NICE green light a win for Lilly in RA market

Eli Lilly’s Olumiant (baricitinib) rheumatoid arthritis pill has passed a major market hurdle after gaining NICE approval.

The cost-effectiveness body recommended the drug after Lilly offered a confidential discount to the list price of around £10,500 per patient annually.

Olumiant is one of a new generation of treatments entering the highly competitive immunology and inflammation market, and its convenient pill formulation is seen as a major advantage for patients.

However NICE has only recommended it in adults who have responded to at least one biological DMARD if disease is severe and they cannot have rituximab.

Olumiant can only be used as a monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, NICE said.

The Janus kinase (JAK) 1/2 inhibitor drug gained EU approval earlier this year, but suffered a setback when the FDA rejected it.

The US regulator asked for further clinical data to determine the appropriate doses. Olumiant had been predicted to be a blockbuster for Lilly, but the FDA rejection has thrown this into doubt, and rival companies are seeking to capitalise on this with their newly launched or later-stage contenders.

NICE is also reviewing Pfizer’s competitor JAK inhibitor, Xeljanz (tofacitinib), which was approved in the EU in March after years of delays following a previous rejection.

Most of these new contenders have generated trial data showing themselves to be at least as good as AbbVie’s Humira (adalimumab), the current market leader.

Aside from Pfizer’s drug, Lilly is competing with Sanofi, which only this week got its latest rheumatoid arthritis drug Kevzara approved in Europe.

GSK and Janssen also have sirukumab under review in the US and EU, and AbbVie and Gilead both have JAK-1 inhibitors in clinical development.

However many biosimilar versions of existing RA treatments are hitting the market, including Sandoz's etanercept copy, Erelzi, which was launched this week in the UK.

These cheaper biosimilar drugs will make it harder for new treatments like Olumiant to gain market share, another reason why Lilly felt it necessary to offer NICE a lower price.