ModifiedPremera BluecrossPolicy N/A

Phosphoinositide 3-kinase (PI3K) Inhibitors

Medical necessity and coverage criteria for PI3K inhibitor drugs used to treat specific oncologic and genetic conditions; applies to providers requesting pharmacy or medical benefit coverage under Premera Bluecross.

Policy Summary

PayerPremera Bluecross

PolicyPhosphoinositide 3-kinase (PI3K) Inhibitors

Policy CodePolicy N/A

Change TypeCoverage additions and authorization/dosing updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, required prior therapy and genomic test results; initial authorizations for oral PI3K inhibitors are now 6 months.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Itovebi (inavolisib).

Updated initial authorization for all other reviews for all oral drugs listed in the policy from 3 months to 6 months.

Updated Itovebi criteria removing requirement for ECOG performance status of 0 or 1.

Updated Piqray (alpelisib) breast cancer criteria to limit dose to 300 mg once daily.

Removed Zydelig coverage criteria for certain follicular lymphoma or small lymphocytic lymphoma indications removed from prescribing information.

2026policy update year

6 monthsinitial authorization (oral)

300 mgPiqray dose limit

removedItovebi ECOG

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.

9+individual drugs listed

Drug-specific Coverage Criteria

Aliqopa (copanlisib) — Relapsed FL

Covered when ALL of the following are met:

Aliqopa (copanlisib) coverage: Individual is aged 18 years or older AND diagnosis of relapsed follicular lymphoma (FL)

IV formulation managed under the medical benefit (HCPCS J9057); dosing per CHRONOS-1 (60 mg IV on Days 1, 8, 15 of a 28‑day cycle)

Copiktra (duvelisib) — R/R CLL/SLL

Covered when ALL of the following are met:

Copiktra (duvelisib) coverage: Individual is aged 18 years or older AND has had at least two prior systemic therapies AND diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Oral agent managed through the pharmacy benefit; note that coverage was removed for relapsed/refractory follicular lymphoma after voluntary withdrawal for that indication

Itovebi (inavolisib) — HR+ HER2- PIK3CA-mutated breast cancer

Covered when ALL of the following are met:

Itovebi (inavolisib) coverage: Individual is aged 18 years or older AND diagnosed with HR-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer AND disease progression following at least one line of endocrine therapy in the metastatic setting OR recurrence on or within 12 months of completing adjuvant therapy AND will be given in combination with palbociclib (Ibrance) and fulvestrant AND has not experienced disease progression on or following other PI3K inhibitors AND Itovebi is prescribed by or in consultation with an oncologist

ECOG performance status requirement removed in 2026; follow product prescribing information for dosing and monitoring

Joenja (leniolisib) — APDS

Covered when ALL of the following are met:

Joenja (leniolisib) coverage: Individual is aged 12 years or older AND diagnosed with activated PI3K delta syndrome (APDS) AND has documented APDS-associated PI3K delta gene mutation with a documented variant in either PIK3CD or PIK3R1 AND Joenja is prescribed by or in consultation with an oncologist, medical geneticist, or hematologist AND dose limited to 140 mg per day (70 mg twice daily)

Genetic documentation required; prescriber specialty required

Piqray (alpelisib) — Breast cancer and PROS

Covered when ALL of the following are met for HR+ HER2- breast cancer (and separate PROS criteria below):

Piqray (alpelisib) coverage for HR+ HER2- breast cancer: Individual is aged 18 years or older AND diagnosed with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer as detected by an FDA-approved test AND has experienced progression on or after an endocrine-based regimen AND will be used in combination with fulvestrant AND dose limited to 300 mg once dailymax dose = 300 mg once daily

FDA-approved test required for PIK3CA mutation; 2026 update added 300 mg dose limit

Piqray (alpelisib) coverage for PROS: Individual is aged 18 years or older AND diagnosed with PIK3CA-related overgrowth spectrum (PROS) AND has at least one target lesion identified on imaging AND has documented PIK3CA gene mutation AND Piqray is prescribed by or in consultation with an oncologist, geneticist, or hematologist AND dose limited to 250 mg once daily

Imaging and genetic documentation required for PROS indication

Truqap (capivasertib) — HR+ HER2- breast cancer

Covered when ALL of the following are met:

Truqap (capivasertib) coverage: Individual is aged 18 years or older AND diagnosed with HR-positive, HER2-negative locally advanced or metastatic breast cancer AND has one or more PIK3CA/AKT1/PTEN alterations AND disease progression following at least one line of endocrine therapy in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy AND will be used in combination with fulvestrant AND has NOT experienced disease progression on or following other PI3K/AKT/PTEN inhibitors AND meets one of: intolerance to Piqray without disease progression OR has a specific solitary AKT1 or PTEN mutation not sensitive to PI3K inhibitors AND dose limited to 250 mg once daily

Combination therapy and mutation-specific logic present; dose limit 250 mg once daily

Vijoice (alpelisib) — PROS (pediatric)

Covered when ALL of the following are met:

Vijoice (alpelisib) coverage: Individual is aged 2 years or older AND diagnosed with PIK3CA-related overgrowth spectrum (PROS) AND has at least one target lesion identified on imaging AND has documented PIK3CA gene mutation AND Vijoice is prescribed by or in consultation with an oncologist, geneticist, or hematologist AND dose limited by age: individuals aged 2-5 years 50 mg once daily; individuals aged 6-17 years 125 mg once daily

Pediatric dosing specified; efficacy measured by reduction in lesion volume per EPIK-P1

Zydelig (idelalisib) — Relapsed CLL

Covered when ALL of the following are met:

Zydelig (idelalisib) coverage for relapsed CLL: Relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab in individuals for whom rituximab alone would be appropriate therapy due to co-morbidities AND dose limited to 300 mg per day (150 mg twice daily)

Not indicated/recommended for first-line treatment; certain FL and SLL indications removed from prescribing information and policy in prior updates

Policy updates and coverage additions

Policy-level coverage posture and recent edits:

policy_updates: Added coverage criteria for multiple agents over time (Ukoniq 2021; Vijoice and Piqray for PROS 2022; Joenja 2023; Truqap 2024; Itovebi 2025) and updated initial authorization durations and select drug criteria in 2026

See individual drug sections for agent-specific criteria.

Updated authorization and dosing criteria

Updated policy-level authorization and dosing rules:

Oral PI3K inhibitor initial authorization: Initial authorizations for oral PI3K inhibitors are for 6 monthsduration=6 months

Updated from prior 3-month initial authorization (effective 2026)

Itovebi (inavolisib) ECOG requirement removed: Itovebi coverage criteria no longer require that the individual have ECOG performance status 0 or 1ECOG requirement removed

Other eligibility and combination requirements remain in place

Piqray (alpelisib) dose limit: For treatment of breast cancer the dose for Piqray (alpelisib) is limited to 300 mg once dailymax dose = 300 mg once daily

Uses of drugs listed in this policy for conditions not specifically included in the coverage criteria are considered investigational and therefore not medically necessary. Providers must document that the requested use matches one of the agent‑and‑indication combinations and clinical requirements described in the policy; otherwise the request may be denied as investigational.

Recent policy history includes removals and edits tied to regulatory and manufacturer decisions: Copiktra (duvelisib) coverage for relapsed or refractory follicular lymphoma was removed after the manufacturer voluntarily withdrew that indication, and Zydelig (idelalisib) coverage for certain follicular lymphoma or SLL indications was removed when those uses were removed from prescribing information. The policy also reflects prior removals of Aliqopa (copanlisib) coverage for CLL/SLL because those indications are not FDA‑approved and are not recommended by NCCN. These changes are documented in the policy history and updates.

The policy treats uses not meeting FDA approval or lacking guideline support as investigational. Historically, the policy has removed indications when approvals were withdrawn or confirmatory trials were not pursued; examples include removed indications for Copiktra, Aliqopa, and Zydelig. Requests for uses outside the documented criteria should include supporting evidence; absent that, they are considered investigational and may be denied.

In general, PI3K inhibitors and related agents in this policy are covered only for the specific, labeled indications and the clinical scenarios described here. Any use of these agents for conditions not outlined in the coverage criteria is considered investigational and is not supported by this policy.

Aliqopa (copanlisib) is not covered for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Coverage was removed for these indications because Aliqopa is not FDA‑approved for CLL/SLL and the NCCN Guidelines do not list or recommend its use for these conditions; this change is reflected in the 2022 policy update and history.

The policy excludes agents or indications that were withdrawn by the manufacturer or removed from prescribing information due to lack of efficacy or safety concerns. Historical examples documented in the policy history include withdrawn or removed indications for Copiktra (R/R FL), Aliqopa (CLL/SLL), Ukoniq (umbralisib), and certain Zydelig indications; such withdrawn/removed uses are considered not covered or investigational.

Billing and Coding

HCPCS codesHCPCS

J9057

Injection, copanlisib (Aliqopa), 1 mg

Historical coding updatesHCPCS

J9057

HCPCS code J9057 added 1/1/19 (historical coding update referenced)

Dose limits — key facts

Piqray (alpelisib) — HR+ HER2- breast cancerDose limited to 300 mg once daily

Piqray (alpelisib) — PROSDose limited to 250 mg once daily

Truqap (capivasertib)Dose limited to 250 mg once daily

Joenja (leniolisib)Dose limited to 140 mg per day

Zydelig (idelalisib)Dose limited to 300 mg per day (150 mg twice daily)

Initial authorization duration

Initial authorization — oral PI3K inhibitors

Prior Authorization, Documentation, and Clinical Requirements

Prior Authorization

Benefit and prior authorization management

Oral agents in this policy are managed through the pharmacy benefit; IV/infusion agents are managed through the medical benefit. Prior authorization is required for drugs listed in this policy. Check the member’s benefit booklet or contact member services for specific benefit limits and routing (pharmacy vs medical) before prescribing.

Pharmacy benefit: Copiktra, Itovebi, Joenja, Piqray, Truqap, Zydelig
Medical benefit: Aliqopa (IV infusion)

Prior Authorization

Prior authorization and initial duration

Prior authorization is required for all drugs in this policy. Initial authorizations for non-formulary exception reviews may be approved up to 12 months; other initial approvals for oral agents in this policy are approved up to 6 months (policy updated 05/01/26).

Non-formulary exception initial approval: up to 12 months
Initial approval for oral drugs (all other reviews): up to 6 months

Clinical Background

PI3K inhibitors target enzymes in the PI3K/AKT/mTOR signaling pathway to suppress tumor growth. Class I PI3Ks include catalytic p110 isoforms (alpha, beta, gamma, delta); different drugs selectively inhibit one or more isoforms and are applied to specific malignancies or genetic disorders based on that selectivity and clinical evidence. The policy aligns coverage to labeled indications and trial evidence rather than class‑wide use.

Terminology and Targets

PI3K isoform targeting

PI3K class I isoformsClass I PI3Ks have p110 catalytic subunits: alpha, beta, gamma, delta

Isoform relevanceDifferent inhibitors selectively target one or more p110 isoforms; targeting influences clinical indications and toxicity profiles

Examples of isoform targetingAlpelisib targets p110 alpha; idelalisib targets p110 delta; other agents target combinations

CLL/SLL definition

DefinitionCLL and SLL are different manifestations of the same lymphocytic malignancy; CLL predominantly involves circulating leukemic B‑cells while SLL involves lymphoid tissue

ClassificationBoth are subtypes of non‑Hodgkin lymphoma (B‑cell lymphoproliferative disorders)

Initial Authorization and Eligibility

Initial authorization durations

Initial authorization durations and rules:

Initial authorization lengths: Non-formulary exception reviews for all drugs may be approved up to 12 months; all other reviews for drugs in this policy may be approved up to 6 months

Drug-specific exceptions exist as noted in continuation criteria

Initial therapy requirements

Initial therapy requirements — approvals should document ALL of the following:

initial_authorization_general: Provider documents patient meets the specific FDA-approved indication (including required genomic/mutation status where applicable), documents prior therapy history consistent with labeling or trial eligibility (e.g., Copiktra: ≥2 prior systemic therapies; Itovebi/Truqap/Piqray: prior endocrine therapy or endocrine‑resistant disease as specified), and documents intent to use the product per prescribing information and required combination regimens

Submit trial or mutation test results when required; see individual drug sections for specifics

Renewal and Ongoing Therapy

Continuation and re-authorization

Continuation and re-authorization — approvals require demonstration of continued benefit:

Re-authorization general rule: Non-formulary exception reviews and other renewals may be approved up to 12 months if drug-specific criteria are met and chart notes demonstrate continued positive clinical response; for Piqray PROS and Vijoice, documentation should include reduction in measurable target lesion volume when applicable

Refer to product prescribing information for monitoring and toxicity management

Continuation therapy guidance

Continuation decisions should be based on clinical benefit and tolerability:

continuation_based_on_response: Continuation supported when there is documented clinical benefit (e.g., objective response or disease stabilization) and tolerable toxicity per the drug's prescribing information or trial evidence

Refer to individual agent labeling and trial evidence (e.g., INAVO120, SOLAR-1, DUO, CHRONOS-1) for expected response metrics

Prior Therapy and Sequencing Requirements

Requirement	Drugs / Indications	Details
Itovebi (inavolisib) — HR-positive, HER2-negative, PIK3CA‑mutated locally advanced or metastatic breast cancer
Truqap (capivasertib) — HR-positive, HER2-negative locally advanced or metastatic breast cancer
Piqray (alpelisib) — HR-positive, HER2-negative PIK3CA‑mutated advanced or metastatic breast cancer

Requirement	Drugs / Indications	Details
Copiktra (duvelisib) — Relapsed or refractory CLL or SLL
Aliqopa (copanlisib) — Relapsed follicular lymphoma (CHRONOS-1 enrolled patients with ≥2 prior treatments; rituximab and an alkylating agent required)

Documentation Required	When Required	Supporting Details
For all agents when prior therapy is a coverage requirement
Piqray and Itovebi: PIK3CA mutation documented by an FDA‑approved test; required for breast cancer and PROS indications
Piqray and Vijoice for PROS: at least one target lesion identified on imaging; continued response for reauthorization requires reduction in measurable target lesion volume when applicable

Policy Sequencing / Prior Lines	Drug-specific Sequencing	Notes
Copiktra (duvelisib): coverage requires at least two prior systemic therapies for R/R CLL/SLL
Itovebi (inavolisib): used in combination with palbociclib (Ibrance) and fulvestrant and requires prior endocrine therapy failure in the metastatic setting or recurrence within 12 months of adjuvant therapy
Policy historically required prior lines or refractory disease evidence for some agents; see individual drug sections for full sequencing criteria

Dose and Quantity Limits

Piqray (alpelisib) — quantity limits

Quantity limit — breast cancerPiqray (alpelisib) limited to 300 mg once daily for HR+ HER2- breast cancer

Quantity limit — PROSPiqray (alpelisib) limited to 250 mg once daily for PROS

Benefit notePrescribed by or in consultation with an oncologist, geneticist, or hematologist as required by criteria

Joenja (leniolisib) — quantity limits

Daily limitJoenja (leniolisib) dose limited to 140 mg per day (taken as 70 mg twice daily)

IndicationJoenja indicated for activated PI3K delta syndrome (APDS) with documented PIK3CD or PIK3R1 variant

Benefit Routing and Infusion Requirements

Billing Rule

Bill IV copanlisib under medical benefit (HCPCS J9057); oral agents via pharmacy

Oral agents are dispensed through the pharmacy benefit; IV copanlisib (Aliqopa) is administered in an infusion setting and billed under the medical benefit using HCPCS J9057. Ensure correct site-of-care billing and use J9057 for copanlisib administration.

Oral PI3K inhibitors: pharmacy benefit (retail/mail-order).
Aliqopa (copanlisib) IV: medical benefit; HCPCS J9057 (injection, copanlisib, 1 mg) for billing.

Step Therapy

Administer copanlisib per IV infusion schedule in infusion-capable site

Copanlisib (Aliqopa) is administered as a 1‑hour IV infusion on Days 1, 8, and 15 of a 28‑day cycle per trial dosing — schedule requires an infusion-capable site and appropriate monitoring for IV oncology therapy.

Policy Summary

PayerPremera Bluecross

PolicyPhosphoinositide 3-kinase (PI3K) Inhibitors

Policy CodePolicy N/A

Change TypeCoverage additions and authorization/dosing updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, required prior therapy and genomic test results; initial authorizations for oral PI3K inhibitors are now 6 months.

SourceLink

On This Page

Change recorded in 2026 update

Initial authorizations for oral PI3K inhibitors are granted for 6 months

Non-formulary exception reviewsNon-formulary exception approvals may be granted up to 12 months (per prior guidance)

Basis for duration changeUpdated from 3 months to 6 months as of 05/01/26

Prior Authorization

Prior authorization duration

Re-authorization may be approved up to 12 months for specific agents (Aliqopa, Copiktra, Itovebi, Joenja, Piqray for breast cancer, Truqap, and Zydelig) when drug-specific coverage criteria are met and chart notes demonstrate continued positive clinical response. Re-authorization for Piqray and Vijoice when used for PROS may be approved up to 12 months with documentation of reduction in measurable target lesion volume.

Re-authorization approval: up to 12 months when criteria met and response documented
Required documentation for PROS continuation: reduction in sum of measurable target lesion volume from baseline

Denial Risk

Investigational uses and contraindicated first-line use

Use of agents in indications not listed in this policy or not supported by FDA labeling and referenced guidelines is considered investigational and not covered. Specific first-line use contraindication: idelalisib (Zydelig) is not indicated and is not recommended for first-line treatment of any individual.

Investigational/unlisted indications: not covered
Zydelig (idelalisib): contraindicated for first-line treatment

Denial Risk

Idelalisib safety and indication limits

Idelalisib (Zydelig) carries significant safety risks including fatal and serious toxicities (hepatic, severe diarrhea/colitis, pneumonitis, infections, intestinal perforation) and a black box warning. Several first-line trials were terminated due to decreased overall survival and serious infections; idelalisib use should be limited to FDA‑approved relapsed indications and monitored closely.

Black box warning: fatal and serious toxicities (hepatic, severe diarrhea/colitis, pneumonitis, infections, intestinal perforation)
Limit use to FDA‑approved relapsed CLL, relapsed SLL, and relapsed FL indications

Denial Risk

Copiktra indication withdrawal

Copiktra (duvelisib) coverage for relapsed/refractory follicular lymphoma (FL) has been withdrawn by the manufacturer and is no longer an approved indication; do not request coverage for R/R FL. Coverage may remain for other FDA‑approved, labeled relapsed indications when criteria are met.

Copiktra R/R FL: indication voluntarily withdrawn — not covered

Denial Risk

Investigational/unsupported indications

Uses not described in the policy or not supported by the product prescribing information and cited guidelines (NCCN) are considered investigational/unsupported and will be denied.

All other uses not outlined in this policy: investigational/not covered

Documentation Required

Required clinical documentation

Submit complete clinical documentation with the prior authorization request: office visit notes with diagnosis, relevant history, physical exam, medication history, and progress/chart notes demonstrating response. For continuation requests include chart notes showing ongoing clinical benefit as required by drug-specific re-authorization rules.

Office visit notes documenting diagnosis, history, physical evaluation, medication history
Progress/chart notes for re-authorization demonstrating continued clinical response

Note

Member benefit and prescribing information guidance

Before ordering therapy, verify benefit coverage and applicable limits in the member’s benefit booklet or with member services. Prescribers should follow the product prescribing information (PI) for dosing and administration; policy drugs are subject to FDA dosing and administration. Check for any dose limits specified in policy updates (e.g., Piqray dose limits updated).

Consult member benefit booklet or member services for coverage limits
Follow product PI for dosing/administration; drugs subject to FDA prescribing information
Example: Piqray dose limits updated in 2026 update

Prior Authorization

Prior therapy requirements

Some agents require prior lines of therapy before approval (e.g., Copiktra, Itovebi, Joenja — at least two prior systemic therapies for certain indications; other agents require disease progression following prior endocrine therapy or specific prior agents). Confirm prior therapy history in submitted records.

Copiktra (duvelisib) and Joenja (leniolisib): at least two prior systemic therapies for listed indications
Itovebi (inavolisib) and Truqap (capivasertib): progression following at least one line of endocrine therapy (or recurrence within 12 months) for breast cancer indications
Aliqopa trial evidence: prior rituximab and an alkylating agent often required in study populations

Prior Authorization

Therapy sequencing and criteria

Therapy sequencing and criteria must follow drug‑specific coverage rules and guideline-supported sequences (e.g., do not use PI3K inhibitors in patients who have progression on prior PI3K/AKT/PTEN inhibitors when that is an exclusion). Some agents are intended for use in combination regimens per their indications (e.g., Itovebi with palbociclib and fulvestrant; Truqap with fulvestrant). Document prior exposure and sequencing decisions in the chart notes.

Exclude use if patient has experienced disease progression on prior PI3K/AKT/PTEN inhibitors when policy requires no prior progression on such agents
Document combination use where required (Itovebi with palbociclib and fulvestrant; Truqap with fulvestrant)
Ensure sequencing follows guideline-supported pathways and policy criteria

Implication for policyCoverage criteria reference CLL and SLL per individual product indications (e.g., duvelisib, idelalisib)

PI3K isoform targets by drug

AlpelisibTargets p110 alpha

Copanlisib (Aliqopa)Targets p110 alpha and p110 delta

Duvelisib (Copiktra)Targets p110 gamma and p110 delta

Idelalisib (Zydelig)Targets p110 delta

Product-specific FDA prescribing information referenced

Primary referenceProduct-specific FDA prescribing information is referenced for dosing and indications (see References list) — e.g., Piqray, Vijoice, Joenja, Zydelig, Aliqopa, Copiktra, Truqap

Piqray (alpelisib) PIPiqray prescribing information (Novartis) cited for breast cancer and PROS dosing and indications

Joenja (leniolisib) PIJoenja prescribing information cited for APDS dosing and genetic mutation requirements

Zydelig (idelalisib) PIZydelig prescribing information cited for relapsed CLL dosing and safety warnings

Initial therapy rules

Initial therapy rules for oral agents (effective 2026):

Initial authorization duration for oral PI3K inhibitors: Initial authorizations for oral PI3K inhibitors are for 6 months6 months

Replaced prior 3-month initial authorizations as of 05/01/26

Continuation therapy

Continuation authorization policy:

Continuation authorization: Renewals and duration limits follow product prescribing information and plan-specific policy; initial oral authorization set to 6 monthsrefer to prescribing information

Non-formulary exception authorizations may be approved up to 12 months

Must be prescribed by or in consultation with an oncologist, medical geneticist, or hematologist

Vijoice (alpelisib) — pediatric dosing

Pediatric dosing — ages 2-5Vijoice (alpelisib) limited to 50 mg once daily for individuals aged 2–5 years

Pediatric dosing — ages 6-17Vijoice (alpelisib) limited to 125 mg once daily for individuals aged 6–17 years

IndicationVijoice indicated for PIK3CA‑Related Overgrowth Spectrum (PROS) with documented PIK3CA mutation and target lesion on imaging

Zydelig (idelalisib) — quantity limits

Daily limitZydelig (idelalisib) dose limited to 300 mg per day, administered as 150 mg twice daily

IndicationCovered for relapsed CLL in combination with rituximab for appropriate candidates

Safety noteNot indicated or recommended for first‑line treatment

Truqap (capivasertib) — quantity limits

Dose limitTruqap (capivasertib) dose limited to 250 mg once daily

UseUsed in combination with fulvestrant for HR+ HER2- breast cancer with relevant genomic alterations

Prior therapy requirementRequires disease progression following at least one line of endocrine therapy in metastatic setting or recurrence within 12 months of adjuvant therapy

Piqray (alpelisib) — reiterated dose limit

Piqray (alpelisib) — breast cancerDose limited to 300 mg once daily (reiterated in updated 2026 criteria)

Piqray (alpelisib) — PROSDose limited to 250 mg once daily

ReferenceDose limit for breast cancer added to coverage criteria in 2026 update

Trial dosing: 1‑hour IV infusion on Days 1, 8, and 15 of a 28‑day cycle.
Site must support IV oncology infusion and monitoring.