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GSK persuades NICE to reconsider negative Benlysta decision

Decision on lupus drug referred to expert committee following appeal

National Institute for Health and Clinical Excellence (NICE)

The UK's cost-effectiveness watchdog the National Institute for Health and Clinical Excellence (NICE) is to reconsider its decision to recommend NHS in England does not make routine use of GlaxoSmithKline's (GSK) lupus drug Benlysta (belimumab).

The agency originally turned down the drug in April this year, claiming it was too expensive for the benefits it provided, but that decision will now be referred to an expert committee after a successful appeal from GSK.

It's not the first time Benlysta has struggled for approval, having been turned down for use in Germany by Institute for Quality and Efficiency in Health Care (IQWiG), but NICE's rejection hit GSK particularly hard with its then UK general manager Simon Jose describing the original decision as “devastating” for patients with the autoimmune disease Lupus.

He said: “By denying access to belimumab, which is the first treatment specifically developed and licensed for lupus in over 50 years, UK patients are being left behind those in other countries including the US, Germany and Spain who already have access to this medicine.”

NICE puts the drug's cost at £2,308.50 for the first four weeks and then £769.50 every following four weeks, although GSK had offered a discount through a patient access scheme.

The appeals board has now upheld two points raised by GSK in its complaint about original the negative recommendation.

GSK's current UK general manager Erik van Snippenberg told Reuters: "The outcome of the appeal is a positive step. However, 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."

The NICE appeals process is set to be overhauled soon though, following industry pressure from the Association of the British Pharmaceutical Industry (ABPI), with the Department of Health set to transfer power to appoint members of the appeal panel from NICE to the government.

7th September 2012

From: Sales, Healthcare



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