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NICE backs Lilly's rheumatoid arthritis drug Olumiant

The drug will be used alongside methotrexate to treat adults with severe, active RA

NICEThe UK medicines cost-effectiveness watchdog has recommended Eli Lilly's JAK inhibitor Olumiant as a treatment for some people with rheumatoid arthritis (RA).

In draft guidance, the National Institute for Health and Care Excellence (NICE) said it recommends Olumiant (baricitinib) alongside methotrexate as an option for severe, active RA in adults whose disease has not responded adequately to conventional disease-modifying anti-rheumatic drugs (DMARDs).

It also says the drug should be used in patients who have had an inadequate response to, or who cannot take other DMARDs, including at least one biological DMARD, and notes the JAK inhibitor can be used on its own if methotrexate is contraindicated.

The wording is tighter than Olumiant's approved indication of moderate-to-severe RA, with NICE giving its backing to the drug only in patents who have a disease activity score of more than 5.1 on the DAS28 scale - in other words patients at the upper end of disease severity.

It also says treatment with the drug should be discontinued if it fails to achieve a moderate response six months after starting therapy.

Olumiant was the first JAK inhibitor to be approved for RA in Europe - although rival drug Xeljanz/Jakvinus (tofacitinib) from Pfizer claimed the first approval in this indication in the US in 2012 - and has been tipped to become a blockbuster with sales of $2.4bn or more at peak. It is still is still under review in the US, where the Food and Drug Administration has asked for additional data before it can consider approval.

Lilly's drug was cleared on the back of studies showing it is more effective than methotrexate and AbbVie's injectable TNF inhibitor Humira (adalimumab) - currently the biggest-selling drug in the world - at alleviating symptoms in RA patients.

Olumiant is estimated to cost around £10,500 per patient per year at its list price, but has been offered at a discount to the NHS via a confidential patient access scheme.

"Clinical trials showed baricitinib plus conventional … DMARDs to be more effective than conventional DMARDs alone for treating severe active RA that has not responded adequately to conventional or biological DMARDs," says the guidance, which subject to a final review process should be finalised next month.

"Some trial evidence also suggests that in people who have not previously had DMARDs, baricitinib works as well when taken alone as it does when taken with conventional DMARDs."

Article by
Phil Taylor

30th June 2017

From: Regulatory



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