IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Apretude (cabotegravir extended-release )BENEF IT TYPE Medical ST AT US Prior Authorization Required Apretude is an HIV-1 integrase strand transf er inhibitor (INSTI) initially approved by the FDA in 2021. It is indicated f or the pre-exposure prophylaxis (PrEP) of HIV inf ection in at-risk adults and adolescents weighing at least 35 kg. Apretude is the f irst injectable medication f or the prevention of HIV, taken every two months. The u se of oral cabotegravir (Vocabria) as a lead-in prior to initiating therapy with Apretude is optional.Individuals must have a negative HIV test prior to initiating Apretude to prevent drug resistance. Apretude (cabotegravir extended-release) will be considered for coverage when the following criteria are met:Pre-exposure Prophylaxis of HIV infectionFor initial authorization: 1. Member must be at least 12 years of age and weigh at least 35 kg; AND 2. Member is not a candidate f or oral PrEP (such as member has dif f iculty with adherence, signif icant renal disease, trouble swallowing pills etc.); AND 3. Member has had or will have completed an HIV RNA test bef ore initial and subsequent injections; AND 4. Provider attests member is NOT taking any of the f ollowing concomitantly with Apretude: a) Rif ampin; b) Carbamazepine, oxcarbazepine, phenobarbital or phenytoin; c) Other antiretroviral therapy. 5. Dosage allowed/Quantity limit: Initiate Apretude with a single 600-mg ( 3-mL) injection given 1 month apart f or 2 consecutive months on the last day of an oral lead-in if used or within 3 days and continue with the injections every 2 months thereaf ter. Quantity Limit: 3 mL per 56 days. If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Member has had or will have completed an HIV RNA test bef ore injections. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Apretude (cabotegravir extended-release) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy. IN-MED-P -366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023DATE ACTION/DESCRIPTION01/12/2022 New policy f or Apretude created. 05/11/2023 Simplif ied HIV RNA testing requirement and removed 7-day window; added quantity limit. 08/16/2023 Rephrased trial of oral PrEP to patient is not a candidate f or oral PrEP and added examples. 04/22/2025 Increased initial auth length to 6 months and reauth length to 12 months; added provider attestation to medications that cannot be administered with Apretude Ref erenc es : 1. Ap retud e [p ac k ag e ins ert]. Glax o SmithKline; 2025.2. Pre-ex p o sure Prophylaxis f o r the Prev entio n o f HIV Inf ec tio n in the United States 2021 Up d ate. Center f o r Dis eas e Co ntrol and Prevention. : Available at : https ://www.cdc.gov /hiv/pdf/ris k/prep/cdc-hiv-p rep-guidelines-2021 . Accessed on January 13, 2022. 3. Land o v itz RJ , Li S, Eron Jr JJ, et al. Tail-p hase s afety , tolerability, and pharmacokinetics of lo ng ac ting injec tab le c ab o teg rav ir in HIV-uninf ec ted ad ults : a s ec o nd ary analy s is o f the HPTN 077 trial. The Lanc et HIV. 2020 4. Land o v itz RJ , Donnell D, Clement ME, et al. Cabotegravir for HIV p revention in c is g end er men and trans g end er wo men. NEng l JMed . 2021;385(7):595-608. 5. Marzink e MA, Grins ztejn B, Fogel JM, et al. Charac terization of human immunodeficienc y v irus (HIV) inf ec tio n in c is g end er men and trans g end er wo men who hav e s ex with men rec eiv ing injec tab le c ab o teg rav ir f o r HIV p rev entio n: HPTN 083. Inf ec t Ds . 2021. Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 04/22/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Amvuttra (vutrisiran)BENEF IT TYPE Medical ST AT US Prior Authorization Required Amvuttra, approved by the FDA in 2022, is a transthyretin-directed small interf ering RNA indicated f or the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It is also indicated f or the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart f ailure visit . Amvuttra is a n RNA interf erence (RNAi) drug that causes degradation of mutant and wild-type TTR mRNA, which results in a reduction of serum TTR protein and TTR protein deposits in tissues by delivering t he vutisiran small interf ering RNA ( siRNA) to hepatocytes where TTR protein is synthesized . hATTR is a rare and progressive inherited disorder where misf olded TTR accumulates as amyloid f ibrils in the body. In polyneuropathy of hATTR (hATTR-PN), these fibrils deposit in the peripheral nerves which leads to pain, muscle weakness, and autonomic dysf unction. In the cardiomyopathy f orm of ATTR (ATTR-CM), the amyloid accumulates in the myocardium, resulting in heart f ailure. The hereditary f orm of ATTR (hATTR) is caused by a mutation in the TTR gene, whereas wild type ATTR (ATTRwt) is associated with aging.Amvuttra (vutrisiran) will be considered for coverage when the following criteria are met:Hereditary Transthyretin Amyloidosis (hAT TR Amyloidosis) : PolyneuropathyFor initial authorization: 1. Member is at le as t 18 years of age; AND 2. Medication must be prescribed by or in consultation with a neurologist; AND 3. Member has a diagnosis of hATTR amyloidosis with documentation of a transthyretin (TTR) mutation conf irmed by genetic testing; AND 4. Member has signs/symptoms of polyneuropathy; AND 5. Member has a polyneuropathy disability (PND) score of IIIb or less (i.e., member is not wheelchair-bound or bedridden) ; AND 6. A mvuttra will NOT be used in combination with another TTR silencer o r a TTR stabilizer . 7. Dosage allowed/Quantity limit: 25 mg subQ every 3 months, administered by a healthcare prof essional . (QL: 1 syringe per 84 days) If all the above requirements are met , the medication will be approved for 9 months . For reauthorization : 1. Chart notes must include documentation of positive clinical response to therapy such as improvement or stabilization of neuropathy impairment, gait speed, nutritional status, disability, or quality of lif e compared to baseline. 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: 5/16/2023T ransthyretin Amyloid Cardiomyopathy (AT TR-CM)For initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a cardiologist; AND 3. Member has a documented diagnosis of ATTR-CM conf irmed by one of the f ollowing (a or b): a) Endomyocardial biopsy showing amyloidosis, with conf irmatory TTR amyloid typing (by immunohistochemistry and/or mass spectrometry) b) Both of the f ollowing: i) Positive technetium-99m (99mTc) bone scintigraphy scan (Perugini grade 2 or 3 myocardial uptake), and ii) Absence of monoclonal light chains (based on both immunof ixation electrophoresis (IFE) of serum and urine, and serum f ree light chain (sFLC) analysis); AND 4. Member has lef t ventricular (LV) wall thickness 12 mm (measured by ECHO or CMR); AND 5. Member has a history of heart f ailure (HF) with at least one of the f ollowing: a) At least 1 previous hospitalization f or HF b) Signs and symptoms of volume overload or elevated intracardiac pressures c) HF symptoms that resulted in diuretic treatment; AND 6. Member has New York Heart Association (NYHA) Class I-III (not class IV) symptoms due to ATTR-CM; AND 7. A mvuttra will NOT be used in combination with another TTR silencer o r a TTR stabilizer . 8. Dosage allowed/Quantity limit: 25 mg subQ every 3 months, administered by a healthcare prof essional . (QL: 1 syringe per 84 days) If all the above requirements are met, the medication will be approved for 6 months. For reauthorization : 1. Chart notes must document a positive clinical response to therapy such as stabilized or improved f unctional capacity (e.g., distance walked on 6-minute walk test [6MWT]), reduced cardiovascular-related hospitalizations, or improved quality of lif e score. If all the above requirements are met, the medication will be approved for an additional 12 months. CareSource considers Amvuttra (vutrisiran) 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/DESCRIPTION08/01/2022 New policy f or Amvuttra created.04/19/2023 Added or stabilization to the renewal section.03/26/2025 hATTR-PN: Updated ref erences. Removed liver transplant exclusion (Karam 2024, Alcantara 2022). Added criteria f or new indication ATTR-CM. Ref erenc es : 1. Amv uttra. Pres c rib ing inf o rmatio n. Alny lam Pharmac eutic als , Inc .; 2025. 2. Ad ams D, To urnev IL, Tay lo r MS, et al. Efficacy and safety of v utris iran for p atients with hered itary trans thy retin-med iated amy loidosis with polyneuropathy: a rand omized clinical trial [publis hed o nline ahead o f p rint, 2022 Jul 23]. Amyloid . 2022;1-9. d o i:10.1080/13506129.2022.2091985IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/20233. And o Y, Adams D, Benson MD, et al. Guid elines and new d irec tio ns in the therap y and mo nito ring o f ATTRv amy lo id o s is [p ub lis hed o nline ahead o f p rint, 2022 Jun 2]. Amyloid . 2022;1-13. d o i:10.1080/13506129.2022.2052838 4. Sek ijima Y, Nakamura K. Hereditary Trans thyretin Amyloido s is . 2001 No v 5 [Up d ated 2024 May 30]. In: Ad am MP, Feld man J , Mirzaa GM, et al., editors . GeneRev iews [Internet]. Seattle (WA): Univ ers ity o f Was hing to n, Seattle; 1993-2025. Av ailab le f ro m: https://www.ncbi.nlm.nih.gov/books/NBK1194/5. Dy c k PJB, Gonzlez-Duarte A, Obici L, et al. Development of measures of polyneuropathy imp airment in hATTR amyloidosis: From NIS to mNIS+7. JNeurol Sc i. 2019;405:116424. d o i:10.1016/j.jns .2019.116424 6. Ad ams D , And o Y, Beiro JM, et al. Ex p ert c o ns ens us rec o mmend atio ns to imp ro v e d iag no s is o f ATTR amy lo id o s is with p o ly neuro p athy . JNeurol . 2021;268(6):2109-2122. d o i:10.1007/s 00415-019-09688-0 7. Karam C, Mauermann ML, Go nzalez-D uarte A, et al. Diag no s is and treatment o f hered itary trans thy retin amy lo idosis with polyneuropathy in the United States : Rec ommendations from a p anel of experts. Mus c le Nerv e. 2024;69(3):273-287. d o i:10.1002/mus .28026 8. Alc antara M, Mezei MM, Bak er SK, et al. Canad ian Guid elines f o r Hered itary Trans thy retin Amy lo id o s is Po ly neuro p athy Manag ement. Can JNeurol Sc i . 2022;49(1):7-18. d o i:10.1017/c jn.2021.34 9. Heid enreic h PA, Bo zk urt B, Ag uilar D , et al. 2022 AHA/ACC/HFSA Guid eline f o r the Manag ement o f Heart Failure: A Rep o rt of the Americ an Co llege of Card iology/American Heart Association Joint Co mmittee o n Clinic al Prac tic e Guid elines [p ub lis hed c o rrec tio n ap p ears in JAm Co ll Card io l. 2023 Ap r 18;81(15):1551. d o i: 10.1016/j.jac c .2023.03.002]. JAm Coll Cardiol. 2022;79(17):e263-e421. d o i:10.1016/j.jac c .2021.12.012 10. Dorbala S, Ando Y, Bokhari S, et al. ASNC/AHA/ASE/EANM/HFSA/ISA/SCMR/SNMMI expert consensus rec o mmendations for multimodality imaging in c ardiac amyloidosis: Part 2 of 2-Diagnostic c riteria and ap propriate utilizatio n [publis hed correc tion appears in JNuc l Card iol. 2021 Aug;28(4):1763-1767. d o i: 10.1007/s 12350-021-02712-9]. JNuc l Cardiol . 2020;27(2):659-673. d o i:10.1007/s 12350-019-01761-5 11. Dorbala S, Ando Y, Bokhari S, et al. ASNC/AHA/ASE/EANM/HFSA/ISA/SCMR/SNMMI expert consensus rec o mmendations for multimodality imaging in c ardiac amyloidosis: Part 1 of 2-ev id enc e b as e and s tand ard ized metho d s o f imag ing [p ub lis hed c o rrec tio n ap p ears in JNuc l Card io l. 2021 Aug ;28(4):1761-1762. d o i: 10.1007/s 12350-021-02711-w]. JNuc l Cardiol . 2019;26(6):2065-2123. d o i:10.1007/s 12350-019-01760-6 12. Brito D , Albrec ht FC, de Arenaza DP, et al. Wo rld Heart Fed eratio n Co ns ens us o n Trans thy retin Amy lo id o s is Cardiomyopathy (ATTR-CM). Glob Heart . 2023;18(1):59. Pub lis hed 2023 Oc t 26. d o i:10.5334/g h.1262 13. Was f y JH, Winn AN, To uc hette DR, Nik itin D , Shah KK, Ric hard s o n M, Lee W, Kim S, Rind DM. Dis eas e Mo d ifying Therap ies for the Treatment of Trans thyretin Amy loid Card iomyopathy ; Final Ev idenc e Report. Ins titute f o r Clinic al and Ec onomic Rev iew, October 21, 2024. ht tps ://icer. org /wp-content/uploads/2024/03/ICER_ATTR – CM_Final-R eport_For-Publication_10212024.pdf Ef f ec tiv e d ate: 10/01/2025 Rev is ed d ate: 03/26/2025
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 StatementINDIANA MEDICAIDPolicy Name Policy Number Date Effective Medical Necessity for Neutral Medications PAD-0003-IN-MCD 09/10/2025 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 ……………………………………………………………………………………………. 4 F. Related Policies/Rules …………………………………………………………………………………………….. 4 G. Review/Revision History …………………………………………………………………………………………… 4 H. References …………………………………………………………………………………………………………….. 4 2 A. Subject Medical Necessity for Neutral Medications Indiana Medicaid PAD-0003-IN-MCD Effective Date: 09/10/2025CareSource uses a preferred medication list that is established, reviewed and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee and the regulatory bodies in each state in which CareSource functions. The preferred is reviewed routinely, and medication can be removed from the preferred drug list when the brand name becomes generically available or when it is no longer cost-effective compared to other existing or newer products. For new drugs or new indications for drugs, the P&T Committee generally reviews for preferred status decision after 180 days from market release. CareSource will follow the guidance of the state Medicaid programs in the states that it services to enforce clinically appropriate lower cost agents as first line therapy for our preferred agents.B. Background The intent of CareSource Pharmacy Policy Statements is to encourage appropriate selection of members for therapy according to product labeling, clinical guidelines, and/or clinical studies as well as to encourage use of preferred agents. The CareSource Pharmacy Policy Statement is a guideline for determining health care coverage for our members with benefit plans covering prescription drugs. Pharmacy Policy Statements are written on selected prescription drugs requiring prior authorization or step therapy. The Pharmacy Policy Statement is used as a tool to be interpreted in conjunction with the member's specific benefit plan. NOTE: The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic or lab. This policy informs providers about when a service may be covered. C. Definitions Clinical Judgment: decisions made within the scope of the expertise of a pharmacist following the review of subjective and objective medical data for a member. A pharmacist can use Clinical Judgment for a benefit determination for an exception request for a Neutral Drug. If the request is outside the scope of a pharmacists expertise, a benefit determination will be made in collaboration with a medical director. Drug: a medication or substance which induces a physiologic effect on the body of a member (i.e., medication, agent, drug therapy, treatment, product, biosimilar drugs, etc.). Preferred Drug List: a list of prescription drugs which includes a group of selected generic and brand-name drugs which are covered by CareSource. Medical Necessity: health care services, supplies, or drugs needed to diagnose, treat or prevent illness, injury, conditions, diseases or the associated symptoms in accordance with accepted standards in the practice of medicine. Medical necessity will be evaluated based on the overall health and well-being of the member and when the members day to day health would be impacted. Neutral Drug: a drug not on the Preferred Drug List. D. Policy CareSource will approve the use of neutral medications and consider their use as medically necessary when the following criteria have been met for situations as listed below. This policy will not supersede drug-specific criteria developed and approved by the CareSource P&T Committee 3 Medical Necessity for Neutral Medications Indiana Medicaid PAD-0003-IN-MCD Effective Date: 09/10/2025 nor drug or therapeutic category benefit exclusions. Prior authorization requests should be submitted for each neutral medication with chart notes and documentation supporting medical necessity. Initial Criteria: I. In accordance with the drugs package insert, the requested medication meets ALL of the following: a. FDA-approved indication and age; b. FDA-approved dosage; c. Member does not have any contraindication; AND II. Chart notes along with any relevant screening results are provided to confirm the diagnosis; AND III. The requested medication is being prescribed by or in consultation with an appropriate specialist, when applicable (e.g., a preferred product from the same class requires a specialist in its prior authorization criteria, or the indication is a complex/rare disease state likely to require experience managing the specific diagnosis ); AND IV. Documentation has been provided supporting one of the following: a. Adequate trial and failure or intolerance of ALL preferred alternatives in the same drug class that can be used for the same diagnosis ( start/end dates must be provided or if member was a CareSource member during trial, must have paid claims in history ); OR b. If there is no alternative in the same drug class, must have adequate trial and failure or intolerance of TWO preferred alternatives, if available, that can be used for the requested indication according to clinical guidelines or standard of care ( start/end dates must be provided or if member was a CareSource member during trial, must have paid claims in history ); OR c. Member has contraindication to ALL other preferred medications based on the members diagnosis, medical conditions, or other medication therapies; OR d. There are no other medications available on the preferred to treat members condition (e.g., orphan drug); AND V. If the requested medication is a combination product, the member has also tried a 90-day trial of the active ingredients separately taken at the same time AND a clinical reason supported by chart notes why the separate agents cannot be used ( request for the purpose of convenience does not meet medical necessity ); AND VI. If the requested medication is a long-acting product, the member has also tried a 90-day trial of a short-acting product AND/OR have a clinical reason why the short-acting product cannot be used. Initial approval is limited to the length of request but no more than 6 months. Renewal Criteria: I. Chart notes have been provided showing the member has had a positive response to therapy; AND II. The requested use and dosage remain consistent with FDA-approved prescribing information in the drug package insert. Renewal approval is limited to the length of request but no more than 12 months. Notes: Adequate trial is defined as a stable dose for up to 90 days or a duration specified in treatment guidelines or package insert as a sufficient duration to observe benefit from 4 Medical Necessity for Neutral Medications Indiana Medicaid PAD-0003-IN-MCD Effective Date: 09/10/2025 treatment. The pharmacist reviewer may also use clinical judgement to determine a sufficient duration of treatment. The members medication trials and adherence are determined by review of pharmacy claim data over preceding 12 months or as reported in chart notes. Additional information may be requested on a case-by-case basis to complete the clinical review. All other uses of Neutral medications are considered experimental/investigational; therefore, will follow CareSources Medical Necessity Off Label policy. Any request for a neutral branded medication when a generic is available must follow CareSources Medical Necessity for DAW policy. E. Conditions of Coverage As above. F. Related Policies/Rules Medical Necessity for DAW Medical Necessity Off Label G. Review/Revision History DATES ACTIONDate Issued 12/06/2013Date Revised 08/01/2020 Policy copied to a new template. The diagnostic requirement and drug trial requirement revised. Added durations for initial authorization and reauthorization. Added reauthorization criteria. 11/08/2022 Section Dpart III: Added complex/rare disease states. Changed renewal duration from up to 6 months to up to 12 months.5/21/2023 Updated non-preferred to neutral to refer to drugs not on the single unified preferred drug list (SUPDL). Date Effective 09/10/2025 Date Archived H. ReferencesNot applicable. This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved.IN-MED-P-3546050 ; Issued Date: 07/01/2025 OMPP Approval Date: 05/21/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENT Indiana Medicaid DRUG NAME Aqneursa (levacetylleucine)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Aqneursa, approved by the FDA in 2024, is a modified amino acid indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing 15 kg. It enters pathways that correct metabolic dysfunction and improve energy production to ameliorate lysosomal dysfunction and reduce storage of unesterified cholesterol and sphingolipids. NPC is a rare neurovisceral lysosomal storage disease with manifestations that vary depending on the age of onset of neurological manifestations, from early infantile (visceral-neurodegenerative form) to adult (psychiatric-neurodegenerative form) . It is caused by mutations in the NPC1 or NPC2 gene resulting in tissue accumulation of multiple lipids due to abnormal cellular trafficking by the involved proteins (NPC1 and 2).Aqneursa (levacetylleucine) will be considered for coverage when the following criteria are met:Niemann-Pick disease type C (NPC)For initial authorization: 1. Member weighs at least 15 kg; AND 2. Medication must be prescribed by or in consultation with a neurologist, metabolic specialist, or geneticist; AND 3. Member has a diagnosis of NPC confirmed by one of the following: a) Genetic testing that shows mutations in both alleles of the NPC1 or NPC2 gene, or b) Mutation in one allele of NPC1 or NPC2, AND either elevated plasma biomarkers (i.e., cholestane-triol or trihydroxy-cholanoyl-glycine and/or lysoSM-509 with normal or slightly elevated lysoSM ) OR positive filipin testing; AND 4. Member has at least mild disease-related neurological symptoms, but not severe; AND 5. If of reproductive potential, prescriber attests the member is not pregnant; AND 6. Aqneursa is not being prescribed in combination with Miplyffa. 7. Dosage allowed/Quantity limit: Granules for oral suspension. Dosage based on actual body weight, to be administered up to 3 times daily. 1 packet = 1 gram QL: 112 packets per 28 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 improvement or stabilization of neurological signs and symptoms compared to baseline. If all the above requirements are met , the medication will be approved for an additional 12 months. CareSource considers Aqneursa (levacetylleucine) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION10/21/2024 New policy for Aqneursa created. References: 1. Aqneursa [prescribing information]. IntraBio Inc.; 2024. 2. Bremova-Ertl T, Ramaswami U, Brands M, et al. Trial of N-Acetyl-l- Leucine in Niemann-Pick Disease Type C. NEngl JMed. 2024;390(5):421-431. doi:10.1056/NEJMoa2310151 3. Geberhiwot T, Moro A, Dardis A, et al. Consensus clinical management guidelines for Niemann-Pick disease type C. Orphanet JRare Dis . 2018;13(1):50. Published 2018 Apr 6. doi:10.1186/s13023-018-0785-7 4. Patterson MC, Clayton P, Gissen P, et al. Recommendations for the detection and diagnosis of Niemann-Pick disease type C: An update. Neurol Clin Pract . 2017;7(6):499-511. doi:10.1212/CPJ.0000000000000399 Effective date: 06/30/2025 Revised date: 10/21/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Niktimvo (axatilimab)BENEFIT TYPE Medical STATUS Prior Authorization Required Niktimvo is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. GVHD is a complication following allogeneic hematopoietic stem cell transplant (HSCT). It occurs when immune cells transplanted from a non-identical donor (graft) recognize the transplant recipient (host) as foreign, initiating an immune response. Chronic GVHD typically occurs more than 100 days posttransplant and involves multiple organ systems. Steroids are the mainstay of treatment but many patients require 2 or more lines of therapy. Niktimvo is a first-in-class drug to target CSF-1R expressed on monocytes and macrophages. Blocking CSF-1R reduces the levels of these circulating proinflammatory and profibrotic monocytes and monocyte-derived macrophages and inhibits the activity of pathogenic macrophages in tissues .Niktimvo (axatilimab) will be considered for coverage when the following criteria are met:C hronic graft-versus-host disease (cGVHD ) For initial authorization: 1. Member weighs at least 40 kg; AND 2. Medication must be prescribed by or in consultation with a transplant or hematology/oncology specialist; AND 3. Member has a documented diagnosis of cGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) ; AND 4. Member has failed at least 2 prior lines of systemic therapy, i.e., systemic corticosteroid and another systemic treatment ( calcineurin inhibitor, Jakafi, mycophenolate mofetil, sirolimus, methotrexate, Imbruvica). 5. Dosage allowed/Quantity limit: IV infusion; 0.3 mg/kg over 30 minutes every 2 weeks until progression or unacceptable toxicity . Max dose 35 mg. QL: 2 vials (2 mL) per 28 days If all the above requirements are met , the medication will be approved for 6 months. For reauthorization : 1. Chart notes must show improvement of signs and symptoms of disease in at least 1 organ/site, without progression in any other organ/site. 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 Niktimvo (axatilimab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION09/19/2024 New policy for Niktimvo created. References: 1. Niktimvo. [prescribing information]. Incyte Corporation; 2024. 2. National Comprehensive Cancer Network. Hematopoietic Cell Transplantation (HCT). Version 2.2024. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed September 20, 2024. Effective date: 06/30/2025 Revised date: 09/19/2024
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Xermelo (telotristat ethyl)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Xermel o is a small molecule tryptophan hydroxylase (TPH) inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy . TPH mediates the rate limiting step in serotonin biosynthesis, which is overproduced in carcinoid syndrome. Inhibiting TPH therefore reduces the production of peripheral serotonin and the frequency of related diarrhea. Carcinoid syndrome (CS) refers to a collection of symptoms that primarily occurs with well-differentiated neuroendocrine tumors (NETs) originating midgut with metastases to the liver. Flushing and diarrhea are the most common manifestations. NETs release a variety of biologically active products, with serotonin thought to be the most important factor in the etiology of CS diarrhea. It is considered refractory if symptoms are inadequately controlled with a long acting SSA. Xermelo is specifically recommended for refractory cases.Xermelo (telotristat ethyl) will be considered for coverage when the following criteria are met:Carcinoid Syndrome DiarrheaFor initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by or in consultation with an oncologist , gastroenterologist or endocrinologist; AND 3. Member has a neuroendocrine tumor; AND 4. Member has a diagnosis of refractory diarrhea secondary to carcinoid syndrome, despite a stable dose of long-acting somatostatin analog ( i.e., octreotide, lanreotide) for at least 3 months, as evidenced by at least ONE of the following: a) Member is experiencing 4 or more bowel movements per day; b) Member has an elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA) level; AND 5. Prescriber attests m ember will continue somatostatin therapy in addition to Xermelo. 6. Dosage allowed/Quantity limit: 250 mg three times daily orally . Quantity limit: 84 tablets per 28 days. 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 a decrease in frequency of bowel movements; AND 2. Prescriber attest m ember will continuing somatostatin analog unless contraindicated or not tolerated. 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 Xermelo (telotristat ethyl) 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/DESCRIPTION11/12/2020 New policy for Xermelo created. 04/18/2022 Transferred to new template. Added supporting reference s. Specified SSA therapy as long acting. 02/17/2025 Updated references. Added provider attestation to concomitant somatostatin therapy requirement; added quantity limit; added endocrinologist as prescriber specialty option. References: 1. Xermelo [package insert]. Deerfield, IL: TerSera Therapeutics LLC; 2022 . 2. Pavel M, berg K, Falconi M, et al. Gastroenteropancreatic neuroendocrine neoplasms: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol . 2020;31(7):844-860. doi:10.1016/j.annonc.2020.03.304. 3. Strosberg JR, Halfdanarson TR, Bellizzi AM, et al. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors. Pancreas . 2017;46(6):707-714. doi:10.1097/MPA.0000000000000850.4. National Comprehensive Cancer Network. Neuroendocrine and Adrenal Tumors. (Version 4.2021 ). https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed April 1, 2022.5. Pavel M, Gross DJ, Benavent M, et al. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocr Relat Cancer . 2018;25(3):309-322. doi:10.1530/ERC-17-0455 6. Strosberg J, Joish VN, Giacalone S, et al. TELEPRO: Patient-Reported Carcinoid Syndrome Symptom Improvement Following Initiation of Telotristat Ethyl in the Real World. Oncologist . 2019;24(11):1446-1452. doi:10.1634/theoncologist.2018-0921 Effective date: 07/01/2025 Revised date: 02/17/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME R evcovi (elapegademase-lvlr )BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Revcovi , approved by the FDA in 2018, is a recombinant adenosine deaminase (rADA) indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients . It acts as an enzyme replacement therapy (ERT). SCID associated with a deficiency of ADA enzyme is a very rare, inherited, and often fatal purine salvage pathway defect. ADA deficiency is a primary immunodeficiency caused by a genetic mutation that affects white blood cell (WBC) production. ADA-SCID is the most complete form of ADA deficiency and typically leads to a severe combined immunodeficiency with dysfunction of T, B, and natural killer cells (T-B -NK-SCID), presenting in the first few months of life. Non-immune symptoms also occur . Revcovi provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotide levels as well as an increase in lymphocyte number. It is a second-generation ADA replacement therapy, taking the place of the discontinued first-generation ADA replacement product, Adagen. Most newly diagnosed patients should initially receive ERT. Ideally, it is used as a bridge prior to allogeneic hematopoietic stem cell transplantation (HSCT) when that is an option. Treatment with Revcovi requires extensive monitoring. Immune function, including the ability to produce antibodies, generally improves after 2-6 months of therapy, and matures over a longer period. Improvement in the general clinical status of the patient may be gradual but should be apparent by the end of the first year .Revcovi (elapegademase-lvlr) will be considered for coverage when the following criteria are met:A denosine D eaminase Severe C ombined Immune D eficiency (ADA-SCID)For initial authorization: 1. Medication must be prescribed by or in consultation with an immunologist, geneticist, or hematologist/oncologist; AND 2. Member has a diagnosis of ADA-SCID confirmed by at least one of the following: a) Absent or very low ADA activity (
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Nemluvio (nemolizumab-ilto)BENEFIT TYPE Pharmacy STATUS Prior Authorization Required Nemluvio, approved in 2024, is an interleukin-31 receptor antagonist indicated for the treatment of adults with prurigo nodularis and the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. It inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemluvio (nemolizumab-ilto) will be considered for coverage when the following criteria are met:Prurigo N odularis (PN) For 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 documented diagnosis of prurigo nodularis with ALL of the following: a) Chronic pruritis lasting more than 6 weeks; b) Severe itch with repeated scratching; c) At least 20 total lesions present; AND 4. Member has had a trial and failure of a medium to super high potency topical corticosteroid for at least 2 weeks . NOTE: If topical corticosteroids are contraindicated, must alternatively try and fail at least ONE of the following: topical emollient, capsaicin, calcipotriol, calcineurin inhibitor, phototherapy, or oral antihistamine; AND 5. Member has tried and failed Dupixent. 6. Dosage allowed/Quantity limit: quantity limit-2 pens per 4 weeks. a) Less than 90 kg: administer 60 mg (two 30 mg injections) subcutaneously , followed by 30 mg given every 4 weeks. b) 90 kg or m ore: administer 60 mg (two 30 mg injections) subcutaneously , followed by 60 mg given every 4 weeks. If all the above requirements are met , the medication will be approved for 4 months . For reauthorization : 1. Chart notes have been provided documenting clinically significant reduction of itch intensity and/or nodule clearance compared to baseline. 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: 5/16/2023Atopic Dermatitis (AD)For initial authorization: 1. Member is at least 12 years of age; AND 2. Medication must be prescribed by or in consultation with a dermatologist, allergist, or immunologist; AND 3. Member has a diagnosis of moderate to severe AD ; AND 4. Provider attests Nemluvio will be used in combination with topical corticosteroids and/or topical calcineurin inhibitors; AND 5. Members atopic dermatitis involves 10% or more of the body surface area (BSA) OR involves highly visible or functional areas (e.g., neck, face, genitals, palms) and is significantly impairing quality of life; AND 6. Member has a documented trial and failure of ONE of the following: a) Medium to very high potency topical corticosteroids for 2 weeks; b) Topical calcineurin inhibitor (e.g., tacrolimus, pimecrolimus) for 6 weeks. Note: Eucrisa for 4 weeks is also acceptable. 7. Dosage allowed/Quantity limit: inject 60 mg (two 30 mg injections) subcutaneously , followed by 30 mg given every 4 weeks . After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. Quantity limit: 1 pen per 28 days. If all the above requirements are met, the medication will be approved for 4 months. For reauthorization :1. Chart notes have been provided showing an improvement in signs and symptoms of disease such as fewer flares, less itching/erythema, improved quality of life, etc. If all the above requirements are met , the medication will be approved for an additional 12 months .CareSource considers Nemluvio (nemolizumab-ilto) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.DATE ACTION/DESCRIPTION09/10/2024 New policy for Nemluvio created. 02/17/2025 Added AD indication. References: 1. Nemluvio [package insert]. Galderma Laboratories, L.P.; 2024. 2. Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: United States expert panel consensus. JAm Acad Dermatol. 2021;84(3):747-760. doi:10.1016/j.jaad.2020.07.025. 3. Stnder S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042. 4. Satoh T, Yokozeki H, Murota H, et al. 2020 guidelines for the diagnosis and treatment of prurigo. JDermatol. 2021;48(9):e414-e431. doi:10.1111/1346-8138.16067. 5. Chisolm SS. A review of the current management and burden of prurigo nodularis in the United States. Am JManag Care. 2023;29(5 Suppl):S63-S72. doi:10.37765/ajmc.2023.89366. 6. Kwatra SG, Yosipovitch G, Legat FJ, et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. NEngl JMed. 2023;389(17):1579-1589. doi:10.1056/NEJMoa2301333 7. Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema: part I-systemic therapy. JEur Acad Dermatol Venereol. 2022;36(9):1409-1431. doi:10.1111/jdv.18345 8. Eichenfield LF, Tom WL, Chamlin SL et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. JAm Acad Dermatol. 2014; 70(1):338-51. 9. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. JAm Acad Dermatol. 2014;71(1):116-132. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202310. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: Section 3. Management and treatment with photot herapy and systemic agents. JAm Acad Dermatol. 2014 Aug;71(2):327-49. 11. Davis DMR, Drucker AM, Alikhan A, et al. Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies. JAm Acad Dermatol. 2024;90(2):e43-e56. doi:10.1016/j.jaad.2023.08.102 12. AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel, Chu DK, Schneider L, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE-and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024;132(3):274-312. doi:10.1016/j.anai.2023.11.00 Effective date: 06/30/2025 Revised date: 02/17/2025
IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 PHARMACY POLICY STATEMENTIndiana Medicaid DRUG NAME Darzalex Faspro (daratumumab and hyaluronidase-fihj)BENEFIT TYPE Medical STATUS Prior Authorization Required Darzalex Faspro is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase used to increase the dispersion and absorption of co-administered drugs, indicated for the treatment of adult patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone (CyBorD) in newly diagnosed patients. In 2021 it became the first drug approved for treating AL amyloidosis. Approval was based on the ANDROMEDA study in which patients treated with CyBorD plus daratumumab experienced a significantly higher rate of complete hematologic response compared to the CyBorD alone group. There is also evidence to support off label use in relapsed cases.Amyloidosis is a group of protein misfolding disorders characterized by deposition of insoluble protein fibrils in organs and tissues and loss of normal protein function. There are multiple forms of systemic amyloidosis, with AL amyloidosis (also known as light-chain amyloidosis) as the most common type. AL amyloidosis occurs from an abnormality of plasma cells in bone marrow and is closely related to multiple myeloma. Darzalex Faspro (daratumumab and hyaluronidase-fihj) will be considered for coverage when the following criteria are met:Light Chain AmyloidosisFor initial authorization: 1. Member is at least 18 years of age; AND 2. Medication must be prescribed by or in consultation with a hematologist/oncologist; AND 3. Member meets ONE of the following: a. Newly diagnosed light chain amyloidosis with one or more organs affected (e.g., heart, kidney) AND medication will be used in combination with bortezomib, cyclophosphamide, and dexamethasone; b. Relapsed light chain amyloidosis previously treated with at least one prior therapy (note: this is an off-label use) 4. Dosage allowed/Quantity limit : Newly diagnosed: 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously (1 single dose vial), in combination with bortezomib, cyclophosphamide, and dexamethasone as follows: IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023 QL: 4 vials per 28 days for weeks 1-8; 2 vials per 28 days for weeks 9-24; 1 vial per 28 days thereafter. For relapsed disease, consult NCCN or another clinical guideline for dosing information (off-label).If all the above requirements are met, the medication will be approved for 12 months.For reauthorization :1. Member has not yet completed 2 years of treatment with Darzalex Faspro; AND 2. Chart notes must show the members disease has not progressed since starting treatment. If all the above requirements are met, the medication will be approved for an additional 12 months, NOT TO EXCEED A TOTAL OF 2 YEARS. Multiple MyelomaAny request for cancer must be submitted through NantHealth/Eviti portal. CareSource considers Darzalex Faspro (daratumumab and hyaluronidase-fihj) 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 09/23/2022 New policy for Darzalex Faspro created. 09/13/2024 Updated NCCN reference ; removed restrictions for stage IIIB heart disease. References: 1. Darzalex Faspro [prescribing information]. Janssen Biotech, Inc.; 2024 . 2. NCCN Clinical practice guidelines. Systemic Light Chain Amyloidosis: Version 2.2024. https://www.nccn.org/professionals/physician_gls/pdf/amyloidosis.pdf . Accessed September 33, 2024 .3. Kastritis E, Palladini G, Minnema MC, et al. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. NEngl JMed . 2021;385(1):46-58. doi:10.1056/NEJMoa2028631. 4. Wechalekar AD, Cibeira MT, Gibbs SD, et al. Guidelines for non-transplant chemotherapy for treatment of systemic AL amyloidosis: EHA-ISA working group [published online ahead of print, 2022 Jul 15]. Amyloid. 2022;1-15. doi:10.1080/13506129.2022.2093635.5. Elsayed M, Usher S, Habib MH, et al. Current Updates on the Management of AL Amyloidosis. JHematol . 2020;10(4):147-161. doi:10.14740/jh866. 6. Abdallah M, Sanchorawala V. Update on the Contemporary Treatment of Light Chain Amyloidosis Including Stem Cell Transplantation. Am JMed. 2022;135 Suppl 1:S30-S37. doi:10.1016/j.amjmed.2022.01.011. Effective date: 06/30/2025 Revised date: 09/ 13/2024
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 , approved in 2017, is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) and prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (d onor 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 6 months of age and 6 kg; 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. Provider attests Prevymis will be initiated within 28 days post-transplant; AND 6. Provider attests that member is NOT currently taking the following: a) Pimozide; b) Ergot akaloids (ergotamine, dihydroergotamine) ; c) Pitavastatin or simvastatin with c yclosporine; AND 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: Quantity limit: 28 tablet/ vials per 28 days or 120 packets per 30 days. a) 6 months to less than 12 years of age or 12 years of age and older and weighing less than 30 kg: dosing based on weight (see below) administered once daily orally or as an IV infusion over 1 hour through 100 days post-HSCT. IN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/2023b) Adult and pediatric patients 12 years of age and older and weighing at least 30 kg: a dminister 480 mg once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-transplant. NOTE: In patients at risk for late CMV infection and disease, Prevymis may be continued through 200 days post-HSC T. If all the above requirements are met, the medication will be approved for 100 days. For reauthorization :1. Medication will not be reauthorized.Kidney Transplant CMV ProphylaxisFor initial authorization: 1. Member is at least 12 years of age and 40 kg; 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. Provider attests Prevymis will be initiated within 7 days post-transplant; AND 6. Member is unable to use valganciclovir; AND 7. Provider attests that member is NOT currently taking the following: a. Pimozide; b. Ergot akaloids (ergotamine, dihydroergotamine) ; c. Pitavastatin or simvastatin with c yclosporine; AND 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 tablet/ vials per 28 days or 120 packets per 30 days. 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 optionIN-MED-P-366647a; Issued Date: 6/1/2023 OMPP Approved: 5/16/202302/05/2025 Updated references; expanded age limit and added weight requirement per PI for both diagnoses; added pediatric dosing; removed note about coadministration with cyclosporine ; added provider attestation for medications member is not taking; added packets to quantity limit; added note for HSCT about continuing through 200 days for patients at risk for late CMV.References: 1. Prevymis [package insert]. County Carlow, Ireland: Merck Sharp & Dohme Corporation; 2024. 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. Malagola M, Radici V, Farina M, et al. Correction: CMV prophylaxis with letermovir significantly improves graft and relapse free survival following allogeneic stem cell transplantation. Bone Marrow Transplant. 2024;59(2):293. doi:10.1038/s41409-023-02158-2 5. 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. 6. 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 7. 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: 06/30/2025 Revised date: 02/05/2025
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