UK NICE agrees to reconsider decision to deny NHS access to GSK's Benlysta

The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) confirmed this morning that it will reconsider its Final Appraisal Determination (FAD) not to recommend National Health Service funding of pharma giant GlaxoSmithKline’s (LSE: GSK) Benlysta (belimumab) for use in adult patients with active autoantibody positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.

This decision follows an appeal by GSK and two organizations representing the needs of UK patients with lupus, Lupus UK and The Primary Care Rheumatology Society, who all challenged the negative FAD reached by the Committee in this spring (The Pharma Letter April 27).

The appeals panel upheld two of the appeal points raised by GSK, and as a result the original appraisal committee will now reconsider these and take steps to demonstrate that they have been adequately considered within their determination. Once they are satisfied the points have been addressed, the Committee may or may not update or change their original decision. GSK hopes that this will result in a positive determination being reached, which will enable patients in England and Wales to gain NHS access to the first treatment specifically developed and licensed for lupus in over 50 years.