NICE provisionally recommends new drug for ankylosing spondylitis
In draft guidance, published today (24 June), the National Institute for Health and Care Excellence (NICE) provisionally recommends golimumab (Simponi) as an option for treating ankylosing spondylitis in specific circumstances.
Golimumab is provisionally recommended for the treatment of severe, active ankylosing spondylitis in adults only if it's used as described for other tumour necrosis factor (TNF) inhibitor treatments - adalimumab and etanercept - as covered by NICE technology appraisal 143, and the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose. NICE has not yet issued final guidance to the NHS.
Ankylosing spondylitis is an inflammatory disease of unknown cause. The principal feature of ankylosing spondylitis is inflammation of the sacroiliac joint at the base of the spine followed by inflammation rising along the spine. The result is back pain and stiffness. Inflammation at the sites where ligaments and tendons attach to bone can lead to new bone development and joint fixation (ankylosis), where joints and bones fuse together.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “Ankylosing spondylitis is a progressive and irreversible condition which causes a great deal of pain and discomfort for individuals, and has a huge impact on day-to-day life. This provisional recommendation of golimumab for this disabling condition means that it could join adalimumab and etanercept as treatment options for ankylosing spondylitis.
“The evidence considered persuaded the Committee that golimumab demonstrated comparable clinical and cost effectiveness to adalimumab and etanercept - the two drugs already recommended by NICE for this condition. Given the resulting positive draft recommendation for golimumab, this appraisal has gone straight to the final draft guidance stage to expedite the process and help people with ankylosing spondylitis to potentially get this further treatment option as quickly as possible.”
The recommendations given in TA143, which now also provisionally apply to golimumab, say that the recommended drugs are treatment options for adults with severe active ankylosing spondylitis only if all of the specified clinical criteria are fulfilled. This includes:
- having active spinal disease as assessed on two separate occasions 12 weeks apart
- failure of conventional treatment with at least two non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage to control symptoms.
Further recommendations in TA 143 are given on how the response to treatment should be monitored and the use of an alternative treatment in the case of intolerance. It is also recommended that treatment should be supervised only by specialist physicians experienced in the diagnosis and management of ankylosing spondylitis.
The provisional recommendations in today's draft guidance say that people currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept as described in TA 143 should have the option to continue golimumab until they and their clinician consider it appropriate to stop.
The final draft guidance on golimumab is now open for appeal. Until final guidance is issued NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the appraisal ‘Golimumab for the treatment of ankylosing spondylitis'
2. NICE currently recommends adalimumab and etanercept for treating severe ankylosing spondylitis.
3. The manufacturer of golimumab (Simponi) is Merck Sharp and Dohme (MSD).
4. Golimumab is a human monoclonal antibody that neutralises the activity of tumour necrosis factor alpha (TNF alpha) by preventing it binding to its receptors. TNF alpha is thought to be involved in causing inflammation of the skin and joints.
Golimumab is injected subcutaneously via a pre-filled injection pen. The recommended dose is 50 mg given monthly on the same day of each month. The SPC states that the available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after three to four doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this period. In people who weigh more than 100 kg and whose ankylosing spondylitis does not show an adequate clinical response after three or four doses, the dose of golimumab may be increased to 100 mg once a month. The cost of golimumab is £762.97 for a 50 mg pre-filled injection pen (excluding VAT; from manufacturer May 2011) which is equivalent to an annual cost of £9155.64 (based on the 50 mg dose). Costs may vary in different settings because of negotiated procurement discounts.
The manufacturer of golimumab has agreed a patient access scheme with the Department of Health in which the 100 mg dose of golimumab will be available to the NHS at the same cost as the 50 mg dose. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.
5. NICE has just approved golimumab both for the treatment of rheumatoid arthritis after failure of previous disease-modifying anti-rheumatic drugs (published 22 June 2011: http://guidance.nice.org.uk/TA225), and recently also for psoriatic arthritis (published 27 April, http://www.nice.org.uk/newsroom/pressreleases/GolimumabForPsoriaticArthritis.jsp).
6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
7. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
8. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
- NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 24 June 2011