Trodelvy™

Drug - Trodelvy™ (sacituzumab govitecan-hziy) [Immunomedics, Inc.]

September 2020

Therapeutic Area - Oncology

Initial approval criteria

Patient ≥ 18 years old AND
Patient does NOT have Gilbert’s disease AND
Therapy will NOT be substituted for or used in combination with irinotecan AND
Patients that are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele will be closely monitored for adverse reactions AND
Used as single agent therapy AND
Therapy will NOT be used in combination with UGT1A1 inhibitors (e.g., nilotinib, regorafenib) or inducers (e.g., phenytoin, carbamazepine) AND
Patient has metastatic breast cancer AND
Patient does NOT have bulky disease (e.g., tumor mass > 7 cm) AND
Patient has unequivocal metastatic triple-negative disease [mTNBC] (e.g., estrogen, progesterone, and HER2-negative) AND
Patient must NOT have hypersensitivity to any component of the product AND
Patient was previously treated with ≥ 2 systemic therapies for metastatic disease including ≥ 1 prior line of therapy that contained a taxane, in any setting
Initial approval is for 6 months

Renewal criteria

Patient must continue to meet the above criteria AND
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. Examples of unacceptable toxicity include the following: severe hypersensitivity, severe nausea/vomiting, severe neutropenia/febrile neutropenia, severe diarrhea.
Renewal approval is for 6 months

Quantity limits

10 mg/kg on days 1 and 8 of 21-day treatment cycles
Patient weight (in kg) must be submitted at time of request

Billing for Trodelvy

Trodelvy must be billed as a medical claim.

Background

Trodelvy is FDA-approved for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Questions?

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