NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE GUIDANCE EXECUTIVE (GE) Consideration of consultation responses on review Review of TA143 Adalimumab, etanercept and infliximab for ankylosing spondylitis This guidance was issued May 2008 with a review date of October 2010. Background At the GE meeting 9 November 2010 it was agreed we would consult on the review plans for this guidance. A four week consultation has been conducted with consultees and commentators and the responses are presented below. Proposal put to consultees: A review of the guidance should be deferred until the ongoing single technology appraisal of golimumab for ankylosing spondylitis is considered for review. GE is asked to consider the original in the light of the comments received from consultees and commentators, together with any responses from the appraisal team. It is asked to agree on the final course of action for the review. Recommendation post consultation: The guidance should be transferred to the static guidance list. The topic of TNF inhibitors for the treatment of pre-radiographic ankylosing spondylitis (AS) or axial spondyloarthritis (ASpA) should be considered by Topic Selection. If the topic is taken forward as an appraisal then incorporation of the review of TA143 and the ongoing appraisal of golimumab for AS into that appraisal can be considered.. Page 1 of 7
Respondent Response to Abbot Laboratories Agree Comment noted. British Health Disagree Professionals in Rheumatology Suggest review It is now possible to diagnose AS earlier using MRI scans therefore a review of the guidance should take place. Comments noted. It has been clarified that people with preradiographic disease (ASpA) diagnosed with MRI are outside the remit of the original appraisal, which specified that the technologies were to be appraised for the treatment of AS. It is recommended that this wider population be considered by Topic Selection. Infliximab is not currently recommended but it is an effective treatment for people who have not responded to other TNF inhibitors. New data is now available on the effectiveness of infliximab. Since the publication of TA143, there is still appears to be insufficient evidence on which to distinguish between the clinical effectiveness of these TNF inhibitors. No trials have been published since TA143 which evaluate the effectiveness of infliximab in people who have not responded to other TNF inhibitors. Page 2 of 7
Respondent British Society for Rheumatology Response to Disagree BSR feel that a review of NICE technology appraisal guidance No. 143 for Ankylosing Spondylitis should go ahead. BSR feel that NICE should review the classification criteria for AS, as the New York criteria are out-dated. We propose that these are replaced by the recent ASAS criteria. BSR feel that particular consideration should be given to the following: Regarding Axial SpA (Early AS - preradiographic AS) and classical AS as a diagnosable continuum, as recognised by the ASAS criteria. Thus, use of MRI to diagnose sacroiliitis - according to published criteria - would be a reasonable way to diagnose ASpA. This would allow use of anti-tnf treatment, in specific circumstances, without meeting NY criteria. Comments noted. It has been clarified that people with preradiographic disease (ASpA) diagnosed with MRI are outside the remit of the original appraisal, which specified that the technologies were to be appraised for the treatment of AS. It is recommended that this wider population be considered by Topic Selection. Currently no new evidence has been published that would have an effect on the original guidance, including evidence on optimal treatment strategies for AS. Data on switching is still in progress, but current data tells a convincing story. As AS is a disease with so few therapeutic options, and where normal practice is now to switch therapies, this needs revising. Page 3 of 7
Respondent Merck Sharp & Dohme / Schering Plough Response to Agree Agreed no new evidence has been published that would have a material effect on the original guidance. However MSD confirmed they are currently looking into the possibility of developing a patient access scheme for infliximab. MSD wishes to know if it were to develop such a scheme and it was approved by the Department of Health, a review of TA143 would be triggered at this time. Comment noted. If a PAS was developed and approved by the Department of Health then a review for TA143 would be developed and consulted on. Page 4 of 7
Respondent National Ankylosing Spondylitis Society Response to Disagree The review date for golimumab is likely to be years ahead as I understand the appraisal of golimumab has been suspended as the first committee meeting scheduled for 17 November 2010 was cancelled as the manufacturer needed to do some further work on their economic model modelling. There are issues that need addressing now. Comments noted. It has been clarified that people with preradiographic disease (ASpA) diagnosed with MRI are outside the remit of the original appraisal, which specified that the technologies were to be appraised for the treatment of AS. It is recommended that this wider population be considered by Topic Selection. The first committee meeting for golimumab is scheduled for September 2011. NHS Quality Improvement Scotland Royal College of Nursing No comment No objection. Comment noted. Comment noted. Page 5 of 7
No response received from: Manufacturers/sponsors Pfizer (etanercept) Patient/carer groups Action on Pain Afiya Trust Arthritic Association Arthritis & Musculoskeletal Alliance (ARMA) Arthritis Care BackCare Black Health Agency Brain and Spine Foundation Chinese National Healthy Living Centre Coalition of Ankylosing Spondylitis Patients Counsel and Care Equalities National Council Leonard Cheshire Disability Muslim Council of Britain Muslim Health Network Pain Concern Pain Relief Foundation Royal Association for Disability & Rehabilitation (RADAR) South Asian Health Foundation Specialised Healthcare Alliance Professional groups British Association for Services to the Elderly British Association of Occupational Therapists General Board of Community Health Councils in Wales British National Formulary Care Quality Commission Commissioning Support s Service Department of Health, Social Services and Public Safety for Northern Ireland Medicines and Healthcare products Regulatory Agency National Association of Primary Care NHS Alliance NHS Commercial Medicines Unit NHS Confederation Public Health Wales NHS Trust Scottish Medicines Consortium Relevant research groups Arthritis Research Campaign Bone Research Society Chronic Pain Policy Coalition Cochrane Musculoskeletal Group MRC Clinical Trials Unit National Institute for Health Research Policy Research Institute on Ageing and Ethnicity Research Institute for the Care of Older People Society for Back Pain Research The UK Occupational Therapy Research Foundation Assessment Group Page 6 of 7
British Geriatrics Society British Institute of Musculoskeletal Medicine British Orthopaedic Association British Pain Society British Society of Rehabilitation Medicine Chartered Society of Physiotherapy College of Occupational Therapists Physiotherapy Pain Association Primary Care Rheumatology Society Royal College of General Practitioners Royal College of Pathologists Royal College of Physicians Royal Pharmaceutical Society Royal Society of Medicine United Kingdom Clinical Pharmacy Association National Institute for Health Research Health Technology Assessment Programme tbc Associated Guideline Groups National Collaborating Centre for Chronic Conditions Associated Public Health Groups None Others Department of Health NHS Dorset Sandwell PCT Welsh Assembly Government GE paper sign-off: Janet Robertson, 21 April 2011 Contributors to this paper: Technical Lead: Helen Tucker Technical Adviser: Joanna Richardson Project Manager: Kate Moore Page 7 of 7