CurrentBlue Cross Blue Shield - IowaPolicy 05.05.90

Vykat XR Medical Necessity Criteria

Covers Vykat XR for treatment of hyperphagia in adults and pediatric patients 4 years and older with genetically confirmed Prader-Willi syndrome when prior authorization criteria are met; includes initial and continuation criteria, exclusions, prescriber specialty, dosing/quantity limits, and required documentation.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVykat XR Medical Necessity Criteria

Policy CodePolicy 05.05.90

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required with submission of genetic testing confirming PWS and documentation of clinical benefit for continuation (e.g., reduction in hyperphagia, body fat mass, or leptin).

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

1FDA-approved indication

4+Minimum age (years)

6Initial authorization (months)

12Continuation authorization (months)

25/75/150 mgAvailable tablet strengths

Coverage Summary

Covers Vykat XR (diazoxide choline) for treatment of hyperphagia in adults and pediatric patients 4 years and older with genetically confirmed Prader-Willi syndrome when prior authorization criteria are met. Genetic confirmation must document a deletion in the chromosomal 15q11-13 region, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15. Initial authorization may be granted for 6 months when initial criteria are met (including assessment for hyperglycemia, ability to swallow tablets whole, absence of clinically significant renal or hepatic impairment, caregiver implementation of a food-secure environment, and a recent weight within 30 days for dosing). Continuation authorization may be granted for 12 months when continuation criteria are met (including documented clinical benefit, recent weight within 30 days, and adherence/ability to swallow tablets whole). Dosing and quantity limits apply per product labeling.

Quick facts & thresholds

FDA-approved indicationTreatment of hyperphagia in adults and pediatric patients 4 years and older with Prader-Willi syndrome

Minimum age (years)4+

Initial authorization duration6 months

Continuation authorization duration12 months

Available tablet strengths25 mg, 75 mg, 150 mg

Threshold: Age>= 4 years

Threshold: Recent weight documentationWithin 30 days

Initial Therapy Criteria (6 months)

Initial Approval (6 months)

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

ALL of the following

ALL of the following
- ANY of
  - Deletion in the chromosomal 15q11-13 region
  - Maternal uniparental disomy in chromosome 15
  - Imprinting defects, translocations, or inversions involving chromosome 15

Continuation Therapy Criteria (12 months)

Continuation of Therapy (12 months)

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Patient has achieved or maintained a positive clinical response (e.g., reduction in hyperphagia, reduction in body fat mass, reduction in leptin levels)
Patient has a recent (within 30 days) weight documented to ensure appropriate dosewithin 30 days
Patient is adherent to therapy and able to swallow tablets whole

Not Medically Necessary / Exclusions

Not Medically Necessary

Vykat XR is considered not medically necessary for members who do not meet the criteria set forth above

Claims will not be covered for members with hyperinsulinemic hypoglycemia or known hypersensitivity to diazoxide or thiazides.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required. Submit genetic testing confirming Prader-Willi syndrome and, for continuation requests, provide chart notes documenting clinical benefit (for example, reduction in hyperphagia, body fat mass, or leptin levels).

Documentation Required

Required documentation for initial and continuation requests

Initial requests: include laboratory test results confirming PWS (deletion in 15q11-13, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15). Continuation requests: include chart notes or medical record documentation confirming clinical benefit from therapy (e.g., reduction in hyperphagia, reduction in body fat mass, reduced leptin levels).

Applicable Codes

Procedures and billing codesmixed

No codes listed

Clinical Evidence

Key trial: Randomized double-blind placebo-controlled trial reported in J Clin Endocrinol Metab 2023 (Miller et al.).

Package insert: Soleno Therapeutics, Inc., March 2025.

Background & Definitions

Vykat XR is FDA-approved for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome. This policy aligns coverage with product labeling, requires genetic confirmation of PWS, and requires documentation of clinical benefit for continuation of therapy.

Prader-Willi syndrome (PWS): a genetic disorder due to deletion in 15q11-13, maternal uniparental disomy of chromosome 15, or imprinting defects/translocations/inversions involving chromosome 15, characterized by hyperphagia.

Revision History

2025-06-01Policy reviewLatest

Last clinical review

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVykat XR Medical Necessity Criteria

Policy CodePolicy 05.05.90

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

Patient has moderate to severe hyperphagia (e.g., food obsession, aggressive food seeking behavior; lack of satiety)

Patient has been assessed for hyperglycemia prior to initiating treatment

Patient has been assessed for ability to swallow tablets whole prior to initiating treatment

Patient does not have clinically significant renal or hepatic impairment

Patient is 4 years of age and older>= 4 years

Patient's caregiver has implemented and will continue to establish a food-secure environment

Patient has a recent (within 30 days) weight documented to ensure appropriate dosewithin 30 days

Documentation Required

Weight documentation

Provide a recent weight documented within 30 days at initiation and for continuation to ensure appropriate dosing.

Documentation Required

Assessment prior to initiation

Prior to initiating therapy, assess the patient for hyperglycemia and confirm the patient's ability to swallow tablets whole.

Denial Risk

Exclusion-related denial risk

Claims will not be covered for members with hyperinsulinemic hypoglycemia or known hypersensitivity to diazoxide or thiazides.

Billing Rule

Quantity limits

Apply per-product standard quantity limits and dosing per labeling. Standard limits: Vykat XR 25 mg tablet = 2 tablets/day; 75 mg tablet = 1 tablet/day; 150 mg tablet = 3 tablets/day. Maximum recommended dosage per labeling is 5.8 mg/kg/day or 525 mg/day with weight-based target maintenance dosing specified (examples by weight bands provided in labeling).