Five years later, GSK's Benlysta wins backing from NICE

By Carly Helfand May 11, 2016 11:29am

GlaxoSmithKline lupus drug Benlysta first won European approval nearly 5 years ago--but it’s just now getting a thumbs-up from England’s cost watchdogs.

After several years of rejecting the drug on the grounds that its value didn’t justify its price, the National Institute of Health and Care Excellence released guidance Tuesday recommending the NHS adopt the Glaxo product.

Of course, there are some conditions. GSK will be offering up the drug at a discounted price, and NICE also stipulated that clinical data on Benlysta’s use should be collected to clear up any lingering questions about the product’s efficacy.

Glaxo is no stranger to price negotiations in its home country. In 2014, NICE demanded another discount--or so-called “patient-access scheme” in exchange for a recommendation on Tafinlar, a melanoma drug that ultimately went to Novartis in the companies’ multibillion-dollar asset swap. The pharma giant had work to do after that transaction closed, too, haggling its way onto the U.K.’s list of routine vaccinations for babies with meningitis B shot Bexsero.

But things took much longer with Benlysta, a med it acquired full rights to with its $3 billion takeover of Human Genome Sciences. Back in 2012, after nixing the med--which ran about $3,700 over the first four weeks and then $1,227 every four weeks--NICE gatekeepers upheld an appeal from the company, agreeing to once again review if Benlysta was worth it. It opened a second public consultation in July 2013.

This time around, the positive opinion will result in a boost for Glaxo’s pharma unit, which has recently been battered by a payer squeeze on lead product Advair.

- read the guidance (PDF)

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