The UK National Institute for Health and Care Excellence (NICE) says it cannot give a positive decision over whether to recommend a new drug for ovarian cancer unless its makers provide more information on cost. A final decision is expected in September.
Pointing to uncertainties in the data and the drug’s high price, the watchdog has asked the manufacturers, AstraZeneca, to provide more details of the possible cost of its use, including genetic tests to find which women are likely to respond to the treatment.
Olaparib – developed by British scientists – has been shown in clinical trials to slow the progression of certain forms of the disease. But evidence that it can extend the lives of women with the disease is less certain.
The drug is designed to target cancers with faults in the BRCA genes, and is licensed for use in women whose cancer has come back after multiple rounds of chemotherapy.
NICE said the price the NHS is being asked to pay for olaparib is too high for the benefit it may give patients who have had fewer than three previous courses of platinum-based chemotherapy, but it is looking at whether it would be appropriate for those patients who have had three or more courses.
Initial estimates suggest the drug could cost around £46,000 for each year of quality life it adds (a measurement known as a QALY). NICE generally approves drugs that cost around £20,000-30,000 per QALY.
NICE chief executive, Sir Andrew Dillon, said: “Our Advisory Committee has asked the company to provide a robust estimate of the cost effectiveness of olaparib for these patients, along with further information on supporting data.”
Professor Peter Johnson, Cancer Research UK’s chief clinician, said the charity was “disappointed” by the decision, saying that olaparib has shown “real promise”.
“Our ovarian cancer survival lags behind the rest of the developed world, and if this is to improve the NHS must be in a position to fund new drugs like this. We hope that NICE and the drug manufacturer can work together to ensure olaparib is approved and funded quickly for all women who could benefit.”
Professor Paul Workman, chief executive of the Institute of Cancer Research, London – where much of the work on the drug was carried out – also expressed frustration.
“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.
“It is at least positive that NICE is actively listening to evidence submitted through consultations, and seems to be looking for ways to make olaparib available.”
[hr] Source: Cancer Research UK