CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vijoice (alpelisib) coverage for PIK3CA-Related Overgrowth Spectrum (PROS)

This policy governs authorization, continuation, and quantity limits for Vijoice (alpelisib) for members with PROS within the payer's Medicaid scope. It applies to providers requesting coverage for Vijoice oral tablets or granules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVijoice (alpelisib) coverage for PIK3CA-Related Overgrowth Spectrum (PROS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2022

Next Review DateN/A

Key ActionSubmit documentation of PIK3CA mutation, PROS diagnosis, and imaging showing at least one target lesion to request initial 6-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

6 mocontinuation authorization

>=2min patient age

20%response threshold

1 pkt/daygranules quantity limit

Coverage Criteria Overview

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVijoice (alpelisib) coverage for PIK3CA-Related Overgrowth Spectrum (PROS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2022

Next Review DateN/A

Key ActionSubmit documentation of PIK3CA mutation, PROS diagnosis, and imaging showing at least one target lesion to request initial 6-month authorization.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met for initial therapy (authorization of 6 months):

Initial PROS criteria: 1) Patient is at least 2 years of age; 2) Documentation of a PIK3CA mutation and confirmed diagnosis of PIK3CA‑Related Overgrowth Spectrum (PROS); 3) At least one target lesion identified on imaging; 4) Vijoice oral granules will not be combined with Vijoice tablets; 5) Documentation that the member has severe or life‑threatening manifestations of disease and requires systemic therapy as determined by the treating physician; 6) If the request is for Vijoice oral granules, the prescribed dose is daily and the member will not use multiple packets per dose (50 mg per packet).

Authorization may be granted for 6 months.

Continuation Therapy

Covered for continuation when ALL of the following are met (authorization of 6 months):

Continuation criteria: 1) Documentation (chart notes or medical records) of a positive response evidenced by at least a 20% reduction in the lesion(s) the approval was based upon and/or improvement in symptoms; 2) Documentation that there is no evidence of unacceptable toxicity or disease progression (e.g., new lesions or progression of non‑target lesions); 3) Vijoice oral granules will not be combined with Vijoice tablets.>=20% reduction for response

Authorization may be granted for 6 months.

All indications for Vijoice (alpelisib) other than the FDA‑approved indication for PIK3CA‑Related Overgrowth Spectrum (PROS) and recognized compendial uses are classified as experimental/investigational and not eligible for coverage.

Use of Vijoice for diagnoses other than the FDA‑approved PROS indication and compendial uses is considered not medically necessary and will not be covered.

Initial Therapy Requirements

Initial

Initial authorization (6 months) requirements for Vijoice:

Initial therapy nodes: Age >= 2 years; documented PIK3CA mutation and confirmed PROS diagnosis; at least one target lesion on imaging; member has severe or life‑threatening manifestations requiring systemic therapy as determined by the treating physician; Vijoice oral granules will not be combined with Vijoice tablets; if granules are requested, dosing is daily and multiple packets per dose are not permitted (50 mg per packet).

Authorization may be granted for 6 months.

Continuation Therapy Requirements

Continuation

Continuation authorization (6 months) requirements:

Continuation nodes: Documentation of >=20% reduction in the target lesion(s) and/or symptom improvement; no evidence of unacceptable toxicity or disease progression (e.g., new lesions or progression of non‑target lesions); Vijoice oral granules will not be combined with Vijoice tablets.>=20%

Authorization may be granted for 6 months.

Provider Actions and Authorization Notes

Prior Authorization

Initial authorization criteria

Initial authorization of 6 months may be granted for Vijoice for PROS when all listed criteria are met, including age ≥ 2 years, documented PIK3CA mutation with confirmed PROS diagnosis, imaging showing at least one target lesion, documentation that disease manifestations are severe or life‑threatening and require systemic therapy as determined by the treating physician, and that oral granules will not be combined with tablets. For oral granules, prescribed dosing must be daily and not use multiple packets per dose.

Member age ≥ 2 years
Documentation of PIK3CA mutation and confirmed PROS diagnosis
At least one target lesion identified on imaging
Severe or life‑threatening manifestations requiring systemic therapy as determined by treating physician
Vijoice oral granules must not be combined with Vijoice tablets
For oral granules: prescribed dose is daily and not multiple packets per dose

Prior Authorization

Continuation authorization criteria

Continuation authorization of 6 months may be granted when documentation shows positive clinical response and no unacceptable toxicity or disease progression. Acceptable documentation includes chart notes or medical records demonstrating at least a 20% reduction in the lesion(s) the approval was based upon and/or improvement in symptoms, and documentation that there is no evidence of unacceptable toxicity or disease progression (for example, new lesions or progression of non‑target lesions). Vijoice oral granules must not be combined with Vijoice tablets.

Positive response defined as ≥ 20% reduction in target lesion size and/or symptomatic improvement
No evidence of unacceptable toxicity
No evidence of disease progression (new lesions or progression of non‑target lesions)
Do not combine oral granules with tablets

Step Therapy

Step therapy

No step therapy sequence is specified; therapy is authorized based on meeting the listed diagnostic and response criteria.

Documentation Required

Required clinical documentation

Required clinical documentation includes confirmation of a PIK3CA mutation and a confirmed PROS diagnosis, imaging documenting at least one target lesion, and chart notes or medical records supporting severity of disease and need for systemic therapy. For continuation requests, include documentation of clinical response (e.g., ≥20% lesion reduction and/or symptom improvement) and absence of unacceptable toxicity or progression. Also document prescribed formulation and dosing; oral granules must not be combined with tablets.

Confirmation of PIK3CA mutation
Confirmed PROS diagnosis
Imaging showing at least one target lesion
Chart notes documenting severe or life‑threatening manifestations and need for systemic therapy
For continuation: documentation of clinical response and absence of unacceptable toxicity or progression
Prescribed formulation and dosing (oral granules vs tablets)

Denial Risk

Indication not approved

Requests for indications other than the FDA‑approved indication for Vijoice (treatment of adult and pediatric patients ≥2 years with severe manifestations of PIK3CA‑Related Overgrowth Spectrum who require systemic therapy) are considered experimental/investigational and are not medically necessary.

Documentation Required

Insufficient clinical documentation

If documentation is incomplete or missing — for example, lack of confirmation of a PIK3CA mutation, absence of a target lesion on imaging, no documentation that disease manifestations are severe or life‑threatening and require systemic therapy, or missing evidence of clinical response for continuation requests — the request may be denied as insufficient clinical documentation. Requests must include clear supporting records; incomplete chart notes, absent imaging, or missing mutation testing will result in a documentation denial risk.

Missing confirmation of PIK3CA mutation
No target lesion documented on imaging
No documentation of severe or life‑threatening manifestations requiring systemic therapy
For continuation: no documentation of clinical response or evidence of unacceptable toxicity/progression

Objective Response Threshold

Objective response threshold for continuation

Objective response threshold>= 20% reduction in the lesion(s) used for approval

Documentation sourceChart notes or medical records must document the >=20% reduction and/or symptom improvement

Continuation authorization periodAuthorization of 6 months may be granted when threshold met

Key Definitions

PIK3CA-Related Overgrowth Spectrum (PROS)

DefinitionPIK3CA-Related Overgrowth Spectrum (PROS) is a spectrum of disorders associated with activating PIK3CA mutations causing segmental overgrowth and vascular malformations

Diagnostic requirementDocumented PIK3CA mutation and confirmed clinical diagnosis of PROS are required

Clinical correlationDiagnosis must be supported by clinical findings and imaging identifying at least one target lesion

Age indicationFDA-approved for patients 2 years of age and older with severe manifestations requiring systemic therapy

Quantity Limits for Vijoice Formulations

Vijoice granule packet

Product formVijoice (50 mg granule packet)

Quantity limit1 packet per day

Unit strength50 mg per packet

Vijoice 50 mg tablet

Product formVijoice (50 mg tablet)

Quantity limit1 tablet per 28 days

Unit strength50 mg per tablet

Vijoice 125 mg tablet

Product formVijoice (125 mg tablet)

Quantity limit1 tablet per 28 days

Unit strength125 mg per tablet

Vijoice 250 mg tablet

Product formVijoice (250 mg tablet)

Quantity limit2 tablets per 28 days

Unit strength250 mg per tablet

Background

PIK3CA‑Related Overgrowth Spectrum (PROS) comprises disorders with severe, segmental overgrowth caused by activating PIK3CA mutations; Vijoice (alpelisib) is FDA‑approved for treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PROS who require systemic therapy.