Rubraca
Drug - Rubraca™ (rucaparib) [Clovis Oncology]
July 2017
Therapeutic area - Oncology
Approval criteria
- Patient is 18 years of age of older AND
- Patient has a diagnosis of advanced ovarian cancer AND
- Patient must have a deleterious BRCA mutation (germline and/or somatic) as detected by FDA-approved companion diagnostic for Rubraca AND
- Patient must have received treatment with two or more prior lines of chemotherapy AND
- Must be used as a single agent AND
- At time of request, provider must attest that reproductive health counseling is provided to patients and their partners of child bearing age
- Initial approval is for 6 months
Renewal criteria
- Absence of unacceptable toxicity including myelodysplatic syndrome/acute myeloid leukemia (MDS/AML) AND
- Absence of disease progression
- Renewal approval is for 6 months
Quantity limits
200 mg, 250 mg and 300 mg tablets: 136 tablets per 34 days
Background information
Rubraca is FDA approved under accelerated approval based on objective 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
