CurrentHealth NetPolicy CP PHAR.430

Alpelisib (Piqray, Vijoice) Coverage and Prior Authorization Criteria

Coverage and prior authorization criteria for alpelisib (Piqray and Vijoice) for treatment of PIK3CA-mutated HR+/HER2- advanced/metastatic breast cancer and PIK3CA-related overgrowth spectrum (PROS); applies to members under Health Net lines of business listed.

Policy Summary

PayerHealth Net

PolicyAlpelisib (Piqray, Vijoice) Coverage and Prior Authorization Criteria

Policy CodePolicy CP PHAR.430

Change TypeAnnual review — no material changes

Effective Date07.09.19

Next Review Date

Key ActionSubmit prior authorization with clinical documentation including diagnosis, age, prescriber specialty, PIK3CA mutation status (when required), and dosing consistent with policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mg/daymax Piqray dose

250 mg/daymax Vijoice adult dose

2+ yearsVijoice indicated age

6 monthsapproval duration (Medicaid/HIM)

12 monthsapproval duration (Commercial)

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multiplerevision history

Coverage Criteria

inv-01: Initial Approval — Piqray for Breast Cancer

Covered when ALL of the following are met

Piqray initial criteria: 1) Request is for Piqray; 2) Diagnosis of breast cancer; 3) Age >= 18 years; 4) Prescribed by or in consultation with an oncologist; 5) Disease is HR-positive (ER/PR-positive) and HER2-negative; 6) Disease is advanced (recurrent) or metastatic; 7) Positive for PIK3CA mutation as detected by an FDA-approved test; 8) Disease has progressed on or after an endocrine-based therapy regimen; 9) If member is a premenopausal female, member is treated with ovarian ablation or suppression; 10) Piqray is prescribed in combination with fulvestrant; 11) Dose does not exceed 300 mg/day (two 150 mg tablets) OR dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use with supporting evidence submitted by the prescriber; 12) Prescribed regimen must be FDA-approved or recommended by NCCN.

Criteria reflect combination use with fulvestrant and requirement for PIK3CA mutation testing.

inv-02: Initial Approval — Vijoice for PROS

Covered when ALL of the following are met

Vijoice initial criteria: 1) Request is for Vijoice; 2) Diagnosis of PIK3CA-related overgrowth spectrum (PROS); 3) Age >= 2 years; 4) Documented evidence of PIK3CA mutation OR, if biopsy cannot be performed, congenital/early childhood onset (birth to age 8), mosaic/sporadic overgrowth, and clinical features meeting Appendix E criteria; 5) For non-cutaneous lesions, at least one target lesion identified on imaging within the last 6 months; 6) Condition is severe or life-threatening requiring systemic therapy as determined by the treating physician; 7) Dose does not exceed age-based maximums (age 2–5: 50 mg/day; age 6–17: 125 mg/day; >=18 years: 250 mg/day).

Oral granules may be used only for the 50 mg dose; do not use multiple 50 mg packets or combine granules and tablets to achieve a prescribed dose.

inv-03: Continued Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation for Piqray (breast cancer): 1) Member is currently receiving Piqray via Centene benefit with documentation that the member has received at least 30 days of therapy; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed 300 mg/day OR the new dose is supported by practice guidelines or peer-reviewed literature with supporting evidence submitted by the prescriber; 4) Prescribed regimen remains FDA-approved or NCCN-recommended.

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation for Vijoice (PROS): 1) Member is currently receiving Vijoice via Centene benefit or has previously met initial approval criteria; 2) Member is responding positively to therapy as evidenced by reduction in size/volume/number of measurable lesions on imaging, improvement in PROS-related signs or symptoms, complications, or functional status; 3) If request is for a dose increase, new dose does not exceed age-based maximums (age 2–5: 50 mg/day; age 6–17: 125 mg/day; >=18 years: 250 mg/day).

Approval duration: 6 months; imaging for response should be obtained within the last 6 months.

Requests for uses not included in this policy (i.e., non–FDA approved indications) are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP PMN.53 for Medicaid) or evidence of coverage documents.

For oral granules, granules may be used only to administer the 50 mg daily dose. Do not use multiple 50 mg packets or a partial packet of oral granules to achieve a higher dose (for example, a 250 mg dose). Additionally, do not combine oral granules and tablets to reach the prescribed milligram dose; dosing must follow the product administration guidance.

Age — product-specific

Piqray age eligibilityAdults (age ≥18) — Piqray is indicated for adults with HR-positive, HER2-negative, PIK3CA‑mutated advanced or metastatic breast cancer (use in combination with fulvestrant).

Vijoice age eligibilityPediatric and adult patients aged ≥2 years — Vijoice is indicated for patients 2 years of age or older with severe manifestations of PROS who require systemic therapy.

Vijoice pediatric dosing by ageDose recommendations vary by age group (see quantity limits): 2–5 years and 6–17 years dosing specified in dosing section and quantity limits.

Initial Therapy Criteria

inv-19: Initial Therapy — Initial therapy criteria and dosing

Initial therapy criteria and dosing

Piqray initial therapy nodes: See Initial Approval — Piqray for Breast Cancer criteria: Piqray must be used in combination with fulvestrant; PIK3CA mutation required; prior progression on endocrine therapy; prescriber is an oncologist or in consultation with oncology; age >=18; maximum dose 300 mg/day (in combination with fulvestrant).

Approval durations: Medicaid/HIM 6 months for initial; Commercial 12 months or duration of request, whichever is less.

Vijoice initial therapy nodes: See Initial Approval — Vijoice for PROS criteria: documented PIK3CA mutation or alternative clinical criteria if biopsy not possible; severe or life‑threatening manifestations requiring systemic therapy; age >=2 years; age-based dosing limits (age 2–5: 50 mg/day; age 6–17: 125 mg/day; >=18 years: 250 mg/day).

Oral granules may be used only for the 50 mg dose; do not combine granules and tablets.

inv-20: PROS initiation options — initiation notes from policy history

Continuation Therapy Criteria

inv-21: Continuation Therapy — requirements to continue therapy

Requirements to continue therapy

Continuation requirements: Member must be currently receiving the drug via Centene benefit or have previously met initial approval criteria; demonstrate clinical response (for breast cancer: responding positively to therapy; for PROS: reduction in lesion size/volume or improvement in signs, symptoms, complications, or functional status); dose increases must not exceed policy-specified maximums or must be supported by practice guidelines/peer-reviewed literature with evidence; prescribed regimen must remain FDA-approved or NCCN-recommended.

Approval durations: Medicaid/HIM and Commercial durations as specified in policy (see policy history for Commercial duration changed to 12 months or duration of request).

inv-22: PROS continuation — continuation requirements for PROS

Continuation requirements for PROS

Continuation criteria (PROS): Demonstrate positive response that includes improvement in PROS-related signs, symptoms, complications, and functional status; obtain imaging within the last 6 months to document reduction in size/volume or number of measurable lesions where applicable; member must be currently receiving Vijoice via Centene benefit or have previously met initial approval criteria; dose increases must not exceed age-based maximums (age 2–5: 50 mg/day; age 6–17: 125 mg/day; >=18 years: 250 mg/day).

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests for non–FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Prior authorization with clinical documentation supporting diagnosis, age, prescriber specialty, and PIK3CA mutation status (when applicable) is required.
Denial triggers: Requests for indications not addressed in this policy will be denied unless off‑label criteria are satisfied per referenced policies.
Provider must submit supporting documentation (office notes, labs, imaging, pathology, genetic testing) demonstrating member meets all approval criteria.

Documentation Required

Regimen and Therapeutic Alternatives

Step Therapy

Step	Requirement
1	Piqray must be prescribed in combination with fulvestrant for the labeled breast cancer indication; the prescribed regimen must be FDA‑approved or recommended by NCCN.

Appendix	Example agents / notes
Appendix B — Therapeutic Alternatives	Examples of NCCN‑recommended CDK4/6 inhibitors to be used in combination with aromatase inhibitors as first‑line therapy: Kisqali (ribociclib), Verzenio (abemaciclib), Ibrance (palbociclib).

Quantity Limits & Dosing

Piqray — maximum quantity/dose 300 mg

Piqray maximum daily dose300 mg per day (In combination with fulvestrant: 300 mg PO daily with food).

Piqray tablet strengths availableTablets available in 50 mg and 150 mg strengths for dosing to achieve up to 300 mg/day.

Piqray quantity limit entryQuantity limit recorded in policy as 300 mg/day maximum.

Vijoice — age-based dosing

Vijoice dose (ages 2–5)50 mg PO daily with food for patients aged 2–5 years.

Vijoice dose (ages 6–17)125 mg PO daily with food (consider increase to 125 mg after 24 weeks of 50 mg for patients ≥6 years).

Coding & Identifiers

Age (coding-affecting clinical eligibility)

Coding-impacting age for PiqrayAdults only — Piqray is indicated for adults (age ≥18) with HR‑positive/HER2‑negative, PIK3CA‑mutated advanced/metastatic breast cancer.

Coding-impacting age for VijoicePatients aged ≥2 years — Vijoice is indicated for pediatric and adult patients 2 years and older with severe PROS requiring systemic therapy.

Age-specific dosing affects billing/quantity limitsVijoice dosing and quantity limits are age‑based (2–5y: 50 mg; 6–17y: 125 mg; ≥18y: 250 mg) which affects allowable quantities and formulation (granules only for 50 mg).

Definitions

PROS — definition (PIK3CA‑related overgrowth spectrum)

Definition of PROSPIK3CA‑related overgrowth spectrum (PROS) — a group of developmental disorders caused by somatic PIK3CA mutations characterized by overgrowth and vascular malformations, with diagnostic criteria and testing eligibility referenced in appendices.

Clinical features and testingDiagnosis may be supported by documented PIK3CA mutation or, if biopsy cannot be performed, by congenital/early childhood onset, mosaic/sporadic overgrowth, and clinical features per Appendix E.

Indication contextVijoice is indicated for severe manifestations of PROS in patients aged ≥2 years who require systemic therapy; continued approval may be contingent on confirmatory data for accelerated approvals.

HR‑positive / HER2‑negative — definition

HR‑positive / HER2‑negative definitionHormone receptor–positive (estrogen and/or progesterone receptor) and human epidermal growth factor receptor 2 (HER2)–negative breast cancer.

Background

Alpelisib is a phosphatidylinositol‑3‑kinase (PI3K) inhibitor. It is indicated in combination with fulvestrant for treatment of hormone receptor–positive (HR+), HER2‑negative, PIK3CA‑mutated advanced or metastatic breast cancer in patients who have progressed on or after endocrine therapy. The labeled dosing for this indication is 300 mg orally once daily with food (administered with fulvestrant).

Revision History

2022-05-17addition

Vijoice (alpelisib) was added to the policy as a newly approved agent for treatment of PROS.

2022-08-30criteria_update

For PROS, initiation option added to allow diagnosis when a PIK3CA gene mutation is not identified; continuation criteria updated to require demonstration of positive response (improvement in PROS-related signs, symptoms, complications, and functional status); imaging requirement added (must be obtained within the last 6 months).

2024-02-01label_update

Revised FDA-approved indication description for Piqray to include all adults regardless of gender and postmenopausal status (no change to clinical criteria).

Policy Summary

PayerHealth Net

PolicyAlpelisib (Piqray, Vijoice) Coverage and Prior Authorization Criteria

Policy CodePolicy CP PHAR.430

Change TypeAnnual review — no material changes

Effective Date07.09.19

Next Review Date

Key ActionSubmit prior authorization with clinical documentation including diagnosis, age, prescriber specialty, PIK3CA mutation status (when required), and dosing consistent with policy.

SourceLink

On This Page

Initiation notes from policy history

PROS initiation when mutation absent: For PROS, initiation of therapy may be allowed even if a PIK3CA gene mutation is not identified when biopsy cannot be performed and clinical criteria (congenital/early childhood onset, mosaic/sporadic overgrowth, and Appendix E features) are met.

Policy history (2022) added option permitting initiation without molecular confirmation when biopsy is not feasible; imaging within 6 months required for non-cutaneous lesions.

Approval duration for continuation: 6 months.

For Piqray (alpelisib) in breast cancer, the prescribed regimen must be FDA‑approved or recommended by NCCN. Piqray must be prescribed in combination with fulvestrant per the approval criteria. Dose limits: dose should not exceed 300 mg (two 150 mg tablets) per day unless documentation supports an alternative dose based on practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Appendix B lists therapeutic alternatives including endocrine therapies and NCCN‑recommended CDK4/6 inhibitors used with aromatase inhibitors as first‑line therapy.

Regimen requirement: Piqray must be used in combination with fulvestrant.
Prescribed regimen must be FDA‑approved or NCCN‑recommended; off‑label dosing requires supporting literature.
Dose cap: 300 mg/day (two 150 mg tablets) unless justified by guidelines/literature.

Note

Therapy Sequencing Examples

Examples of therapy sequencing: Appendix B includes examples of NCCN‑recommended CDK4/6 inhibitors to be used in combination with aromatase inhibitors as first‑line therapy (examples include ribociclib/Kisqali, abemaciclib/Verzenio, and palbociclib/Ibrance). These agents are typically used as first‑line endocrine combinations prior to alpelisib plus fulvestrant in the appropriate clinical context.

Examples: Kisqali (ribociclib), Verzenio (abemaciclib), Ibrance (palbociclib) — used with aromatase inhibitors as first‑line therapy per NCCN.

Documentation Required

Imaging and Response Documentation for PROS

For PIK3CA‑related overgrowth spectrum (PROS) indications (Vijoice), imaging and documentation of response are required: at initiation, at least one target lesion for non‑cutaneous disease must be identified on imaging obtained within the last 6 months. For continuation of therapy, the treating physician must document a positive response, which may include improvement in PROS‑related signs, symptoms, complications, and functional status.

Imaging requirement for initiation (non‑cutaneous lesions): imaging within the last 6 months showing at least one target lesion.
Continuation requirement: documentation of positive response (improvement in signs, symptoms, complications, and functional status).
For PROS, PIK3CA mutation documentation is preferred; if biopsy is not possible, alternative clinical criteria per policy (congenital onset, mosaic distribution, clinical features) may be used.

Note

No‑Significant‑Changes Annual Reviews

Annual reviews: policy history documents multiple annual reviews noting 'no significant changes.' Notable revisions include a change to the Commercial approval duration (length of approval revised to 12 months or duration of request, whichever is less) and addition of Vijoice for PROS. Providers should be aware that the policy is routinely reviewed and updated; check the policy history for the latest requirements.

3Q 2021, 3Q 2022, 3Q 2023, 3Q 2024, and 3Q 2025 annual reviews recorded; most characterized as 'no significant changes.'
Commercial approval duration revised to 12 months or duration of request, whichever is less.
Vijoice (for PROS) was added to the policy in 2022.

Vijoice adult dose (≥18 years)250 mg PO daily with food.

Product availabilityTablets: 50 mg, 125 mg, 200 mg; oral granules single‑use packet: 50 mg (granules may be used only for 50 mg dose).

Piqray — dosing (reference)

Piqray repeated dosing noteMaximum dose listed as 300 mg/day (two 150 mg tablets) when used in combination with fulvestrant.

Dosing contextDose must not exceed 300 mg/day unless supported by practice guidelines or peer‑reviewed literature with evidence (per policy).

AdministrationAdminister PO daily with food as specified in dosing section.

Vijoice — adult maximum dose (reference)

Vijoice adult maximum dose250 mg per day for patients aged ≥18 years (maximum adult dose).

Granules restrictionDo not use multiple 50 mg packets or a partial packet of oral granules for patients prescribed a 250 mg dose; do not combine oral granules and tablets to achieve prescribed dose.

Policy quantity limitPolicy records adult Vijoice maximum as 250 mg/day in quantity limits section.

Clinical implicationPiqray is indicated for this subtype of breast cancer when a PIK3CA mutation is detected and used in combination with fulvestrant after progression on endocrine therapy.

Testing requirementPIK3CA mutation must be detected by an FDA‑approved test for labeled Piqray use (policy requires documented mutation for initial approval).

PROS — alternate definition/notes

Alternate PROS notes — policy optionsPolicy allows initiation of Vijoice for PROS even if a PIK3CA mutation is not identified, using alternative clinical criteria (congenital/early childhood onset, mosaic/sporadic overgrowth, Appendix E features) when biopsy is not feasible.

Continuation documentation for PROSContinuation requires demonstration of positive response including improvement in PROS‑related signs, symptoms, complications, or functional status; imaging must be obtained within the last 6 months.

Policy history relevancePolicy history documents addition of Vijoice and related initiation/continuation options and imaging requirements across 2022–2024 annual reviews.

2024-05-23formulary_update

Oral granules dosage form for Piqray was added per updated prescribing information.

2025-05-19criteria_updateLatest

For breast cancer, removed the word 'locally' from 'locally recurrent' and added requirement that premenopausal female members be treated with ovarian ablation/suppression per NCCN guidance.

2021-05-05annual_review

3Q 2021 annual review recorded as no significant changes; references updated and HIM off-label use reference updated to HIM.PA.154.

2022-05-22approval_duration_change

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

2022-05-17addition

3Q 2022 annual review recorded as no significant changes and Vijoice was added to the policy.

2023-04-20annual_review

3Q 2023 annual review recorded as no significant changes; examples of CDK4/6 inhibitors were added to Appendix B for Piqray.

2024-05-23annual_review

3Q 2024 annual review recorded as no significant changes; oral granules dosage form for Piqray added and references reviewed/updated.

2025-05-19annual_reviewLatest

3Q 2025 annual review recorded changes to breast cancer criteria (removed 'locally' from 'locally recurrent'; added ovarian ablation/suppression requirement for premenopausal females per NCCN); references reviewed and updated.

2021-05-05annual_review

3Q 2021 annual review recorded as no significant changes; references reviewed and updated.

2022-05-17addition

Prior authorization processes reflected the addition of Vijoice for PROS, with policy history noting initiation and continuation documentation requirements for PROS.

2022-08-30criteria_update

Policy history added specific prior-authorization-related continuation requirements for PROS including imaging within the last 6 months and demonstration of positive response for continuation approvals.

2022-01-20approval_duration_change

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less (recorded in policy history).

2025-05-19criteria_updateLatest

3Q 2025 update modified breast cancer prior-authorization criteria to align with NCCN (premenopausal members to receive ovarian ablation/suppression) and removed 'locally' from 'locally recurrent'.