CurrentCignaPolicy IP0741

Vykat XR

This policy governs prior authorization and coverage criteria for Vykat XR (diazoxide choline extended-release tablets) for treatment of hyperphagia in patients with Prader-Willi syndrome under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyVykat XR

Policy CodePolicy IP0741

Change TypeNew policy

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

New policy for coverage of Vykat XR with specified authorization criteria.

≥4minimum age for approval

1 yrinitial approval duration

1FDA-approved indication (PWS)

90-100%PWS patients with hyperphagia

Coverage Criteria for Vykat XR (diazoxide choline)

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FDA-Approved Indication for Prader-Willi Syndrome

A) Age: Patient is ≥ 4 years of age.
B) Diagnostic confirmation: Diagnosis of Prader-Willi syndrome established by identification of abnormal DNA methylation of chromosome 15q11.2-q13 (documentation required).
Documentation may include chart notes, laboratory tests, claims records, and/or other information.
C) Clinical sign: Patient has hyperphagia.
D) Prescriber: Medication is prescribed by or in consultation with an endocrinologist.

Use of Vykat XR for hyperphagia in patients without Prader-Willi syndrome is considered not medically necessary. Vykat XR is indicated only for treatment of hyperphagia in patients with Prader-Willi syndrome, and there are no data supporting its use for hyperphagia outside of this population.

Vykat XR for any indication other than hyperphagia in patients with Prader-Willi syndrome is considered not medically necessary. The policy identifies that Vykat XR tablets are indicated only for treatment of hyperphagia in patients with Prader-Willi syndrome and that other uses are not covered.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — approvals provided for 1 year when criteria are met. Prior authorization is required for prescription benefit coverage of Vykat XR. All approvals are provided for the duration noted (1 year) when criteria are met. Vykat XR must be prescribed by or in consultation with a physician who specializes in the condition being treated (endocrinologist for Prader-Willi syndrome).

Approvals issued: 1 year when clinical criteria met
Prescriber requirement: specialist (endocrinologist) or consult

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Documentation of abnormal DNA methylation of chromosome 15q11.2-q13 is required to establish the diagnosis of Prader‑Willi syndrome. Documentation may include, but is not limited to, chart notes, laboratory test results, claims records, and other pertinent clinical information.

Required diagnostic documentation: evidence of abnormal DNA methylation of chromosome 15q11.2-q13
Acceptable sources: chart notes, lab tests, claims records, other clinical documentation

Denial Risk

Claims and Billing Risk

Claims submitted without a covered diagnosis or appropriate covered codes will be denied. When billing, providers must use the most appropriate codes as of the date of service. Prior authorization is required and approvals are for the specified duration (see Prior Authorization Required above).

Claims without covered diagnosis or appropriate codes = denied as not covered
Use most appropriate codes as of the submission date
Prior authorization required — approvals for 1 year when criteria met

Background

Prader-Willi syndrome is a rare genetic neurobehavioral and metabolic disorder characterized by features that include neonatal hypotonia and, in most patients, development of hyperphagia leading to obesity. Vykat XR (diazoxide choline) is specifically indicated for treatment of hyperphagia in patients with Prader-Willi syndrome; the indication and coverage policy are limited to that population, and use outside of it is considered not medically necessary.

Definitions

Hyperphagia (in context of PWS)

DefinitionExcessive appetite and food-seeking behaviors commonly seen in Prader‑Willi syndrome

Prevalence in PWSEstimated 90–100% of patients with Prader‑Willi syndrome experience hyperphagia

Clinical contextPWS is a rare genetic neurobehavioral and metabolic disorder caused by lack of expression of paternally inherited imprinted genes on chromosome 15q11.2‑q13; diagnosis established by abnormal DNA methylation