Prior Authorization Protocol BELSOMRA® (Suvorexant)

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Prior Authorization Protocol    BELSOMRA  (suvorexant), EDLUAR , INTERMEZZO  (zolpidem sublingual  tablets), ROZEREM  (ramelteon), SILENOR® (doxepin), ZOLPIMIST ® (zolpidem spray)

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Coverage of drugs is first determined by the member’s pharmacy benefit. Please consult with or refer to the Evidence of Coverage document.

I. FDA Approved Indications: Edluar • Short-term treatment of insomnia characterized by difficulties with sleep initiation Intermezzo • Treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep Zolpimist • Short-term treatment of insomnia characterized by difficulties with sleep initiation. Rozerem • Treatment of insomnia characterized by difficulty with sleep onset Silenor • Treatment of insomnia characterized by difficulties with sleep maintenance Belsomra • Treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

II. Health Net Approved Indications and Usage Guidelines: Belsomra, Silenor • Diagnosis of insomnia AND • Failure or clinically significant adverse effects to zolpidem or zolpidem CR Intermezzo • Diagnosis of insomnia AND • History of insomnia with difficulty returning to sleep after middle of the night awakening Edluar, Zolpimist • Diagnosis of insomnia

Confidential and Proprietary Page 1 Date Prepared: 11.23.05JE Approved by Health Net Pharmacy & Therapeutic s Committee: 02.14.06, 04.11.06, 05.16.07, 11.19.08, 11.18.09, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 05.09.06 JE, 10.03.06 RG, 02.08.07CM, 06.13.07 JE, 06.21.07 JE, 01.31.08 A.Myong, MJMcClusky 02.02.08, 08.06.08 A Myong, 06.09.09 A Myong, 6.1.10 A Myong, 6.27.11 PWhite, 2.9.12 S Redline, 3.13.12 S Redline, 3.28.12 S Redline, 5.23.12 S Redline, 6.11.12 S Redline, 6.18.12 S Redline, 4.2.13 S Redline, 6.12.13 A Giordano, 6.20.14 S Ara, 07.22.14 S Ara, 09.09.14 JKawamata, 6.1.15 A Myong, 01.08.16 S Mirando, 06.14.16 S Tabarangao

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AND • Trial of zolpidem unless contraindicated Rozerem • Diagnosis of insomnia AND • Failure or clinically significant adverse effects to zolpidem OR • Patient has a previous history of substance abuse

III. Coverage is Not Authorized For: • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

IV. General Information: • Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. • Rozerem is a melatonin receptor agonist, Silenor is a histamine H1 receptor antagonist and Belsomra is an orexin receptor antagonist. These three agents do not work through the GABA-A receptors, as do the other available agents in this class. • Silenor is not a scheduled controlled substance. • Zolpidem has a Micromedex Class IIa indication for improving sleep in patients with SSRI- induced insomnia. The insomnia had been ongoing for two weeks while on the SSRI. • The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

V. Therapeutic Alternatives: Drug Dosing Regimen Dose/Limit/Maximum Dose flurazepam Adults: 15 - 30 mg PO QHS 30 mg/day (Dalmane ) Elderly**: 15 mg PO QHS **Generally not recommended in the elderly due to long half-life of active metabolite temazepam Adults: 15 - 30 mg PO QHS 30 mg/day (Restoril ) Elderly: 7.5 - 15 mg PO QHS

Confidential and Proprietary Page 2 Date Prepared: 11.23.05JE Approved by Health Net Pharmacy & Therapeutic s Committee: 02.14.06, 04.11.06, 05.16.07, 11.19.08, 11.18.09, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 05.09.06 JE, 10.03.06 RG, 02.08.07CM, 06.13.07 JE, 06.21.07 JE, 01.31.08 A.Myong, MJMcClusky 02.02.08, 08.06.08 A Myong, 06.09.09 A Myong, 6.1.10 A Myong, 6.27.11 PWhite, 2.9.12 S Redline, 3.13.12 S Redline, 3.28.12 S Redline, 5.23.12 S Redline, 6.11.12 S Redline, 6.18.12 S Redline, 4.2.13 S Redline, 6.12.13 A Giordano, 6.20.14 S Ara, 07.22.14 S Ara, 09.09.14 JKawamata, 6.1.15 A Myong, 01.08.16 S Mirando, 06.14.16 S Tabarangao

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Drug Dosing Regimen Dose/Limit/Maximum Dose triazolam Adults: 0.125 - 0.5 mg PO QHS Adults: 0.5 mg/day (Halcion ) Elderly: 0.125 - 0.25 mg PO QHS Elderly: 0.25 mg/day trazodone Adults: 50 - 100 mg PO QHS Up to 600 mg/day for depression. (Desyrel ) Elderly: 25 - 100 mg PO QHS Lower doses are used for insomnia. zolpidem Adults: 5-10 mg PO QHS 10 mg/day (Ambien ) Elderly: 5 mg PO QHS zaleplon Adults: 10 mg PO QHS Adults: 20 mg/day (Sonata ) Elderly: 5 mg PO QHS Elderly: 10 mg/day zolpidem Adults: 6.25-12.5 mg PO QHS 12.5 mg/day extended release Elderly: 6.25 mg PO QHS (Ambien CR  ) *Requires Prior Authorization

VI. Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Authorization Limit Edluar Women: 5 mg SL QHS NAT: Length of Benefit Men: 5 or 10 mg SL QHS Elderly: 5 mg SL QHS HNCA: Length of Benefit Intermezzo Women: 1.75 mg SL QD PRN Men: 3.5 mg SL QD PRN HNMC: Length of Benefit Elderly: 1.75 mg SL QD PRN Belsomra 10 mg PO QHS

If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily. Zolpimist Women: 5 mg PO QHS immediately before bedtime Men: 5-10 mg PO QHS immediately before bedtime Elderly: 5 mg PO QHS immediately before bedtime Rozerem for AHCS requests: Rozerem Adults: 8 mg PO QHS One Year Silenor Adults: 6 mg PO QHS (max 6 mg) Elderly: 3 mg PO QHS

Confidential and Proprietary Page 3 Date Prepared: 11.23.05JE Approved by Health Net Pharmacy & Therapeutic s Committee: 02.14.06, 04.11.06, 05.16.07, 11.19.08, 11.18.09, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 05.09.06 JE, 10.03.06 RG, 02.08.07CM, 06.13.07 JE, 06.21.07 JE, 01.31.08 A.Myong, MJMcClusky 02.02.08, 08.06.08 A Myong, 06.09.09 A Myong, 6.1.10 A Myong, 6.27.11 PWhite, 2.9.12 S Redline, 3.13.12 S Redline, 3.28.12 S Redline, 5.23.12 S Redline, 6.11.12 S Redline, 6.18.12 S Redline, 4.2.13 S Redline, 6.12.13 A Giordano, 6.20.14 S Ara, 07.22.14 S Ara, 09.09.14 JKawamata, 6.1.15 A Myong, 01.08.16 S Mirando, 06.14.16 S Tabarangao

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VII. Product Availability: Edluar sublingual tablets (not scored): 5 mg, 10 mg Intermezzo sublingual tablets: 1.75 mg, 3.5 mg Zolpimist oral spray: 5 mg per actuation Rozerem tablets: 8 mg Silenor tablets (not scored): 3 mg, 6 mg Belsomra tablets: 5 mg, 10 mg, 15 mg, 20 mg

VIII. References: 1. Edluar [Prescribing Information] Somerset, NJ: Meda Pharmaceuticals, Inc.; October 2014. 2. Zolpimist [Prescribing Information] Richmond, VA:ECR Pharmaceuticals. May 2013. 3. Rozerem [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals America Inc. November 2010. 4. Intermezzo [Prescribing Information] Stamford, CT: Purdue Pharma L.P. July 2015 5. Silenor [Prescribing Information] Morristown, NJ: Pernix Therapeutics, LLC, Inc. March 2010. 6. Belsomra [Prescribing Information} Whitehouse Station, NJ: Merck & Co, Inc.; May 2016. 7. Micromedex ® Healthcare Series (Internet Database). Greenwood Village, CO: Thompson Healthcare. Updated periodically. Accessed July 2016

The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract.

Confidential and Proprietary Page 4 Date Prepared: 11.23.05JE Approved by Health Net Pharmacy & Therapeutic s Committee: 02.14.06, 04.11.06, 05.16.07, 11.19.08, 11.18.09, 11.17.10, 11.9.11, 11.14.12, 11.20.13, 11.19.14, 11.18.15 Updated: 05.09.06 JE, 10.03.06 RG, 02.08.07CM, 06.13.07 JE, 06.21.07 JE, 01.31.08 A.Myong, MJMcClusky 02.02.08, 08.06.08 A Myong, 06.09.09 A Myong, 6.1.10 A Myong, 6.27.11 PWhite, 2.9.12 S Redline, 3.13.12 S Redline, 3.28.12 S Redline, 5.23.12 S Redline, 6.11.12 S Redline, 6.18.12 S Redline, 4.2.13 S Redline, 6.12.13 A Giordano, 6.20.14 S Ara, 07.22.14 S Ara, 09.09.14 JKawamata, 6.1.15 A Myong, 01.08.16 S Mirando, 06.14.16 S Tabarangao