Celgene has announced that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral OTEZLA® (apremilast) following a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE).1 The decision is the conclusion of a NICE Rapid Review, and ensures patients in England and Wales join those in Scotland, who have been benefitting from access to OTEZLA since it was recommended by the Scottish Medicines Consortium (SMC) in June 2015.
Psoriasis, an inflammatory disease of the skin,4 is estimated to affect around 960,000 adults in the UK.5,6 Despite there being a number of effective treatment options available for psoriasis, evidence suggests that a substantial proportion of people with psoriasis recognise the need for new treatments.7
Professor Chris Griffiths, Professor of Dermatology, University of Manchester commented: "NICE's decision to recommend apremilast for the treatment of psoriasis is an important step forward in the management of a disease which for many patients can have a significant detrimental effect on their lives. Apremilast offers patients a much needed new oral treatment option that does not require routine laboratory monitoring. Clinical trials of apremilast demonstrated a reduction in severity of psoriasis and associated itching as well as improvement in hard to treat areas, such as the nails and scalp. The drug has the potential to fill an important gap in the psoriasis treatment pathway and its introduction is welcomed by patients and healthcare practitioners."
Unlike current systemic treatments available for psoriasis, OTEZLA does not require regular laboratory monitoring or pre‐treatment screening,2,3 which may help reduce the burden of hospital visits for patients.
NICE recognises the clinical benefit and innovation of OTEZLA by recommending it for use in England and Wales as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet‐A light), or when these treatments are contraindicated or not tolerated, only if:
- the disease is severe, as defined by a total Psoriass Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 101
OTEZLA, a tablet, has a novel mechanism of action reducing the activity of an enzyme called phosphodiesterase 4 (PDE4). PDE4 has been implicated in the process of inflammation. By reducing the activity of this enzyme, OTEZLA can help to modulate the inflammatory process associated with psoriasis.8,9 Over 100,000 patients worldwide have already been treated with OTEZLA.10
In clinical trials, treatment with OTEZLA for psoriasis showed a reduction in psoriatic skin plaques and other signs and symptoms of the disease including itch, skin pain and discomfort.11,12 OTEZLA also showed improvements in nail and scalp psoriasis2,12 and the quality of life in patients with psoriasis.2 Most adverse reactions were considered to be mild or moderate in severity. Gastrointestinal (GI) symptoms including nausea and diarrhoea were the most commonly reported adverse reactions in the Phase III clinical studies.2 In a long‐term pooled analyses for patients taking OTEZLA up to 182 weeks, there was no increase in severity or frequency of adverse events.13
OTEZLA is currently undergoing NICE Rapid Review for active psoriatic arthritis. A positive Appraisal Consultation Document (ACD) recommending OTEZLA for use in the NHS was issued by NICE on 11th October 2016.14 A final decision is expected later this year.