NICE Rebuffs Glaxo's Drug Arzerra On Cost, Lack Of Data

23rd Jun 2010 00:01

By Sten Stovall Of DOW JONES NEWSWIRES LONDON (Dow Jones)--The U.K.'s National Institute for Health and Clinical Excellence, or NICE, said Thursday it won't recommend publicly-funded use of GlaxoSmithKline PLC's (GSK) leukaemia drug Arzerra, due to lack of data and proof the medicine offers value for money. NICE, which rules on which drugs should be paid for on the state-funded National Health Service (NHS), said Arzerra, or ofatumumab, is being appraised for treating patients with chronic lymphocytic leukaemia who haven't responded to two other drugs, fludarabine and alemtuzumab. Chronic lymphocytic leukaemia--the most common form of leukaemia in the U.K.--affects the body's immune system by encouraging a type of white blood cell called B lymphocytes to grow abnormally, causing anaemia and increased susceptibility to infection. Glaxo bought global rights to Arzerra from Danish biotechnology company Genmab A/S (GEN.KO) in December 2006 in a deal worth up to $2.1 billion, a record sum for a biotech product agreement at the time. The medicine has been conditionally approved by the U.S. Food and Drug Administration and by the U.K.'s Medicines and Healthcare products Regulatory Agency on the proviso that more research must be carried out to prove its clinical benefit. NICE Chief Executive Andrew Dillion in a statement said, "We can only recommend drugs where the evidence shows them to work better than current NHS treatments, and when they represent good value for money for the NHS." "In this case, the manufacturer's evidence included interim results from a clinical trial where all patients received the ofatumumab and which is not scheduled to report its full findings until next year. This meant no direct comparison could be made between ofatumumab and best supportive care and the committee that is appraising ofatumumab was unable to judge how well the drug works compared to best supportive care." Arzerra works by targeting a protein called CD-20 that is found on the surface of a type of white blood cell called B lymphocytes and cancer cells. Arzerra kills these cells allowing normal lymphocytes to grow and replace those destroyed. Ofatumumab is administered directly into the bloodstream via an infusion. It is given once a week for eight weeks and then once a month for a total of four months. NICE was unable to recommend the drug despite Glaxo's offering a "patient access scheme" in which Arzerra would be made available to the NHS at a discounted price, as "even with this in place, ofatumumab was judged to be too costly for the uncertain benefit it may offer patients." The recommendation is still preliminary and subject to a second round of consultations. However, NICE's views are closely watched by governments and health insurers worldwide. -By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected] (END) Dow Jones Newswires June 23, 2010 19:01 ET (23:01 GMT)