NICE preliminary decision in appraisal of niraparib as maintenance treatment for relapsed ovarian cancer.

[TheOvacomeTeam]

Dear all,

The National Institute for Health and Care Excellence (NICE) recently announced their preliminary decision in the appraisal of niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer. The recommendation is that niraparib is to be available for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy for those with a germline BRCA mutation.

Unfortunately this decision means those with relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer who are BRCA negative would not be able to access niraparib. This would be a change from the current Cancer Drugs Fund agreement where niraparib is available at recurrence if appropriate, regardless of BRCA status.

This recommendation will not affect anyone currently being treated with niraparib.

There is a still a PARP treatment option for relapsed ovarian cancer for those without a germline BRCA mutation, as rucaparib is available through the Cancer Drugs Fund (under certain criteria).

We are currently writing our response to this decision as part of the ongoing NICE consultation. If you are BRCA negative and being treated with niraparib for a recurrence, we would really like to hear about your experience. It would be particularly helpful to know how long you have been on niraparib.

You can comment here or email me at [e-mail] and we will include your comment in our consultation response.

Thank you to those who have already commented.

Alternatively, you can respond as an individual on NICE’s website. You can view and comment on the consultation from this page: nice.org.uk/consultations/1...

The appraisal consultation is live and accepting comments until 5pm on Friday 17 September.

If you have any concerns about this please do get in touch with our support team on 0800 008 7054 or message through the forum, or email [e-mail]

Thank you very much as always for your help.

Best wishes,

Imogen

Ovacome Policy and Health Inequalities Officer

[Jacky5]

Thanks very much for letting us know about that change and giving us the chance to comment.Liz. S

[bluepeterella]

How unfair for those who didn’t have the chance to see if this would work for them. I feel lucky as I started Niraparib in August, brca neg - at least if it doesn’t work for me I know everything possible has been tried.

[Dollie22]

Thanks for that. Is the decision based on trial results and what about those who are brca negative but have the somatic mutation or are HRD deficient. Just curious . D

[TheOvacomeTeam Partner in reply to Dollie22]

Hi there Dollie22

Thank you very much for your comment and question.

I wanted to let you know that Imogen, our Policy and Health Inequalities officer is currently out of the office, but I have shared your query with her to respond on her return.

In the meantime, please don’t hesitate to get in touch if you would like to speak to a member of our support team. You can speak with us directly on 0800 008 7054.

Best wishes

Annie

Ovacome Support

[TheOvacomeTeam Partner in reply to Dollie22]

Good morning Dollie22

Thank you very much for your questions. Following from on from my reply last week, I have spoken to our Policy and Health Inequalities officer Imogen and here is some information that we hope you find helpful. Niraparib was made available via the Cancer Drug Fund based on the results of the NOVA clinical trial. The Cancer Drugs Fund agreement allows the collection of additional data to decide whether it should be routinely funded, which is the decision currently under review.

Those patients who do not have the BRCA gene change can speak to their team about another PARP inhibitor called rucaparib which is available for those with or without a BRCA gene change at relapse in certain circumstances. Patients who have a germline (inherited) and/or somatic (in their tumour) BRCA gene change could ask their clinical team about olaparib which is also a PARP inhibitor.

BRCA1 and BRCA2 mutations are both types of HRD (homologous recombination deficiency), however there are other gene changes that can also cause HRD too. I will put a link to some more information about this here: ovacome.org.uk/Blog/about-brca

NICE has included HRD status in their decision on the availability of bevacizumab and olaparib in combination as first line maintenance treatment of high grade epithelial ovarian cancer.

I do hope that this is helpful. Please do let us know if you have any further questions.

Best wishes

Annie

Ovacome Support