CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Vijoice (alpelisib) for PIK3CA-Related Overgrowth Spectrum

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Pharmacy prior authorization and coverage criteria for Vijoice (alpelisib) for CareSource Georgia Medicaid members age 2 years and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS).

Policy Summary

PayerCareSource Georgia

PolicyVijoice (alpelisib) for PIK3CA-Related Overgrowth Spectrum

Policy CodePolicy GA-MED-P-366579

Change TypeFormulation and quantity limit update

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization for Vijoice (alpelisib).

SourceLink

POLICY UPDATE CHANGES

Added granules as a Vijoice formulation with a quantity limit of 28 packets per 28 days.

Updated policy references.

Age 2+Minimum age for initial authorization

6 monthsInitial authorization period

6 monthsReauthorization period

≥20%Required lesion volume reduction for reauthorization

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Vijoice (alpelisib) for PIK3CA-Related Overgrowth Spectrum

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Policy Summary

PayerCareSource Georgia

PolicyVijoice (alpelisib) for PIK3CA-Related Overgrowth Spectrum

Policy CodePolicy GA-MED-P-366579

Change TypeFormulation and quantity limit update

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization for Vijoice (alpelisib).

SourceLink

POLICY UPDATE CHANGES

Added granules as a Vijoice formulation with a quantity limit of 28 packets per 28 days.

Updated policy references.

Age 2+Minimum age for initial authorization

6 monthsInitial authorization period

6 monthsReauthorization period

≥20%Required lesion volume reduction for reauthorization

56 tablets or 28 packets/28 days

Quantity limit ages 6 to <18

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following are met:

ALL of the following

Member is at least 2 years of age.
Medication is prescribed by or in consultation with an oncologist, geneticist, metabolic specialist, or dermatologist.
Both of the following are required to confirm a PROS disorder
- Documentation confirms a mutation of the PIK3CA gene.
- At least one measurable target lesion is identified on imaging.
The physician has determined that the member's condition is severe, life-threatening, or requires surgical intervention.

Continuation Therapy

Covered for reauthorization when ALL of the following are met:

ALL of the following

Documentation shows at least a 20% reduction in the sum of measurable target lesion volume from baseline.>= 20% reduction from baseline
There is no progression of non-target lesions.
There is no appearance of new lesions.

CareSource considers Vijoice (alpelisib) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, please refer to the Off-Label policy.

Vijoice (alpelisib) is not medically necessary for conditions that are not listed in this policy.

Reauthorization Target Lesion Response

Required reduction in sum of measurable target lesion volumeAt least 20% from baseline

Authorization and Documentation Actions

Prior Authorization

Pharmacy Prior Authorization Required

Pharmacy prior authorization is required for Vijoice (alpelisib) under the CareSource Georgia Medicaid pharmacy benefit.

Documentation Required

Initial Authorization — Six-Month Approval

Initial authorization is approved for 6 months when all qualifying requirements are met, including age, prescriber specialty, confirmed PROS diagnosis, and severity criteria.

Member is at least 2 years of age.
Medication is prescribed by or in consultation with an oncologist, geneticist, metabolic specialist, or dermatologist.
Member has a PROS disorder confirmed by a PIK3CA gene mutation and at least one measurable target lesion identified on imaging.
The physician determines the condition is severe, life-threatening, or requires surgical intervention.

Clinical Background

PIK3CA-Related Overgrowth Spectrum (PROS) comprises rare disorders involving overgrowth of body tissues caused by mutations in the PIK3CA gene, which regulates cell growth and division. Examples include CLOVES, MCAP, Klippel-Trenaunay syndrome, and facial infiltrating lipomatosis. Vijoice is a PI3K inhibitor indicated for adults and pediatric patients 2 years and older with severe PROS manifestations requiring systemic therapy.

Key Definitions

PIK3CA-Related Overgrowth Spectrum (PROS)

ConditionPIK3CA-Related Overgrowth Spectrum (PROS) is a group of rare conditions characterized by overgrowth of various parts of the body

Genetic basisPROS is caused by mutations in the PIK3CA gene, which regulates cell growth and division

ExamplesExamples include CLOVES, MCAP, Klippel-Trenaunay Syndrome, and Facial Infiltrating Lipomatosis

Alpelisib

Drug classAlpelisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor

PROS productAlpelisib is marketed as Vijoice for the treatment of severe PROS manifestations requiring systemic therapy

Vijoice Initial Therapy

Vijoice Initial Therapy Criteria

For initial authorization, all clinical criteria must be met.

Initial Vijoice therapy

Age and prescriber: Member is at least 2 years of age and Vijoice (alpelisib) is prescribed by or in consultation with an oncologist, geneticist, metabolic specialist, or dermatologist.Age ≥ 2 years
Diagnostic confirmation: The PROS disorder is confirmed by documentation of both a mutation of the PIK3CA gene and at least one measurable target lesion identified on imaging.At least 1 measurable target lesion
Severity:

Vijoice Continuation Therapy

Vijoice Continuation Therapy Criteria

For reauthorization, all of the following must be documented.

Vijoice reauthorization response

Target lesion response: Documentation shows at least a 20% reduction in the sum of measurable target lesion volume from baseline.≥20% reduction
Non-target lesion status: There is no progression of non-target lesions.No progression
New lesion status: There is no appearance of new lesions.0 new lesions

Vijoice Dosage and Quantity Limits

Vijoice (alpelisib) dosage and quantity limit

PopulationAdults age 18 years and older

Dose250 mg by mouth once daily

Quantity limitThe policy does not specify a separate quantity limit for adults age 18 years and older

Vijoice (alpelisib) dosage and quantity limit

PopulationAge 2 to less than 6 years

Dose50 mg once daily

Quantity limitThe policy does not specify a separate quantity limit for members age 2 to less than 6 years

Policy Summary

PayerCareSource Georgia

PolicyVijoice (alpelisib) for PIK3CA-Related Overgrowth Spectrum

Policy CodePolicy GA-MED-P-366579

Change TypeFormulation and quantity limit update

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization for Vijoice (alpelisib).

SourceLink

On This Page

Dosage and quantity limits: adults age 18 years and older—250 mg by mouth once daily; ages 2 to less than 6 years—50 mg once daily; ages 6 to less than 18 years—50 mg once daily, with consideration of an increase to 125 mg once daily after 24 weeks; quantity limit is 56 tablets per 28 days or 28 packets of granules per 28 days.

Documentation Required

Reauthorization — Additional Six-Month Approval

Reauthorization is approved for an additional 6 months when response documentation demonstrates continued clinical benefit and no evidence of disease progression.

Documentation shows at least a 20% reduction from baseline in the sum of measurable target lesion volume.
No progression of non-target lesions.
No appearance of new lesions.

Documentation Required

Initial Clinical Documentation Required

Initial requests must include clinical documentation confirming PROS and supporting the need for systemic therapy.

Document a PIK3CA gene mutation. Although not all patients may present with a mutation, Vijoice was studied only in patients meeting this criterion, and there are no data for use without the mutation.
Identify at least one measurable target lesion on imaging.
Provide the diagnosis, relevant imaging, prescriber specialty or consultation documentation, and physician determination that the condition is severe, life-threatening, or requires surgical intervention.

Documentation Required

Reauthorization Response Documentation

Reauthorization requests must include response documentation demonstrating the required target-lesion volume reduction and absence of progression.

Document at least a 20% reduction from baseline in the sum of measurable target lesion volume.
Document no progression of non-target lesions.
Document no new lesions.

Denial Risk

Initial Criteria Not Met — Denial Risk

Initial authorization criteria are not met when any required condition is absent; the request may be denied.

Member is younger than 2 years of age.
The required prescriber specialty or consultation is not documented.
PROS is not confirmed by both a PIK3CA gene mutation and at least one measurable target lesion on imaging.
The condition is not documented as severe, life-threatening, or requiring surgical intervention.
The requested dose or quantity exceeds the applicable age-based dosage or quantity limits.

Denial Risk

Reauthorization Requirements Not Met — Denial Risk

Reauthorization requirements are not met when the required treatment response or disease-control documentation is absent.

Less than a 20% reduction from baseline in the sum of measurable target lesion volume is documented.
Progression of non-target lesions is documented.
New lesions have appeared.
Required response documentation is missing or insufficient.

Denial Risk

Unlisted Indication — Medical-Necessity Exclusion

CareSource considers Vijoice (alpelisib) not medically necessary for treatment of conditions not listed in this policy. For any other indication, refer to the Off-Label policy.

Unlisted indications are excluded from coverage under this policy.
Use the Off-Label policy for review of other indications.

Other product context

Alpelisib is also marketed under the brand name Piqray for the treatment of breast cancer

The physician has determined that the member's condition is severe, life-threatening, or requires surgical intervention.

Vijoice (alpelisib) dosage and quantity limits

PopulationAge 6 to less than 18 years

Starting dose50 mg once daily

Possible escalationMay consider an increase to 125 mg once daily after 24 weeks

Tablet quantity limit56 tablets per 28 days

Granule quantity limit28 packets of granules per 28 days