Hetlioz — Medica

Initial criteria

• age ≥ 18 years
• patient is totally blind with no perception of light
• diagnosis of Non-24 confirmed by at least one physiologic circadian phase marker OR if not feasible, by actigraphy performed ≥ 1 week plus evaluation of sleep logs recorded ≥ 1 month
• patient has received ≥ 6 months of continuous melatonin therapy under the guidance of a physician who specializes in sleep disorders
• inadequate efficacy with melatonin therapy according to prescriber (e.g., lack of entrainment or meaningful improvement in sleep parameters)
• medication prescribed by or in consultation with a physician who specializes in treatment of sleep disorders

Reauthorization criteria

• age ≥ 18 years
• patient is totally blind with no perception of light
• patient has received ≥ 6 months of continuous melatonin therapy under the guidance of a physician who specializes in sleep disorders with inadequate efficacy
• patient has received ≥ 6 months of continuous tasimelteon capsule therapy under the guidance of a physician who specializes in sleep disorders
• patient has achieved adequate results with tasimelteon capsule therapy per prescriber (e.g., entrainment or meaningful improvements in sleep parameters)
• medication prescribed by or in consultation with a physician who specializes in treatment of sleep disorders

Approval duration

initial: 6 months; continuation: 1 year