Fam-trastuzumab Deruxtecan-nxki (Enhertu®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. HER2-positive Breast Cancer
Enhertu is indicated for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received a prior anti-HER2 based regimen either:
i. in the metastatic setting, or
ii. in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
2. HER2-low Breast Cancer
Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-low [immunohistochemistry score (IHC) 1+ or IHC 2+/ in situ hybridization test (ISH) negative] breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
3. Gastric or Gastroesophageal Junction Adenocarcinoma
Enhertu is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
4. Non-Small Cell Lung Cancer (NSCLC)
Enhertu is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
B. Compendial Uses
1. HER2-positive breast cancer, treatment of recurrent disease
2. HER2-low breast cancer, treatment of recurrent disease
3. Non-small cell lung cancer with HER2 mutations, treatment of recurrent and advanced disease
4. HER2-amplified and RAS and BRAF wild-type colorectal cancer (including appendiceal and anal adenocarcinoma)
5. HER2-positive esophageal cancer
6. HER2-positive cervical cancer
7. HER2-positive endometrial carcinoma
8. HER2-positive salivary gland tumor
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: human epidermal growth factor receptor 2 (HER2) status (e.g., immunohistochemistry (IHC) score, in situ hybridization (ISH) test), RAS mutation status (where applicable), BRAF mutation status (where applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Breast cancer
Authorization of 12 months may be granted for treatment of breast cancer when either of the following criteria are met:
1. Member has HER2-positive breast cancer and meets all of the following criteria:
i. The disease had no response to preoperative systemic therapy, or the disease is recurrent, metastatic, or unresectable
ii. The requested medication will be used as a single agent.
2. Member has HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer and meets all of the following criteria:
i. The disease had no response to preoperative systemic therapy, or the disease is recurrent, metastatic or unresectable
ii. The member has tried at least one prior chemotherapy in the metastatic setting or developed recurrence during or within 6 months of completing adjuvant chemotherapy
iii. The requested medication will be used as a single agent
B. Non-small cell lung cancer
Authorization of 12 months may be granted for subsequent treatment of non-small cell lung cancer with HER2 (ERBB2) mutations when both of the following criteria are met:
1. The disease is recurrent, advanced, metastatic or unresectable
2. The requested medication will be used as a single agent
C. Colorectal Cancer
Authorization of 12 months may be granted for treatment of colorectal cancer (including appendiceal and anal adenocarcinoma) with HER2-amplified and RAS and BRAF wild-type disease as a single agent when the requested medication will be used as subsequent therapy for progression of advanced or metastatic disease.
D. Esophageal, Gastric or Gastroesophageal Junction Adenocarcinoma
Authorization of 12 months may be granted for subsequent treatment of HER2-positive locally advanced, recurrent or metastatic esophageal, gastric or gastroesophageal junction adenocarcinoma as a single agent.
E. Cervical Cancer
Authorization of 12 months may be granted for subsequent treatment of recurrent or metastatic HER2-positive (IHC 3+ or 2+) cervical cancer when used as a single agent.
F. Endometrial Carcinoma
Authorization of 12 months may be granted for subsequent treatment of recurrent HER2-positive (IHC 3+ or 2+) endometrial carcinoma when used as a single agent.
G. Salivary Gland Tumor
Authorization of 12 months may be granted for treatment of recurrent HER2-positive salivary gland tumor when used as a single agent.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Enhertu (Fam-trastuzumab deruxtecan-nxki) |
Breast Cancer, Cervical Cancer, Non-Small Cell Lung Cancer |
Route of Administration: Intravenous 5.4mg/kg every 3 weeks |
|
Enhertu (Fam-trastuzumab deruxtecan-nxki) |
Colorectal Cancer or Appendiceal Adenocarcinoma, Endometrial Carcinoma, Esophageal, Gastric or Gastroesophageal Junction Adenocarcinoma, Salivary Gland Tumor |
Route of Administration: Intravenous 6.4mg/kg every 3 weeks |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Enhertu [package insert]. Basking Ridge, NJ: Daiichi Sankyo Inc.; August 2022.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed October 10, 2023.
3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 2.2022. Accessed December 12, 2022. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf.
ORIGINAL EFFECTIVE DATE: 4/1/2020
MOST RECENT REVIEW DATE: 4/30/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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