UK's NICE Does Not Want to Pay for Pixurvi

The UK public body NICE has issued a draft appraisal recommending that NICE not pay for a proposed thirdline therapy for B-cell non-Hodgkin's lymphoma.

According to an announcement by biotech Cell Therapeutics (CTI), the National Institute for Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the United Kingdom, has issued a second draft guidance on the use of CTI's Pixurvi (pixantrone) as a single-agent treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma (patients with aggressive B-cell NHL who failed two or three prior lines of therapy).

CTI is not taking this lying down. Working with NICE's Patient Access Scheme Liaison Unit (PASLU), the company has struck a deal with the UK's Department of Health on a patient access scheme. They have also applied for "rapid reappraisal" by NICE.

Said James A. Bianco, MD, president and CEO of CTI:

Our intention is to continue to work with NICE to provide support for Pixurvi as an important therapy for what we believe is an unserved patient population and for whom Pixurvi represents the first pharmaceutical product approved specifically for patients with aggressive B-cell NHL who have failed 2 or 3 prior lines of therapy. The overall data from the pivotal Phase 3 PIX301 clinical trial demonstrated a favorable benefit-to-risk ratio. We believe continued support among UK lymphoma experts, the data in the labeled population of patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy, and the recent approval of a patient access scheme by the Department of Health in England and Wales demonstrates our commitment to bringing this new approved therapy to patients with aggressive NHL in the third line salvage setting.

The European Commission (EC) granted CTI conditional marketing authorization for Pixurvi in Europe as monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL. The drug has been rejected in the United States, though the company is appealing that FDA ruling.

Source: CTI