Hetlioz (generic) — Medica

Initial criteria

• age ≥ 18 years
• Patient is totally blind with no perception of light
• Diagnosis of Non-24 is confirmed by assessment of at least one physiologic circadian phase marker OR, if assessment cannot be done, by actigraphy performed for ≥ 1 week plus evaluation of sleep logs recorded for ≥ 1 month
• Patient has received at least 6 months of continuous therapy with melatonin under the guidance of a physician who specializes in the treatment of sleep disorders
• According to the prescriber, patient had inadequate efficacy with melatonin therapy (e.g., entrainment, clinically meaningful or significant increases in nighttime sleep, and/or clinically meaningful or significant decreases in daytime sleep)
• Medication is prescribed by or in consultation with a physician who specializes in the treatment of sleep disorders

Reauthorization criteria

• age ≥ 18 years
• Patient is totally blind with no perception of light
• Patient has received at least 6 months of continuous therapy with melatonin under the guidance of a physician who specializes in the treatment of sleep disorders
• According to the prescriber, patient had inadequate efficacy with melatonin therapy (e.g., entrainment, clinically meaningful or significant increases in nighttime sleep, and/or clinically meaningful or significant decreases in daytime sleep)
• Patient has received at least 6 months of continuous therapy with tasimelteon capsules under the guidance of a physician who specializes in the treatment of sleep disorders
• According to the prescriber, patient has achieved adequate results with tasimelteon capsules therapy (e.g., entrainment, clinically meaningful or significant increases in nighttime sleep, and/or clinically meaningful or significant decreases in daytime sleep)
• Medication is prescribed by or in consultation with a physician who specializes in the treatment of sleep disorders

Approval duration

Initial: 6 months; Reauthorization: 1 year