NICE U-turn over Janssen arthritis drug

pharmafile | December 9, 2014 | News story | Sales and Marketing |  Janssen, NHS, NICE, Stelara, arthritis, ustekinumab 

NICE has reversed its decision on Janssen’s Stelara and is now recommending the active psoriatic arthritis drug.

The pricing watchdog previously rejected Stelara (ustekinumab) in March, stating that although the drug is clinically effective it ‘appeared less effective’ than the standard TNF alpha inhibitors.

This, combined with an average annual cost of between £10,000 and £18,600, led the body to conclude that it “could not be considered a good use of NHS resources”.

Janssen has now agreed a patient access scheme with the Department of health, which has allowed NICE to issue preliminary draft guidance recommending the treatment – although the drug is only being recommended for patients who are unable to use the existing treatments.

“Psoriatic arthritis is a debilitating condition that still has a lot of unmet clinical needs,” says Professor Iain McInnes, director of the Institute of Infection Immunity and Inflammation in the University of Glasgow. “It can have quite a devastating effect on a patient’s appearance and mobility, their self-esteem and thus on many elements of their quality of life.

“One of the challenges that we face as clinicians is that current psoriatic arthritis treatments do not work for every patient, or if they do, they may stop working over time. We are therefore delighted that we may be able to offer our patients another effective treatment option on the NHS, which works in a different way to other licenced therapies.”

Psoriatic arthritis is a chronic immune-mediated disorder characterised by inflammation of joints and connective tissues, as well as the skin lesions caused by psoriasis. Its severity ranges from mild inflammation to progressive joint erosion.

The disease affects an estimated 1.8 million people in the UK, approximately 2–3% of the population. Among patients with psoriasis the prevalence of psoriatic arthritis varies from 6% to 42 per cent. The condition can also occur in people without skin psoriasis, although this is less common.

The exact cause of the disorder is unknown: but genetic susceptibility, changes in the immune system and environmental factors are all believed to play a role. Stelara works by altering a specific part of the body’s immune system response thought to be linked to the development of psoriasis and psoriatic arthritis.

George Underwood