The National Institute for Health and Care Excellence (NICE) has approved a revolutionary new ovarian cancer drug for use in England on the Cancer Drugs Fund (CDF). We, together with our supporters, have worked hard to campaign for this announcement. I know what this means for women who can now access treatment where previously there was nothing; for their family members who now have hope that their loved one will survive for longer; for clinicians who now have more avenues to help treat women with ovarian cancer. For all of us, this is personal.
I am proud that Target Ovarian Cancer played a key role in the NICE review process, responding to both consultations, giving oral evidence as an expert witness and raising the issue with MPs. We have already submitted our response to the consultation in Scotland (informed by a survey of women with ovarian cancer living in Scotland) and are due to take part in their review process later this month.
Why is niraparib such a gamechanging ovarian cancer drug?
Niraparib (trade name Zejula®) is one of a new group of drugs called PARP inhibitors, which work by stopping cancer cells from repairing themselves, effectively crippling them. Niraparib can offer crucial progression-free survival for women with ovarian cancer. This is the length of time when the disease is stable and not progressing. According to clinical trial data, niraparib offers an additional 5.4 months for women without a BRCA mutation and an additional 15.5 months for women who have a BRCA1 or BRCA2 mutation (up to 20 per cent of women). The reason it is more effective in women with a BRCA mutation is because in these women, the tumour DNA is already weakened and therefore more vulnerable.
While some women with a BRCA mutation can access other PARP inhibitors, the decision to fund niraparib for women who don’t have a BRCA mutation is significant, because it gives access to a larger group of women who had very few treatment options previously.
In fact, niraparib is performing so well that we don’t yet have data on the impact on overall survival, which is what NICE looks at when it’s deciding which cancer drugs to fund routinely on the NHS. Overall survival is the total extra months of survival someone on a new treatment would have, when compared to existing treatments. If NICE doesn’t have enough overall survival data from a clinical trial, it can choose to fund the drug on the CDF so researchers can gather more data on overall survival – that is what will happen with niraparib now.
Above all, women who have been treated with ovarian cancer report having a good quality of life while on the treatment. There is no need to regularly go to hospital as niraparib comes in the form of pills. Some side effects have been reported, but generally these are minimal.
Who will be able to access niraparib on the Cancer Drugs Fund (CDF)?
Niraparib has been approved for use for women who have 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 if:
- they have a germline BRCA mutation and have had two courses of platinum-based chemotherapy or
- they do not have a germline BRCA mutation and have had two or more courses of platinum-based chemotherapy.
The drug is available, from today, in England until June 2020, and we hope that after that we will have enough positive data on overall survival for NICE to approve it routinely on the NHS. We expect decisions from Wales’ New Treatments Fund and the Scottish Medicines Consortium later this year.
At the moment, without full NICE approval, niraparib is not available in Northern Ireland. I have written to the Permanent Secretary for Health in Northern Ireland to ask about interim arrangements for women in Northern Ireland, who must be able to access the drug in the same way as women in the rest of the UK. If you live in Northern Ireland, you can help by asking your MLA to support women to access niraparib.
Niraparib is truly a trailblazer for new ovarian cancer treatment – now that it has been approved, it paves the way for other new treatments in the future.
Update January 2019
Our campaigners in Northern Ireland helped secure access to niraparib through the recently announced new early access scheme. Women in Northern Ireland who have recurrent ovarian cancer can access niraparib on the same basis as the Cancer Drugs Fund in England, as set out above.
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