German gatekeepers nix GSK's lupus drug Benlysta

GlaxoSmithKline's ($GSK) Benlysta can't catch a break from European gatekeepers. First, the U.K.'s cost-effectiveness watchdog rejected the lupus treatment, despite a discount scheme. Now, Germany's new, tougher reimbursement regime has given Benlysta another thumbs-down.

Benlysta is the first new treatment for lupus in 50 years, and it was approved to great fanfare last year. Lupus patients and advocacy groups had been anticipating the launch. Nevertheless, the drug has been slow to take off, sales-wise, and negative rulings from the National Institute for Health and Clinical Excellence, and now the German Institute for Quality and Efficiency in Health Care, certainly won't help matters.

Glaxo greeted NICE's final "No" with strong criticism, not just of the Benlysta decision, but of NICE's record at adopting new drugs in general. The company's U.K. chief, Simon Jose, said at the time that NICE shouldn't have compared Benlysta to cheap, off-patent drugs, because it ended up skewing the results and failed "to recognize the benefit of this clinically proven medicine." Patient groups weren't happy either; there's a petition drive underway, and plenty of Benlysta-sympathetic media coverage.

And now, GSK says it's befuddled by IQWiG's draft decision on Benlysta. The agency said the drug did not offer "therapeutically significant additional benefit" for any patient groups, compared with older treatments. That decision could mean a large, forced discount to Benlysta's price on the German market. The agency's announcement was "completely inexplicable form a medical point of view and disregards genuine progress in therapy," the company said (as quoted by Reuters).

- see the Reuters news