CurrentAvMedPolicy N/A

Pharmacy prior authorization form for Vijoice (alpelisib)

This document is a pharmacy prior authorization and step-edit request form for Vijoice (alpelisib) that specifies prescriber, member, dosing, quantity limits, clinical eligibility, and documentation requirements for initial and reauthorization requests. It applies to providers submitting authorization requests to AvMed for covered members.

Policy Summary

PayerAvMed

PolicyPharmacy prior authorization form for Vijoice (alpelisib)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and fax it to 1-305-671-0200; incomplete forms may delay authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsReauthorization duration

≥2 yrsMinimum age

250 mgAdult max daily dose

FaxAuth fax

Coverage Criteria

Initial Therapy — Initial Authorization

Covered when ALL of the following are met:

Initial authorization criteria: Member is 2 years of age or older; Requesting provider is an oncologist with specialty in treating patients with PIK3CA-Related Overgrowth Spectrum; Diagnosis of PIK3CA-Related Overgrowth Spectrum confirmed by BOTH documented evidence of a PIK3CA gene mutation AND at least one target lesion identified on imaging; Condition is severe or life‑threatening requiring systemic therapy with documentation of severe clinical manifestations (examples include CLOVES, FIL, KTS, MCAP); Member's age and weight meet ONE of the following dosing categories: Age 2-5 years: 50 mg (1 tablet or granule packet) per day; Age 6-17 years: 125 mg (1 tablet) per day; Age >18 years: 250 mg therapy pack (2 tablets) per day.

Initial authorization duration 6 months

Continuation Therapy / Reauthorization

Covered when ALL of the following are met:

Reauthorization criteria: Member is responding positively to therapy as evidenced by imaging showing a reduction in the sum of measurable lesion volume assessed across 1 to 3 target lesions (radiological response defined as a ≥20% reduction from baseline in the sum of target lesion volume); Member is not experiencing severe toxicity from therapy (examples include severe cutaneous adverse reactions, severe hyperglycemia, severe lung toxicity).

Policy Summary

PayerAvMed

PolicyPharmacy prior authorization form for Vijoice (alpelisib)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form and fax it to 1-305-671-0200; incomplete forms may delay authorization.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coding and Dosing Information

ICD-10 (placeholder on form)ICD-10

ICD Code, if applicable (blank on form)

Quantity/strengths listedNDC | dosing

50 mg	granule packet or therapy pack per day
125 mg	therapy pack per day
250 mg	therapy pack (56 tablets per 28 days)

inv-06: Minimum age

Minimum ageMember must be at least 2 years of age (Age ≥2 years)

Initial authorization duration6 months

Reauthorization interval (related)Reauthorization evaluated at 12 months

inv-07: Radiologic response threshold

Radiologic response thresholdRadiological response defined as a ≥20% reduction from baseline in the sum of target lesion volume across 1 to 3 target lesions

Reauthorization requirementImaging must show the ≥20% reduction to support continued coverage

Assessment scopeReduction assessed across 1 to 3 target lesions (sum of measurable lesion volume)

Provider Actions and Documentation Requirements

Prior Authorization

Form submission and signature required

The prescribing provider must complete and sign the prior authorization form and fax it to 1-305-671-0200. If the form or any required fields (including phone/fax numbers) are incomplete, incorrect, or illegible, the authorization process may be delayed or the request may be denied.

Fax: 1-305-671-0200
Prescriber signature required (handwritten; preprinted stamps not valid)

Documentation Required

Required supporting documentation

Provide documentation supporting each clinical criterion checked on the form. Include relevant lab results, diagnostic imaging (with date and findings), pathology/genetic test reports (e.g., documented PIK3CA mutation), and chart notes demonstrating diagnosis, severity, and rationale for systemic therapy. For reauthorization requests include prior response data (e.g., imaging showing ≥20% reduction in target lesion volume) and monitoring for toxicity.

Lab results and dates
Diagnostic imaging reports identifying target lesion(s) with measurements
Genetic testing report confirming PIK3CA mutation
Chart notes documenting severe clinical manifestations and treatment response

Denial Risk

Triggers for delay or denial

Use of drug samples to start therapy does not satisfy step-edit or preauthorization requirements. Prior therapies will be verified through pharmacy paid claims or submitted chart notes. Authorization may be delayed or denied if required documentation is missing or if the form is incomplete, incorrect, or illegible.

Samples do not meet step-edit/preauthorization criteria
Previous therapies verified via pharmacy paid claims or chart notes
Incomplete/illegible forms or missing documentation may result in delay or denial

Background

PIK3CA-Related Overgrowth Spectrum (PROS) describes a group of disorders caused by somatic PIK3CA gene mutations that result in abnormal tissue overgrowth and vascular malformations. Severe or life‑threatening manifestations of PROS (examples include CLOVES, fibroadipose overgrowth, and other segmental overgrowth syndromes) may require systemic therapy such as alpelisib.

Imaging is used to identify and measure target lesions for baseline assessment and to monitor response. For continuation or reauthorization, radiologic response is defined by policy as a ≥20% reduction from baseline in the sum of target lesion volume across up to three measurable target lesions. The policy applies to patients aged ≥2 years and specifies age‑based initial dosing categories and authorization durations.

Definitions

inv-13: PIK3CA-Related Overgrowth Spectrum

Definition (term)PIK3CA-Related Overgrowth Spectrum (PROS)

Etiology summaryGroup of disorders associated with PIK3CA gene mutations leading to abnormal tissue overgrowth and vascular malformations (supports need for systemic therapy in severe cases)

Clinical manifestations examplesIncludes severe presentations such as CLOVES, Facial Infiltrating Lipomatosis (FIL), Klippel-Trenaunay Syndrome (KTS), Megalencephaly-Capillary Malformation (MCAP)

inv-14: Radiological response

Radiological response definitionA radiological response is a ≥20% reduction from baseline in the sum of target lesion volume across 1 to 3 target lesions

Use for reauthorizationRequired imaging evidence of this reduction is used to determine continuation of therapy

Measurement methodSum of measurable lesion volume assessed across 1 to 3 target lesions on imaging

OpenPayer

Pharmacy prior authorization form for Vijoice (alpelisib)

Coverage Criteria

Coding and Dosing Information

Provider Actions and Documentation Requirements

Background

Definitions

Initial Therapy Criteria and Dosing

Continuation / Reauthorization Criteria

Step Therapy Rules

Quantity Limits

Site of Care