In new preliminary advice, the National Institute for Health and Clinical Excellence (NICE) says it does not recommend Novartis' Lucentis (ranibizumab) for the treatment of visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion (RVO).
NICE's independent appraisal committee concluded that Lucentis could not be recommended because of gaps and uncertainties in the evidence of its effectiveness compared with the treatments currently used the UK. The panel also concluded that the analysis provided by the manufacturer was not a true reflection of clinical practice or the efficacy of the drug.
The manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for Lucentis compared with standard care, says the appraisal committee, which concluded that "a model that relied on more plausible assumptions would be certain to produce an ICER that exceeded the range that NICE considers an effective use of NHS resources."
The committee "recognises the profound effect that RVO can have on everyday life. However, in order for NICE to recommend any drug or technology, we have to be sure that it is both clinically effective and good value for money," said Professor Carole Longson, director of the health technology evaluation centre at NICE.
This is the second appraisal of a treatment for this condition on which NICE has consulted this year - in July it published final guidance recommending Allergan's Ozurdex (dexamethasone intravitreal implant) as a clinically and cost-effective treatment for macular oedema caused by RVO.
In contrast, the evidence presented for Lucentis "did not support a positive recommendation for this condition," said Prof Longson.
Novartis has agreed a patient access scheme (PAS) with the Department of Health in which a discount on Lucentis' list price is offered. The size of the discount is confidential.
The draft recommendations are now available for public consultation, with comments invited until December 15, and Novartis and other consultees have the opportunity to respond to concerns and comments made by the appraisal committee. After consultation, the appraisal committee will meet again on January 10 to consider the evidence, this appraisal consultation document and comments from the consultation. At the meeting, the committee will also consider comments made by people who are not consultees.
Final guidance is likely to be published next March.
- In July, final draft guidance from NICE rejected the use of Lucentis in the treatment of diabetic macular oedema (DMO).