In reversal, NICE backs Rubraca after Clovis agrees to a price cut
NICE has changed its mind, agreeing to cautiously endorse Clovis Oncology’s Rubraca after the drugmaker agreed to cut its price — about two months after the UK cost-effectiveness agency’s initial rejection.
Rubraca, known chemically as rucaparib, is approved for use in the EU as monotherapy for the maintenance treatment of adult patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after platinum-based chemotherapy.
The drug was originally developed at Newcastle University, with a team involving researchers from the Northern Institute for Cancer Research and Cancer Research UK-funded scientists. It generated second-quarter sales of $33 million globally.
In its August draft guidance, NICE suggested that while Rubraca extends the time until cancer progresses compared with routine care — the magnitude of this benefit is uncertain because mature trial data are not available yet. In addition, the agency said its cost-effectiveness estimates surpass what NICE typically considers acceptable.
On Friday, the agency said that if the new — undisclosed — price is supported by overall survival data, rucaparib has the potential to be a cost-effective use of NHS resources. Therefore, NICE has recommended its use within the Cancer Drugs Fund — a fund that aims to make promising cancer drugs available to patients before they are fully sanctioned for use in the NHS — while more data are collected.
The list price for Rubraca is £3,562.00 per 60-tablet pack and the company estimates that the average cost of a course of treatment until discontinuation is £110,897 (about $139,000 currently).
Rubraca is one of three approved poly-ADP ribose polymerase (PARP) inhibitors. PARP is a protein used by damaged cells to initiate repair, and PARP inhibitors — including Rubraca, AstraZeneca’s $AZN Lynparza and GSK’s $GSK Zejula — are engineered to prevent cancer cells from repairing themselves, thereby catalyzing their destruction.
In July, NICE backed the use of Zejula in the same patient group as a maintenance treatment as well as adopting Lynparza in patients that carry the BRCA mutation.
So far, PARP inhibitors have been primarily used in ovarian cancers containing BRCA mutations, but trial data show they sometimes work in a broader group of patients. This could be because while the assault on DNA repair is being waged, these drugs are also attacking ribosomes — the machinery that makes proteins, scientists theorized in the journal Molecular Cell earlier this year.