Effect of strategic purchasing of antiviral drugs and the clinical pathway for the treatment of Chronic Hepatitis C in Colombia (hepC-STRATEGY): study protocol for a quasi-experimental study

Abstract

Objective: Describe a study protocol to establish the effect of DAA's strategic purchase and the clinical pathway in the clinical outcomes, general costs, and quality of healthcare of patients with CHC in Colombia. Methods: A quasi-experimental study will be carried out to compare clinical outcomes (treatment effectiveness), healthcare quality (access to treatment, time to treatment, patient's satisfaction and barriers/facilitators perceived) and direct costs before/after the implementation of the mentioned strategies. Patients ≥18 years old initiating DAA treatment between January 2015 and December 2019 in an outpatient pharmacist-led center in Colombia will be included. In order to reduce selection bias, the propensity score method will be used. In the bivariate analysis, χ2 tests and t student will be used to analyse the study outcomes. A regression analysis will be used to explain the association of multiple variables with access to treatment, time to treatment and effectiveness. Descriptive statistics will be used to analyse the patient's satisfaction and barriers/facilitators perceived. Key findings: Implementing local government policies is necessary to improve access to medicines and decrease disease burden. The strategies adopted by the Colombian Ministry of Health to manage CHC needs to be evaluated.Therefore, studies are required to establish their effects on clinical outcomes, overall costs, and quality of care. Conclusions:This study will provide evidence on the effect of Colombian strategies to address the problem of HCC. It will provide information to policymakers in low- and middle-income countries that could reduce disease burden.