CurrentViva HealthPolicy IC-0092

Kadcyla (ado-trastuzumab emtansine) — coverage criteria

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Defines Viva Health prior authorization, dosing, approval and renewal criteria, and billing codes for Kadcyla (ado-trastuzumab emtansine) for oncology indications; applies to providers requesting coverage for members receiving this intravenous oncology drug.

Policy Summary

PayerViva Health

PolicyKadcyla (ado-trastuzumab emtansine) — coverage criteria

Policy CodePolicy IC-0092

Change TypeNo material clinical or coverage changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initial 6 months) and submit documentation showing baseline and recent LVEF and indication-specific evidence to support coverage.

SourceLink

6 moinitial prior authorization duration

480max units/21 days

J9354HCPCS code

3.6 mg/kg q3wdosing schedule

Noted

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CurrentViva HealthPolicy IC-0092

Kadcyla (ado-trastuzumab emtansine) — coverage criteria

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Policy Summary

PayerViva Health

PolicyKadcyla (ado-trastuzumab emtansine) — coverage criteria

Policy CodePolicy IC-0092

Change TypeNo material clinical or coverage changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initial 6 months) and submit documentation showing baseline and recent LVEF and indication-specific evidence to support coverage.

SourceLink

6 moinitial prior authorization duration

480max units/21 days

J9354HCPCS code

3.6 mg/kg q3wdosing schedule

Noted

Coverage Criteria for Kadcyla (ado-trastuzumab emtansine)

Initial Therapy

Prior authorization validity is provided when ALL of the following universal and indication-specific criteria are met:

Initial general requirements

Universal Criteria: Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months); AND used as a single agent (unless otherwise specified); AND therapy will not be substituted with or for any trastuzumab-based formulation

Initial drug therapy dosing: Administer 3.6 mg/kg IV every 3 weeks (21-day cycle); for adjuvant breast cancer up to 14 cycles (may be given up to 17 cycles if no preoperative therapy); for other indications continue until disease progression or unacceptable toxicity

Central Nervous System (CNS) Cancer

CNS (brain metastases) from HER2-positive breast cancer:

CNS criteria: Member has brain metastases from HER2 (ERBB2)-positive breast cancer as determined by an FDA-approved or CLIA-compliant test; AND used as a single agent or in combination with neratinib

Non-Small Cell Lung Cancer (NSCLC)

NSCLC with ERBB2 (HER2) mutation:

NSCLC criteria: Member has ERBB2 (HER2) mutation–positive disease as determined by an FDA-approved or CLIA-compliant test; AND used as subsequent therapy; AND member 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

Head and Neck Cancer

Head and neck cancers (salivary gland tumors):

Head and neck criteria: Member has HER2-positive disease as determined by an FDA-approved or CLIA-compliant test; AND member has salivary gland tumors; AND member has recurrent disease with one of the following: distant metastases; OR unresectable locoregional recurrence with prior radiation therapy; OR unresectable second primary with prior radiation therapy

As part of the universal criteria for prior authorization, therapy substitution with or for any trastuzumab‑based formulation is not allowed. Providers must request coverage specifically for ado‑trastuzumab emtansine (Kadcyla) and may not substitute another trastuzumab-containing product in place of Kadcyla, nor use Kadcyla as a substitute for another trastuzumab formulation when the policy criteria require this agent to be used as prescribed.

Initial Drug Therapy Requirements

Initial Drug Therapy

Initial coverage requires meeting age, universal criteria, and indication-specific criteria:

Initial drug therapy: Administer 3.6 mg/kg IV every 3 weeks; for adjuvant breast cancer up to 14 cycles (may be given up to 17 cycles if no preoperative therapy); for other settings continue until disease progression or unacceptable toxicity; member must be ≥18 years and meet universal and indication-specific criteria

Universal and documentation requirements: Left ventricular ejection fraction (LVEF) within normal limits prior to therapy and will be assessed at regular intervals (e.g., every 3 months); used as a single agent unless otherwise specified; therapy will not be substituted with or for any trastuzumab-based formulation; submit appropriate documentation to demonstrate criteria are met

Renewal and Continuation Requirements

Renewal / Continuation Therapy

Renewal/continuation requires ongoing benefit and safety evaluation:

Renewal criteria: Member continues to meet the universal and indication-specific relevant criteria; duration of authorization has not been exceeded; disease response demonstrated (stabilization or decrease in tumor size or spread); absence of unacceptable toxicity (examples include left ventricular dysfunction, hepatotoxicity, pulmonary toxicity, thrombocytopenia, neurotoxicity, infusion/hypersensitivity reactions, hemorrhage, extravasation); AND a recent LVEF obtained within the previous 3 months meeting specified thresholds: for metastatic/recurrent breast cancer LVEF >45% OR 40%–≤45% with absolute decrease <10% from baseline; for all other indications LVEF ≥50% OR 45%–<50% with absolute decrease <10% from baseline

Provider Actions, Documentation & Authorization

Prior Authorization

Prior authorization required; initial approval 6 months (180 days)

Prior authorization (PA) is required for ado‑trastuzumab emtansine (Kadcyla). Initial authorization is valid for 6 months (180 days) and may be renewed every 6 months; for adjuvant breast cancer renewals are limited to a maximum of 14 cycles (42 weeks) — up to 17 cycles if the member did not receive preoperative therapy. Member must be at least 18 years of age and meet the universal and indication‑specific criteria in the policy.

Initial PA duration: 6 months (180 days).
Renewal: may be renewed every 6 months; adjuvant breast cancer renewal limited to max 14 cycles (may be given up to 17 cycles if no preoperative therapy).
Member age requirement: ≥18 years.

Prior Authorization

NQTL justification for prior authorization

The PA was implemented after consideration of indication relevance, clinical safety/efficacy, and drug cost per the NQTL factor checklist; potential for misuse/abuse was not identified as a priority for PA.

Billing Codes, NDCs, Quantity Limits, and Diagnosis Codes

HCPCS CodesHCPCSCovered

J9354

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

NDCsNDC

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

Covered ICD-10 Diagnosis CodesICD-10Covered

C06.9	Malignant neoplasm of mouth, unspecified.
C07	Malignant neoplasm of parotid gland.
C08.0	Malignant neoplasm of submandibular gland.
C08.1	Malignant neoplasm of sublingual gland.
C08.9	Malignant neoplasm of major salivary gland, unspecified.
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.

1–10 of 82

1/9

Maximum billable units per cycle

Maximum billable units per 21-day cycle480 billable units every 21 days

HCPCS unit definition1 billable unit = 1 mg (per policy HCPCS unit convention)

Cycle length21-day cycle (every 3 weeks)

Quantity limits

Quantity limit for ado-trastuzumab emtansine (Kadcyla)480 billable units per 21 days

Dosing schedule contextStandard dosing 3.6 mg/kg IV every 3 weeks (21-day cycle)

Step-Therapy / Prerequisite Exposure

Prerequisite	Required for
Prior exposure to trastuzumab (trastuzumab-based therapy)	Metastatic disease that recurred during or within 6 months of completing adjuvant therapy — member must have previously received trastuzumab (alone or with a taxane)
Prior exposure to a taxane (separately or in combination with trastuzumab)	Metastatic disease that recurred during or within 6 months of completing adjuvant therapy — member must have previously received a taxane (alone or with trastuzumab)

Site of Care and Medicare Applicability

Note

Site of care: infusion center

Infusion center is an intended site of care for administration of Kadcyla.

Site of care listed: infusion center.

Billing Rule

Medicare/Part B: follow CMS NCD/LCD/LCA guidance for outpatient administration

For hospital outpatient administration and Medicare members, Medicare Part B policies and applicable CMS NCDs/LCDs/LCAs may apply; the plan follows Medicare guidance where applicable and providers should check CMS coverage documents for Part B billing and payment rules.

Medicare Part B guidance (Medicare Benefit Policy Manual, Chapter 15 §50) and any relevant NCDs/LCDs/LCAs apply for outpatient administration.
Providers may need to reference the CMS Medicare Coverage Database for local/ national coverage documents when billing Part B.

Background and Drug Overview

Ado‑trastuzumab emtansine (Kadcyla) is an antibody‑drug conjugate targeting HER2 (ERBB2)‑positive tumors. The policy specifies use as a single agent unless otherwise noted, and requires HER2 positivity to be documented by FDA‑approved or CLIA‑compliant testing before authorization is approved.

Definitions and Biomarker Criteria

HER2-positive definition

IHC criteriaImmunohistochemistry (IHC) assay 3+

Dual-probe ISH ratio criterionDual-probe ISH HER2/CEP17 ratio ≥ 2.0 AND average HER2 copy number ≥ 4.0 signals/cell

Additional ISH + IHC combinationsISH ratio ≥2.0 with average HER2 <4.0 and concurrent IHC 3+; OR ISH ratio <2.0 with average HER2 ≥6.0 and concurrent IHC 2+ or 3+; OR ISH ratio <2.0 with average HER2 ≥4.0 and <6.0 with concurrent IHC 3+

Policy Revision History

2026-06-02policy_reviewLatest

Policy last reviewed and updated; Medicare Part B guidance and CMS NCD/LCD/LCA considerations noted in Appendix 2, with link to CMS coverage database.

2026-06-02medicare_information

Medicare Part B covered diagnosis codes listed as N/A and MAC jurisdiction details provided to clarify applicability of NCD/LCD/LCA documents.

Policy Summary

PayerViva Health

PolicyKadcyla (ado-trastuzumab emtansine) — coverage criteria

Policy CodePolicy IC-0092

Change TypeNo material clinical or coverage changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization (initial 6 months) and submit documentation showing baseline and recent LVEF and indication-specific evidence to support coverage.

SourceLink

On This Page

NQTL checklist factors considered: Indication = yes; Safety and efficacy = yes; Cost of drug = yes; Potential for misuse/abuse = no.

Step Therapy

Prerequisite: prior trastuzumab and taxane exposure for select breast cancer scenarios

For certain metastatic or recurrent breast cancer scenarios (including disease recurring during or within 6 months of completing adjuvant therapy), prior exposure to trastuzumab and a taxane (given separately or in combination) is required as a prerequisite.

Prerequisite applies where metastatic disease recurred during or within 6 months of completing adjuvant therapy.
Documentation must show prior trastuzumab and taxane exposure (separately or in combination).

Step Therapy

Step therapy: no specified sequence in this policy

No specific step therapy sequence or mandatory medication trial order is listed in this policy.

Policy does not prescribe a stepwise sequence beyond the prerequisite trastuzumab/taxane requirement described for certain breast cancer scenarios.

Documentation Required

Required clinical documentation: baseline and interval LVEF, therapy details, and renewal evidence

Clinical documentation submitted with the PA must demonstrate the member meets the universal criteria, including baseline LVEF within normal limits and interval LVEF monitoring; for renewals, include a recent LVEF obtained within the previous 3 months and evidence of disease response or absence of unacceptable toxicity.

Baseline LVEF within normal limits prior to initiating therapy and assessed at regular intervals (e.g., every 3 months).
For renewal, LVEF obtained within previous 3 months per indication‑specific thresholds and documentation of disease stabilization or decrease in tumor burden.
Document that therapy is used as a single agent unless otherwise specified and that trastuzumab‑based formulations are not substituted.

Billing Rule

Required diagnosis coding: use ICD‑10 code(s) from Appendix 1

Submit an appropriate ICD‑10 diagnosis code from Appendix 1 to support the PA request; covered codes for breast, lung, salivary gland, brain metastasis, history and neoplasm codes are listed in Appendix 1.

Use one or more ICD‑10 codes from Appendix 1 that correspond to the member’s diagnosis (e.g., C50.x series for breast cancer, C34.x for lung cancer, C07–C08.x for salivary gland tumors, C79.31 for brain metastasis).

Denial Risk

Renewal denial triggers: lack of benefit, unacceptable toxicity, LVEF or duration limits

Renewal may be denied if documentation does not demonstrate ongoing benefit (disease response), unacceptable toxicity is present, LVEF thresholds are not met, or the duration/number of authorized cycles has been exceeded.

Denial triggers include: no demonstrated disease response (stabilization or decrease), presence of unacceptable toxicities (e.g., left ventricular dysfunction, hepatotoxicity, pulmonary toxicity, thrombocytopenia, severe infusion reactions), LVEF outside policy thresholds, or exceeding authorized duration (see Section I limits).

Note

Prior authorization considerations per NQTL checklist

PA application and design considered the NQTL checklist factors: indication relevance, safety/efficacy, and drug cost were reasons to apply PA; potential misuse/abuse was not considered a priority.

NQTL findings: Indication = consider for PA; Safety/efficacy = consider for PA; Cost = consider for PA; Potential for misuse/abuse = PA not a priority.

Per-unit interpretationLimit corresponds to total mg billed per 21-day cycle (HCPCS unit = 1 mg)