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New HTA Decisions in England
March 2021
Drug name
KINERET® (anakinra)
Company
Sobi
Decision date
01/03/2021
Therapeutic area
Musculoskeletal conditions
Therapeutic sub area
Arthritis
Decision
Recommended with restrictions
Indication
Anakinra is recommended as an option for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Decision Detail
It is only recommended for: • adult-onset Still's disease that has responded inadequately to 2 or more conventional disease‑modifying antirheumatic drugs (DMARDs); • systemic juvenile idiopathic arthritis in people 8 months and older with a body weight of 10 kg or more that has not responded to at least 1 conventional DMARD.
Summary
The company's clinical-effectiveness evidence included: • for systemic JIA: 2 randomised controlled trials comparing anakinra with placebo and 1 non randomised registry study comparing it with tocilizumab; • for AOSD: 1 open-label randomised controlled trial comparing anakinra with conventional DMARDs. The clinical trials were either open label or had a short, blinded phase followed by short open-label extensions. The placebo-controlled trials had very small patient numbers, which the committee heard was because of the rarity of Still's disease. Clinical evidence about the efficacy of anakinra after treatment with NSAIDs and corticosteroids is highly uncertain, but it is reasonable to assume that it is as effective as tocilizumab. Cost-effectiveness estimates for anakinra are also uncertain because of issues with the company's economic model and the lack of robust clinical evidence to support it. However, a comparison of the costs of anakinra and tocilizumab shows that they have similar weekly costs for: • adult-onset Still's disease that has responded inadequately to 2 or more conventional DMARDs; • systemic juvenile idiopathic arthritis that has not responded to at least 1 conventional DMARD. Anakinra is therefore recommended for use in the NHS in these circumstances.