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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-15

Original Effective Date: 09/15/14

Reviewed: 05/13/15

Revised: 11/01/15

Subject: Tasimelteon (Hetlioz™) Capsules

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates
           

DESCRIPTION:

Non-24 sleep-wake disorder (also known as non-24 or free-running disorder) is a chronic primary circadian rhythm sleep disorder (CSRD) that alters sleep patterns, causes daytime sleepiness, and results in impaired social and occupational functioning. Most blind individuals perceive enough light to prevent non-24. However, some have no light perception. Because light cannot enter their eyes, people with non-24 cannot synchronize or “entrain” the suprachiasmatic nucleus (SCN). The presence of light in the daytime stimulates the SCN to inhibit melatonin secretion from the pineal gland, while the absence of light at night stimulates melatonin secretion. Thus, in absence of any light, the SCN cannot set the circadian “body clock” to a 24-hour light-dark cycle. About 80,000 to 100,000 totally blind individuals in the U.S. may have non-24.

Tasimelteon is a high-affinity, oral dual melatonin receptor agonist at both the MT1 (sleep-promoting) and MT2 (circadian rhythm-regulating) melatonin receptors. Tasimelteon was approved by the U.S. Food and Drug Administration (FDA) in 2014 for treatment of non-24-hour sleep-wake disorder. Prior to FDA approval, tasimelteon received orphan drug status for the treatment of non-24-hour sleep-wake disorder.

The evidence base for tasimelteon consists of 2 distinct pivotal trials called SET (N=84) and RESET (N=20). Both were randomized, placebo-controlled, double-blind trials with an overlapping patient population. There was a disagreement between FDA and the sponsor in the choice of primary end point in SET. The sponsor used a biomarker-based end point of entrainment as the primary end point while FDA used clinical measures that focused on measuring sleep on the days when symptoms were worst because FDA argued that those measures would have the greatest likelihood of identifying a clinical beneficial effect.

SET

In totally blind patients, tasimelteon, compared with placebo, significantly increased nighttime sleep (50 vs 22 minutes) and significantly decreased daytime napping (49 vs 22 minutes) compared with baseline. In a randomized, double-masked study, 84 patients with non-24-hour sleep-wake disorder (median age, 54 years) received tasimelteon 20 mg or placebo 1 hour before bedtime, at the same time every night, for up to 6 months. Nighttime total sleep time, on the 25% of nights with the least sleep, was significantly increased from 195 minutes at baseline by 50 minutes in the tasimelteon arm compared with 22 minutes in the placebo arm. Daytime nap duration, on 25% of days with the most nap time, was significantly reduced from 137 minutes at baseline by 49 minutes in the tasimelteon arm compared with 22 minutes in the placebo arm. Twenty-nine percent of patients in the tasimelteon arm and 12% of patients in the placebo arm had both an increase of 45 minutes or more in nighttime sleep and a decrease of 45 minutes or more in daytime napping. Adverse reactions with tasimelteon compared with placebo included headache (17% vs 7%), increased ALT (10% vs 5%), abnormal dreams (10% vs 0%), upper respiratory tract infection (7% vs 0%), and urinary tract infection (7% vs 2%).

RESET

In totally blind patients treated with tasimelteon, continued maintenance therapy with tasimelteon, compared with placebo, produced significant differences in nighttime sleep (-7 vs -74 minutes) and daytime napping (-9 vs +50 minutes) compared with baseline. In a randomized, double-masked study, patients with non-24-hour sleep-wake disorder received tasimelteon 20 mg 1 hour before bedtime, at the same time every night, for approximately 12 weeks. The 20 patients whose peak melatonin level occurred at approximately the same time of day during that 12 weeks were randomized to continue to receive tasimelteon 20 mg daily or placebo for 8 weeks. Nighttime total sleep time, on the 25% of nights with the least sleep, decreased by 7 minutes in the tasimelteon maintenance arm compared with a decrease of 74 minutes in the placebo arm. Daytime nap duration, on the 25% of days with the most nap time, decreased by 9 minutes in the tasimelteon maintenance arm compared with an increase of 50 minutes in the placebo arm.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of tasimelteon (Hetlioz) meets the definition of medical necessity when ALL of the following criteria are met:

  1. Member is diagnosed with non-24- hour sleep-wake disorder
  2. Prescriber has ruled out all other sleep disorders causing inability to initiate sleep or excessive sleepiness
  3. Member is totally blind and has no light perception – documentation must be provided
  4. Member has a history of at least three months of difficulty initiating sleep, difficulty awakening in the morning, or excessive daytime sleepiness
  5. Member has failed treatment with melatonin
  6. Member has no other sleep disorders
  7. Member has no other psychiatric disorders
  8. Treatment is prescribed or supervised by a board certified sleep medicine specialist
  9. Dose does not exceed 20 mg daily

Duration of approval: 6 months

Continuation of tasimelteon (Hetlioz) meets the definition of medical necessity when ALL of the following criteria are met:

  1. Member meets Florida Blue’s initial criteria
  2. Member has a beneficial response to treatment
  3. Member has been evaluated by a board certified sleep medicine specialist in the previous month
  4. Treatment is prescribed or supervised by a board certified sleep medicine specialist

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• 20 mg prior to bedtime, at the same time every night

Drug Availability

• 20 mg capsules

PRECAUTIONS:

Boxed Warning

None

Contraindications

None

Precautions/Warnings

• May cause somnolence

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

G47.24

Circadian rhythm sleep disorder, free-running type

H54.0

Blindness, both eyes

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None

OTHER:

None

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2015 [cited 2015 Apr 17]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2015 [cited 2015 Apr 17]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2015 Apr 17]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2015 Apr 17]. Available from: http://www.thomsonhc.com/.
  5. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 2015 Apr 17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  6. Vanda Pharmaceuticals. Hetlioz (tasimelteon) capsule. 2014 [cited 2014 Jul 16]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ca4a9b63-708e-49e9-8f9b-010625443b90 /.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/13/15.

GUIDELINE UPDATE INFORMATION:

09/15/14

New Medical Coverage Guideline.

06/15/15

Review and revision to guideline; consisting of updating references.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 20, 2017: 12:02 PM