NICE Approves Baricitinib After Maker Prices for Competition With Biologics, Biosimilars

The United Kingdom (UK)’s National Institute for Health and Care Excellence (NICE), which provides value guidance to the National Health Service, has published its final appraisal determination for baricitinib (Olumiant), a Janus kinase inhibitor, recommending use of the drug as an option for treating severe active rheumatoid arthritis (RA).

NICE recommends the drug together with methotrexate in adults whose RA has not responded adequately to therapy with conventional disease-modifying anti-rheumatic drugs (DMARDs), and as monotherapy for patients who cannot tolerate methotrexate.

The clinical trial data reviewed by NICE demonstrated that combining baricitinib with DMARDs is more effective than treatment with DMARDs alone. The institute also referred to trial evidence that suggested that, in patients who had not previously been treated with DMARDs, baricitinib worked as well when taken alone as it did when taken with a DMARD. Clinical evidence was derived from 4 phase 3, randomized, controlled trials along with 1 long-term safety and tolerability study. NICE noted that the safety profile of baricitinib was similar to that of DMARDs, and that a head-to-head comparison of baricitinib and adalimumab also demonstrated a similarity in safety.

NICE’s evaluation of baricitinib stands in contrast to the US FDA’s opinion of the drug; while baricitinib received its European marketing approval earlier this year, the FDA issued Eli Lilly and Incyte a complete response letter in April, citing a need for additional clinical data that would help to determine an appropriate dose of the therapy.

According to NICE, Eli Lilly arrived at a confidential deal with the UK’s Department of Health to offer baricitinib at a discount to its list price of £10,501 per patient per year. Some have suggested that the recent influx of biosimilar products, including Sandoz’s newly approved Erelzi, into the European RA market explains Lilly’s apparent eagerness to arrive at a price deal with NICE; if new small-molecule drugs such baricitinib are to gain market share, their price points will have to compete with the cost savings provided by biosimilars in the same therapeutic areas.