CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1494

Drug Policy: Truqap (capivasertib) — Coverage Criteria

Defines authorization, inclusion and exclusion criteria, coding, and management for Truqap (capivasertib) for oncology indications (primarily HR+/HER2- advanced/metastatic breast cancer) for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTruqap (capivasertib) drug policy — coverage criteria

Policy CodePolicy UM ONC_1494

Change TypeNo material change

Effective DateDec 27, 2024

Next Review DateDec 12, 2024

Key ActionObtain prior authorization and provide documentation of HR+/HER2- status, prior endocrine and CDK4/6 inhibitor therapy, and tumor genomic testing showing AKT/PTEN aberration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

HR+/HER2-Preferred covered indication

Endocrine + CDK4/6Required prior therapies

400 mg singleDosing limits

J8999, C9399Billing codes

Coverage Criteria

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Initial/covered indication — HR+/HER2- breast cancer with AKT/PTEN aberration

Covered when ALL of the following are met

Breast cancer indication criteria: Member is an adult with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer; disease has progressed on prior endocrine therapy, including a CDK4/6 inhibitor; tumor testing demonstrates one or more genomic aberrations involving AKT and/or PTEN; capivasertib (Truqap) will be administered in combination with fulvestrant.

Based on policy position referencing clinical evidence and prescribing information.

Use of Truqap (capivasertib) is excluded when any of the following apply: the member experienced disease progression while taking Truqap; the member has not received prior endocrine-based therapy; the member has not received prior therapy with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib); dosing would exceed a single dose of 400 mg; treatment would exceed monthly tablet limits of 64 (160 mg) and 64 (200 mg) tablets; or the requested use is investigational/off-label without sufficient supporting evidence (not supported by CMS-recognized compendia or acceptable peer-reviewed literature).

Truqap (capivasertib) is not supported by this policy for metastatic ER/PR-positive, HER2-negative breast cancer that is positive for a PI3K mutation. This position reflects the lack of Level 1 evidence (randomized trials or meta-analyses) demonstrating superior outcomes with capivasertib versus the Evolent-supported alternative, alpelisib (Piqray), in that patient population.

Initial Therapy Criteria

Initial therapy criteria — 1 top-level node

Initial authorization criteria: Adult with HR-positive, HER2-negative locally advanced or metastatic breast cancer; disease progression on prior endocrine therapy including a CDK4/6 inhibitor; tumor positive for one or more AKT/PTEN genomic aberrations; planned use of capivasertib in combination with fulvestrant.

PI3K-mutant tumors are not supported for capivasertib per policy.

Continuation Therapy Criteria

Continuation therapy rules — continuation request exemptions and related logic

Continuation requests are exempt from prior authorization when ALL of the following are met:

Continuation exemption conditions: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; no additional medication(s) are being added to the continuation request.

If all conditions are met, continuation requests are exempt from the Evolent prior authorization requirements.

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Truqap (capivasertib). Continuation requests are exempt from a new prior authorization when ALL of the following are met: the member has not experienced disease progression on Truqap, the medication was used within the last year without a lapse of more than 30 days of an active authorization, and no additional medications are being added to the continuation request.

PA required for initial and new regimen requests
Continuation exemption: no progression + used within last year with ≤30-day lapse + no additional meds

Documentation Required

Required Supporting Clinical Documentation

Requests must include documentation that supports the requested use and aligns with FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature meeting CMS criteria. Documentation should demonstrate the member's cancer genomic status (e.g., AKT/PTEN aberration), prior therapies received, and lack of exclusion criteria (see denial triggers).

Include pathology/genomic testing confirming AKT/PTEN aberration when indicated
Provide prior treatment history (endocrine therapy and CDK4/6 inhibitor) and dates
Supply relevant FDA label or guideline/compendia citations

Step Therapy

Prior Therapy Requirement

Authorization is contingent on prior therapy requirements and will be denied if these are not met. For breast cancer, Truqap in combination with fulvestrant is authorized only for HR‑positive, HER2‑negative locally advanced or metastatic disease after disease progression on prior endocrine therapy including a CDK4/6 inhibitor, and when the tumor harbors one or more AKT/PTEN genomic aberrations.

Prior endocrine therapy required, including a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib)
Requests lacking documentation of prior endocrine and CDK4/6 inhibitor therapy will be denied

Denial Risk

Exclusion-based Denial Triggers

Denial risks include: disease progression while on Truqap, lack of required prior endocrine or CDK4/6 inhibitor therapy, absence of documented AKT/PTEN genomic aberration when indicated, dosing or quantity exceeding specified limits, or use for investigational/off‑label indications without sufficient supporting evidence.

Progression on Truqap → exclusion
No prior endocrine therapy → exclusion
No prior CDK4/6 inhibitor → exclusion
Dosing limits: single dose >400 mg and monthly tablet limits exceeded → exclusion
Investigational/off‑label uses without CMS compendia or adequate peer‑reviewed evidence → exclusion

Coding

Reported HCPCS codes for capivasertibHCPCS

J8999	capivasertib
C9399	capivasertib

Step Therapy

Step	Requirement	Notes / Evidence
1
Prior endocrine therapy
Member must have experienced disease progression on prior endocrine therapy; policy specifies endocrine therapy including a CDK4/6 inhibitor is required for HR+/HER2- advanced/metastatic breast cancer with AKT/PTEN aberration (capivasertib used in combination with fulvestrant).

Quantity Limits

capivasertib (Truqap) — quantity limits

Single dose limit400 mg

Monthly maximum (160 mg tablets)64 tablets per month

Monthly maximum (200 mg tablets)64 tablets per month

Definitions

AKT/PTEN genomic aberration — definition and role

DefinitionGenomic alterations in the AKT or PTEN pathway reported on tumor testing that support use of capivasertib in combination with fulvestrant for HR-positive, HER2-negative locally advanced or metastatic breast cancer

Clinical roleEvidence of an AKT/PTEN aberration is required for coverage when disease has progressed on prior endocrine therapy including a CDK4/6 inhibitor

Exclusion noteCapivasertib is not supported for tumors with PI3K mutations per policy (alpelisib is the supported alternative)

Background

Capivasertib (Truqap) is an oral AKT inhibitor administered in combination with fulvestrant for adults with hormone receptor–positive, HER2–negative locally advanced or metastatic breast cancer. The policy supports its use when tumors harbor one or more AKT/PTEN genomic aberrations and the disease has progressed on prior endocrine therapy including a CDK4/6 inhibitor; supporting evidence cited includes the CAPItello‑291 trial and the FDA prescribing information.