The future of Schering-Plough/Merck & Co’s (and Johnson & Johnson’s*) Simponi within the National Health Service is looking shaky after the National Institute for Health and Clinical Excellence said it was minded not to recommend the drug for rheumatoid arthritis (RA).

In its preliminary recommendations, the cost watchdog rejected the use of Simponi (golimumab) to treat patients who have already tried conventional disease-modifying anti-rheumatic drugs (DMARDs) and TNF inhibitors but for whom Roche’s MabThera (rituximab) is still an appropriate option, because it is “associated with greater costs and fewer QALYs” than its rival.

There is, however, still a glimmer of hope for Simponi, as NICE’s appraisal committee has asked for more clinical and cost effectiveness data on its use for treating patients with RA who have had therapy with conventional DMARDs only, and in those who have had therapy with a TNF inhibitor and have not responded or are intolerant to therapy with MabThera.

According to NICE, it is trying to establish in what circumstances Simponi might be represent a good use of NHS funds for treating patients when previous therapies have failed, and the additional information - which it hopes will be available in time for the second Appraisal Committee meeting on November 25 - should help it decide whether the drug has any role to play in health service’s management of the disease.

Annual therapy with Simponi is estimated to cost around £9,294, and so “we need to be sure that golimumab offers real benefits for patients - and we need to be confident that those benefits justify the cost,” explained Carole Longson, Director of Health Technology Evaluation Centre.

This is the second set-back for the drug this month, as the Institute also issued a preliminary rejection of its use on the NHS for the treatment of psoriatic arthritis, after ruling that it is not as effective as the current standard therapy, Amgen/Pfizer's Enbrel (etancercept).

* Merck & Co sells Simponi in Europe under a marketing agreement with Johnson & Johnson, but the latter is trying to break free of the partnership and regain rights to the drug after Merck acquired Schering-Plough, as it argues this led to a “change of control” at the company. The matter is pending arbitration in the USA.

Resolor wins backing

Meanwhile, the Institute has given its blessing for the use of Movetis’ Resolor on the NHS to treat chronic constipation in women when laxatives have failed to provide adequate relief.

In draft guidance the cost regulator said the treatment should only be considered for women who have tried at least two different types of laxatives for at least six months and for whom invasive treatment is being considered.