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 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

10. The patient will commence maintenance niraparib monotherapy 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.
11. The patient has not previously received any PARP inhibitor unless the patient received 1st line maintenance rucaparib which 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
• the patient has a positive status for homologous recombination deficient disease and received 1st line maintenance rucaparib which 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.
• the patient has a negative status for homologous recombination deficient disease and received 1st line maintenance rucaparib which 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.

12. Niraparib will be used as monotherapy.
13. Maintenance niraparib is not being administered concurrently with maintenance bevacizumab.
14. 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
15. 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.
16. 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

17. 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.
18. 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.
19. 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.
20. 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.
21. Niraparib is to be otherwise used as set out in its Summary of Product Characteristics

CDF funded From: 15 January 2021

Additional information

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.348 of the CDF list, downloaded from an archive of NHS England’s website on 19 February 2025 at 18:00.

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.