CurrentMass General Brigham Health PlanPolicy N/A

Vykat XR (diazoxide choline extended-release) prior authorization

Defines prior authorization requirements for Vykat XR (diazoxide choline XR) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including initial and continuation criteria and specialty pharmacy designation.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVykat XR (diazoxide choline extended-release) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PWS confirmed by an FDA‑approved genetic test, evidence of hyperphagia, patient age, and prescriber specialty/consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥4minimum age for therapy

6 moinitial approval duration

12 moreauthorization duration

90 drecent-plan-membership exception

Specialtydispensing restriction

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Coverage Criteria for Vykat XR (diazoxide choline XR)

COVERAGE CRITERIA

Authorization may be granted when ALL of the following are met:

Initial Authorization for Vykat XR

Diagnosis: Documented diagnosis of Prader‑Willi syndrome (PWS) confirmed by the presence of mutation in chromosome 15 as detected by an FDA‑approved test
Symptom: Documentation member has hyperphagia (e.g., food obsession, aggressive food seeking behavior, lack of satiety)
Age: Member is 4 years of age or older>= 4 years
Prescriber: Requested medication is prescribed by or in consultation with an endocrinologist, geneticist, or specialist knowledgeable in the treatment of PWS

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Continuation Therapy

Reauthorization will be approved when the following criterion is met:

Reauthorization: Documentation demonstrating member has had a positive clinical response to therapy (e.g., decreased hunger or thoughts about food, decreased weight or BMI)

Authorization exclusions: products obtained only as samples or through a manufacturer's patient assistance program are excluded from the new-to-plan continuation provision and are not eligible for consideration under that pathway.

Provider Actions, Documentation, and Prescribing Rules

Prior Authorization

Prior authorization and specialty fill

Prior authorization is required under the pharmacy benefit. Vykat XR is designated as a specialty medication and must be dispensed through a contracted specialty pharmacy.

Benefit: Pharmacy benefit; Program type: Prior Authorization
Specialty dispensing restriction: must be filled at a contracted specialty pharmacy

Note

New-to-plan continuation (90-day exception)

Members new to the plan within the past 90 days who are already receiving Vykat XR may be eligible for authorization to continue therapy, but this does not apply when the product was obtained only as samples or through the manufacturer's patient assistance programs.

Eligibility window: within 90 days of plan enrollment
Exclusion: does not apply if medication was obtained as samples or via manufacturer patient assistance

Definitions

Prader‑Willi syndrome (PWS) — definition and diagnostic confirmation requirement

DefinitionPrader‑Willi syndrome (PWS) is a genetic disorder; diagnosis must be confirmed by detection of a chromosome 15 mutation via an FDA‑approved test.

Diagnostic confirmation requirementAuthorization requires documented PWS confirmed by presence of a mutation in chromosome 15 as detected by an FDA‑approved test.

Associated indication in policyVykat XR is indicated for treatment of hyperphagia in patients with PWS aged 4 years and older.

Prescriber expectationRequested medication should be prescribed by or in consultation with an endocrinologist, geneticist, or specialist knowledgeable in PWS.

Hyperphagia — definition and clinical manifestations

Definition

Background

Vykat XR (diazoxide choline) is indicated for the treatment of hyperphagia associated with Prader‑Willi syndrome (PWS) in patients aged 4 years and older. Clinical response for continuation is defined as measures such as reduced hunger or food‑related behaviors and/or reductions in weight or body mass index.

For initial authorization, the policy requires a documented diagnosis of PWS confirmed by detection of a chromosome 15 mutation via an FDA‑approved test, documentation of hyperphagia (for example, food obsession, aggressive food‑seeking behavior, or lack of satiety), that the member is aged ≥ 4 years, and that the medication is prescribed by or in consultation with an endocrinologist, geneticist, or clinician experienced in treating PWS.

Documentation Required

Required clinical documentation

Provide documentation confirming the diagnosis of Prader‑Willi syndrome by detection of a chromosome 15 mutation using an FDA‑approved test; evidence of hyperphagia (e.g., food obsession, aggressive food‑seeking behavior, or lack of satiety); patient age; prescriber specialty or consultation note; and for reauthorization, documentation of positive clinical response (e.g., decreased hunger or decreased weight/BMI).

Confirmatory test: detection of chromosome 15 mutation by FDA‑approved test
Clinical signs: documentation of hyperphagia (examples provided)
Prescriber: note showing prescribing provider is an endocrinologist, geneticist, or PWS‑knowledgeable specialist
Reauthorization: evidence of positive clinical response (decreased hunger or weight/BMI)