UK NICE Appraisal Consultation on Merck & Co's Simponi for rheumatoid arthritis initially negative

The UK’s drug watchdog body the National Institute for Health and Clinical Excellence (NICE) has issued its Appraisal Consultation Document (ACD) on the use of US drug giant Merck & Co’s (NYSE: MRK) Simponi (golimumab) for the treatment of rheumatoid arthritis (RA) after the failure of previous disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate.

The appraisal committee is currently minded not to recommend golimumab as a first line treatment option for RA in people who have had previous therapy with conventional DMARDs only, or for those who have had therapy with a tumor necrosis factor (TNF) inhibitor and for whom rituximab is contraindicated or is withdrawn because of an adverse event. As the ACD clearly states, this document is not the NICE's final guidance on this technology, and the recommendations may change after consultation, noted the company.

Carole Longson, Health Technology Evaluation Centre Director at the NICE, said: “Finding ways to relieve pain, improve mobility and reduce long-term damage are the aims in treating rheumatoid arthritis. The evidence indicates that using golimumab isn't cost effective if both conventional treatments and TNF inhibitors have already been tried and rituximab is an option. However, the additional information requested will be important in deciding whether golimumab can work effectively and cost effectively for patients in certain other circumstances. We need to be sure that golimumab offers real benefits for patients - and we need to be confident that those benefits justify the cost. We're looking forward to receiving the manufacturer's response to help us decide whether golimumab should be added to the options already available to patients living with this very disabling disease.”