NICE blocks AZ's ovarian cancer drug again, but leaves door open a crack

NICE has formally rejected AstraZeneca's (AZ) new ovarian cancer drug Lynparza for the second time in as many months, although it has agreed to a second consultation on the decision.

The cost-effectiveness watchdog said it intends to reject Lynparza (olaparib) as a maintenance treatment for patients with relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer, to the consternation of patients and cancer charities.

The drug – the first PARP inhibitor to reach the market – was approved in December in the EU and became the first targeted maintenance therapy for patients with these cancers whose tumours express the BRCA mutation.

"We remain disappointed that women with ovarian cancer and mutations to their BRCA genes are still not being granted this world-first drug on the NHS," commented Prof Paul Workman, chief executive of the Institute of Cancer Research (ICR) in London.

"I'd urge NICE and the manufacturer to keep talking and do everything they can to make the drug available," he added.

Clinical trials have shown that the drug can give BRCA-positive patients an extra seven months without the disease progressing compared to standard treatment, and up to two years in some cases, but have so far not revealed a survival benefit.

There is at least an opportunity for further discussion, as NICE's independent appraisal committee has asked AZ to provide what it describes as "a robust estimate of the cost effectiveness of olaparib" in patients with relapsed disease who have had three or more courses of platinum-based chemotherapy.

The panel said it did not consider that, for any patient treated with fewer than three cycles, the price of the drug – which is listed as £3,950 for 28 days of treatment – is simply too high for the benefit it bestows.

AZ has agreed an access scheme with the Department of Health, which involves payment for the drug for a certain period of time only, after which it would be provided free of charge, although the precise details remain under wraps.

In recent months Lynparza has become a focal point for debate over what has been described as deadlock over access to cancer drugs in the UK.

NICE rejected Lynparza in June, shortly after the news emerged that the drug had been withdrawn from the Cancer Drugs Fund evaluation process, effectively putting it beyond the reach of English patients. Since then, it has also been turned down by the Scottish Medicines Consortium (SMC).

Responding to today's news, AZ said it "continues to be extremely disappointed that NICE has not recommended second-line treatment with olaparib according to its licensed indication in Europe."

However, the company added that the opportunity to secure a positive recommendation for patients who have had three or more courses of platinum-based chemotherapy is welcomed.

"AZ will focus on providing NICE with the relevant information it needs to make olaparib available to NHS patients in England and Wales," it said.

The next appraisal committee meeting at which olaparib will be discussed takes place on 29 September.