NICE has published final draft guidelines now supporting the use of AstraZeneca’s Lynparza on the NHS in England and Wales, marking the first time a cancer drug targeting an inherited genetic fault will be made available on the health service.

The Institute said it intends to recommend the drug for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer, in people who have tested positive for the BRCA1 or BRCA2 mutations, and whose disease has responded to platinum-based chemotherapy.

Specifically, the draft recommendations also stipulate that Lynparza (olaparib) should be available for people only if they have had three or more courses of platinum-based chemotherapy, and that the drug cost for people who remain on treatment after 15 months is met by the company.

The Institute had initially rejected the drug’s use earlier in the treatment pathway, and then asked AZ or more info on its use in patients with relapsed disease who have had three or more courses of platinum-based chemotherapy. The analysis supplied by the company included both a patient access scheme and a proposed reduction to the list price, which allowed the draft guidance to move from potentially not recommending the drug to instead saying that Lynparza should be available for this subset.

For this subgroup, the Committee accepted that the most plausible incremental cost-effectiveness ratios were £46,600 to £46,800 per QALY gained, and that there was enough evidence to suggest that the drug met the end-of-life criteria.

A 'defining moment'

Paul Workman, chief executive of The Institute of Cancer Research said "it’s great news that NICE has changed its decision, and made olaparib available for women with BRCA-mutated ovarian cancer”. Its approval is “a defining moment in the history of targeted cancer treatments, although it is still frustrating that under the terms of the judgement patients cannot benefit until they have had at least three rounds of chemotherapy”.

Up to 21% of women with the most aggressive form of ovarian cancer have the genetic BRCA mutation and it is this patient group for whom olaparib is licensed, the only other options are chemotherapy or surgery.

Ovarian cancer is a serious and life-threatening condition that causes more than 4,000 deaths in the UK every year. But the UK’s survival rate lags well behind other major European countries, with England having the lowest five-year survival rate in Europe. 

While NICE’s decision to endorse Lynparza “will be welcomed by all those involved in treating and supporting women with this disease, it is disappointing that the decision has taken so long and some will still not have access,” said Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute and lead olaparib clinical trial investigator.