{
  "abstract": "Objectives Glecaprevir/pibrentasvir (GLE/PIB), despite being a highly costly medication, is considered a cost-effective approach compared with sofosbuvir/velpatasvir (SOF/VEL) and sofosbuvir/daclatasvir (SOF/DCV) in the treatment of hepatitis C virus (HCV) infection. No study has evaluated the effect of GLE/PIB’s introduction into Iran’s drug list from a health policy perspective and estimated the budgetary impact change. Therefore, this study was conducted to analyse the fiscal effect of the introduction of GLE/PIB into Iran’s drug list.Design Budget impact analysis. The assumptions and costs of including GLE/PIB in Iran’s drug list for the treatment of patients with hepatitis C were derived from a conducted cost-effectiveness analysis.Setting National level. In this study, the budgetary changes in Iran’s pharmaceutical market and health system, from the Ministry of Health’s perspective, have been estimated for a 5-year time horizon following the introduction of GLE/PIB in the country.Results Based on the results obtained from the budget impact model, currently, 4112 patients are receiving SOF/DCV and SOF/VEL therapeutic regimens, which is expected to decrease to 1093 in 2029 owing to the affordability of medications and a 50% estimated market share for GLE/PIB. According to the results, with the introduction of GLE/PIB into the market and assuming a market share of 10% in the first year, growing to 50% by the fifth year, the healthcare system costs will increase by approximately $0.61, $1.77, $3.86, $7.45 and $13.51 million over the next 5 years, respectively. Additionally, based on the drug’s selling price, there will be a 468% increase in hepatitis C drug market costs after 5 years, resulting in an overall budget increase of approximately 0.13% for Iran’s pharmaceutical market. According to the sensitivity analysis, a 20% reduction in chronic hepatitis C (CHC) costs could decrease the projected increase in health sector costs from $13.51 million (an 18.84% increase) to $10.52 million (an 18.16% increase). Conversely, a 20% rise in CHC costs would raise those costs to $16.49 million (a 19.31% increase).Conclusion Considering the high price of the GLE/PIB compared with the available options in Iran, with the introduction of GLE/PIB into Iran’s drug list, insurance coverage and appropriate allocation of necessary resources, a reduction in the cost burden because of hepatitis C treatment is expected for individuals and households. Additionally, with a well-regulated market share of existing medications, the optimal treatment choice for patients will be feasible.",
  "authors": [
    {
      "affiliations": [
        "Student Research Commite, Baqiyatallah University of Medical Sciences, Tehran, Iran (the Islamic Republic of)",
        "Health Human Resources Research Center, Department of Health Economics, School of Health Management and Information Sciences, Shiraz University of Medical Sciences Shiraz Transplant Research Center, Shiraz, Iran (the Islamic Republic of)"
      ],
      "name": "Mojtaba Jafari"
    },
    {
      "affiliations": [
        "Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran (the Islamic Republic of)"
      ],
      "name": "Parisa Mehdizadeh"
    },
    {
      "affiliations": [
        "Health Human Resources Research Center, School of Health Managementand Information Sciences, Shiraz University of Medical Sciences, Shiraz, Iran, Iran (the Islamic Republic of)"
      ],
      "name": "Khosro Keshavarz"
    },
    {
      "affiliations": [
        "Health Management Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran (the Islamic Republic of)"
      ],
      "name": "Ehsan Teymourzadeh"
    },
    {
      "affiliations": [
        "Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Clinical sciences Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran (the Islamic Republic of)"
      ],
      "name": "Mohammad Ali Abyazi"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran (the Islamic Republic of)"
      ],
      "name": "Parsa Gholamreza Shirazi"
    }
  ],
  "title": "Budget impact analysis of glecaprevir/pibrentasvir treatment for hepatitis C in Iran: a modelling study",
  "uid": "59bec3cb-8c46-55cd-bc10-0c7aa3edd4cb"
}