Cost regulators for the National Health Service in England and Wales have asked Allergan to provide more data on its macular oedema eye implant Ozurdex.
Specifically, the National Institute for Health and Clinical Excellence's independent Appraisal Committee has requested extra information on the clinical and cost effectiveness of Ozurdex (dexamethasone) for the treatment of macular oedema secondary to retinal vein occlusion compared with Roche/Genetech's rival product Avastin (bevacizumab), in order to determine whether the product could have a place on the NHS treatment list.
The Ozurdex implant is a potent corticosteroid injected into the eye once every six months to suppress inflammation, while Avastin - which is currently being used outside its licensed indication as a treatment for eye conditions by some NHS trusts as an alternative to Novartis/Genentech's NICE-approved Lucentis (ranibizumab) - is also injected into the eye and works by preventing the formation of new blood vessels.
The Committee also wants Allergan to provide a revised base case for the cost effectiveness of Ozurdex, and more detail on the location and extent of macular haemorrhage for those patients who cannot have laser treatment, the Institute said.
“The Appraisal Committee recognises that for people living with retinal vein occlusion, poor vision can have a very significant impact on their everyday lives. From the evidence presented, however, it is not clear how clinically and cost-effective dexamethasone intravitreal implant is for treating this serious condition," explained Carole Longson, Health Technology Evaluation Centre Director at NICE.
So the ball is very much now in Allergan's court, and final guidance is likely to be published in June 2011.