Vykat XR — CareFirst (Caremark)

Initial criteria

• Member has diagnosis of Prader-Willi syndrome (PWS) confirmed by genetic testing demonstrating any of the following: deletion in the chromosomal 15q11-q13 region, maternal uniparental disomy in chromosome 15, imprinting defects, translocations, or inversions involving chromosome 15.
• Member has hyperphagia (e.g., food obsession, aggressive food seeking behavior, lack of satiety).
• Member has been assessed for hyperglycemia prior to initiating treatment.
• Member does not have clinically significant renal or hepatic impairment.
• Member is age ≥ 4 years and weight ≥ 20 kilograms.
• Coverage will not be provided if member has hyperinsulinemic hypoglycemia or known hypersensitivity to diazoxide or thiazides.

Reauthorization criteria

• Member has achieved or maintained a positive clinical response (e.g., reduction in hyperphagia, reduction in body fat mass, reduced levels of leptin).

Approval duration

12 months