The National Institute for Health and Clinical Excellence has published a trio of negative pieces of guidance for new cancer treatments on the National Health Service, rejecting GlaxoSmithKline’s Arzerra, Pfizer’s Torisel and Napp Pharmaceutical’s Levact.
As largely expected, the cost watchdog has turned away GlaxoSmithKline’s Arzerra (ofatumumab) for chronic lymphocytic leukaemia in patients who have failed to respond to therapy with fludarabine and Genzyme’s Campath (alemtuzumab), after a lack of data made it hard to pit the drug against therapies currently available on the health service.
Consequently, the incremental cost of Arzerra was calculated to be between more than £60,500 and £81,500 per QALY gained, and the Institute’s appraisal committee felt that “the benefit it offers over and above current NHS treatments does not justify its cost”.
The news came as no surprise as Arzerra is cleared in Europe under conditional approval, which means that its dossier is lacking the full data set required for normal approval but that regulators felt the benefits of its immediate availability to patients outweighed the risks.
As per the rules of such an approval, GSK is required to provide the European Medicines Agency with data on Arzerra as it becomes available, which may well help to change the Institute's position at a later date.
Elsewhere, NICE was also unable to recommend the use of Pfizer’s Torisel (temsirolimus) for mantle cell lymphoma and Napp Pharmaceutical’s Levact (bendamustine) for the treatment of low-grade non-Hodgkin's lymphoma on the NHS, after being forced to terminate these appraisals when the companies failed to submit any evidence to demonstrate their drugs’ effectiveness in these settings.
“We are disappointed to have to terminate the two appraisals involving temsirolimus and bendamustine but NICE is left with little choice if manufacturers choose not to submit any evidence,” noted Sir Andrew Dillon, the cost watchdog’s chief executive.