Generic Versus Branded Atorvastatin: A Single-Center Comparative Analysis of Clinical Effectiveness and Post-Delisting Cost Savings in Saudi Arabia.

Background

Dyslipidemia is becoming an increasingly important issue from a public health point of view and is generally treated with statins. However, as generic versions of these drugs are now widely available, doubts have emerged about their effectiveness. The current study examines the clinical effectiveness and impact on the national budget of using generic atorvastatin compared to the branded version.

Methods

A retrospective comparative study was conducted at King Khalid University Hospital between 2015 and 2025, involving 286 patients (142 receiving the generic form and 144 receiving the branded form). Changes in lipid panel values were assessed using a Generalized Linear Model (GLM) to account for multiple factors. The economic outcomes were estimated using probabilistic (10,000 Monte Carlo iterations) and deterministic scenario analyses.

Results

The mean adjusted decrease in low-density lipoprotein (LDL) was 26.11% in the generic group and 19.34% in the branded group. After adjusting for multiple variables, the branded group showed a non-significant lower reduction in LDL (β-estimate: -0.255, 95% CI: -0.119 to 0.391, p = 0.3318). The Monte Carlo simulations showed large projected mean annual savings when using the generic formulation: $29,717,778 based on tender pricing and $295,432,159 based on retail pricing. The deterministic sensitivity analyses consistently found positive projected savings across all population and market-share scenarios tested.

Conclusions

Generic atorvastatin was found to have similar clinical effectiveness to the branded version in terms of reducing atherogenic lipids, with no statistically significant difference between the two groups. Furthermore, the economic modeling shows that using generic atorvastatin yields considerable national-level cost savings.