3 Committee discussion
The appraisal committee (section 5) considered evidence submitted by Merck Sharp & Dohme and a review of this submission by the evidence review group (ERG). See the committee papers for full details of the evidence.
3.1 NICE has already produced technology appraisal guidance on adalimumab, etanercept and certolizumab pegol for non-radiographic axial spondyloarthritis, which recommends that if more than one treatment is suitable then the least expensive treatment (taking into consideration costs and patient access schemes) should be used. The company presented a cost comparison case, in which it proposed that:
the overall health benefits associated with golimumab are similar to or greater than those associated with adalimumab, etanercept and certolizumab pegol
the acquisition cost of golimumab is similar to or lower than those associated with adalimumab, etanercept and certolizumab pegol.
The committee understood that treatment with adalimumab, etanercept and certolizumab pegol is standard for non-radiographic axial spondyloarthritis in the NHS. The committee concluded that it was appropriate for the company to compare golimumab with adalimumab, etanercept and certolizumab pegol.
3.2 The company presented results of the GO‑AHEAD trial which compared golimumab with placebo in 198 people with non-radiographic axial spondyloarthritis. Golimumab showed statistically significant improvement in all outcomes at 16 weeks (Assessment in Spondyloarthritis International Society [ASAS] 20, ASAS 40, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] 50 and ASAS partial response) compared with placebo in the full analysis set and in the population with objective markers of active disease (abnormal MRI and/or elevated C‑reactive protein [CRP] at baseline). The committee agreed that golimumab is a clinically effective treatment compared with placebo.
3.3 The company presented a fixed-effects network meta-analysis, which compared the clinical effectiveness outcomes of golimumab with those of adalimumab, etanercept and certolizumab pegol (all assessed at 12 weeks). The network meta-analysis included the pivotal trial for golimumab (GO‑AHEAD) and the same trials that were assessed for the NICE technology appraisal of adalimumab, etanercept and certolizumab pegol for the comparator treatments. The network meta-analysis showed a statistically significant benefit for golimumab compared with placebo for all outcomes (ASAS 20, ASAS 40 and BASDAI 50). The clinical effectiveness of golimumab was similar to adalimumab, etanercept and certolizumab pegol for Bath Ankylosing Spondylitis Functional Index (BASFI), BASDAI and Bath Ankylosing Spondylitis Metrology Index (BASMI) scores. Golimumab was statistically significantly superior to etanercept and adalimumab for change from baseline in BASFI score, etanercept for change from baseline in BASDAI score, and adalimumab for change from baseline in BASMI score. The ERG's view was that a random-effects network meta-analysis would have been more suitable for capturing variation between the trials. The point estimates in the ERG's random-effects network meta-analysis were similar to those in the company's submission, but had wider confidence intervals. The committee considered the impact of using 12‑week outcomes for golimumab in the network meta-analysis (for consistency with the comparator treatments) compared with the 16‑week outcomes reported in the GO‑AHEAD trial. An additional analysis conducted by the ERG showed that the network meta-analysis results were robust regardless of whether 12- or 16‑week outcomes were used. The committee concluded that the clinical effectiveness of golimumab was likely to be similar to those of the comparators.
Adverse events with golimumab are likely to be similar to those with adalimumab, etanercept and certolizumab pegol
3.4 The adverse event profile for golimumab is well established and is similar to those of adalimumab, etanercept and certolizumab pegol. Patients receiving the 100‑mg dose of golimumab may or may not have a greater risk of adverse events than those receiving the 50‑mg dose. The committee concluded that the adverse events associated with golimumab were likely to be similar to those associated with adalimumab, etanercept and certolizumab pegol when treating non-radiographic axial spondyloarthritis.
3.5 The committee agreed that the network meta-analysis provided by the company was suitable for the purpose of decision-making. It considered the clinical effectiveness and adverse event profiles of golimumab to be similar to those of the comparator treatments and that, therefore, golimumab was likely to provide similar overall health benefits.
It is appropriate to assume that all resource use and costs other than drug acquisition costs are identical across golimumab and the comparators
3.6 The company assumed that resource use and costs including drug administration, treatment initiation and monitoring, management of adverse events and long-term disease management are identical across golimumab and the comparators. The committee agreed with the company's assumption.
3.7 The company presented results of a cost comparison analysis for the first and subsequent years of treatment. It showed that the acquisition cost of golimumab is the same as that of adalimumab in the first and subsequent years of treatment (£9,156), and lower than the cost of etanercept in the first and subsequent years (£9,295). The acquisition cost of certolizumab pegol in the first year (£5,720) is lower than that of golimumab because of a patient access scheme which provides the first 10 vials of certolizumab pegol at no cost, but its cost in subsequent years (£9,295) is higher than that of golimumab. The committee concluded that the criteria for a positive cost comparison were met, because:
the overall health benefits of golimumab are similar to those of adalimumab, etanercept and certolizumab pegol
the acquisition costs of golimumab are similar to or lower than those of adalimumab, etanercept and certolizumab pegol (taking into account that although certolizumab pegol is approximately half the cost of golimumab in the first year, the subsequent annual cost in the long term is higher than that of golimumab).
The committee therefore recommended golimumab as a cost-effective use of NHS resources for treating non-radiographic axial spondyloarthritis in adults.