Abiraterone
Drug - Abiraterone
Yonsa® (abiraterone acetate tablet) [Sun Pharmaceutical Industries, Inc.]
Zytiga® (abiraterone acetate tablet) [Janssen Biotech Inc.]
April 2019
Therapeutic area - Oral Oncology
Abiraterone, Yonsa
Initial approval criteria
- Patient must be at least 18 years old AND
- Patient has a diagnosis of metastatic castration-resistant prostate cancer OR
- Patient has a diagnosis that is listed on the FDA-approved label AND
- Patient will receive a GnRH analog or has had a bilateral orchiectomy AND
- Abiraterone or Yonsa will be used in combination with prednisone or methylprednisolone
- Initial approval will be for 6 months
Renewal criteria
- Patient continues to meet above criteria AND
- Tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug
- Renewal approval will be for 6 months
Zytiga
Initial approval criteria
- Patient must be at least 18 years old AND
- Patient has a diagnosis of metastatic high-risk castration-sensitive prostate cancer OR
- Patient has a diagnosis of metastatic castration-resistant prostate cancer OR
- Patient has a diagnosis that is listed on the FDA-approved label AND
- Patient will receive a GnRH analog or has had a bilateral orchiectomy AND
- Zytiga will be used in combination with prednisone or methylprednisolone
- Initial approval will be for 6 months
Renewal criteria
- Patient continues to meet above criteria AND
- Tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
- Absence of unacceptable toxicity from the drug
- Renewal approval will be for 6 months
Quantity limits
- Abiraterone, Yonsa, Zytiga: 1000mg per day
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
