CurrentCentenePolicy CP.PHAR.430

Alpelisib (Piqray, Vijoice) Coverage

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 Centene-affiliated health plans and lines of business listed. Affects prescribers requesting coverage under Centene benefits.

Policy Summary

PayerCentene

PolicyAlpelisib (Piqray, Vijoice) Coverage

Policy CodePolicy CP.PHAR.430

Change TypeNo material changes

Effective DateJul 9, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets the listed criteria for Piqray (breast cancer) or Vijoice (PROS).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mg/daymaximum Piqray dose

250 mg/daymaximum Vijoice adult dose

≥18min age Piqray (breast cancer)

≥2min age Vijoice (PROS)

6 monthsinitial approval duration

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Coverage Criteria

Initial Therapy - Breast Cancer

Covered when ALL of the following are met

Breast Cancer Initial Approval: Request is for Piqray; diagnosis of breast cancer; prescribed by or in consultation with an oncologist; age >= 18 years; disease is HR-positive AND HER2-negative AND advanced/recurrent or metastatic AND positive for PIK3CA mutation; Piqray is prescribed in combination with fulvestrant; disease has progressed on or after an endocrine-based therapy; if premenopausal, treated with ovarian ablation/suppression; member must use alpelisib if available unless contraindicated or clinically significant adverse effects occur; request meets one of the following: (a) dose does not exceed 300 mg/day OR (b) dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); prescribed regimen must be FDA-approved or recommended by NCCN.

Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - PROS

Covered when ALL of the following are met

PROS Initial Approval: Request is for Vijoice; diagnosis of PROS (PIK3CA-related overgrowth spectrum); age >= 2 years; either documented PIK3CA gene mutation OR if biopsy not possible, congenital/early childhood onset (birth to age 8) AND sporadic/mosaic overgrowth AND either two clinical features from Category A or one isolated feature from Category B per Appendix E; condition is severe or life-threatening requiring systemic therapy as determined by the treating physician; for non-cutaneous lesions, at least one target lesion identified on imaging within the last 6 months; dose does not exceed age-based maxima (age 2-5: 50 mg/day; age 6-17: 125 mg/day; age >=18: 250 mg/day).age-based dosing

Oral granules may be used to administer a 50 mg daily dose only; do not use multiple 50 mg packets or a partial packet to achieve higher doses; do not combine oral granules and tablets to achieve the prescribed dose.

Continuation Therapy - Breast Cancer

Covered when ALL of the following are met

Breast Cancer Continued Therapy: Member is currently receiving Piqray via Centene benefit or documentation supports current use for at least 30 days; request is for Piqray; member is responding positively to therapy; if request is for a dose increase, new dose does not exceed 300 mg/day OR new dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); prescribed regimen must be FDA-approved or recommended by NCCN.

Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy - PROS

Covered when ALL of the following are met

PROS Continued Therapy: Member meets either: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; request is for Vijoice; member is responding positively as evidenced by at least one of: reduction in size/volume/number of measurable lesions on imaging from baseline; improvement in at least one sign, symptom, or complication of PROS (e.g., pain, fatigue, vascular malformation, limb asymmetry, DIC); or improvement in functional status (e.g., mobility, performance, work/school attendance); if request is for a dose increase, new dose does not exceed age-based maxima (age 2-5: 50 mg/day; age 6-17: 125 mg/day; age >=18: 250 mg/day).

Requests for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies or evidence of coverage documents. Applicable off‑label policies include CP.CPA.09 for commercial plans, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid; documentation should demonstrate that the requested use meets those criteria.

For Vijoice oral granules: the single‑use 50 mg packets may be used only to administer a 50 mg daily pediatric dose. Do not use multiple 50 mg packets or a partial packet of oral granules to achieve a 125 mg or 250 mg prescribed dose. Additionally, do not combine oral granules and tablets to achieve the prescribed dose.

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (such as office chart notes, lab results, imaging, or other clinical information) supporting that the member has met all applicable approval criteria. Requests lacking sufficient documentation may be denied.

Prior authorization is required for Piqray and Vijoice per this policy.
Include supporting clinical documentation with the prior authorization request (office notes, pathology/genetic test results, imaging, lab results, treatment history).
For PROS (Vijoice) requests with non-cutaneous lesions, include imaging obtained within the last 6 months showing at least one target lesion.

Denial Risk

Non‑FDA Indications — Supporting Evidence Required

Requests for non‑FDA approved indications that are not specifically addressed in this policy will be considered only with sufficient supporting evidence of efficacy and safety per the applicable off‑label use policies. Commercial: CP.CPA.09; Health Insurance Marketplace (HIM): HIM.PA.154; Medicaid: CP.PMN.53. Prescriber must submit peer‑reviewed literature or guideline support when approval is sought for an off‑label use.

Non‑FDA indications require documentation consistent with the referenced off‑label use policies.
If dose exceeds FDA‑approved dosing but is supported by practice guidelines or peer‑reviewed literature, prescriber must submit supporting evidence.
Policy does not authorize coverage for non‑FDA indications without adequate evidence per the off‑label policies.

Documentation Required

Dosing & Administration Documentation

Prescriber must document dosing and administration consistent with the product labeling or supported literature. For Piqray, the prescribed dose must not exceed 300 mg PO once daily with food (maximum 300 mg/day) and when used for breast cancer must be in combination with fulvestrant. For Vijoice, follow age‑based dosing and administration instructions, including use of oral granules only as specified in the product labeling.

Piqray: 300 mg PO daily with food; maximum 300 mg/day; must be used in combination with fulvestrant for breast cancer.
Vijoice pediatric dosing: age 2–5: 50 mg PO daily (oral granules single‑use packet may be used for 50 mg only); age 6–17: consider 50 mg PO daily with potential increase to 125 mg PO daily after 24 weeks for patients >6 years; adult: 250 mg PO daily with food.
Do not combine oral granules and tablets to achieve prescribed Vijoice doses; do not use multiple 50 mg granule packets or partial packets to reach 125 mg or 250 mg dosing.

Step Therapy

Step Therapy / Therapeutic Alternatives

Step therapy and therapeutic alternative considerations may apply. For breast cancer, Piqray is indicated after progression on an endocrine‑based therapy regimen; Appendix B lists endocrine therapy alternatives and, where applicable, examples of CDK4/6 inhibitors to be used with aromatase inhibitors as first‑line therapy. Prior use of alternative agents should be documented when required by line of therapy rules.

Piqray: member’s disease must have progressed on or after an endocrine‑based therapy regimen (see Appendix B for examples).
Appendix B includes therapeutic alternatives and, per 3Q2023 update, added examples of CDK4/6 inhibitors to be used with aromatase inhibitors as first‑line therapy.
If the request is contingent on step therapy (e.g., use of CDK4/6 inhibitors or aromatase inhibitors first), document prior therapies and reasons for failure or intolerance.

Note

Other Provider Actions / Review the Full Policy

Not all provider‑action items are contained in this single section. Review full policy for denial triggers, continuation criteria, age restrictions, indication‑specific requirements (e.g., PIK3CA mutation for breast cancer or PROS diagnostic options), and appendices for detailed requirements.

For breast cancer: confirm diagnosis, age ≥18, HR‑positive, HER2‑negative, advanced or metastatic disease, PIK3CA mutation, and use in combination with fulvestrant.
For PROS: confirm diagnosis criteria (PIK3CA mutation or clinical criteria), age ≥2, severe/life‑threatening disease requiring systemic therapy, and imaging within 6 months for non‑cutaneous lesions.
See the full policy for continuation criteria and any additional documentation required to demonstrate response or ongoing benefit.

Initial Therapy Criteria

Initial Therapy — Initial authorization criteria are indication-specific and require documentation of diagnosis, age, mutation status (or clinical criteria...

Initial authorization criteria are indication-specific and require documentation of diagnosis, age, mutation status (or clinical criteria for PROS), prescriber specialty, combination therapy for breast cancer, and adherence to dose limits.

Initial therapy—general requirements: Provider must document diagnosis, patient age, PIK3CA mutation status or clinical criteria for PROS (per Appendix E), prescribing clinician specialty (oncologist for breast cancer), and that combination therapy requirements are met for breast cancer (Piqray + fulvestrant).

Prescriber must submit supporting evidence when dose is outside standard maximums; prior authorization required.

Initial dosing — Initial dosing regimens by product and patient age:

Initial dosing regimens by product and patient age:

Piqray initial dosing: Piqray: 300 mg PO daily with food in combination with fulvestrant; maximum 300 mg/day.<= 300 mg/day

Administer with food.

Vijoice pediatric initial dosing (age 2-5): Age 2 to <6 years: 50 mg PO daily with food (one tablet or single-use oral granules 50 mg packet).<= 50 mg/day

Oral granules single-use 50 mg packet may be used only for 50 mg dose; do not combine packets to reach higher doses.

Vijoice pediatric initial dosing (age 6-17): Age 6-17 years: 125 mg PO daily with food; consider increase from 50 mg to 125 mg after 24 weeks in patients >6 years for response optimization.<= 125 mg/day

Vijoice adult initial dosing: Adults (age >=18): 250 mg PO daily with food.<= 250 mg/day

Continuation Therapy Criteria

Continuation Therapy — Continuation therapy requirements mirror initial criteria and require documented positive response.

Continuation therapy requirements mirror initial criteria and require documented positive response.

Continuation therapy—general: Continuation requests must demonstrate the member is responding positively to therapy (see indication-specific continuation criteria); member should have been receiving therapy for the required minimum duration (e.g., >=30 days for breast cancer).

Dose limits from initial therapy continue to apply.

PROS continuation — Policy history notes continuation criteria changes for PROS:

Policy history notes continuation criteria changes for PROS:

PROS continuation option: Continuation of therapy may be demonstrated by positive response that includes improvement in PROS-related signs, symptoms or complications and functional status.

This option and the imaging timeframe requirement (imaging within last 6 months) were added in policy history updates.

Step	Requirement	Notes / Appendix reference
1	Policy requires use of examples of CDK4/6 inhibitors in combination with aromatase inhibitors as first-line therapy prior to Piqray	Examples of CDK4/6 inhibitors were added to Appendix B as first-line therapy options for use with aromatase inhibitors (see Appendix B)

Quantity Limits & Maximum Doses

Piqray — 300 mg/day

DrugPiqray (alpelisib)

Maximum daily dose300 mg/day

Dosing regimen (breast cancer)300 mg PO daily with food in combination with fulvestrant

Tablet strengths50 mg, 150 mg, 200 mg

Vijoice (age 2-5) — 50 mg/day

DrugVijoice (alpelisib) — pediatric 2 to <6 years

Daily dose50 mg/day

Dosage form for 50 mg doseOral granules single-use 50 mg packet or 50 mg tablet; oral granules may be used to administer 50 mg daily dose only

Note on combining formulationsDo not use multiple 50 mg packets or a partial packet to create higher doses; do not combine oral granules and tablets to achieve prescribed dose

Vijoice (age 6-17) — 125 mg/day

DrugVijoice (alpelisib) — pediatric 6 to 17 years

Standard daily dose50 mg/day initial; consider increase to 125 mg/day for patients >6 years after 24 weeks for response optimization

Maximum daily dose125 mg/day

Tablet strengths50 mg, 125 mg, 200 mg

Vijoice (age ≥18) — 250 mg/day

DrugVijoice (alpelisib) — adults (≥18 years)

Daily dose250 mg/day

Dosing regimen250 mg PO daily with food

Tablet strengths50 mg, 125 mg, 200 mg

Piqray — 300 (quantity limit entry)

DrugPiqray (alpelisib)

Quantity limit (mg per day)300 mg/day

Perday

NotesAdminister with food; used in combination with fulvestrant for breast cancer indication

Vijoice — 250 (quantity limit entry)

DrugVijoice (alpelisib)

Quantity limit (mg per day)250 mg/day (adult maximum)

Perday

NotesAge-based maxima apply: Age 2-5:50 mg; 6-17:125 mg; ≥18:250 mg. Do not combine oral granules and tablets to achieve dose

Definitions & Background

Alpelisib is a phosphatidylinositol‑3‑kinase (PI3K) inhibitor with an approved indication in combination with fulvestrant for adults with hormone receptor (HR)‑positive, HER2‑negative, PIK3CA‑mutated advanced or metastatic breast cancer after progression on or after endocrine therapy. The approved dosing for Piqray in this indication is 300 mg PO once daily with food, with a maximum daily dose of 300 mg.

PROS — PROS (PIK3CA-related overgrowth spectrum)

TermPROS (PIK3CA-related overgrowth spectrum)

DefinitionA group of disorders with congenital/early childhood asymmetric or mosaic overgrowth and vascular malformations; NIH workshop clinical features summarized in Appendix E and syndromic subdivisions listed (e.g., CLOVES, CLAPO, Klippel-Trenaunay, hemimegalencephaly)

Clinical relevanceIndication for Vijoice in patients age ≥2 years with severe manifestations requiring systemic therapy

Oral granules — Oral granules: single-use 50 mg packet formulation of Vijoice used to administer 50 mg daily pediatric dose; not to be combined with tabl...

TermOral granules (Vijoice)

DefinitionSingle-use 50 mg packet formulation used to administer a 50 mg daily pediatric dose

Usage limitsOral granules may be used to administer a 50 mg daily dose only; do not use multiple 50 mg packets or a partial packet to achieve 125 mg or 250 mg doses; do not combine oral granules and tablets to achieve the prescribed dose

PROS — PROS: PIK3CA-related overgrowth spectrum, an indication for Vijoice per prescribing information and policy updates.

TermPROS (PIK3CA-related overgrowth spectrum)

Policy notePROS is a labeled indication for Vijoice per prescribing information and policy updates; clinical features and syndrome subdivisions are summarized in Appendix D and NIH Appendix E

Age requirementIndication applies to patients age ≥2 years

OpenPayer

Alpelisib (Piqray, Vijoice) Coverage

Coverage Criteria

Provider Actions & Documentation

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy

Quantity Limits & Maximum Doses

Definitions & Background

Site of Care & Administration