Published

May 11, 2025

Niraparib, Niraparib [NIR3, NIR3]

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 [NICE TA673] where the following criteria have been met: There is a separate form NIR4 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 DO NOT HAVE a deleterious or suspected deleterious BRCA germline and/or somatic BRCA mutation, 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 (TA673) where the following criteria have been met: There is a separate form NIR4 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 DO NOT 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 results are known at the time of this application:
  • proven germline BRCA mutation or
  • proven somatic BRCA mutation only i.e. somatic BRCA mutation positive and germline BRCA mutation negative or
  • somatic BRCA mutation positive and germline BRCA mutation test not yet known
  1. This patient HAS a documented deleterious or suspected deleterious BRCA 1 or BRCA 2 mutation(s). Please enter below as to which deleterious or suspected deleterious BRCA mutation(s) the patient has:
  • BRCA 1 mutation or
  • BRCA 2 mutation or
  • both BRCA1 and BRCA 2 mutations
  1. 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.
  2. 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 chemotherapy 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 Criteria continue over the page
  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.
  1. The patient will commence maintenance niraparib within 12 weeks from the date of the first day of the last cycle of 1st line chemotherapy unless the patient was previously entered into the company’s early access scheme for maintenance niraparib after 1st line chemotherapy and all the other treatment criteria set out in this form are fulfilled.
  2. The patient has not previously received any PARP inhibitor unless either the patient has received niraparib as part of a company early access scheme for this 1st line maintenance indication and the patient meets all the other criteria set out in this form or 1st line maintenance olaparib monotherapy has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression. Please mark below which scenario applies to this patient:
  • the patient has never previously received a PARP inhibitor or
  • the patient has received niraparib as part of a company early access scheme for this 1st line maintenance indication and all the other criteria set out in this form are fulfilled or
  • the patient has previously received olaparib monotherapy as 1st line maintenance therapy and this has had to be stopped within 3 months of its start solely as a consequence of dose- limiting toxicity and in the clear absence of disease progression
  1. Niraparib will be used as monotherapy.
  2. Maintenance niraparib is not being administered concurrently with maintenance bevacizumab.
  3. The patient has an ECOG performance status of either 0 or 1. Note: a patient with a performance status of 2 or more is not eligible for niraparib
  4. Niraparib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner. Note: NICE heard evidence during the niraparib appraisal that clinicians would wish to discuss with patients in continued complete remission when it would be an appropriate time to discontinue maintenance niraparib therapy and that this time was likely to be after approximately 3 years of maintenance treatment.
  5. The prescribing clinician understands that the recommended starting dose for niraparib is 200mg daily unless the patient weighs ≥77Kg and has a platelet count ≥150,000 x 10⁹/uL in which case the recommended starting dose is 300mg daily. Please indicate below the starting dose for this patient:
  • niraparib 200mg daily or
  • niraparib 300mg daily
  1. The prescribing clinician understands that the marketing authorisation for niraparib recommends that full blood counts are performed weekly for the 1st month of treatment with niraparib, monthly for the next 10 months of therapy and then periodically thereafter during drug treatment with niraparib.
  2. The prescribing clinician understands that the marketing authorisation for niraparib recommends that the patient’s blood pressure is monitored weekly for the first 2 months of treatment, monthly for the 1st year of therapy and then periodically thereafter during drug treatment with niraparib.
  3. A first formal medical review as to whether maintenance treatment with niraparib should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
  4. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  5. Niraparib is to be otherwise used as set out in its Summary of Product Characteristics

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.