NICE Won’t Support Celgene’s Otezla
Citing cost concerns, the UK’s healthcare watchdog is recommending against Celgene’s Otezla alone or in combination with disease-modifying antirheumatic drug therapies for adults with active psoriatic arthritis.
In draft guidance, the National Institute for Health and Care Excellence says Otezla’s cost of approximately $105,000 for a 12-month treatment is substantially more than the acceptable range of $31,750 to $47,600.
The setback comes just weeks after Germany’s cost control agency recommended against Otezla (apremilast), citing a lack of evidence that it offers added benefit over available therapies for patients with moderate to severe chronic plaque psoriasis or active psoriatic arthritis.
Otezla received FDA approval in March 2014 to treat adults with psoriatic arthritis. In September, the agency granted an extended indication for use in treatment-experienced and treatment-naïve patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy are appropriate.
Celgene could not be reached for comment by press time. Read the NICE draft guidance at www.fdanews.com/06-22-15-otezlaguidance.pdf. — John Bechtel