3 June 2014

NICE Guidance on Ustekinumab for Psoriatic Arthritis

NICE has published final guidance today which does not recommend ustekinumab (Stelara) for psoriatic arthritis.

Psoriatic arthritis is an inflammatory disease affecting the joints and connective tissue, and is associated with psoriasis of the skin or nails. It is a progressive disorder, ranging from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

The Independent Appraisal Committee examined the clinical and cost effectiveness of using ustekinumab alone or in combination with methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

This final guidance does not mean that people currently taking ustekinumab will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Sir Andrew Dillon, NICE chief executive, said: “The Independent Appraisal Committee reviewed the evidence on ustekinumab, including evidence on the nature of psoriatic arthritis, the views of people with the condition, those who represent them, and clinical specialists. The Committee understood that psoriatic arthritis is a chronic condition that can have a significant physical and psychological impact on an individual's life, employment and social activities.

“The Committee accepted that ustekinumab is clinically effective compared with conventional DMARD treatment, but the Committee concluded that ustekinumab appeared less effective than TNF alpha inhibitors. The Committee also noted that the economic analyses found that ustekinumab was not a cost-effective option. Whilst recognising the severity of the disease, the Committee concluded that ustekinumab could not be considered a good use of NHS resources. NICE currently recommends golimumab, adalimumab, etanercept and infliximab for treating active and progressive psoriatic arthritis in adults (technology appraisal guidance 220 and 199).”


About the guidance

  1. The guidance is available at http://guidance.nice.org.uk/ta313.
  2. The recommendations are:
    • Ustekinumab is not recommended within its marketing authorisation for treating active psoriatic arthritis, that is, alone or in combination with methotrexate in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
    • People currently receiving treatment initiated within the NHS with ustekinumab that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
  3. Ustekinumab (Stelara, Janssen) is a monoclonal antibody (a biological therapy designed to recognise and attach to specific proteins on the surface of cells). It acts as a cytokine inhibitor (blocker of molecular messages) by targeting interleukin-12 (IL-12) and interleukin-23 (IL-23) (interleukins are proteins produced by white blood cells for regulating immune responses).
  4. The Committee concluded that ustekinumab is not a cost-effective treatment option for people who have not previously received TNF alpha inhibitors, for those cannot take them, or for those who have received TNF alpha inhibitors. In the economic analysis for people who have not previously received TNF alpha inhibitors (the ‘TNF alpha inhibitor-naive' population), ustekinumab was dominated by - that is, was more expensive and less effective than - adalimumab. In all other populations, including people who have previously received TNF alpha inhibitors (the ‘TNF alpha inhibitor-exposed' population) and people for whom TNF alpha inhibitors are not appropriate, the most plausible incremental cost-effectiveness ratio (ICER) for ustekinumab is likely to exceed £30,000 per quality-adjusted life year (QALY) gained.
  5. Ustekinumab is administered by subcutaneous injection. Ustekinumab has a UK marketing authorisation for use alone or in combination with methotrexate ‘for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate'. The recommended dose of ustekinumab is an initial dose of 45 mg, followed by a dose 4 weeks later and further doses every 12 weeks thereafter. A dose of 90 mg may be used in people with a body weight over 100 kg. The summary of product characteristics notes that consideration should be given to discontinuing treatment in people whose psoriatic arthritis has shown no response after up to 28 weeks of treatment.
  6. The list price for ustekinumab is £2147 per 45-mg vial (excluding VAT; British National Formulary edition 66, September 2013). The average annual acquisition costs for ustekinumab 45 mg and 90 mg are £10,735 and £21,470 in the first year and £9304 and £18,608 per year thereafter respectively. Costs may vary in different settings because of negotiated procurement discounts.
  7. DMARDs (disease-modifying antirheumatic drugs) are medicines that help reduce damage to the joints by altering the underlying disease rather than treating the symptoms caused by the condition. Conventional DMARDs include methotrexate and sulfasalazine. Biological treatments, including TNF alpha inhibitors such as golimumab and etanercept are also disease-modifying antirheumatic drugs, but in this guidance they are referred to as TNF alpha inhibitors.


About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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