NICE decides laser treatment better than Lucentis
pharmafile | July 18, 2011 | News story | Sales and Marketing | Lucentis, NICE, Novartis
Novartis says it is “disappointed” with health watchdog NICE’s decision not to recommend Lucentis for the treatment of eye problems due to diabetic macular oedema (DMO).
NICE decided the VEGF drug Lucentis (ranibizumab) did not offer better value for money than laser treatment, which is the current standard of care, for patients in England and Wales.
It also suggested Novartis’ costing model was flawed. “By not accounting in its submission for the need to treat both eyes in a proportion of people with DMO, the manufacturer significantly underestimated the cost of treatment,” insisted NICE chief executive Andrew Dillon.
Novartis’ stance is that laser therapy has been shown to only prevent further vision loss, while Lucentis can improve vision in four out of 10 cases.
Clinical trials have suggested Lucentis can double the likelihood of gaining vision and reduce – by up to three times – the chance of losing vision versus laser treatment.
“Individuals with visual impairment due to DMO could greatly benefit from ranibizumab, a treatment which can potentially restore vision rapidly, often within a week of receiving the first dose, prevent vision loss and sustain visual improvement,” Novartis said.
But NICE believes Novartis underestimated the amount of the drug patients would need over time. “The manufacturer’s assumption that the benefits of ranizumab during the treatment phase continued indefinitely were unrealistic,” said Dillon.
However, the manufacturer retorted in a statement: “The information submitted to NICE by Novartis was based on available clinical data and consultation with NHS expert ophthalmologists on how ranibizumab would be used in the ‘real-life’ setting.”
Novartis says NICE’s decision is therefore “based on a conservative view on issues where the evidence is sparse or does not yet exist”.
Another of NICE’s problems with the treatment was that glycaemic control was much better in the trial population than it is in clinical practice.
“The evidence presented by the manufacturer suggested that the ICER [incremental cost-effectiveness ratio] would be higher in people with less well-controlled glycaemic control than observed in the trial,” Dillon said.
Lucentis gained approval from European regulators in January for DMO and is already the standard of treatment for wet aged-related macular degeneration (AMD).
However, Bayer is snapping at the company’s heels, with its own VEGF Trap Eye candidate entering phase III trials three months ago.
Adam Hill
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