Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
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).
Food and Drug Administration (FDA) Indications
Breast Cancer
- Diagnosis of HER2-positive unresectable or metastatic breast cancer; and
- The individual has had two (2) or more prior anti-HER2-based regimens in the metastatic setting; 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
National Comprehensive Cancer Network (NCCN) Recommendations
Breast Cancer
- As single-agent therapy for recurrent or stage IV (M1) HER2-positive disease, following two or more lines of prior HER2-targeted therapy that is either of the following:
- Hormone receptor-negative; or
- Hormone receptor-positive; or
Colon Cancer
- Therapy as a single agent in individuals (HER2-amplified and RAS and BRAF wild-type) who are not appropriate for intensive therapy:
- As primary treatment for locally unresectable or medically inoperable disease; or
- For unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy; or
- As primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for individuals with existing or imminent obstruction; or
- For synchronous unresectable metastases of other sites; or
- As primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy; or
- For unresectable metachronous metastases that remain unresectable after primary treatment; or
Rectal Cancer
- Therapy as a single agent in individuals (HER2-amplified and RAS and BRAF wild-type) who are not appropriate for intensive therapy:
- As primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant or total neoadjuvant therapy; or
- For synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with no progression of primary tumor) after primary systemic therapy; or
- Following palliative radiation therapy (RT) or chemo/RT for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with progression of primary tumor) after primary systemic therapy; or
- As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction; or
- As primary treatment for synchronous unresectable metastases of other sites; or
- As primary treatment for unresectable isolated pelvic/anastomotic recurrence; or
- As primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy; or
- For unresectable metachronous metastases that remain unresectable after primary treatment; or
- Therapy as a single agent in patients (HER2-amplified and RAS and BRAF wild-type) who are not appropriate for intensive therapy
- As adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in individuals who have received previous chemotherapy; or
- As adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy.
The use of fam-trastuzumab deruxtecan (Enhertu) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
Procedure Codes