CurrentCignaPolicy N/A

Prader-Willi Syndrome – Vykat XR - (IP0741)

Defines prior authorization and medical necessity criteria for coverage of Vykat XR (diazoxide choline extended-release tablets) for treatment of hyperphagia in patients with Prader-Willi syndrome for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyPrader-Willi Syndrome – Vykat XR - (IP0741)

Policy CodePolicy N/A

Change TypeNew policy; no subsequent criteria changes

Effective DateJul 1, 2025

Next Review DateMay 29, 2025

Key ActionPrior Authorization is required for Vykat XR; approvals are for 1 year and require prescription by or consultation with an endocrinologist.

SourceLink

POLICY UPDATE CHANGES

New policy created with review date 5/29/2025 and effective date 7/01/2025.

No criteria changes on subsequent reviews (4/16/2026 and effective date 5/1/2026 noted).

1Covered Indication (Prader-Willi syndrome with hyperphagia)

1 yrAuthorization Duration

Coverage Summary

Coverage stance: Covered with criteria for Vykat XR (diazoxide choline extended-release) for the treatment of hyperphagia in patients with Prader-Willi syndrome aged ≥ 4 years. Prior authorization is required and approvals are provided for 1 year.

FDA-Approved Indication - Approve for 1 year

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

A: Patient is ≥ 4 years of age
B: The diagnosis of Prader-Willi syndrome has been established by identification of abnormal DNA methylation of chromosome 15q11.2Q13
Documentation Required
C: Patient has hyperphagia
D: The medication has been prescribed by or in consultation with an endocrinologist
Documentation Required

Conditions Not Covered

Vykat XR for any other use is considered not medically necessary, including:

Hyperphagia in a patient without Prader-Willi syndrome
Not medically necessary

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior Authorization is required for prescription benefit coverage of Vykat XR; approvals are provided for 1 year and require prescription by or consultation with a specialist (endocrinologist).

Documentation Required

Documentation of diagnosis

Documentation is required to establish the diagnosis of Prader-Willi syndrome by identification of abnormal DNA methylation of chromosome 15q11.2-q13. Acceptable documentation may include chart notes, laboratory tests, claims records, and/or other information.

Chart notes
Laboratory tests
Claims records
Other information

Denial Risk

Not medically necessary for non-PWS hyperphagia

Claims for Vykat XR for hyperphagia in patients without Prader-Willi syndrome are considered not medically necessary and will be denied.

Clinical Evidence

16-weekPivotal trial design: 16-week double-blind, placebo-controlled, randomized withdrawal study

LS mean diff -5.0Primary endpoint (HQ-CT): LS mean change from baseline Vykat XR 2.6 vs placebo 7.5; LS mean difference -5.0 (95% CI -8.1, -1.8)

Vykat XR is indicated for treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome. Efficacy was established in a 16-week randomized withdrawal study in which patients withdrawn to placebo experienced a statistically significant worsening of hyperphagia and greater increases in weight and BMI compared with those who continued Vykat XR.

Background & Definitions

Background: Vykat XR (diazoxide choline extended-release) is indicated for treatment of hyperphagia in adults and pediatric patients 4 years and older with Prader-Willi syndrome. Efficacy was demonstrated in a 16-week, double-blind, placebo-controlled, randomized withdrawal study where patients switched to placebo showed worsening hyperphagia and increases in weight and BMI.

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