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NICE demands more evidence of Lynparza benefits

Published on 06/08/15 at 09:36am

AstraZeneca must provide a "robust estimate of the cost effectiveness" of its ovarian cancer treatment Lynparza, or risk being rejected by NICE. 

The UK healthcare guidance body says it is unable to complete its appraisal of Lynparza (olaparib) for the maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer. 

The independent appraisal committee which is developing the draft guidance has gone back to AstraZeneca to ask the company to provide a robust estimate of the cost effectiveness of Lynparza, in patients with relapsed disease who have had three or more courses of platinum-based chemotherapy. 

NICE also needs more information on the cost of somatic testing, as the appraisal committee has concerns about previous cost estimates the company has provided. Somatic testing involves testing the tumour to pick up those that are linked to inherited gene mutations.

Lynparza is for ovarian cancer, the fifth most common cancer in women, in people who have tested positive for the BRCA1 or BRCA2 mutations, and whose disease has responded to platinum-based chemotherapy.

But NICE currently says, based on the cost effectiveness data AstraZeneca has supplied, that: "For people who’ve had fewer than three previous courses of platinum-based chemotherapy, the evidence provided shows that the price that the NHS is being asked to pay for olaparib is too high for the benefit it may provide to these particular patients, so the preliminary guidance does not recommend it in this situation."

Commenting on the draft guidance, Sir Andrew Dillion, NICE chief executive, says: “Olaparib slows the progression of the disease for patients with some forms of ovarian cancer but the evidence that it can extend life is uncertain. Life expectancy for patients who’ve had three  or more courses of platinum-based chemotherapy could be less than two years so the end-of-life criteria, which allows more flexibility in our guidance could apply in this situation. Our advisory committee has therefore asked the company to provide a robust estimate of the cost effectiveness of olaparib for these patients, along with further information on supporting data.

He continues: "However for patients who’ve had fewer than three courses of platinum-based chemotherapy, we weren’t able to apply the flexibility we can sometimes use when we appraise cancer drugs as they are already living longer than two years with this conventional treatment. For this group of patients, the cost to the NHS of using this new drug isn’t consistent with the benefits that patients for whom it works will gain and so we were disappointed not to be able to recommend it in this circumstance in this draft guidance.”

In a statement AstraZeneca says: "While AstraZeneca continues to be extremely disappointed that NICE has not recommended second-line treatment with olaparib according to its licensed indication in Europe, the opportunity to secure a positive recommendation for patients who have had three or more courses of platinum-based chemotherapy is welcomed. AstraZeneca will focus on providing NICE with the relevant information it needs to make olaparib available to NHS patients in England and Wales. 

"AstraZeneca firmly believes in the value of olaparib to patients and the NHS. The scientific and clinical data supporting olaparib in BRCAm ovarian cancer are unprecedented and demonstrate a consistent benefit when used as both a second and third line of treatment. NICE has however stated that the end-of-life criteria could apply to the third-line population and, therefore, the cost per QALY threshold for this group of patients would be increased from £30,000 to £50,000."

Lilian Anekwe


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