IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Dysport (abobotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Dysport is a neurotoxin produced from Clostridium botulinum serotype A. It works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. Dysport was initially approved by the FDA in 2009 and is approved for the treatment of adults with cervical dystonia and for the treatment of spasticity in patients 2 years of age and older . Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head.Dysport (abobotulinumtoxinA) will be considered for coverage when the following criteria are met:C ervical DystoniaFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist or other specialist experienced with treating cervical dystonia; AND 3. Member has a documented diagnosis of moderate to severe cervical dystonia with dystonic symptoms localized to the head, neck, shoulder areas. 4. Dosage allowed /Quantity limit: Up to 1000 units every 12 weeks, divided among affected muscles. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show improved severity, disability, or pain compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months . SpasticityFor initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury; AND IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20235. Member has tried or is unable to try one conventional treatment modality such as physical therapy or oral medication (e.g. baclofen, tizanidine).6. Dosage allowed /Quantity limit: Adult: Not to exceed 1500 total units every 12 weeks (given intramuscularly as a divided dose among affected muscles). Pediatric: Not to exceed 1000 total units or 30 units per kg (whichever is lower) every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g., decrease in severity of increased muscle tone). If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Dysport (abobotulinumtoxinA) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION 08/06/2018 New policy for Dysport created. Diagnoses of Blepharospasm and Upper extremity dystonia (e.g. writers cramp) are no longer covered. Diagnoses of Spasticity and Lower Limb spasticity combined, patient weight and age are no longer required. Criterion no in fection at proposed injection site removed from Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. 08/17/2020 Cervical dystonia : Added age limit and specialist requirement. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Corrected the dose. Extended re-auth duration. Updated references. Spasticity : Add age and specialist. Update to match latest drug label. Relaxed list of co-existing conditions. Added trial of conventional treatment. Extended initial auth duration. Added reference. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Annual review; no changes 11/14/2023 Cervical dystonia : removed Symptoms affect quality of life and daily functions . Updated references and clarified renewal criteria. References: 1. Dysport [package insert]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 202 3. 2. MCG 20th Edition, 2016. 3. Clinical use of botulinum toxin. National Institutes of Health Consensus Development Conference Statement, November 12-14, 1990. Arch Neurol . 1991;48(12):1294-1298. 4. Benecke R, Jost WH, Kanovsky P, et al, A New Botulinum Toxin Type A Free of Complexing Proteins for Treatment of Dystonia, Neurology, 2005, 64(11):1949-51. 5. Borodic GE and Pearce LB, New Concepts in Botulinum Toxin Therapy, Drug Saf, 1994, 11(3):145-52. 6. Jankovic Jand BrinMF, Therapeutic Uses of Botulinum Toxin, NEngl JMed,1991, 324(17):1186-94. 7. Naumann Mand Jankovic J, "Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis," Curr Med Res Opin, 2004, 20(7):981-90. 8. Russman BS, Tilton A, Gormley ME Jr. Cerebral palsy: a rational approach to a treatment protocol, and the role of botulinum toxin in treatment. Muscle Nerve Suppl . 1997;6:S181-S193. 9. Fishman LM, Anderson C, Rosner B. BOTOX and physical therapy in the treatment of piriformis syndrome. Am JPhys Med Rehabil . 2002;81(12):936-942. doi:10.1097/00002060-200212000-00009. 10. Simpson DM, Gracies JM, Graham HK, et al. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology . 2008;70(19):1691-1698. doi:10.1212/01.wnl.0000311391.00944.c4. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202311. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-706. 12. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 70:1707-14. 13. Keam SJ, Muir VJ, Deeks ED. Botulinum toxin A (Dysport): in dystonias and focal spasticity. Drugs 2011;71(8):1043-58. 14. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826. doi:10.1212/wnl.0000000000002560 15. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission. 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 16. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 17. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 18. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 19. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 Effective date: 04/01/2024 Revised date: 11/14/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Rituximab (Rituxan, Truxima, Ruxience, Riabni)BENEFIT TYPE Medical STATUS Prior Authorization Required Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-Band mature B-lymphocytes. Upon binding to CD20, rituximab mediates B-cell lysis. Bcells are believed to play a role in the pathogenesis of rheumatoid arthri tis (RA) and associated chronic synovitis. In this setting, Bcells may be acting at multiple sites in the autoimmune/inflammatory process.Rituximab will be considered for coverage when the following criteria are met:Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)For initial authorization: 1. Member is 2 years old or older; AND 2. Medication must be prescribed by or in consultation with a nephrologist or rheumatologist; AND 3. Member has a diagnosis of ONE of the following: a) Severe GPA or MPA, b) Non-severe GPA or MPA (non-organ threatening, non-life-threatening) refractory to glucocorticoid in combination with methotrexate or mycophenolate mofetil (MMF); AND 4. Rituximab will be initiated in combination with glucocorticoids; AND 5. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 6. Dosage allowed/Quantity limit: Please refer to the dosing and administration section of the package insert. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes demonstrate clinical improvement of disease signs and symptoms. If all the above requirements are met, the medication will be approved for an additional 12 months. Pemphigus Vulgaris (PV)For initial authorization: 1. Member is 18 years old or older; AND 2. Must be prescribed by or in consultation with a dermatologist; AND 3. Member has a documented diagnosis of moderate to severe PV ; AND 4. Rituximab will be initiated in combination with a corticosteroid taper (unless contraindicated); AND IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20235. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 6. Dosage allowed/Quantity limit: Initial: Two 1000mg doses separated by 2 weeks; Maintenance: 500mg infusion at month 12 and every 6 months thereafter or based on clinical evaluation. Relapse: 1000mg infusion. Subsequent infusions may be administered no sooner than 16 weeks following the previous infusion. If all the above requirements are met , the medication will be approved for 12 months . For reauthorization : 1. Chart notes demonstrate clinical improvement of signs and symptoms (e.g. healed lesions, fewer new lesions, etc.) If all the above requirements are met, the medication will be approved for an additional 12 months. Rheumatoid Arthritis (RA)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication is being prescribed by or in consultation with a rheumatologist; AND 3. Member has a documented diagnosis of moderately-to severely-active RA; AND 4. Rituximab is being used in combination with methotrexate, or another non-biologic DMARD if unable to tolerate methotrexate; AND 5. Member must have inadequate response or intolerance to ONE or more tumor necrosis factor (TNF) antagonists (e.g. adalimumab, etanercept, infliximab) for at least 3 months each. Note: TNF antagonists require prior authorization; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: Two 1000mg doses separated by 2 weeks; subsequent courses repeated no sooner than every 16 weeks (every 24 weeks is typical). If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes demonstrate improvement of RA signs and symptoms (e.g. fewer number of painful and swollen joints, achievement of remission, etc.) If all the above requirements are met, the medication will be approved for an additional 12 months. Acquired Thrombotic Thrombocytopenic Purpura (aTTP)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with a hematologist; AND 3. Member has a presumptive or confirmed diagnosis of aTTP including ALL of the following: a) Lab results showing thrombocytopenia (platelet count less than 150,000); b) Microangiopathic hemolytic anemia (MAHA) confirmed by presence of schistocytes on blood smear; IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 c) Documentation of a PLASMIC score between 5 and 7 (intermediate to high risk);1. Testing shows an ADAMTS13 activity level less than 10%, OR test has been ordered and results are pending. 4. Members platelet count has not responded after at least 4 days of plasma exchange and glucocorticoid; AND 5. Rituximab is being used in addition to plasma exchange and glucocorticoid; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: 375mg/m2 once weekly for 4 doses (off label). If all the above requirements are met , the medication will be approved for 30 days.For reauthorization :1. Member is experiencing a relapse of symptoms (thrombocytopenia and MAHA); AND 2. ADAMTS13 activity is less than 20% (lab report required). If all the above requirements are met, the medication will be approved for an additional 30 days.Neuromyelitis Optica Spectrum Disorder (NMOSD)For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of NMOSD and is seropositive for aquaporin-4 (AQP4) IgG antibodies (documentation required); AND 4. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 5. Dosage allowed/Quantity limit: 1g on day 1 and day 15, then 1g every 6 months (off label) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must document disease stabilization, symptom improvement, and/or reduced frequency of relapses. 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: 5/16/2023Generalized Myasthenia Gravis (gMG)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member meets ONE of the following: a) Member has a documented diagnosis of gMG that is seropositive for MuSK antibodies AND has tried and failed corticosteroid treatment with or without a non-steroid immunosuppressant b) Member has a documented diagnosis of refractory gMG that is seropositive for AChR antibodies AND has tried and failed ALL of the following: pyridostigmine, corticosteroid, and at least 2 non-steroid immunosuppressives (e.g., azathioprine, mycophenolate mofetil, tacrolimus); AND 4. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 5. Dosage allowed/Quantity limit: Consult updated clinical literature for recommendations. A variety of regimens have shown efficacy. (Off label use) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must document clinically meaningful improvement in symptom severity and functioning compared to previous treatment. If all the above requirements are met, the medication will be approved for an additional 12 months. Multiple Sclerosis (MS)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of MS, including documentation of baseline relapse rate, lesion count, and/or disability status (e.g., EDSS) ; AND 4. Member has documentation of ONE of the following: a) For primary progressive MS (PPMS): Trial and failure of Ocrevus b) For relapsing forms of MS (RMS): Trial and failure of at least 2 preferred disease-modifying drugs indicated for MS; AND 5. Rituximab will not be used concurrently with another disease-modifying drug for MS; AND 6. If the request is for a non-preferred product, member has had a trial of a preferred product where applicable, or acceptable clinical reason must be provided as to why it cannot be used. See Appendix A for named preferred and non-preferred products. 7. Dosage allowed/Quantity limit: Consult updated clinical literature for recommendations. (Off label use) If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Chart notes must indicate a positive clinical response such as lower relapse rate compared to baseline (i.e., for RMS) or overall stability of disease (i.e., for PPMS). 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: 5/16/2023Immune Thrombocytopenia (ITP)For initial authorization: 1. Medication is prescribed by or in consultation with a hematologist; AND 2. Member has a documented diagnosis of ITP of at least 6 months duration; AND 3. Members platelet count is
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Zilbrysq (zilucoplan)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Zilbrysq, approved by the FDA in 2023, is a C5 complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are antiacetylcholine receptor (AChR) antibody positive. Approval was based on results of the Phase 3 RAISE study. Myasthenia gravis is an autoimmune disorder affecting the neuromuscular junction, characterized by muscle weakness and fatigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AChR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Ocular motility, swallowing, speech, mobility, and respiratory function can all be affected. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed for MG. It eases symptoms by slowing the breakdown of acetylcholine. If control is inadequate, immunosuppressive treatment is added, such as prednisone and/or azathioprine. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency.Zilbrysq (zilucoplan) will be considered for coverage when the following criteria are met:Myasthenia GravisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist ; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive for AChR antibodies; AND 5. Member has tried and failed at least 1 conventional therapy: A. Pyridostigmine B. Corticosteroid for at least 3 months C. Non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months; AND 6. Member has received meningococcal vaccine. 7 . Dosage allowed/Quantity limit: SubQ once daily based on actual body weight: a)
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Yutiq (fluocinolone acetonide)BENEFIT TYPE Medical STATUS Prior Authorization Required Yutiq is a 0.18 mg fluocinolone acetonide intravitreal implant that was approved by the FDA in 2018. It is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and lasts 36 months. Uveitis is an inflammation of the uvea (middle layer of the eye). It can be infectious or non-infectious. Non-infectious uveitis (NIU) is often associated with inflammatory conditions such as rheumatoid arthritis. If the anterior segment of the uvea is aff ected, it can be treated with topical glucocorticoids. If resistant or affecting the intermediate or posterior segments, more invasive or systemic treatment is needed.Yutiq (fluocinolone acetonide) will be considered for coverage when the following criteria are met:Uveitis For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of chronic (1 year or more) non-infectious uveitis affecting the posterior segment of the eye ; AND 4. Member has tried and failed at least one of the following for at least 3 months: a) Systemic corticosteroid (e.g., prednisone) b) Non-biologic immunosuppressive (e.g., mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus); AND 5. Member does not have any active or suspected infections in or around the eye. 6. Dosage allowed/Quantity limit: One implant (0.18 mg) per eye Limit: 2 implants (1 per eye) per 36 months If all the above requirements are met , the medication will be approved for 3 months. For reauthorization : 1. Chart notes must show improved or stabilized visual acuity following treatment and/or an improved vitreous haze score ; AND 2. At least 36 months have elapsed since the prior treatment (of the same eye) ; AND 3. Member has recurrent symptoms . If all the above requirements are met , the medication will be approved for an additional 3 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 CareSource considers Yutiq (fluocinolone acetonide) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION11/02/2021 New policy created for Yutiq . 10/18/2023 Updated references. References: 1. Yutiq [prescribing information]. EyePoint Pharmaceuticals US, Inc.; 2022. 2. Jaffe GJ, Pavesio CE; Study Investigators. Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results. Ophthalmology . 2020;127(10):1395-1404. doi:10.1016/j.ophtha.2020.04.001 3. Steeples LR, Pockar S, Jones NP, Leal I. Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment. Clin Ophthalmol . 2021;15:1433-1442. Published 2021 Apr 7. doi:10.2147/OPTH.S216912 4. Reddy A, Liu SH, Brady CJ, Sieving PC, Palestine AG. Corticosteroid implants for chronic non-infectious uveitis. Cochrane Database Syst Rev . 2023;1(1):CD010469. Published 2023 Jan 16. doi:10.1002/14651858.CD010469.pub3 5. Tan HY, Agarwal A, Lee CS, et al. Management of noninfectious posterior uveitis with intravitreal drug therapy. Clin Ophthalmol . 2016;10:1983-2020. Published 2016 Oct 13. doi:10.2147/OPTH.S89341 6. Wu X, Tao M, Zhu L, Zhang T, Zhang M. Pathogenesis and current therapies for non-infectious uveitis. Clin Exp Med. 2023;23(4):1089-1106. doi:10.1007/s10238-022-00954-6 Effective date: 04/01/2024 Revised date: 10/18/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Xipere (triamcinolone )BENEFIT TYPE Medical STATUS Prior Authorization Required Xipere, approved by the FDA in 2021, is an injectable suspension formulation of triamcinolone acetonide, indicated for the treatment of macular edema associated with uveitis. It is injected into the suprachoroidal space to deliver the medication to the choroid and retina at the back of the eye. Xipere is currently the only FDA approved medication administered by this particular route and the first specifically for macular edema associated with uveitis. It was approved based on results of the phase 3 PEACHTREE trial. Xipere will compete with t he intravitreal injectable, Triesence, and with the intravitreal implants, i.e., Retisert, Ozurdex, and Yutiq. Uveitis is an inflammation of the uvea (middle layer of the eye). It can be infectious or non-infectious. Non-infectious uveitis (NIU) is often associated with inflammatory conditions such as rheumatoid arthritis. Approximately one-third of uveitis patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for central vision. Suprachoroidal administration is a more targeted technique which has shown to lessen the risk of the ocular adverse effects of intravitreal corticosteroids and systemic adverse effects of oral corticosteroids.Xipere (triamcinolone) will be considered for coverage when the following criteria are met:Uveitic Macular Edema For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a diagnosis of non-infectious uveitis (pan, anterior, intermediate, or posterior) ; AND 4. Member has a diagnosis of macular edema associated with uveitis; AND 5. Documentation of best corrected visual acuity (BCVA) at baseline; AND 6. Member does not have any active or suspected ocular or periocular infections . 7. Dosage allowed/Quantity limit: 4 mg (0.1mL) via suprachoroidal injection every 12 weeks (per eye) QL: 2 vials per 12 weeks If all the above requirements are met , the medication will be approved for 3 months . For reauthorization : 1. Chart notes must show improved or stabilized visual acuity following treatment and/or reduction from baseline in central subfield thickness (CST) 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 Xipere (triamcinolone) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION11/10/2021 New policy for Xipere created. 10/05/2023 Corrected dosing interval. Added QL. Added references. References: 1. Xipere [prescribing information]. Clearside Biomedical, Inc; 2022. 2. Yeh S, Khurana RN, Shah M, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial. Ophthalmology . 2020;127(7):948-955. doi:10.1016/j.ophtha.2020.01.006 3. Price KW, Albini TA, Yeh S. Suprachoroidal Injection of Triamcinolone-Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis. US Ophthalmic Rev . 2020;13(2):76-79. doi:10.17925/usor.2020.13.2.76 4. Khurana RN, Merrill P, Yeh S, et al. Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA) [published online ahead of print, 2021 Mar 12]. Br JOphthalmol . 2021;bjophthalmol-2020-317560. doi:10.1136/bjophthalmol-2020-317560 5. Singer MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal CLS-TA versus Rescue Therapies for the Treatment of Uveitic Macular Edema: A Post Hoc Analysis of PEACHTREE [published online ahead of print, 2021 Nov 6]. Clin Exp Ophthalmol . 2021;10.1111/ceo.14024. doi:10.1111/ceo.14024 6. Merrill PT, Henry CR, Nguyen QD, Reddy A, Kapik B, Ciulla TA. Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial [published online ahead of print, 2021 Aug 18]. Ocul Immunol Inflamm . 2021;1-8. doi:10.1080/09273948.2021.1954199 7. Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am JManag Care. 2023;29(2 Suppl):S19-S28. doi:10.37765/ajmc.2023.89324 8. Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther . 2023;12(1):577-591. doi:10.1007/s40123-022-00603-x Effective date: 04/01/2024 Revised date: 10/05/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Xeomin (incobotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Xeomin is a neurotoxin produced from Clostridium botulinum serotype A. Xeomin works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. Blepharospasm is the abnormal contraction of eyelids. Xeomin is indicated for the treatment or improvement of blepharospasm in adults . Cervical dystonia (also known as spasmodic torticollis) involves the involuntary contractions of the neck that cause abnormal movements and postures of the neck and head. Xeomin is indicated for the treatment or improvement of cervical dystonia in adults. Chronic sialorrhea, or excessive drooling, is a common symptom for patients with Parkinsons Disease or other neurological or cognitive impairments. Xeomin is indicated for the treatment or improvement of chronic sialorrhea in patients 2 years of age and older . Xeomin is also indicated for the treatment or improvement of upper limb spasticity in adults and in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy . Xeomin (incobotulinumtoxinA) will be considered for coverage when the following criteria are met:B lepharospasmFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or ophthalmologist; AND 3. Member has a diagnosis of blepharospasm, characterized by spasms inducing narrowing or closure of the eyelids. 4. Dosage allowed /Quantity limit: Not to exceed 50 units per eye (100 units per treatment session) every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , lessening of involuntary contraction). If all the above requirements are met, the medication will be approved for an additional 12 months . Cervical DystoniaFor initial authorization: 1. Member is at least 18 years of age ; AND IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20232. Medication must be prescribed by or in consultation with a neurologist or other specialist experienced with treating cervical dystonia; AND3. Member has a documented diagnosis of moderate to severe cervical dystonia with dystonic symptoms localized to the head, neck, shoulder areas. 4. Dosage allowed /Quantity limit: Up to 300 units every 12 weeks, divided among affected muscles. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show improved severity, disability, or pain compared to baseline. If all the above requirements are met, the medication will be approved for an additional 12 months . C hronic SialorrheaFor initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has diagnosis of chronic sialorrhea impacting quality of life for at least 3 months; AND 4. Member has tried and failed or has a contraindication to at least one anticholinergic drug (e.g. scopolamine, benztropine, glycopyrrolate, amitriptyline). 5. Dosage allowed /Quantity limit : May repeat no sooner than every 16 weeks . Adult : Pediatric : If all the above requirements are met, the medication will be approved for 16 weeks. For reauthorization : 1. Chart notes have been provided that show the member has improvement of signs and symptoms of disease. 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: 5/16/2023Spasticity (upper limb)For initial authorization: 1. Member is at least 2 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of UPPER limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try a conservative treatment approach such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed /Quantity limit: (adult and pediatric) Maximum of 400 units per treatment session, every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , decrease in severity of increased muscle tone). If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Xeomin (incobotulinumtoxinA) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION 08/06/2018 New policy for Xeomin created. Age requirement removed for diagnoses of Cervical Dystonia and Upper Limb Spasticity. Criterion no infection at proposed injection site removed from Cervical Dystonia diagnosis; pain and abnormal head position requirements clarified and medications trial added. For Upper Limb Spasticity Ashworth scale requirement removed, post-stroke requirement and chart notes requirement of abnormal muscle tone documentation added. 04/05/2019 New indication of Chronic Sialorrhea added. Dose allowance increased for diagnosis of Cervical Dystonia. Trial of Botox removed form diagnosis of Blepharospasm. 06/09/2020 Edited criteria for Chronic Sialorrhea to more closely align with Myobloc simplified exclusion criteria and added trial of anticholinergics. Changed qty limit at top of document. 08/24/2020 Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing. Added reference. Cervical dystonia : Added age limit and specialist requirement. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Corrected the dose. Extended re-auth duration. Updated references. Spasticity : Added age and specialist. Added trial of conventional treatment. Extended initial auth duration. Corrected the dose. Added references. Label recently expanded to include pediatrics. 12/31/2020 Updated the age limit and dosing for chronic sialorrhea to include pediatric patients, per recent label change. Added a couple references. Changed from try 2 anticholinergics to try 1 anticholinergic. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Allowing higher dose for cervical dystonia. 11/14/2023 Cervical dystonia: removed Symptoms affect quality of life and daily functions. Updated references and clarified renewal criteria. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 References: 1. Xeomin [package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023. 2. Teasell R, et al. Evidence to practice: botulinum toxin in the treatment of spasticity post stroke. Top Stroke Rehabil. 2012 Mar-Apr;19(2):115-21. 3. Chen R, et al. Botulinum toxin for Post-stroke Limb Spasticity. Ischemic Stroke Therapeutics. 2016; 203-207. 4. Cameron MH, et al. Botulinum toxin for symptomatic therapy in multiple sclerosis. Curr Neurol Neurosci Rep. 2014 Aug;14(8):463. 5. Bavikatte G, Sit PL, Hassoon A. Management of Drooling of Saliva. BJMP. 2012;5(1):a507. [https://www.bjmp.org/content/management-drooling-saliva ]6. Pellegrini A, Lunetta C, et. al. Sialorrhea: How to manage a frequent complication of motor neuron disease. EMJ Neurol . 2015;3[1]:107-113. [ https://emj.emg-health.com/wp-content/uploads/sites/2/2018/02/Sialorrhoea-How-to – Manage-a- Frequent-Complication-of-Motor-Neuron-Disease.pdf ] 7. Jost WH, Friedman A, Michel O, et al. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism & Related Disorders . 2020;70:23-30. doi:10.1016/j.parkreldis.2019.11.024 8. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology. 2016;86(19):1818-1826. doi:10.1212/wnl.0000000000002560 9. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission. 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 10. Defazio G, Hallett M, Jinnah HA, Berardelli A. Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology . 2013;81(3):236-240. doi:10.1212/WNL.0b013e31829bfdf6 11. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 12. Seppi K, Chaudhuri KR, Coelho M, et al. Update on treatments for nonmotor symptoms of Parkinson's disease an evidence based medicine review. Movement Disorders . 2019;34(2):180-198. doi:10.1002/mds.27602 13. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 14. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 15. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 Effective date: 04/01/2024 Revised date: 11/14/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Soliris (eculizumab)BENEFIT TYPE Medical STATUS Prior Authorization Required Soliris is a C5 Complement inhibitor initially approved by the FDA in 2007. It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis , atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy , generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive, and neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. PNH is a rare hematopoietic stem cell disorder in which activation of the complement system destroys red blood cells . aHUS is a type of t hrombotic microangiopathy (TMA) , a group of syndromes defined by the presence of hemolytic anemia, low platelets and organ damage due to microscopic blood clots in the capillaries . Unlike typical HUS, aHUS is usually genetic . The three main signs of aHUS are hemolytic anemia, thrombocytopenia, and acute kidney failure. Of note, the other type of TMA is called thrombotic thrombocytopenic purpura (TTP); Soliris is not used to treat TTP.Soliris (eculizumab) will be considered for coverage when the following criteria are met:Paroxysmal N octurnal H emoglobinuria (PNH)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication is prescribed by or in consultation with a hematologist; AND 3. Member has a diagnosis of PNH as confirmed by flow cytometry; AND 4. Member has a lactate dehydrogenase (LDH) level >1.5x upper limit of normal (ULN); AND 5. Member has at least one PNH-related sign/symptom e.g., fatigue, hemoglobin 10% (to rule out TTP); AND 5. Member has tried and failed or is unable to try Ultomiris; AND 6. Member has received meningococcal vaccine. 7. Dosage allowed/Quantity limit: Pediatrics: See weight-based dosing in package insert. Adults: 900mg IV weekly x 4 weeks, then 1200mg 1 week later, then 1200mg every 2 weeks thereafter. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Chart notes must demonstrate hematologic normalization as evidenced by increased platelet count or LDH maintained below upper limit of normal; AND 2. Improved or preserved kidney function. If all the above requirements are met, the medication will be approved for an additional 12 months . Generalized Myasthenia Gravis (gMG)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see Appendix); AND 4. Lab result in chart notes shows the member is seropositive for AChR antibodies ; AND 5. Member has tried and failed at least 1 conventional therapy: a) Pyridostigmine b) Corticosteroid for at least 3 months c) Non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months; AND 6. Member has tried and failed or is unable to try Ultomiris (requires trial of IV Vyvgart) ; AND 7. Member has received meningococcal vaccine. 8. Dosage allowed/Quantity limit: 900 mg IV weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization :1. Chart notes must demonstrate improvement in activities of daily living, muscle strength, and/or health related quality of life; fewer exacerbations or hospitalizations, or reduced use of rescue medication. 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: 5/16/2023N euromyelitis O ptica Spectrum D isorder (NMOSD)For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of NMOSD and is seropositive for aquaporin-4 (AQP4) IgG antibodies ; AND 4. Member had had 1 or more relapses within the past year; AND 5. Member has tried and failed at least one of the following for 6 months or longer: azathioprine, mycophenolate, rituximab (requires prior auth); AND 6. Member has received meningococcal vaccine. 7. Dosage allowed/Quantity limit: 900 mg IV weekly for the first 4 weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200 mg every 2 weeks thereafter. If all the above requirements are met , the medication will be approved for 6 months . For reauthorization : 1. Chart notes must document disease stabilization, symptom improvement, and/or reduced frequency of relapses . If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Soliris (eculizumab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION11/14/2017 New policy for Soliris created. 10/26/2019 New diagnosis of Neuromyelitis optica spectrum disorder (NMOSD) added . 10/15/2020 Revised criteria for NMOSD to align with other products. Only require at least 1 relapse in past year. Added trial of a standard therapy. Added trial of Enspryng. Reworded the criteria for meningitis vaccine. Removed the part about stable immunosuppressive therapy (just assessed for study purpose). Removed restrictions on prior Rituxan, mitoxantrone, IVIG (only applicable to the study design). Changed initial auth duration to 6 months. Edited the renewal criteria to be more appropriate. Also corrected the dose info rmation error. Changed to nonpreferred drug status. 02/08/2021 gMG: Updated references. Added specialist requirement. Removed MG-ADL score. Amended prerequisite drugs to more closely match guidelines and literature. Removed clinical trial exclusion criteria. Reduced initial auth duration to 6 months. Revised renewal c riteria 06/02/2021 aHUS: Updated references. Added specialist requirement. Revised diagnostic parameters. Removed list of restrictions from clinical trials. Stated Ultomiris as preferred. Amended dosing information. Revised renewal criteria. PNH: Updated references. Added age limit. Removed nephrology as specialist. Removed transfusion and organ damage requirements. Preference for Ultomiris. Amended dosing information. Reduced initial auth duration from 12 months to 6 months. Revised renewal c riteria. 07/25/2023 Transferred to new template. PNH: Updated references . Added that they must be symptomatic . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023aHUS: Updated and added references. Corrected ADAMTS13 level cutoff. Changed evidence of hemolysis to evidence of MAHA . NMOSD: Added references. Removed requirement for trial of Enspryng. MG: Added reference. Removed severe, refractory and added MGFA class II-IV . Added MGFA appendix. Added trial of Ultomiris. Shortened and simplified list of conventional therapy trials.APPENDIX: References: 1. 2021 Georgia Code Title 33 Insurance Chapter 20A-Managed Health Care Plans Article 2-Patient's Right to Independent Review 33-20A-31 Definitions . Justia US Law. Accessed April 25, 2023. https://law.justia.com/codes/georgia/2021/title-33/chapter-20a/article-2/section-33-20a-31/.2. Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals Inc; 2020. 3. Hillmen P, Young NS, Schubert J, et. al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. NEng JMed. 2006;355:1233-1243. Doi: 10.1056/NEJMMoa061648. 4. Brodsky RA, Young NS, Antonioli E, et. al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobulinemia. Blood. 2008;111:1840-1847. Doi: 10.1182/blood-2007-06-094136. 5. Sahin F, Akay OM, Ayer M, et al. Pesg PNH diagnosis, follow-up and treatment guidelines. Am JBlood Res . 2016;6(2):19-27. Published 2016 Aug 5 . 6. Parker CJ. Update on the diagnosis and management of paroxysmal nocturnal hemoglobinuria. Hematology Am Soc Hematol Educ Program. 2016;2016(1):208-216. doi:10.1182/asheducation-2016.1.208 7. Devos T, Meers S, Boeckx N, et al. Diagnosis and management of PNH: Review and recommendations from a Belgian expert panel. Eur JHaematol. 2018;101(6):737-749. doi:10.1111/ejh.13166 8. Patriquin CJ, Kiss T, Caplan S, et al. How we treat paroxysmal nocturnal hemoglobinuria: A consensus statement of the Canadian PNH Network and review of the national registry. Eur JHaematol . 2019;102(1):36-52. doi:10.1111/ejh.13176 9. Bod I, Amine I, Boban A, et al. Complement Inhibition in Paroxysmal Nocturnal Hemoglobinuria (PNH): A Systematic Review and Expert Opinion from Central Europe on Special Patient Populations. Adv Ther. 2023;40(6):2752-2772. doi:10.1007/s12325-023-02510-4 10. Legendre CM, Licht C, Muus P, et. al. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. NEng JMed. 2013;368:2169-2181. Doi: 10.1056/NEJMMoa1208981. 11. Kato H, Nangaku M, Hataya H, et al. Clinical guides for atypical hemolytic uremic syndrome in Japan. Clin Exp Nephrol . 2016;20(4):536-543. doi:10.1007/s10157-016-1276-6 12. Loirat C, Fakhouri F, Ariceta G, et al. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. Pediatr Nephrol. 2016;31(1):15-39. doi:10.1007/s00467-015-3076-8 13. Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev . 2021;3(3):CD012862. Published 2021 Mar 23. doi:10.1002/14651858.CD012862.pub2 14. Tseng MH, Lin SH, Tsai JD, et al. Atypical hemolytic uremic syndrome: Consensus of diagnosis and treatment in Taiwan. JFormos Med Assoc . 2023;122(5):366-375. doi:10.1016/j.jfma.2022.10.006 15. Lee H, Kang E, Kang HG, et al. Consensus regarding diagnosis and management of atypical hemolytic uremic syndrome. Korean JIntern Med. 2020;35(1):25-40. doi:10.3904/kjim.2019.388 16. Scully M, Goodship T. How I treat thrombotic thrombocytopenic purpura and atypical haemolytic uraemic syndrome. Br JHaematol . 2014;164(6):759-766. doi:10.1111/bjh.12718 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202317. Howard Jr, James F., et al. "Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study." The Lancet Neurology 16.12 (2017): 976-986. 18. Dhillon, Sohita. "Eculizumab: A Review in Generalized Myasthenia Gravis." Drugs 78.3 (2018): 367-376. 19. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology . 2016;87(4):419-425. doi:10.1212/WNL.0000000000002790 20. Narayanaswami P, Sanders DB, Wolfe G, et al. International Consensus Guidance for Management of Myasthenia Gravis: 2020 Update. Neurology . 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 21. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. JClin Med. 2022;11(6):1597. Published 2022 Mar 14. doi:10.3390/jcm11061597 22. Weinshenker B. Neuromyelitis Optica Spectrum Disorder. NORD (National Organization for Rare Disorders). https://rarediseases.org/rare-diseases/neuromyelitis-optica/. Published August 25, 2020. Accessed October 2, 2020. 23. Kessler RA, Mealy MA, Levy M. Treatment of Neuromyelitis Optica Spectrum Disorder: Acute, Preventive, and Symptomatic. Curr Treat Options Neurol . 2016;18(1):2. doi:10.1007/s11940-015-0387-9 24. Mealy MA, Wingerchuk DM, Palace J, Greenberg BM, Levy M. Comparison of relapse and treatment failure rates among patients with neuromyelitis optica: multicenter study of treatment efficacy. JAMA Neurol. 2014;71(3):324-330. doi:10.1001/jamaneurol.2013.5699 25. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. NEngl JMed . 2019;381(7):614-625. doi:10.1056/NEJMoa1900866 26. Pardo S, Giovannoni G, Hawkes C, Lechner-Scott J, Waubant E, Levy M. Editorial on: Eculizumab in aquaporin4-positive neuromyelitis optica spectrum disorder. Mult Scler Relat Disord. 2019;33:A1-A2. doi:10.1016/j.msard.2019.07.001 27. Frampton JE. Eculizumab: A Review in Neuromyelitis Optica Spectrum Disorder [published correction appears in Drugs. 2020 Apr 21;:] [published correction appears in Drugs. 2020 Apr 22;:]. Drugs. 2020;80(7):719-727. doi:10.1007/s40265-020-01297-w 28. Pittock SJ, Fujihara K, Palace J, et al. Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension. Mult Scler . 2022;28(3):480-486. doi:10.1177/13524585211038291 29. Aungsumart S, Youngkong S, Dejthevaporn C, et al. Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis. Front Neurol . 2023;14:1166490. Published 2023 Apr 4. doi:10.3389/fneur.2023.1166490 30. Wingerchuk DM, Zhang I, Kielhorn A, et al. Network Meta-analysis of Food and Drug Administration-approved Treatment Options for Adults with Aquaporin-4 Immunoglobulin G-positive Neuromyelitis Optica Spectrum Disorder. Neurol Ther . 2022;11(1):123-135. doi:10.1007/s40120-021-00295-8 Effective date: 01/01/2024 Revised date: 07/25/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Rystiggo (rozanolixizumab-noli)BENEFIT TYPE Medical STATUS Prior Authorization Required Rystiggo is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive. Approval was based on the Phase 3 MycarinG study. It is the second FcRn antagonist to be approved; the first was Vyvgart , however, Vyvgart is not approved for the MuSK population. Myasthenia gravis is an autoimmune disorder affecting the neuromuscular junction, characterized by muscle weakness and fatigue. The cause is an antibody-mediated immunologic attack directed at proteins in the postsynaptic membrane of the neuromuscular junction, most commonly the acetylcholine receptor (90%). Autoantibodies attack the AC hR, blocking or destroying the receptors and damaging the neuromuscular junction, which impairs neuromuscular transmission and prevents muscles from contracting, as acetylcholine is unable to activate its receptor. Ocular motility, swallowing, speech, mobility, and respiratory function can all be affected. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed for MG. It eases symptoms by slowing the breakdown of acetylcholine. If control is inadequate, immunosuppressive treatment is added, such as prednisone and/or azathioprine. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency.Rystiggo (rozanolixizumab-noli) will be considered for coverage when the following criteria are met:Myasthenia GravisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix); AND 4. Lab result in chart notes shows the member is seropositive for AChR or MuSK antibodies; AND 5. Member has tried and failed at least 1 conventional therapy: A. pyridostigmine B. corticosteroid for at least 3 months C. non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months. 6. Dosage allowed/Quantity limit: Subcutaneous infusion once weekly for 6 weeks as 1 cycle of treatment; subsequent treatment cycles are based on clinical evaluation and must be at least 63 days apart. QL: 18 vials per 42 days If all the above requirements are met , the medication will be approved for 6 months . IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must document clinically meaningful improvement in symptom severity and daily functioning compared to pre-treatment baseline (e.g., improved MG-ADL or QMG scores) ; AND 2. Treatment cycles are being prescribed at least 63 days apart. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Rystiggo (rozanolixizumab-noli) 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/DESCRIPTION07/05/2023 New policy for Rystiggo created.Appendix:MG Foundation of America (MGFA) Clinical ClassificationClass I any ocular weakness; all other muscle strength is normal Class II mild weakness affecting other than ocular muscles; may also have ocular weakness at any level Class III moderate weakness affecting other than ocular muscles; may also have ocular weakness at any level Class IV severe weakness affecting other than ocular muscles; may also have ocular weakness at any level Class V defined by intubation, with or without mechanical ventilation References: 1. Rystiggo [prescribing information]. UCB Inc.; 2023. 2. Narayanaswami P, Sanders DB, Wolfe G, et al. International Consensus Guidance for Management of Myasthenia Gravis: 2020 Update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 3. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425. doi:10.1212/WNL.0000000000002790 4. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. JClin Med. 2022;11(6):1597. Published 2022 Mar 14. doi:10.3390/jcm11061597 5. Bril V, Drud A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol . 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7 Effective date: 01/01/2024 Revised date: 07/05/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Prevymis (letermovir)BENEFIT TYPE Pharmacy or Medical STATUS Prior Authorization Required Prevymis is a terminase complex inhibitor initially approved by the FDA in 2017. It is indicated for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) and adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative). Prevymis works by inhibiting the CMV DNA terminase complex which is required for viral DNA processing and packaging.Prevymis ( letermovir) will be considered for coverage when the following criteria are met:HSCT CMV ProphylaxisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with an infectious disease specialist, hematologist, or transplant specialist; AND 3. Member is the recipient of an allogeneic stem cell transplant; AND 4. Member must be CMV-seropositive; AND 5. Prescriber attests Prevymis will be initiated within 28 days post-transplant ; AND 6. Member is not currently taking the following: a) Pimozide b) Ergot Akaloids ( ergotamine, dihydroergotamine) c) Pitavastatin or Simvastatin with Cyclosporine 7. For the IV formulation: Documentation must be submitted that the member cannot tolerate or has a contraindication to the oral tablet. 8. Dosage allowed/Quantity limit: Administer 4 80 mg once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant. Quantity Limit: 28 tablets or vials per 28 days. NOTE: If PREVYMIS is given with cyclosporine, the dosage of Prevymis should be decreased to 240 mg once daily. If all the above requirements are met , the medication will be approved for 100 days . For reauthorization : 1. Medication will not be reauthorized. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Kidney Transplant CMV ProphylaxisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an infectious disease specialist, hematologist, or transplant specialist; AND 3. Member is the recipient of a kidney transplant; AND 4. Member must be at high risk (donor CMV-seropositive and recipient CMV seronegative); AND 5. Prescriber attests Prevymis will be initiated within 7 days post-transplant ; AND 6. Member is unable to use valganciclovir; AND 7. Member is not currently taking the following: a. Pimozide b. Ergot Akaloids ( ergotamine, dihydroergotamine) c. Pitavastatin or Simvastatin with Cyclosporine 8. For the IV formulation: Documentation must be submitted that the member cannot tolerate or has a contraindication to the oral tablet. 9. Dosage allowed/Quantity limit : Administer 480 mg once daily orally or as an intravenous (IV) infusion over 1 hour through 200 days post-transplant. Quantity Limit: 28 tablets or vials per 28 days. NOTE: If PREVYMIS is given with cyclosporine, the dosage of Prevymis should be decreased to 240 mg once daily. If all the above requirements are met, the medication will be approved for 200 days. For reauthorization : 1. Medication will not be reauthorized. CareSource considers Prevymis (letermovir) 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/DESCRIPTION02/14/2022 New policy for Prevymis created. 07/05/2023 Added kidney transplant indication; added quantity limit; added references; added medical benefit option References: 1. Prevymis [package insert]. County Carlow, Ireland: Merck Sharp & Dohme Corporation; June 2023. 2. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. NEngl JMed. 2017; 377(25):2433-44. 3. Kropeit D, McCormick D, Erb-Zohar K, et al. Pharmacokinetics and safety of the anti-human cytomegalovirus drug letermovir in subjects with hepatic impairment. Br JClin Pharmacol. 2017a;83(12):2678-2686. 4. Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation 2018; 102:900. 5. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13512. doi:10.1111/ctr.13512 6. Limaye AP, Budde K, Humar A, et al. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA . 2023;330(1):33-42. doi:10.1001/jama.2023.9106 Effective date: 01/01/2024IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 Revised date: 07/05/2023
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Enzyme Replacement Therapy (ERT) for Fabry Disease: Fabrazyme (agalsidase beta) and Elfabrio (pegunigalsidase alfa – iwxj ) BENEFIT TYPE Medical STATUS Prior Authorization Required Fabrazyme is an enzyme replacement therapy (ERT) indicated f or the treatment of conf irmed Fabry disease, to replace the enzyme alpha-galactosidase A (alpha-Gal A).Fabry disease, a lysosomal storage disorder, is a rare genetic disease caused by certain mutations of the GLA gene resulting in def icient alpha-Gal A. Normally this enzyme breaks down certain lipids in lysosomes, such as globotriaosylceramide (GL-3). Without it, GL-3 accumulates in blood vessels, the kidneys, heart, nerves, and other organs. The continuous build-up of GL-3 results in progressive cell damage and subsequent symptoms and manif estations in the af f ected organ systems. Elf abrio is a biobetter of Fabrazyme and was designed to have an increased half-lif e and reduced immunogenicity. ERT for Fabry Disease will be considered for coverage when the following criteria aremet:Fabry DiseaseFor initial authorization: 1. For Fabrazyme: Member is at least 2 years of age OR f or Elf abrio: Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a medical geneticist, nephrologist, cardiologist, neurologist, or metabolic specialist ; AND 3. Member has a diagnosis of Fabry disease conf irmed by genetic testing which identif ies a pathogenic mutation of the GLA gene; AND 4. Member displays symptoms of Fabry disease (i.e., neuropathic pain, renal disease, cardiac disease, abdominal pain, impaired sweating) NOTE: Exception — Males with “classic” gene variants do not need to be symptomatic to qualif y f or treatment. Males with “non-classic” gene variants and asymptomatic f emales may be treated if there is evidence of injury to the heart, kidney, or central nervous system (CNS) ; AND 5. ERT will NOT be used in combination with Galaf old. 6. Dosage allowed/Quantity limit: 1 mg/kg every 2 weeks as an IV inf usion . If all the above requirements are met , the medication will be approved for 6 months .For reauthorization :1. Chart notes must show positive clinical response such as stabilized kidney f unction (e.g., GFR, proteinuria), reduced plasma or tissue GL-3 levels, or other improved Fabry symptoms (such as neuropathic pain) . If all the above requirements are met , the medication will be approved for an additional 12 months .IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023CareSource considers ERT for Fabry Disease 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 E ACT ION/DESCRIPT ION06/17/2021 New policy f or Fabrazyme created.11/22/2022 Annual review; added ref erence.06/28/2023 Changed name of policy and added Elf abrio. Clarif ied note in #4. Ref erences:1. Fab razyme (ag alsid ase b eta) [p ackag e insert]. Camb rid g e, MA; Genzyme Co rp o ratio n; Revised 03/2021. 2. Laney DA, Bennett RL, Clarke V, et al. Fab ry d isease p ractice g uid elines: reco mmend atio ns o f the Natio nal So ciety o f Genetic Co unselo rs. JGenet Couns . 2013;22(5):555-564. d o i:10.1007/s10897-013-961 3-3 3. Ho p kin RJ, Jef f eries JL, Laney DA, et al. The manag ement and treatment o f child ren with Fab ry d isease: A United States-b ased p ersp ective. Mol Genet Metab . 2016;117(2):104-11 3. d o i:10.1016/j.ymg me.2015.10.007 4. Banikazemi M, Bultas J, Wald ek S, et al. Ag alsid ase-b eta therap y f o r ad vanced Fab ry d isease: a rand o mized trial. Ann Intern Med . 2007;146(2):77-86. d o i:10.7326/0003-4819-14 6-2-2 00 701 16 0-001 48 5. Eng CM, Guf f o n N, Wilco x WR, et al. Saf ety and ef f icacy o f reco mb inant human alp ha-g alacto sid ase A rep lacement therap y in Fab ry’s d isease. NEngl JMed . 2001;345(1):9-16. d o i:10.1056/NEJM20010705345 01 02 6. Lend ers M, Brand E. Fab ry Disease: The Current Treatment Land scap e. Drugs . 2021;81(6):635-64 5. d o i:10.1007/s40265-021-01 486-1 7. Ortiz A, Germain DP, Desnick RJ, et al. Fab ry d isease revisited : Manag ement and treatment reco mmend atio ns f o r ad ult p atients. Mol Genet Metab . 2018;123(4):416-427. d o i:10.1016/j.ymg me.2018.02.014 8. Germain DP, Fo uilho ux A, Decramer S, et al. Co nsensus reco mmend atio ns f o r d iag no sis, manag ement and treatment o f Fab ry d isease in p aed iatric p atients. Clin Genet . 2019;96(2):107-117. d o i:10.1111/cg e.13546 9. Elf ab rio . [p rescrib ing inf o rmatio n]. Chiesi USA, Inc.; 2023. 10. Schif f mann R, Go ker-Alp an O, Ho lid a M, et al. Peg unig alsid ase alf a, a no vel PEGylated enzyme rep lacement therap y f o r Fab ry d isease, p ro vid es sustained p lasma co ncentratio ns and f avo rab le p harmaco d ynamics: A 1-year Phase 1/2 clinical trial. JInherit Metab Dis . 2019;42(3):534-5 44. d o i:10.1002/jimd .12080 11. Stud y o f the Saf ety and Ef f icacy o f PRX-102 Co mp ared to Ag alsid ase Beta o n Renal Functio n (BALANCE). ClinicalTrials.g o v Id entif ier: NCT02795676. Up d ated 10/13/22. Accessed 6/16/23. Availab le at http s://clinicaltrials.g o v/ct2/sho w/NCT02795676 12. Germain DP, Altarescu G, Barriales-Villa R, et al. An exp ert co nsensus o n p ractical clinical reco mmend atio ns and g uid ance f o r p atients with classic Fab ry d isease. Mol Genet Metab . 2022;137(1-2):49-61. d o i:10.1016/j.ymg me.2022.07.010 13. Bieg straaten M, Arng rmsso n R, Barb ey F, et al. Reco mmend atio ns f o r initiatio n and cessatio n o f enzyme rep lacement therap y in p atients with Fab ry d isease: the Euro p ean Fab ry Wo rking Gro up co nsensus d o cument. Orphanet JRare Dis . 2015;10:36. Pub lished 2015 Mar 27. d o i:10.1186/s13023-015-025 3-6 Ef f ective d ate: 01/01/2024Revised d ate: 06/28/2023
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