Drug application to NICE
Belimumab application to NICE
As some of you may be aware, the National Institute for Clinical Excellence (NICE) has considered the drug belimumab for the treatment of active autoantibody-positive SLE following an application by GlaxoSmithKline. Earlier this year it was approved by the United States Food and Drug Administation (FDA) and European Medicines Agency: both of these bodies only assess the safety and efficacy of the drug. NICE makes recommendations to the NHS on new and existing medicines, treatments and procedures. NICE works with experts from the NHS, local authorities and others in the public, private, voluntary and community sectors - as well as patients and carers to make independent decisions in an open, transparent way, based on the best available evidence and including input from experts and interested parties. Cost effectiveness to the NHS is always considered.
The drug is a monoclonal antibody which targets the B-lymphocyte stimulator (BLyS) and inhibits its biological activity. The name of any drug which is a monoclonal antibody will end in ‘mab’: some of you are currently being treated with rituximab: infiximab and adilumumab are used to treat patients with other auto-immune illnesses. The action in these drugs is to bind to tumour necrosis factor alpha (TNF-α) to blunt the activity of Th1 cells.
Two clinical trials have been undertaken comparing treating some patients with belimumab compared to patients on ‘standard’ therapies. BLISS-76 studied 819 patients from mainly from North America and EU countries with a small number from South America and lasted for 76 weeks. BLISS-52 studied 865 patients from mainly from Asia Pacific, Latin America and a small number from EU countries, and lasted for 52 weeks. Patients were selected to receive either 1mg or 10mg per kg of weight or to receive placebo. The drug did meet its endpoints in these trials though the benefit compared to those patients given a placebo together with the steroids and immunosuppressive drugs which all of the patients were taking, was modest.
NICE conducted meetings during 2011 for an appraisal for the therapy at which they considered evidence submitted by a number of organisations such as the British Society of Rheumatologists, British Renal Society, British Association of Dermatologists, Primary Care Rheumatology Society, Royal College of Nursing, Royal College of Physicians, British Health Professionals in Rheumatology and LUPUS UK. During the 2nd meeting Professor David Isenberg (UCL), Dr Liz Lightstone (Hammersmith hospital), Johanna Taylor (Pharmacist, Bolton PCT and NHS Commissioning expert), Jane and Chris from LUPUS UK were interviewed by the Committee following submitting written evidence to the Committee on specific questions. They were all asked to leave before sensitive discussions on the costing of the drug and commercial information was discussed. The drug manufacturers GlaxoSmithKline attended the second meeting: their contribution was only at the invitation of the Committee chair to clarify specific issues and comment on factual accuracy.
NICE’s Preliminary Response
The preliminary response by NICE is not to recommend belimumab for use within the NHS. They considered the evidence on the nature of active autoantibody-positive SLE and the value placed on the benefits of belimumab by people with the condition, those who represent them and clinical specialists. It also took into account the effective use of NHS resources. The committee ‘considered the evidence from the clinical trials and concluded that currently the effect of belimumab on the full range of manifestations of SLE was uncertain’. They concluded that ‘there are no reliable data to show the relative efficacy of belimumab compared with rituximab’ and ‘that there was no sound case presented to it on the cost effectiveness of belimumab compared with rituximab’. The committee was aware of a potential equalities issue relating to the lower response rates observed in the clinical trials for the subgroup of black patients, but concluded that its recommendations did not limit access to the technology for any specific group, compared with other groups.
A Public consultation period finished on October 21st. A final decision will be made by NICE at the end of November.
LUPUS UK, the British Society for Rheumatology and other interested parties are going to be appealing for this adverse decision to be reversed.
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