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NICE has published final guidance recommending ustekinumab (Stelara) as a treatment option for psoriatic arthritis in certain circumstances.

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 that can range from mild synovitis (inflammation of the tissue lining joints such as the hip or shoulder) to severe progressive erosion of the joints.

In May 2014, NICE issued technology appraisal guidance 313 which did not recommend 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 updated guidance – which now recommends ustekinumab in specific circumstances – is a rapid review of TA313 following the introduction of a patient access scheme which the company that manufactures ustekinumab has agreed with the Department of Health.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “Psoriatic arthritis is a chronic condition that can have a significant physical and psychological impact on an individual’s day-to-day life. NICE has already recommended a range of treatments (referred to as TNF-alpha inhibitors) – golimumab, adalimumab, etanercept and infliximab – to help manage active and progressive psoriatic arthritis in adults.  

“This guidance resulting from the rapid review of TA313 now recommends that ustekinumab could be a treatment option for people who are unable to use the drugs that NICE has already recommended, or who have already had treatment with 1 or more of those drugs. This applies if the company provides the drug as agreed in the patient access scheme.”

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the guidance on ustekinumab for psoriatic arthritis

1. The guidance is available on the NICE website athttp://www.nice.org.uk/guidance/ta340.
2. The guidance states that:

•   Ustekinumab is recommended as an option, alone or in combination with methotrexate, for treating active psoriatic arthritis in adults only when:

- treatment with TNF-alpha inhibitors is contraindicated but would otherwise be  considered (as described in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis and golimumab for the treatment of psoriatic arthritis) or

- the person has had treatment with 1 or more TNF-alpha inhibitors.

Ustekinumab is recommended only if the company provides the 90 mg dose of ustekinumab for people who weigh more than 100 kg at the same cost as the 45 mg dose, as agreed in the patient access scheme.

• Ustekinumab treatment should be stopped if the person’s psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 24 weeks. An adequate response is defined as an improvement in at least 2 of the 4 criteria (1 of which must be joint tenderness or swelling score) with no worsening in any of the 4 criteria. As recommended in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis, people whose disease has a Psoriasis Area and Severity Index (PASI) 75 response but whose PsARC response does not justify continuing treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see NICE technology appraisal guidance on ustekinumab for the treatment of adults with moderate to severe psoriasis).
• When using the Psoriatic Arthritis Response Criteria (PsARC) healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person's responses to components of the PsARC and make any adjustments they consider appropriate.
• People whose treatment with ustekinumab is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

 About ustekinumab            

1. 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).
2. Ustekinumab has a marketing authorisation in the UK 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’.
3. DMARDs 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.
4. The Committee concluded that, with the patient access scheme, ustekinumab is a cost effective option:

• in people who have not previously had TNF-alpha inhibitors and for whom TNF alpha inhibitors are inappropriate; the most plausible incremental cost effectiveness ratio (ICER) was £21,900 per quality-adjusted life year (QALY) gained, compared with conventional management.
• in people who have previously had TNF-alpha inhibitors and for whom treatment with a subsequent TNF-alpha inhibitor is appropriate; the most plausible ICER was £25,400 per QALY gained.
• in people who have previously had TNF-alpha inhibitors and for whom TNF-alpha inhibitors as a class have failed; the most plausible ICER was £25,300 per QALY gained, compared with conventional management.

1. The summary of product characteristics recommends that ustekinumab is used at 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 stopping treatment in people whose psoriatic arthritis has shown no response after up to 28 weeks of treatment.

The average annual acquisition costs for ustekinumab 45 mg is £10,735 in the first year and £9304 per year thereafter. The company has agreed a patient access scheme with the Department of Health, in which the company provides the 90 mg dose (2 vials) at the same cost as the 45 mg dose (1 vial), for people who weigh more than 100 kg and need the higher dose. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

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.

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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