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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+

Renewal criteria

  • 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

Quantity limits

  • 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

Billing for Phesgo

Phesgo must be billed as a medical claim.

Questions?

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

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