NICE’s provisional rejection of Astra Zeneca’s olaparib (Lynparza) for a genetic subset (BRCA1/2 gene mutation) of ovarian cancers has several themes which have not been commented on.
One is that Astra Zeneca may have handled matters poorly. In particular it withdrew olaparib from consideration by the cancer drugs fund in December 2014. The reported reason was that the company had been trying to sell the drug through the cancer drugs fund in advance of NICE, but that NICE had caught up with it. If so, the company may well go back to the cancer drugs fund if NICE’s provisional rejection holds.
The drug was priced at £48k or £4k per month. This gave a cost per QALY of around £50k which would have met the threshold provided it qualified for the end of life criteria. The NICE Appraisal Committee considered, but rejected this on the grounds that the relevant patients had a life expectancy of more that 24 months.
Astra Zeneca offered special terms via a patient access scheme whereby the NHS would pay for the drug for a specified time after which the company would provide the drug free. This was part of the estimated £50k/QALY. Astra Zeneca seem to have gambled that olparaib would qualify for the higher cost effectiveness threshold for end-of-life drugs.
The appraisal committee was also very critical of the methods used to establish the claimed £50k/QALY. Criticisms included reliance on a post hoc sub group analysis of the genetic subset and of outcomes, omission of the cost of diagnostic and tumour tests and unconventional extrapolation methods. Critically, the committee found “considerable uncertainty about the survival benefit with olaparib” (para 4.14).
What happens next will be interesting. Charities and oncologists have predictably called for the drug to be made available. None have criticised Astra Zeneca’s strategy which has raised the stakes by withdrawing from the cancer drugs fund. And none have risen the challenge of explaining why they choose to believe the company rather than NICE about the claimed survival benefit of olaparib.
James Raftery is a health economist with several decades’ experience of the NHS. He is professor of health technology assessment at Southampton University. A keen “NICE watcher,” he has provided economic input to technical assessment reports for NICE, but has never been a member of any of its committees. The opinions expressed here are his personal views.
Competing interests: The author has no further interests to declare.