Patients with rheumatoid arthritis are being given access to a new treatment on the National Health Service in England and Wales, following a U-turn by the National Institute for Health and Clinical Excellence.

The cost watchdog has this morning published final draft guidance in which it recommends the use of Belgian drugmaker UCB Pharma’s Cimzia (certolizumab pegol) in patients with the disease, under the same conditions/restrictions as other TNF inhibitors already in use.

Preliminary guidance from NICE published back in October had been leaning towards a rejection of the drug, but the subsequent submission of additional information by the company helped to change the Institute’s mind.

The decision to allow the drug’s use on the NHS is based on clinical trial data demonstrating Cimzia’s effectiveness as a treatment for moderate-severe RA, and that, with a price tag of around £9,295 a year (£10,725 for the first including a loading dose), the therapy is a cost-effective use of resources, but only when taking into account a patient access scheme proposed by the drugmaker - under which it pays for the first 12 weeks of treatment - to reduce the financial burden.

Cimzia won European regulatory approval in October last year on the back of data from the Rapid 1 and Rapid 2 Phase III clinical trials, which showed that the drug – the first PEGylated anti-TNF therapy launched in the UK – induced significant improvements in the signs and symptoms of the disease that were sustained for at least two years.

Furthermore, radiographic data showed that the drug is also capable of halting the progression of joint damage associated with the condition, and that this effect was sustained for at least 100 weeks.

New option
While Cimzia will be competing with other TNF inhibitors already endorsed by NICE - Johnson & Johnson/Schering-Plough’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab) and Amgen/Wyeth's Enbrel (etanercept) - its inclusion in the NHS is good news for the 400,000 or so patients with RA in the UK because it offers a new treatment option for managing the disease.

In addition, the new treatment is available in an innovative pre-filled syringe, designed in consultation with
RA patients to take into account the challenges they face - such as limited dexterity faced - when self-injecting, the firm said.

"This is the first time a new NICE recommended RA treatment has been made available for almost two years - and could make a big difference to patients’ day to day lives," commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society.

The Institute’s change of heart comes just weeks after patients with RA in England and Wales were dealt a blow by on its preliminary decision to bar Roche’s new therapy RoActemra from the NHS, feeling that the drug is too expensive, even though clinical trials have demonstrated its ability to significantly reduce the signs and symptoms of RA, regardless of previous therapy or disease severity, compared to disease-modifying anti-rheumatic drugs alone.

However, NICE has asked Roche to provide more evidence on RoActemra to help it decide whether the drug has a place in the NHS for the treatment of RA or not. This week cost regulators in Scotland approved RoActemra's use, once again highlighting the differences in the UK's health systems.