NICE draft guidance approves maintenance niraparib for gynaecological cancers

  • National Institute for Health and Care Excellence

  • curated by Dawn O'Shea
  • Medical news
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New draft guidance from NICE recommends niraparib for use within the Cancer Drugs Fund as an option for maintenance treatment of advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer after response to first-line platinum-based chemotherapy.

Clinical evidence to support the decision was taken from the ongoing clinical PRIMA trial, which showed that niraparib delays disease progression.

However, the trial did not show whether people having niraparib live longer, because they have not been followed up for long enough.

Because of the clinical uncertainty, the cost-effectiveness estimates are very uncertain and may be higher than what NICE normally considers an acceptable use of NHS resources. Hence, the treatment is not recommended for routine use in the NHS.

Longer follow-up data from PRIMA could help address the uncertainty around the clinical effectiveness of niraparib in this population. Having reviewed the clinical evidence, the appraisal committee concluded that niraparib has the potential to be a cost-effective use of NHS resources. Consequently, it is being recommended for use through the Cancer Drugs Fund while more data from the trial are collected.

The list price is £4,500 for 56 × 100 mg capsules. However, the manufacturer has agreed to a discount patient access scheme and a managed access agreement, including a commercial access agreement.

The draft guidance is now open for public consultation. Comments can be submitted here. The closing date for receipt of comments is 5:00 pm, January 28, 2021.

The final guidance is expected to be published next month.