The National Institute for Health and Clinical Excellence (NICE) has opened a consultation on draft guidance which recommends Bristol-Myers Squibb (B-MS)'s Orencia (abatacept) for rheumatoid arthritis (RA) after conventional disease-modifying anti-rheumatic drugs (DMARDs) have failed.
NICE's draft recommendations state that Orencia in combination with methotrexate should be an option for treating people with RA only if:
- the disease has responded inadequately to two conventional non-biological DMARDs including methotrexate, and it is used in line with the recommendations for other biological DMARDs as set out in NICE's Technology Appraisal Guidance 130, which deals with the use of Abbott's Humira (adalimumab), Pfizer/Amgen's Enbrel (etanercept) and Johnson & Johnson (J&J)'s Remicade (infliximab) for the treatment of RA; and
- the manufacturer provides Orencia with the discount agreed in the patient access scheme (PAS).
The draft guidance also says that people currently receiving Orencia, but whose disease does not meet these criteria, should be able to continue treatment until they and their clinician consider it appropriate to stop.
In August 2011, NICE issued guidance TA234 not recommending the drug as a treatment option after conventional DMARDs, as it was not cost-effective for this use when compared to a range of alternatives including Humira, Enbrel and UCB's Cimzia (certolizumab pegol), which were already recommended.
This new guidance is a rapid review of TA234, following the introduction of a PAS which B-MS has agreed with the Department of Health.
NICE has previously recommended Orencia and other drugs as an option for people with RA if there has been an inadequate response to one or more tumour necrosis factor (TNF) inhibitors and who cannot receive Roche's MabThera/Rituxan (rituximab) because it is contraindicated or withdrawn because of an adverse event (TA195, August 2010).
"NICE has already recommended a range of treatments to help patients manage rheumatoid arthritis, which can be a disabling condition," said Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE.
"This draft guidance resulting from the rapid review of TA234 provisionally recommends that abatacept could be a treatment option at an earlier stage in the treatment pathway, after treatment with conventional drugs has failed," she added.
NICE points out that it has already recommended the TNF inhibitors Humira, Enbrel, Remicade and Cimzia, plus J&J's Simponi (golimumab) and Roche's RoActemra/Actemra (tocilizumab) for some people with RA as options for use at this stage.
"The draft guidance could potentially widen the choice of treatments available at this stage of the treatment pathway, by offering abatacept in specific clinical circumstances, and only if the manufacturer provides it will the discount agreed as part of the patent access scheme," said Prof Longson, who added that NICE welcomes comments on these draft recommendations as part of the consultation, which closes on January 10, 2013.
- Orencia is administered as a 30-minute intravenous infusion. Its annual costs vary according to body weight and the number of infusions required, but for a person weighing 60-100kg the cost, based on the list price, is £12,700.80 in the first year and £11,793.60 in subsequent years. Costs may vary in different settings because of negotiated procurement discounts, and B-MS has agreed a PAS with the Department in which Orencia in its licensed indications would be available with a discount - the level of which is commercial-in-confidence at the manufacturer's request.