Following a newly-agreed patient access scheme (PAS), the National Institute for Health and Clinical Excellence (NICE) has said that Roche's RoActemra (tocilizumab) can be used on the NHS at an additional stage in treating rheumatoid arthritis (RA).
In new guidance - which is a rapid review of TA198, the guidance issued by NICE in 2010 - the Institute says that, in specific clinical circumstances and only when Roche makes the drug available with the discount agreed as part of the PAS, RoActemra is also now recommended alongside other options for treating RA at an earlier point in the treatment pathway. This is where the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and RoActemra is used as described for tumour necrosis factor (TNF) inhibitor treatments in NICE guidance TA130.
In TA198, NICE had recommended that the NHS should offer RoActemra as an option for people with RA if there had been an inadequate response to one or more TNF inhibitors, and where Roche's MabThera (rituximab) had also produced an inadequate response, was contraindicated or had produced undesirable side effects. The new guidance still includes these recommendations, and in all cases this is on the basis that Roche provides RoActemra with the discount agreed as part of the PAS.
"Rheumatoid arthritis can have a huge impact on quality of life and for many it's a disabling condition, so we're pleased to recommend tocilizumab at an additional stage in treating the condition," said Professor Carole Longson, director of NICE's health technology evaluation centre.
'We have already recommended the TNF inhibitors adalimumab, etanercept, infliximab, certolizumab pegol and golimumab for some people with rheumatoid arthritis as options for use at this stage - tocilizumab is now added as another option alongside these treatments," she said, adding: ""this guidance complements the range of treatments that NICE has previously recommended for different stages of rheumatoid arthritis to help patients manage this difficult condition."
Around 400,000 people across England and Wales have RA, and NICE estimates that around 10% of them might be able to use RoActemra.
The level of the discount agreed between Roche and the Department of Health for the drug is commercial in confidence, but NICE points out that RoActemra’s annual acquisition cost is £9,295 per year for a patient weighing approximately 70kg. However, it adds that costs may vary in different settings because of negotiated procurement discounts.