NICE (National Institute for Clinical Excellence) in the UK has decided not to recommend Lucentis (ranibizumab) for diabetic macular edema (British spelling: oedema) treatment. NICE approves or turns down treatments that will be covered by the NHS (National Health Service), the UK’s universal health care system. Patients will still be able to get Lucentis prescriptions for diabetic macular edema, but at a much higher personal cost (private prescription).
According to NICE, an Appraisal Committee decided that Novartis’ model underestimated the ICER (incremental cost-effectiveness ratio) for Lucentis monotherapy versus standard current treatment for patients with diabetic macular edema (DMO) – photocoagulation.
The independent Committee determined that the ICER would be far greater than what NICE would consider represents effective use of NHS money.
For this reason, NICE says, it cannot recommend Lucentis for patients with DMO. Those currently on Lucentis for DMO treatment can continue until their physicians decide when to stop.
The macula is responsible for color vision and the perception of fine detail; it is the central part of the retina. Among some patients with diabetes, changes in retinal blood vessels occur, leading to DMO. While the number of connective tissues is reduced around the capillaries, the amount of VEGF (vascular endothelial growth factor) rises, causing increased permeability of the blood retinal barrier. The plasma constituents in the surrounding retina start to leak, causing edema (accumulation of too much fluid) which disrupts the area responsible for sharp vision (fovea). The affected eye’s vision can become impaired.
Lucentis (ranibizumab) is injected directly into the eye and prevents VEGF production, thus decreasing the edema and limiting loss of vision, and sometimes improving it.
Sir Andrew Dillon, Chief Executive at NICE said:
“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 DMO, especially since it can affect people’s ability to manage their diabetes.
NICE already recommends ranibizumab for wet age-related macular degeneration, and although it has been shown in clinical trials to be an effective treatment for DMO, the Appraisal Committee was unable to recommend the drug as a cost-effective use of NHS resources compared to laser photocoagulation for this condition. The manufacturer’s analysis produced a cost per 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. The Committee considered that, had a more plausible set of assumptions been used, the resulting cost per QALY gained would substantially exceed this range.
In particular, the Committee concluded that 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. One of the other factors that the Committee was concerned about was 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.
The Committee also considered that the amount of ranibizumab that people with diabetic macular oedema are likely to need over time was underestimated in the manufacturer’s model and that the manufacturer’s assumption that the benefits of ranizumab during the treatment phase continued indefinitely were unrealistic.”
NICE says it has not yet told the NHS about its recommendation. Registered stakeholders can now appeal against the (draft) recommendation. The final guidance will be issued in August this year.
Written by Christian Nordqvist