CurrentUnitedHealthcarePolicy N/A

Vijoice (alpelisib) prior authorization

Defines UnitedHealthcare pharmacy prior authorization requirements for Vijoice (alpelisib) for treatment of PIK3CA-Related Overgrowth Spectrum (PROS) in members age ≥2; affects providers submitting pharmacy PA requests and claims.

Policy Summary

PayerUnitedHealthcare

PolicyVijoice (alpelisib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization request demonstrating diagnosis of PROS, patient age ≥2 years, and severe manifestations requiring systemic therapy to receive up to a 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

≥2minimum age

PROSindication

Prior Authprogram type

2025 P 1388-4program id

Coverage Criteria for Vijoice (alpelisib)

Initial Authorization

Covered when ALL of the following are met

Initial authorization criteria: Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS).

Initial authorization criteria: Patient is 2 years of age or older.>= 2 years

Initial authorization criteria: Patient has severe manifestations of PROS requiring systemic therapy.

Authorization will be issued for 12 months.

Reauthorization

Covered when ALL of the following are met

Policy Summary

PayerUnitedHealthcare

PolicyVijoice (alpelisib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization request demonstrating diagnosis of PROS, patient age ≥2 years, and severe manifestations requiring systemic therapy to receive up to a 12‑month approval.

SourceLink

On This Page

Reauthorization criteria: Documentation of positive clinical response to Vijoice therapy.

Authorization will be issued for 12 months. State mandates, federal regulatory requirements, and member-specific benefit plan provisions may affect required documentation.

No explicit ancillary coverage exclusions are listed in this policy. The document states that "Notwithstanding Coverage Criteria, UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic," and that "Supply limits, Medical Necessity, and/or Step Therapy may be in place," but it does not identify any specific services, settings, or uses that are expressly excluded from coverage.

Additional program rules note that automated approval and re-approval processes may be used and that approvals can be issued based on prior claim or medication history and diagnosis codes. The policy also indicates that Supply limits, Medical Necessity, and/or Step Therapy may be in place, but specific step requirements or supply limits are not detailed in this document.

Coding and Age Requirements

No specific CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

Minimum age

Minimum age requirementPatient must be 2 years of age or older (≥ 2 years).

Context in criteriaMinimum age is part of the initial authorization: diagnosis of PROS AND age ≥2 years AND severe manifestations requiring systemic therapy.

Authorization durationWhen criteria are met (including age ≥2), authorization is issued for 12 months.

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior Authorization required. Initial approvals are issued for 12 months when all initial criteria are met.

Initial approval duration: 12 months
Applies when Initial Authorization criteria for PIK3CA-Related Overgrowth Spectrum (PROS) are satisfied

Step Therapy

Step Therapy May Apply

Step therapy or other program-specific rules may apply and could affect approval. Specific step requirements are governed by UnitedHealthcare program rules and member benefit design.

Step therapy may be enforced per program rules
Supply limits and other utilization controls may apply

Documentation Required

Required Documentation for Reauthorization

Reauthorization requires documentation of positive clinical response and adherence to any applicable mandates or program conditions. Authorizations (including reauthorizations) will be issued for 12 months when criteria are met.

Required documentation: evidence of positive clinical response to therapy
State mandates and federal regulatory requirements may affect required documentation
Authorization duration on reauthorization: 12 months

Denial Risk

Denial Risks

Requests may be denied for automated-logic determinations, failure to meet medical necessity, unmet step therapy, exceeding supply limits, or exclusions in the member's benefit plan.

Denial risks include automated approval/denial logic based on prior claims or diagnosis coding
Denial risks include Medical Necessity, Step Therapy, supply limits, and benefit plan exclusions

Initial Therapy Criteria

Initial Therapy

Initial coverage rules

Initial therapy: Diagnosis of PROS.

Initial therapy: Patient age ≥ 2 years.>= 2 years

Initial therapy: Severe manifestations of PROS requiring systemic therapy.

Authorization for 12 months.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements

Continuation therapy: Documentation of positive clinical response to Vijoice therapy is required for reauthorization.

Reauthorization issued for 12 months; state mandates, federal regulatory requirements, and member benefit plan provisions may affect required documentation.

Step Therapy

Step	Requirement / Note
1	Step therapy may be in place per program rules and supply limits; specifics not provided in this document.

Site of Care

Note

Infusion center — no site‑of‑care restrictions specified

No site‑of‑care restrictions are specified in this document for infusion centers.

Background

Vijoice (alpelisib) is described in the policy as a kinase inhibitor indicated for the treatment of patients with PIK3CA-Related Overgrowth Spectrum (PROS). The coverage rules apply to adult and pediatric patients aged ≥ 2 years with severe manifestations of PROS who require systemic therapy. The policy highlights that approvals may be granted for initial therapy and reauthorization when specified clinical criteria are met and that automated approval processes and prior claim/medication history may be used to determine coverage.

Definitions

PIK3CA-Related Overgrowth Spectrum (PROS)

DefinitionPIK3CA-Related Overgrowth Spectrum (PROS): a group of disorders caused by PIK3CA mutations leading to segmental overgrowth and severe manifestations that may require systemic therapy.

Indication for Vijoice (alpelisib)Vijoice is indicated for treatment of pediatric and adult patients 2 years and older with severe manifestations of PROS who require systemic therapy.

Regulatory noteThe PROS indication for Vijoice is approved under accelerated approval based on response rate and duration; continued approval may depend on confirmatory trials.