CurrentCignaPolicy N/A

Piqray (alpelisib) — Prior Authorization and Medical Necessity Criteria

Defines prior authorization requirements and medical necessity criteria for coverage of Piqray (alpelisib) in combination with fulvestrant for adults with HR-positive, HER2-negative, PIK3CA‑mutated advanced or metastatic breast cancer after progression on an endocrine-based regimen. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPiqray (alpelisib) — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 4, 2025

Key ActionObtain prior authorization and documentation showing age ≥18, HR+/HER2‑ disease, PIK3CA mutation by an FDA‑approved test, prior progression on at least one endocrine-based regimen, and plan to use Piqray with fulvestrant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearInitial approval duration

≥18Minimum patient age for approval

PIK3CA-mutatedRequired biomarker

With fulvestrantRequired regimen

Not coveredOther uses

Coverage Criteria for Piqray (alpelisib)

FDA-Approved Indication (Breast Cancer)

Covered when ALL of the following are met:

FDA-Approved Indication Criteria: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of the following: (i) postmenopausal female or male; OR (ii) pre/perimenopausal and either (a) receiving ovarian suppression with a GnRH agonist OR (b) has had surgical bilateral oophorectomy or ovarian irradiation; AND C) Patient has advanced or metastatic hormone receptor (HR)-positive disease; AND D) Patient has HER2-negative disease; AND E) Patient has PIK3CA-mutated breast cancer as detected by an FDA-approved test (tumor tissue or plasma; if plasma negative, tumor tissue should be tested); AND F) Patient has progressed on or after at least one prior endocrine-based regimen (examples include anastrozole, letrozole, exemestane, tamoxifen, toremifene, or fulvestrant); AND G) Piqray will be used in combination with fulvestrant injection.

Examples of endocrine-based regimens include anastrozole, letrozole, exemestane, tamoxifen, toremifene, or fulvestrant.

Regimen	Indication	Line of therapy	Coverage status
Piqray (alpelisib) in combination with fulvestrant	PIK3CA-mutated hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer after progression on or after at least one prior endocrine-based regimen	Second-line or subsequent-line (use after progression on or after at least one prior endocrine-based regimen)	Covered when criteria are met

Piqray (alpelisib) is considered not medically necessary for any other use(s) not meeting the specified criteria. Requests for coverage for indications, regimens, or patient populations outside the criteria outlined in this policy will be denied.

Policy Summary

PayerCigna

PolicyPiqray (alpelisib) — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 4, 2025

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.

Any use of Piqray outside the specified criteria in this policy is considered not medically necessary. Coverage will not be provided for requests that do not meet the medical necessity criteria described in this document.

Billing, Codes, and Approval Duration

Covered codes / billing guidancemixed

No codes listed

inv-05: Approval duration

Approval duration1 year

Approval renewalApprovals provided for the duration noted; reauthorization required after 1 year

Applies when criteria metDuration applies when all FDA‑approved indication criteria are satisfied

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Piqray; approvals are provided for the duration noted (approve for 1 year when criteria are met).

Step Therapy

Prior endocrine therapy required

Policy requires prior progression on or after at least one endocrine-based regimen before approval; examples of endocrine-based regimens include anastrozole, letrozole, exemestane, tamoxifen, toremifene, or fulvestrant.

Examples: anastrozole, letrozole, exemestane, tamoxifen, toremifene, fulvestrant

Documentation Required

Required clinical documentation

Documentation must support that the patient is ≥18 years old; has HR-positive, HER2-negative advanced or metastatic breast cancer; a PIK3CA mutation detected by an FDA‑approved test (tumor tissue or plasma, with reflex to tissue if plasma negative); prior progression on at least one endocrine-based regimen; and that Piqray will be used in combination with fulvestrant.

Age ≥ 18 (policy criteria A)
HR-positive, HER2-negative advanced/metastatic disease (criteria C and D)
PIK3CA-mutated by an FDA-approved test; test plasma or tumor tissue (criteria E and chunk 3)
Progression on or after ≥1 endocrine-based regimen (criteria F)
Planned use in combination with fulvestrant (criteria G)

Denial Risk

Non‑covered uses — denial risk

Requests for Piqray for any use not meeting the specified coverage criteria are considered not medically necessary and will be denied.

Billing Rule

Billing, coding, and plan-term requirements

Claims submitted without covered diagnosis or procedure codes per the policy’s coding instructions or that do not meet the plan's benefit terms may be denied; when billing, providers must use the most appropriate codes and covered code(s) for reimbursement.

Claims lacking covered diagnosis/procedure codes will be denied as not covered (Instructions for Use).
Ensure submission meets applicable benefit plan terms and coding requirements.

Line of Therapy Requirements

second-line | subsequent-line

Line of therapy: Use after progression on or after at least one prior endocrine-based regimen; recommended by NCCN as a preferred second-line or subsequent-line therapy for PIK3CA-mutated HR+/HER2-negative advanced/metastatic breast cancer.

PIK3CA Mutation Requirements

inv-15: PIK3CA — Detected by an FDA‑approved test in tumor tissue or plasma (if plasma negative, test tumor tissue)

Required biomarker testPIK3CA mutation detected by an FDA‑approved test in tumor tissue or plasma

Reflex testingIf no mutation is detected in plasma, tumor tissue should be tested

Test resourceInformation on FDA‑approved tests is available on the FDA website

Covered Drug Regimens

Regimen component	Required conditions / documentation	Approval duration	Notes
Alpelisib (Piqray) — oral tablets, used in combination with fulvestrant injection	Patient ≥ 18 years; HR-positive, HER2-negative advanced/metastatic disease; PIK3CA mutation detected by an FDA‑approved test (tumor tissue or plasma; if plasma negative, test tumor tissue); progressed on or after at least one endocrine-based regimen; plan to use with fulvestrant	Approve for 1 year when all criteria are met	Examples of endocrine-based regimens include anastrozole, letrozole, exemestane, tamoxifen, toremifene, or fulvestrant; refer to policy for menopausal/ovarian suppression requirements

Key Definitions

inv-12: endocrine-based regimen — examples of endocrine agents

Examples of endocrine agentsAnastrozole, letrozole, exemestane, tamoxifen, toremifene, fulvestrant

Role in pathwayUsed as prior endocrine‑based regimens required before Piqray

Documentation noteProvider must document progression on or after at least one endocrine‑based regimen

inv-13: PIK3CA-mutated — definition and testing approach (tumor tissue or plasma, tumor if plasma negative)

DefinitionPIK3CA‑mutated: presence of one or more activating PIK3CA mutations detected by an FDA‑approved test

Specimen types acceptedTumor tissue or plasma specimens can be used for detection

If plasma negativeIf no mutation is detected in a plasma specimen, tumor tissue should be tested

Test referencesFDA maintains information on approved tests for PIK3CA mutation detection

Background

Piqray (alpelisib) is a PI3K alpha pathway inhibitor indicated in combination with fulvestrant for the treatment of hormone receptor (HR)-positive, HER2-negative, PIK3CA‑mutated advanced or metastatic breast cancer after progression on an endocrine-based regimen. PIK3CA mutation status should be determined by an FDA‑approved test on tumor tissue or plasma (with reflex to tumor tissue if plasma is negative).