ModifiedHealth NetPolicy CP.PHAR.229

Ado-Trastuzumab Emtansine (Kadcyla) Coverage

Defines medical necessity, authorization criteria, dosing, and coding guidance for ado-trastuzumab emtansine (Kadcyla) for Health Net lines of business including Commercial, HIM/ICHRA, and Medicaid.

Policy Summary

PayerHealth Net

PolicyAdo-Trastuzumab Emtansine (Kadcyla) Coverage

Policy CodePolicy CP.PHAR.229

Change TypeMaterial updates to indications and approval durations (added NCCN off‑label usesextended Medicaid/HIM approval)

Effective Date06.01.16

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of HER2‑positive diagnosis, oncologist involvement, age ≥18, and required prior therapies or adjuvant exception.

SourceLink

POLICY UPDATE CHANGES

Added off-label indication for brain metastases in HER2-positive breast cancer per NCCN.

Added criterion to allow single-agent therapy for off-label indications of NSCLC and salivary gland tumor per NCCN.

Clarified for NSCLC that disease must be recurrent, advanced, or metastatic per NCCN.

Added bypass of prior use of trastuzumab-based therapy and a taxane if prescribed in the adjuvant setting per NCCN.

For Medicaid and HIM, initial approval duration extended from 6 to 12 months.

For NSCLC, added criteria for use as subsequent therapy per NCCN.

3.6 mg/kgStandard dose per 21-day cycle

14Maximum adjuvant doses

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Coverage Criteria

Initial Therapy - Breast Cancer

Covered when ALL of the following are met:

Breast Cancer Initial: 1. Diagnosis of HER2-positive breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed as a single agent; 5. One of the following: (a) documentation of prior use of trastuzumab-based therapy and a taxane; (b) Kadcyla prescribed as adjuvant treatment; 6. Request meets one of the following: (a) as adjuvant treatment: dose does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses; (b) for metastatic treatment: dose does not exceed 3.6 mg/kg every 21 days; (c) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy - NCCN Recommended Off-label Uses

Covered when ALL of the following are met:

Off-label NCCN Uses: 1. Diagnosis of one of the following: (a) recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); (b) recurrent salivary gland tumor; (c) brain metastases due to breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is HER2-positive; 5. Prescribed in one of the following ways: (a) as a single agent; (b) in combination with neratinib for brain metastases; 6. For NSCLC, Kadcyla is prescribed as subsequent therapy; 7. Request meets one of the following: (a) dose does not exceed 3.6 mg/kg every 21 days; (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy: 1. Member is currently receiving Kadcyla via the Centene benefit, or documentation supports that the member has received Kadcyla for a covered indication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets one of the following: (a) as adjuvant treatment for breast cancer: new dose does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses; (b) for all other indications: new dose does not exceed 3.6 mg/kg every 21 days; (c) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA-approved or recommended by NCCN.

Summary of policy changes to coverage criteria

Policy updates (summary):

Updated indications: Added indication: brain metastases in HER2-positive breast cancer per NCCN.

Supported by NCCN; full clinical detail in source document.

NSCLC subsequent therapy: Added criteria: NSCLC use specified as subsequent therapy per NCCN.

Specific sequencing details referenced to NCCN; see full policy for operationalization.

Approval duration change: For Medicaid and HIM/ICHRA, initial approval duration extended from 6 to 12 months.

Applies to Medicaid and HIM/ICHRA lines of business.

Requests for uses that are non‑FDA approved and are not specifically addressed in this policy are considered excluded unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 (Commercial), HIM.PA.154 (HIM/ICHRA), or CP.PMN.53 (Medicaid), or unless coverage is provided by the member’s evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Coverage decisions remain subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents and applicable state and federal requirements.

Uses that are non‑FDA approved and that are not supported by sufficient evidence as defined by the applicable off‑label use policy are considered not authorized for coverage under this policy.

This clinical policy is intended as a guide to medical necessity to assist in coverage decisions and benefit administration. It does not itself modify member coverage documents or contract terms, nor does it guarantee payment; final coverage determinations are governed by the member’s evidence of coverage and applicable law.

Initial Therapy Criteria

Initial Therapy — Initial approval criteria

Initial approval — requests are approved when ALL of the following initial criteria are satisfied:

Initial therapy nodes: 1. Diagnosis consistent with an indicated covered condition (see indication-specific criteria for HER2-positive breast cancer and NCCN off-label uses); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Prescribed as a single agent unless combination is specified (e.g., with neratinib for brain metastases); 5. For metastatic breast cancer: documentation of prior use of trastuzumab-based therapy and a taxane unless Kadcyla is prescribed as adjuvant treatment (adjuvant bypass applies); 6. Dose meets indication-specific limits (does not exceed 3.6 mg/kg every 21 days for metastatic use, and for adjuvant breast cancer does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses) or is supported by practice guidelines or peer-reviewed literature for off-label uses (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA-approved or recommended by NCCN.

Prior authorization required and prescriber must supply supporting clinical documentation as indicated.

Initial therapy approval duration

Approval duration for initial therapy (by line of business):

Continuation Therapy Criteria

Continuation Therapy — Continuation criteria

Continuation (renewal) requests are approved when ALL of the following are met:

Continuation nodes: 1. Member is currently receiving Kadcyla via the Centene benefit or documentation confirms the member has received Kadcyla for at least 30 days for a covered indication; 2. Member is responding positively to therapy as evidenced by clinical documentation; 3. Any requested dose increase meets one of the following: (a) for adjuvant breast cancer: new dose does not exceed 3.6 mg/kg every 21 days for a maximum of 14 doses; (b) for all other indications: new dose does not exceed 3.6 mg/kg every 21 days; (c) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); 4. Prescribed regimen must be FDA-approved or recommended by NCCN.

Providers must submit office chart notes, lab results, or other clinical information to document continued benefit.

Step Therapy / Prior Treatment Requirements

Step	Requirement
1	Prior use of a trastuzumab‑based therapy and a taxane is required for metastatic HER2‑positive breast cancer unless Kadcyla is prescribed as adjuvant treatment (adjuvant bypass applies).

Step	Requirement
1	For NSCLC (recurrent, advanced, or metastatic), Kadcyla is covered only when prescribed as subsequent therapy per NCCN (i.e., after prior lines of therapy as indicated by NCCN).

Provider Actions and Requirements

Documentation Required

Required documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Documentation should include evidence of HER2-positive diagnosis, prior trastuzumab and taxane use when required, prior therapy details for metastatic disease, and any supporting literature for off‑label uses.

Prior Authorization

Prior Authorization and Non‑covered Indications Risk

Prior authorization is required. Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, CP.PMN.53 for Medicaid) or per evidence of coverage documents.

Prior authorization will reflect updated indications and approval durations, including NSCLC subsequent‑therapy criteria per NCCN and extended initial approval durations for Medicaid and HIM.

Coding and Billing

HCPCS CodesHCPCS

J9354

Injection, ado-trastuzumab emtansine, 1 mg

Maximum adjuvant doses

Maximum adjuvant doses14 cycles (3.6 mg/kg IV every 21 days for adjuvant therapy)

Adjuvant dosing regimen3.6 mg/kg IV every 21 days

Stop criteria for adjuvant courseComplete 14 cycles unless disease recurrence or unmanageable toxicity

Site of Care and Administration

Billing Rule

Administer IV every 21 days in infusion center

Administer Kadcyla intravenously every 21 days (3.6 mg/kg per dosing guidance) in an infusion/infusion‑center setting per the dosing regimen.

Dosing regimen: 3.6 mg/kg IV every 21 days (Q3WK) (chunk 13).
Adjuvant regimen: 3.6 mg/kg IV Q3WK for a total of 14 cycles unless recurrence or toxicity (chunk 13).

Background

Ado‑trastuzumab emtansine (Kadcyla) is a HER2‑targeted antibody‑drug conjugate that combines the monoclonal antibody trastuzumab with the cytotoxic agent emtansine (a microtubule inhibitor). It is indicated for adjuvant treatment of HER2‑positive early breast cancer with residual invasive disease after neoadjuvant taxane and trastuzumab‑based therapy, and for HER2‑positive metastatic breast cancer following prior trastuzumab and a taxane; the policy also addresses selected NCCN‑recommended off‑label uses such as recurrent/advanced/metastatic NSCLC, recurrent salivary gland tumors, and brain metastases from HER2‑positive breast cancer under specified conditions.

Definitions

HER2

DefinitionHER2 = human epidermal growth factor receptor 2 protein

Clinical contextTargeted by ado-trastuzumab emtansine (Kadcyla), a HER2-directed antibody-drug conjugate

Relevant FDA indicationsUsed for HER2-positive early breast cancer with residual invasive disease and HER2-positive metastatic breast cancer after prior trastuzumab and a taxane

Adjuvant therapy

DefinitionAdjuvant therapy = treatment given after primary therapy (e.g., surgery) to reduce risk of recurrence; for Kadcyla: adjuvant treatment of HER2-positive early breast cancer with residual invasive disease following neoadjuvant taxane and trastuzumab-based therapy

Dose and schedule (adjuvant)3.6 mg/kg IV every 21 days for a total of 14 cycles unless disease recurrence or unmanageable toxicity

Revision History

05.26policy_revisionLatest

Added indication: brain metastases in HER2-positive breast cancer per NCCN; added NSCLC criteria requiring use as subsequent therapy per NCCN; for Medicaid and HIM extended initial approval duration from 6 to 12 months; references reviewed and updated; added ICHRA line of business.