CurrentEmblemHealthPolicy MG.MM.PH.88

Kadcyla (ado-trastuzumab emtansine) Intravenous

Defines EmblemHealth medical necessity criteria, coding, and authorization rules for intravenous Kadcyla for HER2-positive breast cancer and ERBB2 (HER2)-mutant non-small cell lung cancer in affected members and providers requesting coverage.

Policy Summary

PayerEmblemHealth

PolicyKadcyla (ado-trastuzumab emtansine) Intravenous

Policy CodePolicy MG.MM.PH.88

Change TypeNo material changes

Effective Date

Next Review DateMar 28, 2025

Key ActionTreating provider must submit clinical evidence demonstrating the member meets specific policy criteria (age, HER2 status, baseline LVEF) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsLength of initial authorization

480Max billed units per 21 days

≥18Minimum patient age

J9354Applicable HCPCS code

14Adjuvant renewal max cycles

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Initial Approval Criteria

Covered when ALL of the following are met:

Initial Requirements: 1. Patient is at least 18 years of age; AND 2. Disease is HER2-positive; AND 3. Baseline left ventricular ejection fraction (LVEF) within normal limits.

Indication-specific requirements: Breast cancer: A. Kadcyla must be used as single-agent therapy; AND B. Patient's cancer is metastatic or recurrent; AND (i) Patient was previously treated with trastuzumab and a taxane (separately or in combination) OR C. Kadcyla is being used as adjuvant treatment for patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Breast cancer statements include both metastatic/recurrent and adjuvant residual disease scenarios.

NSCLC requirement: Non‑Small Cell Lung Cancer: A. Patient has ERBB2 (HER2) mutation‑positive disease as determined by an FDA‑approved or CLIA‑compliant test; AND B. Patient has recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy.

NSCLC indication is Compendia‑recommended.

Renewal Criteria

Authorization renewal permitted when ALL of the following are met:

Renewal requirements: 1. Patient continues to meet all Initial Approval Criteria; AND 2. Evidence of tumor response with stabilization of disease or decrease in tumor size; AND 3. Absence of unacceptable toxicity from the drug (examples include hepatotoxicity; left ventricular dysfunction; pulmonary toxicity such as pneumonitis; thrombocytopenia; neurotoxicity; infusion‑related or hypersensitivity reactions; hemorrhage; extravasation); AND 4. Recent LVEF (obtained within the previous 3 months) meeting specified thresholds: for metastatic/recurrent breast cancer: LVEF >45% OR LVEF 40%–≤45% with absolute decrease <10% from baseline; for all other indications: LVEF ≥50% OR LVEF 45%–<50% with absolute decrease <10% from baseline; AND 5. For breast cancer adjuvant treatment only: patient has not exceeded a maximum of 14 cycles (42 weeks) of therapy.

second-line | adjuvant

Breast cancer sequencing: Metastatic/recurrent breast cancer: prior treatment with trastuzumab and a taxane (separately or in combination) is required; Kadcyla must be administered as single‑agent therapy. Adjuvant use: permitted for patients with residual invasive disease after neoadjuvant taxane and trastuzumab‑based therapy (see cycle limits under Renewal Criteria).

Kadcyla (ado-trastuzumab emtansine) is not considered medically necessary for indications other than those listed in this policy due to insufficient evidence of therapeutic value.

Use of Kadcyla for indications not specified in the Initial Approval Criteria is considered not medically necessary and may be denied.

Covered Regimens and Dosing

Indication	Regimen / Requirements	Coverage status
Metastatic or recurrent HER2-positive breast cancer
Kadcyla as single‑agent intravenous therapy per dosing limits; patient must have been previously treated with trastuzumab and a taxane (separately or in combination). Adjuvant use allowed for patients with residual invasive disease after neoadjuvant taxane and trastuzumab‑based treatment (see renewal limits).
Covered

Indication	Regimen / Requirements	Coverage status
Non‑small cell lung cancer (ERBB2/HER2 mutation‑positive)
Kadcyla for patients with confirmed ERBB2 (HER2) mutation positive disease as determined by an FDA‑approved or CLIA‑compliant test; patient has recurrent, advanced, or metastatic disease (excludes locoregional recurrence or symptomatic local disease without disseminated disease).
Covered with criteria

Coding: HCPCS, NDC, and ICD-10

Applicable HCPCS CodesHCPCSCovered

J9354

Injection, ado-trastuzumab emtansine, 1 mg; 1 billable unit = 1 mg

Applicable NDCsNDC

50242-0088-xx	Kadcyla 100 mg single-use vial
50242-0087-xx	Kadcyla 160 mg single-use vial

Applicable ICD-10 Diagnoses (breast and lung neoplasms and histories)ICD-10Covered

C33	Malignant neoplasm of trachea
C34.00	Malignant neoplasm of unspecified main bronchus
C34.01	Malignant neoplasm of right main bronchus
C34.02	Malignant neoplasm of left main bronchus
C34.10	Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11	Malignant neoplasm of upper lobe, right bronchus or lung
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung
C34.2	Malignant neoplasm of middle lobe, bronchus or lung
C34.30	Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31	Malignant neoplasm of lower lobe, right bronchus or lung

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Unit limit per dosing period — 21-day dosing period

Unit limit480 billable units every 21 days

Billing unit definition1 billable unit = 1 mg (see HCPCS J9354)

Authorization period relatedMax applies per 21-day dosing period for prior authorization and post-payment review

LVEF thresholds for renewal

Metastatic/recurrent breast cancer renewal LVEFLVEF >45% OR LVEF 40%–≤45% with absolute decrease <10% from baseline

All other indications renewal LVEFLVEF ≥50% OR LVEF 45%–<50% with absolute decrease <10% from baseline

Timing of LVEF assessmentLVEF must be obtained within the previous 3 months for renewal consideration

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Unit Limits

Prior Authorization Required: Prior authorization is required for Kadcyla. Coverage is provided for an initial period of 6 months. Maximum dosing limit is 480 billable units every 21 days.

Prior authorization required for initiation
Initial authorization period: 6 months
Quantity limit: Maximum 480 units per 21 days

Documentation Required

Provider Documentation Requirements

Provider must submit clinical evidence that the member meets the policy criteria at the time of preauthorization or post-payment review. Required documentation includes, at minimum, patient age (≥18 years), documentation of HER2‑positive disease, and baseline left ventricular ejection fraction (LVEF) within normal limits. Failure to submit the required clinical evidence will prevent EmblemHealth from properly reviewing the request and may result in denial or delay of authorization.

Document patient age (≥18 years)
Document HER2-positive status
Document baseline LVEF within normal limits
Failure to submit required clinical evidence prevents proper review of preauthorization or post-payment review

Documentation Required

Renewal Documentation Specifics

For renewal of authorization, submit current documentation showing the member continues to meet initial criteria plus: tumor response with stabilization or decreased tumor size; absence of unacceptable toxicity from Kadcyla (examples include hepatotoxicity, left ventricular dysfunction, pulmonary toxicity, thrombocytopenia, neurotoxicity, infusion-related or hypersensitivity reactions, hemorrhage, extravasation); and a recent LVEF measurement obtained within the previous 3 months that meets policy thresholds. For metastatic or recurrent breast cancer: LVEF >45% OR LVEF 40%–≤45% with an absolute decrease <10% from baseline. For all other indications: LVEF ≥50% OR LVEF 45%–<50% with an absolute decrease <10% from baseline. For adjuvant breast cancer only: patient has not exceeded a maximum of 14 cycles (42 weeks total).

Provide evidence of tumor response or disease stabilization
Document absence of unacceptable toxicity (list examples)
Provide LVEF obtained within past 3 months meeting policy thresholds
Adjuvant breast cancer renewal: total cycles ≤14 (42 weeks)

Denial Risk

Denial Risk for Unsupported Indications

Denial Risk for Unsupported Indications: Requests for Kadcyla for indications not listed in the policy are considered not medically necessary and may be denied.

Requests for unlisted indications may be denied as not medically necessary

Key Definitions and Safety Terms

HER2-positive / ERBB2 (HER2) mutation positive — Definitions

HER2-positive disease (breast cancer)Disease defined as HER2-positive per policy criteria for breast cancer (FDA‑approved indications)

ERBB2 (HER2) mutation-positive NSCLCERBB2 (HER2) mutation positive disease must be determined by an FDA‑approved or CLIA‑compliant test

Applicable NSCLC disease stateIndication applies to recurrent, advanced, or metastatic NSCLC (compendia-recommended)

Unacceptable toxicity — Examples

HepatotoxicityListed as an example of unacceptable toxicity that may preclude renewal

Left ventricular dysfunctionListed as an example of unacceptable toxicity (cardiac toxicity)

Pulmonary toxicity (pneumonitis)Pulmonary toxicity, including pneumonitis, is listed as an example of unacceptable toxicity

ThrombocytopeniaListed as an example of unacceptable toxicity

NeurotoxicityListed as an example of unacceptable toxicity

Infusion-related and hypersensitivity reactionsIncluded among examples of unacceptable toxicity (also hemorrhage; extravasation)

HER2 / ERBB2 biomarker requirement — NSCLC testing

NSCLC biomarker requirementERBB2 (HER2) mutation must be positive by an FDA‑approved or CLIA‑compliant test

Test types acceptedFDA‑approved tests or CLIA‑compliant laboratory tests as specified in policy

Indication linkageBiomarker positivity required for use in recurrent, advanced, or metastatic NSCLC per policy

OpenPayer

Kadcyla (ado-trastuzumab emtansine) Intravenous

Coverage Criteria for Kadcyla (ado-trastuzumab emtansine)

Covered Regimens and Dosing

Coding: HCPCS, NDC, and ICD-10

Provider Actions, Prior Authorization, and Documentation

Key Definitions and Safety Terms

Background

Revision History