1 Recommendations
1.1
Rucaparib is recommended as an option for the maintenance treatment of advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after complete or partial response to first-line platinum-based chemotherapy in adults, only if:
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it is BRCA mutation-negative and homologous recombination deficiency (HRD)-positive, or
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it is BRCA mutation-negative, and HRD status is negative or unknown, and bevacizumab is not a treatment option because:
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NHS England's BEV3 and BEV10 commissioning approval criteria for having it are not met, or
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it is contraindicated or not tolerated, and
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the company provides rucaparib according to the commercial arrangement.
1.2
These recommendations are not intended to affect treatment with rucaparib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.
Why the committee made these recommendations
For this evaluation, the company asked for rucaparib to be considered only for BRCA mutation-negative and HRD‑positive or HRD‑negative advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer (from now, described as advanced ovarian cancer) after complete or partial response to first-line platinum-based chemotherapy. This does not include everyone who it is licensed for.
Standard treatment for the HRD‑positive type is olaparib plus bevacizumab, bevacizumab alone or routine surveillance if these are not suitable or not tolerated. For the HRD‑negative type, it is bevacizumab alone or routine surveillance if this is not suitable or not tolerated.
Clinical trial evidence shows that rucaparib increases how long people have before their cancer gets worse compared with placebo. It is unclear whether they also live longer because the trial is still ongoing, so there is not enough long-term evidence. Rucaparib has only been indirectly compared with olaparib plus bevacizumab or bevacizumab alone. The results suggest that rucaparib is likely to work as well as bevacizumab alone, but is not as effective as olaparib plus bevacizumab.
BRCA mutation-negative HRD-positive advanced ovarian cancer
The most likely cost-effectiveness estimates for rucaparib compared with olaparib plus bevacizumab and bevacizumab alone are within what NICE normally considers to be an acceptable use of NHS resources for BRCA mutation-negative advanced ovarian cancer that is HRD positive. So, rucaparib is recommended for routine use for this type of cancer. People should be informed that rucaparib is less effective than olaparib plus bevacizumab. But the availability of rucaparib will provide more treatment choices.
BRCA mutation-negative, HRD-negative or HRD-unknown advanced ovarian cancer
The most likely cost-effectiveness estimates for rucaparib compared with routine surveillance are within what NICE normally considers to be an acceptable use of NHS resources for BRCA mutation-negative advanced ovarian cancer that is HRD negative or HRD unknown in people who cannot have bevacizumab. So, it is recommended for routine use for the type of cancer in people who cannot have bevacizumab.
For BRCA mutation-negative advanced ovarian cancer that is HRD negative or HRD unknown in people who can have bevacizumab, the results of further data collection in the Cancer Drugs Fund are unlikely to sufficiently support recommending rucaparib. Also, rucaparib is unlikely to be cost effective compared with bevacizumab maintenance for this group. So, it is not recommended for this type of cancer in people who can have bevacizumab.