The UK's cost watchdog has confirmed that Merck Sharpe and Dohme's Simponi will be allowed on the National Health Service for psoriatic arthritis.
The National Institute for Health and Clinical Excellence has issued final guidance recommending Simponi (golimumab) for the treatment of active and progressive PA in adults if it is used as described for the other tumour necrosis factor inhibitor treatments already available on the NHS – Amgen/Pfizer's Enbrel (etanercept), Johnson & Johnson/Merck's Remicade (infliximab) and Abbott Laboratories Humira (adalimumab).
The recommendation of Simponi is also on the condition that Merck provides the 100mg dose of golimumab to the NHS at the cost of the 50mg dose, "as agreed by the manufacturer and the Department of Health as part of a patient access scheme".
Patient access scheme helps wins NICE nod
It seems this concession has been key to Simponi getting the NICE thumbs-up. The drug was actually turned down for PA in previous draft guidance, on doubts whether it is as effective as treatments already recommended for the condition.
Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We’re pleased to recommend golimumab as another option for treating PA, a condition that can cause significant distress and psychological impact on an individual’s life, employment and social activities. We recognise that patients may welcome the option of a self-injectable treatment administered once a month".
She added that “we have already recommended three TNF inhibitor treatments for PA that has not responded to first-line treatment, and golimumab is a welcome addition". A 50mg pre-filled injection pen of Simponi costs £774.58, with the annual price tag estimated to be around £9,294 and analysts believe its once-monthly dosing regimen may give the drug a competitive edge over the other anti-TNFs used by the NHS; Enbrel needs to be injected every week and Humira every other week.
Simponi and Remicade were at the heart of a two year-long marketing rights that has just been settled. A voluntary agreement has now been reached which will see Merck relinquish exclusive marketing rights for the two drugs in Canada, Central and South America, the Middle East, Africa and Asia Pacific, effective July 1. However it will retain rights throughout Europe, Russia and Turkey._