In justifying its decision, the National Institute of Health and Care Excellence (NICE), the U.K. agency that provides healthcare guidance, cited a lack of evidence supporting a clear benefit in terms of patient survival and an excessive cost.
“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,” Rose Gray, policy manager at Cancer Research UK, said in a press release.
NICE will review its decision in September, but until then, Gray urges the agency, the NHS, and Clovis Oncology, Rubraca’s developer, “to work together … to explore how the drug can be made available to NHS patients.”
Rubraca is a type of anti-cancer agent known as a PARP inhibitor. These agents block an enzyme called poly (ADP-ribose) polymerase (PARP), which helps repair DNA. By blocking this process, PARP inhibitors keep cancer cells from repairing their damaged DNA, causing their death.
Rubraca is approved as a maintenance therapy for patients with cancers of the ovary, fallopian tube, or the peritoneum (the membrane lining the abdomen), whose disease came back and who are responding to platinum-based therapies, or in patients with these cancers who carry BRCA mutations and had been previously treated with two or more lines of chemotherapy.
The medication is typically offered to patients whose cancers responded to platinum-based chemotherapy, preventing the need to wait until their disease relapses before additional treatment is offered.
As a result, the therapy could help extend the time until patients have another relapse and delay the need for further chemotherapy. The latter could reduce the chance that the cancer develops a resistance to platinum-based treatment, after which few options are available.
“Clinical trial evidence suggests rucaparib could give patients more time before their disease gets worse and delay the need for further treatment,” Gray said.
Results from the ARIEL 3 clinical trial (NCT01968213), a randomized, placebo-controlled Phase 3 study, suggests that Rubraca extends the time patients live without disease worsening to 10.8 months, compared with 5.4 months under routine care. In this trial, patients both with and without BRCA mutations were included.
Despite these promising results, long-term data is not yet available, so NICE considers it too early to know exactly how large this survival benefit is, that is, how much longer patients will live by taking Rubraca.
In addition, the treatment’s price relative to its effectiveness (cost-effectiveness estimates) is above what NICE typically considers acceptable.
England’s Cancer Drugs Fund already pays for Zejula, which works through a similar principle as Rubraca, for certain ovarian cancer patients who had two or more prior courses of platinum-based chemotherapy.
If approved, Rubraca could be an additional option for this group of patients.
NICE is currently reviewing the approval of Lynparza, which is indicated for patients with BRCA-mutant cancers who have had three or more prior platinum-based chemo treatments.