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Utah Medicaid Dur Report March 2019

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Utah Medicaid Dur Report March 2019 UTAH MEDICAID DUR REPORT MARCH 2019 CANNABIDIOL AND STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT AND DRAVET SYNDROMES Cannabidiol Oral Solution (Epidiolex) Stiripentol Oral Capsule and Powder for Oral Suspension (Diacomit) Report finalized: February 2019 Drug Regimen Review Center Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Valerie Gonzales, Pharm.D., Clinical Pharmacist Lauren Heath, Pharm.D., MS, BCACP, Assistant Professor (Clinical) Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Jacob Crook, MStat, Data and Statistical Analyst Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2019 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Introduction .................................................................................................................................... 1 Methods .......................................................................................................................................... 2 Disease Overview ............................................................................................................................ 2 Table 1. ILAE Multilevel Classification of Epilepsies ............................................................... 3 Table 2. Diagnosis of Lennox-Gastaut Syndrome ................................................................... 6 Table 3. Diagnosis of Dravet Syndrome .................................................................................. 7 Treatment Strategies and Guideline Recommendations ............................................................... 8 Table 4. Clinical Guideline Recommendations for the Management of LGS in Adults and Pediatrics ................................................................................................................................. 9 Table 5. Treatment Algorithm for the Management of LGS (as suggested by Cross et al) .. 10 Table 6. Recommendations from the Task Force of the ILAE Pediatric Commission Concerning Treatment of DS................................................................................................. 10 Table 7. North American Consensus Panel Recommendations (2017) for the Management of DS with AEDs ..................................................................................................................... 11 Cannabidiol and Stiripentol Information ...................................................................................... 12 Table 8. Prescribing Information for Cannabidiol and Stiripentol ........................................ 12 Table 9. Warnings, Contraindications, and Adverse Reactions for Cannabidiol and Stiripentol .............................................................................................................................. 15 Clinical Trial and Systematic Review Evidence ............................................................................. 16 Utah Medicaid Utilization Data ..................................................................................................... 18 Discussion Topics and Potential Prior Authorization Criteria ....................................................... 19 Summary ....................................................................................................................................... 21 References .................................................................................................................................... 23 Appendix A: FDA-Approved Antiepileptic Drugs as of January 2019 ........................................... 27 Appendix B: Literature Search Strategies ..................................................................................... 29 Appendix C: FDA-Approved Cannabinoid-Containing Products ................................................... 30 Appendix D: Drug Interactions with Cannabidiol and Stiripentol ................................................ 31 Appendix E: Key Findings in Published Clinical Trials ................................................................... 32 Introduction Cannabidiol (Epidiolex) and Stiripentol (Diacomit) are two antiepileptic orphan drugs approved in 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with 2 rare epilepsy syndromes: Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).1-3 Both cannabidiol and stiripentol are new molecular entities in the antiepileptic drug (AED) class.4,5 • Cannabidiol, a natural compound from the Cannabis sativa plant, is approved as an add-on medication for the “treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.”1,4 • Stiripentol, a synthetic aromatic allylic alcohol, is approved as an add-on medication for the “treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.”2,5 Stiripentol is additionally approved in Europe, Japan, and Canada for DS in combination with clobazam and valproate.4,6 As evaluated in clinical trials, these agents are used as adjunctive treatments to conventional AEDs (mainly valproic acid and clobazam).4,5 Cannabidiol- and stiripentol-containing products are available as oral formulations whose recommended dosage is adjusted based on the patient’s body weight.1,2 The mechanisms of action of cannabidiol and stiripentol as anticonvulsants are not clearly understood;1,2 however, studies suggest each agent acts on a different target that is key in the reduction of seizures.4,7 Cannabidiol has a lower affinity for cannabinoid receptors preventing the occurrence of psychoactive and abuse-related adverse effects.1,8 Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) are rare, severe, treatment-resistant forms of epilepsy presenting in early childhood.9-11 Both disorders are typically characterized by multiple seizure types (focal and generalized onset seizures) that are recurrent and refractory to antiepileptic drugs (AEDs) and medical interventions (eg, ketogenic diet and surgery).9,10,12 Developmental retardation, learning disability, and behavior impairment are usually observed in these patients.9-11 Patients with these complex epileptic syndromes are unlikely to achieve seizure freedom even with AED therapy and disease prognosis is very unfavorable.4,5,10,13 Quality of life is profoundly affected and mortality risk is increased due to the severity and recurrence of seizures.14 Treatment strategies focus on reducing the frequency of seizures, optimizing cognitive ability and behavior, and improving quality of life.10 Current therapeutic options with FDA approval for the treatment of seizures in patients with LGS include clobazam, felbamate, lamotrigine, rufinamide, topiramate, clonazepam, and the recently approved agent, cannabidiol.1,10,15,16 In addition, some broad- spectrum AEDs such as valproic acid and levetiracetam may be used, off-label, for this condition.10 Cannabidiol and stiripentol are the first FDA approved agents for the reduction of seizures in patients with Dravet syndrome.1,2 Clobazam and valproic acid, although not approved for the treatment of seizures in patients with DS, are the most frequently used AEDs in this population.4,7,14 Currently, there are approximately 29 AEDs available in the United States.15,16 Table 1 of Appendix A includes a list of FDA-approved AEDs as of January 2019 with their labeled indications and suggested mechanisms of action. 1 Cannabidiol (Epidiolex) has Utah Medicaid prior authorization criteria in place since February 2019. The purpose of this review is to provide evidence that can assist the Medicaid Drug Utilization Review (DUR) Board in assuring appropriate use of cannabidiol and stiripentol. Methods A literature search for systematic reviews and meta-analyses addressing the efficacy and safety of cannabidiol and stiripentol was conducted in the Cochrane Library and Ovid Medline. Reference lists of relevant systematic reviews were additionally screened. Search strategies are provided in Appendix B. Information concerning product labeling and FDA clinical review documents was obtained from the FDA website. Additional information was found in Micromedex and Lexicomp. Treatment guidelines for the management of LGS and Dravet syndrome were searched for in the American Academy of Neurology and the American Epilepsy Society websites. Disease Overview A. Definition and Classification of Epilepsy Epilepsy is a neurological disorder characterized by repetitive seizures.17 In 2015, the Centers for Disease Control and Prevention (CDC) estimated a prevalence of active epilepsy in the United States of 1.2%.17 This percentage represents approximately 3 million adults and 470,000 children.17 In Utah, the number of patients with active epilepsy in 2015 was approximately 29,300 (24,000 patients 18 years and older and 5,300 patients younger than 18 years).17 An epileptic seizure is defined by the International League Against Epilepsy (ILAE) as “a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.”18,19 Significant signs and symptoms may include automatic behaviors, emotions, extension or flexion of postures, jerking arrhythmically (ie, myoclonus), jerking rhythmically (ie, clonus), and thinking problems. In 2014, the ILAE clinically defined epilepsy as a disease of the brain characterized by any of the following conditions18:
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