As part of the National Institute for Health and Clinical Excellence (NICE) 
single technology appraisal (STA) process, the manufacturer of apremilast was 
invited to submit evidence for its clinical and cost effectiveness for the 
treatment of active psoriatic arthritis (PsA) for whom disease-modifying 
anti-rheumatic drugs (DMARDs) have been inadequately effective, not tolerated or 
contraindicated. The Centre for Reviews and Dissemination and Centre for Health 
Economics at the University of York were commissioned to act as the independent 
Evidence Review Group (ERG). This paper provides a description of the ERG review 
of the company's submission, the ERG report and submission and summarises the 
NICE Appraisal Committee's subsequent guidance (December 2015). In the company's 
initial submission, the base-case analysis resulted in an incremental 
cost-effectiveness ratio (ICER) of £14,683 per quality-adjusted life-year (QALY) 
gained for the sequence including apremilast (positioned before tumour necrosis 
factor [TNF]-α inhibitors) versus a comparator sequence without apremilast. 
However, the ERG considered that the base-case sequence proposed by the company 
represented a limited set of potentially relevant treatment sequences and 
positions for apremilast. The company's base-case results were therefore not a 
sufficient basis to inform the most efficient use and position of apremilast. 
The exploratory ERG analyses indicated that apremilast is more effective (i.e. 
produces higher health gains) when positioned after TNF-α inhibitor therapies. 
Furthermore, assumptions made regarding a potential beneficial effect of 
apremilast on long-term Health Assessment Questionnaire (HAQ) progression, which 
cannot be substantiated, have a very significant impact on results. The NICE 
Appraisal Committee (AC), when taking into account their preferred assumptions 
for HAQ progression for patients on treatment with apremilast, placebo response 
and monitoring costs for apremilast, concluded that the addition of apremilast 
resulted in cost savings but also a QALY loss. These cost savings were not high 
enough to compensate for the clinical effectiveness that would be lost. The AC 
thus decided that apremilast alone or in combination with DMARD therapy is not 
recommended for treating adults with active PsA that has not responded to prior 
DMARD therapy, or where such therapy is not tolerated.