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  • Question on Document

    Has all of the relevant evidence been taken into account?
  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Document

    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Niraparib is recommended as an option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults. It is recommended only if:

  • they have a BRCA mutation and

  • have had 2 courses of platinum-based chemotherapy and their disease has responded to the most recent one and

  • the company provides it according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with niraparib that was funded by the Cancer Drugs Fund before final guidance was published. If this applies, when that funding ends niraparib will be funded by the company until the patient and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer (NICE technology appraisal guidance 528).

Niraparib improves how long people with a BRCA mutation live before their disease progresses and new evidence suggests it may also extend how long these people live.

Cost-effectiveness estimates for niraparib in this population are in the range usually considered a cost-effective use of NHS resources. Therefore, niraparib is recommended for people with a BRCA mutation whose disease has responded to 2 courses of platinum-based chemotherapy.

Although niraparib also improves how long people without a BRCA mutation live before their disease progresses, it is uncertain if niraparib increases how long people live in this population. Because it is uncertain if people without a BRCA mutation live longer than 3 months, niraparib does not meet NICE's criteria for a life-extending treatment at the end of life.

Cost-effectiveness estimates for people without a BRCA mutation are highly uncertain and are higher than what NICE considers cost effective. So, niraparib is not recommended for people without a BRCA mutation.