Cell Therapeutics: NICE Issues Second Draft Guidance On PIXUVRI - Quick Facts

(RTTNews) - Cell Therapeutics, Inc. (CTIC) said the National Institute for Health and Care Excellence or NICE, a non-departmental public body of the Department of Health in the UK, issued second draft guidance on PIXUVRI as a monotherapy for the treatment of multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma or aggressive B-cell NHL.

NICE's independent Appraisal Committee met on September 11, to consider the cost effectiveness of PIXUVRI taking into account CTI's initial patient access scheme, approved by the Department of Health in July 2013. The result is a second appraisal consultation document, or ACD, whereby the Committee concluded that this scheme does not overcome the uncertainties in the evidence for PIXUVRI's clinical effectiveness and once again requests that consultees, including CTI, healthcare professionals and members of the public, comment on the draft guidance via the NICE website.

The ACD consultation would close on November 4, 2013, and any comments received would be considered by the NICE appraisal committee to enable them to develop the next stage of guidance. This is not NICE's final guidance on PIXUVRI and that a third Appraisal Committee meeting is likely to be held on November 13, where subject to approval, CTI believes that the Committee would consider an 'enhanced' patient access scheme to show the cost effectiveness of PIXUVRI for use by the NHS in the UK.