IMPACT OF SEQUENTIAL ORAL LIPID-LOWERING THERAPY OPTIMIZATION ON LDL-C GOAL ATTAINMENT AND INCLISIRAN ELIGIBILITY IN UK PATIENTS WITH ASCVD: A MONTE CARLO SIMULATION BASED ON SANTORINI
Author(s)
Alistair Gordon, BA, MSc, PG Dip1, Christian Becker, PhD2.
1Market Access Director, Daiichi Sankyo UK, London, United Kingdom, 2Daiichi Sankyo Europe GmbH, München, Germany.
1Market Access Director, Daiichi Sankyo UK, London, United Kingdom, 2Daiichi Sankyo Europe GmbH, München, Germany.
OBJECTIVES: To evaluate the impact of sequential oral lipid-lowering therapy (LLT) optimisation with ezetimibe and bempedoic acid (BA) on LDL-C goal attainment, predicted cardiovascular (CV) risk, and inclisiran eligibility in UK patients with atherosclerotic cardiovascular disease (ASCVD).
METHODS: Data from UK SANTORINI participants were used to generate a synthetic cohort of 100,000 patients through resampling with replacement. Monte Carlo simulation was used to model guideline-based sequential LLT optimisation. Patients not receiving ezetimibe received simulated ezetimibe treatment, followed by BA in statin-intolerant patients who remained above LDL-C goal. Two statin intolerance (SI) definitions were evaluated: (1) no statin therapy and (2) no, low-, or medium-intensity statin therapy. Outcomes included LDL-C goal attainment according to ESC/EAS recommendations, predicted 10-year CV risk (REACH), and inclisiran eligibility. NHS England lipid targets were assessed in a sensitivity analysis.
RESULTS: Among 44,114 simulated patients with ASCVD, 2,561 met the narrow SI definition and 17,658 the broader SI definition. Under the narrow SI definition, LDL-C goal attainment increased from 20.5% at baseline to 36.5% following sequential oral LLT optimisation. Predicted 10-year CV risk decreased from 33.1% to 27.1%. Inclisiran eligibility decreased from 1,454 to 605 per 100,000 UK SANTORINI-like patients. Under the broader SI definition, LDL-C goal attainment increased from 14.1% to 67.7%, predicted 10-year CV risk decreased from 30.0% to 25.5%, and inclisiran eligibility decreased from 4,152 to 1,302 patients. Findings were consistent using NHS England lipid targets, with goal attainment reaching 70.2% and 88.4% under the narrow and broader SI definitions, respectively.
CONCLUSIONS: Simulated sequential optimisation of oral LLT with ezetimibe and BA substantially increased LDL-C goal attainment and reduced predicted CV risk among UK patients with ASCVD. Across all scenarios, the number of patients remaining eligible for inclisiran reduced by more than half, suggesting that optimisation of oral LLT may reduce the need for escalation to injectable treatment.
METHODS: Data from UK SANTORINI participants were used to generate a synthetic cohort of 100,000 patients through resampling with replacement. Monte Carlo simulation was used to model guideline-based sequential LLT optimisation. Patients not receiving ezetimibe received simulated ezetimibe treatment, followed by BA in statin-intolerant patients who remained above LDL-C goal. Two statin intolerance (SI) definitions were evaluated: (1) no statin therapy and (2) no, low-, or medium-intensity statin therapy. Outcomes included LDL-C goal attainment according to ESC/EAS recommendations, predicted 10-year CV risk (REACH), and inclisiran eligibility. NHS England lipid targets were assessed in a sensitivity analysis.
RESULTS: Among 44,114 simulated patients with ASCVD, 2,561 met the narrow SI definition and 17,658 the broader SI definition. Under the narrow SI definition, LDL-C goal attainment increased from 20.5% at baseline to 36.5% following sequential oral LLT optimisation. Predicted 10-year CV risk decreased from 33.1% to 27.1%. Inclisiran eligibility decreased from 1,454 to 605 per 100,000 UK SANTORINI-like patients. Under the broader SI definition, LDL-C goal attainment increased from 14.1% to 67.7%, predicted 10-year CV risk decreased from 30.0% to 25.5%, and inclisiran eligibility decreased from 4,152 to 1,302 patients. Findings were consistent using NHS England lipid targets, with goal attainment reaching 70.2% and 88.4% under the narrow and broader SI definitions, respectively.
CONCLUSIONS: Simulated sequential optimisation of oral LLT with ezetimibe and BA substantially increased LDL-C goal attainment and reduced predicted CV risk among UK patients with ASCVD. Across all scenarios, the number of patients remaining eligible for inclisiran reduced by more than half, suggesting that optimisation of oral LLT may reduce the need for escalation to injectable treatment.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
MSR66
Topic
Methodological & Statistical Research
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory)