Medical Policy

Effective Date:06/01/2013 Title:Kadcyla (Ado-Trastuzumab Emtansine)
Revision Date:08/01/2023 Document:BI409:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Kadcyla (ado-trastuzumab) requires pre-authorization.

2)    Kadcyla is used to treat a type of metastatic breast cancer and a type of lung cancer.

3)  Kadcyla is considered a specialty drug and is covered under the medical benefit.

Medical Statement

Kadcyla (ado-trastuzumab) is considered medically necessary for members > 18 years when prescribed as a single agent who meet the following criteria:

 

1)    Diagnosis of HER2-positive, metastatic breast cancer  AND

2)    Previously received treatment with Herceptin (trastuzumab) and a taxane, separately or in combination   OR

3)    Diagnosis of recurrent, advanced, or metastatic HER2-positive Non-Small Cell Lung Cancer OR

4)    Diagnosis of recurrent HER2=positive salivary gland tumor

Limits
Intentially left empty
Reference

1)    Kadcyla Prescribing Information. Genentech, Inc. South San Francisco, CA.  February 2022.

2)    Ado-trastuzumab emtansine. In: National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed February 7, 2023.

3)    Minckwitz GV, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med 2019;380:617-28.

4)    National Comprehensive Cancer Network Guidelines. Breast Cancer Version 2.2023. Available at https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed February 7, 2023.

Addendum:

Effective 04/01/2018: Added covered diagnosis of non-small cell lung cancer.

Effective 08/01/2023: Updated NSCLC criteria to indicate recurrent, advanced, or metastatic and added coverage criteria for salivary gland tumor.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.