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Rucaparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy

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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:

  • it is homologous recombination deficiency (HRD) positive, and

  • BRCA mutation-negative, and

  • the company provides it according to the commercial arrangement (see section 2).

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 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.

The most likely cost-effectiveness estimates for rucaparib are only within what NICE normally considers to be an acceptable use of NHS resources in people with BRCA mutation-negative advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that is HRD‑positive. So, rucaparib is recommended for routine use in the NHS only for people with this type of cancer. People should be informed that rucaparib is less effective than olaparib plus bevacizumab. But the availability of rucaparib will allow people more treatment choices.

The results of further data collection on rucaparib in people with BRCA mutation-negative cancer that is HRD‑negative are unlikely to sufficiently support the case for recommending it. Also, for this group, rucaparib is unlikely to be cost effective, so it is not recommended for managed access in the Cancer Drugs Fund.