Ado-trastuzumab emtansine (Kadcyla) (ARCHIVED)

Policy ID: I-113-012

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-113-012

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Ado-trastuzumab emtansine (Kadcyla®) is a human epidermal growth factor receptor 2 (HER2) targeted antibody-drug conjugate comprised of trastuzumab and emtansine. Ado-trastuzumab emtansine (Kadcyla) is an antagonist of HER2 that is intended as treatment for individuals with HER2-overexpressing cancer.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Human epidermal growth factor receptor 2 (HER2) protein over expression must be verified by ANY ONE of the following FDA approved diagnostic tests:

An immunohistochemical (IHC) assay with a result of 3+ (positive); or
A positive fluorescence in situ hybridization (FISH) test (ratio greater than 2.2); or
In situ hybridization (ISH) positive by ANY of the following:
- Single-probe in situ hybridization (ISH) test with average HER2 copy number greater than or equal to 6.0 signals/cell; or
- Dual-probe ISH test: HER2/CEP17 (chromosome enumeration probe 17) ratio greater than or equal to 2.0; or
- HER2/CEP17 ratio less than 2.0 and average HER2 copy number greater than or equal to 6.0 signals/cell.

Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for individuals 18 years of age and older for the following:

Breast Cancer

As single agent therapy for treatment of HER2-positive metastatic breast cancer:
- In individuals who previously received trastuzumab and a taxane, separately or in combination; and
- Individual has received prior therapy for metastatic disease or developed disease recurrence during or within six months of completed adjuvant therapy; or
As single agent adjuvant therapy for treatment of HER2-positive early breast cancer in individuals who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment; or

Compendia Sources

Ado-trastuzumab emtansine (Kadcyla)may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of ado-trastuzumab emtansine (Kadcyla) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9354

NOTE:In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Note: Do not substitute ado-trastuzumab emtansine (Kadcyla) for or with other trastuzumab-based products.

Diagnosis Codes

C06.9

C07

C08.0

C08.1

C08.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C79.31

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020

Added additional NCCN recommendation for Salivary Gland Cancer

Internal Medical Policy Committee 1-19-2021

Updated NCCN Breast Cancer recommendation, and
Updated with other minor wording changes, and
Added additional Note

Internal Medical Policy Committee 9-21-2021

Added additional NCCN recommendations and
Added Diagnosis codes, C06.9, C07, C08.0, C08.1, C08.9 and C79.31

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Removed NCCN recommendations and added this statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Removed diagnosis codes Z85.118 and Z85.3
Updated experimental/investigational statement

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search