The National Institute for Health and Clinical Excellence (NICE)'s final draft guidance rejecting the use of Novartis' Lucentis (ranibizumab) for the treatment of diabetic macular oedema (DMO) has been condemned by the charity Diabetes UK.
The charity says NICE has turned the drug down on grounds of cost, and that this decision "means more people will needlessly lose their sight."
"The cost of looking after people with sight loss far outweighs the cost of Lucentis treatment, let alone the human cost," said Diabetes UK chief executive Barbara Young, who added: "we are very concerned local health services will use this decision as an excuse to stop treatment."
Discussing the NICE Independent Appraisal Committee’s decision not to recommend the drug, Institute chief executive Sir Andrew Dillon said the panel had been "acutely aware that visual impairment can have a substantial negative impact on quality of life and activities of daily living in people with DMO, especially since it can affect people's ability to manage their diabetes."
However, the Committee had concluded that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for Lucentis monotherapy compared with laser photocoagulation, which uses heat to seal ocular blood vessels and is the current standard treatment for people with DMO.
NICE already recommends Lucentis for wet age-related macular degeneration (wet AMD) and the drug has been shown in clinical trials to be an effective treatment for DMO. However, the Committee had been unable to recommend it as a cost-effective use of NHS resources compared to laser photocoagulation for this condition, said Sir Andrew.
Injections with Lucentis cost £742 per eye, and some patients can require multiple monthly injections.
"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 NHS resources. However, the Committee found that the manufacturer's analyses were based on implausible assumptions," and it considered that, had a more plausible set of assumptions been used, the resulting cost per QALY gained would "substantially exceed this range," said Sir Andrew.
In particular, the Committee decided that, by not accounting in its submission for the need to treat both eyes in a proportion of people with DMO, the manufacturer had significantly underestimated the cost of treatment. The panel was also concerned that glycaemic control was much better in the trial population than it is in clinical practice, and that the evidence presented by the manufacturer suggested that the ICER would be higher in people with less well-controlled glycaemic control than observed in the trial.
Moreover, the Committee was concerned that the manufacturer's model had underestimated the amount of Lucentis which patients would be likely to need over time, while its assumption that the drug's benefits during the treatment phase continued indefinitely "were unrealistic," said Sir Andrew.
Diabetes UK notes that laser treatment has been the current standard of treatment for DMO - which affects around 50,000 people in the UK - for the last 25 years, and although it does stop deterioration, it has not been shown to improve vision. Over time, laser surgery can cause irreversible damage to the surrounding eye tissue due to the destructive nature of the treatment, it adds.
NICE's final guidance on the use of Lucentis in DMO is expected to be published in August, but registered stakeholders now have the opportunity to appeal against the draft recommendations, and these could consequently change in the event of an appeal being received, says the Institute.
Ms Young said that Diabetes UK had "pressed hard" to make Lucentis available on the NHS for the treatment of DMO and will campaign for NICE to reconsider its decision.
"We will monitor the situation across the country closely to ensure patients currently receiving Lucentis continue to do so as per the NICE guidance," she added.