The Scottish Medicines Consortium has turned down Novartis’ Afinitor for patients with advanced kidney cancer, deeming the drug too expensive for use on the National Health Service.

While the SMC acknowledged the clinical effectiveness of Afinitor (everolimus) and recognised that patients with this stage of the disease have no other effective treatment options available to them, the drug’s cost in relation to its health benefits was not sufficient to gain acceptance, Novartis said.

Afinitor won European approval back in August last year on the back of Phase III data showing that the drug - a once-daily, oral treatment that inhibits the mTOR protein - more than doubled the average time without tumour growth or death in patients with advanced kidney cancer (4.9 versus 1.9 months) and reduced the risk of disease progression or death by 67%.

But its future in the UK was hit by a huge setback after the cost watchdog for the National Health Service in England and Wales published preliminary recommendations in February rejecting the drug as a second-line agent for RCC.

Despite reviewing the drug under guidelines for appraising end-of-life treatments, Afinitor’s incremental cost effectiveness ratio was calculated by NICE’s Expert Review Group to be between £65,200 and £75,700, which was considered simply too expensive for NHS use.

In addition, a patient access scheme (PAS) proposed by Novartis, under which the Swiss drugmaker offered to provide the first treatment pack of Afinitor to the NHS free of charge and subsequent packs at £2,822 (a 5% discount), also failed to sway the Committee’s decision.

Novartis said it has also had discussions about a potential PAS with the Patient Access Scheme Assessment Group (PASAG), which advises NHS Scotland on the feasibility of proposed schemes for implementation, and that following recent discussions with key members of the SMC, it will consider a resubmission of Afinitor later in the year.

'Devastating news'
Every year in the UK there are 7,000 newly diagnosed cases of kidney cancer, which kills around 3,700 patients annually, and the SMC’s decision to bar people with the disease from access to a clinical effective treatment is “devastating news”, said Pat Hanlon, trustee of Kidney Cancer UK.

“Advanced kidney cancer is an extremely difficult disease to treat and does not respond to traditional chemotherapy. For this group of patients, there is now an urgent unmet need,” she stressed.

“It is incomprehensible that the SMC cites cost as a justification to deny advanced kidney cancer patients access to an effective licensed treatment that is available in, and reimbursed by, many countries in Europe and in the US”, said Panos Alexakos, Oncology Business Unit Head for Novartis UK, particularly as both the SMC and NICE agree that everolimus is indeed clinically effective.