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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.
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.
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.
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).
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.
This study aimed to develop atorvastatin-loaded emulgel and nano-emulgel dosage forms and investigate their efficiency on surgical wound healing and reducing post-operative pain. This double-blind randomized clinical trial was conducted in a surgical ward of a tertiary care hospital affiliated with university of medical sciences. The eligible patients were adults aged 18 years or older who were undergoing laparotomy. The participants were randomized in a 1:1:1 ratio to one of three following groups of atorvastatin-loaded emulgel 1% (n = 20), atorvastatin-loaded nano-emulgel 1% (n = 20), and placebo emulgel (n = 20) twice a day for 14 days. The primary outcome was the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scores to determine the rate of wound healing. The Visual Analogue Scale (VAS) and quality of life were the secondary outcomes of this study. A total of 241 patients assessed for eligibility; of them, 60 patients completed the study and considered for final evaluation. A significant decrease in REEDA score was observed on Days 7 (63%) and 14 (93%) of treatment with atorvastatin nano-emulgel (p-value < 0.001). A significant decrease of 57% and 89% in REEDA score was reported at Days 7 and 14, respectively, in atorvastatin the emulgel group (p-value < 0.001). Reduction in pain VAS in the atorvastatin nano-emulgel was also recorded at Days 7 and 14 of the intervention. The results of the present study suggested that both topical atorvastatin-loaded emulgel and nano-emulgel 1% were effective in acceleration of wound healing and alleviation of pain of laparotomy surgical wounds, without causing intolerable side effects.
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