The National Institute for Health and Clinical Excellence (NICE) wants to examine the company's R&D costs for the drug to help it determine the appropriate reimbursement, considering its high cost.
Soliris is the most expensive drug in the world. Annual treatment cost runs £340,000 (US$569,000).
NICE's evaluation of the cost/benefits of the product falls under its new "ultra orphan" disease treatment review process. For Soliris, it has taken three years with no end in sight.
There are ~170 patients in the UK that would be eligible for Soliris, representing a cost to the National Health Service of 58M Pounds ($97M).
Soliris sales were $1.6B last year, with a forecast of $3.4B by 2018.