CurrentNeighborhood Health Plan of Rhode IslandPolicy Medicaid_Vykatxr.20250521

Vykat XR (diazoxide choline) for hyperphagia in Prader-Willi syndrome

Defines coverage criteria, initial and continuation authorization requirements, dosing/quantity limits, monitoring, and diagnostic confirmation requirements for Vykat XR (diazoxide choline) for treatment of hyperphagia in members with Prader-Willi syndrome (PWS). All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVykat XR (diazoxide choline) for hyperphagia in Prader-Willi syndrome

Policy CodePolicy Medicaid_Vykatxr.20250521

Change TypeReviewed (05/2025)

Effective Date

Next Review Date

Key ActionSubmit prior authorization for an initial 6-month course (and for 6-month continuations) with required documentation including genetic confirmation of PWS, recent weight, swallowing ability, hyperglycemia assessment, and monitoring plan.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed: 05/2025 per header

1Covered Indication (PWS hyperphagia)

3Required genetic confirmation options

6 moAuthorization duration (initial/continuation)

3Tablet strengths with quantity limits

Coverage Summary

Policy subject: Vykat XR (diazoxide choline) for hyperphagia in Prader-Willi syndrome. Status: CURRENT — covered with criteria. Scope: defines coverage criteria for treatment of hyperphagia in members with genetically confirmed PWS, including initial authorization of 6 months and 6-month continuation requirements. Initial authorization requires meeting age/weight thresholds, documentation of recent weight and ability to swallow tablets, prescriber specialty, genetic confirmation, assessment of hyperphagia severity, pre-treatment assessment for hyperglycemia, and implementation of caregiver food-security strategies. Continuation requires documented clinical improvement in hyperphagic symptoms, adherence, ability to swallow prescribed tablets, and recent weight documentation. Dosing must follow the FDA-labeled dosing for PWS and quantity limits apply by tablet strength.

Initial Therapy

Authorization of 6 months may be granted when all the following criteria are met:

Initial Therapy criteria

Age and weight: Member is 4 years of age or older with a weight greater than or equal to 20 kilograms>= 4 years AND >= 20 kg
Weight documentation: Documentation of member's weight within the past 30 dayswithin the past 30 days
Swallowing ability: Documentation that the member is able to swallow tablets whole
Prescriber specialty: Drug is prescribed by or in consultation with an endocrinologist, psychiatrist, or other physician with expertise in the treatment of PWS
Genetic confirmation - ONE of
- Deletion in chromosomal 15q11-q13 region
- Uniparental disomy: Maternal uniparenteral disomy in chromosome 15
- Imprinting defects, translocations, or inversions involving chromosome 15
Symptom severity: Documentation that member experiences moderate to severe symptoms of hyperphagia (e.g., food obsession, aggressive food seeking behavior, lack of satiety)
Pre-initiation hyperglycemia assessment: Documentation that the member has been assessed for hyperglycemia prior to initiating treatment
Metabolic monitoring: Fasting glucose will be monitored at least once every 4 weeks and HbA1c will be monitored every 3 monthsFasting glucose: at least once every 4 weeks; HbA1c: every 3 months
Ongoing monitoring requirement
Caregiver food security: Documentation that caregiver has implemented and intends to continue strategies to establish a food-secure environment (e.g. locked food storage)
No significant organ impairment: Documentation that the member does not have clinically significant renal or hepatic impairment
Dosing per label: Vykat XR is dosed according to FDA labeled dosing for PWS (see dosing table)

Continuation of Therapy

Authorization of 6 months may be granted for continued treatment when all of the following criteria are met:

Continuation criteria

Clinical improvement: Member has experienced an improvement in hyperphagic symptoms (e.g. decrease in food related aggression or manipulation, lessened food preoccupation interfering with normal daily activities)
Adult benefit assessment: For adult members, provider has determined that the patient is likely to still benefit from therapy (i.e. patient has not entered the phase of symptom improvement sometimes observed in adulthood)
Adherence and swallowing: Member is adherent to therapy and able to successfully swallow the prescribed number of tablets daily
Current weight documentation:

Not Covered

Indications not listed below are considered not medically necessary or experimental/investigational

Exclusions: All indications other than treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for initial 6-month authorization and for 6-month continuation authorizations when all specified clinical criteria and documentation requirements are met.

Documentation Required

Diagnostic confirmation documentation

Provide genetic confirmation of PWS via one of the following:

Deletion in chromosomal 15q11-q13 region
Maternal uniparenteral disomy in chromosome 15
Imprinting defects, translocations, or inversions involving chromosome 15

Applicable Codes

No procedure/drug billing codes listed in policy textmixed

No codes listed

Clinical Evidence & References

Evidence includes the product labeling (Vykat XR [package insert], Soleno Therapeutics, March 2025) and the pivotal randomized double-blind placebo-controlled trial (J Clin Endocrinol Metab. 2023;108(7):1676-1685). The policy cites the FDA-approved indication for hyperphagia in PWS and specifies pre-treatment assessment and ongoing monitoring for hyperglycemia as a safety rationale.

Background & Definitions

Vykat XR is FDA-indicated for treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome. The policy requires genetic confirmation of PWS (deletion in 15q11-q13, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15) and mandates metabolic monitoring because of the risk of hyperglycemia: fasting glucose at least every 4 weeks and HbA1c every 3 months, with assessment for hyperglycemia prior to initiation.

Prader-Willi syndrome (PWS): genetic disorder confirmed by deletion in 15q11-q13, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15.

minimum age/weight>= 4 years AND >= 20 kg

weight documentation recencywithin the past 30 days

fasting glucose monitoring frequencyat least once every 4 weeks

HbA1c monitoring frequencyevery 3 months

Revision History

2025-05reviewLatest

Policy reviewed: 05/2025 per header