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NICE recommends earlier use of tocilizumab in treating rheumatoid arthritis
London, UK (February 21, 2012) – The National Institute for Health and Clinical Excellence (NICE) has today (Wednesday 22 February 2012) (RoActemra, Roche) at an additional stage in treating rheumatoid arthritis.
The new guidance published today is a rapid review of the 2010 guidance, TA198, following a new patient access scheme which the manufacturer has agreed with the Department of Health. The guidance sets out that in specific clinical circumstances, and only if the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme, tocilizumab is also now recommended alongside other options for treating rheumatoid arthritis at an earlier point in the treatment pathway. This is where the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and tocilizumab is used as described for tumour necrosis factor (TNF) inhibitor treatments in .
NICE’s original guidance TA198 recommended that the NHS offers tocilizumab as an option for people with rheumatoid arthritis if there has been an inadequate response to one or more TNF inhibitors and where rituximab has also produced an inadequate response or where rituximab is contraindicated or has produced undesirable side effects. TNF inhibitors are treatment options after DMARDs have failed to produce an adequate response. The new guidance still includes these recommendations, and in all cases this is on the basis that the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme.
Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: "Rheumatoid arthritis can have a huge impact on quality of life and for many it’s a disabling condition, so we’re pleased to recommend tocilizumab at an additional stage in treating the condition.
"Today’s new guidance recommends tocilizumab alongside other treatment options earlier in the treatment pathway: after treatment with conventional drugs – DMARDS – has failed. We have already recommended the TNF inhibitors adalimumab, etanercept, infliximab, certolizumab pegol and golimumab for some people with rheumatoid arthritis as options for use at this stage; tocilizumab is now added as another option alongside these treatments.
"If TNF inhibitor treatments have failed and patients are unable to take rituximab or rituximab has also failed, the guidance also recommends that tocilizumab could be a treatment option at this point. This guidance complements the range of treatments that NICE has previously recommended for different stages of rheumatoid arthritis to help patients manage this difficult condition."
Notes to Editors
About the final guidance: Tocilizumab for the treatment of rheumatoid arthritis (rapid review of technology appraisal guidance 198)
2. This guidance replaces NICE technology appraisal guidance 198 issued in August 2010. The guidance recommendations are:
2.1 Tocilizumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults if:
the disease has responded inadequately to DMARDs and a TNF inhibitor and the person cannot receive rituximab because of a contraindication to rituximab, or because rituximab is withdrawn because of an adverse event, and tocilizumab is used as described for TNF inhibitor treatments in (NICE technology appraisal guidance 195), specifically the recommendations on disease activity or
the disease has responded inadequately to one or more TNF inhibitor treatments and to rituximab
and the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme.
2.2 People currently receiving tocilizumab for the treatment of rheumatoid arthritis who do not meet the criteria in 2.1 should have the option to continue treatment until they and their clinicians consider it appropriate to stop).
3. The recommendations in this new guidance place tocilizumab alongside other recommended treatment options, not automatically ahead of the other options. In line with the recommendation in TA130 (section 1.7), treatment should normally be initiated with the least expensive drug (taking into account administration costs, required dose and product price per dose). This may need to be varied in individual cases due to differences in the mode of administration and treatment schedules.
4. The annual acquisition cost of tocilizumab is £9295 per year for a patient weighing approximately 70 kg. Costs may vary in different settings because of negotiated procurement discounts. The Department of Health and the manufacturer have agreed that tocilizumab will be available to the NHS with a patient access scheme in which a discount from the list price is applied to original invoices. The level of the discount is commercial in confidence.
5. The committee considered several of scenarios for including tocilizumab in the treatment pathway. Across all of these scenarios, the most plausible estimate for the ICER ranged from £10,700 per QALY gained to £30,100 per QALY gained. Further detail is given is sections 4.21 to 4.23 of the guidance.
6. The number of people with rheumatoid arthritis is estimated to be 400,000 across England and Wales. The number of people that might be able to use tocilizumab will be comparable to the number of patients that are considered eligible to use TNF inhibitors, which is approximately 10% of the number of people with rheumatoid arthritis.
Tocilizumab (RoActemra), in combination with methotrexate, is recommended for the treatment of rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more TNF inhibitors and:
whose rheumatoid arthritis has responded inadequately to rituximab
in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.
8. A rapid review facility is available to consider new patient access schemes if submitted within 16 weeks of original guidance publication. NICE can only consider these schemes after ministerial approval and confirmation by the Department of Health. Further information on the rapid review process is given in the , sections 5. 11 and 5.12 at:
9. NICE has previously recommended the following drugs as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs:
10. After treatment with a TNF inhibitor has failed, NICE has previously recommended as treatment options:
6. The National Institute for Health and Clinical 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
9. 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: 21 February 2012
National Institute for Health and Clinical Excellence (NICE), 21.02.2012 (tB).