CurrentUnitedHealthcarePolicy N/A

Truqap (capivasertib) prior authorization — coverage criteria

Criteria and authorization rules for coverage of Truqap (capivasertib) in combination with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with specified alterations; affects prescribers and prior authorization staff.

Policy Summary

PayerUnitedHealthcare

PolicyTruqap (capivasertib) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeMaterial clinical change (criteria addition)

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documented HR-positive, HER2-negative breast cancer, qualifying PIK3CA/AKT1/PTEN alteration, prior endocrine therapy history, and plan to use with fulvestrant.

SourceLink

POLICY UPDATE CHANGES

Added 'recurrent unresectable' to disease type of the clinical criteria.

Added reference to package insert and NCCN Compendium.

12 monthsauthorization period

fulvestrantrequired concomitant med

PIK3CA/AKT1/PTENrequired genomic alterations

HR+, HER2-disease receptor status

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Coverage Criteria for Truqap (capivasertib)

COVERAGE CRITERIA

Covered when ALL of the following are met

Initial Authorization

1 Diagnosis: Diagnosis of breast cancer
2 Disease extent: One of the following: locally advanced; recurrent unresectable (local or regional); metastatic
3 HR status: Disease is hormone receptor (HR)-positive
4 HER2 status: Disease is human epidermal growth factor receptor 2 (HER2)-negative
5 Genomic alteration: Presence of one or more PIK3CA/AKT1/PTEN-alterations
6 Prior therapy: One of: has progressed on at least one endocrine-based regimen in the metastatic setting (e.g., anastrozole, letrozole, exemestane, tamoxifen); OR recurrence on or within 12 months of completing adjuvant therapy
7 Concomitant therapy: Used in combination with fulvestrant

Initial Authorization (compact)

1 Diagnosis: Diagnosis of breast cancer
2 Disease extent: Locally advanced OR recurrent unresectable (local or regional) OR metastatic
3 HR status: HR-positive disease
4 HER2 status: HER2-negative disease
5 Genomic alteration: One or more PIK3CA/AKT1/PTEN alterations present

Initial Authorization (clinical)

1 Diagnosis: Breast cancer diagnosis documented
2 Disease extent: Documented disease extent: locally advanced OR recurrent unresectable (local or regional) OR metastatic
3 HR status: Disease documented as hormone receptor (HR)-positive
4 HER2 status: Disease documented as HER2-negative
5 Genomic alteration: Molecular testing demonstrates one or more PIK3CA, AKT1, or PTEN alterations

Initial Authorization (operations)

1 Diagnosis: Breast cancer diagnosis recorded in request
2 Disease extent: Specify locally advanced, recurrent unresectable (local or regional), or metastatic
3 HR status: Confirm HR-positive status
4 HER2 status: Confirm HER2-negative status
5 Genomic alteration: Attach molecular test showing PIK3CA/AKT1/PTEN alteration(s)

Initial Authorization (summary): All of the above criteria must be met for approval

Authorization issued for 12 months

Initial Authorization

Initial therapy coverage criteria

Initial: All initial criteria must be met

Authorization issued for 12 months

No explicit exclusions are listed beyond the coverage criteria set forth for Truqap (capivasertib). Coverage is determined by whether the patient meets all required elements of the initial or reauthorization criteria (diagnosis, disease extent, receptor status, qualifying genomic alteration, prior endocrine therapy history, and concomitant use with fulvestrant).

As such, there are no additional named exclusions in the policy text; requests that do not meet the specified criteria should be handled per the not medically necessary provisions and standard denial processes.

Use of Truqap (capivasertib) outside the disease states specified in the coverage criteria — that is, for diagnoses other than locally advanced, recurrent unresectable (local or regional), or metastatic breast cancer — would not meet coverage. Similarly, therapy administered without documentation of a qualifying PIK3CA/AKT1/PTEN genomic alteration or without being prescribed in combination with fulvestrant fails to satisfy the policy requirements and therefore would not be covered.

Operationally, prior authorization staff should confirm the documented disease extent, receptor status (HR-positive, HER2-negative), presence of one or more qualifying genomic alterations, and a plan for concurrent fulvestrant before approving a request.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Truqap (capivasertib). Initial approval requires a documented diagnosis of HR-positive, HER2-negative breast cancer with one or more PIK3CA/AKT1/PTEN alterations, and all coverage criteria must be met.

Medication: Truqap (capivasertib)
Initial authorization duration: 12 months
Reauthorization duration: 12 months

Note

Automated Approval Note

UnitedHealthcare may approve initial and reauthorization requests based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Automated approval and re-approval processes may be used and vary by program; supply limits may apply.

Automated approval may rely on prior claims/medication history and ICD-10 diagnosis coding
Use of automation varies by program/therapeutic class

Key Definitions

Genomic alterations required for eligibility

Required genomic alterationsPresence of one or more PIK3CA, AKT1, or PTEN gene alterations

Test documentationMolecular test demonstrating the PIK3CA/AKT1/PTEN alteration must be provided

Relation to indicationAlteration requirement applies to HR-positive, HER2-negative locally advanced or metastatic breast cancer for Truqap use in combination with fulvestrant

Timing/contextAlteration must be identified prior to initiation as part of prior authorization documentation

Recurrent unresectable (local or regional) — definition

DefinitionRecurrent disease that is not amenable to surgical resection (local or regional) = 'Recurrent unresectable (local or regional)' as listed in initial authorization criteria

Background

Truqap (capivasertib) is a kinase inhibitor used in combination with fulvestrant for adult patients with hormone receptor–positive, HER2‑negative locally advanced, recurrent unresectable, or metastatic breast cancer who harbor one or more PIK3CA/AKT1/PTEN alterations and have progressed on at least one endocrine‑based regimen in the metastatic setting or recurred on/within 12 months of completing adjuvant therapy. The medication is intended to be administered only as part of the combination with fulvestrant per the clinical criteria, and initial authorization is issued for 12 months when all criteria are met.

Reauthorization / Continuation Criteria

Step Therapy / Automated Approval Logic

Step	Rule
1	UnitedHealthcare may approve initial authorization and reauthorization based solely on previous claim or medication history, diagnosis codes (ICD‑10), and/or claim logic; automated approval and re‑approval processes vary by program or therapeutic class.

Quantity Limits

Truqap (capivasertib) — supply limits

Quantity limits noteSupply limits may apply to Truqap (capivasertib)

Program variabilitySupply limits are part of UnitedHealthcare additional clinical rules and may vary by program or therapeutic class

Authorization interactionSupply limits do not replace prior authorization requirements; prior authorization is still required

Site of Care

Note

No site‑of‑care restriction stated — supply limits may apply

No specific site‑of‑care restriction is stated for infusion centers; however, supply limits and other utilization management programs (including quantity/supply limits and program‑specific automated processes) may apply.

Policy Summary

PayerUnitedHealthcare

PolicyTruqap (capivasertib) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeMaterial clinical change (criteria addition)

Effective DateApr 1, 2025

Next Review DateN/A

SourceLink

On This Page

6 Prior therapy: Progression on ≥1 endocrine-based regimen in the metastatic setting OR recurrence on/within 12 months of completing adjuvant therapy

examples: anastrozole, letrozole, exemestane, tamoxifen

7 Concomitant therapy: Planned use in combination with fulvestrant

6 Prior therapy: Either progression on at least one endocrine-based regimen in the metastatic setting OR recurrence on or within 12 months of completing adjuvant therapy

7 Concomitant therapy: Therapy will be used in combination with fulvestrant

6 Prior therapy: Provide prior endocrine therapy history: progression on ≥1 endocrine regimen in metastatic setting OR recurrence on/within 12 months of adjuvant therapy

examples: anastrozole, letrozole, exemestane, tamoxifen

7 Concomitant therapy: Plan to administer with fulvestrant

Supply limits may be enforced

Documentation Required

Required Documentation

Required documentation must include confirmation of breast cancer diagnosis with receptor status and genomic testing demonstrating one or more PIK3CA, AKT1, or PTEN alterations. Documentation should also support prior endocrine therapy and disease setting (locally advanced, recurrent unresectable, or metastatic) as applicable, and that Truqap will be used in combination with fulvestrant.

Pathology or clinical documentation confirming breast cancer and receptor status: HR-positive, HER2-negative
Molecular/genomic test results showing ≥1 PIK3CA, AKT1, or PTEN alteration
Evidence of progression on ≥1 endocrine-based regimen in the metastatic setting OR recurrence on/within 12 months of completing adjuvant therapy
Plan or prescription showing combination use with fulvestrant
Clinical notes supporting disease stage: locally advanced, recurrent unresectable, or metastatic

Denial Risk

Triggers for Denial

Requests lacking required disease characteristics or genomic testing, or insufficient documentation of prior endocrine therapy and planned combination with fulvestrant, may be denied.

Missing confirmation of HR-positive, HER2-negative status
No molecular test results demonstrating PIK3CA/AKT1/PTEN alterations
Insufficient evidence of progression on prior endocrine therapy or eligible recurrence timeframe
No documentation that Truqap will be used with fulvestrant

ScopeIncluded as one of the disease extent options along with locally advanced and metastatic disease for Truqap eligibility

Implication for coveragePatients with recurrent unresectable local or regional disease meet the disease extent requirement when other criteria are satisfied