Vykat XR (diazoxide choline extended-release) — Point32Health
hyperphagia in adults and pediatric patients age ≥4 years with Prader-Willi syndrome (PWS)
Initial criteria
- Documented diagnosis of Prader-Willi syndrome (PWS) confirmed by presence of a mutation in chromosome 15
- Member age ≥4 years
- Prescribed by or in consultation with an endocrinologist or geneticist
- Documentation of baseline hyperphagia questionnaire for clinical trials (HQ-CT) score ≥13
- Prescriber attests that member experiences moderate to severe symptoms of hyperphagia related to PWS and provides documentation of associated symptoms (e.g., food-seeking behaviors)
- Caregiver has implemented and intends to continue strategies to establish a food-secure environment (e.g., locked food storage)
- Recent weight documentation (within 30 days) to ensure appropriate dose
Reauthorization criteria
- Member has experienced an improvement in hyperphagic symptoms such as a decrease in food-related aggression or manipulation, or lessened food preoccupation that interferes with normal daily activities OR prescriber has determined that adult member is likely to still benefit from therapy
- Member is adherent to therapy and able to successfully swallow the prescribed number of tablets daily
- Improvement in hyperphagia questionnaire for clinical trials (HQ-CT) score
- Recent weight documentation (within 30 days) to ensure appropriate dose
Approval duration
initial 6 months; reauth 12 months