NICE deem ranibizumab too expensive for treating diabetic macular edema
MedWire News: Draft guidance issued by the National Institute for Clinical Excellence (NICE) in the UK does not recommend ranibizumab treatment for patients with sight loss due to diabetic macular edema (DME).
The reasoning behind this decision, say the authors, is that although ranibizumab has been shown in clinical trials to be an effective treatment for DME, as reported by MedWire News, it is not cost effective in comparison with the current standard treatment for DME in the UK, laser photocoagulation.
"The independent Appraisal Committee was acutely aware that visual impairment can have a substantial negative impact on quality of life and activities of daily living in people with DME, especially since it can affect people's ability to manage their diabetes," said Andrew Dillon, Chief Executive at NICE.
He explained: "The manufacturer's analysis produced a cost per quality adjusted life year (QALY) gained that was at the upper limit of the range NICE considers to represent an effective use of National Health Service (NHS) resources.
"However, the Committee found that the manufacturer's analyses were based on implausible assumptions. The Committee considered that, had a more plausible set of assumptions been used, the resulting cost per QALY gained would substantially exceed this range."
Specifically, the review of evidence found that the manufacturers did not account for the fact that many people with DME would require treatment in both eyes and underestimated the amount of ranibizumab that patients are likely to require over time.
The authors add that glycemic control in the trial populations was better than that commonly seen in clinical trials, which they suggest would increase costs. Furthermore, they say the assumption that the relative benefit achieved during the treatment phase would last indefinitely is unrealistic.
The manufacturers model produced an incremental cost-effectiveness ratio (ICER) of £30,277 (US $48,709; €34,501), which the committee says is at the upper limit of the range that would represent an effective use of NHS resources.
But if certain other factors were taken into account, such as 35% of people needing treatment in both eyes, the authors of the guidance document found that the ICER increased to £44,400 (US $71,406; €50,592) per QALY or higher, which they say greatly exceeds the cost-effectiveness range.
Final guidance to the NHS is still subject to any changes in the event of an appeal.
Publication of the final guidance is expected in August 2011.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Helen Albert