Celgene announced today that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of OTEZLA (apremilast) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response to or have been unable to tolerate Disease Modifying Anti-Rheumatic Drugs (DMARDs). OTEZLA does not require pre-screening for tuberculosis or regular laboratory monitoring.
“Psoriatic arthritis is a chronic disease that causes significant strain on NHS resources,” said Dr Helena Marzo-Ortega, Honorary Senior Lecturer and Consultant at Leeds Teaching Hospitals NHS Trust. “Addressing the symptoms of both psoriasis and psoriatic arthritis, the availability of Otezla on the NHS marks a major milestone in the management of psoriatic arthritis.”
Psoriatic arthritis is a complex disease which involves multiple manifestations that can impact skin and joints and is most common in people aged 30 years to 50 years. It is estimated that over 296,000 people in the UK are affected by this incapacitating disease.Living with psoriatic arthritis can hinder a person’s ability to carry out simple everyday activities; from getting in or out of bed, to walking outdoors on flat ground.
Following initial negative guidance issued by NICE in September 2015, the drug was reappraised under the NICE Rapid Review process. Alone or in combination with DMARDs, is now recommended with a Patient Access Scheme for adults with active psoriatic arthritis when:
- they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and
- their disease has not responded to adequate trials of at least 2 standard DMARDs, given either alone or in combination
Today’s decision brings access for patients in England and Wales in line with those in Scotland, where OTEZLA was recommended by the Scottish Medicines Consortium (SMC) in June 2015.
Dr Dani Thomas, Medical Director, Celgene UK & Ireland, commented: “We are delighted that patients in England and Wales can now access OTEZLA via the NHS, bringing availability in line with patients in Scotland. Otezla’s novel mechanism of action and oral administration provides psoriatic arthritis patients with a much needed treatment option. Celgene will continue our dedication to develop and deliver innovative medicines for people affected by diseases where there is a high unmet need.“