Published

May 11, 2025

Niraparib [NIR4]

Niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy AND who DO NOT HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation [NICE TA673] There is a separate form NIR3 for use of niraparib monotherapy as maintenance treatment in patients with high grade epithelial stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma who are in response following platinum-based FIRST line chemotherapy and who HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation

  1. This application for maintenance niraparib is being made by and the first cycle of systemic anti-cancer therapy with niraparib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. This patient has a proven histological diagnosis of predominantly high grade serous or high grade endometrioid or high grade clear cell ovarian, fallopian tube or primary peritoneal carcinoma. Please enter below as to which is the predominant histology in this patient:
  • high grade serous adenocarcinoma or
  • high grade endometrioid adenocarcinoma or
  • high grade clear cell carcinoma
  1. This patient has had germline and/or somatic (tumour) BRCA testing. Please enter below the type of tissue on which BRCA mutation testing has been done:
  • negative germline BRCA mutation test with somatic BRCA mutation test not done or
  • negative somatic BRCA mutation test
  1. This patient DOES NOT HAVE a documented deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s).
  2. The patient has recently diagnosed FIGO stage III or IV ovarian, fallopian tube or primary peritoneal carcinoma and has just completed 1st line platinum-based chemotherapy. Note: maintenance niraparib in this 1st line maintenance indication is not funded for patients with recently diagnosed and treated stage I-IIC disease.
  3. One of the following scenarios applies to the surgical management of the patient in relation to the stage of the disease:
  • the patient has stage III disease and had an upfront attempt at optimal cytoreductive surgery and had no visible residual disease at the end of surgery or
  • the patient has stage III disease and had an upfront attempt at optimal cytoreductive surgery and had visible residual disease at the end of surgery or
  • the patient has stage III disease and had an interval attempt at optimal cytoreductive surgery and had no visible disease at the end of surgery or
  • the patient has stage III disease and had an interval attempt at optimal cytoreductive surgery and had visible disease at the end of surgery or
  • the patient has stage III disease and has had a biopsy only with no upfront or interval attempt at cytoreductive surgery or
  • the patient has stage IV disease and had an upfront attempt at optimal cytoreductive surgery and had no visible disease at the end of surgery or
  • the patient has stage IV disease and had an upfront attempt at optimal cytoreductive surgery and had visible residual disease at the end of surgery or
  • the patient has stage IV disease and had an interval attempt at optimal cytoreductive surgery and had no visible disease at the end of surgery or
  • the patient has stage IV disease and had an interval attempt at optimal cytoreductive surgery and had visible disease at the end of surgery or
  • the patient has stage IV disease and has had a biopsy only with no upfront or interval attempt at cytoreductive surgery
  1. The patient has been treated with platinum-based 1st line chemotherapy and has received a minimum of 4 cycles of platinum-based treatment.
  2. The patient has either received bevacizumab as part of 1st line platinum-based treatment or not: Please indicate below whether bevacizumab was used in combination with the 1st line chemotherapy:
  • bevacizumab 7.5mg/Kg given in combination with platinum-based chemotherapy or
  • bevacizumab 15mg/Kg given in combination with platinum-based chemotherapy or
  • no bevacizumab used in combination with chemotherapy
  1. This patient is in response to the recently completed 1st line platinum-based chemotherapy and has achieved a partial or complete response to treatment according to the definitions given below and has no evidence of progressive disease on the post-treatment scan or a rising CA125 level. Please enter below as to which response assessment applies to this patient:
  • achieved a complete response at the end of 1st line platinum-based chemotherapy i.e. has no measurable or non-measurable disease on the post-chemotherapy scan and the CA125 is normal or
  • achieved a complete response at the end of 1st line platinum-based chemotherapy i.e. has no measurable or non-measurable disease on the post-chemotherapy scan and the CA125 has not decreased to within the normal range or
  • achieved a partial response at the end of 1st line platinum-based chemotherapy i.e. has had a ≥30% reduction in measurable or non-measurable disease from the start of to the completion of 1st line chemotherapy and the CA125 is normal or
  • achieved a partial response at the end of 1st line platinum-based chemotherapy i.e. has had a ≥30% reduction in measurable or non-measurable disease from the start of to the completion of 1st line chemotherapy and the CA125 has not decreased to within the normal range. Criteria continue over the page

CDF funded From: 15 January 2021

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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