Pemfexy®

Drug - Pemfexy® (pemetrexed) [Eagle Pharmaceuticals Inc.]

October 2022

Therapeutic area - Oncology, Injectable

Initial approval criteria

Patient is at least 18 years of age or must meet the age limit in the FDA-approved label AND
The prior authorization request is for an indication that is in the FDA-approved label, including:
- in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer
- as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
- as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy
- in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery AND
Prescriber provides a patient-specific, clinically significant reason why the patient is not a candidate for Alimta or generic pemetrexed
Initial approval is for 6 months

Patient continues to meet the initial approval criteria AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: bone marrow suppression (e.g., neutropenia, febrile neutropenia, thrombocytopenia, anemia), renal impairment (CrCl < 45 mL/min), bullous and exfoliative skin toxicity (e.g., Stevens-Johnson Syndrome/Toxic epidermal necrolysis), interstitial pneumonitis, radiation recall, etc. AND
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Renewal approval is for 6 months, unless otherwise specified in quantity limits

When administered with cisplatin for initial treatment of locally advanced or metastatic non-squamous NSCLC: 500 mg/m2 on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity
Maintenance treatment of non-squamous NSCLC in patients: 500 mg/m2 on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy
Treatment of recurrent non-squamous NSCLC: 500 mg/m2 on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity
When administered with cisplatin, in patients with mesothelioma: 500 mg/m2 on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity

Pemfexy must be billed as a medical claim.

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