Sedative Hypnotics

The Louisiana Uniform Prescription Drug Prior Authorization Form should be utilized to request: • Prior authorization for non-preferred sedative hypnotics; OR • Clinical authorization for tasimelteon (Hetlioz®, Hetlioz LQ™).

Additional Point-of-Sale edits may apply. Some of tThese agents may have Black Box Warnings and/or may be subject to Risk Evaluation and Mitigation Strategy (REMS) under FDA safety regulations. Please refer to individual prescribing information for details. ______

Non-Preferred Agents

Approval Criteria for Initial and Reauthorization Requests

• There is no preferred alternative that is the exact same chemical entity, formulation, strength, etc.; AND • The requested medication has been prescribed for an approved diagnosis (if applicable); AND • Previous use of a preferred product - ONE of the following is required: o The recipient has had a treatment failure with at least one preferred product; OR o The recipient has had an intolerable side effect to at least one preferred product; OR o The recipient has documented contraindication(s) to all of the preferred products that are appropriate to use for the condition being treated; OR o There is no preferred product that is appropriate to use for the condition being treated; AND • By submitting the authorization request, the prescriber attests to the following: o The prescribing information for the requested medication has been thoroughly reviewed, including any Black Box Warning, Risk Evaluation and Mitigation Strategy (REMS), contraindications, minimum age requirements, recommended dosing, and prior treatment requirements; AND o All laboratory testing and clinical monitoring recommended in the prescribing information have been completed as of the date of the request and will be repeated as recommended; AND o The recipient has no concomitant drug therapies or disease states that limit the use of the requested medication and will not receive the requested medication in combination with any medication that is contraindicated or not recommended per FDA labeling. The recipient has no concomitant drug therapies or disease states that limit the use of the requested medication and will not be receiveing the requested medication in combination with any other medication that is contraindicated or not recommended per FDA labeli ***Duration of initial and reAauthorization aApproval: 3 months*** ______Tasimelteon (Hetlioz®, Hetlioz LQ™)

Approval Criteria

• The recipient has a documented diagnosis of non-24-hour sleep-wake disorder (also known as circadian rhythm sleep disorder, free-running type); AND • The recipient is 18 years of age or older on date of request; AND • The recipient has a documented diagnosis of being totally blind (has no light perception in either eye); AND • ONE of the following is true and is stated on the request: o The recipient has had insufficient response or intolerance to other preferred medication(s) used for sleep; OR o The medication is prescribed by, or the request states that this medication is being prescribed in consultation with, a physician who specializes in the treatment of sleep disorders; AND • By submitting the authorization request, the prescriber attests to the following: o The prescribing information for the requested medication has been thoroughly reviewed, including any Black Box Warning, Risk Evaluation and Mitigation Strategy (REMS), contraindications, minimum age requirements, recommended dosing, and prior treatment requirements; AND o All laboratory testing and clinical monitoring recommended in the prescribing information have been completed as of the date of the request and will be repeated as recommended; AND o The recipient has no concomitant drug therapies or disease states that limit the use of the requested medication and will not receive the requested medication in combination with any medication that is contraindicated or not recommended per FDA labeling.

OR The recipient has no concomitant drug therapies or disease states that limit the use of the requested medication. • The recipient has a documented diagnosis of Smith-Magenis Syndrome (SMS) with nighttime sleep disturbances; AND • The recipient is 3 years of age or older on date of request; AND • ONE of the following is true and is stated on the request: o The recipient has had insufficient response or intolerance to other preferred medication(s) used for sleep; OR o The medication is prescribed by, or the request states that this medication is being prescribed in consultation with, a physician who specializes in the treatment of sleep disorders; AND • By submitting the authorization request, the prescriber attests to the following: o The prescribing information for the requested medication has been thoroughly reviewed, including any Black Box Warning, Risk Evaluation and Mitigation Strategy (REMS), contraindications, minimum age requirements, recommended dosing, and prior treatment requirements; AND

o All laboratory testing and clinical monitoring recommended in the prescribing information have been completed as of the date of the request and will be repeated as recommended; AND o The recipient has no concomitant drug therapies or disease states that limit the use of the requested medication and will not receive the requested medication in combination with any medication that is contraindicated or not recommended per FDA labeling.

Duration of initial approval: 6 months

Reauthorization Criteria • The recipient continues to meet initial approval criteria; AND • The recipient is tolerating and is adherent to current treatment; AND • The prescriber states on the request that the recipient is established on the medication with evidence of ahas a documented positive clinical response to tasimelteon (Hetlioz®) therapy. (e.g., the recipient is experiencing increased total nighttime sleep and/or decreased daytime nap duration).

Duration of reauthorization approval: 12 months ______

References

Ambien (zolpidem) [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; August 2019. http://products.sanofi.us/ambien/Ambien.pdf

Ambien CR (zolpidem) [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; August 2019. http://products.sanofi.us/ambien_cr/ambien_CR.pdf

Belsomra (suvorexant) [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; March 2020. https://www.merck.com/product/usa/pi_circulars/b/belsomra/belsomra_pi.pdf

Estazolam [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; December 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a1e3b4bf-22e9-430a-a768- 4d86ae886c9e&type=display

Flurazepam [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; December 2018. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2f2db2f5-49d3-4d47-a08a- 628df49d2120&type=display

Halcion (triazolam) [package insert]. New York, NY: Pharmacia & Upjohn Co Division of Pfizer Inc; December 2019. http://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=586

Hetlioz (tasimelteon) [Doctor Discussion Guide]. Washington, D.C.: Vanda Pharmaceutical Inc; 2014. https://hetlioz.com/assets/HETLIOZ_DoctorDiscussionGuide.pdf

Hetlioz (tasimelteon) [package insert]. Washington, D.C.: Vanda Pharmaceuticals Inc; December 202014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214517s000lbl.pdf

Hetlioz: Uncovering Non-24 in your patients who are totally blind. (2018, September 19). https://www.hetliozpro.com/uncovering-non-24-hour-sleep-wake-disorder/diagnostic-tools

Intermezzo (zolpidem) [package insert]. Stamford, CT: Purdue Pharma L.P.; August 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=913b6cfe-1fb0-44a8-817a- 26374bbce995&type=display

Lunesta (eszopiclone) [package insert]. Marlborough, MA: Sunovion Pharmaceuticals Inc; August 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=fd047b2b-05a6-4d99- 95cb-955f14bf329f&type=display

Restoril (temazepam) [package insert]. Webster Groves, MO: SpecGx LLC; February 2020. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=bc56f7fd-1aaf-48ff-8aa7- d467e59e1015&type=display

Rozerem (ramelteon) [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc; December 2018. https://general.takedapharm.com/rozerempi

Silenor (doxepin) [package insert]. Morristown, NJ: Pernix Therapeutics, LLC; March 2010. https://www.silenor.com/Content/pdf/prescribing-information.pdf

Sonata (zaleplon) [package insert]. New York, NY: Pfizer Inc; December 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=710

ZolpiMist (zolpidem) [package insert]. Englewood, CO: Aytu Bioscience, Inc; August 2019. https://myzolpimist.com/wp-content/uploads/2019/10/Zolpimist-Full-Prescribing-Information.pdf

Revision / Date DateImplementaton Date Single PDL Implementation May 2019 Separated “Select Therapeutic Classes Not Established” into individual November 2019January therapeutic class documents / November 2019 2020 Combined sedative-hypnotic criteria and Hetlioz® clinical criteria into July 2020 one document, formatting changes, updated references / July 2020 Added criteria for Smith-Magenis Syndrome (SMS) with nighttime sleep disturbances and minimum ages to Hetlioz®, formatting changes, January 2021July 2021 updated references, added Hetlioz LQ™ formulation / January 2021