CurrentCignaPolicy IP0741

Vykat XR (diazoxide choline) for Prader-Willi syndrome

Defines Cigna coverage and prior authorization requirements for Vykat XR (diazoxide choline extended-release tablets) for treatment of hyperphagia in patients with Prader-Willi syndrome, including required documentation, prescriber specialty, duration of approval, and exclusions.

Policy Summary

PayerCigna

PolicyVykat XR (diazoxide choline) for Prader-Willi syndrome

Policy CodePolicy IP0741

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior Authorization is required for Vykat XR; approvals are provided for 1 year when criteria are met.

POLICY UPDATE CHANGES

New policy created for Vykat XR (diazoxide choline) with effective date 07/01/2025.

1Covered Indications (FDA-approved)

1Not Covered Indications (example)

1 yrApproval Length (when criteria met)

Coverage Summary & Criteria

FDA-Approved Indication - Approval Criteria

Approve for 1 year if the patient meets the following (A, B, C, and D):

Patient is ≥ 4 years of age≥ 4 years
The diagnosis of Prader-Willi syndrome has been established by identification of abnormal DNA methylation of chromosome 15q11.2-q13
Documentation Required
Patient has hyperphagia
The medication has been prescribed by or in consultation with an endocrinologist

Not Medically Necessary

Vykat XR is considered not medically necessary for uses other than the FDA-approved indication, including but not limited to:

Hyperphagia in a patient without Prader-Willi syndrome
Vykat XR is indicated only for hyperphagia in patients with Prader-Willi syndrome; no data available for treatment of hyperphagia without Prader-Willi.

Prior Authorization, Documentation & Prescriber Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Vykat XR. Approvals are provided for 1 year when criteria are met.

Documentation Required

Diagnosis documentation required

Documentation is required to confirm the diagnosis of Prader-Willi syndrome by identification of abnormal DNA methylation of chromosome 15q11.2-q13 (examples: chart notes, laboratory tests, claims).

Documentation Required

Prescriber specialty requirement

Vykat XR must be prescribed by or in consultation with a physician who specializes in the condition being treated; for the FDA‑approved indication this is an endocrinologist.

Billing Rule

Sample product exclusion

Receipt of sample product does not satisfy any criteria requirements for coverage.

Key Clinical Evidence

-5.0HQ-CT Week 16 LS mean difference (Vykat XR vs placebo); 95% CI: -8.1 to -1.8

77Patients randomized in pivotal withdrawal trial (sample contributing to HQ-CT outcome)

1Supporting source: Vykat XR prescribing information (Soleno, March 2025)

Pivotal trial outcome: LS mean change from baseline at Week 16: Vykat XR 2.6 vs placebo 7.5; LS mean difference -5.0 (95% CI: -8.1, -1.8).

FDA Prescribing Information: Vykat XR prescribing information, Soleno, March 2025.

Background & Definitions

Vykat XR (diazoxide choline extended-release) is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome. Prader-Willi syndrome is a rare genetic neurobehavioral and metabolic disorder caused by lack of expression of paternally inherited imprinted genes on chromosome 15q11.2-q13, and the majority (approximately 90–100%) of patients develop hyperphagia. Scope summary: defines Cigna coverage and prior authorization requirements for Vykat XR, including required documentation of diagnosis, prescriber specialty (endocrinologist), duration of approval (1 year), and exclusions.

Prader-Willi syndrome diagnosis: Established by identification of abnormal DNA methylation within the Prader-Willi critical region at 15q11.2-q13.