Cost regulators for the National Health Service in England and Wales have endorsed funding for Roche’s cancer therapy Gazyvaro, Bayer’s eye jab Eylea and Allergan’s eye implant Ozurdex.
The Institute has published final guidance recommending Roche’s Gazyvaro (obinutuzumab) alongside chlorambucil as a first-line treatment for chronic lymphocytic leukaemia and co-existing medical conditions in patients who can’t take fludarabine-based therapy, and only if bendamustine-based therapy is also not suitable.
Gazyvaro is the first ‘type II’ anti-CD20 monoclonal antibody licensed for the treatment of CLL and is designed to attack blood cancers more aggressively than ‘type I’ treatments such as MabThera (rituximab). The Swiss drugmaker says the drug has a dual mode of attack as it kills tumour cells directly and alerts the body’s immune system to ‘enemy’ cancer cells, boosting its response.
In clinical trials, a regimen of Gazyvaro/chemotherapy reduced the risk of death by 53% and meant that patients remained in remission more than 18 months longer than those receiving chemotherapy alone. And fresh data from the Phase III GADOLIN study just presented at the American Society of Clinical Oncology meeting also show that Gazyvaro in combination with bendamustine cut the risk of disease worsening or death by 45% versus the latter alone.
Eylea for DMO
Elsewhere, in a Final Appraisal Determination the Institute is recommending use of Eylea (aflibercept) for sight problems due to diabetic macular oedema (DMO), which affects around 50,000 patients across the UK and is the commonest cause of preventable blindness in people of working age.
Eylea is administered as a single 2mg intravitreal injection monthly for five months and every two months thereafter, and in Phase III trials most patients treated with the drug experienced a significant two-line improvement in visual acuity.
NICE is backing its use when the eye has a central retinal thickness of at least 400 micrometres at the start of treatment. But Bayer says this means that patients will be denied treatment until their disease has progressed “to a stage where permanent damage to the eye has already begun”.
Also for DMO, NICE has recommended use of Allergan’s eye implant Ozurdex (dexamethasone) on the NHS, but only in an eye with an intraocular lens and if patients fail on corticosteroid therapy or it is not available.