Cost–Utility Analysis of Inclisiran Added to Standard of Care for Secondary Prevention of Cardiovascular Disease in Egypt: A Public Payer Perspective

Background: Inclisiran, a novel siRNA therapy, offers significant LDL-C reduction, yet its economic value in the Egyptian healthcare system remains unquantified. This study evaluated the cost-utility of adding Inclisiranto standard of care (SoC) for the secondary prevention of cardiovascular disease (CVD) in Egypt. Methods: A Markov cohort model with a lifetime horizon was developed from a public payer perspective. Clinical efficacy was derived from ORION trials, while costs were sourced from local Egyptian hospital tariffs. Uncertainty was explored through deterministic and probabilistic sensitivity analyses (PSA). Results: The base-case ICER was 11,623,189 EGP per QALY gained , far exceeding the Egyptian willingness-to-pay (WTP) threshold of 150,000–450,000 EGP per QALY (1–3× GDP per capita) . Probabilistic sensitivity analysis demonstrated that the probability of Inclisiran being cost-effective remained 0% across the evaluated WTP range . The tornado analysis identified the drug acquisition cost as the primary driver of cost-effectiveness outcomes . Conclusion: At its current list price, Inclisiranis not a cost-effective strategy for the Egyptian public payer. To achieve the 1x GDP threshold (150,000 EGP), a price reduction exceeding 90% (to approximately 3,000–5,000 EGP per dose) is required. Strategic value-based pricing is essential for sustainable integration into the national formulary.