5 Recommendations for research and data collection

5.1 The company confirmed to the committee that it was developing a randomised controlled trial (ORION-17) of the effectiveness of inclisiran compared with placebo. This will be a UK-based trial in people who have not previously had a cardiovascular event (primary prevention). The main outcomes of interest are cardiovascular events and mortality.

5.2 The committee was also aware that ORION-4, an ongoing randomised controlled UK trial of inclisiran compared with placebo in people with a history of cardiovascular disease (secondary prevention), is due to complete in 2026. In addition, the company stated that an additional global trial of a similar design was also in development. The main outcomes of interest in these trials are also cardiovascular events and mortality.

5.3 The committee noted that there was an ongoing trial that aimed to compare inclisiran and lipid-lowering medication with or without behavioural support and lipid-lowering medication without inclisiran with behavioural support (SPIRIT). This trial will also assess the feasibility of delivering inclisiran within a primary care setting in England and is due to complete in 2022. The committee considered that this evidence was also of interest.

5.4 The committee also recommended that additional evidence collection should be carried out. Mindful of the issues raised concerning equality (see section 3.19), the committee strongly encouraged the collection of data to assess whether implementing inclisiran into the treatment pathway leads to a reduction in health inequalities. This should include real-world evidence on assessing inclisiran uptake in areas of high deprivation and across various population groups, as well as data on treatment adherence. The committee encouraged the collection of this data as it would be of interest in a review of this guidance.

  • National Institute for Health and Care Excellence (NICE)