Draft NICE Guidance Does Not Recommend Abatacept For Second-line Use In Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Article Date: 30 Mar 2011 – 3:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) has today (30 March 2011) opened a consultation on draft guidance which does not recommend abatacept (Orencia, Bristol-Myers Squibb), in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease modifying anti-rheumatic drugs (DMARDs) including methotrexate.

NICE already recommends adalimumab, etanercept, infliximab and certolizumab pegol for second-line use, the same point in the clinical pathway at which abatacept is being considered in this appraisal. Furthermore, for adults with severe active rheumatoid arthritis who have had an inadequate response to at least one tumor necrosis factor (TNF) inhibitor, NICE also recommends rituximab, and for those people who cannot take rituximab following an inadequate response to at least one TNF inhibitor, NICE recommends adalimumab, etanercept, infliximab, tocilizumab and abatacept.

The manufacturer of abatacept had noted that their product would not be cost-effective for second-line use when compared to adalimumab, etanercept and certolizumab pegol, which are administered by subcutaneous injection. They therefore suggested that abatacept should be compared with infliximab, the only other intravenous treatment option at this stage in the pathway of care. However, the Committee did not consider this to be a relevant comparison since route of administration rarely determines which drug to prescribe. This is because devices used to self-administer subcutaneous injections have improved considerably and few people experience problems handling the injection devices. Subcutaneous injections can also be administered at home by a nurse or a family member.

The Committee also considered whether abatacept could be a cost-effective treatment option for people for whom treatment with a TNF inhibitor was contraindicated. However, the available evidence did not support the view that using abatacept in these circumstances would be a cost-effective use of NHS resources.

Sir Andrew Dillon, NICE Chief Executive, said: “We recognise that rheumatoid arthritis can be an extremely debilitating condition, and that patients need a range of options if their disease does not respond adequately to first-line treatment. We currently recommend seven biological treatments, including abatacept, for use at various points in the pathway, once conventional DMARDs have been tried. Unfortunately, the evidence available to the committee did not support the use of abatacept as a second-line treatment option.”

The manufacturer and other consultees, including the public, have until 20 April 2011 to comment on this draft guidance, and can do so via the NICE website. Any feedback received during this consultation will be considered by the committee and, following their next meeting, the next version of draft guidance will be issued.

Final guidance for this use of abatacept for rheumatoid arthritis is expected to be published later this year. Until then, NHS bodies should make decisions locally on the funding of specific treatments. NICE has not yet issued final guidance to the NHS.


More information on this appraisal can be found here.

Other treatments for rheumatoid arthritis recommended by NICE:

TA130 – Adalimumab, etanercept and infliximab

TA186 – Certolizumab pegol

TA195 – Adalimumab, etanercept, infliximab, rituximab and abatacept

TA198 – Tocilizumab

About the appraisal

Abatacept (Orencia, Bristol-Myers Squibb) is a selective T-cell co-stimulation modulator that blocks a co-stimulatory signal required to activate T-cells.

Abatacept is administered as a 30-minute intravenous infusion. After an initial infusion (week 0), a patient receives an infusion at week 2, week 4 and every 4 weeks thereafter. Abatacept is available in 250-mg vials at a cost of £242.17 per vial (excluding VAT; ‘British national formulary’ [BNF] edition 61). A patient requires fourteen infusions in the first year, and 13 infusions in subsequent years. The dose of abatacept depends on body weight: people weighing less than 60 kg, 60-100 kg and over 100 kg require 500 mg, 750 mg and 1000 mg respectively. The annual drug costs associated with abatacept vary according to body weight and the number of infusions required. For a person weighing between 60 and 100 kg, the annual drug cost is £10,171.14 in the first year and £9444.63 in subsequent years. Costs may vary in different settings because of negotiated procurement discounts.



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