Patient experience with expanded Basic Benefits Package coverage for treatment of Hepatitis C in Armenia

Abstract

The World Health Organization (WHO) considers viral hepatitis as an international public health challenge, which, given its global magnitude, is comparable to other major communicable diseases. An estimated 71 million people had chronic Hepatitis C (HCV) infection in 2016, which had resulted in approximately 399,000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). The prevalence of HCV in adult population (above 18) of Armenia is estimated to be around 4%. Incidence of the viral hepatitis, including HCV, is significantly growing during recent years in Armenia, which is explained by implementation of improved testing procedures since 2016. A year-to-year increase in total incidence of HCV per 100,000 population was 53.1% in 2017, 24.0% in 2018 and 6.7% in 2019. In May 2019, the Ministry of Health (MOH) of Armenia has approved the “The 2019-2023 Program for prevention and control of parenteral viral hepatitis in the Republic of Armenia”. Starting 2019, the Government of Armenia (GOA) has embarked on expanding health coverage and improving the financial risk protection of the population by allocating additional funding from the public budget for the Basic Benefits Package (BBP) services. One of the new BBP programs, which is planned to start in June 2020, will cover provision of free pan-genotype medicine (combined Sofosbuvir/Daclatasvir therapy) for patients with HCV (hereinafter referred to as the Program). The Program will initially cover around 1,000 chronic HCV patients for the first year (2020), aiming at gradual expansion over the next years, depending on availability of additional funds from public budget. According to the draft MOH guidelines, the Program will cover both the preliminary diagnostic tests and provision of the combined Sofosbuvir 400mg/Daclatasvir 60mg therapy. To be covered by the Program, patients should meet certain medical and social criteria. Depending on the HCV genotype and stage of the disease, patients will receive either 12- or 24-weeks treatment course. The goal of the proposed evaluation is to assess patients experience with the Program during the first year of its implementation (2020-2021). The objective of the study is to assess and describe the concept of patient experience, and its association with demographic and socio-economic characteristics of patients, self-reported health-related indicators, and health care providers' characteristics. The proposed evaluation will be conducted utilizing a cross-sectional, pre- experimental one-shot study design. There will be no baseline measurement, as the intervention (Sofosbuvir/ Daclatasvir therapy) is a new type of HCV treatment that was not widely used in Armenia before. The Program evaluation will be the first in Armenia to address the patient experience with expanded BBP coverage for provision of outpatient medicine, which can set a precedent for the MOH to conduct similar studies in the future for evaluation of health policy initiatives in improving access to pharmaceuticals.