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)    Enhertu requires prior authorization.

2)    Enhertu is used to treat advanced or unresectable breast cancer and gastric and esophagogastric junction cancer.

3)    Enhertu is considered a specialty medication.

Enhertu (fam-trastuzumab deruxtecan-nxki) is considered medically necessary for members meeting the following criteria:

A. Breast Cancer (must meet all):

1)    Diagnosis of unresectable or metastatic HER2-positive or HER2-low (IHC1+ or IHC2+/ISH-)breast cancer;

2)    Prescribed by or in consultation with an oncologist;

3)    Age > 18 years;

4)    For HER2-positive breast cancer, member meets one of the following (a or b):

a.    Failure of one anti-HER2-based regimen;*

b.    Rapid disease progression within 6 months of neoadjuvant or adjuvant therapy (12 months for pertuzumab-containing regimens);

5)    For HER2-low(IHC1+ or IHC2+/ISH-) breast cancer, members meets one of the following:

a.    Failure of at least one prior line of chemotherapy (if hormone-receptor [HR]-positive, previouis therapy should include an endocrine therapy, unless ineligible);

b.    DIsease recurrence during or within 6 months of completing adjuvant cheomotherapy;

6)    Dose does not exceed 5.4mg/kg every 3 weeks or off-label dose is recommended by NCCN

B. Gastric and Esophagogastric Junction Cancer (must meet all):

1)    Diagnosis of HER2-positive gastric or EGJ adenocarcinoma;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    Disease is locally advanced or metastatic;

5)    Failure of trastuzumab-based regimen (see Appendix B);

6)    Dose does not exceed 6.4 mg/kg every 3 weeks or off-label dose is recommended by NCCN

C. Non-Small Cell Lung Cancer (must meet all):

            1) Diagnosis of unresectable or metastatic NSCLC;

2) Disease has activating HER2 (ERBB2) mutations;

3) Prescribed by or in consultation with an oncologist;

4) Age > 18 years;

5) Failure of one prior line of chemotherapy (if know EGFR mutation, BRAF mutation, ALK fusion, or ROS1 fusion, previous systemic therapy should include at least one targeted therapy corresponding to the driver mutation or rearrangement) (see Appendix B for examples);

6) Requests meets one of the following (a or b):*

            a) Dose does not exceed 5.4mg/kg every 3 weeks;

            b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Initial Approval Duration: 6 months

*Anti-HER2-based regimens

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. 

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.

Codes Used In This BI:

1)    J9358       Injection, fam-trastuzumab deruxtecan-nxki, 1mg

1)    Enhertu Prescribing Information. Basking Ridge, NJ: Daiichi Sankyo, Inc.; January 2021.

2)    NCCN Drugs & Biologics Compendium. Accessed online 11-04-2022.

3)    Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med. 2019 Dec 11: doi: 10.1056/NEJMoa1914510.

Addendum:

1)    Effective 07-01-2020: Updated Enhertu code (J9358).

2)    Effective 06-01-2021: Added Gastric and Esophagogastric Junction Cancer.

3)    Effective 09-01-2022: Updated coverage criteria for breast cancer.

4)    Effective 01/01/2023: Updated breast cancer coverage criteria to include HER2-low indication. Added criteria for NSCLC.