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New HTA Decisions in England
December 2019
Drug name
RUBRACA® (rucaparib)
Company
Clovis Oncology
Decision date
11/10/2019
Therapeutic area
Cancer
Therapeutic sub area
Ovarian cancer
Decision
Recommended (CDF)
Indication
Rucaparib is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment of relapsed platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults.
Decision Detail
Only if the conditions in the managed access agreement for rucaparib are followed.
Summary
ARIEL3 provided the clinical evidence for rucaparib. The committee concluded that rucaparib improves progression-free survival compared with placebo. Overall survival (OS) is a secondary endpoint in ARIEL3. At data cut-off, median OS was not reached and no statistically significant difference between the treatment arms had been seen. The committee concluded that rucaparib is expected to provide a similar survival benefit to other PARP inhibitors. The estimated ICERs for the ITT population incorporating the updated patient access scheme range from £29,138 (company) to £32,455 (ERG) per QALY. The committee considered that the results are uncertain because of the immaturity of the overall-survival data and concluded that this uncertainty could only be resolved with the availability of more mature data from ARIEL3. Therefore, the committee was not confident that rucaparib represents a cost-effective use of NHS resources and could not recommend it for routine use in the NHS. Rucaparib has the potential to be cost effective if further data confirm the estimated overall-survival benefit. Rucaparib is therefore recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, while further data are collected. Rucaparib is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment of relapsed platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, only if the conditions in the managed access agreement for rucaparib are followed.