Soliris (eculizumab), a monoclonal antibody treatment for atypical Haemolytic Uraemic Syndrome (aHUS) manufactured by US-based Alexion, was acknowledged as an effective treatment option for patients by the National Institute for Health and Clinical Excellence (NICE) Evaluation Committee Monday.
However, the condition is estimated to only affect around 200 people in England – and is recognised as having orphan status - and at an annual price tag of £340,000 ($567,000) per patient, the first draft guidance produced by NICE’s new Highly Specialised Technologies programme has called upon Alexion to justify the costs.
“Eculizumab is an effective treatment for aHUS. The NHS has already recognised this by making it available on an interim basis, pending the outcome of NICE's appraisal,” said NICE CEO Sir Andrew Dillon.
“However, before we can make a confident recommendation for routine use, which we estimate would cost the NHS about £58 million in the first year, rising to over £80 million in 5-years, we need more information.”
On top of costs associated with R&D, NICE has asked for clarity from the company on whether aspects of the manufacturing have contributed. Biopharma-Reporter.com contacted Alexion for comment but had received nothing at the time of going to press.
However, the firm has asked NICE to remain tight-lipped about the overall cost of Soliris, NICE spokesperson Laura Gibson told us this morning, meaning details of the original submission could not be divulged.
“This isn’t something that happens routinely,” she said. “In our technology appraisals programme costs are always provided, unless the drug is being provided under a patient access scheme.”
Cost Comparisons
Drugs for orphan diseases “are inevitably more expensive than for more common diseases,” Dillon said, and biologics are generally more expensive than small molecule drugs, but there is a huge disparity when comparing Soliris’ price per patient with other monoclonal antibody information available via NICE’s website, as the chart below shows.
AbbVie’s TNF inhibiting anti-inflammatory drug Humira (adalimumab), for example clocks in at a cost of £357 (excluding value added tax) for a 40-mg prefilled syringe. At an average of 26 doses over a year, the total price comes to £9,295.
Roche’s Avastin (bevacizumab) costs £16,824 per patient annually, whilst 52 once-weekly doses of 50 mg of Pfizer’s Enbrel (etanercept) comes to £9,295.