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New HTA Decisions in Scotland
March 2021
Drug name
COSENTYX® (secukinumab)
Company
Novartis Pharmaceuticals UK Limited
Decision date
04/12/2020
Therapeutic area
Musculoskeletal conditions
Therapeutic sub area
Spinal conditions
Decision
Recommended
Indication
Treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs.
Decision Detail
Following a full submission, secukinumab (COSENTYX®) is accepted for use within NHS Scotland. This advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.
Summary
The key evidence supporting the efficacy and safety of secukinumab in the indication under review comes from PREVENT, an international, randomised, double-blind, phase III study that evaluated the efficacy and safety of secukinumab compared with placebo. In the study, secukinumab, compared with placebo, significantly improved symptoms in adults with active non-radiographic axial spondyloarthritis. The company submitted cost-utility analyses for the comparison of secukinumab versus licensed TNF-alpha inhibitors including adalimumab, adalimumab (biosimilar), etanercept, etanercept (biosimilar), golimumab, certolizumab pegol, and conventional care in biologic-naïve adult patients (primary analysis) and biologic-experienced patients (secondary analysis) versus conventional care only in the licensed indication. A cost-minimisation analysis was also presented. A short-term decision-tree followed by a long-term cohort Markov model were used, with three health states: treatment maintenance for responders, conventional care for non-responders and dead. The time horizon for the cost-utility analysis was 60 years due to the chronic nature of the disease and early age of onset and the cycle length was 3 months. The main limitations associated with the analyses were: • Lack of direct comparative clinical-effectiveness data for secukinumab and TNF-alpha inhibitors leading to reliance on a NMA associated with uncertainties, as described in the clinical effectiveness section above; • Lack of clinical effectiveness evidence for TNF-alpha inhibitors in biologic-experienced population leading to the assumption of non-responding patients only receiving conventional care in the economic model. In clinical practice, patients who lose response are likely to start treatment with a different TNF-alpha inhibitor. The scenario analysis which included treatment-sequencing produced consistent results but was primarily based on assumptions. Experts suggested that secukinumab might be used as a second line of therapy for TNF-alpha inhibitors non-responders; • There are uncertainties around the long-term disease progression in terms of BASFI and treatment discontinuation associated with secukinumab due to lack of clinical data. The economic model assumed secukinumab-treated patients to progress and discontinue treatment at the same rate as patients treated with TNF-alpha inhibitors. Additionally, important outcomes such as assessment of spinal mobility were not considered in the model; • The cost-minimisation analysis compared annual medicine acquisition costs without accounting for discontinuation. Therefore, the results are only applicable to living responders. Results from the cost-utility analysis were considered by the committee as most relevant for decision-making. Despite these limitations, the economic case has been demonstrated.