Pharmacy Prior Authorization Criteria

Vykat XR (diazoxide choline)

Indications for Prior Authorization

Vykat XR (diazoxide choline)

• For diagnosis of Hyperphagia in Prader-Willi Syndrome
  Indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

Criteria

Vykat XR

Prior Authorization (Initial Authorization)

Length of Approval: 6 months [A, 1]

• Diagnosis of Prader-Willi syndrome (PWS) [D, 5]
AND
• Medication is being used for hyperphagia due to PWS [B, 2]
AND
• Disease is confirmed by the presence of a mutation in chromosome 15 as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [C, 2]
AND
• Patient is 4 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Endocrinologist
• Geneticist
• Specialist knowledgeable in the treatment of Prader-Willi syndrome

Vykat XR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., decreased hunger or thoughts about food, decreased weight or BMI)

P & T Revisions

1970-01-01

References

1. Vykat prescribing information. Soleno Therapeutics Inc. Redwood City, CA. March 2025.
2. Driscoll, D., Miller, J., and Cassidy, S. Prader-Willi Syndrome. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1330/. Accessed April 14, 2025.
3. Soleno Therapeutics Announces U.S. FDA Approval of VYKAT™ XR to Treat Hyperphagia in Prader-Willi Syndrome. Available at: https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-announces-us-fda-approval-vykattm-xr-treat. Accessed April 14, 2025.
4. VYKAT XR Start Form, Available at: https://www.vykatxrhcp.com/. Accessed April 14, 2025.
5. Prader-willi syndrome. Available at: https://rarediseases.info.nih.gov/diseases/5575/prader-willi-syndrome. Accessed April 14, 2025.

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End Notes

1. The primary efficacy endpoint was the Change from Baseline in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Total Score at Week 16. Initial authorization of 6 months is to allow sufficient time to assess effect on patient hunger.[1]
2. Hyperphagia in PWS is believed to be caused by a hypothalamic abnormality resulting in lack of satiety. Food-seeking behaviors such as hoarding or foraging for food, eating of inedible objects, and stealing of food or money to buy food are common. At this time there are no consistently identified hormonal abnormalities to explain the hyperphagia, and the metabolic correlates of hyperphagia in PWS remain uncertain. [2]
3. The diagnosis of PWS is established in a proband by identification of abnormal DNA methylation within the Prader-Willi critical region (PWCR) at 15q11.2-q13. [2]
4. Prader-Willi syndrome (PWS) also known as Prader-Willi-Labhart syndrome, Prader-Labhart-Willi syndrome and Willi-Prader syndrome. [5]

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Revision History

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