A preliminary decision by the National Institute for Health and Clinical Excellence that patients with rheumatoid arthritis should not be offered the sequential use of tumour necrosis factor alpha inhibitors (anti-TNFs) on the National Health Service in England and Wales has been condemned by doctors and patient groups.

Offering patients Abbott Laboratories’ Humira (adalimumab), Amgen/Wyeth’s Enbrel (etanercept) or Schering-Plough’s Remicade (infliximab) after an initial TNF-alpha inhibitor has failed would not be a cost-effective use of NHS resources, says the Appraisal Committee’s preliminary guidance. However, it adds that patients who are currently receiving any of these drugs should have the option to continue them “until they and their clinicians consider it appropriate to stop.”

NICE is inviting comments on the preliminary decision from formal consultees, to be received by May 20, ahead of the Committee’s next meeting on June 3. However, the charity Arthritis Care is pessimistic, pointing out that “rarely” do NICE decisions change between preliminary and final stages.

The Committee has agreed that patients should have access to a new therapy, Roche’s MabThera/Rituxan (rituximab), but Arthritis Care says that if this also fails, their disease will progress, causing irreversible damage to their joints, disability, poverty and a significantly shortened life expectancy.

A penny-pinching decision
There is much evidence that where one anti-TNF does not work, another may be very effective - each works in a different way but it is difficult to know which will be best in advance of treatment, says the charity. Four out of five people respond to a second anti-TNF therapy and, in most parts of Europe, sequential use is not only allowed but recommended, it adds, pointing out that while NICE is supposed to make its decisions based on both clinical and cost effectiveness, this “penny-pinching” decision appears to be have been made on the grounds of cost alone.

According to Arthritis Care chief executive Neil Betteridge, the decision simply “robs Peter to pay Paul” as patients denied these treatments will then need higher levels of NHS intervention, more in-patient bed days, more orthopaedic surgery, and “probably end up leaving their jobs and having to claim incapacity benefit instead of being active, productive members of UK Inc.”

The British Society for Rheumatology also said it was “extremely disappointed” with the preliminary decision. “There is a large and growing data base indicating successful treatment with a second anti-TNF…clinicians need access to these treatments in order to provide the best possible care for patients,” said BSR president Deborah Bax.