CurrentBlue Cross Blue Shield - IowaPolicy 05.05.32

Truqap (capivasertib) — coverage criteria with fulvestrant for HR-positive, HER2-negative, PIK3CA/AKT1/PTEN‑altered breast cancer

Defines benefit authorization criteria, documentation, dosing limits, and billing guidance for Truqap (capivasertib) when used with fulvestrant for adult patients with HR-positive, HER2-negative, PIK3CA/AKT1/PTEN-altered locally advanced or metastatic breast cancer.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTruqap (capivasertib) — coverage criteria with fulvestrant for HR-positive, HER2-negative, PIK3CA/AKT1/PTEN‑altered breast cancer

Policy CodePolicy 05.05.32

Change TypeRoutine review — no material changes

Effective DateApr 17, 2024

Next Review DateAug 1, 2025

Key ActionObtain prior authorization with documentation of at least one tumor alteration (PIK3CA, AKT1, or PTEN) and HR/HER2 status; approvals are for up to 12 months when used with fulvestrant and prior endocrine therapy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial authorization duration

PIK3CA/AKT1/PTENrequired genomic alterations

64 tabsquantity limit (28 days)

400 mg BIDFDA dosing schedule

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Coverage Criteria for Truqap (capivasertib) with fulvestrant

inv-01: Initial Therapy

Authorization of 12 months may be granted when ALL of the following are met:

Initial approval: Requested medication will be used in combination with fulvestrant; documentation of at least one tumor alteration (PIK3CA, AKT1, or PTEN) and HR-positive, HER2-negative status; AND member meets one of the prior disease criteria below

See Required Documentation for accepted tests and HR/HER2 confirmation.

Prior disease state (one required): A: Disease progression on or after at least one endocrine-based regimen including a CDK4/6 inhibitor in the metastatic setting; OR B: Disease recurrence on or within 12 months of completing adjuvant endocrine-based therapy

inv-02: Continuation Therapy / Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Reauthorization: Indication corresponds to initial approval criteria AND there is no evidence of unacceptable toxicity or disease progression while on current regimen

inv-03: Not Medically Necessary

Not medically necessary: Use of Truqap when the initial approval criteria are not met (for example, not used in combination with fulvestrant; no documentation of PIK3CA, AKT1, or PTEN alteration; HR-positive, HER2-negative status not documented; or member does not meet the prior disease-state requirements)

Truqap is considered not medically necessary for members who do not meet the criteria set forth above.

This policy may not apply to the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the Federal Employee Program and are made separately from the provisions of this document. Verify individual member benefits and contract language to confirm applicability before proceeding with authorization.

Truqap (capivasertib) is considered not medically necessary when the member does not meet the coverage criteria specified in this policy. Specifically, use of Truqap without documentation that it will be given in combination with fulvestrant and without meeting the required tumor biomarker (PIK3CA, AKT1, or PTEN) and prior therapy criteria (disease progression after at least one endocrine-based regimen including a CDK4/6 inhibitor in the metastatic setting, or recurrence on/within 12 months of completing adjuvant endocrine therapy) is not covered.

Regimen	Dosing (per FDA labeling)	Dose reductions	Coverage status
Capivasertib (Truqap) in combination with fulvestrant for HR-positive, HER2-negative, PIK3CA/AKT1/PTEN-mutated locally advanced, recurrent, or metastatic breast cancer (after specified prior therapy)
400 mg orally twice daily for four consecutive days, followed by 3 days off (cycle repeats)
First reduction: 320 mg orally twice daily for four consecutive days, followed by 3 days off; Second reduction: 200 mg orally twice daily for four consecutive days, followed by 3 days off
covered with criteria

Biomarker and Diagnostic Requirements

PIK3CA, AKT1, PTEN — biomarker requirement (inv-16)

Biomarker requirementPresence of at least one alteration in PIK3CA, AKT1, or PTEN as detected by an FDA-approved test

Test documentationSubmit test report confirming the specific altered gene (PIK3CA, AKT1, or PTEN)

Relation to indicationAlteration required for Truqap use in combination with fulvestrant for eligible breast cancer patients

PIK3CA/AKT1/PTEN‑altered — definition (inv-13)

DefinitionTumors with documented alterations in PIK3CA, AKT1, or PTEN as detected by an FDA-approved test

Use in coverage decisionRequired for eligibility when prescribing Truqap with fulvestrant

Documentation neededProvide test confirmation showing at least one of the specified alterations

HR‑positive, HER2‑negative — definition (inv-14)

DefinitionBreast cancer that is hormone receptor (HR)-positive and HER2-negative as documented by pathology testing

Role in indicationHR-positive, HER2-negative status is required for Truqap plus fulvestrant therapy

Documentation neededProvide pathology report confirming HR and HER2 status

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit documentation confirming tumor biomarker status (PIK3CA, AKT1, or PTEN) and hormone receptor (HR) and HER2 status. Approval may be granted for up to 12 months when criteria are met; reauthorization may be approved for 12 months if there is no unacceptable toxicity or disease progression.

Prior authorization required before initiation of therapy
Required documentation: tumor biomarker test (PIK3CA, AKT1, or PTEN) and HR/HER2 status
Initial approval: up to 12 months when all criteria met
Reauthorization: up to 12 months if no unacceptable toxicity or disease progression
Denial trigger: therapy is not medically necessary if criteria (combination with fulvestrant, biomarker positivity, prior therapy requirements) are not met

Step Therapy

Step Therapy / Sequence

Step therapy/sequence requirements: The patient must have progressed on at least one endocrine-based regimen. For initial approval, one of the following must be met: (A) disease progression while on or after receiving at least one endocrine-based regimen that included a CDK4/6 inhibitor in the metastatic setting, OR (B) disease recurrence while on or within 12 months of completing adjuvant endocrine-based therapy. Use in combination with fulvestrant is required.

Prior endocrine-based regimen required
Prior CDK4/6 inhibitor exposure required for metastatic progression pathway (e.g., palbociclib, ribociclib, abemaciclib)

Documentation Required

Required Documentation

Document submission required to initiate prior authorization review. Provide test results confirming presence of at least one alteration (PIK3CA, AKT1, or PTEN) and documentation of hormone receptor (HR) and HER2 status. Include clinical history showing progression on required prior therapy or timing of recurrence relative to adjuvant therapy.

Include biomarker test report specifying PIK3CA, AKT1, or PTEN alteration
Include HR and HER2 receptor status documentation
Include treatment history showing prior endocrine-based regimen and CDK4/6 inhibitor exposure or adjuvant recurrence timing

Denial Risk

Denial Triggers

Denial may occur if the member does not meet all specified criteria — for example, if capivasertib is not being used in combination with fulvestrant, the required tumor biomarker alteration is not present, or the member lacks the required prior therapy or recurrence timing.

Treatment not medically necessary if used without fulvestrant
Treatment not medically necessary if no PIK3CA, AKT1, or PTEN alteration documented
Treatment not medically necessary if prior endocrine/CDK4/6 inhibitor therapy or recurrence timing criteria are not met

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTruqap (capivasertib) — coverage criteria with fulvestrant for HR-positive, HER2-negative, PIK3CA/AKT1/PTEN‑altered breast cancer

Policy CodePolicy 05.05.32

Change TypeRoutine review — no material changes

Effective DateApr 17, 2024

Next Review DateAug 1, 2025

SourceLink

On This Page

OpenPayer

Truqap (capivasertib) — coverage criteria with fulvestrant for HR-positive, HER2-negative, PIK3CA/AKT1/PTEN‑altered breast cancer

Coverage Criteria for Truqap (capivasertib) with fulvestrant

Approved Regimens and Dosing

Line of Therapy Restrictions

Biomarker and Diagnostic Requirements

Provider Actions, Prior Authorization, and Documentation

Procedures, Billing Codes, and Quantity Limits

Background and Drug Information