Allergan will no doubt be breathing a sigh of relief after cost regulators published final draft guidance endorsing its eye implant Ozurdex for use in National Health Service patients with macular oedema.
The National Institute for Health and Clinical Excellence has concluded that Ozurdex (dexamethasone) is a cost-effective option for the treatment of macular oedema due to central retinal vein occlusion (CRVO) and also for branch retinal vein occlusion (BRVO) if the use of laser photocoagulation is not considered appropriate.
If no objections are raised, the decision means that Ozurdex will become the first treatment to be recommended by NICE for macular oedema associated with RVO, which is good news for the 25,000 UK patients who could be eligible for treatment with the implant.
Ozurdex is a first-of-its-kind biodegradable intravitreal implant that contains the potent corticosteroid dexamethasone, which is slowly released to control oedema, tackle inflammation and improve vision.
According to Allergan, clinical trials showed a significant improvement in vision (more tan 15 letters or 3 lines on an eye chart) after two months in up to 30% of patients with macular oedema due to RVO after just one injection of Ozurdex, an improvement maintained in some patients for up to six months.
Things were looking a little uncertain for the product in terms of its future on the NHS as the Institute's Appraisal Committee had asked Allergan to provide more data on the cost and clinical effectiveness of its implant compared to with Roche/Genetech's rival product Avastin (bevacizumab), 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).
Cost effective therapy
But ultimately the Committee concluded that any decisions on the cost effectiveness of Ozurdex compared with best supportive care should be based on Allergan's
revised estimate of £26,300 per QALY gained, which is considered an acceptable level in this case.
“After receiving the information requested from the manufacturer following the consultation, we are pleased to be able to recommend dexamethasone intravitreal implant for this condition," said Professor Peter Littlejohns, clinical and public health director at NICE. "RVO can be very debilitating and have a very profound effect on everyday life so this draft decision will be welcome news to all those affected".
The decision was welcomed by Ian Pearce, Consultant Ophthalmologist and the Clinical Expert representative of the Royal College of Ophthalmologists, who noted that the availability of a licensed, effective and now NICE recommended treatment is "a significant step forward for management of RVO patients in England and Wales".
Final guidance is likely to be published next month.