Janssen’s Stelara could be recommended by NICE as a treatment option for patients with active psoriatic arthritis a year after the Institute was minded to reject the treatment.
In final appraisal determination, Stelara (ustekinumab) could be recommended either alone, or in combination with methotrexate, as a second-line therapy.
It is specifically for patients whose response to previous non-biological disease modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
It is also likely to be recommended for patients who have had treatment with one of more TNF-alpha inhibitors, such as Janssen’s own Simponi (golimumab) and Remicade (infliximab), as well as AbbVie’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept).
NICE last year said it would not recommend the drug as it was too costly, but a patient access scheme – which cuts the price of the medicine – has since been offered by the firm, helping it get onto the NHS’s funding stream.
The FAD also limits the drug to be used after others have been tried, meaning its sales potential in England will be knocked as it will not be funded as a first-line therapy.
Peter Barnes, medical director at Janssen UK, said of the decision: “We are delighted with today’s recommendation from NICE. We know that people living with psoriatic arthritis are in real need of additional treatment choices that can help them manage a debilitating and often painful condition.
“Ustekinumab could have a marked positive impact of the quality of life for many of these patients living with active psoriatic arthritis and represents an important additional treatment option for this condition.”
The list price for the treatment is £2,147 per 45mg vial, and NICE estimates that the average annual cost for a 45mg and a 90mg dose are £10,735 and £21,470 in the first year, and £9,304 and £18,608 per year thereafter respectively.
Stelara is already recommended by NICE to treat the skin disease plaque psoriasis.
The drug works by altering a specific part of the body’s immune system response that is thought to be linked to the development of psoriasis and psoriatic arthritis.
Professor Dennis McGonagle, honorary consultant rheumatologist at Leeds NHS Trust Teaching Hospitals, added: “We know that [Stelara] is an effective treatment option, which works in a different way to other licensed therapies.
“The ability to prescribe varied treatment options is of the utmost importance when managing patients with active psoriatic arthritis, given that so many patients struggle to find a treatment which works for them with some patients also experiencing toxicities from the available treatments.”
Psoriasis affects around 1.8 million people in the UK – around 2-3% of the population.