Roche discounts RoActemra but only gets limited NICE recommendation

Roche has won partial NICE backing for RoActemra (tocilizumab) as a treatment for systemic juvenile idiopathic arthritis.

But the recommendation depends on Roche discounting RoActemra's price, and even then the drug can only be used for patients that haven't responded to other treatments.

Professor Carole Longson, Health Technology Evaluation Centre director at NICE, said: “The discount agreed as part of the patient access scheme put forward by the manufacturer, in addition to the further information they provided at the committee's request, has enabled the committee to recommend tocilizumab.

“Tocilizumab now being recommended as a possible treatment on the NHS is good news for children with systemic juvenile idiopathic arthritis and those caring for them.”

Details of the patient access scheme Roche submitted to the Department of Health remain 'commercial in confidence'.

RoActemra was recommended to treat systemic juvenile idiopathic arthritis (JIA) in children and young people aged two years and older, where non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate have not produced an adequate response.

But RoActemra wasn't recommended if those patients' disease continues to respond to methotrexate, or who have not been treated with methotrexate.

NICE said that children and young people currently receiving tocilizumab for the treatment of systemic JIA, but who don't meet its recommendation criteria, should have the option to continue treatment until it is considered appropriate to stop, in agreement with their clinicians and parents/carers.

Systemic juvenile idiopathic arthritis (JIA), has no known cause and covers various forms of the condition. It causes severe pain and other difficulties in children of any age.

The Institute did say there was considerable uncertainty around RoActremra's ICER (incremental cost-effectiveness ratio), but that the most plausible ICER for the RoActemra followed by Remicade (infliximab) compared with Remicade alone were within a range that would be considered an acceptable use of NHS resources.

NICE put RoActemra's average cost at £7987.20 per year for a 30kg patient and £9984 per year for a 25kg patient, due to more of the drug being used in smaller children.

The drug, an interleukin-6 (IL-6) receptor-inhibiting antibody, received European approval for systemic JIA in August, having first been approved in Europe in January 2009 for adults with rheumatoid arthritis (RA).

In October NICE issued draft guidance widening its initial recommendation on RoActemra's use in RA. The Institute backed the drug's use after treatment with disease-modifying anti-rheumatic drugs (DMARDs), but only after Roche proposed a new patient access scheme, details of which also remain confidential.