Pfizer succeeds in NICE appeal

28 December 2017
2019_biotech_test_vial_discovery_big

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology