UK NICE gives draft "No" to Benlysta, and negative final guidance for Tyverb and Herceptin

There was a batch of bad news emanating from the US drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today (April 27) for UK pharma major GlaxoSmithKline (LSE: GSK) regarding its lupus drug Benlysta (belimumab) and its breast cancer agent Tyverb (lapatinib, as well as for Switzerland’s Roche (ROG. SIX) on its Herceptin (trastuzumab).

The NICE published final draft guidance on the use of Benlysta for treating systemic lupus erythematosus. In the draft guidance, belimumab is not recommended within its licensed indication as add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus who have a high degree of disease activity (for example, positive anti-double-stranded DNA and low complement) despite the individual receiving standard therapy.

Sir Andrew Dillon, the NICE’s chief executive said: “NICE’s independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating systemic lupus erythematosus (SLE), including the views of people with the condition, those who represent them, and clinical specialists. The Committee concluded that compared with standard care, there was some evidence of the clinical effectiveness of belimumab. However, the evidence considered did not persuade the Committee that belimumab provided enough health benefit for patients in view of how much the NHS would need to pay for it compared to standard care, as the cost of the drug in relation to how well it works is very high…Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources compared with current clinical practice.”