Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy StatementINDIANA MEDICAID PLANSPolicy Name Policy Number Date Effective Multi-ingredient Compound Policy PAD-0045-IN-MCD 01/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ………………………………………………………………………………………. 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ……………………………………………………………………………………………. 2 F. Related Policies/Rules …………………………………………………………………………………………….. 3 G. Review/Revision History …………………………………………………………………………………………… 3 H. References …………………………………………………………………………………………………………….. 4 Pharmacy Multi-ingredient Compound Policy Indiana Medicaid Plans PAD-0045-IN-MCD Effective Date: 01/01/2025 A. Subject Pharmacy Multi-ingredient Compound Policy. 2 B. BackgroundPharmacy compounding is defined as the combining, mixing or altering of ingredients to create a customized medication for a specific patient. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient. C. Definitions Multi-ingredient Compound a product containing two or more ingredients that is not FDA approved and is prepared upon the order of a physician for a patient. D. Policy All multi-ingredient compounds (except topical pain compounds) will be considered medically necessary when ALL of the following criteria are met: I. The primary active ingredients in the compound are approved by the FDA for the indication, age or route of administration; OR II. If any active ingredient in the compound is not FDA approved for the requested indication, age, or route of administration, must have evidence from TWO published studies from major scientific or medical peer-reviewed journals to support the use of the compound as safe and effective AND III. The active ingredients are prescribed in therapeutic amounts based on FDA approved indications AND IV. The compound contains only one active ingredient per any specific therapeutic class of drugs as defined by First Data Bank AND V. If a compound is similar to a commercially available product but differs in dosage, dosage form, or inert ingredient (such as flavoring, dye, or preservative), chart notes are required from the prescriber supporting the need for the compound (i.e. documented difficulty or inability to swallow oral dosage forms, documented allergies to inactive ingredients) AND VI. If any ingredient in the compound, active or inactive, otherwise requires prior authorization, the member must meet criteria established for medical necessity for that ingredient AND VII. The member has tried and failed a trial at least 3 preferred medications (if available) that can be used to treat the members condition. Trial dates must be included with prior authorization request AND VIII. Compound will not be covered under the following circumstances: 1. The compound is being used for an excluded benefit (e.g., cosmetic, obesity, sexual dysfunction, infertility, etc.) 2. The compound contains ingredients that were withdrawn or removed from the market for safety reasons 3. The compound is for a product that is commercially available 4. The compound is for purposes of convenience only. Topical pain compounds will be considered medically necessary when ALL of the following criteria are met: I. Member must have a diagnosis of chronic moderate to severe pain associated with neuropathic pain or nociceptive pain AND Pharmacy Multi-ingredient Compound Policy Indiana Medicaid Plans PAD-0045-IN-MCD Effective Date: 01/01/2025 3 II. Member must have tried at least 3 of the following drugs from different groups for at least 30 days each:a. Non-opioid oral medications or a documented contraindication b. Diclofenac sodium gel 1% or over-the-counter (OTC) Voltaren gel c. Topical lidocaine (e.g., lidocaine cream 3%, 4%, lidocaine patch 4%) d. Topical capsaicin AND III. The compound contains no more than 1 active ingredient per any specific drug class as defined by First Data Bank AND IV. The compound contains no more than 3 drug classes for active ingredients AND V. The compound does NOT contain any controlled substances AND VI. The active ingredients must be FDA approved or compendia supported for topical use and for the pain indication. Reauthorization: Pain compound: Member must have documented improvement of pain supported by chart notes (defined as improvement of at least 3 points on a 0 to 10 point pain scale) All other compounds: Evidence of effectiveness and safety for compound must be documented in chart notes for continuation of approval. Additional notes: Reimbursement will not be provided for additives such as flavorings, dyes, or preservatives. Requests resulting from a drug shortage will be considered on a case-by-case basis. E. Conditions of Coverage HCPCS CPT AUTHORIZATION PERIOD Initial approval: 3 months or prescribers requested length of therapy (if shorter than 3 months) Reauthorization: 12 months F. Related Policies/Rules Medical Necessity-Off Label Medicaid Drug Rebate Program (MDRP) Coverage Rules AC Reject G. Review/Revision History DATES ACTIONDate Issued 07/01/2016 Initial Release to P&P CommitteeDate Revised 08/01/2016 2016 Annual Review with No Changes 06/01/2017 2017 Annual Review with No Changes02/01/2018 Updated criteria to limit compounds to having one ingredient per drug class and 30 day trial of preferred medications Pharmacy Multi-ingredient Compound Policy Indiana Medicaid Plans PAD-0045-IN-MCD Effective Date: 01/01/2025 4 06/11/2020 Policy moved to the new template. No changes.11/30/2021 Updated criteria to include requirement of 2 published studies for off-label requests, reauth criteria, approval durations. Added separate criteria set for pain compounds. Revised trial requirement to be 3 preferred medications. Changed MediSpan to First Data Bank. Removed not medically necessary section under Additional notes.11/16/2022 Added individual ingredieents must be FDA Approved via indication, age and ROA; Added MDRP Coverage Rules AC Reject policy reference. 5/21/2024 Annual review, no changes.Date Effective 01/01/2025Date Archived H. ReferencesN/A The Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved.IN-MED-P-354604 8; Issued Date: 04/14/2025 OMPP Approval Date: 03/06/2025
Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy Statement INDIANA MEDICAID Policy Name Policy Number Date Effective Lost, Stolen, Damaged, Vacation and School Supply of Medication PAD-0091-IN-MCD 01/01/2025 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ………………………………………………………………………………………. 1 A. Subject ………………………………………………………………………………………………………………….. 2 B. Background ……………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy ……………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ……………………………………………………………………………………………. 2 F. Related Policies/Rules ……………………………………………………………………………………………… 3 G. Review/Revision History …………………………………………………………………………………………… 3 H. References …………………………………………………………………………………………………………….. 3 2 A. Subject Lost, Stolen, Damaged, Vacation, School Supply of Medication INDIANA MEDICAID PAD-0091-IN-MCD Effective Date: 01/01/2025Early refill override requests due to reports of additional medication needed beyond initial dispensing.B. Background The CareSource pharmacy benefit design places limits on how early a member can refill a prescription. This limit is intended to ensure appropriate and cost-effective use of medications. A pharmacy may request an exception to the refill-too-soon threshold on behalf of a member by calling the pharmacy help desk. This policy serves as guidance for the Pharmacy Help Desk and CareSource operations team member processing of member and pharmacy requests for an override for an early refill resulting from: Lost medication Stolen medication Damaged medication Out of state or out of country travel Separate supply for separated households, school or daycare C. Definitions I. Refill-Too-Soon An early refill; additional medication that is requested following an earlier-dispensed medication request but sooner than allowed by the members coverage benefits. II. Override Authorization for early refill that allows the claim to process at the point of sale (at the pharmacy) III. Refill-Too-Soon Threshold The date before which a claim for a medication refill will reject at the point-of-sale. When a pharmacy attempts to fill a medication refill before this threshold, the rejection message at the point of sale will provide the refill-too-soon threshold date. D. Policy I. The pharmacy help desk will provide a refill-too-soon override in the following circumstances: A. For a lost medication override, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months. The days supply allowed by the refill-too-soon override will be subject to standard days supply coverage restrictions (30-or 90-days, depending on the medication and the plan). B. For a stolen medication override, the pharmacy help desk will place a single refill -3 too-soon override per medication (including strength) per rolling twelve (12) months when member attests that the theft has been reported to the police. Note: Attestation can be relayed through the pharmacy. Documentation is not required. C. For a refill-too-soon override related to damaged medication, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months when the medication was not damaged as a result of pharmacy action or in the process of shipment to the member. a. If the request is for a blood glucose or continuous glucose monitor that is malfunctioning, the member should confirm the manufacturer has been contacted for assistance and was unable to resolve the issue. b. If medication damage occurs as a result of pharmacy action or in the process of shipment to the member, the pharmacy is responsible for replacing the damaged medication. D. For a refill-too-soon override related to member travel, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) per rolling twelve (12) months when ALL of the following are met: a. The member is traveling to a location where a network, rostered pharmacy is not available, AND b. The days supply of the refill-too-soon request is subject to the plans benefit limits. E. For a refill-too-soon override related to additional medication supply to be provided to a separate household, school or daycare, the pharmacy help desk may place refill-too-soon overrides for medications that are in unbreakable packaging (such as inhalers or epinephrine injectors) when needed. F. For members requesting a refill-too-soon supply due to permanent relocation to a new address out-of-state, the pharmacy help desk will place a single refill-too-soon override per medication (including strength) for up to a 30-day supply. II. The pharmacy help desk will NOT provide a refill-too-soon override when ANY of the following circumstances is true: A. The requested medication is an opioid, B. The total cost of the damaged medication is greater than $8,000, C. The loss or damage is a result of an action on the part of the pharmacy or shipping company, D. The member has already received a refill-too-soon override for the requested medication for any reason in the previous rolling twelve (12) months, E. The requested days supply of the medication exceeds plan benefit limits (30-or 90-days supply, depending on the medication and plan), OR F. The requested medication is not a Covered product under the plan (including products that are not CMS rebateable). III. All requests for refill-too-soon overrides not permitted by the pharmacy help desk are subject to review and approval or denial by the CareSource Pharmacy Operations team. Any overrides not permitted by the pharmacy help desk will be considered at the discretion of the CareSource Pharmacy Operations team in consultation with the Markets when appropriate. 4 E. Related Policies/Rules F. Review/Revision History Lost, Stolen, Damaged, Vacation, School Supply of Medication INDIANA MEDICAID PAD-0091-IN-MCD Effective Date: 01/01/2025 DATES ACTIONDate Issued 01/22/2022Date Revised 06/28/2024 Complete review with updated criteria and restrictions Date Effective 01/01/2025 Date Archived G. ReferencesThe Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved.IN-MED-P-354604 6; Issued Date: 04/14/2025 OMPP Approval Date: 03/06/2025
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Bevacizumab (Alymsys, Avastin, Mvasi, Zirabev)BILLING CODE See below BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient STATUS Prior Authorization Required Bevacizumab was initially approved by the FDA in 2004 as Avastin. Since then, the FDA approved Mvasi (2017), Zirabev (2019), Alymsys (2022), and Vegzelma (2022) as biosimilars to Avastin. Bevacizumab is approved for use in the treatment of metastatic color ectal cancer. All oncology treatments, including bevacizumab, must be submitted to Eviti Connect for review via the NantHealth Eviti Connect portal . For additional information and details, please refer to the CareSource policystatement Oncology Treatment Regimen Review. Approval of Avastin, Alymsys, or Vegzelma requires trial of Mvasi and Zirabev. The off-label use of Avastin (bevacizumab) for intravitreal use is considered safe and efficacious by the ophthalmologic community as reported by the American Academy of Ophthalmology (AOO). While Avastin (bevacizumab) has not been FDA approved for ophthalmic indications, compelling evidence has been published of its widespread clinical use for the following conditions: Choroidal neovascularization (CNV) in age-related macular degeneration (AMD) Proliferative diabetic retinopathy Neovascular glaucoma Diabetic macular edema Retinal and iris neovascularization Macular edema following branch and central retinal vein occlusions CareSource does not require a Prior Authorization for the use of Avastin (bevacizumab) in Ophthalmology and is considered medically reasonable and necessary only when furnished by a qualified Ophthalmologist. Reimbursement under this policy is dependent on, but not limited to meeting the following: Billing codes J3490 and J3590 will be reimbursed as follows, when billed with NDC 50242-0061-01 or 50242-0060-01: 1. For units 1 to 1.25, reimbursement is up to $70.00 per eye, per calendar month. 2. For units 2 to 2.50, reimbursement is up to $140.00 for both eyes, pe r calendar month. It is the responsibility of the submitting provider to submit accurate documentation of services performed. Providers are expected to use the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code i n a policy does not imply any right to reimbursement or guarantee claims payment. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION12/13/ 2022 New policy for Avastin (bevacizumab) use in ophthalmology billing guidance 10/5/2023 Added trial of Mvasi and Zirabev . Added link to Eviti Connect portal. 1/9/2025 Removed billing code J7999 (not covered). References: 1. Alymsys. Package insert . Amneal Pharmaceuticals LLC; 2022. 2. Avastin. Package insert. Genentech; 2004. 3. Mvasi. Package insert. Amgen Inc; 2017. 4. Zirabev. Package insert. Pfizer Inc; 2019. 5. What is Avastin https://www.aao.org/eye-health/drugs/avastin 6. “Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices-Information Sheet. (2018, July 12). Retrieved October 29, 2018, from https://www.fda.gov/regulatoryinformation/guidances/ucm126486.htm 7. Avastin Prescribing Information https://www.gene.com/download/pdf/avastin_prescribing.pdf 8. CMS Billing and Coding: Bevacizumab and biosimilars https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52370&keyword=&areaId=all&docType=6,3,5,1,F,P&contractOption=all&hcp csOption=code&hcpcsStartCode=J9035&hcpcsEndCode=J9035&sortBy= title&bc=1#:~:text=Bevacizumab%20sh ould%20be%20reported%20with,MVASI)%2C%2010%20mg). 9. CMS Intraocular Bevacizumab Billing and Coding Guidelines https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=53008&ver=35& Effective date: 04 /01/2024 Revised date: 10/5/2023
IN-MED-P -366647 OMPP Approved Template on: 01/22/2021PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Daxxify (DaxibotulinumtoxinA-lanm )BENEFIT TYPE Medical STATUS Prior Authorization Required Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia in adult patients . It was designed to have a longer duration of effect than other botulinum neurotoxin products and may also have a lower incidence of dysphagia side effects . Cervical dystonia, also known as spasmodic torticollis, is a painful , chronic neurological condition characterized by involuntary contractions of neck muscles, leading to abnormal movements and awkward postures of the head, neck, and shoulders . Botulinum toxin products are first line treatment. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -total score is used to assess the severity and treatment success of cervical dystonia, and its change from baseline was the primary outcome in the Phase 3 ASPEN-1 clinical trial, in which Daxxify was superior to placebo.Daxxify (DaxibotulinumtoxinA-lanm) will be considered for coverage when the following criteria are met:Cervical 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: 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles no more frequently than every three months . If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improv ed severity, disability, or pain compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Daxxify (DaxibotulinumtoxinA-lanm ) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. IN-MED-P -366647 OMPP Approved Template on: 01/22/2021DATE ACTION/DESCRIPTION10/20/2023 New policy for Daxxify created. References: 1. Daxxify [prescribing information] . Revance Therapeutics, Inc. ; 2023. 2. 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 3. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(19):1818-1826. doi:10.1212/WNL.0000000000002560 4. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia [published correction appears in JNeural Transm (Vienna). 2016 Mar;123(3):259]. JNeural Transm (Vienna) . 2016;123(3):251-258. doi:10.1007/s00702-015-1453-x 5. 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 6. 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 7. Solish N, Carruthers J, Kaufman J, Rubio RG, Gross TM, Gallagher CJ. Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs . 2021;81(18):2091-2101. doi:10.1007/s40265-021-01631-w Effective date: 04/01/2024 Revised date: 10/20/2023
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Rivfloza (nedosiran)BENEFIT TYPE Medical or Pharmacy STATUS Prior Authorization Required Rivfloza is an LDHA-directed small interfering RNA indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR 30 mL/min/1.73 m2. PH1, which is caused by mutations of the AGXT gene, is a rare autosomal recessive disease that mainly affects the kidneys. It results from buildup of oxalate, which normally is filtered through the kidneys and excreted in the urine. Stone formation (calcium oxalate) in the kidneys and urinary tract occurs, as well as elevated levels of calcium in the kidneys. Eventually, if kidney function declines far enough, oxalate can start to accumulate in other body tissues, leading to a variety of problems (systemic oxalosis).Rivfloza (nedosiran) will be considered for coverage when the following criteria are met:Primary Hyperoxaluria Type 1 (PH1) For initial authorization: 1. Member is at least 9 years of age ; AND 2. Medication must be prescribed by or in consultation with a urologist or nephrologist ; AND 3. Member has a diagnosis of primary hyperoxaluria type 1 confirmed by genetic testing that shows a mutation in the AGXT gene; AND 4. Member has documentation of elevated urinary oxalate levels (24-hour Uox excretion 0.7 mmol (per 1.73 m2 body surface area [BSA] in age
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Ozurdex (dexamethasone)BENEFIT TYPE Medical STATUS Prior Authorization Required Ozurdex is an intravitreal implant containing dexamethasone 0.7 mg. It is indicated for the treatment of retinal vein occlusion (RVO), posterior segment uveitis, and diabetic macular edema (DME). RVO occurs when there is a partial or complete obstruction of a retinal vein. Macular edema is a complication of RVO and can lead to vision loss. First-line treatment is with anti-vascular endothelial growth factor ( anti-VEGF) drugs. DME is a common consequence of diabetic retinopathy. It is caused by leakage from retinal capillaries and leads to fluid build-up in the macula part of the retina. This can result in loss of central vision. The importance of maintaining glucose control cannot be understated. 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 affected, it can be treated with topical glucocorticoids. If resistant or affecting the intermediate or posterior segments, more invasive or systemic treatment is needed. Ozurdex (dexamethasone) will be considered for coverage when the following criteria are met:Retinal Vein Occlusion (RVO) 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 documented diagnosis of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO ); AND 4. Trial and failure of or contraindication to an anti-VEGF drug; bevacizumab is the preferred product; AND 5. Member does NOT have any of the following: a) A ctive or suspected ocular or periocular infections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 4 months If all the above requirements are met, the medication will be approved for 3 months . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must include documentation of improved or stabilized visual acuity; AND 2. At least 4 months have elapsed since the prior treatment (of the same eye) . If all the above requirements are met, the medication will be approved for an additional 12 months . UveitisFor 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 documented diagnosis of 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 of the following: a) A ctive or suspected ocular or periocular infections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 6. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 6 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 6 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 12 months . Diabetic Macular Edema (DME)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with an ophthalmologist; AND 3. Member has a documented diagnosis of diabetic macular edema; AND 4. Member does NOT have any of the following: a) A ctive or suspected ocular or periocular infections b) Glaucoma with a cup to disc ratio of greater than 0.8 c) Torn or ruptured posterior lens capsule. 5. Dosage allowed/Quantity limit: One implant (0.7 mg) per eye Limit: 2 implants (1 per eye) per 3 months If all the above requirements are met , the medication will be approved for 3 months . IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For reauthorization :1. Chart notes must show improved or stabilized visual acuity following treatment; AND 2. At least 3 months have elapsed since the prior treatment (of the same eye). If all the above requirements are met, the medication will be approved for an additional 12 months . CareSource considers Ozurdex (dexamethasone) 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/DESCRIPTION11/03/2021 New policy created for Ozurdex. 10/23/2023 Updated references. Changed treatment interval from 6 months to 4 months for RVO. 07/16/2024 Updated references; changed treatment interval from 6 mo to 3 mo for DME. Extended reauth durations from 3 mo to 1 yr. References: 1. Ozurdex [prescribing information]. Allergan USA, Inc.; 2024. 2. 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 3. 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. 4. 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 5. Flaxel CJ, Adelman RA, Bailey ST, et al. Diabetic Retinopathy Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(1):P66-P145. doi:10.1016/j.ophtha.2019.09.025 6. Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev . 2020;11(11):CD005656. Published 2020 Nov 17. doi:10.1002/14651858.CD005656.pub3 7. Zur D, Iglicki M, Loewenstein A. The Role of Steroids in the Management of Diabetic Macular Edema. Ophthalmic Res . 2019;62(4):231-236. doi:10.1159/000499540 8. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, et al. Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA). Ophthalmologica . 2017;237(4):185-222. doi:10.1159/000458539 9. Yuen YS, Gilhotra JS, Dalton M, et al. Diabetic Macular Oedema Guidelines: An Australian Perspective. JOphthalmol . 2023;2023:6329819. Published 2023 Feb 14. doi:10.1155/2023/6329819 10. Flaxel CJ, Adelman RA, Bailey ST, et al. Retinal Vein Occlusions Preferred Practice Pattern [published correction appears in Ophthalmology. 2020 Sep;127(9):1279]. Ophthalmology . 2020;127(2):P288-P320. doi:10.1016/j.ophtha.2019.09.029 11. Schmidt-Erfurth U, Garcia-Arumi J, Gerendas BS, et al. Guidelines for the Management of Retinal Vein Occlusion by the European Society of Retina Specialists (EURETINA). Ophthalmologica . 2019;242(3):123-162. doi:10.1159/000502041 12. Malcles A, Dot C, Voirin N, et al. Safety of intravitreal dexamethasone implant (Ozurdex): The SAFODEX study. Incidence and risk factors of ocular hypertension. Retina. 2017;37(7):1352-1359. 13. Spinetta R, Petrillo F, Reibaldi M, et al. Intravitreal DEX Implant for the Treatment of Diabetic Macular Edema: A Review of National Consensus. Pharmaceutics . 2023;15(10):2461. Published 2023 Oct 13. doi:10.3390/pharmaceutics15102461 Effective date: 01/01/2025 Revised date: 07/16/2024
IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Uplizna (inebilizumab-cdon)BENEFIT TYPE Medical STATUS Prior Authorization Required Uplizna is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease of the central nervous system that primarily attacks the optic nerves and spinal cord leading to blindness and paralysis.Uplizna (inebilizumab-cdon) will be considered for coverage when the following criteria are met:Neuromyelitis Optica Spectrum Disorder (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 has had 1 or more relapses within the past year; AND 5. Member has tried and failed rituximab for at least 6 months (requires prior auth); AND 6. Member has tested negative for hepatitis Band tuberculosis within the past year or there is attestation they will be tested before starting treatment. 7. Dosage allowed/Quantity limit: 300mg IV infusion followed two weeks later by a second 300 mg infusion. Subsequently, (starting 6 months from the first infusion): 300 mg every 6 months . QL: 3 vials every 6 months (maintenance) 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 compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months . CareSource considers Uplizna (inebilizumab-cdon) 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/DESCRIPTIONIN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202310/02/2020 New policy for Uplizna created.07/1 7/2023 Transferred to new template. Corrected QL. 04/22/2024 Removed azathioprine, mycophenolate trial options (rituximab more effective per guidelines). 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. Uplizna [package insert]. Horizon Therapeutics; 2021. 3. 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 4. 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. 5. 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 6. IPD Analytics. Accessed October 2, 2020. 7. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363. doi:10.1016/S0140-6736(19)31817-3 Effective date: 10/01/2024 Revised date: 04/22/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Livmarli (maralixibat)BENEFIT TYPE Pharmacy Coverage Requirements Prior Authorization Required Livmarli, approved by the FDA in 2021, is an ileal bile acid transport (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC) . In cholestatic liver disease, biliary substances arent eliminated from the liver, thus they re-enter circulation. Cholestatic itch is thought to be related to the accumulation of bile acids in the skin. Inhibiting IBAT decreases reuptake of bile salts to reduce serum bile acids and pruritis. ALGS is a rare genetic disorder that can affect multiple organ systems, most commonly the liver, with a paucity of interlobular ducts. PFIC is an ultra-rare group of genetic disorders that disrupt bile formation in the liver. It usually presents during infancy with cholestasis, jaundice, and intense itching. Most patients will eventually require biliary diversion surgery or liver transplant. PFIC1 involves extrahepatic manifestations while PFIC2 does not. However, PFIC2 can be complicated by hepatocellular carcinoma . Livmarli (maralixibat) will be considered for coverage when the following criteria are met:Alagille Syndrome (ALGS)For initial authorization: 1. Member is at least 3 months of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND 3. Member has a diagnosis of Alagille syndrome (ALGS) confirmed by the involvement of at least 3 of the following abnormalities : a) Hepatic Features (e.g., hyperbilirubinemia or scleral icterus) b) Cardiac Features (e.g., lesions confirmed on imaging or murmur) c) Facial Features (e.g., inverted triangular face, straight nose with bulbous tip) d) Ocular Features (e.g., embryotoxon, optic disk drusen) e) Skeletal Features (e.g., vertebral anomalies, osteopenia f) Renal Features (e.g., renal dysplasia, renal tubular acidosis) g) Vascular Features (e.g., narrowing of internal carotid artery, moyamoya disease) 4. Member must have liver biopsy demonstrating reduced number of the interlobular bile ducts OR confirmed finding of JAG1 or NOTCH2 gene mutation; AND 5. Member has symptoms of moderate to severe pruritus ; AND 6. Member does NOT have any of the following: a) Previous liver transplant b) Previous surgical disruption of enterohepatic circulation (partial external bile diversion or ileal exclusion) c) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) d) History or presence of other concomitant liver disease IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20237. Member must have a trial and failure of at least 2 of the following:a) Cholestyramine b) Ursodiol c) Rifampin d) Naltrexone 8. Dosage allowed/Quantity limit: Starting dose is 190mcg/kg orally once daily, titrating up to 380 mcg/kg once daily. Max dose 28.5 mg (3 mL) per day. QL: 3 bottles (90 mL) per 30 days. If all the above requirements are met , the medication will be approved for 6 months. For reauthorization: 1. Pruritis has improved in response to therapy with Livmarli. If all the above requirements are met, the medication will be approved for an additional 12 months.Progressive Familial Intrahepatic C holestasis (PFIC ) For initial authorization: 1. Member is at least 5 years of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist OR hepatologist; AND 3. Member has a diagnosis of PFIC confirmed by genetic testing results: PFIC 1 (ATP8B1 mutation), PFIC2 (ABCB11 mutation), PFIC3 (ABCB4 mutation), PFIC4 (TJP2 mutation), or PFIC6 (MYO5B mutation) ; AND 4. Member has significant pruritis not attributed to another cause; AND 5. Documentation of total serum bile acid (sBA) 3 ULN; AND 6. Documentation of baseline liver function tests (e.g., ALT, AST, bilirubin, INR); AND 7. Trial and failure of ursodiol (may also continue concurrently); AND 8. Member does NOT have any of the following: a) Variants of the ABCB11 gene (PFIC type 2) that code for non-functional or complete absence of the bile salt export pump (BSEP-3) protein (per submitted genetic test result) b) Prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) c) Liver transplant . 9. Dosage allowed/Quantity limit: Starting dose is 285 mcg/kg orally once daily, titrating up to recommended dose of 570 mcg/kg twice daily. Max dose 38 mg ( 4 mL) per day. QL: 4 bottles ( 120 mL) per 30 days. If all the above requirements are met , the medication will be approved for 6 months. For reauthorization: 1. Pruritis has improved in response to therapy with Livmarli. If all the above requirements are met, the medication will be approved for an additional 12 months.CareSource considers Livmarli (maralixibat ) 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 IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202310/15/2021New policy for Livmarli created.03/28/2023 Updated/added references. Changed lower age limit from 1 year to 3 months per updated drug label. Added QL. Added naltrexone to list of trial options and removed specific trial duration. 03/28/2024 Added criteria for new PFIC indication. Expanded description of hepatic decompensation contraindication in ALGS section (to match label). References: 1. Livmarli. [Prescribing information]. Mirum Pharmaceuticals, Inc.; 2024 . 2. Shneider BL, Spino C, Kamatha BM, et al. Placebo-Controlled Randomized Trial of an Intestinal Bile Salt Transport Inhibitor for Pruritus in Alagille Syndrome. Hepatol Commun. 2018 Oct; 2(10): 1184-1198. Doi 10.1002/hep4.1244 3. Ayoub MD and Kamath BM. Alagille Syndrome: Diagnostic Challenges and Advances in Management. Diagnostics . 2020; 10(11):907. https://doi.org/10.3390/diagnostics101109074. Lin, Henry. Alagille Syndrome. National Organization for Rare Disorders; updated 2020. Accessed October 12, 2021. https://rarediseases.org/rare-diseases/alagille-syndrome/ 5. Kamath BM, Goldstein A, Howard R, et al. Maralixibat Treatment Response in Alagille Syndrome is Associated with Improved Health-Related Quality of Life. JPediatr . 2023;252:68-75.e5. doi:10.1016/j.jpeds.2022.09.001 6. Diaz-Frias J, Kondamudi NP. Alagille Syndrome. [Updated 2022 Aug 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan- . Available from: https://www.ncbi.nlm.nih.gov/books/NBK507827/7. Shirley M. Maralixibat: First Approval [published correction appears in Drugs. 2021 Dec 6;:]. Drugs . 2022;82(1):71-76. doi:10.1007/s40265-021-01649-0 8. Shneider BL, Spino CA, Kamath BM, et al. Impact of long-term administration of maralixibat on children with cholestasis secondary to Alagille syndrome. Hepatol Commun. 2022;6(8):1922-1933. doi:10.1002/hep4.1992 9. Loomes KM, Squires RH, Kelly D, et al. Maralixibat for the treatment of PFIC: Long-term, IBAT inhibition in an open-label, Phase 2 study. Hepatol Commun. 2022;6(9):2379-2390. doi:10.1002/hep4.1980 10. Gunaydin M, Bozkurter Cil AT. Progressive familial intrahepatic cholestasis: d iagnosis, management, and treatment. Hepat Med. 2018;10:95-104. Published 2018 Sep 10. doi:10.2147/HMER.S137209 11. Srivastava A. Progressive familial intrahepatic cholestasis. JClin Exp Hepatol. 2014;4(1):25-36. doi:10.1016/j.jceh.2013.10.005 Effective date: 10/01/2024 Revised date: 03/28/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Botox (onabotulinumtoxinA)BENEFIT TYPE Medical STATUS Prior Authorization Required Botox is a neurotoxin produced from Clostridium botulinum serotype A. It works through the inhibition of acetylcholine release from peripheral nerve endings, causing neuromuscular blockage and muscle paralysis. There are seven types of botulinum toxin serotypes. Only serotypes A and Bare used for medicinal purposes. Botox was initially approved in 1989 by the FDA for the treatment of b lepharospasm. Since then, Botox has gained additional therapeutic indications for overactive bladder, neurogenic detrusor overactivity , chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, and strabismus .Botox (onabotulinumtoxinA) will be considered for coverage when the following criteria are met:Primary Axillary HyperhidrosisFor initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a dermatologist; AND 3. Member has a diagnosis of severe axillary hyperhidrosis, including documentation in the chart notes of visible, excessive sweating of at least 6 months duration which significantly impairs daily activities; AND 4. Secondary causes of hyperhidrosis (e.g., hyperthyroidism) have been ruled out; AND 5. Member has tried and failed topical prescription-strength aluminum chloride (e.g. Xerac) for at least 3 0 days. 6. Dosage allowed / Quantity limit: 50 Units per axilla. Note: Medication will not be covered for treatment of hyperhidrosis in body areas other than axillary. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes have been provided that show improvement of signs and symptoms (i.e. , reduced axillary sweat production). If all the above requirements are met, the medication will be approved for an additional 12 months . B lepharospasmFor initial authorization: 1. Member is at least 12 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. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20234. Dosage allowed /Quantity limit : The cumulative dose of Botox treatment for blepharospasm in a 30-day period should not exceed 200 Units. Treatment may be repeated every 3 months. 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 .C ervical DystoniaFor initial authorization: 1. Medication must be prescribed by or in consultation with a neurologist or other specialist experienced with treating cervical dystonia; AND 2. Member has a documented diagnosis of moderate to severe cervical dystonia as evidenced by involuntary contractions of neck muscles, leading to abnormal movements or postures . 3. Dosage allowed /Quantity limit: Up to 300 units every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , severity of abnormal head position, neck pain). If all the above requirements are met, the medication will be approved for an additional 12 months . Esophageal AchalasiaFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a gastroenterologist; AND 3. Member has a diagnosis of achalasia confirmed by high resolution esophageal manometry; AND 4. Chart notes must document that the member is NOT a candidate for ALL of the following: Laparoscopic Heller myotomy, pneumatic dilation, and peroral endoscopic myotomy (POEM); AND 5. Other esophageal motility disorders and malignancy have been ruled out. 6. Dosage allowed /Quantity limit: 100 units every 6 months (off label). If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes must show the member had symptomatic improvement of dysphagia and/or regurgitation. If all the above requirements are met, the medication will be approved for an additional 12 months . M igraine Headache ProphylaxisIN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For initial authorization:1. Member is at least 18 years of age ; AND 2. Medication is being prescribed for the prevention of chronic migraine, with both of the following documented in chart notes: a) 15 headache days per month for at least 3 months; b) 8 migraine days per month for at least 3 months; AND 3. Medication must be prescribed by a neurologist or a headache specialist; AND 4. Member has tried and failed at least 1 of the following prophylactic medications for 8 weeks : a) Beta-blockers (e.g., metoprolol, timolol, or propranolol) b) Calcium channel blockers (e.g., verapamil) c) Antidepressants (e.g., amitriptyline or venlafaxine) d) Anticonvulsant (e.g., topiramate or valproic acid) e) Candesartan ; AND 5. Medication is NOT being used in combination with a prophylactic CGRP product (e.g., Emgality, Aimovig, Ajovy, or Vyepti); AND 6. Member does not have medication-overuse headaches. 7. Dosage allowed /Quantity limit: 155 Units every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Member has improvement in prevention of migraines documented in chart notes (e.g., reduced migraine frequency, reduced use of medication for acute migraines attacks). If all the above requirements are met, the medication will be approved for an additional 12 months . O veractive Bladder (OAB) For initial authorization: 1. Member is at least 18 years of age ; AND 2. Medication must be prescribed by or in consultation with a urologist or gynecologist; AND 3. Member has a diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency; AND 4. Member has tried and failed at least TWO prior pharmacologic therapies for at least 30 days each (e.g. oxybutynin, solifenacin, Myrbetriq); AND 5. Member does not have a urinary tract infection. 6. Dosage allowed /Quantity limit: 100 Units every 12 weeks. If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Chart notes have been provided that show decreased symptoms of urge urinary incontinence, urgency, and frequency. If all the above requirements are met, the medication will be approved for an additional 12 months . Spasticity IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023For initial authorization:1. Member is at least 2 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or other specialist experienced with treating spasticity (e.g., PM&R); AND 3. Member has a documented diagnosis of upper or lower limb spasticity that affects daily functioning and quality of life; AND 4. Spasticity is secondary to a neurologic condition such as cerebral palsy, stroke, or brain or spinal cord injury; AND 5. Member has tried or is unable to try one conventional treatment modality such as physical therapy or oral medication (e.g. baclofen, tizanidine). 6. Dosage allowed /Quantity limit: Adult: Not to exceed 400 total units every 12 weeks (given intramuscularly as a divided dose among affected muscles). Pediatric: Not to exceed 340 total units or 10 units per kg (whichever is lower) every 3 months. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization : 1. Chart notes show improved signs and symptoms (e.g. , decrease in severity of increased muscle tone, increased functional ability or range of motion). If all the above requirements are met, the medication will be approved for an additional 12 months . StrabismusFor initial authorization: 1. Member is at least 12 years of age ; AND 2. Medication is prescribed by or in consultation with a neurologist or ophthalmologist; AND 3. Member has a diagnosis of a strabismus type with binocular potential, unlikely to spontaneously resolve. 4. Dosage allowed: See package insert. 1 If all the above requirements are met, the medication will be approved for 6 months . For reauthorization :1. Chart notes have been provided showing that the members ocular alignment has improved. If all the above requirements are met, the medication will be approved for an additional 6 months.U rinary Incontinence (associated with neurologic condition)For initial authorization: 1. Member is at least 5 years of age ; AND 2. Medication is prescribed by or in consultation with a urologist, neurologist, or gynecologist; AND 3. Member has a diagnosis of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g. brain or spinal cord injury, stroke, multiple sclerosis, Parkinsons, spina bifida); AND 4. Member has tried and failed at least one anticholinergic medication for 30 days (e.g. oxybutynin, solifenacin, tolterodine); AND 5. Member does not have a urinary tract infection. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20236. Dosage allowed /Quantity limit : For adults and pediatric patients weighing 34kg or more: 200 units per treatment, no sooner than every 12 weeks. If weight is less than 34kg: 6mg/kg, no sooner than every 12 weeks. If all the above requirements are met, the medication will be approved for 6 months . For reauthorization :1. Chart notes have been provided that show decreased frequency of urinary incontinence. If all the above requirements are met, the medication will be approved for an additional 12 months .Anal FissureFor initial authorization: 1. Medication must be prescribed by or in consultation with a gastroenterologist or colorectal surgeon; AND 2. Member has a diagnosis of chronic anal fissure, present for at least 6 weeks ; AND 3. Member has tried and failed one of the following: a) Topical calcium channel blocker (nifedipine or diltiazem) for 8 weeks OR b) Topical nitr ate for 3 weeks . 4. Dosage allowed /Quantity limit: 20-50 units single injection. May repeat after 2 months if healing is incomplete or fissure recurs (off label). If all the above requirements are met, the medication will be approved for 3 months. For reauthorization : 1. Medication will not be re-authorized for this indication. CareSource considers Botox (onabotulinumtoxinA) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION08/03/2018 Criterion no infection at proposed injection site removed from Blepharospasm and Cervical Dystonia diagnosis. Age limitation removed from Cervical Dystonia; pain and abnormal head position requirements clarified and medications trial added. On diagnosis of Urinary Incontinence criterion Surgical treatment or balloon sphincter dilatation is not indicated, has been refused, or has failed was removed. On diagnosis of Spasticity rehabilitation program is not required anymore. Strabismus diagnosis got criter ia expanded. Lower Limb Spasticity is combined into Spasticity diagnosis. For diagnosis of Migraine Headache Prophylaxis trial length for abortive therapeutic options decreased. 01/19/2020 Updated Overactive Bladder criteria from three to two trials of an adequately titrated overactive bladder medication. 08/17/2020 Removed criteria for upper extremity focal dystonia/writers cramp (off label). Hyperhidrosis: added specialist requirement, changed re-auth duration, changed dx title to match drug label, changed the ordering, removed sweat quantification requirement and changed diagnostic phrase to match guidelines. Added reference. Blepharospasm : Extend re-auth duration to 12 mo, added specialist, re-phrased dose, revised diagnostic phrasing. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Added reference. Strabismus : Added specialist, referred dose to PI, simplified diagnostic wording. Added reference. Cervical dystonia: Added specialist. Re-worded the diagnosis requirement. Removed trial of oral medication. Removed exclusions. Added frequency to dose. Extended re-auth duration. Added references. Achalasia (off label use): added age and specialist, changed initial auth duration from 12 mo to 6mo. Removed requirement for oral therapy (not effective). Specified high resolution manometry per guideline. Included surgical procedures per guideline. Removed redundancy. Simplified other causes. Added frequency to dose. Added references. Migraine: removed symptoms and duration of migraine episode from diagnostic requirement; trial length reduced to 2 months/trial; added one of the abortive trials must be a triptan; added no concurrent use with prophylactic CGRP; removed statement about episodic migraine because not an FDA approved indication. OAB: added frequency to dose. Added specialist. Amended dx per drug label. Specified length of alternate drug trials. Added examples of drugs. Added reference. Urinary incontinence: added specialist, added frequency to dose, edited dx to match fda label wording, changed initial auth duration. Changed order of criteria to match others. Removed statement about urinary retention. Expanded examples of neurologic disease, added examples of anticholinergic, specified length of trial. Added reference. Spasticity : Add age and specialist. Update to match latest drug label. Generalized list of co-existing conditions. Added trial of conventional treatment. Extended initial auth duration. Edited dose allowed. Added reference. All: specified type of symptom improvement to look for at re-auth. 11/23/2020 Hyperhidrosis: Replaced Drysol with Xerac and changed trial length to 60 days. 02/15/2021 Per label change: Updated age to 5 yrs old for urinary incontinence due to detrusor overactivity assoc. with neurologic condition; added spina bifida to list of examples; added dosing for peds. 08/10/2021 Transferred to new template. Allowing additional specialists for cervical dystonia and spasticity indications. 03/04/2022 Annual review; no changes 11/14/2023 Cervical dystonia: removed Symptoms affect quality of life and daily functions. Updated references. 07/09/2024 Migraine: Changed from 2 prior prophylactic trials to 1 and added candesartan to list of trial options (per AHS 2024 statement). Removed requirement for trial of abortive drugs. Hyperhidrosis: Reduced topical product trial from 60 days to 30 days. Added section for anal fissure (off label). References: 1. Botox [package insert]. Madison, NJ: Allergan USA, Inc.; 2023. 2. Clinical use of botulinum toxin. National Institutes of Health Consensus Development Conference Statement, November 12-14, 1990. Arch Neurol . 1991;48(12):1294-1298. 3. Borodic GE and Pearce LB, New Concepts in Botulinum Toxin Therapy, Drug Saf, 1994, 11(3):145-52. 4. Jankovic Jand Brin MF, Therapeutic Uses of Botulinum Toxin, NEngl JMed,1991, 324(17):1186-94. 5. Naumann Mand Jankovic J, "Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis," Curr Med Res Opin, 2004, 20(7):981-90. 6. Russman, BS, Tilton, A, Gormley ME. Jr. Cerebral palsy; a rational approach to a treatment protocol, and the role of botulinum toxin in treatment, Muscle Nerve Suppl 1997; 6:S181. 7. Fishman LM, Anderson C, Rosner B. Botox and physical therapy in the treatment of Piriformis syndrome Am JPhys Med Rehabil. 2002 Dec;81(12):936-42. 8. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1699-706. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20239. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 70:1707-14. 10. Pasricha, P.J., Ravich, W.J., Hendrix, T.R., et al. M.D. Intrasphincteric Botulinum Toxin for the Treatment of Achalasia. NEngl JMed (1995); 332:774-778. March 23, 1995. DOI: 10.1056/NEJM199503233321203 11. Storr M, Born P, Frimberger E, et al. Treatment of achalasia: the short-term response to botulinum toxin injection seems to be independent of any kind of pretreatment. BMC Gastroenterology. 2002;2:19. doi:10.1186/1471-230X-2 -19. 12. Fock J, Galea MP, Stillman BC, et al. Functional outcome following Botulinum toxin A injection to reduce spastic equinus in adults with traumatic brain injury. Brain Inj. 2004;18(1):57-63. 13. Biglan AW, Burnstine RA, Rogers GL, Saunders RA. Management of strabismus with botulinum A toxin. Ophthalmology. 1989;96(7):935-943. 14. Munksgaard SB, et al. Medication overuse headache. Headache. 2014 Jul-Aug;54(7):1251-7. 15. Gmez-Caravaca MT, et al. The use of botulinum toxin in the treatment of sialorrhea in parkinsonian disorders. Neurol Sci. 2015 Feb;36(2):275-9. 16. Hornberger J, Grimes K, Naumann M, et al. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. JAm Acad Dermatol . 2004;51(2):274-286. doi:10.1016/j.jaad.2003.12.029 17. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology . 2016;86(19):1818-1826. doi:10.1212/WNL.0000000000002560 18. Defazio G, Hallett M, Jinnah HA, Berardelli A. Development and validation of a clinical guideline for diagnosing blepharospasm. Neurology . 2013;81(3):236-240. doi:10.1212/WNL.0b013e31829bfdf6 19. Rowe FJ, Noonan CP. Botulinum toxin for the treatment of strabismus. Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD006499. DOI: 10.1002/14651858.CD006499.pub4. 20. Dressler D, Altenmueller E, Bhidayasiri R, et al. Strategies for treatment of dystonia. Journal of Neural Transmission. 2015;123(3):251-258. doi:10.1007/s00702-015-1453-x 21. Khashab MA, Vela MF, Thosani N, et al. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020;91(2):213-227.e6. doi:10.1016/j.gie.2019.04.231 22. Zaninotto G, Bennett C, Boeckxstaens G, et al. The 2018 ISDE achalasia guidelines. Dis Esophagus . 2018;31(9):10.1093/dote/doy071. doi:10.1093/dote/doy071 23. Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am JGastroenterol . 2013;108(8):1238-1250. doi:10.1038/ajg.2013.196 24. The American Headache Society Position Statement on Integrating New Migraine Treatments into Clinical Practice. Headache: The Journal of Head and Face Pain. 2019;59: 1-18. 25. Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. JUrol . 2015;193(5):1572-1580. doi:10.1016/j.juro.2015.01.087 26. Groen J, Pannek J, Castro Diaz D, et al. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016;69(2):324-333. doi:10.1016/j.eururo.2015.07.071 27. Lindsay C, Kouzouna A, Simcox C, Pandyan AD. Pharmacological interventions other than botulinum toxin for spasticity after stroke. Cochrane Database of Systematic Reviews 2016, Issue 10. Art. No.: CD010362. DOI: 10.1002/14651858.CD010362.pub2. 28. Dashtipour K, Mari Z, Jankovic J, Adler CH, Schwartz M, Brin MF. Minimal clinically important change in patients with cervical dystonia: Results from the CD PROBE study. JNeurol Sci. 2019;405:116413. doi:10.1016/j.jns.2019.07.031 29. Dressler D, Adib Saberi F, Rosales RL. Botulinum toxin therapy of dystonia. JNeural Transm (Vienna). 2021;128(4):531-537. doi:10.1007/s00702-020-02266-z 30. Rodrigues FB, Duarte GS, Marques RE, et al. Botulinum toxin type A therapy for cervical dystonia. Cochrane Database Syst Rev. 2020;11(11):CD003633. Published 2020 Nov 12. doi:10.1002/14651858.CD003633.pub4 31. Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A; American Headache Society. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024;64(4):333-341. doi:10.1111/head.14692 32. Wald A, Bharucha AE, Limketkai B, et al. ACG Clinical Guidelines: Management of Benign Anorectal Disorders. Am JGastroenterol . 2021;116(10):1987-2008. doi:10.14309/ajg.0000000000001507 IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202333. Davids JS, Hawkins AT, Bhama AR, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Anal Fissures. Dis Colon Rectum. 2023;66(2):190-199. doi:10.1097/DCR.0000000000002664 34. Cross KLR, Brown SR, Kleijnen J, et al. The Association of Coloproctology of Great Britain and Ireland guideline on the management of anal fissure. Colorectal Dis . 2023;25(12):2423-2457. doi:10.1111/codi.16762 Effective date: 01/01/2025 Revised date: 07/09/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Vyvgart (efgartigimod alfa-fcab) andVyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) BENEFIT TYPE Medical STATUS Prior Authorization Required Vyvgart, approved by the FDA in 2021, is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Vyvgart is a first-in-class IgG1 antibody Fc fragment designed to reduce pathogenic IgG autoantibody levels by inhibiting IgG recycling via the neonatal Fc receptor (FcRn) and increasing IgG degradation. Vyvgart Hytrulo is a combination of efgartigamod and hyaluronidase for subcutaneous administration. Myasthenia gravis is an autoimmune disorder affecting the neuromuscular junction. It is 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 ace tylcholine is unable to activate its receptor. Pyridostigmine, an acetylcholinesterase inhibitor, is the initial drug of choice prescribed for MG. If control is inadequate, immunosuppressive treatment is added. Other drugs are used in cases of severe or refractory MG or myasthenic crisis, which is an emergency. Vyvgart Hytrulo is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) , a rare autoimmune disorder characterized by progressive peripheral neuropathy with typical and atypical phenotypes. Demyelination manifests as weakness, numbness, paresthesia, and sensory ataxia.Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be considered for coverage when the following criteria are met:Generalized 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 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. 6. Dosage allowed/Quantity limit: IV infusion (Vyvgart) or SubQ injection (Vyvgart Hytrulo) once weekly for 4 weeks (1 cycle) . Subsequent treatment cycles may take place no sooner than 50 days from the start of the previous cycle. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023Vyvgart — Weight
© Copyright CareSource 2026. All rights reserved.
System Details