BioCentury on BioBusiness, Regulation
NICE refusal of Benlysta could leave U.K. lupus patients with no treatments
Left out in lupus
By Stephen Hansen
Senior Writer
Published on Monday, October 17, 2011
Though it has become routine for the U.K.'s National
Institute for Health and Clinical Excellence to reject novel drugs
unless or until manufacturers cut a deal that lowers the cost, the agency has
set an especially improbable hurdle in lupus. For Benlysta belimumab, NICE has
asked for a comparison to MabThera rituximab - an unapproved drug that failed
Phase III trials and that Primary Care Trusts are increasingly refusing to pay
for.
The agency also said a patient access scheme proposed by
sponsor GlaxoSmithKline
plc wasn't enough to make the drug cost-effective.
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