Cell Therapeutics faces yet more attempts to convince authorities in England of the worth of its blood cancer treatment Pixuvri after it received its second negative opinion for the drug’s use on the NHS.
The National Institute for Health and Clinical Excellence (NICE), which assess the cost-effectiveness of medicines for use in England and Wales, posted initial draft guidance in April that said Pixuvri (pixantrone) was not an efficient use of NHS resources as a treatment for non-Hodgkin’s lymphoma.
The organisation has now followed this up with a second round of draft guidance which again doesn’t recommend the drug, which has also been turned down by the health technology assessment (HTA) body IQWIG in Germany.
The latest negative NICE guidance comes despite Cell Therapeutics revising its pricing plan to offer Pixuvri through a patient access scheme that would see the company cover part of the drug’s cost.
This has not been enough for NICE’s appraisal committee to change its mind, however, with the organisation noting that other treatments are already recommended for non-Hodgkin’s lymphoma.
“Unfortunately, the committee concluded that this scheme – the details of which are confidential in accordance with the agreement between the company and the Department of Health – does not overcome the uncertainties in the evidence for the drug’s clinical effectiveness over and above current treatments for this disease,” said Sir Andrew Dillon, chief executive of NICE.
Cell Therapeutics now has another consultation period in which it can try and convince NICE to recommend Pixuvri. This closes on November 4, 2013. Healthcare professionals and members of the public can also comment.
The NICE guidance is the latest hurdle for Cell Therapeutics in a series of challenges related to Pixuvri – the company’s first drug to reach market.
In addition to the IQWIG decision, Cell Therapeutics was also forced to pull its marketing application for Pixuvri in the US after the Food and Drug Administration (FDA) denied it additional time to prepare for an advisory committee meeting.
Despite these setbacks, the company has managed to win market access recommendations in several markets, including France and Italy.