Cell Therapeutics announced that the National Institute for Health and Care Excellence, or NICE, a non-departmental public body of the Department of Health in the United Kingdom, issued second draft guidance on Pixuvri as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL. NICE's independent Appraisal Committee met on September, to consider the cost effectiveness of pixantrone taking into consideration CTI's initial patient access scheme that was approved by the Department of Health in July. 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 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once again requests that consultees, including CTI, healthcare professionals and members of the public, comment on the draft guidance via the NICE website.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 will close on November 4, and any comments received will be considered by the NICE appraisal committee to enable them to develop the next stage of guidance. It should be noted that this is not NICE's final guidance on pixantrone and that a third Appraisal Committee meeting is expected to be held on November 13, where subject to approval, CTI hopes the Committee will consider an 'enhanced' patient access scheme to demonstrate the cost effectiveness of pixantrone for use by the NHS in the UK.
- Cell Therapeutics