CurrentEmblemHealthPolicy N/A

Kadcyla (ado-trastuzumab emtansine) Usage Policy

Defines accepted indications, continuation and exclusion criteria, applicable evidence sources, billing code, and line-of-business applicability for Kadcyla (ado-trastuzumab emtansine) medication requests processed by Evolent for EmblemHealth plans.

Policy Summary

PayerEmblemHealth

PolicyKadcyla (ado-trastuzumab emtansine) Usage Policy

Policy CodePolicy N/A

Change TypeTemplate conversion; verbiage update (non-clinical)

Effective Date

Next Review Date

Key ActionAuthorization requires support from FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature meeting CMS Chapter 15 standards.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template (February 2025) replacing prior UM ONC_1238 Kadcyla policy.

Updated 'continuation request' verbiage (February 2024).

2Explicit covered indications (HER2-positive recurrent/metastatic; adjuvant residual disease)

5Explicit exclusion criteria listed

1HCPCS code listed

Coverage Summary

This policy applies to Kadcyla (ado-trastuzumab emtansine) medication requests processed by Evolent on behalf of EmblemHealth lines of business. Coverage stance: mixed — the policy defines explicit covered indications and specific exclusions. Scope includes accepted indications, continuation and exclusion criteria, applicable evidence sources, and billing code(s). Effective/last review date: 2025-02-01. Payer: EmblemHealth (requests processed by Evolent).

General Authorization Requirements

Use of Kadcyla must be supported by one of the following sources and continuation requests have special conditions:

ALL of the following

Requested use is supported by FDA approved product labeling; CMS‑approved compendia; NCCN; ASCO clinical guidelines; or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Continuation requests exemption criteria
- Member has not experienced disease progression on the requested medication.
- 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.

Initial Therapy Criteria / Covered Indications

Covered Indications / Medically Necessary

Kadcyla may be authorized when ALL applicable indication-specific criteria below are met:

Indications

Recurrent/metastatic HER2-positive breast cancer: Kadcyla used as a single agent for members who have experienced disease progression after therapy with trastuzumab + pertuzumab with or without chemotherapy (e.g., a taxane).
Adjuvant therapy for residual disease (KATHERINE indication): Kadcyla used as a single agent for members with stage I-III HER2-positive breast cancer who have undergone neoadjuvant chemotherapy (taxane and trastuzumab-based treatment) and were found to have residual disease in the breast and/or axillary nodes after surgery.

Continuation Therapy Criteria

Continuation Requests — Conditions for Approval

For continuation approval (exemptions to non-approvable status), all of the following must be documented:

Continuation request requirements

No progression: Member has not experienced disease progression on the requested medication.
Recent active authorization: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No regimen additions: No additional medication(s) are being added to the continuation request.

Exclusions / Not Medically Necessary

Exclusion / Not Medically Necessary Criteria

The following are exclusions; presence of any of these should result in non-authorization.

ANY of the following

Concurrent use with trastuzumab, lapatinib, pertuzumab, fam-trastuzumab deruxtecan-nxki, or other chemotherapy (endocrine therapy may continue concurrently if indicated).
Disease progression while taking Kadcyla (ado-trastuzumab emtansine).
Dosing exceeds single dose limit of Kadcyla 3.6 mg/kg.
Dosing exceeds maximum duration of 14 cycles for adjuvant (curative-intent) treatment.
Investigational/off-label use lacking sufficient evidence or not generally accepted by the medical community (not supported by CMS-recognized compendia or acceptable peer-reviewed literature).

Denial Risk

Exclusion triggers for denial

Presence of any listed exclusion should result in non-authorization.

Concurrent use with trastuzumab, lapatinib, pertuzumab, fam-trastuzumab deruxtecan-nxki, or other chemotherapy (endocrine therapy may continue).
Disease progression while taking Kadcyla (ado-trastuzumab emtansine).
Single dose exceeds 3.6 mg/kg.
Adjuvant treatment duration exceeds 14 cycles.
Investigational/off-label use lacking sufficient evidence or not supported by CMS-recognized compendia or acceptable peer‑reviewed literature.

Evidence Sufficiency Considerations & References

Evidence Sufficiency Considerations

When evaluating investigational/off-label uses, consider ALL of the following evidence domains:

Evidence sufficiency domains

Whether clinical characteristics of the patient and cancer are adequately represented in published evidence.
Whether the administered chemotherapy/biologic/immune/targeted/other oncologic regimen is adequately represented in published evidence.
Whether reported study outcomes represent clinically meaningful outcomes (ASCO guidance: Hazard Ratio < 0.80; recommended survival benefit for OS and PFS at least 3 months).
Whether experimental design is appropriate to address the investigative question (recognizing some non-randomized trials may be supportive).
Case reports and meeting abstracts without full peer‑reviewed articles generally do not provide adequate supportive clinical evidence.

Acceptable evidence sources for authorization include FDA-approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements. Key evidence cited in the policy includes the KATHERINE trial (von Minckwitz et al.), the EMILIA trial (Verma et al.), and the Kadcyla prescribing information (Genentech 2022).

KATHERINESupports adjuvant use for residual invasive HER2+ disease after neoadjuvant chemo (taxane + trastuzumab) — cited as covered indication

EMILIASupports single‑agent use in recurrent/metastatic HER2+ disease after prior trastuzumab+pertuzumab ± chemo

PI/CompendiaPrescribing info and CMS‑recognized compendia listed as acceptable evidence sources for authorization

Provider Actions / Authorization Requirements

Prior Authorization

Authorization required and evidence sources

Authorization requires documentation supported by recognized evidence sources and applies to requests billed with J9354.

FDA approved product labeling
CMS‑approved compendia
National Comprehensive Cancer Network (NCCN)
American Society of Clinical Oncology (ASCO) clinical guidelines
Acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements
Affected code: J9354

Prior Authorization

Continuation request conditions

Continuation approval is allowed only when all specified conditions are met.

No disease progression on Kadcyla.
Active authorization within the past year with an authorization lapse of 30 days or less (Continuation lapse allowance: Authorization lapse <= 30 days within last year).
No addition of other medication(s) to the continuation request.

Documentation Required

Evidence documentation for off-label requests

Off-label requests must be supported by adequate peer‑reviewed literature or compendia evidence demonstrating that study populations, regimens, and outcomes are representative and clinically meaningful.

Citations must demonstrate that patient clinical characteristics are adequately represented in the published evidence.
Citations must demonstrate that the administered regimen is adequately represented in the published evidence.
Citations must report clinically meaningful outcomes (ASCO guidance: HR < 0.80; recommended survival benefit for OS and PFS at least 3 months).
Citations should reflect an appropriate experimental design for the investigative question; non-randomized trials with adequate sample size may be supportive.
Case reports and meeting abstracts without full peer‑reviewed articles are insufficient.

Applicable Codes

J-code for KadcylaHCPCS

J9354

Injection, ado-trastuzumab emtansine, mg

Billing Rule

Dosing and billing thresholds

Billing should ensure dosing does not exceed single-dose or adjuvant duration thresholds and verify mg/kg calculations against member weight.

Single dose limit: 3.6 mg/kg — deny if a single administered dose exceeds this limit.
Maximum adjuvant duration: 14 cycles — deny if adjuvant (curative-intent) treatment exceeds 14 cycles.
Verify the billed single-dose mg/kg calculation against the member's documented weight before approving; deny when calculated mg/kg exceeds the single-dose threshold.

Background

Evolent processes medication requests for EmblemHealth lines of business and requires that use of Kadcyla be supported by FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature per CMS Chapter 15. Continuation requests are exempt from re‑authorization requirements when the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the regimen.

Definition — Sufficient evidence: Evidence supported by CMS-recognized compendia or acceptable peer-reviewed literature demonstrating adequate patient/regimen representation and clinically meaningful outcomes (ASCO thresholds such as Hazard Ratio < 0.80 and recommended survival benefit for OS and PFS of at least 3 months).