Rucaparib - NICE appraisal

[OvacomeSupport]

Dear All

The National Institute for Health and Care Excellence (NICE) have contacted Ovacome regarding preparation for their appraisal of a PARP inhibitor (a drug that interferes with the cancer's DNA - Olaparib is a PARP inhibitor). At this stage they are asking us for opinions regarding what they need to take into account when they are considering whether to recommend Rucaparib availability for NHS treatment.

The name of the appraisal is: Rucaparib for treating relapsed ovarian, fallopian tube or peritoneal cancer that has a BRCA mutation. (So unlike Olaparib, it does not specify platinum sensitivity).

If any of you have any feedback you would like us to give regarding this, please do leave a message below, or private message me through this forum, or email [e-mail] or call 0800 0087054.

In particular, if you took Rucaparib as part of a trial (the ARIEL trials) and would like to let us know of your experience, that would be really helpful.

Also, anything you think NICE should take into account when considering the quality of life issues around treatment.

Please do let me know if you need any further information on this.

Best wishes

Anna

Support Service Manager

[Stephgrey]

Is this different to niraparib?

[OvacomeSupport Partner My Ovacome Team in reply to Stephgrey]

Hi Stephgrey

Yes it is. Niraparib is also going through NICE, the advantage of that is that it offers a PARP inhibitor to non-BRCA women. With Rucaparib, it potentially offers a PARP to platinum resistant women.

Best wishes

Anna

[Julie40]

I have been on the Ariel tria from April 2016. It has been successful for me. My first recurrence was 9 months after diagnosis however after finishing chemo in Feb 2016 I have not had chemo again. I'm 15 months and still going with Rucaparib. I'm delighted with these results as I have a really good quality of life on the drug. It was difficult at the start for the first 2 months but it all settled down. Im hoping I can remain in it for a long time but either way it's giving me a good break from cheno with a great quality of life and most importantly prolonging my life. Would have no hesitation in tryIng it again afterwards should I need more chemo in the future

I was stage 4 with a very poor prognosis in March 2014. This trial has been a blessing for me.

Julie

[OvacomeSupport Partner My Ovacome Team in reply to Julie40]

Dear Julie

Thank you for this very helpful feedback. That's great to hear that you're having such a positive experience.

Best wishes

Anna

[Nicky100 in reply to Julie40]

Amazing news x

[Nicky100]

Thank you for posting this. I would be interested in knowing more about the results of these PARP inhibitors and when they become available? I am currently crowd-funding to pay for Olaparib but J u detstand that Rucapatib might be an option? But not sure on if or when this might be available?

Thank you, Nicky

[Julie40 in reply to Nicky100]

How many times have you had chemo Nicky ?

If you google Ariel trial there are stats online. Are you brca ?

[Nicky100 in reply to Julie40]

Hi Julie, I have had one chemo and am about to start my second. Yes I am BRCA.

Thank you I will look at the trial.

Are you still on the drugs now? That is amazing news I am thrilled for you! ...lovely to hear from you thank you xxx

[OvacomeSupport Partner My Ovacome Team in reply to Nicky100]

Hello Nicky

We will certainly keep everyone updated with regard to the progress of availability of PARP inhibitors.

Rucaparib isn't avaiable at the moment except through clinical trial, the trial for ARIEL4 is recruiting in some centres, other centres are yet to start recruiting. There are details on the clinicaltrials.gov website here:

clinicaltrials.gov/ct2/show...

I hope this information is helpful.

Best wishes

Anna

[Nicky100 in reply to OvacomeSupport]

Hi Anna, thank you. Is it possible to PM you?

Best wishes

Nicky

[OvacomeSupport Partner My Ovacome Team in reply to Nicky100]

Hi Nicky

Yes of course. If you PM OvacomeSupport I'll pick it up, or email [e-mail]

Best wishes

Anna

[gwyn64]

Hi Anna,

When NICE look at PARP Inhibitors for BRCA or Non-BRCA for Ovarian/peritoneal cancer does it cover both high grade and low grade types? Apologies for late comment as not had easy access to internet over last 2/3 weeks.

[OvacomeSupport Partner My Ovacome Team]

Hi gwyn64

In outlining the populations for both the consultation for Rucaparib and the approval for Olaparib, NICE does not distinguish between high and low grade cancers. However, as both of these are for BRCA mutated cancers, which is associated much more with high- grade, these would be for primarily high grade cancers.

Niraparib is another PARP inhibitor going through approval at the moment, the population was defined as:

"People who have recurrent, platinum-sensitive ovarian, fallopian tube or peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy"

This does not distinguish between BRCA and non-BRCA. However, in the trials for Niraparib, participants had to have either a BRCA mutation or a high-grade cancer, so this may indicate the population it will be licensed for, and NICE assess based on the license/marketing authorisation.

Niraparib is part of an expanded access programme (EA) to enable people to access it earlier. When I contacted the company to ask about eligibility criteria, they explained that the consultant would access their online portal and this would display the eligibility criteria, so I'm afraid I don't have confirmed details as to who would be eligible for this, but if you are interested in it do discuss with your consultant who could advise you.

I hope this is helpful, please let me know if you need further information.

Best wishes

Anna

[mpelaez in reply to OvacomeSupport]

Hello, do you know if Niraparib will be on trial in Australia? or if there are any other parp inhibitors for non BRCA apart from Olaparib? mum just completed 3rd line of chemo for OC, diagnosed in 2014. Breast cancer in 2000, although OC is not secondary. She was on Rucaparib trial, Ariel 3, she could have got placebo, as recurred 6 months after treatment. BRCA gene tested inconclusive. Thank you

[OvacomeSupport Partner My Ovacome Team]

Hello

I looked on the drug company website for the trials they are running worldwide and it didn't look like Australia was included, but you may want to email them yourself to double check this. Details of the trial sites and a contact email are at the following link: primaclinicaltrial.com/clin...

If you want to search for trials in Australia, the clinicaltrials.gov website lists trials worldwide and you can search under country and condition (ie ovarian cancer). I searched with these criteria and the results are here: clinicaltrials.gov/ct2/resu...

I hope this information is helpful. Do come back to me if you have any other queries.

Best wishes

Anna