Pfizer succeeds in NICE appeal

The UK subsidiary of US pharma giant Pfizer (NYSE: PFE) today announced that its appeal has been upheld against the National Institute for Health and Care Excellence’s (NICE) decision not to recommend Besponsa (inotuzumab ozogamicin) as a treatment for adults with relapsed or refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

The NICE appraisal committee will now re-assess the evidence for inotuzumab ozogamicin before issuing a second Final Appraisal Determination (FAD).

Besponsa was approved by the European Medicines agency in July this year, and in the USA in August. In June this year, NICE, the medicines cost-effectiveness watchdog for England and Wales, declined to approve use of the drug for regular National Health Service (NHS) use. At that time, the NICE said the incremental cost effectiveness ratio (ICER) for Besponsa was over £100,000 ($134,000) per QALY for inotuzumab ozogamicin, which is substantially higher than the range considered cost effective for routine use in the NHS.

Inotuzumab ozogamicin is an antibody drug conjugate approved by the European Medicines Agency (EMA) for patients with Philadelphia chromosome positive (Ph+) and Philadelphia chromosome negative (Ph-) relapsed or refractory CD22-positive B-cell ALL. It is a medicine that could fulfill significant unmet needs for patients with relapsed or refractory ALL, particularly those with Ph+ disease, according to Pfizer.