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NICE provisionally recommends wider use of tocilizumab in treating rheumatoid arthritis

The National Institute for Health and Care Excellence (NICE) has today (7 October 2011) opened a consultation on draft guidance which provisionally recommends the use of tocilizumab (RoActemra, Roche) at additional stages in treating rheumatoid arthritis.

In August 2010, NICE issued guidance TA198 to the NHS recommending 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 it is contraindicated or has produced undesirable side effects. The new draft guidance is a rapid review of TA 198 following a new patient access scheme which the drug's manufacturer has agreed with the Department of Health.

The draft guidance sets out that in specific clinical circumstances, and only if the manufacturer provides tocilizumab with the discount agreed as part of the patient access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 provisionally recommended as an option 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 other TNF inhibitor treatments in NICE guidance TA130. The draft guidance also includes using tocilizumab as originally recommended in TA198 for people whose disease responded inadequately after both rituximab and TNF inhibitors were tried, and a recommendation on using tocilizumab when rituximab can't be used after TNF inhibitor treatment has failed. 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 major impact on quality of life, and can be a disabling condition. NICE has already recommended a range of treatments to help patients manage the disease. The draft guidance resulting from the rapid review of TA198 provisionally recommends that tocilizumab could be a treatment option at an earlier stage in the treatment pathway: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.

"If TNF inhibitor treatments have failed and patients are unable to take rituximab, the guidance also provisionally recommends that tocilizumab could be a treatment option at this point, potentially widening the choice of treatments available. We welcome comments on these draft recommendations as part of the consultation."

This is draft guidance: NICE has not yet issued final guidance to the NHS on the potential wider uses of tocilizumab for treating rheumatoid arthritis.

Ends

Notes to Editors

About the appraisal

1. The draft guidance recommendations in the consultation document, Tocilizumab for the treatment of rheumatoid arthritis (rapid review of technology appraisal guidance 198), are:

1.1 Tocilizumab in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults with active disease if:

  • the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and
  • the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme and
  • it is used as described for other tumour necrosis factor (TNF) inhibitor treatments in ‘Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis' (NICE technology appraisal guidance 130).

1.2 Tocilizumab, in combination with methotrexate, is only recommended for the treatment of rheumatoid arthritis in people whose disease has responded inadequately to one or more tumour necrosis factor alpha (TNF-α) inhibitors if:

  • their rheumatoid arthritis has responded inadequately to rituximab or rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect and
  • the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme.

1.3 Tocilizumab in combination with methotrexate is recommended as an alternative to rituximab for the treatment of rheumatoid arthritis in adults with active disease if:

  • there has been an inadequate response to other DMARDs, including a TNF inhibitor and
  • people cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event and
  • the manufacturer provides tocilizumab with the discount agreed as part of the patient access scheme and
  • it is used as described for other TNF inhibitor treatments in ‘Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor' (NICE technology appraisal guidance 195).

2. Further information on this appraisal is at http://guidance.nice.org.uk/TA/Wave18/63.

3. 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 manufacturer has agreed a patient access scheme with the Department of Health in which tocilizumab for the treatment of rheumatoid arthritis would be available with a discount applied to all invoices. The level of discount is commercial-in-confidence.

4. The guidance on tocilizumab published in August 2010 (http://guidance.nice.org.uk/TA198) recommends:

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

or

  • in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.

5. 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. Until final guidance is published, the current guidance on tocilizumab, TA198, remains in force. Further information on the rapid review process, is given in the NICE Single Technology Appraisal process guide, sections 5. 11 and 5.12 at: http://www.nice.org.uk/media/42D/B3/STAGuideLrFinal.pdf

6. NICE has previously recommended the following drugs as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs:

7. After treatment with a TNF inhibitor has failed, NICE has previously recommended as treatment options:

About NICE

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

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: 06 October 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.