NICE confirms negative guidance for Celgene's Otezla

The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has published final draft guidance today which does not recommend US biotech major Celgene (Nasdaq: CELG) Otezla (apremilast) for adults with active psoriatic arthritis that has either not responded to disease-modifying antirheumatic drug (DMARD) therapy, or where such therapy is not tolerated.

The latest guidance confirms an interim decision  earlier this year. Otezla received European marketing authorization early this year, and Celgene has previously forecast it could achieve annual sales of $1.5-$2.0 billion .

People with psoriatic arthritis are usually treated initially with non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. Most people whose disease doesn’t respond to these drugs will be treated with a tumor necrosis factor alpha inhibitor (TNF-alpha inhibitor) starting with the lowest-cost drug as recommended in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis and golimumab for the treatment of psoriatic arthritis.

NICE Health Technology Evaluation Centre director Carole Longson commented: “Psoriatic arthritis is a chronic condition that can have a significant physical and psychological impact on an individual’s life, employment and social activities. Around 10% of patients stop TNF-alpha inhibitor treatment each year, either because it is contraindicated, or because of loss of effectiveness or adverse effects. There is, therefore, a clear clinical need for a range of treatment options.”