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news.The UK’s National Institute for Health and Care Excellence (NICE) has issued final positive recommendation for national commissioning of Alexion Pharmaceuticals' Soliris (eculizumab) for all patients in England suffering from atypical hemolytic uremic syndrome (aHUS).
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aHUS is a severe and life-threatening ultra-rare disorder that affects around 200 people in England, with 20-30 new patients diagnosed with the condition each year.
The disease causes inflammation of blood vessels and the formation of blood clots throughout the body.
In the final evaluation determination, NICE’s Highly Specialised Technologies Evaluation Committee (EC) again confirmed that Soliris represents an important treatment option of significant value to patients with aHUS.
Alexion chairman and chief executive officer Leonard Bell said: "Today’s decision is an important victory for patients with aHUS and physicians who now have assurance that they will have access to the life-transforming efficacy of Soliris.
"We are pleased that Soliris will be made available on the NHS for patients with aHUS and we commend NHS England for its previous decision to provide interim funding to patients for the extended period it took for NICE to make this final determination."
The NICE EC recommended the commissioning of Soliris, within its marketing authorization, for aHUS subject to the conditions provided in the evaluation consultation document released in September 2014.
In November 2011, the European Commission approved Soliris for the treatment of patients with aHUS.
NICE noted that after stopping Soliris, severe TMA complications were reported including graft failure needing hemodialysis, renal insufficiency, end-stage renal failure and respiratory distress needing intubation.