Rheumatology Advance Access originally published online on March 31, 2007
Rheumatology 2007 46(6):1044-1045; doi:10.1093/rheumatology/kem065
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The impact of the NICE appraisal consultation document on anti-TNF therapy for ankylosing spondylitis
Department of Rheumatology, Derbyshire Royal Infirmary, London Road, Derby DE1 2QY, UK.
Correspondence to: Dr Chris Deighton, Department of Rheumatology, Derbyshire Royal Infirmary, London Road, Derby DE1 2QY, UK. E-mail: chris.deighton{at}derbyhospitals.nhs.uk
SIR, We would like to draw to the attention of colleagues the potentially devastating impact of the National Institute for Health and Clinical Excellence (NICE) Appraisal Consultation Document (ACD) on the use of anti-TNF in ankylosing spondylitis (AS) [1], which was put out for public consultation in December 2006. The criteria that this sets out are more restrictive than the BSR guidelines [2] and the updated international Assessment in AS (ASAS) consensus statement for the use of anti-TNF in AS [3], both in terms of severity of disease activity to qualify for starting treatment and the response to treatment required to be eligible for continuing treatment. A recently published report in Rheumatology [4] presented the responses of 30 AS patients in Derby, to anti-TNF agents. This demonstrated that the BSR guidelines selected patients with ongoing severe active disease to qualify for anti-TNF therapy, and that this intervention led to rapid and sustained benefit measured by the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI). By applying the proposed NICE criteria and the existing BSR criteria retrospectively to a cohort of AS patients at Derby, we wanted to demonstrate the impact that the NICE recommendations would have on patient eligibility for treatment.
There are two main differences between the NICE ACD and the BSR and ASAS criteria. The NICE ACD states that:
- Baseline BASDAI must be at least 6 units (4 units in BSR/ASAS);
- Assessment at 3 months must show a drop of at least 6 units in BASDAI (2 unit drop or a 50% drop in baseline BASDAI per BSR/ASAS); this must continue to be maintained at regular 3-monthly assessments.
The published report [4] demonstrated that all 30 patients were eligible to go onto anti-TNF therapy according to the BSR guidelines (with a mean baseline BASDAI of 6.8) and only one failed the BSR re-assessment criteria at 3 months. A total of 29 patients showed a rapid and dramatic response with a mean BASDAI at 2-month assessment of 3.2, which was maintained for up to 20 months of follow up.
Current data was available on 31 patients (10 female, 21 male) with a mean age of 51.2 yrs (range 23–70 yrs). Twenty-two patients were on etanercept and nine were on infliximab. Only 24 patients had a baseline BASDAI 
6.0 units rendering them eligible for treatment under the NICE ACD, although the mean BASDAI at baseline was 7.4 (Table 1). Of these 24 patients, 15 failed to have a drop of 6.0 units at their first assessment, with a mean BASDAI of all 31 patients of 2.9 units.
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All 31 patients would have met the BSR guidelines for starting treatment and 93.5% passed the 3-month assessment and 89.5% the 12-month assessment, as shown in Fig. 1. This compares with only 77.4% of patients being eligible for treatment under the NICE ACD recommendations, only 29.0% achieving the required 6.0 unit drop in BASDAI at the first assessment, and 21.1% remaining eligible at 12 months. All 31 patients reported feeling considerable benefit whilst on this anti-TNF treatment and were able to reduce or stop their NSAIDs and analgesics.
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In conclusion, this review of 31 patients’ eligibility for, and response to, treatment with anti-TNF therapy indicates that many patients who would have been eligible for treatment under the BSR guidelines would no longer qualify for treatment if NICE's ACD recommendations are implemented. This is despite showing a rapid and sustained response to this treatment.
The current NICE ACD, if allowed to proceed, will deny many patients the opportunity of exposure to anti-TNF therapy, who would otherwise receive significant benefit from this treatment. The Minimum Clinically Important Difference (MCID) for BASDAI has been calculated to be 1.0 unit [5]. The patients in Derby dropped by a mean of 4.6 units (95% confidence interval 3.9 to 5.3) between baseline and 3 months. Consequently these patients would have noticed a considerable improvement in their disease activity and yet the current NICE proposals would deny the majority from continuing on this medication. It would be cruel to take patients off this medication having achieved such marked benefit.
Further evidence needs to be gathered to establish the natural history of AS in patients not exposed to anti-TNF. With these data, appropriate adjustments can be made to health economic models to widen the availability of anti-TNF well beyond those currently proposed by NICE.
Conflict of Interest: The Department of Rheumatology at Derbyshire Royal Infirmary has received sponsorship from Wyeth, Abbott and Schering Plough Pharmaceuticals for support of clinical meetings, and unrestricted grants from Wyeth and Schering Plough to support an anti-TNF audit clerk and research nurse. Kate Gadsby sits on an advisory board for Schering Plough, and has received honoraria for talks at symposia sponsored by Wyeth and Abbott. Dr Deighton has previously sat on an advisory board for Schering Plough and received honoraria for talks at symposia sponsored by Wyeth and Abbott.
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- NICE. Appraisal Consultation Document – Adalimumab, etanercept and infliximab for ankylosing spondylitis. (2006) December. www.nice.org.uk/guidance/TA - Appraisals in development.
- Keat A, Barkham N, Bhalla A, et al. BSR guidelines for prescribing TNF- blockers in adults with ankylosing spondylitis. Report of a working party of the British Society for Rheumatology. Rheumatology (2005) 44:939–47.
[Free Full Text] - Braun J, Davis J, Dougados M, et al. First update of the international ASAS consensus statement for the use of anti-TNF agents in patients with ankylosing spondylitis. Ann Rheum Dis (2006) 65:316–20.
[Abstract/Free Full Text] - Gadsby K, Deighton C. Characteristics and treatment responses of patients satisfying the BSR guidelines for anti-TNF in ankylosing spondylitis. Rheumatology. Advance Access published 25 January 2007. doi:10.1093/Rheumatology/kel430.
- Pavy S, Brophy S, Calin A. Establishment of the Minimum Clinically Important Difference for the Bath Ankylosing Spondylitis Indices: a prospective study. J Rheumatol (2005) 32:80–5.
[Abstract/Free Full Text]
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