The National Institute for Health and Care Excellence (NICE) has issued a positive final appraisal recommending the use of Celgene’s Otezla (apremilast) for adult patients with chronic plaque psoriasis in England and Wales.
This positive decision ensures patients in England and Wales will join their Scottish counterparts, who have had access to Otezla OA since its recommendation by the Scottish Medicines Consortium (SMC) in June 2015.
Affecting about 960,000 adults in the U.K., psoriasis is an immune condition that causes symptoms on the skin and sometimes in the joints. Psoriasis causes the skin replacement process to speed up, and skin cells build up to form raised “plaques” on the skin, which also can be flaky, scaly, red and itchy.
Professor Chris Griffiths, MD, professor of dermatology at the University of Manchester, said in a press release that “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 … ,” Griffiths said.
Otzela is a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4) and inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells. The drug helps to control the inflammation associated with psoriasis, and reduces symptoms of the condition.
The drug is approved for the treatment of patients with moderate-to-severe plaque psoriasis for whom phototherapy (PUVA), or systemic therapy, such as ciclosporin or methotrexate, is not appropriate. The tablet has a novel mode of action, not requiring patients to be pre-screened for tuberculosis or regular laboratory checkups.
While NICE recognized the clinical benefit of Otezla for treating chronic plaque psoriasis, it has stipulated that the disease must be classified as severe – as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10.
Carla Renton, Information and Communications Manager at the Psoriasis Association said “This decision is welcomed by the Psoriasis Association. … An increase in the choice of treatment options for people with psoriasis is invaluable in helping them regain control of their condition and of their day-to-day lives.”
Dani Thomas, MD, medical director at Celgene UK & Ireland, added that “Celgene has been working with NICE over the past year to ensure patients in England and Wales can benefit from Otezla. We are delighted that eligible people with psoriasis looking for a much needed oral treatment will now have access to Otezla.”
The U.S. Food and Drug Administration approved Otezla for the treatment of certain types of psoriasis and psoriatic arthritis in 2014.
In clinical trials, Otezla has been shown to lead to clinical improvements in patients with psoriatic arthritis, including signs and symptoms such as itch, skin pain and discomfort. Recently, a Phase 3 clinical trial reported the beneficial clinical effects of Otezla in the setting of psoriasis arthritis. Results from the clinical trial (NCT01212757) are published in The Journal of Rheumatology, in in the article “A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.” This study showed that Otezla led to clinical improvements in psoriatic arthritis for up to 52 weeks, including signs and symptoms, physical function and psoriasis.
Otezla is currently undergoing NICE Rapid Review for active psoriatic arthritis. NICE has issued a positive Appraisal Consultation Document recommending the drug for use in the National Health Service on Oct. 11, with a decision expected later this year.
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