The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Novartis' Lucentis (ranibizumab) as a treatment for sight problems caused by macular oedema, provided Novartis makes the drug available under an agreed patient access scheme (PAS).
The draft guidance, which is now out for consultation, recommends Lucentis as an option for treating macular oedema following central retinal vein occlusion (CRVO). It also recommends it as a treatment option following branch retinal vein occlusion (BRVO) when standard treatment with laser photocoagulation has not worked, or when it is not suitable because of the extent of macular haemorrhage."The loss of vision associated with macular oedema can have a significant effect on the patient's quality of life and independence," noted NICE chief executive Sir Andrew Dillon. "We are recommending this treatment for NHS use in people with CRVO and some people with BRVO only if the manufacturer provides it to the NHS under terms agreed in a patient access scheme, which makes the treatment more cost-effective," he said.
The draft guidance follows consideration of further evidence and a PAS submitted by the firm, as well as the results of further work done by the NICE Decision Support Unit. Terms of the PAS, which have been agreed with the Department of Health and revised in the context of NICE Technology Appraisal Guidance 274, are commercial in confidence.
In CRVO, Lucentis is associated with an Incremental Cost-Effectiveness Ratio (ICER) of £26,200 per Quality-Adjusted Life Year (QALY) gained compared with best supportive care, NICE's independent appraisal committee concluded. It also found that, for the treatment of BRVO, the most plausible ICER for the drug compared with best supportive care was in excess of £44,800 per QALY gained, which is above the usual range considered cost-effective (£20,000-£30,000 per QALY gained).The timelines for this appraisal have been extended to enable the results of further work, related to the use of Roche's Avastin (bevacizumab) conducted by Moorfields Eye Hospital Pharmaceuticals and Royal Liverpool and Broadgreen University Hospital Pharmacy as a comparator, to become available.
Closing date for comments on the draft recommendation is April 25, and NICE expects to publish its final guidance next month.
Meantime, NICE has also issued draft guidance not recommending the use of Cell Therapeutics' Pixuvri (pixantrone) as a treatment for an aggressive form of non-Hodgkin's lymphoma, after an independent committee of experts concluded there was insufficient evidence to show that the drug is more effective than current NHS treatments and also found that it does not represent good value for money.
Pixuvri has a conditional licence to treat adults with aggressive non-Hodgkin B-cell lymphoma (NHL) that has either returned after treatment (relapsed) or become resistant to current therapy (refractory) multiple times and who have received at least two previous types of treatment. NICE is developing guidance for the NHS on the use of the drug for this specific group of people.
The clinical trial evidence submitted to the committee for Pixuvri "highlighted a number of uncertainties that called into question the true benefit people might receive from this treatment," said Sir Andrew.
Consultees, including the manufacturers, healthcare professionals and members of the public are now able to comment on NICE's preliminary recommendation until May 1.