PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Otezla (apremilast) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 60 per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Otezla (apremilast) is a preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. ORAL ULCERS ASSOCIATED WITH BEHETS DISEASE For initial authorization: 1. Member is 18 y ears old or older and has diagnosis of Behets disease ; AND 2. Member has at least 2 oral ulcers (documented in chart notes) ; AND 3. Medication must be prescribed by a rheumatologist or dermatologist ; AND 4. Member has prior treatment with at least 1 non-biologic Behet’s Disease therapy, such as, but not limited to, topical corticosteroids, or systemic treatment ; AND 5. Member has tried and failed to respond to treatment with at least one therapy for oral ulcers (e.g., t riamcinalone acetonide, t etracycline, colchicine , dapsone, p entoxifylline , MAGIC mouthwash, etc.) . 6. Dosage allowed: Initial: 10 mg in the morning. Titrate upward by additional 10 mg per day on days 2 to 5 as follows: Day 2: 10 mg twice daily; Day 3: 10 mg in the morning and 20 mg in the evening; Day 4: 20 mg twice daily; Day 5: 20 mg in the morning and 30 mg in the evening. Maintenance dose: 30 mg twice daily starting on day 6. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by a rheumatologist or dermatologist; AND 3. Member has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 8-week trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 8-week trial of sulfasalazine or azathioprine or cyclosporine). 4. Dosage allowed : Initial: 10 mg in the morning. Titrate upward by additional 10 mg per day on days 2 to 5 as follows: Day 2: 10 mg twice daily; Day 3: 10 mg in the morning and 20 mg in the evening; Day 4: 20 mg twice daily; Day 5: 20 mg in the morning and 30 mg in the evening. Maintenance dose: 30 mg twice daily starting on day 6. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older ; AND 2. Medication must be prescribed by a rheumatologist or dermatologist; AND 3. Member has PsO involves 10% or more of the members body surface area; AND 4. Member has PsO for 6 months or longer; AND 5. Members Psoriasis Area and Severity Index (PASI) score is greater than or equal to 12; AND 6. Member has tried and failed to respond to treatment with at least one of the following: a) At least 12 weeks of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 12 weeks of phototherapy (i.e., UVB light ther apy, Excimer laser treatments; tanning beds emit mostly UVA light and therefore would not meet this criteria). c) At least a 4 week trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 7. Member ha s tried and f ailed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, aci tretin) for at least a 12 week trial. 8. Dosage allowed: Initial: 10 mg in the morning. Titrate upward by additional 10 mg per day on days 2 to 5 as follows: Day 2: 10 mg twice daily; Day 3: 10 mg in the morning and 20 mg in the evening; Day 4: 20 mg twice daily; Day 5: 20 mg in the morning and 30 mg in the evening. Maintenance dose: 30 mg twice daily starting on day 6. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.) . If member meets all the reauthorization requirements above, the medication will be app roved for an additional 12 months. CareSource considers Otezla (apremilast) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Active infections Ankylosing Spondylitis Asthma Cellulitis Crohns disease Dissecting scalp cellulitis For use in combination with TNF-inhibitors (i.e., Enbrel, Humi ra, Remicade, Kineret) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Relapsing polychondritis Rheumatoid Arthritis Sarcoidosis Sciatica Spondyloarthritis Takayasus arteritis Ulcerative colitis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/10/2017 New policy for Otezla created. Policies SRx-0042 and SRx-0043 archived. For diagnosis of PsO: immunosuppressive criterion was separated from phototherapies and topical agents trials; TNF inhibitors Humira and Enbrel we re listed as required trials; Psoriasis Area and Severity Index (PASI) score requirement was added. For diagnosis of PsA: TN Finhibitors Humira and Enbrel were listed as required trials. List of diagnoses considered not medically necessary was added. 02/26/2019 Status changed to preferred. Humira and Enbrel trials removed from criteria. Clarifications entered for AS and PsA on NSAIDs trial length. Requirements on axial disease type removed from PsA. Physician Global Assessment score removed from diagnosis of PsO. References added. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. 07/28/2019 New diagnosis of Oral Ulcers Associated With Behets Disease added. References: 1. Otezla [prescribing information]. Summit, NJ : Celgene Corporation; July 201 9. 2. US Food and Drug Administration Drug Safety Data. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf (October 14, 2014) . 3. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 4. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions. JAm Acad Dermatol. 2011 Feb 7. 5. Poddubnyy D. Axial spondyloarthritis: is there a treatment of choice? Ther Adv Musculoskelet Dis. 2013;5(1):45-54. 6. Gladman DD. Axial disease in psoriatic arthritis. Curr Rheumatol Rep. 2007 Dec;9(6):455-60. 7. Kang EJ, et al. Psoriatic arthritis: la test treatments and their place in therapy. Ther Adv Chronic Dis. 2015;6 (4):194-203. 8. ClinicalTrials.gov. Identifier:NCT02307513. A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behcet's Disease. Available at: https://clinicaltrials.gov/ct2/show/NCT02307513?term=BCT-002&rank=2. 9. American Behcets disease Association. Treatment of Behcet's Disease. https://www.behcets.com. Effective date: 09/26/2019 Revised date: 07/28/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Onpattro (patisiran) BILLING CODE J3490 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Onpattro (patisiran) is a non-preferred product and will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (hATTR) For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescr ibed by or in consultation with neurologist ; AND 3. Member has diagnosis of hATTR confirmed by ALL of the following: a) The demonstration of amyloid deposits via tissue biopsy; b) Genetic testing confirming TTR gene mutation; c) Documentation of f amilial amyloid polyneuropathy (FAP) stage 1 (unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs) or stage 2 (assistance with ambulation required; mostly moderate impairment progression to the lower limbs, upper limbs, and trunk) . See Appendix for details on all stages of FAP for your reference; AND 4. Member does not have ANY of the following: a) Prior liver transplant ; b) Known human immunodeficiency virus (HIV) infection; c) Hepatitis Bvirus (HBV) and hepatitis Cvirus (HCV) ; AND 5. Member is not receiving Onpattro with Vyndagel, Vyndamax or Tegsedi. 6. Dosage allowed: For members weighting less than 100 kg: 0.3 mg/kg every 3 weeks IV. For members weighing 100 kg or more, the recommended dosage is 30 mg every 3 weeks. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member continues to have FAP stage 1 or stage 2; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease ( e.g., quality of life and motor function improved, neuropathic pain decreased, serum TTR levels reduced); AND 3. Member is not receiving Onpattro with Vyndagel, Vyndamax or Tegsedi. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Onpattro ( patisiran) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 08/05/2019 New policy for Onpattro created. References: 1. Onpattro [prescribing information]. Cambridge, MA: Alnylam Pharmaceuticals, Inc. ; August, 2018. 2. Ando Y, Coelho T, Berk JL, et al. Guideline of transthyretin-related hereditary amyloidosis for clinicians. Orphanet JRare Dis. 2013;8:31. 3. ClinicalTrials.gov Identifier: NCT01960348. APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR) -Mediated Amyloidosis . Available at: https://clinicaltrials.gov/ct2/show/NCT01960348?term=01960348&rank=1. 4. National Institutes of Health (NIH). Transthyretin amyloidosis. Available at: https://ghr.nlm.nih.gov/condition/transthyretin-amyloidosis. Effective date: 09/26/2019 Revised date: 08/05/2019 Appendix. Stages of FAP. Stage 0 This is an asymptomatic stage. Patients in this stage do have a mutation in the TTR gene and show evidence of amyloid deposits, but do not show any symptoms of the disease. Stage 1 Symptoms are mild at this stage, with the functioning of the lower limbs affected but not impaired. This is the stage for early detection of FAP symptoms. Stage 2 Symptoms turn from mild to moderate in severity in stage 2. Lower limb function is even m ore affected, with patients possibly requiring walking assistance. Further damage to nerves caused by amyloid deposits is observed. Stage 3 Symptoms have significantly worsened in stage 3, and the patient needs a wheelchair for mobility. There is no data to support the efficacy of drug therapies at this stage of the disease.
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Nucala (mepolizumab) BILLING CODE Medical: J2182 (1 unit = 1 mg) Pharmacy: Must use valid NDC code BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office/Home/Outpatient hospital COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 100 units LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Nucala (mepolizumab) is a non-preferred product and will only be con sidered for coverage under the medical and pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (EGPA/Churg-Strauss Syndrome) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by or under the recommendation of a pulmonologist, immunologist, allergist , or rheumatologist; AND 3. Member is on glucocorticoid therapy (i.e., stable dose of oral prednisolone or prednisone of 7.5-50 mg/day for at least 4 weeks ) and/or on i mmunosuppressive therapy ; AND 4. Member has diagnosis of EGPA for at least 6 months based on the history or presence of asthma plus eosinophilia (> 1000 cells/L and/or > 10% of leucocytes) and at least two of the follow ing additional features of EGPA: a) A biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous i nflammation; b) Neuropathy, mono or poly (motor deficit or nerve conduction abnormality); c) Pulmonary infiltrates, non-fixed; d) Sino-nasal abnormality; e) Cardiomyopathy (established by echocardiography or magnetic resonance imaging); f) Glomerulonephritis ( hematuria, red cell casts, proteinuria); g) Alveolar hemorrhage (by bronchoalveolar lavage); h) Palp able purpura; i) Anti-neutrophil cytoplasmic anti-body ( ANCA) positive (my eloperoxidase or proteinase); AND 5. Member has a h istory of relapsing OR refractory disease defined as one of the following: a) At least one confirmed EGPA relapse ( i.e., requiring increase in oral corticosteroids (OCS) dose, initiation/increased dose of immunosuppressive therapy or hospitalization related to EGPA worsening) within the past 2 years while receiving glucocorticoids ; b) Failure to attain remission (Birmingham Vasculitis Activity Score [BVAS]=0 and OCS dose 7.5 mg/day prednisolone or equivalent) within the last 6 months following induction treatment with astandard regimen (i.e., cyclophosphamide, azathioprine, methotrexate, or mycophenolate mofetil, glucocorticoid dose was 1 5 mg/day prednisolone or equivalent ) adm inistered for at least 3 months; 6. Member does not have infectious disease, parasitic infection, HIV, Hepatitis Bor hypersensitivity to monoclonal antibody or biologic therapy AND member was not receiving any of the following: a) Oral glucocorticoid dose of > 50 mg/day prednisolone/prednisone or IV or subcutaneous (SC) glucocorticoids in the last 4-weeks ; b) Omalizumab within 130 days ; c) Oral or IV cyclophosphamide within 2 weeks ; d) Rituximab within 12 m onths; e) IV or SC immunoglobulin within 6 months ; f) Interferon-within 6 months ; g) Anti tumor necrosis factor therapy within 12 weeks ; h) Anti-CD52 (alemtuzumab) within 6 months ; AND 7. Member does not have a history (or suspected history) of alcohol misuse or substance abuse within 2 years . 8. Dosage allowed: 3 00 mg as 3 separate 100-mg injections administered subcutaneously once every 4 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member must be in compliance with all other initial criteria. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. SEVERE ASTHMA For initial authorization: 1. Member must be 12 years of age or older; AND 2. Medication must be prescribed by or under the recommendation of a pulmonologist, immunologist or allergist; AND 3. Member has a baseline peripheral blood eosinophil count 150 cells/microliter or greater at initiation of therapy (within past 90 days) or 300 cells/microliter in the past 12 months ; AND 4. Members asthma has been inadequately controlled after 3 months of conventional treatment including one of the following: a) High-dose inhaled corticosteroids (ICS) and long-acting inhaled beta-2 agonists (LABA); b) ICS and leukotriene receptor antagonist (LTRA); c) ICS and theophylline; AND 5. Medication is being used as the add-on maintenance treatment to conventional therapies for asthma (i.e. , ICS, LABA, LTRA, etc.); AND 6. Medication is not used in combination with Cinqair (reslizumab) or Fasenra (benralizumab) . 7. Dosage allowed: 100 mg by subcutaneous injection once every 4 weeks . If member meets all the requirements listed above, the medication will be approved for 16 weeks. For reauthorization: 1. Medication not being used as monotherapy for asthma; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has demonstrated improvement during 16 weeks of medication therapy: a) Decreased frequency of emergency department visits; OR b) Decreased frequency of hospitalizations due to asthma symptoms; OR c) Increase in percent predic ted FEV1 from pretreatment baseline; OR d) Im proved functional ability (i.e. decreased effect of asthma on ability to exercise, function in school or at work, or quality of sleep); OR e) Decreased utilization of rescue medications. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Nucala (mepolizumab) not medically necessary for the treatment of the following disease states based on a lack o f robust clinical controlled trials showing superior efficacy compared to currently available treatments: Granulomatosis with polyangiitis (GPA; Wegeners) Microscopic polyangiitis (MPA) Organthreatening EGPA (i.e., organ failure due to active vasculitis, creatinine >5.8 g/dL [>513 mol/L]) within 3 months Lifethreatening EGPA (severe alveolar hemorrhage or hemoptysis, rapidly progressive glomerulonephritis, severe gastrointestinal involvement, central nervous system involvement or cardiac involvement)DATE ACTION/DESCRIPTION 05/18/2017 New policy for Nucala created. Conventional treatment options expanded. 03/16/2018 New indication of Eosinophilic Granulomatosis With Polyangiitis added. References: 1. Nucala [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; June, 2019. 2. Nucala. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: http://www.micromedexsolutions.com. Accessed March 2, 2017. 3. Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. JAsthma Allergy. 2014;7:53 65. 4. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): A multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-659. 5. Pagnoux C.EGPA: early diagnosi s is better. Version June 2013. Division of Rheumatology Vasculitis clinic . Mount Sinai Hospital, Toronto, ON, Canada . Available at: http://www.cssassociation.org/tl_files/pages/news_%26_events/early%20diagnosis%20egpa%205.2013%20final%20pdf.pdf. Accessed on January 26, 2018. 6. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT00287391, A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis ; 2018 Jan 26. Available at: https://clinicaltrials.gov/ct2 /show/NCT02020889?term=mepolizumab&recrs=e&rank=9. 7. Wechsler ME, Akuthota P, Jayne D, et al. EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. NEngl JMed. 2017 May 18;376(20):1921-1932. doi: 10.1056/NE JMoa1702079. 8. Matteson EL. Eosinophilic Granulomatosis with Polyangiitis (EGPA/Churg-Strauss Syndrome). Vascuiltis Foundation. Available at: https://www.vasculitisfoundation.org/education/forms/eosinophilic-granulomatosis-with-polyangiitis-churg-strauss-syndrome/. 9. Birmingham Vasculitis Activity Score (version 3) . Available at: http://golem.ndorms.ox.ac.uk/calculators/bvas.html. 10. Wechsler ME, Akuthota P, Jayne Det al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. NEngl JMed 2017; Supplementary Appendix . Effective date: 09/07/2018 Revised date: 03/16/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Mulpleta (lusutrombopag) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Promacta and Doptelet QUANTITY LIMIT 7 tablets LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Mulpleta (lusutrombopag) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. THROMBOCYTOPENIA (with chronic liver disease) For initial authorization: 1. Member is 18 years of age or older with diagnosis of thrombocytopenia with chronic liver disease and is scheduled to undergo a procedure; AND 2. Medication must be prescribed by or in consultation with a hematologist; AND 3. Members platelet count is
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Mayzent (siponimod) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Mayzent (siponimod) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. RELAPSING-REMITTING MULTIPLE SCLEROSIS, ACTIVE SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (SPMS)1, CLINICALLY ISOLATED SYNDROME For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by, or in consultation with, or under the guidance of a neurologist; AND 3. A complete blood count (CBC) must be obtained before treatment start; AND 4. Member has ALL of the following: a) CYP29C genotype determination documented; b) An evaluation of the fundus, including the macula; c) Cardiac evaluation; AND 5. A potential risk of progressive multifocal leukoencephalopathy (PML) was discussed with member before starting Mayzent; AND 6. Member must not have experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospital ization or Class III/IV heart failure within the last 6 months; AND 7. Member must not have history or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker; AND 8. Member must have documentation in chart notes that baseline QTc interval is not greater than 500 msec; AND 9. Member must not currently be receiving treatment with Class Ia or Class III anti-arrhythmic drugs. 10. Dosage allowed: Titration is required for treatment initiation (see prescribing information of the drug for details). The recommended maintenance dosage is 2 mg. The recommended maintenance dosage in patients with a CYP2C9*1/*3 or *2/*3 genotype is 1 mg. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months . CareSource considers Mayzent (siponimod) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/07/2019 New policy for Mayzent created. References: 1. Mayzent [package insert]. East Hanover, New Jersey : Novartis Pharmaceuticals Corporation , March 2019. 2. FDA News Release : FDA approves new oral drug to treat multiple sclerosis . Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-oral-drug-treat-multiple-scleros is. 3. Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis . The 2013 revisions . Neurology 2014;83:278 286. Effective date: 09/26/2019 Revised date: 06/28/2019 1CareSource considers active secondary progressive multiple sclerosis (SPMS) as one of the relapsing forms of multiple sclerosis ( MS). Majority of patients would have MS started as a relapsing-remitting course of disease where episodes of worsening function (relapses) are followed by recovery periods (remi ssions). When episodes of remissions are not compl eted it can leave patient with remaining disabilities that can, in some cases, worsen over time. SPMS occurred when disability progress es independent ly of relapses . A non-active SP MS defined as no new relapses over time in patient with SPMS.
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Mavenclad (cladribine) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT based on weight LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Mavenclad (cladribine) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. RELAPSING-REMITTING MULTIPLE SCLEROSIS, ACTIVE SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS For initial authorization: 1. Member is 18 years old or older; AND 2. Medication must be prescribed by, or in consultation with, or under the guidance of a neurologist; AND 3. Chart notes have been provided confirming diagnosis of Multiple Sclerosis; AND 4. Member must have a documented negative TB test (i.e., tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy; AND 5. Chart notes submitted with baseline of ALL of the following: a) Complete blood count; b) Lymphocyte count; c) Liver function test; AND 6. Member does not have any of the following: a) Current malignancy ; b) HIV infection; c) Active chronic infections (e.g ., hepatitis or tuberculosis); AND 7. One of the following: a) If female, she must: i) be post-menopau sal or surgically sterilized; OR ii) uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the treatment ; AND iii) be neither pregnant nor breast-feeding; b) If male, he must be willing to use contraception to avoid pregnancies ; AND 8. Member has documented trial and failure or contraindication to at least two preferred multiple sclerosis agents (two injectable drugs OR two oral drugs OR one injectable and one oral drug) and one of the following infusions: Lemtrada, Tysabri or Ocrevus. 9. Dosage allowed: Cumulative dosage of 3.5 mg/kg administered orally and divided into 2 treatment courses (1.75 mg/kg per treatment course). Each treatment course is divided into 2 treatment cycles.Drug dose in mg and amount of tablets per cycle depend on members weight, please see prescribing information for details. Administration of First Treatment Course: First Cycle: start any time. Second Cycle: administer 23 to 27 days after the last dose of First Course/First Cycle. Administration of Second Treatment Course: First Cycle: administer at least 43 weeks after the last dose of First Course/Second Cycle. Second Cycle: administer 23 to 27 days after the last dose of Second Course/First Cycle. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Medication will not be reauthorized since t he safety and efficacy of reinitiating Mavenclad more than 2 years after completing 2 treatment courses has not been studied. CareSource considers Mavenclad (cladribine) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled tria ls showing superior efficacy compared to currently available treatments: Clinically Isolated Syndrome (CIS) in Multiple Sclerosis DATE ACTION/DESCRIPTION 07/02/2019 New policy for Mavenclad created. References: 1. Mavenclad [package insert]. Rockland, MA : EMD Serono, Inc. ; April, 2019. 2. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan;58(2):169-78. 3. Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria. Annals of Neurology. 2011;69(2):292-302. doi:10.1002/ana.22366. 4. FDA News Release: FDA approves new oral treatment for multiple sclerosis . www.fda.gov. 5. ClinicalTrials.gov. Identifier: NCT00725985. Oral Cladribine in Early Multiple Sclerosis (MS) (ORACLE MS). Available at: https://clinicaltrials.gov/ct2/show/NCT00725985?term=cladribine&recrs=e&rank=5. 6. ClinicalTrials.gov. Identifier: NCT00213135. A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (CLARITY) . Available at: https://clinicaltrials.gov/ct2/show/NCT00213135?term=cladribine&recrs=e&rank=6. 7. Siddiqui, Mohd Kashif, et al. “Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing remitting multiple sclerosis.” Current medical research and opinion 34.8 (2018): 1361-1371. 8. Kalincik, Tomas, et al. “Cladribine versus fingolimod, natalizumab and interferon for mult iple sclerosis." Multiple Sclerosis Journal 24.12 (2018): 1617-1626 Effective date: 09/26/2019 Revised date: 07/02/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Immune globulin: Intravenous : Bivigam, Carimune NF, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Privigen, and Thymoglobulin Subcutaneous: Cuvitru, Hizentra, HyQvia and Xembify BILLING CODE J1556-Bivigam; J1566-Carimune NF; J1572-Flebogamma DIF; J1569-Gammagard Liquid; J1566-Gammagard S/D ; J1561-Gammaked ; J1557-Gammaplex; J1561-Gamunex-C ; J1568-Octagam ; J1459-Privigen ; J7511-Thymoglobulin; J3590-Cuvitru ; J1559-Hizentra; J1575-HyQvia; J3590-Xembify. BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Outpatient/Office/Home COVERAGE REQUIREMENTS Prior Authorization Required QUANTITY LIMIT N/A LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Immune Globulin (intravenous [IVIG] : Bivigam, Carimune NF, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaple x, Gamunex-C, Octagam, Privigen and Thymoglobulin; subcutaneous [SC IG]: Cuvitru, Hizentra, HyQvia, and Xembify ) is a product that will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. Limitations: SCIG are only indicated for primary humoral immunodeficiency. AUTOIMMUNE BULLOUS DISEASE For initial authorization: 1. Member has c ontraindications to, failure of (refractory to), or significant side effects from systemic corticosteroids or immunosuppressive treatment (e.g., azathioprine, cyclophos phamide, mycophenolate mofetil); AND 2. Member has dermatologic condition, as indicated by one or more of the following: a) Bullous pemphigoid; b) Epidermolysis bullosa acquisita; c) Linear IgA bullous dermatosis ; d) Mucous membrane (cicatricial) pemphigoid; e) Pemphigoid gestationis ; f) Pemphigus foliaceus ; g) Pemphigus vulgaris . 3. Dosage allowed: Please see dosage and administration information in individual drug package insert . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Chart notes have been provided that show the member has shown i mprovement of signs and symptoms of disease; AND 2. Documentation of titration to the minimum dose and frequency needed to maintain a sustained clinical effect is provided with chart notes. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) For initial authorization: 1. IVIG is prescribed for prophylaxis of bacterial infections; AND 2. Member has a history of recurrent sinopulmonary infections requiring intravenous antibiotics or hospitalization; AND 3. Member has a pretreat ment serum IgG level 2 serious bacterial infections in a 1-year period); b) Member is not able to take com bination antiretroviral therapy; c) Antibiotic prophylaxis was tried but was not effective (e .g ., trimethoprim-sulfamethoxazole). 4. Dosage allowed: Please see dosage and administration information in individual drug package insert. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Reduction in the frequency of bacterial infections has been demonstrated since initiation of IVIG therapy and documented in chart notes. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. STIFF-PERSON SYNDROME For initial authorization: 1. Medication is used for treatment of stiff-person syndrome in members who have experienced an inadequate response or intolerance, or have a contraindication to first-line therapy such as a benzodiazepine (e. g., diazepam) and/or baclofen. 2. Dosage allowed: Please see dosage and administration information in individual drug package insert. If member meets all the requirements listed above, the m edication will be approved for 6 months. For reauthorization: 1. Medication will not be reauthorization for continuous use. CareSource considers Immune Globulin (intravenous [IVIG]: Bivigam, Carimune NF, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Privigen, Thymoglobulin; subcutaneous [SCIG]: Cuvitru, Hizentra, HyQvia ) not medically necessar y for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Acquired hemophilia Myocarditis, acute Adrenoleukodystrophy Neonatal sepsis, prevention Alzheimers disease Neonatal sepsis, treatment Amyotrophic lateral sclerosis (ALS) Ocular myasthenia Antiphospholipid antibody syndrome (APS) in pregnancy Paraneoplastic cerebellar degeneration, sensory neuropathy, or encephalopathy Asthma, non-steroid dependent Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) Atopic dermatitis POEMS syndrome Autism spectrum disorders Postinfectious cerebellar ataxia Autoimmune liver disease Postoperative sepsis Autoimmune neutropenia Pseudomembranous colitis Campylobacter species-induced enteritis Respiratory syncytial virus (RSV) lower respiratory tract infection Cerebral infarctions with antiphospholipid antibodies Rheumatic fever, acute Chronic fatigue syndrome Sjogren's syndrome Demyelinative brain stem encephalitis Spontaneous recurrent abortions, prevention Demyelinating neuropathy associated with monoclonal IgM Systemic lupus erythematosus Dilated cardiomyopathy Urticaria, chronic HIV infection or prophylaxis Vasculitides and antineutrophil antibody syndromes HTLV-1-associated myelopathy Routine prophylaxis of Measles, Varicella, and Rubella Idiopathic dysautonomia, acute Treatment of Measles, Varicella, and Rubella Inclusion body myositis Isolated IgA deficiency Isolated IgG4 deficiency Lumbosacral or brachial plexitis DATE ACTION/DESCRIPTION 11/15/2017 New policy for Immune Globulin created. Diagnoses associate with impatient life-threatening therapies were removed. Diagnoses of CIDP, Dermatomyositis or Polymyositis , ITP, MMN, Primary Immunodeficiency and Stiff-Person Syndrome got criteria expanded. Diagnosis of Acquired red cell aplasia was revised to PRCA with criteria. Length of coverage and reauthorization length were added. 08/21/2019 New medication Xembify added to the list of subcutaneous immune globulins. References: 1. Bivigam [package insert]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; October 2013. 2. Carimune NF [package insert]. Kankakee, IL: CSL Behring LLC; September 2013. 3. Flebogamma 10% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; January 2016. 4. Flebogamma 5% DIF [package insert]. Los Angeles, CA: Grifols Biologicals, Inc.; April 2015. 5. Gammagard Liquid [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; April 2014. 6. Gammagard S/D [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; April 2014. 7. Gammagard S/D IgA less than 1 mcg/mL [package insert]. Westlake Vil lage, CA: Baxter Healthcare Corporation; September 2013. 8. Gammaked [package insert]. Fort Lee, NJ: Kedrion Biopharma, Inc.; September 2013. 9. Gammaplex [package insert]. Hertfordshire, United Kingdom: Bio Products Laboratory; July 2015. 10. Gamunex-C [packag e insert]. Research Triangle Park, NC: Grifols Therapeutics Inc.; July 2014. 11. Octagam 10% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; April 2015. 12. Octagam 5% [package insert]. Hoboken, NJ: Octapharma USA, Inc.; October 2014. 13. Privigen [package insert]. Kankakee, IL: CSL Behring LLC; November 2013. 14. Cuvitru [package insert]. Westlake Village, CA: Baxalta US Inc.; September 2016. 15. Hizentra [package insert]. Kankak ee, IL: CSL Behring LLC; October 2016 . 16. HyQvia [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2016. 17. Thymoglobin [package insert]. Cambridge, MA: Genzyme Corporation; April 2017. 18. Xembify [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC ; July 2019. 19. Amagai M, Ikeda S, Shimizu H, et al. A randomized double-blind trial of intravenous immunoglobulin for pemphigus. JAm Acad Dermatol 2009; 60(4):595-603. 20. Kirtschig G, Middleton P, Bennett C, Murrell DF, Wojnarowska F, Khumalo NP. Interventions for bullous pemphigoid. Cochrane Database of Systematic Reviews 2010, Issue 10. Art. No.: CD002292. 21. Orange JS, Hossny EM, Weiler CR, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma, and Immunology. JAllergy Clin Immunol. 2006;417(4 Suppl):S525-553. 22. Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunis tic Infections in HIV-Exposed and HIV-Infected Children. Department of Health andHuman Services. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf. Accessed November 8 , 2017 . 23. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Biol Blood Marrow Transplant. 2009;15(10):1143-1238. 24. Feasby T, Banwell B, Bernstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21(2):S57-S107. 25. Donofrio PD, Berger A, Brannagan TH 3rd, et al. Consensus statement: the use of intravenous immunoglobulin in the treatment of neuromuscular conditions report of the AANEM ad hoc committee. Muscle Nerve. 2009;40(5):890-900. 26. Elovaara I, Apostolski S, van Doorn P, et al. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases. Eur JNeurol. 2008;15(9):893-908. 27. Patwa HS, Chaudhry V, Katzberg H, et al. Evi dence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012;78(13);1009-1015. 28. Anderson D, Kaiser A, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev. 2007;21(2):S9-S56. 29. Picard C, Al-Herz W, Bousfiha A, et al. Primary immunodeficiency diseases: an update on the classification from the International Union of Immunological Societies Expert Committee for Primary Immunodeficiency. JClin Immunol. 2015; 35(8):696-726. 30. Bonilla FA, Khan DA, Ballas ZK, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. JA llergy Clin Immunol. 2015;136(5):1186-205.e1-78. 31. Orange JS, Ballow M, Stiehm ER, et al. Use and interpretation of diagnostic vaccination in primary immunodeficiency: a working group report of the Basic and Clinical Immunology Interest section of the Amer ican Academy of Allergy, Asthma and Immunology. JAllergy Clin Immunol. 2012;130:S1-S24. 32. Ameratunga R, Woon ST, Gillis D, Koopmans W, Steele R. New diagnostic criteria for common variable immune deficiency (CVID), which may assist with decisions to treat with intravenous or subcutaneous immunoglobulin. Clin Exp Immunol. 2013;174(2):203-11. 33. Immune Deficiency Foundation. About primary immunodeficiencies. Specific disease types. http://primaryimmune.org/about-primary-immunodeficiencies/specific-disease-types/. Accessed November 8, 2017 . 34. Immune Deficiency Foundation. Diagnostic and Clinical Care Guidelines for Primary Immunodeficiency Diseases. 3rd edition. Towson, MD: Immune Deficiency Foundation; 2015. http://primaryimmune.org/wp-content/uploads/2015/03/ 2015-Diagnostic-and-Clinical-Care-Guidelines-for-PI.pdf. Accessed November 8, 2017 . 35. The NCCN Clinical Practice Guidelines in Oncology B-cell Lymphomas (Version 2.2017 ). 201 7 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 8, 2017. 36. Van den Bergh PY, Hadden RD, Bouche P, et al. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of t he European Federation of Neurological Societies and the Peripheral Nerve Society-first revision. Eur JNeurol. 2010;17(3):356-363. 37. Joint Task Force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Societies guidel ine on management of multifocal motor neuropathy. JPeripher Nerv Syst. 2010;15:295-301. 38. Olney RK, Lewis RA, Putnam TD, Campellone JV. Consensus criteria for the diagnosis of multifocal motor neuropathy. Muscle Nerve. 2003;27:117-121. 39. Dalakas M. Inflammatory muscle diseases. NEngl JMed. 2015;372(18):1734-1747. 40. Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207. 41. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115(2):168-186. 42. Shearer WT, Dunn E, Notarangelo LD, et al. Establishing diagnostic criteria for severe combined immunodefici ency disease (SCID), leaky SCID, and Omenn syndrome: the Primary Immune Deficiency Treatment Consortium experience. JAllergy Clin Immunol. 2014;133(4):1092.Effective date: 09/26/2019 Revised date: 08/21/2019 APPENDICES Appendix A: Examples of Risk Factors for Bleeding (not all inclusive) Undergoing a medical or dental procedure where blood loss is anticipated Comorbidity (e.g., peptic ulcer disease, hypertension) Mandated anticoagulation therapy Profession or lifestyle predisposes patient to trauma (e.g., construction worker, fireman, professional athlete) Appendix B: Impaired Antibody Response to Pneumococcal Polysaccharide Vaccine Age 6 years and older: antibody levels are not 1.3 mcg/mL for at least 70% of serotypes in the vaccine Age 2 to 5 years: antibody levels are not 1.3 mcg/mL for at least 50% of serotypes in the vaccine Not established for children less than 2 years of age
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Forteo (teriparatide injection) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include alendronate, ibandronate and zoledronic acid QUANTITY LIMIT 600 mcg/2.4 mL per month LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Forteo (teriparatide injection) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. OSTEOPOROSIS For initial authorization: 1. Medication is intended to be used for one the following (see Appendix for details on risk factors for fracture for all indications) : a) Treatment of postmenopausal women with osteoporosis at high risk for fracture; b) Treatment to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture ; c) Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture (member has been taking 5 mg of prednisone (or equivalent) daily for 3 months); AND 2. Members osteoporosis evidenced by one of the following: a) Bone mineral density (BMD) T-score 2.5 or below in the lumbar spine, femoral neck, total, and/or 33% (one-third) radius ; b) Low-trauma spine or hip fracture (regardless of BMD) ; c) Osteopenia or low bone mass (T-score between 1 and 2.5) with a fragility fracture of proximal humerus, pelvis, or possibly distal forearm ; d) Osteopenia or low bone mass and high FRAX fracture probability (a 10-year probability for major osteoporotic fracture is 20% or the 10-year probability of hip fracture is 3% ); AND 3. Member does not have ANY of the following: a) Uncorrected hypocalcemia; b) Dental disease; AND 4. Member was instructed to take calcium 1,000 mg daily and at least 400 IU of vitamin Ddaily; AND 5. Member cannot take oral bisphosphonate therapies (i.e., alendronate and /or ibandronate) as evidenced by one or more of the following: a) Esophogeal dysmotility or varices; b) Member is unable to stand or sit upright for 30-60 minutes; c) Presence of anatomic or functional esophageal abnormalities that might delay tablet transit (e.g., achalasia, stricture, or dysmotility); d) Presence of documented or potential GI malabsorption (e.g., gastric bypass procedures, celiac disease, Crohns disease, infiltrative disorders, etc.); e) Member has experienced intolerance to or treatment failure of one or more bisphosphonate medications; f) Member has a history of non-adherence to oral bisphosphonate medications ; AND 6. Member has had a documented trial and inadequate response to zoledronic acid. 7. Dosage allowed: 2 0 m cg daily . Note: use of the drug for more than 2 years during a members lifetime is not recommended. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member meets all initial criteria; AND 2. Chart notes have been provided that show the member has shown an increase in bone mineral density. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Forteo (teriparatide injection) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Bone metastases from solid tumors Giant Cell Tumor of Bone Hypercalcemic disorder Multiple Myeloma Pagets disease Pediatric and young adult members with open epiphyses Prior external beam or implant r adiation involving the skeleton Skeletal malignancies DATE ACTION/DESCRIPTION 08/02/2019 New policy for Forteo created. References: 1. Forteo [prescribing information]. Indianapolis, IN :Lilly USA, LLC; March, 2002. 2. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis 2016. Endocr Pract. 2016;22(Suppl 4). Doi: 10.4158/ EP161435.GL. 3. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. JClin Endocrinol Metab. 2012;97(6):1802-1822. Doi: 10.1210/jc.2011-3045. 4. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2017;69(8):1521-1537. Doi: 10.1002/art.40137.5. Hadji P, Aapro MS, Body JJ, et al. Management of aromatase inhibitor-associated bone loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG. JBone Oncol. 2017;7:1-12. Doi: 10.1016/j.jbo.2017.03.001. 6. Tu KN, Lie JD, Wan CKV, et al. Osteoporosis: A Review of Treatment Options. P&T. 2018 Feb; 43(2): 92 104. 7. Porter JL, Varacallo M. Osteoporosis. StatPearls Publishing LLC. Bookshelf ID: NBK441901, PMID: 28722930. Available at: https://www.researchgate.net/profile/Matthew_Varacallo/publication/329717790_Osteoporosis/links/5c17f5314585157ac1ca042b/Osteoporosis.pdf?origin=publication_detail. Effective date: 09/26/2019 Revised date: 08/02/2019Appendix. Risk Factors for Fracture: 1. Prior fracture ; 2. Age 65; 3. Low body weight (
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Evenity (romosozumab-aqqg) BILLING CODE J3590 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include alendronate, ibandronate and zoledronic acid QUANTITY LIMIT 210 mg monthly for 12 months LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Evenity (romosozumab-aqqg) is a non-preferred product and will only be con sidered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. OSTEOPOROSIS For initial authorization: 1. Medication is intended to be used for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture ( see Appendix ), or who have failed or are intolerant to other available osteoporosis the rapy; AND 2. Members osteoporosis evidenced by one if the following: a) Bone mineral density (BMD) T-score 2.5 or below at the total hip or femoral neck and either one moderate or severe vertebral fracture or two mild vertebral fractures ; b) BMD T-score less than or equal to 2.0 at the total hip or femoral neck and either two moderate or severe vertebral fractures or a history of a proximal femur fracture ; AND 3. Member does not have ANY of the following: a) Uncorrected hypocalcemia; b) Dental disease c) History of hip fracture ; AND 4. Member was instructed to take at least 500 mg daily of calcium and at least 600 IU of vitamin Ddaily; AND 5. Member cannot take oral bisphosphonate therapies (i.e., alendronate and /or ibandronate) as evidenced by one or more of the following: a) Esophogeal dysmotility or varices; b) Member is unable to stand or sit upright for 30-60 minutes; c) Presence of anatomic or functional esophageal abnormalities that might delay tablet transit (e.g., achalasia, stricture, or dysmotility); d) Presence of documented or potential GI malabsorption (e.g., gastric bypass procedures, celiac disease, Crohns disease, infiltrative disorders, etc.); e) Member has experienced intolerance to or treatment failure of one or more bisphosphonate medications; f) Member has a history of non-adherence to oral bisphosphonate medications; AND 6. Member has had a documented trial and inadequate response to zoledronic acid. 7. Dosage allowed: 210 mg monthly. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Evenity will not be reauthorized for continued therapy. CareSource considers Evenity (romosozumab-aqqg) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Bone metastases from solid tumors Giant Cell Tumor of Bone Multiple Myeloma Pagets disease DATE ACTION/DESCRIPTION 08/01/2019 New policy for Evenity created. References: 1. Evenity [prescribing information]. Thousand Oaks, CA: Amgen Inc.; April, 2019. 2. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis 2016. Endocr Pract. 2016;22(Suppl 4). Doi: 10.4158/ EP161435.GL. 3. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. JClin Endocrinol Metab. 2012;97(6):1802-1822. Doi: 10.1210/jc.2011-3045. 4. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2017;69(8):1521-1537. Doi: 10.1002/art.40137. 5. Bienz M, Saad F. Androgen-deprivation therapy and bone loss in prostate cancer patients : a clinical review. Bonekey Rep. 2015;4:Article 716. Doi: 10.1038/bonekey.2015.85. 6. ClinicalTrials.gov. Identifier: NCT01575834. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME) . Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. 7. Michael R. McClung, et al. Sclerostin antibodies in osteoporosis: latest evidence and therapeutic potential. Ther Adv Musculoskelet Dis. 2017 Oct; 9(10): 263-270. 8. Kristie N. Tu, et al. Osteoporosis: A Review of Treatment Options. PT. 2018 Feb; 43(2): 92-104. Effective date: 09/26/2019 Revised date: 08/01/2019Appendix. Risk Factors for Fracture: 1. Prior frac ture; 2. Age 65; 3. Low body weight (
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Emflaza (deflazacort) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product includes Prednisone QUANTITY LIMIT 6 mg tablets-60 per 30 days 18 mg tablets-30 per 30 days 30 mg tablets-90 per 30 days 36 mg tablets-90 per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Emflaza (deflazacort ) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. DUCHENNE MUSCULAR DYSTROPHY (DMD) For initial authorization: 1. Member must be 2 years of age or older; AND 2. Member has documented onset of weakness before 5 years of age; AND 3. Member has documented serum creatinine kinase activity at least 10 times the upper limit of normal (ULN) at some stage in their illness; AND 4. Medication is prescribed by or in consultation with a physician who specializes in the treatment of DMD and/or neuromuscular disorders; AND 5. Member has documented trial and failure of prednisone for at least 30 days ; AND 6. Member has documented baseline of Medical Research Council (MRC) 11-point scale score for Muscle Strength. 7. Dosage allowed: 0.9 mg/kg/day once daily. If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Member has documented improvement of Medical Research Council (MRC) for Muscle Strength score. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Emflaza (deflazacort) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/15/2017 New policy for Emflaza created. 07/25/2019 Age coverage expanded from 5 years of age and older to 2 years of age and older. References: 1. Emflaza [package insert]. Northbrook, IL; Marathon Pharmaceuticals, LLC: June, 2019. Effective date: 09/26/2019 Revised date: 07/25/2019
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