OBJECTIVES: In September 2021, following NICE’s restricted recommendation for inclisiran (TA733), NHS England announced its first ‘population health agreement’. This enabled the treatment of up to 300,000 patients with primary hypercholesterolaemia or mixed dyslipidaemia, potentially avoiding 55,000 myocardial infarctions and saving 30,000 lives. This unprecedented deal enabled twice-yearly subcutaneous injections to be provided by GPs in primary care at a reimbursed-price of £55 per injection vs. list-price £1,987.36, with a large-scale primary prevention trial to collect CV outcomes in 40,000 UK patients (ORION-17). This research evaluated the success of this agreement in terms of inclisiran uptake/prescribing.

METHODS: Inclisiran uptake data from primary care prescribing (https://openprescribing.net/) was identified between December 2021 and March 2023 by the seven NHS England commissioning regions (26-JUNE-2023).

RESULTS: Only 5,931 injections have been prescribed in total. In 2021, only 50 injections were prescribed. In 2022, 3,156 injections were prescribed, with the South-West leading with 1,245 injections, compared to the lowest, 141 injections in London. Although annual uptake is increasing, this trend continues in the first three months of 2023, with South-West having 831 injections and again the lowest in London of 126 injections. Assuming two injections per patient per annum and without accounting for the initiation phase of two injections in the first three months, less than 3,000 patients have been treated in total. This represents ~1% of the eligible population quoted.

CONCLUSIONS: Despite the company committing to provide inclisiran at a substantially discounted price and initiating a large-scale UK CV outcomes trial, only ~1% of the eligible patient population appear to have been treated 1.5 years since this ‘population health agreement’ was set up. Further, in March 2023, the company announced they would not be going ahead with the ORION-17 trial. This highlights the multiple, substantial barriers facing companies in UK market access despite competitive and innovative approaches.