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 lifelong, 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.

People with psoriatic arthritis are usually treated initially with non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. Most people whose disease doesn’t respond to these drugs will be treated with a tumour necrosis factor alpha inhibitor (TNF-alpha inhibitor) starting with the lowest-cost drug as recommended in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis and golimumab for the treatment of psoriatic arthritis.

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 life, employment and social activities. Around 10% of patients stop TNF-alpha inhibitor treatment each year, either because it is contraindicated, or because of loss of effectiveness or adverse effects. There is, therefore, a clear clinical need for a range of treatment options.  

“The Committee considered the evidence on the use of apremilast both before and after TNF-alpha inhibitors and for people who aren’t able to take TNF-alpha inhibitors. The Committee concluded that apremilast is clinically effective compared with no other treatment. However, compared with TNF-alpha inhibitors, apremilast was the least clinically effective for treating psoriatic arthritis although some costs were saved by its use. Importantly, there was not enough robust evidence demonstrating that apremilast slows progression of the disease compared to TNF-alpha inhibitors. The Committee concluded that they were unable to recommend apremilast for treating active psoriatic arthritis because the costs saved were not sufficient to justify the health losses.”

This draft guidance does not mean that people currently taking apremilast will stop receiving it.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

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until final guidance is issued to the NHS, NHS organisations should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country. 

Ends

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Notes to Editors

About the draft guidance

1. The draft guidance is available from the NICE website at http://www.nice.org.uk/guidance/indevelopment/gid-tag468

 About psoriatic arthritis

1. Psoriatic arthritis is a type of inflammatory arthritis, which is often characterised by pain, stiffness and swelling around the joints - particularly the fingers, toes, wrists, knees and ankles. It is associated with the skin and nail condition psoriasis, which affects up to 3% of the UK population.
2. Up to 30% of people with psoriasis will develop inflammatory arthritis, usually within ten years of their diagnosis.

 About apremilast

1. Apremilast is a small-molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast down-regulates the inflammatory response by modulating the expression of inflammatory and anti-inflammatory cytokines and mediators associated with psoriatic arthritis (including tumour necrosis factor [TNF]-alpha and interleukin [IL]-23).
2. Apremilast has a marketing authorisation in the UK for its use ‘alone or in combination with disease-modifying antirheumatic drugs (conventional DMARDs), for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy’.
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. Apremilast is an oral tablet. The recommended dosage is 30 mg twice daily after an initial titration schedule. A single 10 mg dose is given on the first day of treatment; this is titrated to 30 mg twice daily over 5 days.
5. The price of apremilast is £265.18 for a 14-day treatment initiation pack (4×10 mg tablet; 4×20 mg tablet; 19×30 mg tablet) and £550.00 for a 28-day-treatment standard pack (56×30 mg) (excluding VAT; ‘Monthly Index of Medical Specialities’ [MIMS] online accessed March 2015). The cost of 12 months of treatment with apremilast is estimated at £7140.18 (company submission). Costs may vary in different settings because of negotiated procurement discounts.