INTRODUCTION

  1.  The Arthritis and Musculoskeletal Alliance (ARMA) is an umbrella body bringing together 33 national organisations working in the field of arthritis and other musculoskeletal conditions. This includes service user groups, professional associations and research bodies. It is a registered charity.

  2.  ARMA welcomes the opportunity to respond to the Health Select Committee's inquiry. Although drawing its membership from a number of fields, ARMA unites them around a common purpose of improving quality of life for people with arthritis and other musculoskeletal conditions.

  3.  In this submission ARMA will comment on the following questions:

—  Why NICE's decisions are increasingly being challenged.

—  NICE's evaluation process and whether any particular groups are disadvantaged by the process.

—  The implementation of NICE guidance, both technology appraisals and clinical guidelines.

Why NICE's Decisions are Increasingly Being Challenged

  4.  ARMA does not wish to present a comprehensive list of reasons for NICE's decisions being challenged; however there is one particular area of concern for ARMA.

  5.  NICE health economics focus on the costs to the NHS without sufficient regard for the wider societal impact of recommendations for the use of certain treatments. Not having access to a particular drug might mean that someone is unable to work, but no consideration is given to the economic impact of their having to claim incapacity benefit and not contributing income tax.

  6.  Patient representative organisations come into contact on a daily basis with people who would describe their lives as being of poorer quality as a consequence of the scenario described above, hence more challenges and questions about the effectiveness of NICE. Whilst the NICE regime might not be able to share patient representatives' sense of frustration and injustice about the plight of such people, it should at the very least take into account the impact on the public purse of these circumstances.

NICE's Evaluation Process and Whether any Particular Groups are Disadvantaged by the Process

  7.  Organisations such as ARMA do not currently have sufficient resources to participate in the volume of appraisals relating to the group of conditions in which it is interested. ARMA has an annual income of approximately £140,000 and employs three staff. Much of its work on NICE appraisals is led by volunteers.

  8.  Small organisations like ARMA often have staff who are generalists across a range of work areas. Such organisations, especially smaller patient representative bodies, are therefore unlikely to have any staff that have sufficient depth of specialist knowledge of disciplines such as health economics to have the capacity to engage effectively in NICE evaluation processes.

The Implementation of NICE Guidance, Both Technology Appraisals and Clinical Guidelines

  9.  ARMA has evidence from three studies conducted in 2003, 2005 and 2006 that demonstrate that there is significant non-implementation of NICE guidance.

  10.  In March 2002, NICE approved the use of TNF-a inhibitors for people with severe rheumatoid arthritis (RA) who had failed existing treatments.

  11.  Since then, three studies conducted by Arthritis and Musculoskeletal Alliance (ARMA) and the British Society for Rheumatology (BSR) have demonstrated that there are persistent problems in obtaining access to this treatment for a significant number of people who meet the strict eligibility criteria and would benefit from it.

  12.  This is despite the Department of Health issuing directions in December 2001 to place statutory obligations on the NHS to provide appropriate funding for recommended treatments within three months of NICE guidance being issued.

  13.  The third and most recent study was conducted in Spring 2006, which found that:

  13.1  Four years on from NICE's original decision, people with rheumatoid arthritis were still being affected by post-code prescribing.

  13.2  Twenty percent of the 81 rheumatology units who responded stated that they were unable to prescribe TNF-a inhibitors to every rheumatoid arthritis patient they identified as being eligible in accordance with NICE guidance. The larger surveys in 2003 and 2005 demonstrated that around one-third of consultants were unable to prescribe the treatment in both those years as well.

  13.3  In those units that were unable to prescribe TNF-a inhibitors to every RA patient they identified as being eligible, waiting lists ranged from 10 to 126 patients.

  13.4  Fifteen% of units stated that a cap had been imposed on the number of RA patients for whom they could prescribe TNF-a inhibitors. In some units funding was only available for 10 patients. In units where there was no cap; as many as 500 patients were being prescribed TNF-a inhibitors.

  13.5  The top three barriers to prescribing TNF-a inhibitors were cited as:

—  PCT has overspent and will not release funding—28%;

—  PCT has not released funding yet—21%; and

—  Trust has allocated funding for TNF-a inhibitors, but is lacking nursing support to deliver treatment—17%.

  14.  It was easy to generate these data and give voice to problems in non-implementation. What has been more difficult has been finding an effective authority that will do something about it. Ministerial interest came with the caveat that it was ultimately a local matter and it is beyond NICE's power to deal with non-implementation.

  15.  ARMA would welcome greater clarity and government interest in dealing with significant matters of non-implementation, not just for organisations, but for individual patients who may believe that they are being treated contrary to NICE guidance.

Bill Freeman

Director, The Arthritis and Musculoskeletal Alliance

March 2007