Advanced ovarian cancer drug gets initial 'no' for NHS in England
A targeted drug with potential to slow the progress of ovarian cancer has been rejected for use on the NHS in England.
In making its provisional decision on rucaparib (Rubraca), the National Institute of Health and Care Excellence (NICE) cited a lack of evidence over the treatment's impact on survival.
"NICE felt there wasn't enough evidence to be confident about the drug's long-term benefits, and that the benefit it gave wasn't enough to justify its cost," said Rose Gray, policy manager at Cancer Research UK.
NICE will review its decision in September—before which Gray urges further exploration of how to make the drug available to patients.
The drug would be used as a maintenance treatment for adults with ovarian cancer. It would be offered to patients whose disease has already responded to platinum-based chemotherapy, preventing patients having to wait until their cancer relapses before additional treatment is offered.
Rucaparib would be used to help extend the time before the disease comes back and delay the need for further platinum-based chemotherapy. Importantly, this could reduce the chance that patients' cancers develop resistance to platinum-based treatment, after which there are few options available.
As well as advanced ovarian cancer, the decision will also impact some patients with gynaecological cancers of the fallopian tube and the tissue layer covering the stomach (peritoneum).
Gray said the decision would be disappointing for people affected by these types of cancers. "Clinical trial evidence suggests rucaparib could give patients more time before their disease gets worse and delay the need for further treatment."
Uncertainty and cost
But as long-term data from the trial are not yet available, too much uncertainty remains over exactly how much longer people may live after taking rucaparib.
In addition to this lack of information, cost-effectiveness estimates were higher than NICE typically considers acceptable.
"NICE will review this decision next month, and we urge them, NHS England and the manufacturer to work together in that time to explore how the drug can be made available to NHS patients," Gray added.
NICE decisions are usually adopted in Wales and Northern Ireland as well. Decisions about what drugs the NHS should fund in Scotland are made separately by the Scottish Medicines Consortium.
Not the only targeted drug
Rucaparib isn't the only PARP inhibitor that's been tested for adults with ovarian and gynaecological cancers.
Another drug, niraparib, which works in a similar way to rucaparib is available through the Cancer Drugs Fund for some patients who have had two or more previous courses of platinum-based chemotherapy. If approved, rucaparib could be an additional option for this group of patients.
And a third PARP inhibitor, olaparib, is currently available for patients who carry a fault in one of their BRCA genes and who've received three or more rounds of platinum-based chemotherapy, a decision that's currently being reviewed by NICE.
More information: Robert L Coleman et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial, The Lancet (2017). DOI: 10.1016/S0140-6736(17)32440-6
Journal information: The Lancet
Provided by Cancer Research UK