND 7. Member does NOT have CAD secondary to infection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy. 8. Dosage allowed/Quantity limit: Initiate Enjaymo intravenously weekly for the first two weeks, with administration every two weeks thereafter. Quantity Limit: 14 vials per 30 days. For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion (6 vials). For patients weighing 75 kg or more : 7,500 mg by intravenous infusion (7 vials) . 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. Labs must show the members hemoglobulin has increased by at least 1.5 g/dL; OR 2. Chart notes must show improvement or stabilized signs and symptoms of disease (such as reduced fatigue, decrease in bilirubin, decrease in the number of blood transfusions, etc.). If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Enjaymo (sutimlimab ) 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/DESCRIPTION03/21/2022 New policy for Enjaymo created.05/22/2023 Removed requirement of history of blood transfusion to align with FDA labeling; added criteria to confirm diagnosis per clinical trial; removed not using in combination with rituximab; adjusted hemoglobulin increase goal in reauthorization criteria from 2 to 1.5 g/dL per updated clinical trial; added references; added a quantity limit; changed reauthorization example from QOL to reduced fatigue per clinical trial; included exclusion of CAD secondary to other causes.References: 1. Enjaymo [package insert]. Waltham, MA; Bioverativ USA Inc. March 2023.2. Tvedt THA, et al. Sutimlimab, an investigational C1s inhibitor, effectively prevents exacerbation of hemolytic anemia in a patient with cold agglutinin disease undergoing major surgery. Am JHematol. 2022 Feb 1;97(2):E51-E54. 3. Rth A, et al. Sutimlimab in Cold Agglutinin Disease. NEngl JMed. 2021 Apr 8;384(14):1323-1334. 4. Gabbard AP, Booth GS. Cold Agglutinin Disease. Clin Hematol Int. 2020;2(3):95-100. 5. Rth A, Berentsen S, Barcellini W, et al. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022;140(9):980-991. doi:10.1182/blood.2021014955 6. Brugnara C, Berentsen S, Cold agglutinin disease. In: UpToDate, Post, TW (Ed), UpToDate, Waltham, MA, 2023 . Effective date: 10/01/2023 Revised date: 05/22/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME M ulpleta (lusutrombopag )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Mulpleta, approved by the FDA in 2018, is a small molecule thrombopoietin (TPO) receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure . The agonistic effect upregulates the production of platelets. Mulpleta should not be administered in an attempt to normalize platelet counts. TPO receptor agonists have been associated with thrombotic and thromboembolic complications. Approval of Mulpleta was based on the placebo-controlled L-PLUS 1 and L-PLUS 2 clinical trials. Doptelet is another TPO receptor agonist (TPO-RA) with the same indication as Mulpleta. TPO is important for regulating thrombopoiesis. Thrombocytopenia is a condition of low platelet counts. It is the most common hematologic complication in patients with CLD, and 1% experience severe thrombocytopenia (platelet count
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME NPlate (romiplostim)BENEFIT TYPE Medical STATUS Prior Authorization Required Nplate , approved by the FDA in 2008, is a thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of thrombocytopenia in 1) Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and 2) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is also indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HSARS]) . ITP is a rare autoimmune disorder characterized by low levels of platelets due to platelet destruction and insufficient platelet production. According to the most current definitions, ITP duration of less than 3 months is referred to as newly diagnosed, 3-12 months as persistent, and greater than 12 months is considered chronic. As a TPO-RA, Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO .NPlate (romiplostim) will be considered for coverage when the following criteria are met:Immune Thrombocytopenia (ITP)For initial authorization: 1. Member is at least 1 year of age ; AND 2. Medication must be prescribed by or in consultation with a hematologist; AND 3. Member has a documented diagnosis of immune thrombocytopenia (ITP); AND 4. If member is less than 18 years of age, disease duration must be at least 6 months; AND 5. Member meets one of the following : a) Current platelet count is 60 years), other clearly identified comorbidity :AND 6. Member had an inadequate response, intolerance, or contraindication to documented prior therapy with at least one of the following treatments: a) Corticosteroids (prednisone, prednisolone, methylprednisolone, or dexamethasone); b) Immunoglobulins c) Splenectomy ; AND 7. Current weight is provided for dose calculation; AND 8. Member does NOT have any of the following: a) Thromboembolic condition b) A ny cause of thrombocytopenia other than primary ITP c) Concurrent use with another TPO-RA or with Tavalisse. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20239. Dosage allowed/Quantity limit: Administer 1mcg/kg subcutaneously once weekly, then adjust the weekly dose by increments of 1 mcg/kg until the patient achieves a platelet count 50 x 10 9/L. Max dose 10 mcg/kg. Note: Discontinue if platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the max dose. If all the above requirements are met , the medication will be approved for 3 months .For reauthorization :1. Chart notes improvement in platelet count from baseline to a level sufficient to avoid clinically important bleeding; AND 2. Members platelet count is less than 400 x 109/L ; AND 3. Dose will be reduced if platelet count is between 200 x 10 9/L and 400 x 10 9/L . If all the above requirements are met , the medication will be approved for an additional 12 months. Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS)Any request related to oncology must be submitted through NantHealth/Eviti portal. CareSource considers Nplate (romiplostim) 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 10/04/2018 New policy for N plate created. Platelets requirement threshold expanded. 02/08/2023 Transferred to new template. Updated and added references. Updated terminology from chronic immune (idiopathic) thrombocytopenic purpura to immune thrombocytopenia. Corrected age limit from 18 years to 1 year and added 6 mo duration for peds. Modified descriptions under 30,000-50,000 platelet count to be consistent with our other TPO-RA drug policies. Added documentation of current weight. Added exclusion for thrombotic events. Added not to be used in combo with another TPO-RA or Tavalisse. Rephrased renewal criteria to be consistent with drug label to address bleeding avoidance, added dose adjustment for PC >200. Added HSARS as an Eviti diagnosis. References: 1. Nplate [Package Insert]. Thousand Oaks, CA: Amgen, Inc.; 2022. 2. Cooper N, Terrinoni I, Newland A. The efficacy and safety of romiplostim in adult patients with chronic immune thrombocytopenia. Ther Adv Hematol. 2012 Oct; 3(5): 291 298. 3. Kuter DJ, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. NEngl JMed. 2010 Nov 11;363(20):1889-99. 4. Kuter DJ, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. 5. Kuter DJ, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br JHaematol. 2013 May;161(3):411-23. 6. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia [published correction appears in Blood Adv. 2020 Jan 28;4(2):252]. Blood Adv . 2019;3(23):3829-3866. doi:10.1182/bloodadvances.2019000966 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20237. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. doi:10.1182/bloodadvances.2019000812 8. Tarantino MD, Despotovic J, Roy J, et al. Romiplostim treatment for children with immune thrombocytopenia: Results of an integrated database of five clinical trials. Pediatr Blood Cancer. 2020;67(11):e28630. doi:10.1002/pbc.28630 9. Grainger J, Bussel J, Tarantino M, et al. A single-arm, long-term efficacy and safety study of subcutaneous romiplostim in children with immune thrombocytopenia. Blood Adv . 2023;7(3):396-405. doi:10.1182/bloodadvances.2021006014 10. Grainger JD, Khne T, Hippenmeyer J, Cooper N. Romiplostim in children with newly diagnosed or persistent primary immune thrombocytopenia. Ann Hematol . 2021;100(9):2143-2154. doi:10.1007/s00277-021-04590-0 11. Kuter DJ, Newland A, Chong BH, et al. Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. Br JHaematol. 2019;185(3):503-513. doi:10.1111/bjh.15803 12. Wojciechowski P, Wilson K, Nazir J, et al. Efficacy and Safety of Avatrombopag in Patients with Chronic Immune Thrombocytopenia: A Systematic Literature Review and Network Meta-Analysis. Adv Ther. 2021;38(6):3113-3128. doi:10.1007/s12325-021-01752-4 Effective date: 08/01/2023 Revised date: 02/08/2023
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