CurrentColorado Rocky Mountain Health Plans | UnitedHealthcarePolicy 2026 P 1429-3

Truqap™ (capivasertib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization/notification policy for Truqap (capivasertib) for UnitedHealthcare Commercial Plans defining initial and reauthorization criteria, pediatric auto-approval, NCCN recognition, and administrative rules; effective 2026 program with P&T approvals 2024-2026.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare

PolicyTruqap™ (capivasertib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 1429-3

Change TypeAdded clinical disease descriptor; references updated

Effective DateApr 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization/notification and meet the listed clinical criteria for coverage; members under age 19 auto-process without coverage review. Authorization is issued for 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

Added 'recurrent unresectable' to disease type of the clinical criteria in 1/2025 review.

Annual review 1/2026: No changes to coverage criteria; updated references.

Program created (new program) in 1/2024 and recorded as new program in 1/2025.

12Authorization duration

HR+/HER2- w/ alterationsCovered biomarker-defined population

RequiredPrior therapy requirement

Coverage Summary

Truqap (capivasertib) is indicated, in combination with fulvestrant, for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer who have one or more PIK3CA/AKT1/PTEN-alterations and who have progressed on at least one endocrine-based regimen in the metastatic setting or who had recurrence on or within 12 months of completing adjuvant therapy.

Policy summary

Authorization duration12 months

Covered populationHR+/HER2- with PIK3CA/AKT1/PTEN alterations (adult patients with locally advanced/recurrent unresectable or metastatic breast cancer)

Prior therapy requirementProgression on at least one endocrine-based regimen in metastatic setting OR recurrence on/within 12 months of completing adjuvant therapy

Effective date2026-04-01

Last review2026-01-01

Policy number2026 P 1429-3

Initial Therapy Criteria (Adults)

Initial Authorization (Adults)

Truqap will be approved based on all of the following criteria:

ALL of the following

Diagnosis of breast cancer
Disease stage
- Locally advanced
- Recurrent unresectable (local or regional)
- Metastatic
Prior endocrine therapy or recurrence timing

Pediatric Authorization (<19 years)

Pediatric (<19 years) Authorization

Truqap will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age
Pediatric prescriptions auto-process without coverage review per provider actions.

Continuation / Reauthorization Criteria

Reauthorization

Truqap will be approved based on both of the following criteria:

ALL of the following

Patient does not show evidence of progressive disease while on Truqap therapy
Used in combination with fulvestrant

Exclusions / Unproven Uses

Claims may be denied if the member does not meet the specified diagnostic, biomarker, treatment history, or combination-use criteria (e.g., required documentation of diagnosis, disease stage, HR/HER2 status, PIK3CA/AKT1/PTEN alterations, prior endocrine therapy or recurrence timing, and planned combination with fulvestrant).

Applicable Codes

ICD-10 Diagnosis Logic (per policy: diagnosis codes may be used for automated approval)ICD-10

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required for Truqap (capivasertib)

Providers must obtain prior authorization/notification and meet the listed clinical criteria for coverage; members under age 19 will auto-process without a coverage review. Authorization is issued for 12 months when criteria are met.

Authorization issued for 12 months

Documentation Required

Required clinical documentation for initial authorization

Document the following to support initial authorization:

Diagnosis of breast cancer
Disease stage: locally advanced, recurrent unresectable (local or regional), or metastatic

Clinical Evidence & References

Evidence recognition includes NCCN listing: Truqap is recognized in the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B, and the product reference is the Truqap package insert (AstraZeneca, November 2025).

Definitions

Recurrent unresectable: Recurrence that is not amenable to surgical resection (local or regional).

Revision History

2024-01program_created

Program created / new program (P&T approval 1/2024).

2025-01criteria_added

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

2026-01annual_reviewLatest

Annual review: references updated; coverage criteria unchanged (non-material).

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare

PolicyTruqap™ (capivasertib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 1429-3

Change TypeAdded clinical disease descriptor; references updated

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Has progressed on at least one endocrine-based regimen in the metastatic setting (e.g., anastrozole, letrozole, exemestane, tamoxifen)
Recurrence on or within 12 months of completing adjuvant therapy

Used in combination with fulvestrant

Disease is hormone receptor (HR)-positive

Disease is human epidermal growth factor receptor 2 (HER2)-negative

Presence of one or more PIK3CA/AKT1/PTEN-alterations

The regimen is recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Hormone receptor (HR)–positive and HER2‑negative status

Presence of one or more PIK3CA/AKT1/PTEN alterations

Prior endocrine-based regimen progression in the metastatic setting OR recurrence on or within 12 months of completing adjuvant therapy

Planned use in combination with fulvestrant

Documentation Required

Reauthorization documentation

For reauthorization, document that the patient does not show evidence of progressive disease while on Truqap and that therapy is continued in combination with fulvestrant.

Billing Rule

Authorization duration

Authorizations — including initial, pediatric, and reauthorization approvals — will be issued for 12 months.

Denial Risk

Denial if criteria not met

Claims may be denied if the member does not meet the specified diagnostic, biomarker, prior treatment history, or required combination-use criteria.

Documentation Required

Automated approvals

UnitedHealthcare may approve initial and reauthorization requests solely based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic via automated approval processes.