Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of fam-trastuzumab deruxtecan (Enhertu) may be considered medically when the presence of the HER2-overexpression is confirmed by the following:
HER2-overexpression 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 2.0); or
- Single-probe in situ hybridization (ISH) test with average HER2 copy number 6.0 signals/cell or greater; or
- Dual-probe ISH test HER2/CEP17 (chromosome enumeration probe 17) ratio 2.0 or greater; or HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 6.0 signals/cell or greater; and
Confirmatory tests should be performed for borderline results as follows:
- If IHC assay has a result of 2+, confirm with ISH test of the same sample or a new test with IHC or ISH (if new sample available); or
- If FISH test has a HER2 gene/chromosome 17 ratio of 1.8-2.0, confirm with FISH re-test; additional cell counting and recalculation of the ratio; or IHC assay; or
- If single-probe ISH assay has an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with dual-probe ISH or with IHC (if same sample), or with a new ISH or IHC (if new sample available); or
- If dual-probe ISH assay has a HER2/CEP17 ratio less than 2.0 and an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with one of the following: IHC (if same sample), alternative ISH chromosome 17 probe, or order a new test with ISH or IHC (if new sample available).
The use of fam-trastuzumab deruxtecan (Enhertu) may be considered medically necessary in individuals 18 years of age and older when the following criteria are met:
Breast Cancer
- Diagnosis of HER2-positive or HER2-low unresectable or metastatic breast cancer; and
- The individual has received a prior anti-HER2-based regimen in the metastatic setting; or
- The individual has had disease recurrence during or within six (6) months of completing neoadjuvant or adjuvant therapy; or
Gastric or Gastroesophageal Junction Adenocarcinoma
- Diagnosis of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma; and
- The individual has received a prior trastuzumab-based regimen; or
HER2-Positive Unresectable or Metastatic Solid Tumors
- Diagnosis of unresectable or metastatic HER2-postive solid tumor; and
- The individual has received a prior systemic treatment and have no satisfactory alternative treatment options; or
Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Diagnosis of unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations; and
- The individual has received prior systemic based therapy; or
Compendia Sources
Fam-trastuzumab deruxtecan (Enhertu) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of fam-trastuzumab deruxtecan (Enhertu) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
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