LEO Pharma has welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending the use of Kyntheum®▼(brodalumab) 210mg for the treatment of adult patients with severe plaque psoriasis, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10, who have not responded to standard systemic therapies or who are unable to take them.
This recommendation is also contingent on the continued provision of a Patient Access Scheme (PAS), under which brodalumab is offered at a confidential discount to the NHS.
Following completion of the final consultation and subsequent publication of the technology appraisal guidance (TAG), expected in March 2018, brodalumab will be available to appropriate patients on the NHS in England and Wales.
Until that time, brodalumab continues to be available via an early use scheme.
NICE concluded that the clinical trial results showed brodalumab improves severe psoriasis more than placebo and ustekinumab, and is generally more cost-effective compared with other biological treatments used as comparators within the submission. Based on the strength of the submission, NICE issued a Final Appraisal Determination (FAD) rather than an Appraisal Consultation Document (ACD). The FAD forms the basis of the guidance that NICE issues to the NHS in England and Wales.
The prevalence of psoriasis in England specifically is approximately 959,000 people (1.75%), with 144,000 (15%) and 50,000 (5%) classified as moderate and severe, respectively.
Professor Richard Warren, Consultant Dermatologist, North West, Salford Royal NHS Foundation Trust and The University of Manchester, said: “This decision from NICE will be welcomed by dermatology clinicians. Once this recommendation is implemented, brodalumab, with its differentiated mode of action, will represent a valuable treatment option.”
Dr Sathish Kolli, Medical Director at LEO Pharma UK/IE, added, “As experts in the field of dermatology, we are determined to tackle the significant unmet needs facing people living with psoriasis and we welcome this news from NICE.”