Currentblue cross blue shield - tennesseePolicy ID_CHS_2025

Ado-Trastuzumab Emtansine (Kadcyla®)

Policy governs coverage and prior authorization criteria for Kadcyla (ado-trastuzumab emtansine) for FDA-approved and compendial indications (HER2-positive metastatic and early breast cancer, selected HER2-mutant NSCLC, and HER2-positive salivary gland tumors), plus quantity limits, dosing, and documentation requirements for BlueCross BlueShield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyAdo-Trastuzumab Emtansine (Kadcyla®)

Policy CodePolicy ID_CHS_2025

Change Typeclarified

Effective DateJun 2, 2026

Next Review Date

Key ActionSubmit HER2 status to initiate prior authorization review; authorization may be granted up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Medical Policy Manual Approved Rev:: Do Not Implement until 6/2/26

12Typical authorization duration

3.6 mg/kgMaximum dosing regimen (q3w)

4Covered indication count

Coverage Summary & Covered Indications

Coverage stance: covered_with_criteria for Kadcyla (ado-trastuzumab emtansine) when used for the listed FDA-approved and compendial indications provided all approval criteria are met and the member has no exclusions to the prescribed therapy. Submission of HER2 status is required to initiate prior authorization review.

Covered Indications and General Requirement

The indications below (FDA-approved and compendial) are considered covered provided all approval criteria are met and the member has no exclusions to the prescribed therapy. Submission of HER2 status is required to initiate prior authorization review.

Covered Indications

Metastatic Breast Cancer (MBC): Kadcyla as a single agent for patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane (separately or in combination). Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
Early Breast Cancer (EBC): Kadcyla as a single agent for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
Compendial Uses: Non-small cell lung cancer with HER2 mutations; HER2-positive breast cancer (compendial reference); HER2-positive recurrent, unresectable or metastatic salivary gland tumors.
Compendial uses covered when compendial evidence meets policy.

Initial Therapy Criteria

Non-Small Cell Lung Cancer (NSCLC) Specific Criteria

Authorization of 12 months may be granted when ALL of the following criteria are met:

NSCLC Specific Criteria (initial-therapy)

Single agent use: The requested medication will be used as a single agent.
Disease status: The disease is recurrent, advanced or metastatic.
Prior HER2-targeted therapy: The member has not experienced disease progression on a HER2 targeted drug (e.g., Enhertu).

Salivary Gland Tumor Specific Criteria

Authorization may be granted when the following are met:

Salivary Gland Tumor Specific Criteria (initial-therapy)

Diagnosis: Recurrent, unresectable or metastatic HER2-positive salivary gland tumor.
Single agent use: Planned use as a single agent.

Continuation & Reauthorization Criteria

Authorization Duration and Continuation

Authorization and reauthorization rules:

Initial or subsequent authorization: up to 12 months may be granted for covered indications (HER2-positive metastatic or recurrent breast cancer; first-line therapy in select cases; adjuvant therapy where specified; NSCLC with HER2 mutations; salivary gland tumors).
Continuation/reauthorization: Continuation of therapy/reauthorization: up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Adjuvant breast cancer limit: Adjuvant treatment of breast cancer approved for a total of 12 months of therapy.

Unproven / Not Medically Necessary

Usage Restrictions / Experimental Exclusion

Exclusions:

Experimental/Investigational Exclusion: All other indications not listed (outside FDA-approved indications or recognized compendial uses) are considered experimental/investigational and not medically necessary.

Prior Authorization, Documentation & Billing

Prior Authorization

Prior authorization required with HER2 status

Submit HER2 status to initiate prior authorization review; authorization may be granted up to 12 months when criteria are met.

Documentation Required

Documentation of prior therapies for breast cancer

For metastatic breast cancer, document prior receipt of trastuzumab and a taxane (separately or in combination) and whether recurrence occurred during or within six months of completing adjuvant therapy. For early breast cancer, document residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Prior Authorization

NSCLC prior therapy constraint

For NSCLC with HER2 mutations, document that Kadcyla will be used as a single agent, the disease is recurrent, advanced, or metastatic, and the member has not experienced disease progression on a HER2-targeted drug (e.g., Enhertu).

Billing Rule

Authorization duration limit

Authorization and reauthorization are generally limited to up to 12 months per approval.

Relevant Drug Identifiers & Dosing Codes

Relevant drug identifiers and dosing regimen (administration rules referenced)mixed

3.6 mg/kg every 3 weeks

Maximum dosing regimen; intravenous route of administration

Surface dosing threshold

Dosing interval and weight-based dose3.6 mg/kg every 3 weeks

Route of administrationIntravenous

Maximum dosing regimen (policy stat)3.6 mg/kg q3w

Clinical Evidence & References

Primary evidence sources: Kadcyla [package insert], Genentech, May 2025; NCCN Drugs & Biologics Compendium 2025; NCCN Guidelines (Head & Neck Cancers) v5.2025; and Micromedex.

Policy references FDA labeling and standard compendia (e.g., NCCN, Micromedex, AHFS) for dosing, contraindications, warnings and monitoring.

Background and Scope

Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate indicated for HER2-positive breast cancers and selected compendial uses (including HER2-mutant non-small cell lung cancer and HER2-positive salivary gland tumors).

This policy governs coverage and prior authorization criteria for BlueCross BlueShield of Tennessee members, including quantity limits, dosing, and documentation requirements (e.g., submission of HER2 status and documentation of prior therapies where applicable).

Maximum dosing regimen referenced: 3.6 mg/kg every 3 weeks (intravenous).

Policy scope — quick facts

Typical authorization duration12 months

Maximum dosing regimen3.6 mg/kg every 3 weeks

Covered indications (count)4

Covered indications (list)Metastatic breast cancer (MBC); Early breast cancer (EBC); NSCLC with HER2 mutations; HER2-positive salivary gland tumors

Prior authorization requirementSubmission of HER2 status required to initiate review