Within the next three months patients with lupus should get 'routine' access to a new treatment option on the NHS in England and Wales after cost regulators issued final guidance for GlaxoSmithKline's Benlysta.

In line with draft recommendations, the National Institute for Health and Care Excellence has recommended use of Benlysta (belimumab) to treat systemic lupus erythematosus (SLE), but only under a managed access agreement between GSK and NHS England, which will provide the drug at a discounted price, and on the condition that data is collected to help address remaining questions over its efficacy.

Benlysta was actually cleared by European regulators back in 2011 for autoantibody-positive SLE but, until now, NICE had barred patients from accessing it on the NHS because on the belief that it did not represent a cost-effective use of resources.

The drug is the first in a new class of drugs called BLyS-specific inhibitors, which work by targeting a naturally occurring protein believed to play a role in the production of antibodies which attack and destroy the body's own healthy tissues.

Lupus - a chronic autoimmune disease that, if uncontrolled, can lead to severe, debilitating symptoms, long-term organ damage and premature death - affects more than 20,000 people in England and Wales, and some patients with advanced disease fail to respond to current therapy.

Earlier this year, a long-term analysis demonstrated low rates of organ damage progression in patients with moderate-to-severe SLE taking the drug for five years, regardless of their level of damage at the start of the trial.

Interim analysis of data from two pooled, open-label, continuation studies (BLISS-52 and BLISS-76) showed that 85.1 percent of patients taking Benlysta plus the standard of care showed no organ damage at study years five-six, as measured by change in SLICC Damage Index from baseline, a validated score to quantify organ damage.