OH-MED-P -366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Somatostatin analogs (Injectable; First generation): Sandostatin (octreotide), Sandostatin LAR (octreotide), Somatuline D epot (lanreotide)BENEFIT TYPE Medical : Sandostatin, Sandostatin LAR, Somatuline depot STATUS Prior Authorization Required The four injectable first-generation somatostatin analogs approved are Sandostatin, Sandostatin LAR, Somatuline Depot and Bynfezia. They treat multiple conditions including acromegaly, carcinoid syndrome , vasoactive intestinal peptide tumor (VIPoma) and gastroenteropancreatic neuroendocrine tumors (GEP-NETs) . Acromegaly is typically the result of a GH-secreting pituitary adenoma, thus surgical resection is the preferred treatment whenever possible. If disease persists after surgery or surgery is not possible, a first-generation long-acting somatostatin receptor ligand is recommended as first-line therapy. The goal of treatment is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal , with IGF-1 as the best reflection of disease control. Carcinoid syndrome refers to a collection of symptoms that primarily occurs with well-differentiated neuroendocrine tumors (NETs) originating midgut with metastases to the liver. Flushing and diarrhea are the most common manifestations. Somatostatin analogs are typically the first line approach to alleviate symptoms.Somatostatin analogs (Injectable; First generation) will be considered for coverage when the following criteria are met:Acromegaly For initial authorization: 1. Member is 18 years of age or older; AND 2. Medication must be prescribed by or in consultation with an endocrinologist; AND 3. Member has diagnosis of uncontrolled acromegaly confirmed by insulin-like growth factor (IGF-1) elevation above normal level (lab report required); AND 4. Member had an inadequate response to surgery or member is ineligible for these treatments (documentation required); AND 5. For Somatuline Depot only: must have a trial and failure of Sandostatin LAR. 6. For Bynfezia only: a) Baseline thyroid function testing is required; AND b) Trial and failure of short acting octreotide (generic Sandostatin). 7. Dosage allowed/Quantity limit: Octreotide : initial dose of 50 mcg subcutaneously or intravenously three times daily for two weeks. Titrate per GH/IGF-1 levels up to m ax imum dose of 500 mcg three times daily. Quantity limit: 84 ampules per 28 days. Sandostatin LAR : initial dose of 20 mg intramuscularly every 4 weeks for 3 months . Titrate according to GH and IGF-1 dosing scheme per package insert . The maximum dose is 40 mg every 4 weeks. Note: patients not currently on octreotide injections must trial them for two weeks prior to switching to sandostatin LAR per the dosing scheme in the package insert . Quantity limit: 1 kit per 28 days . OH-MED-P -366685Somatuline depot : initial dose of 90 mg subcutaneously every 4 weeks for 3 months . Titrate according to GH and IGF-1 per package insert . The maximum dose is 120 mg every 4 weeks. Quantity limit: 1 syringe per 28 days . I al , 6 m. For reauthorization :1. Chart notes/lab report must show normalized or improved (decreased) IGF-1. I al ,12Carcinoid SyndromeFor initial authorization: 1. Member is 18 years of age or older; AND 2. Medication must be prescribed by or in consultation with an oncologist , gastroenterologist or endocrinologist ; AND 3. Member has a neuroendocrine tumor, including carcinoid tumor or vasoactive intestinal peptide tumor (VIPoma); AND 4. Member is experiencing flushing and/or diarrhea symptoms associated with carcinoid syndrome (or VIPoma syndrome), not attributed to another cause; AND 5. For Somatuline Depot only: must have a trial and failure of Sandostatin LAR. 6. Dosage allowed/Quantity limit: Octreotide : inject 100 mcg-750 mcg per day subcutaneously or intravenously in divided doses. Sandostatin LAR: inject 20 mg intramuscularly every 4 weeks for two months . Titrate based on symptom control outlined in package insert. The maximum dose is 30 mg every 4 weeks. Note: patients not currently on octreotide injections must trial them for two weeks prior to switching to sandostatin LAR per the dosing scheme in the package insert. Quantity limit: 1 kit per 28 days . Somatuline depot : inject 120 mg subcutaneously every 4 weeks. Quantity limit: 1 syringe per 28 days . Bynfezia: inject 100-750 mcg per day subcutaneously in divided doses. Quantity limit: 3 pens per 28 days. I al , 6 m. For reauthorization :1. For short-acting products (octreotide, Bynfezia): chart notes must document symptomatic improvement of flushing and/or diarrhea episodes. 2. For long-acting products (Sandostatin LAR, Somatuline Depot): chart notes must document reduced frequency of short-acting somatostatin analog rescue therapy for symptom control. I al ,12 NOTE to reviewer: A short-acting product may be used concurrently with a long-acting product.Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)Any request for cancer must be submitted through NantHealth/Eviti portal. CareSource considers Somatostatin analogs (Injectable; First generation) 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.
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio 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 f or intramuscular injection, initially approved by the FDA in 1944 with prescribing inf ormation updated in 2018. Indications f or Gamastan include preexposure and postexposure prophylaxis f or hepatitis A, prevention or modif ication of measles (Rubeola) f ollowing exposure, modif ication of varicella f ollowing exposure , and modif ication 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 f rom human blood and carries the potential risk of transmitting inf ection. Gamastan (immune globulin (human) ) will be considered for coverage when thefollowing criteria are met:Hepatitis A For initial authorization:1. Medication is prescribed by or in consultation with an inf ectious disease specialist ; AND2. Member meets one of the f ollowing: 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 manif estations 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 bef ore 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 IM0.2 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 f or 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 . Measles (Rubeola)OH-MED-P-366685For initial authorization:1. Medication is prescribed by or in consultation with an inf ectious 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 f or 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.Varicella For initial authorization:1. Medication is prescribed by or in consultation with an inf ectious disease specialist ; AND2. 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. Rubella OH-MED-P – 366685 For initial authorization: 1. Medication is prescribed by or in consultation with an inf ectious disease specialist ; AND2. Member is pregnant; AND3. Member was exposed to rubella with in the last 72 hours ; AND4. Member will not consider therapeutic abortion; AND5. Dosage allowed/Quantity limit : 0.55 mL/kg IMIf 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.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. DAT EACT ION/DESCRIPT ION 01/31/2023 New policy for Gamastan created. ODM approved 4/9/25. Ref erences: 1. Gamastan . Prescrib ing inf o rmatio n . Grif o ls Therap eutics LLC ; 20 18 . Accessed January 31, 2023.2. Immune Glo b ulin. Lexi-Drug s. Lexico mp Online. Wo lters Kluwer Health Inc. January 31, 2023. Accessed January31, 2023. http ://o nline.lexi.co m3. Gamastan S/D Immune Glo b ulin (Human). U.S. FDA. Current as o f January 26, 2023. Accessed January 31,2023. http s://www.f d a.g o v/vaccines-b lo o d-b io lo g ics/ap p ro ved-b lo o d-p ro d ucts/g amastan-sd-immune-g lo b ulin-human4. Grif o ls. Gamastan Immune Glo b ulin (Human). Accessed January 31, 2022. http s://www.g amastan.co m/en/hcp5. CDC. Up d ate: p reventio n o f hep atitis A af ter exp o sure to hep atitis A virus and in internatio nal travelers. Up d ated reco mmend atio ns o f the Ad viso ry Co mmittee o n Immunizatio n Practices (ACIP). MMWR Mo rb Mo rtal Wkly Rep2007;56:1080 4.6. Tejad a-Stro p A, Co staf red a MI, Dimitro va Z, Kap lan GG, Teo CG. Evaluatio n o f p o tencies o f immune g lo b ulin p ro d ucts ag ainst hep atitis A. JAMA Intern Med 2017; 177:430 2.7. Nelso n NP. Up d ated Do sing Instructio ns f o r Immune Glo b ulin (Human) Gamastan S/D f o r Hep atitis A VirusPro p hylaxis. MMW R. 2017. 66(36): 959-960. d o i: 10.15585/mmwr.mm6636a58. Nelso n NP, Weng MK, Ho f meister MG, et al. Preventio n o f Hep atitis A Virus Inf ectio n in the United States:Reco mmend atio ns o f the Ad viso ry Co mmittee o n Immunizatio n Practices, 2020. MMWR Reco mm Rep2020;69(No . RR-5):1 38. DOI: http ://d x.d o i.o rg /10.15585/mmw r.rr6905a19. Kro w-Lucal E, Marin M, Shep ersky L, Bahta L, Lo ehr J, Do o ling K. Measles, Mump s, Rub ella Vaccine (PRIORIX):Reco mmend atio ns o f the Ad viso ry Co mmittee o n Immunizatio n Practices United States, 2022. MMWR Mo rbMo rtal Wkly Rep 2022;71:1465 1470. DOI: http :// d x.d o i.o rg /10.15585/mmwr.mm7146a1Ef f ective d ate: 01/01/2024 Revised d ate: 01 / 31/2023
OH-MED-P-366685PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Qalsody (tofersen)BENEFIT TYPE Medical STATUS Prior Authorization Required Qalsody , approved by the FDA in 2023, is an antisense oligonucleotide indicated f or 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 neurof ilament light chain (Nf L) observed in patients treated with Qalsody. There is literature to support the use of Nf Las a prognostic marker of ALS disease progression. It is a biomarker of nerve injury and neurodegeneration, reasonably believed to pre dict clinical benef it in SOD1-ALS. ALS, also known as Lou Gehrigs disease, is a f atal, progressive neurodegenerative disorder in which motor neuron loss leads to muscle weakness, with most patients succumbing to respiratory f ailure . SOD1-ALS is a rare gen etic f orm of ALS, accounting f or a pproximately 2% of ALS cases . Qalsody binds to SOD1 mRNA to cause its degradation, resulting in a reduction of SOD1 protein synthesis. Ef f icacy was assessed in the Phase 3 VALOR study in which Qalsody did not meet the prim ary endpoint for clinical f unction (ALS Functional Rating Scale Revised [ALSFRS-R] score change over 24 weeks ). Conf irmatory 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 f or 3 loading doses, then every 28 days thereaf ter f or 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 Nf Llevel or reduced rate of disease progression/f unctional decline.If all the above requirements are met , the medication will be approved for an additional 6 months .OH-MED-P – 366685 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/DESCRIPTION 05/08/2023 New policy for Qalsody created. ODM approved 4/3/25. Ref erences: 1. Qalso d y [p rescrib ing inf o rmatio n]. Bio g en MA Inc.; 2023.2. Miller TM, Cud kowicz ME, Geng e A, et al. Trial o f Antisense Oligonucleo tid e To f ersen f o r SOD1 ALS. NEngl JMed . 2022;387(12):1099-1110. d o i:10.1056/NEJMo a22047053. van d en Berg LH, Sorenson E, Gronseth G, et al. Revised Airlie Ho use co nsensus g uid elines f o r d esig n and imp lementatio n o f ALS clinical trials. Neurology . 2019;92(14):e1610-e1623. d o i:10.1212/WNL.00000000000072424. ALS Functio nal Rating Scale. Availab le at: http ://www.o utco mes-umassmed .o rg /als/alsscale.asp x .Ef fective date: 07/01/2025Revised date: 05/08/2023
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio 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 inf ection (CDI) in patients 18 years and older who are receiving standard of care antibacterial treatment f or CDI and are at high risk f or CDI recurrence. Zinplava acts by binding to C. difficile toxin Band neutralizing its ef f ects.Zinplava is administered as a one-time 60-minute intravenous inf usion during antibacterial treatment f or 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; AND2. Medication is prescribed by or in consultation with a gastroenterologist or inf ectious disease specialist ;AND3. Member has documentation of 3 or more loose stools or liquid stools within 24 hours; AND4. Member has a positive stool test f or the presence of Clostridioides difficile within the past 7 days; AND5. Member is receiving standard of care antibacterial drug treatment f or CDI (i.e., vancomycin,f idaxomicin, or metronidazole); AND6. Member will receive Zinplava (bezlotoxumab) bef ore completing antibacterial treatment f or CDI; AND7. Member meets one or more of the f ollowing 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); AND8. Dosage allowed/Quantity limit : Administer a single dose of 10 mg/kg during antibacterial treatment f or 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. DAT EACT ION/DESCRIPT ION OH-MED-P – 366685 04/25/2023 New policy for Zinplava created. ODM approved 4/9/25. Ref erences: 1. Zinp lava. Packag e Insert, Merck & Co . Inc.; 2016. Accessed Ap ril 25, 2023.2. Stuart Jo hnso n, Valry Laverg ne, And rew MSkinner, Anne JGo nzales-Luna, Kevin WGarey , Ciaran PKelly,Mark HWilco x, Clinical Practice Guid eline b y the Inf ectio us Diseases So ciety o f America (IDSA) and So ciety f o rHealthcare Ep id emio lo g y o f America (SHEA): 2021 Fo cused Up d ate Guid elines o n Manag ement o f Clo strid io id es d if f icile Inf ectio n in Ad ults, Clinical Inf ectio us Diseases, Vo lume 73, Issue 5, 1 Sep temb er 2021, Pag es e1029 e1044, http s://d o i.o rg /10.1093/cid /ciab 5493. Wilco x MH, Gerd ing DN, Po xto n IR, et al. Bezlo to xumab f o r Preventio n o f Recurrent Clo strid ium d if f icile Inf ectio n. NEng l JMed . 2017;376(4):305-317. d o i:10.1056/NEJMo a16026154. Gerd ing DN, Kelly CP, Rahav G, et al. Bezlo to xumab f o r Preventio n o f Recurrent Clo strid ium d if f icile Inf ectio n inPatients at Increased Risk f o r Recurrence. Clin Inf ect Dis. 2018;67(5):649-656. d o i:10.1093/cid /ciy1715. d e la Villa S, Herrero S, Muo z P, et al. Real-wo rld Use o f Bezlo to xumab and Fecal Micro b io ta Transp lantatio n f o r the Treatment o f Clo strid io id es d if f icile Inf ectio n. Op en Fo rum Inf ect Dis. 2023;10(2):o f ad 028. Pub lished 2023Jan 25. d o i:10.1093/o f id /o f ad 02 86. Birch T, Go lan Y, Rizzard ini G, et al. Ef f icacy of b ezlo to xumab b ased o n timing o f ad ministratio n relative to start of antib acterial therap y f o r Clo strid ium d if f icile inf ectio n. JAntimicro b Chemo ther. 2018;73(9):2524-2528. d o i:10.1093/jac/d ky1827. Basu A, Prab hu VS, Do rr MB, et al. Bezlo to xumab Is Asso ciated With a Red uctio n in Cumulative Inp atient-Days:Analysis o f the Ho sp italizatio n Data Fro m the MODIFY I and II Clinical Trials. Op en Fo rum Inf ect Dis.2018;5(11):o f y218. Pub lished 2018 No v 15. d o i :10.1093/o f id /o f y2188. Kelly CR, Fischer M, Alleg retti JR, et al. ACG Clinical Guid elines: Preventio n, Diag no sis, and Treatment o fClo strid io id es d if ficile Inf ectio ns [p ub lished co rrectio n ap p ears in Am JGastro entero l. 2022 Feb 1;117(2):358]. Am JGastro entero l. 2021;116(6):112 4-11 47. d o i:10.14309/ajg .00000000000 01 27 8Ef f ective d ate: 01/01/2024 Revised d ate: 04/25/2023
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Rebyota (fecal microbiota, live-jslm ) BENEFIT TYPE Medical STATUS Prior Authorization Required Background statement: Rebyota is a f ecal microbiota suspension f or rectal administration approved by the FDA in 2022 f or the prevention of Clostridioides difficile i nf ection (CDI) in patients 18 years and older f ollowing completion of antibiotic treatment f or recurrent CDI . This is th e f irst FDA-approved microbiota-based therapy f or prevention of recurrent CDI. Antibiotics including vancomycin and f idaxomicin are ef f ective at treating CDI, however symptoms recur in ~15% of patients. Preceding FDA approval of Rebyota, Fecal Microbiota Transplantation (FMT) f rom donor stool administered via colonoscopy was used f or 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 ; AND2. Medication is prescribed by or in consultation with a gastroenterologist or inf ectious disease specialist ;AND3. Member has documentation of one or more recurrences of CDI (two or more episodes); AND4. Member has a positive stool test f or the presence of Clostridioides difficile within the past 30 days;AND5. Member has had a trial and failure of Zinplava; AND6. Member has completed or will have completed an appropriate antibiotic treatment regimen f or recurrent CDI 24-72 hours prior to administration supported by claims history and/or provider documentation; AND7. Rebyota is not prescribed f or the treatment of CDI; AND8. Dosage allowed/Quantity limit :Administer a single dose of 150 mL rectally 24-72 hours af ter the last dose of antibiotics f or 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. OH-MED-P – 366685 DATE ACTION/DESCRIPTION 01/30/2023 New policy f or Rebyota created. 07/13/2023 Added trial of Zinplava.ODM approved 4/15/25.Ref erences: 1. Reb yo ta . Packag e Insert. Ferring Pharmaceuticals Inc. ; 2022. Accessed January 30 , 202 3 .2. Reb yo ta . Prescrib ing inf o rmatio n. Parsip p any, NJ: Ferring Pharmaceuticals Inc; 2022.3. McDo nald LC, Gerding DN, Johnson S, Bakken JS, Carro ll KC, Coffin SE, et al. Clinical Practice Guid elines f o rClo stridium difficile Inf ection in Adults and Children: 2017 Up date b y the Infectious Diseases So ciety o f America(IDSA) and So ciety for Healthcare Epidemio lo g y o f America (SHEA). Clin Inf ect Dis. 2018 Feb 15;66(7):1-48. http s://d o i.o rg /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, aPhase III, Rand o mized , Do ub le-Blind , Placeb o-Co ntro lled Trial with a Bayesi an Primary Analysis f o r thePreventio n o f Recurrent Clo strid io id es d if f icile Inf ectio n. Drug s. 2022 Oct;82(15):1527-38. http s://d o i.o rg /10.1007/s40265-022-01797-x .5. Orenstein R. The Ro le o f Microbiome-Based Therap eutics in Clostridioides d ifficile Infection: Durable, Lo ng-TermResults o f RBX2660. Inf ect Dis Ther. 2023;12(1):1-7. d o i:10.1007/s40121-022-00714-96. Orenstein R, Dub berke ER, Khanna S, et al. Durable reducti on of Clostridioides d ifficile inf ectio n recurrence and micro b iome restoration after treatment with RBX2660: results from an o pen-label phase 2 clinical trial. BMC Inf ectDis. 2022;22(1):245. Pub lished 2022 Mar 12. d o i:10.1186/s12879-022-07256-y.7. Dub b erke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerd ing DN. Results f ro m a rand o mized , p laceb o-co ntro lled clinical trial of a RBX2660-a microbiota-based drug for the prevention of recurrent Clo strid ium d if f icile inf ectio n. Clin Inf ect Dis. 2018;67(8):1198-1204 . d o i:10.1093/cid /ciy259. Ef fective date: 07/01/2025 Revised date: 01/30/2023
PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Cortrophin Gel (corticotropin)BILLING CODE J0800 BENEFIT TYPE Medical STATUS Prior Au th orization Requ ired Purif ied Cortrophin Gel is a porcine derived purif ied corticotropin (ACTH) in a sterile solution of gelatinindicated in a variety of conditions such as rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, symptomatic sarcoidos is, nephrotic syndrome and multiple sclerosis(MS). Purif ied Cortrophin Gel is the anterior pituitary hormone which stimulates the f unctioning adrenal cortex to produce and secrete adrenocortical hormones. Clinical trials have provided suf f icient evidence to support its use in acute exacerbations of MS. However, a recent review f ound Cortrophin was not superior to corticosteroids f or treating relapses of MS. Cortrophin Gel (corticotropin) will be considered for coverage when the followingcriteria are met:Multiple SclerosisFor initial authorization: 1. Member is at least 18 years of age or older; AND 2. Medication must be prescribed by a neurologist; AND 3. Member must have documentation of a current acute exacerbation of MS; AND 4. Member must have a previous 3-day trial and f ailure of intravenous methylprednisolone at a dose of at least 1000 mg daily; AND 5. Medication is being used as add-on treatment to disease modif ying therapy (ex. Copaxone, Gilenya, Plegridy, etc.) 6. Member does not have ANY of the f ollowing: a. Scleroderma b. Osteoporosis c. Systemic f ungal inf ections d. Ocular herpes simplex e. History of or the presence of a peptic ulcer f. Congestive heart f ailure g. Primary adrenocortical insuf f iciency or adrenocortical hyperf unction 7. Dosage allowed/Quantity limit: Administer 80-120 units daily intramuscularly f or 2-3 weeks . Quantity Limit : 7 vials per 21 days. If all the above requirements are met, the medication will be approved for 3 weeks.For reauthorization :Cortrophin Gel will not be reauthorized f or chronic use. CareSource considers Cortrophin Gel (corticotropin) 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. DAT EACT ION/DESCRIPT ION 07/22/2022 New policy for Cortroph in Gel created. 03/14/2023 Updated referen ces. Added requ iremen t for cu rren t u se of disease modifyin g th erapy. Clarified backgrou nd in formation . ODM approved 4/9/25. Ref erences: 1. Co rtro p hin Gel [p ackag e insert]. Baud ette, MN: ANI Pharmaceuticals, Inc; No vemb er 2021.2. Tran KA, Harro d C, Bo urd ette DN, Co hen DM, Deo d har AA, Hartung DM. Characterizatio n o f the ClinicalEvid ence Sup p o rting Rep o sito ry Co rtico tro p in Injectio n f o r FDA-Ap p ro ved Ind icatio ns: A Sco p ing Review.JAMA Intern Med. 2022;182(2):206 2 17.3. Grant AR, Day GS, Ann Marrie R, et al. Practice g uid elines: Disease-mo d if ying therap ies f o r ad ults with multip le sclero sis: rep o rt o f the Guid eline Develo p ment, Disseminatio n, and Imp lementatio n Sub co mmittee o f the American Acad emy o f Neuro lo g y. Neuro lo g y. 2018; 90(17): 777-7884. Filip p ini G, Brusaf erri F, Sib ley WA, et al. Co rtico stero id s o r ACTH f o r acute exacerb atio ns in multip le sclero sis. Co chrane Datab ase Syst Rev. 2000;(4):CD001331. d o i:10.1002/14651858.CD0013 315. Berko vich R. Treatment o f acute relap ses in multip le sclero sis. Neuro therap eutics. 2013;10(1):97-105. d o i:10.1007/s13311-012-01 60-7.6. Tran KA, Harro d C, Bo urd ette DN, Co hen DM, Deo d har AA, Hartung DM. Characterizatio n o f the ClinicalEvid ence Sup p o rting Rep o sito ry Co rtico tro p in Injectio n f o r FDA-Ap p ro ved Ind icatio ns: A Sco p ing Review.JAMA Intern Med . 2022;182(2):206-2 17. d o i:10.1001/jam ainternmed .2021.717 1Ef f ective d ate: 01/01/2024 Revised d ate: 03/14/2023
OH-MED-P – 366685 PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Enjaymo ( sutimlimab ) BENEFIT TYPE Medical STATUS Prior Authorization Required Enjaymo is a classical complement inhibitor indicate d f or the treatment of hemolysis in adults with cold agglutinin disease (CAD) . It i s an immunoglobulin G (IgG), subclass 4 (IgG4) monoclonal antibody (mAb) that inhibits the classical complement pathway (CP) and specif ically binds to complement protein component 1, s subcomponent (C1s), a serine proteas e which cleaves C4. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surf ace of RBCs, resulting in inhibition of hemolysis in patients with CAD. CAD is a f orm of autoimmune hemolytic anemi a (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 CA D (also called idiopathic CAD) is used to ref er 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 ; AND2. Medication must be prescribed by or in consultation with hematologist or CAD specialist ; AND3. Member has a diagnosis of primary CAD conf irmed by ALL of the f ollowing:a) Cold agglutinin titer of 64;b) Positive polyspecif ic direct antiglobin test (DAT);c) Positive monospecif ic DAT f or C3d;d) Immunogloulin G (IgG) DAT 1+;e) Evidence of chronic hemolysis (such as elevated reticulocyte count or increased lactate dehydrogenase (LDH)); AND4. Member has documentation of one or more of the f ollowing symptoms: symptomatic anemia,acrocyanosis, Raynauds phenomenon, hemoglobinuria, disabling circulatory s ymptoms, or a major adverse vascular event ; AND5. Member has a documented hemoglobulin level 10.0 g/dL; AND6. Member has a documented bilirubin level above normal ref erence range; AND7. Member does NOT have CAD secondary to inf ection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy.8. Dosage allowed/Quantity limit: Initiate Enjaymo intravenously weekly f or the f irst two weeks, with administration every two weeks thereaf ter. Quantity Limit: 14 vials per 30 days.For patients weighing 39 kg to less than 75 kg : 6,500 mg by intravenous inf usion (6 vials) .For patients weighing 75 kg or more : 7,500 mg by intravenous inf usion (7 vials) .If all the above requirements are met , the medication will be approved for 6 months . OH-MED-P – 366685 For reauthorization : 1. Lab s must show the members hemoglobulin has increased by at least 1.5 g/dL; OR2. Chart notes must show improvement or stabilized signs and symptoms of disease (such as reduced f atigue, decrease in bilirubin, decrease in the number of blood transf usions, 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/DESCRIPTION 03/21/2022 New policy f or Enjaymo created. 05/22/2023 Removed requirement of history of blood transf usion to align with FDA labeling; added criteria to conf irm diagnosis per clinical trial; removed not using in combination with rituximab; adjusted hemoglobulin increase goal in reauthorization criteria f rom 2 to 1.5 g/dL per updated clinical trial; added ref erences; added a quantity limit; changed reauthor ization example f rom QOL to reduced f atigue per clinical trial; included exclusion of CAD secondary to other causes. Approved by ODM 4/15/25. Ref erences: 1. Enjaymo [p ackag e insert]. Waltham, MA; Bio verativ USA Inc. March 2023 .2. Tved t THA, et al. Sutimlimab , an investig atio nal C1s inhib ito r, ef f ectively p revents exacerb atio n o f hemo lytic anemia in a p atient with cold agglutinin disease und ergoing major surgery. Am JHematol. 2022 Feb 1;97(2):E51-E54.3. Rth A, et al. Sutimlimab in Co ld Ag g lutinin Disease. NEn g l JMed . 2021 Ap r 8;384(14):1323-1334.4. Gab b ard AP, Bo o th GS. Co ld Ag g lutinin Disease. Clin Hemato l Int. 2020;2(3):95-100.5. Rth A, Berentsen S, Barcellini W, et al. Sutimlimab in p atients with co ld ag g lutinin d isease: results o f the rand o mized p laceb o-co nt ro lled p hase 3 CADENZA trial. Blo o d . 2022;140(9):980-991. d o i:10.1182/b lo o d .20210149556. Brug nara C, Berentsen S, Co ld ag glutinin d isease. In: Up To Date, Post, TW (Ed), UpTo Date, Waltham, MA, 2023 .Ef fective date: 07/01/2025 Revised date: 05/22/2023
OH-MED-P -366685PHARMACY POLICY STATEMENTOhio 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. OH-MED-P -366685 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. ODM approved 4/3/25. 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: 01/01/2024 Revised date: 04/20/2023
OH-MED-P-366685PHARMACY POLICY STATEMENTOhio Medicaid DRUG NAME Radicava (edaravone injection); Radicava ORS (edaravone oral suspension)BILLING CODE J1301 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office/Outpatient STATUS Prior Authorization Required Radicava is a pyrazolone free radical scavenger initially approved by the FDA in 2017 as an IV formulation. It is the second drug to be approved for the treatment of patients with Amyotrophic Lateral Sclerosis (ALS) behind Riluzole . In May of 2022, the FDA approved a new oral suspension formulation, Radicava ORS. ALS is a progressive neurodegenerative disease characterized by the weakness of voluntary muscles due to the loss of motor neurons. Although the exact mechanism of action is unknown, it is hypothesized Radicava works via a mechanism involving antioxidants, which nullifies the oxidative stress believed to be involved in ALS .Radicava (edaravone) will be considered for coverage when the following criteria are met: Amyotrophic Lateral Sclerosis (ALS) For initial authorization: 1. Member must be at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist or a physician specializing in ALS; AND 3. Member must have detailed chart notes confirming members Definite or Probable ALS based on EL Escorial revised criteria 3; AN D 4. Member must have had the diagnosis of ALS for a duration of 2 years or less; AND 5. Member must have a baseline percent forced vital capacity (FVC%) of 80% or greater; AND 6. Member must have a baseline score of 2 points or greater for each individual item of the ALS Functional Rating Scale-Revised (ALSFRS-R), *Note: Should be a minimum score of 24 4. 7. Dosage allowed/Quantity limit: a. Radicava: 60 mg (two 30mg bags) administered as an IV infusion over 60 minutes as follows: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period; Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. Quantity Limit: 20 bags per 28 days b. R adicava ORS: Initial treatment cycle: 105 mg (5 mL) taken orally or via feeding tube daily for 14 days followed by a 14-day drug-free period; Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods. Quantity limit: 50mL per 28 days OH-MED-P-366685If all the above requirements are met, the medication will be approved for 6 months. For reauthorization :1. Member has documentation of disease stability or clinical benefit from therapy, such as improved ALS functional rating scale score or no rapid disease progression while on therapy; AND 2. Member does not require invasive ventilation. If all the above requirements are met, the medication will be approved for an additional 12 months. Appendix:Diagnostic Criteria for ALS.Diagnosis El Escorial Revised Airlie House CriteriaDefinite ALS UMN (clinical exam) and LMN (clinical, electrophysiological or neuropathological exam) signs: Bulbar region and > two spinal regions OR Three spinal regions Probable ALS UMN and LMN signs in > two regions and UMN signs rostral to LMN signs Probable ALS laboratory-supported UMN + LMN signs in one region OR UMN signs alone in one region and LMN signs via electrophysiological criteria of LMN loss > two regions Possible ALS UMN and LMN signs in one region OR UMN signs alone in > two regions OR LMN rostral to UMN and unable to prove clinically probably ALS UMN Upper motor neuron; LMN Lower motor neuron. CareSource considers Radicava (edaravone) 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.
OH-MED-P-366685PHARMACY POLICY STATEMENT Ohio Medicaid DRUG NAME Alpha 1-Proteinase Inhibitor (Aralast NP,Glassia, Prolastin C, Zemaira [human]) BENEFIT TYPE Medical (Pharmacy allowed f or Glassia) STATUS Prior Authorization Required Alpha1-proteinase inhibitor (alpha1 antitrypsin) f rom pooled human plasma donors acts as augmentation therapy f or maintenance treatment in adults with clinical evidence of emphysema due to severe alpha1 – antitrypsin def iciency (AATD) . The available products are Aralast NP, Glassia, Prolastin C, and Zemaira, with none of them being clinically pref erred over the others. Prolastin was the f irst, approved by the FDA in 1987 (and later replaced by Prolastin C). The goal of this therapy is to restore and maintain alpha1-antitrypsin to protective levels and slow the progression of lung damage and emphysema by inhibiting proteases such as neutrophil elastase . Alpha-1 antitrypsin def iciency (A ATD ) is a hereditary disorder caused by pathogenic mutations in the SERPINA1 gene responsible f or producing the protein alpha-1 antitrypsin (A AT ) and leads to low levels of AAT . This def iciency results in an imbalance that allows relatively unopposed protease activity to cause destruction in the lungs . The liver, and less likely the skin (panniculitis) , can also be af f ected . Alpha 1-Proteinase Inhibitor (Aralast NP, Glassia, Prolastin C, Zemaira [human]) willbe considered for coverage when the following criteria are met:Alpha 1-Antitrypsin Deficiency (AATD)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a pulmonologist; AND 3. Member has a diagnosis of clinically evident emphysema due to severe AATD; AND 4. Member is a never-smoker or has been a non-smoker f or at least 3 months; AND 5. Member is in compliance with any prescribed supportive therapy (at least one) (e.g., bronchodilators, pulmonary rehabilitation, oxygen); AND 6. Chart notes must include lab reports showing ALL of the f ollowing: a) Pre-treatment alpha1-antitrypsin (AAT) serum level less than 11 micromol/L (or equivalent ) b) High risk genotype ( e.g., Pi*ZZ, Pi*ZNull, Pi*NullNull) c) Pre-treatment FEV1 is 65% predicted or less; AND 7. Member has NOT had a liver transplant. Dosage allowed/Quantity limit: 60 mg/kg once weekly IV inf usion . If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Member continues to abstain f rom smoking; AND2. At least ONE of the f ollowing: a) AAT level at or above protective threshold (11 micromol/L) b) Slowed rate of FEV1 decline per spirometry results c) CT densitometry demonstrates slowed progression of anatomic lung disease OH-MED-P – 366685 If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Alpha1-Proteinase Inhibitor (Aralast NP, Glassia, Prolastin C, Zemaira [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. DAT EACT ION/DESCRIPT ION 07/14/2020 Transf erred to new template; revised and updated content . 06/29/2023 Transf erred to new template. Updated and added ref erences. Removed lower FEV limit and rate of decline. Added liver transplant exclusion. 4/9/2025 Approved by ODM Ref erences: 1. 2021 Geo rg ia Co d e Title 33 Insurance Chap ter 20A-Manag ed Health Care Plans Article 2-Patient’s Rig ht toInd ep end ent Review 33-20A-31 Def initio ns . Justia US Law. Accessed Ap ril 25, 2023. http s://law.justia.co m/co d es/g eo rg ia/2021/title-33/chap ter-20a/article-2/sectio n-33-20a-31/ .2. Sto ller JK. Treatment o f alp ha-1 – antitryp sin d ef iciency. Up To Date. http ://www.up to d ate.co m. Up d ated July 13,2020. Accessed July 13,2020.3. Marciniuk DD, Hernand ez P, Balter M, et al. Alp ha-1 antitryp sin d ef iciency targ eted testing and aug mentatio n therap y: a Canad ian Tho racic So ciety clinical p ractice g uid eline [p ub lished co rrectio n ap p ears in Can Resp ir J.2012 Jul-Aug ;19(4):272]. Can Resp ir J. 2012;19(2):109-116. d o i:10.1155/2012/9209184. Sand haus RA, Turino G, Brantly ML, et al. The Diag no sis and Manag ement o f Alp ha-1 Antitryp sin Def iciency in the Ad ult. Chro nic Ob structive Pulmo nary Diseases: Jo urnal o f the COPD Fo und atio n. 2016;3(3):668-682. d o i:10.15326/jco p d f .3.3.2015.01825. Miravitlles M, Dirksen A, Ferraro tti I, et al. Euro p ean Resp irato ry So ciety statement: d iag no sis and treatment o f p ulmo nary d isease in 1-antitryp sin d ef iciency. Eur Resp ir J 2017; 50: 1700610[http s://d o i.o rg /10.1183/13993003.00610-2017].6. Gtzsche PC, Jo hansen HK. Intraveno us alp ha 1 antitryp sin aug mentatio n therap y f o r treating p atients with alp ha 1 antitryp sin d ef iciency and lung d isease. Co chrane Datab ase o f Systematic Reviews 2016, Issue 9. Art.No .: CD007851. DOI: 10.1002/1465185 8.CD0 078 51.p ub 3.7. Glo b al Initiative f o r Chro nic Ob structive Lung Disease (GOLD). Glo b al Strateg y f o r Preventio n, Diag no sis, andManag ement o f COPD : 202 3 Rep o rt. www.g o ld co p d .o rg (Accessed June 28, 2023 ).8. Aralast NP [p rescrib ing inf o rmatio n]. Taked a Pharmaceuticals U.S.A., Inc.; 2023.9. Glassia [p rescrib ing inf o rmatio n]. Taked a Pharmaceuticals U.S.A., Inc.; 2022.10. Pro lastin C[p rescrib ing inf o rmatio n]. Grif o ls Therap eutics LLC; 2020.11. Zemaira [p rescrib ing inf o rmatio n]. CSL Behring LLC; 2022.12. Chap man KR, Cho ro sto wska-Wynimko J, Ko czulla AR, Ferraro tti I, McElvaney NG. Alp ha 1 antitryp sin to treat lung d isease in alp ha 1 antitryp sin d ef iciency: recent d evelo p ments and clinical imp licatio ns. Int JChron ObstructPulmon Dis . 2018;13:419-432. Pub lished 2018 Jan 31. d o i:10.2147/COPD.S14942913. Dummer J, Do b ler CC, Ho lmes M, et al. Diag no sis and treatment o f lung d isease asso ciated with alp ha o ne-antitryp sin d ef iciency: A p o sitio n statement f ro m the Tho racic So ciety o f Australia and New Zealand . Respirology .2020;25(3):321-3 35. d o i:10.1111/resp .13774Ef f ective d ate: 0 4 /01/2024 Revised d ate: 06/29/2023
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