Cost-utility analysis of Macitentan Vs. Bosentan in pulmonary atrial hypertension.

OBJECTIVE: Endothelin (ET) receptor antagonists (ERAs) have considerable improvements in pulmonary arterial hypertension (PAH) patients' symptoms. Macitentan, a novel ERA, has more significant positive effects like reduction of morbidity and mortality in PAH patients by 45% and decreases PAH hospitalization. Besides, macitentan was able to improve both the physical and mental aspects of patients' lives. This study aimed to evaluate an incremental cost-utility analysis of macitentan compared with bosentan in PAH patients in the Iranian health care system. METHODS: We developed a hybrid model consisting of a decision tree in which PAH patients would take and continue either macitentan or bosentan with different probabilities. Subsequently, each patient would enter one of the 4 Markov's, each consisting of 5 states, PAH fraction I, PAH fraction II, PAH fraction III, PAH fraction IV, and death. The cycles and time horizon were considered 3 months and lifetime, respectively. We assessed the impact of each medicine on patients' quality-adjusted life-years (QALYs) and costs, consequently calculated the ICER (Incremental Cost-Effectiveness Ratio). The costs were measured in the dollar (1 dollar is equal to 42000 rials) with the perspective of the payer. The discount rates were assumed 3% for utility and 5% for costs. In addition, a sensitivity analysis was conducted. RESULTS: The costs are about 14163 dollars for bosentan and 13876 dollars for macitentan for each patient in a lifetime. The QALY produced per patient by macitentan was 0.81 more than that of bosentan. The calculated ICER was -357.47 which means that for each incremental QALY, the payer is charged less. CONCLUSION: Macitentan is preferable to and dominant over bosentan in both effectiveness and expenditure. Thus, the therapeutic regimen containing macitentan is introduced as a favorable treatment strategy.

Pegylated versus non-pegylated interferon beta 1a in patients with relapsing-remitting multiple sclerosis: A cost-effectiveness analysis.

Background: Pegylated (PEG) interferon beta 1a has been approved by the United States Food and Drug Administration (USFDA) as an alternative to interferon beta 1a for multiple sclerosis (MS). Due to its higher price, this study aimed to evaluate the cost-effectiveness of PEG-interferon beta 1-a compared with interferon beta 1a from an Iranian payer perspective. Methods: A Markov model was designed according to health states based on Expanded Disability Status Scale (EDSS) and one-month cycles over a 10-year time horizon. Direct medical and non-medical costs were included from a payer perspective. Results: The incremental cost-effectiveness ratio (ICER) was estimated around 11111 US dollars (USD) per quality-adjusted life-year (QALY) gained for the PEG-interferon versus interferon regimen [with currency rate of 29,000 Iranian Rial (IRR) to 1 USD in 2016]. Conclusion: Considering the cost-effectiveness threshold in Iran [three times of gross domestic product (GDP) per capita or 15,945 USD], PEG-interferon beta 1-a could be considered as a cost effective treatment for Iranian patients with MS.

Tumor Necrosis Factor-alpha Antibodies in Fistulizing Crohn's Disease: An Updated Systematic Review and Meta-analysis.

Medical treatment for fistulizing Crohn's disease (FCD) is changing rapidly over the time by the introduction of novel therapeutic medicines, while no global consensus is available. This study aims to accomplish a systematic review and meta-analysis on the efficacy of tumor necrosis factor-alpha antibodies (anti-TNF-α antibodies) versus placebo in FCD. A systematic review of published literature was carried out till December 2016, and a meta-analysis of identified studies was done. Data have been explored from PubMed, Scopus, Cochrane Library Database, and Web of Science. Predefined exclusion criteria for included studies in meta-analysis are based on search methodology and are as follows: Randomized clinical trial about Crohn's disease (CD) patients without fistula, pediatrics CD, randomized clinical trials about pregnant women with FCD, nonhuman studies, randomized clinical trials with surgical therapies interventions, conference abstracts, case reports, and language other than English studies. All randomized placebo-controlled trials were included. To assess risk of bias, Jadad score was applied to evaluate trials' methodological quality. Relative risk (RR) and 95% confidence intervals were computed using Mantel-Haenszel and/or Rothman-Boice (for fixed effects) or Der Simonian-Laird (for random effects) techniques. Nine studies attained defined inclusion criteria. The meta-analysis results showed that anti-TNF-α antibodies are remarkably more effective in comparison to placebo for fistula closure maintenance (RR = 2.36; 95% confidence interval: 1.58-3.55; P < 0.0001) in patients with FCD, whereas anti-TNF-α antibodies were not superior to placebo neither in fistula improvement nor in fistula closure. We concluded that adalimumab and certolizumab pegol are both effective in fistula closure maintenance in adult patients with FCD.

Cost-Utility Analysis of Single-Fraction Versus Multiple-Fraction Radiotherapy in Patients with Painful Bone Metastases: An Iranian Patient's Perspective Study.

OBJECTIVES: To evaluate two of the various treatment strategies of bone metastasis- single-fraction radiotherapy and multiple-fraction radiotherapy. METHODS: A multistage Markov decision model was applied to assess the incremental costs per quality-adjusted life-year (QALY) gained of single fraction against multiple fractions. The model had a monthly cycle length over a lifetime horizon with 1000 hypothetical cohort samples. The EuroQol five-dimensional questionnaire was used to estimate the health-related quality of life in patients. To cope with parameters of uncertainty, we conducted a probabilistic sensitivity analysis using a Monte-Carlo simulation technique. Both cost and utility variables were discounted by 3% in the base model. Strategies were assessed considering a willingness-to-pay threshold of US $6578 per QALY gained. RESULTS: The expected mean cost and quality-adjusted life-years were, respectively, US $447.28 and 5.95 months for patients receiving single-fraction radiotherapy and US $1269.66 and 7.87 months for those receiving multiple-fraction radiotherapy. The incremental cost-utility ratio was US $428.38 per QALY. Considering the Iranian gross domestic product per capita (US $6578) as the recommended willingness to pay for 1 QALY gained, the multiple-fraction method was found to be a cost-effective strategy. CONCLUSIONS: Policymakers should advocate the multiple-fraction method instead of the single-fraction method in the treatment of patients with painful bone metastases.

Pharmaceutical laws and regulations in Iran: An overview.

The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.