Press Release -NICE approves

MabThera (rituximab)- 03 July 2007

22/08/07: Roche
 
NICE approves MabThera (rituximab)- offering new hope for patients with severe rheumatoid arthritis

NICE joins Scotland and opens the door for thousands of rheumatoid arthritis patients in England and Wales

22 August 2008, UK – Today NICE has issued guidance to the NHS approving the use of MabThera (rituximab), in combination with methotrexate, for the treatment of severe active rheumatoid arthritis (RA) in people who have failed on one or more anti-TNF* therapies. ¹ This decision should now allow every eligible NHS patient to receive MabThera, the first and only NICE approved therapy for these patients, offering a much needed new option for thousands of RA patients who previously had been left with very limited treatment alternatives after failing on an anti-TNF medication.

RA affects around 487,000 people in the UK^3,4 and is a painful, debilitating and incurable auto-immune disease in which the body viciously attacks itself. Up to 30% of people with RA either do not respond to or cannot tolerate anti-TNF’s– the current standard biologic treatment for moderate to severe RA. NICE has recommended MabThera as both clinically and cost effective- making it the only NICE approved medicine for this group of patients. The medicine has the lowest average annual drug cost of all the ‘biologic’ treatments, at £4,657 , almost half the cost of the other therapies including abatacept, and anti-TNF’s.

Professor Paul Emery, Arc Professor of Rheumatology at University of Leeds, said, “The decision to make this important medication available on the NHS is very good news indeed for the thousands of people in the UK with rheumatoid arthritis. The green light from NICE is further validation of the evidence demonstrating the significant clinical benefits patients gain from being given MabThera. It will offer patients who fail on anti-TNF therapies a viable alternative where in the past they had no NICE approved options.”

Recently hailed as part of a ‘new era of treatment’ for RA in The Lancet,² MabThera received a UK licence from the Medicines and Healthcare Regulatory Agency (MHRA) in July 2006 and a positive guidance from the Scottish Medicines Consortium ( SMC ) in November 2006. The positive NICE decision should now provide people in England and Wales equal access to the drug.

The disease commonly starts in people aged between 30 and 40 and causes relentless pain, extreme fatigue and disability, and has a significant impact on people’s social and working lives. The total direct and indirect costs of RA in England alone have been estimated at as much as £1.2 billion per year.⁵

With this publication of final guidance, Primary Care Trusts (PCTs) and NHS Trusts, which manage the implementation of NICE approved therapies, have a maximum of three months in which to fully implement use of MabThera, ensuring all eligible patients have access this NICE approved treatment. However, with postcode prescribing still evident with anti-TNFs 5 years post NICE approval whereby almost 50% of rheumatologists are still facing funding restrictions in prescribing the NICE approved anti-TNF’s⁶, the challenge now will be to ensure that all patients eligible for MabThera are in fact offered the opportunity to benefit from it.

ENDS

Editor’s Notes

About Rheumatoid Arthritis and MabThera

Rheumatoid arthritis is an autoimmune disease characterised by inflammation that leads to stiff, swollen and painful joints. Current treatments include disease-modifying drugs (DMARDS) and biologic therapy such as the TNF inhibitor drugs.

MabThera is a first-in-class therapy that selectively targets B cells early in the inflammatory cascade of rheumatoid arthritis. B cells are known to play a key role in the inflammation associated with rheumatoid arthritis and MabThera breaks the inflammatory cascade of RA – a series of reactions inflaming the synovia and leading to the cartilage loss and bone erosion that is characteristic of the disease, and may provide an innovative new treatment even in patients with severe and long-standing disease. MabThera has a strong heritage in the treatment of a form of lymphatic cancer called non-Hodgkin’s lymphoma (NHL) and the treatments safety profile has now been established in more than 960,000 patient exposures over the last nine years in oncology and more recently rheumatoid arthritis.

MabThera is indicated, in combination with methotrexate, for the treatment of adults with severe rheumatoid arthritis who cannot tolerate or do not respond to anti-TNF therapy.

About Roche in Rheumatoid Arthritis

Roche has prioritised research and development of new treatments for auto-immune diseases, including rheumatoid arthritis. Following the launch of MabThera® (rituximab) for RA in 2006 there are a number of projects in development ensuring a rich pipeline including compounds in Phase I, II and III clinical trials. Tocilizumab (to be called Actemra) is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. This treatment is not yet licenced in the Europe and is the result of research collaboration by Roche and Chugai , it is being co-developed globally. Ocrelizumab, a fully humanised anti-CD20 antibody, is just entering Phase III development for RA.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Find out more at www.rocheuk.com

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