Phesgo™

Drug - Phesgo™ (pertuzumab, tras tuzumab, and hyaluronidas e-zzxf) [Genentech, Inc.]

March 2021

Therapeutic area - Oncology

Initial approval criteria

Patient is ≥18 years of age AND
Patient has a diagnosis of breast cancer AND
Patient has human epidermal growth factor receptor 2 (HER2)-positive* disease AND
Used as neoadjuvant therapy as part of a complete chemotherapy regimen AND
Patient has locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) OR
Used as adjuvant therapy in patients at high risk of recurrence OR
Used for metastatic disease in combination with docetaxel in patients who have not received prior anti-HER2 therapy or other chemotherapy for metastatic disease AND
Will not be used in combination with pertuzumab or any trastuzumab-based formulation (e.g., trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan, trastuzumab-hyaluronidase) AND
Will not be substituted for or with pertuzumab or any trastuzumab-based formulation (e.g., trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan or trastuzumab hyaluronidase) AND
Patient does not have a known hypersensitivity to an alternative formulation of trastuzumab or pertuzumab AND
Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals during treatment
Initial approval is for 12 months (up to 18 cycles)

*HER2-positive overexpression criteria:

Immunohistochemistry (IHC) assay 3+ OR
Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2 and average HER2 copy number ≥ 4 signals/cell OR
Dual-probe in situ hybridization (ISH) assay and concurrent IHC indicating 1 of the following:
- HER2/CEP17 ratio ≥ 2 and average HER2 copy number < 4 signals/cell and concurrent IHC 3+ OR
- HER2/CEP17 ratio < and average HER2 copy number ≥ 6 signals/cell and concurrent IHC 2+ or 3+ OR
- HER2/CEP17 ratio < 2 AND average HER2 copy number ≥ 4 and < 6 signals/cell and concurrent IHC 3+

Patient continues to meet criteria above AND
Has disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
Absence of unacceptable toxicity from the drug AND
If used in the neoadjuvant/adjuvant treatment of breast cancer setting, patient has not exceeded a maximum of 1 year of therapy (18 cycles) AND
Patient meets the following disease state requirements:
- Early breast cancer: LVEF is ≥ 50% or has not had an absolute decrease of ≥ 10% from pre-treatment baseline OR
- Metastatic breast cancer: LVEF is > 45% or is between 40% to 45% and has not had an bsolute decrease of ≥ 10% from pre-treatment baseline
Renewal approval is for 12 months

1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase per 15 mL vial; 1 vial every 21 days as initial dose
600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase per 10 ml vial; 1 vial every 21 days

Phesgo must be billed as a medical claim.

MHCP Provider Call Center 651-431-2700 or 800-366-5411