Vizimpro®
Drug - Vizimpro® (dacomitinib) [Pfizer Inc.]
June 2019
Therapeutic area - Oncology, Oral – Lung Cancer
Initial approval criteria
- Patient has a diagnosis that is listed on the FDA-approved label
OR
- Patient is at least 18 years old AND
- Patient has a diagnosis of metastatic non-small cell lung cancer AND
- Patient’s tumor has EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as confirmed by a FDA-approved test AND
- Vizimpro will be used as a single-agent first-line therapy AND
- Patient does not have metastases to the central nervous system (CNS) or leptomeninges
- Initial approval is for 6 months
Renewal criteria
- Patient continues to meet the above criteria AND
- Patient has documented tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
- Patient has absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: interstitial lung disease, severe/persistent diarrhea, and exfoliative skin disorders, etc.
- Renewal approval is for 6 months
Quantity limits
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411