NICE Recommends Simponi for Severe Non-Radiographical AS in England, Wales

Treatment with Merck’s Simponi (golimumab) is now recommended for patients with severe non-radiographic axial spondyloarthritis (nr-axial SpA) in England and Wales.

Nr-axial SpA and ankylosing spondylitis (AS) are collectively called axial spondyloarthritis. The term Nr-axial SpA was originally used to define cases of AS that do not exhibit radiographic evidence of sacroilitis, which is a potentially painful inflammation of one or both of the sacroiliac joints, located at the connection of the lower spine and pelvis.

Simponi is an antibody designed to block the pro-inflammatory cytokine (a molecule released by immune cells) tumor necrosis factor (TNF)-alpha, which is over-produced in ankylosing spondylitis. Treatment with Simponi reduces the excessive immune response and the inflammation observed in the patients’ joints.

The drug has now been recommended by The National Institute for Health and Care Excellence (NICE), an entity that works as a cost regulator for therapies funded by the U.K.’s National Health Service (NHS). The guidelines support Simponi’s use in adult patients with inadequate response to, or who cannot tolerate, nonsteroidal anti-inflammatory drugs (NSAIDs).

NICE already endorses the use of Humira (adalimumab, marketed by AbbVie), Enbrel (etanercept, by Amgen), and Cimzia (certolizumab pegol, by UCB) for the treatment of ankylosing spondylitis. Simponi has shown similar overall health benefits and acquisition costs as these medications, factors that led to its recommendation.

Specifically, NICE’s guidance adds Simponi to the list of suitable treatments and states that the least expensive option, considering administration costs and patient access plans, should be chosen.

Simponi was developed by Janssen, which markets the product in the U.S., Canada, Central and South America, the Middle East, and other regions. In Europe, Simponi’s distribution rights are held by MSD (called Merck in the U.S. and Canada).

MSD has established a patient access plan together with the U.K.’s Department of Health under which both the 100 mg and the 50 mg doses of Simponi will be available at the same cost. Therefore, the annual cost of treatment with Simponi is estimated at around £9,156 British pounds (approximately $12,814 U.S.) regardless of patient weight or response to the lower dose.

NICE had issued guidelines supporting Simponi and other TNF-alpha blockers for the treatment of AS in 2016. Both the U.S. Food and Drug Administration and the European Commission approved the medication for AS treatment in 2009.