Vykat™ XR

Drug - Vykat™ XR (diazoxide choline) [Soleno Therapeutics, Inc.]

January 2026

Therapeutic Area - Prader-Willi syndrome (PWS)

Initial approval criteria

  • Age ≥ 4 years; AND
  • Diagnosis of Prader-Willi syndrome and BOTH of the following:
    • Presence of hyperphagia; AND
    • Diagnosis has been confirmed by genetic testing indicating mutation on chromosome 15 (medical records required); AND
  • Patient does NOT have known hypersensitivity to diazoxide, other components of Vykat XR or thiazides; AND
  • Vykat XR is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis; AND
  • Prescriber has reviewed Vykat XR Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate.
  • Initial approval is for 4 months

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient must have clinical benefit with the use of Vykat XR (e.g., reduction in hyperphagic and/or food-related behaviors); AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., severe hyperglycemia).
  • Renewal approval is for 12 months

Quantity limits

  • 5.8 mg/kg/day or 525 mg/day
  • Patient’s weight (in kg) must be submitted at time of request.
  • When a combination of two Vykat XR strength is needed, provide the requested quantity, number of refill(s) and directions for use for each of the Vykat XR strength on the prior authorization request form.

Questions

Provider Call Center: (844) 575-7887