Subject: Enhertu 3470-A SGM P2023a
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ENHERTU
(fam-trastuzumab deruxtecan-nxki)
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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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Enhertu [package insert]. Basking Ridge, NJ: Daiichi Sankyo Inc.; August 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed October 10, 2023.
- 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
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
December 09, 2023
