NICE has failed to recommend Novartis’ Afinitor (everolimus) for the second-line treatment of advanced renal cell carcinoma (RCC).
Draft guidance concluded that Afinitor does not provide enough benefits to justify its high cost, despite Novartis submitting an amended Patient Access Scheme (PAS).
Sir Andrew Dillon, NICE Chief Executive, said there is ‘too much uncertainty’ around the drug’s cost effectiveness.
A PAS which offered a 5% discount was initially agreed between Novartis and the DH, but a further offer was then devised – and agreed again – following the publication of the first Final Appraisal Determination (FAD).
As a result, the consultation on the original FAD was suspended and a new appraisal began.
“NICE asked the independent Appraisal Committee to consider the newly amended patient access scheme and a further cost effectiveness analysis that NICE asked the manufacturer to provide,” said Sir Andrew. “However, the committee felt that there was still too much uncertainty around how cost effective everolimus is to enable the committee to recommend the drug.”
Evidence suggests that Afinitor increased survival by more than three months compared with best supportive care. Sir Andrew Dillon understood that patients may be unhappy about the decision, but NICE could not provide a recommendation at this difficult financial time.
“We know that patients with renal cancer want to try all the treatment options and are disappointed not to be able to recommend everolimus as a second line treatment option,” he added.
“However, we have to ensure that the money available to the NHS, for treating cancer and other conditions is used to best effect, particularly when NHS funds, like the rest of the public sector, is under considerable financial pressure.”
The number of people diagnosed with advanced RCC each year is less than 4000. But those eligible for Afinitor, who have received first-line treatment (Sutent) sunitinib and are still fit enough to receive a second-line treatment, would be lower.