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Sodium Oxybate) Policy Number: C3925-A

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Sodium Oxybate) Policy Number: C3925-A Prior Authorization Criteria Xyrem (sodium oxybate) Policy Number: C3925-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 10/1/2013 7/17/2019 7/17/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J8499 (NOC) RxPA Q3 2019 20190828C3925-A PRODUCTS AFFECTED: Xyrem (sodium oxybate) DRUG CLASS: Anti-Cataplectic Agents ROUTE OF ADMINISTRATION: Oral PLACE OF SERVICE: Specialty Pharmacy The recommendation is that medications in this policy will be for pharmacy benefit coverage and patient self-administered AVAILABLE DOSAGE FORMS: Xyrem SOLN 0.5 g per mL (180 mL bottle), Xyrem is a Schedule III drug under the Controlled Substances Act FDA-APPROVED USES: indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Excessive daytime sleepiness/cataplexy REQUIRED MEDICAL INFORMATION: A. CATAPLEXY AND EXCESSIVE DAYTIME SLEEEPINESS (EDS) IN NARCOLEPSY: 1. Documented diagnosis of narcolepsy confirmed by overnight polysomnography (PSG) followed by multiple sleep latency test (MSLT). Documentation of testing results and provider interpretation for the PSG and MSLT AND 2. Prescriber attests that patient is not taking CNS depressants concomitantly (e.g. ethanol, sedative hypnotics, anxiolytics, barbiturates, benzodiazepines AND 3. Documentation patient does NOT have a succinic semialdehyde dehydrogenase deficiency AND 4. Patient must experience episodes of cataplexy OR excessive daytime sleepiness (ESD); AND Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 3 Prior Authorization Criteria 5. Both the patient and physician are registered in the “Xyrem REMS Program” provided by the manufacturer AND 6. (a) For those with cataplexy, patient has tried one of the following: a tricyclic antidepressant (TCA) [e.g., amitriptyline, desipramine, imipramine], a selective serotonin reuptake inhibitor (SSRI) [e.g., fluoxetine, sertraline, paroxetine], or venlafaxine; OR (b) For those with EDS, patient has tried two central nervous system (CNS) stimulant (e.g., methylphenidate, dexmethylphenidate, dextroamphetamine), modafinil, or armodafinil; DURATION OF APPROVAL: Initial authorization: 3 months, Continuation of therapy: up to 6 months at a time QUANTITY: Quantity limit: 9 grams per day; 18 mL per day OR 540 mL per 30 days PRESCRIBER REQUIREMENTS: Prescribed by, or in consultation with, a board-certified Sleep Medicine Specialist, neurologist, pulmonologist, or psychiatrist. Submit consultation notes if applicable. Prescriber is registered with the Xyrem REMS Program AGE RESTRICTIONS: 7 years of age or older GENDER: Male and female CONTINUATION OF THERAPY: A. CATAPLEXY AND EXCESSIVE DAYTIME SLEEEPINESS (EDS) IN NARCOLEPSY: 1. Adherence to therapy at least 85% of the time as verified by Prescriber and member’s medication fill history (review Rx history for compliance) AND 2. Prescriber attests that patient is not taking CNS depressants concomitantly (e.g. ethanol, sedative hypnotics, anxiolytics, barbiturates, benzodiazepines OR consuming any alcohol concomitantly with sodium oxybate AND 3. Dose requested for continuation of therapy does not exceed 9 gm/day (18 mL/day or 540 mL per 30 days) NOTE: The efficacy and safety at doses higher than 9 grams per night have not been established, and doses greater than 9 grams per night generally should not be administered. Therefore, requests for higher doses will not be authorized. AND 4. Prescriber attests to a positive response to Xyrem (sodium oxybate) therapy as evidenced by response decrease or reduction in the frequency of cataplexy events/attacks, Decrease or reduction in symptoms of excessive daytime sleepiness, OR Improvement in the Epworth Sleepiness Scale (ESS), Clinical Global Impression of Change or Maintenance of Wakefulness Test (MWT) CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: All other uses of Xyrem (sodium oxybate) that are not an FDA-approved indication or not included in this policy are considered experimental/investigational or not a covered benefit of this policy. This Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 2 of 3 Prior Authorization Criteria subJect to change based on research and medical literature, or at the discretion of Molina Healthcare. OTHER SPECIAL CONSIDERATIONS: None BACKGROUND: Xyrem (sodium oxybate) is a central nervous system depressant that reduces excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy. Sodium oxybate is intended for oral administration. Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Xyrem is subJect to the Xyrem REMS program. APPENDIX: REFERENCES: 1. Xyrem oral solution (prescribing information). Indianapolis, IN: Jazz Pharmaceuticals; October 2018. 2. Morgenthaler TI, Kapur VK,.Brown TM, et al. Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin: An American Academy of Sleep Medicine Report. Available at: http://www.aasmnet.org/Resources/PracticeParameters/PP_Narcolepsy.pdf. Accessed on 13 August 2018 3. Wise MS, Arand DL, Auger R, et al. Treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine Review. Available at: http://www.aasmnet.org/Resources/PracticeParameters/Review_Narcolepsy.pdf. Accessed on 13 August 2018. 4. Food and Drug Administration (FDA) drug safety communication: warning against the use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression. Page last updated: 1/19/2016. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm332029.htm.. 5. Spaeth, Michael, et al. “Long-Term Tolerability and Maintenance of Therapeutic Response to Sodium Oxybate in an Open-Label Extension Study in Patients with Fibromyalgia.” Arthritis Research & Therapy, vol. 15, no. 6, 2013, doi:10.1186/ar4375. Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 3 of 3 .
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