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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCareOregon Vijoice (alpelisib) Prior Auth Coverage…
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    CurrentcareoregonPolicy N/A

    Vijoice (alpelisib) prior authorization for PIK3CA-Related Overgrowth Spectrum (PROS)

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    This prior authorization guideline establishes coverage criteria, required documentation, and approval lengths for Vijoice (alpelisib) for members with PIK3CA-Related Overgrowth Spectrum (PROS) and applies to CareOregon prior authorization reviewers and prescribing clinicians.

    Policy Summary
    Payercareoregon
    PolicyVijoice (alpelisib) prior authorization for PIK3CA-Related Overgrowth Spectrum (PROS)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of PROS diagnosis, genetic confirmation of a PIK3CA mutation, evidence of severe clinical manifestations, and prescriber specialty (geneticist or PROS specialist).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 moInitial approval
    12 moReauthorization length

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    ≥2 yrMinimum age for reauth
    ≥20%Radiologic response threshold

    Coverage and Medical Necessity Criteria

    Initial Therapy — Initial Authorization

    Covered when ALL of the following are met:

    Initial Authorization criteria: 1) Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS). 2) Disease confirmed by presence of a mutation in the PIK3CA gene detected by an FDA-approved test or a test performed at a CLIA-approved facility. 3) Documentation of severe clinical manifestations consistent with PROS (examples: Congenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal [CLOVES]; Facial Infiltrating Lipomatosis [FIL]; Klippel-Trenaunay Syndrome [KTS]; Megalencephaly-Capillary Malformation Polymicrogyria [MCAP]). 4) Prescribed by or in consultation with a geneticist or a physician who specializes in the treatment of PROS.

    Initial approval length: 6 months

    Continuation / Reauthorization — Reauthorization

    Covered when ALL of the following are met:

    Reauthorization criteria: 1) Patient demonstrates positive clinical response to therapy (example: radiological response defined as ≥20% reduction from baseline in the sum of target lesion volume). 2) Patient is 2 years of age or older. 3) Prescribed by or in consultation with a geneticist or a physician who specializes in the treatment of PROS.>=20% radiologic reduction

    Reauthorization approval length: 12 months

    No explicit exclusions are listed in the guideline text for Vijoice (alpelisib) use in PIK3CA‑Related Overgrowth Spectrum (PROS). The approval criteria specify required diagnostic and clinical findings but do not enumerate any separate exclusion list.

    Per the guideline's endnotes, patients without any response assessment at Week 24 are considered nonresponders. Absence of a documented Week‑24 response may therefore preclude continuation/reauthorization under the policy.

    Clinical Thresholds & Coding-related Criteria

    inv-05: Radiological response threshold — >= 20% reduction from baseline in the sum of target lesion volume
    Radiological response threshold≥ 20% reduction from baseline in the sum of target lesion volume
    Measurement timingChange measured from baseline to assessment timepoint (example used in reauthorization criteria)
    Example useUsed as evidence of positive clinical response for reauthorization of Vijoice (alpelisib)
    inv-06: Week 24 assessment — Patients without any response assessment at Week 24 are considered nonresponders
    Week 24 assessment rulePatients without any response assessment at Week 24 are considered nonresponders
    Implication for continuationAbsence of a Week 24 response assessment may lead to classification as nonresponder and affect reauthorization decisions

    Prior Authorization, Documentation, and Prescriber Requirements

    Prior Authorization

    Prior authorization required; approval lengths

    Prior authorization is required for Vijoice (alpelisib). Initial approvals are for 6 months; reauthorization approvals are for 12 months and require submitted supporting documentation and prescriber specialty consultation.

    Step Therapy

    Prescriber specialty requirement

    Prescriptions must be written by — or in consultation with — a geneticist or a physician who specializes in the treatment of PROS.

    Documentation Required

    Required documentation to support PA

    Background and Context

    PIK3CA‑Related Overgrowth Spectrum (PROS) encompasses disorders caused by somatic activating mutations in the PIK3CA gene that produce segmental overgrowth and vascular malformations. The policy recognizes severe clinical manifestations associated with PROS — examples include CLOVES (Congenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal), Facial Infiltrating Lipomatosis (FIL), Klippel‑Trénaunay Syndrome (KTS), and MCAP (Megalencephaly‑Capillary Malformation Polymicrogyria).

    Key Definitions

    inv-12: PROS — PIK3CA-Related Overgrowth Spectrum (PROS)
    DefinitionPIK3CA-Related Overgrowth Spectrum (PROS)
    Clinical features examplesCongenital Lipomatous Overgrowth, Vascular malformations, Epidermal nevi, Scoliosis/skeletal and spinal (CLOVES), Facial Infiltrating Lipomatosis (FIL), Klippel-Trenaunay Syndrome (KTS), Megalencephaly-Capillary Malformation Polymicrogyria (MCAP)
    Underlying causeDisorders characterized by somatic activating mutations in the PIK3CA gene resulting in segmental overgrowth and vascular malformations
    inv-13: Genetic confirmation — Confirmation of mutation via FDA-approved test or CLIA-approved laboratory
    Required confirmationPresence of mutation in the PIK3CA gene detected by an FDA-approved test or a test performed at a CLIA-approved facility
    Accepted testing locations

    Initial Authorization Requirements

    Initial Therapy — Initial authorization requirements (detailed criteria)

    Initial authorization requirements

    Initial: Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS).
    Initial: Disease confirmed by presence of mutation in the PIK3CA gene detected by an FDA-approved test or a test performed at a facility approved by CLIA.
    Initial: Documentation of severe clinical manifestations consistent with PROS (examples: CLOVES, Facial Infiltrating Lipomatosis, KTS, MCAP, vascular malformations, epidermal nevi, scoliosis/skeletal and spinal involvement).
    Initial: Prescribed by or in consultation with one of the following: geneticist; physician who specializes in the treatment of PROS.

    Reauthorization and Continuation Requirements

    Reauthorization — Reauthorization requirements (continuation criteria)

    Reauthorization requirements

    Reauthorization: Evidence of positive clinical response to therapy (example: radiological response defined as ≥20% reduction from baseline in the sum of target lesion volume).>=20% reduction from baseline in sum of target lesion volume

    Patients without any response assessment at Week 24 are considered nonresponders.

    Reauthorization: Patient is 2 years of age or older.
    Reauthorization: Prescribed by or in consultation with a geneticist or a physician who specializes in the treatment of PROS.

    Reauthorization approval length: 12 months

    Policy Summary
    Payercareoregon
    PolicyVijoice (alpelisib) prior authorization for PIK3CA-Related Overgrowth Spectrum (PROS)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documentation of PROS diagnosis, genetic confirmation of a PIK3CA mutation, evidence of severe clinical manifestations, and prescriber specialty (geneticist or PROS specialist).
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaClinical Thresholds & Coding-related CriteriaPrior Authorization, Documentation, and Prescriber RequirementsBackground and ContextKey DefinitionsInitial Authorization RequirementsReauthorization and Continuation Requirements
    Source noteSpecified in policy endnotes as the definition applied to Week 24 assessments

    Submit documentation that includes the diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) and confirmation that the PIK3CA mutation was detected by an FDA‑approved test or a test performed at a CLIA‑approved facility; include evidence of severe clinical manifestations consistent with PROS. For reauthorization, include evidence of positive clinical response (e.g., ≥20% reduction in sum of target lesion volume) and patient age.

    • Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) (chunk 4)
    • PIK3CA mutation confirmed by FDA‑approved test or CLIA‑approved laboratory (chunk 4)
    • Documentation of severe clinical manifestations (examples listed in chunk 4)
    • For reauthorization: evidence of positive clinical response (≥20% radiologic reduction) and patient age ≥2 years (chunk 6)
    Denial Risk

    Triggers for denial

    Denial may be triggered if the PIK3CA mutation is not documented by an FDA‑approved test or a CLIA‑certified laboratory, or if there is absence of documented severe clinical manifestations consistent with PROS; additionally, lack of a response assessment at Week 24 will be considered nonresponse and may lead to denial.

    • No documented PIK3CA mutation by FDA‑approved or CLIA‑certified test (chunk 4)
    • No documentation of severe clinical manifestations consistent with PROS (chunk 4)
    • No response assessment at Week 24 — patients without any response assessment were considered nonresponders (chunk 7)
    FDA-approved tests or tests performed at facilities approved under Clinical Laboratory Improvement Amendments (CLIA)
    Role in coverageGenetic confirmation is a required element of initial authorization for Vijoice (alpelisib)

    Initial approval length: 6 months