CurrentNeighborhood Health Plan of Rhode IslandPolicy 6252-A

Capivasertib (Truqap) — coverage criteria for HR-positive/HER2-negative breast cancer

Coverage policy for Truqap (capivasertib) when used with fulvestrant to treat adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA, AKT1, or PTEN alterations. Applies to members of Neighborhood Health Plan of Rhode Island eligible for pharmacy/specialty drug benefits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCapivasertib (Truqap) — coverage criteria for HR-positive/HER2-negative breast cancer

Policy CodePolicy 6252-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of a PIK3CA, AKT1, or PTEN alteration and use plan for Truqap in combination with fulvestrant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

PIK3CA/AKT1/PTENgenetic alterations required

Fulvestrantmust be used with

Post-endocrine progressionprior progression requirement

Coverage Criteria for Truqap (capivasertib)

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Breast cancer — initial therapy

Covered when ALL of the following are met:

Initial approval requirements: Patient is an adult with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer; tumor harbors at least one alteration in PIK3CA, AKT1, or PTEN as detected by an FDA‑approved test; therapy will be administered in combination with fulvestrant; and the patient has disease progression while on or after at least one endocrine-based regimen that included a CDK4/6 inhibitor in the metastatic setting OR had disease recurrence while on or within 12 months of completing adjuvant endocrine-based therapy that included a CDK4/6 inhibitor.

Authorization may be granted for 12 months.

Continuation therapy

Covered for continuation when ALL of the following are met:

Continuation of therapy: No evidence of unacceptable toxicity and no disease progression while on the current regimen.

Authorization of 12 months may be granted.

All indications for Truqap (capivasertib) that are not specifically listed in this policy (other than the compendial use for recurrent breast cancer and the FDA‑approved indication) are considered experimental/investigational and are not medically necessary.

Use of Truqap for indications outside of the FDA‑approved indication or the compendial use identified in this policy (recurrent breast cancer) is considered not medically necessary and will not be covered.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval may be granted for up to 12 months when used in combination with fulvestrant for treatment of HR-positive, HER2-negative, PIK3CA/AKT1/PTEN-mutated locally advanced, recurrent, or metastatic breast cancer when ALL authorization criteria are met (see step therapy requirement and required documentation).

Authorization may be granted for 12 months when used with fulvestrant.
Applies to requests for treatment of HR-positive, HER2-negative, PIK3CA/AKT1/PTEN-altered locally advanced, recurrent, or metastatic breast cancer.

Step Therapy

Step Therapy / Prior Treatment Requirement

Requires prior progression on or recurrence after an endocrine-based regimen that included a CDK4/6 inhibitor. Specifically, member must have either: disease progression while on or after receiving at least one endocrine-based regimen including a CDK4/6 inhibitor in the metastatic setting; OR disease recurrence while on or within 12 months of completing adjuvant therapy with an endocrine-based regimen including a CDK4/6 inhibitor.

Examples of CDK4/6 inhibitors: palbociclib (Ibrance), ribociclib (Kisqali), abemaciclib (Verzenio).

Documentation Required

Required Clinical Documentation

Submit documentation confirming tumor testing results and biomarker status to initiate prior authorization review. At minimum, provide evidence of an FDA-cleared test (or equivalent) showing presence of at least one alteration (PIK3CA, AKT1, or PTEN), and documentation of hormone receptor (HR) positive and HER2-negative status.

Documented test confirming presence of PIK3CA, AKT1, or PTEN alteration.
Documentation of HR and HER2 status (HR-positive, HER2-negative).

Denial Risk

Non‑covered / Investigational Indications

Requests for indications other than the FDA‑approved or compendial uses listed (HR-positive, HER2-negative, PIK3CA/AKT1/PTEN‑altered locally advanced, recurrent, or metastatic breast cancer in combination with fulvestrant following progression on an endocrine-based regimen including a CDK4/6 inhibitor) are considered investigational and will be denied.

Key Definitions

Pathogenic or actionable genomic alteration in PIK3CA, AKT1, or PTEN as detected by an FDA-approved test

Required genomic alterationsPathogenic or actionable alteration in PIK3CA, AKT1, or PTEN detected by an FDA-approved test

Test documentationSubmit documentation of the FDA-approved test confirming presence of at least one alteration (PIK3CA, AKT1, or PTEN)

Associated indicationAlteration required for Truqap (capivasertib) use in HR-positive, HER2-negative locally advanced or metastatic breast cancer

Therapy contextUse is indicated in combination with fulvestrant following progression on at least one endocrine-based regimen or recurrence on/within 12 months of completing adjuvant therapy

Purpose of definitionDefines the biomarker requirement used to establish clinical eligibility and support prior authorization

Initial Authorization Criteria

Initial therapy — Initial authorization rules for Truqap

Initial authorization rules for Truqap

Initial authorization: Truqap (capivasertib) will be used in combination with fulvestrant; documented presence of at least one alteration in PIK3CA, AKT1, or PTEN confirmed by an FDA‑approved test; and prior progression on at least one endocrine-based regimen including a CDK4/6 inhibitor in the metastatic setting OR recurrence on or within 12 months of completing adjuvant endocrine-based therapy that included a CDK4/6 inhibitor.

Authorization may be granted for 12 months.

Step	Requirement	Notes
1	Prior progression on or recurrence after an endocrine-based regimen that included a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, abemaciclib).	Member must have disease progression while on or after at least one endocrine-based regimen with a CDK4/6 inhibitor in the metastatic setting, OR recurrence while on or within 12 months of completing adjuvant endocrine-based therapy that included a CDK4/6 inhibitor.

Background

Truqap (capivasertib) is indicated as targeted therapy for adult patients with hormone receptor (HR)‑positive, HER2‑negative locally advanced or metastatic breast cancer whose tumors harbor a pathogenic or actionable alteration in PIK3CA, AKT1, or PTEN. Per this policy, use is intended in combination with fulvestrant after progression on at least one endocrine‑based regimen or for recurrence on or within 12 months of completing adjuvant endocrine‑based therapy; authorization may be granted for 12 months when criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCapivasertib (Truqap) — coverage criteria for HR-positive/HER2-negative breast cancer

Policy CodePolicy 6252-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of a PIK3CA, AKT1, or PTEN alteration and use plan for Truqap in combination with fulvestrant.

SourceLink

On This Page

OpenPayer

Capivasertib (Truqap) — coverage criteria for HR-positive/HER2-negative breast cancer

Coverage Criteria for Truqap (capivasertib)

Provider Actions, Prior Authorization, and Documentation

Key Definitions

Initial Authorization Criteria

Continuation / Reauthorization Criteria

Step Therapy Requirements

Background