The UK’s cost-effectiveness watchdog, the National Institute for Health and Clinical Excellence, has delivered a blow to Bristol-Myers Squibb and rheumatoid arthritis patients after it issued draft guidance failing to back Orencia's use on the country’s National Health Service.

Orencia (abatacept) is the first in class of so-called selective T-cell co-stimulation modulators that is designed to block a signal required in the activation of T-cells, which play a key role in the disease’s inflammatory cascade. In the UK, Orencia is licensed for use in combination with the disease-modifying drug methotrexate for the treatment of moderate-to-severely active RA in patients who have not responded to other DMARDs, including at least one tumour necrosis factor alpha inhibitor (for example Wyeth and Amgen’s Enbrel [etanercept] and Schering Plough’s Remicade [infliximab]).

Around 40,000 people in the UK alone suffer from severe RA, and around one-third fail to respond to the anti-TNF inhibitors – with no treatment alternative currently available to them.

Orencia is currently available to the National Health Service at a cost of £252 per vial, but because the dose is dependent on body weight the annual costs of treating a patient with Orencia will vary. For a patient weighing 60–100 kg the annual drug cost will be £10,584 in the first year and £9,828 in subsequent years, says NICE. While BMS argues that this price compares with the anti-TNF inhibitors, NICE’s draft recommendations state Orencia is not cost-effective for use on the NHS; on various measures of cost per QALY (quality adjusted life year), the medicine consistently came in above the watchdog’s £30,000 cut off point.

Lack of comparator trials affected analysis

The Committee also commented that its assessment was stymied by the lack of comparator trials, with no direct head-to-head studies of Orencia versus the anti-TNF drugs or Roche’s Rituxan (rituximab) – which is currently in NICE’s preliminary consultation process for use in RA. Despite being further behind in the system, the guidance states: “The Committee considered that rituximab had very similar outcomes to abatacept at a significantly lower price and therefore concluded that abatacept could not be considered a cost effective use of NHS resources in comparison with rituximab.” It also suggested BMS conducts additional trials comparing Orecia to conventional DMARDs, anti-TNF drugs and rituximab.

Bristol-Myers Squibb was understandably disappointed by the news, saying the decision had been made “despite NICE accepting the clinical benefits of Orencia and commending the quality of the evidence behind the product. BMS challenges this view very strongly and we believe that objective and credible economic modelling shows that Orencia is cost-effective in NICE's terms. We intend to press this view with NICE in the consultation period ahead”.

The second appraisal committee meeting is on September 12 and a final decision on the drug is expected towards the end of the year. Orencia was launched in the UK on June 5, 2007, following a green light by the European Commission in May.

During the second quarter, Orencia generated global sales of $55 million for BMS.

The guidance can be found at: http://guidance.nice.org.uk/page.aspx?o=444490