Plan to ban drug that would help thousands with incurable immune system disease put on holdThe NHS rationing body said Benlysta was too expensive at 9,000 a year despite there being no alternative treatments for lupus.But an appeal has ruled that a ban on the drug is put on hold
16:16 GMT, 7 September 2012
A plan to ban a new drug that would help thousands of women with an incurable immune system disease has been put on hold.
The NHS rationing body said Benlysta was too expensive at 9,000 a year despite there being no alternative treatments for lupus.
But patient groups, doctors and drug makers GlaxoSmithKline won an appeal against the decision not to fund the drug on the NHS.
Cure: Benlysta can help treat the symptoms of lupus
The National Institute for health and Clinical Excellence (NICE) will now reconsider banning the drug, which is available in the US, Germany and Spain.
Around 25,000 Britons, mostly women, suffer from lupus, in which the body turns on itself by producing antibodies that attack tissue and organs, causing pain, fatigue and potentially life-threatening damage.
Benlysta is the first treatment specifically developed to treat the disease for half a century and trials show it improves patients’ health and wellbeing.
At present patients are given cheap, off-patent steroids to reduce inflammation and occasionally an anti-cancer drug that has no proven efficacy.
An estimated 5,000 patients a year whose disease cannot be controlled would be eligible to receive the new drug, given monthly by infusion.
But in April NICE, which covers England and Wales, and its Scottish equivalent the SMC said Benlysta, also known as belimumab, was not cost-effective.
However, GSK claims it has priced the drug ‘responsibly’ through a discount scheme that will cut the amount actually paid by the NHS.
The appeal to NICE was made by GSK and the charity Lupus UK and the Primary Care Rheumatology Society, representing GPs.
The Worldwide Lupus Patient Organisations also called for a re-think, saying a ban could have a ‘devastating international impact on the survival of this important new treatment.
‘It may have a chilling effect on the future development of new lupus drugs thereby denying physicians and patients appropriate treatment options’ it said in a 5,000-strong petition.
Erik van Snippenberg, General Manager, GlaxoSmithKline UK said the drug was the first specifically developed for lupus in 50 years.
He said ‘The outcome of the appeal is a positive step towards potentially gaining NHS access to Benlysta.
Support: GSK brought the appeal against plans to ban the drug
‘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.
‘Ultimately, gaining access to Benlysta for UK patients remains our primary objective and we are committed to making this happen, as we believe that this is a really important treatment innovation for certain types of adult patients living with lupus.’
The ban heightened criticism of NICE by drug companies and campaigners who say NHS patients are failing to benefit from drugs – some of which have been developed here – because they are judged too expensive.
A NICE spokeswoman said ‘The appeal panel has upheld two points and has directed that the final appraisal determination be returned to the independent appraisal committee.
‘Once this has been added to the committee’s work schedule the website will be updated accordingly.
‘The Institute is not in a position to make any further comments on the appraisal until after the committee has had the opportunity to consider and address the points which have been upheld by the appeal panel.’