The battle to secure patient access to Novartis' Afinitor on the National Health Service has reached the end of the road after cost regulators published final guidance this morning stating the drug was too expensive to use in kidney cancer.
Despite appeals from Novartis and Kidney Cancer UK against the National Institute for Health and Clinical Excellence's decision, the watchdog maintains that Afinitor (everolimus) simply does not provide enough benefit to justify its high cost.
The Institute's Appraisal Committee agreed that there is sufficient evidence to show that Afinitor increases progression-free and overall survival compared with best supportive care, but concluded that the magnitude of the overall survival gain was uncertain because it was only based on modelled data.
Novartis' first patient access scheme offered the first treatment pack of Afinitor free to the NHS and following ones at £2,822 (including a 5% discount), which put the overall treatment cost at about £34,235 per patient per year, or around £205,000 for a full course of treatment.
The drugmaker subsequently agreed a revised PAS with the Department of Health, the nature of which remains confidential, but this was evidently not enough to persuade NICE that Afinitor is a cost-effective option for the NHS in this setting.
“We regret not to be able to recommend this drug, but we have to ensure that the money available to the NHS, for treating cancer and other conditions is used to best effect, particularly when the NHS, like the rest of the public sector, is under considerable financial pressure," said Sir Andrew Dillon, the Institute's chief executive, explaining the decision.
Around 4,000 patients are diagnosed with advanced RCC every year, but the number eligible for treatment with Afinitor, i.e. those who have received first-line Sutent (sunitinib; Pfizer) or Votrient (pazopanib; GSK) and still fit enough to receive a second-line treatment, is lower.
If doctors feel that any of these individual patients would benefit from the drug then they can still apply for exceptional funding from their primary care trust or the Cancer Drugs Fund, the Institute noted.