Britain's largest drug company has launched a forthright attack on the NHS's drug rationing body, accusing it of blocking innovation after it failed to approve the first new medicine in a decade to treat the disabling condition lupus.
GlaxoSmithKline was unusually critical of the decision by Nice, the National Institute for Health and Clinical Excellence, and also the Scottish Medicines Consortium, to reject its drug belimumab (brand name Benlysta) in final draft guidance. The UK's appraisal system, said GSK, was "a fundamental problem".
In a statement, Simon Jose, general manager of GlaxoSmithKline UK, warned that the system for approval of drugs on the NHS needed to change. "The failure to recognise and adopt innovative new medicines continues to be a systemic problem in the UK … The UK is a world leader in the research, development and manufacture of medicines, but is one of the slowest to enable patients to have access to innovative new treatments. This is a situation that must be addressed."
Nice's rejection of new drugs has frequently outraged patient groups. When Health Secretary Andrew Lansley took office, he let it be known he would strip Nice of its powers to turn down new medicines, but there has been little information since as to how a new system would work. Most experts believe something like Nice is needed to assess the value of a new drug. There is agreement, however, that drug companies should get a premium price for new medicines that are "innovative", rather than variants on those already on the market. GSK's attack on Nice adds to the pressure on government for change.
Nice caused further controversy by turning down two drugs to check the spread of certain types of advanced breast cancer. Patients groups expressed their diappointment as Nice said it was unclear whether lapatinib (Tyverb, also made by GSK) and trastuzumab (Herceptin, made by Roche) extended women's lives and they did not appear to represent good value for money for the NHS.
Jose, who is also president of the Association of the British Pharmaceutical Industry, said he recognised that difficult funding decisions had to be made because the NHS had limited money. But Nice should not compare belimumab to cheap, older medicines that are now out of patent. That, he said, "fails to recognise the benefit of this clinically proven medicine".
He said: "These are devastating decisions for patients with lupus whose disease is currently uncontrolled by existing therapies. 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."
He said the company had "priced belimumab responsibly" and offered an NHS discount via a patient access scheme "which we firmly believe represents value for both a cost-constrained NHS and patients with uncontrolled lupus".
Lupus is an incurable autoimmune condition which affects the whole body. The immune system, which should be fighting disease, instead attacks healthy tissue. It can lead to serious damage to organs such as the kidneys and the heart. The standard treatment is non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen, which are very cheap. Around 25,000 people are affected in the UK - mostly women aged between 15 and 44. Some of them do not respond to the available drugs – and it is those who would be prescribed belimumab.
Nice's defended its final draft guidance, which now goes out to consultation. Chief executive, Sir Andrew Dillon, said the independent appraisal committee had looked very carefully at the evidence and taken into account the views of people with lupus and their doctors.
"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," said Sir Andrew in a statement.
Nice says the cost of the drug – without the discount – is more than £2,300 for the first month and then £769.50 every subsequent four weeks. That equates to more than £61,000 per QALY (a year of good quality life). Nice usually rejects drugs costing more than £30,000 per QALY except in terminal illness. GSK declined to make public the amount of the offered discount, which it says is commercially confidential.
Lupus is an incurable autoimmune condition which affects the whole body. The immune system, which should be fighting disease, instead attacks healthy tissue. It can lead to serious damage to organs such as the kidneys and the heart. The standard treatment is non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen, which are very cheap. Around 25,000 people are affected in the UK - mostly women aged between 15 and 44. Some of them do not respond to the available drugs, and it is those who would be prescribed belimumab. The Guardian
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