GlaxoSmithKline's Benlysta will get another shot at being funded by the National Health Service after cost regulators said they would reconsider their preliminary decision to reject its use in patients with lupus.
The National Institute for Health and Clinical Excellence had published a Final Appraisal Determination turning down the use of Benlysta (belimumab) on the National Health Service for patients with active autoantibody positive systemic lupus erythematosus back in May, claiming that its benefit was not enough to justify its cost.
But now, following an appeal by GSK and patient groups Lupus UK and The Primary Care Rheumatology Society, the Institute has been asked to take another look at certain elements of the appraisal and demonstrate they have been "adequately considered" in reaching a decision.
This may not mean that NICE will alter its original position, but GSK said it is hoping that a positive determination will be reached, giving patients in England and Wales to gain NHS access to the first treatment specifically developed and licensed for lupus in over 50 years.
"The outcome of the appeal is a positive step towards potentially gaining NHS access to Benlysta," said Erik van Snippenberg, General Manager, GlaxoSmithKline UK.
But he also stressed that "the restrictive nature of the NICE appraisal and appeal process remains a challenge and we continue to be concerned about our probability of achieving a successful outcome and reversing the negative determination".
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.
Benlytsa, approved in Europe in 2011, 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.