Effect of chromium on glucose and lipid profiles in patients with type 2 diabetes; a meta-analysis review of randomized trials.

PURPOSE: Chromium (Cr) as an essential trace element in metabolism of carbohydrate, lipid and protein is currently prescribed to control diabetes mellitus (DM). The objective of this meta-analysis was to compare the effect of Cr versus placebo (Pl) on glucose and lipid profiles in patients with type 2 DM. METHODS: Literature searches in PubMed, Scopus, Scirus, Google Scholar and IranMedex was made by use of related terms during the period of 2000-2012. Eligible studies were randomized clinical trials (RCTs) with intake of Cr higher than 250 µg at least for three months in type 2 DM. Glycated hemoglobin (HbA1c), fasting blood sugar (FBS), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglyceride (TG), and body mass index (BMI) were the main outcomes. RESULTS: Seven out of 13 relevant studies met the criteria and were included in the meta-analysis. HbA1c change in diabetic patients in Cr supplement therapy comparing to Pl was -0.33 with 95%CI= -0.72 to 0.06 (P= 0.1). Change of FBG in Cr therapy vs. Pl was -0.95 with 95%CI= -1.42 to -0.49 (P< 0.0001). TC change in Cr therapy vs. Pl was 0.07 with 95%CI= -0.16 to 0.31 (P= 0.54). TG change in diabetic patients in Cr supplement therapy comparing to Pl was -0.15 with 95%CI= -0.36 to 0.07 (P= 0.18). CONCLUSIONS: Cr lowers FBS but does not affect HbA1c, lipids and BMI.

Budget impact analysis of temocillin insurance coverage for urinary tract infections caused by ESBL-producing pathogens in Iran.

BACKGROUND: One of the most prevalent infections with a significant disease burden is urinary tract infections (UTIs), which occurs in approximately 50% of women at least once in their lifetime. Antimicrobial resistance to pathogens causing UTIs is expanding worldwide and has been associated with increased use of broad-spectrum antibiotics, including carbapenems, leading to significant costs for insurance and healthcare systems. The emergence of resistance to carbapenems has led to an increasing need for and interest in carbapenem-sparing strategies, including the use of narrow-spectrum antibiotics, such as temocillin. Temocillin has a strong bactericidal effect, along with high tolerability and a good safety profile. It is also stable toward most extended-spectrum beta-lactamases (ESBL). The purpose of our study was to design a budget impact analysis (BIA) model and estimate the budget impact of temocillin insurance coverage for the treatment of UTIs caused by ESBL-producing bacteria from the perspective of the payer. METHODS: The BIA model with insurance payer perspective was used to estimate the impact of temocillin insurance coverage on the treatment of UTIs caused by ESBL-producing bacteria over a 1-year time horizon in Iran. Direct medicine costs, hospitalization and paraclinical costs, and side effect costs were considered in this model. To assess the impact of uncertainty on the model inputs, 1-way sensitivity analyses were performed. RESULTS: The model demonstrates that inclusion of temocillin in insurance coverage, decreasing treatment costs from $36 million to $34 million, will result in overall savings of > $1.9 million and lead to > $9 million savings in insurance costs for antimicrobial resistance. CONCLUSION: The inclusion of temocillin in the insurance coverage in Iran for patients developing UTIs caused by ESBL-producing bacteria would be cost-saving for insurance and decrease the risk associated with emerging antimicrobial resistance.

Consumers' Willingness to Pay for Pharmacist Counselling Services and the Factors Affecting It in Community Pharmacies.

Background: Community pharmacists play an important role in improving outcome by providing advice and counselling services to patients. Objectives: The aim of this study was to measure the willingness to pay (WTP) for pharmacist counselling services in community pharmacies and identify determinant factors on consumers' WTP. Methods: A self-administered questionnaire-based survey was conducted in community pharmacies in Tehran (capital of Iran) from January 1, 2020 to February 20, 2021. Contingent valuation method was applied to evaluate respondents' maximum WTP using three hypothetical scenarios illustrating different levels of counselling services. Logistic regression was used to analyze the association between different variables and WTP for pharmacy services. Results: Total number of participants who completed the questionnaire were 332 and 60% of the participants were male. In the first scenario 70.2% of participants were willing to pay for oral counselling pharmacy services. In the second and third scenario, percentage of people willing to pay increased to 79.5%. and 86.1%, respectively. In the first scenario, monthly income (OR = 0.041, P value = 0.04), the duration of underlying illness (OR = 0.04, P value = 0.04) and the using internet (OR = 2.59, P value = 2.59) had a statistically significant relationship with willingness to pay. In the third scenario, the willingness to pay increased as the age decreased. The possibility of using the internet (OR = 3.32, P value = 0.00) and the need for a community pharmacist (OR = 2.19, P value = 0.03) increased the chance of willingness to pay. Conclusions: More consumers are willing to pay for more pharmacist counselling services. Therefore, improving the quality of counselling services could have positive economic effects on community pharmacies.

Utilization patterns of cardiovascular medications in patients with diabetes mellitus; a retrospective cross-sectional study, 2013-17.

BACKGROUND: Diabetes Mellitus (DM) is a prominent health care issue worldwide. One of the most prevalent comorbidities of DM is cardiovascular disease (CVD). The objective of this study was to assess the utilization patterns of cardiovascular medications in patients with DM in Iran from 2013 to 2017. METHODS: This retrospective cross-sectional study was undertaken using prescription claims data from 2013 to 2017 in Iran. Epidemiological data elements used in this study were obtained from the Global Burden of Disease (GBD) 2019 study. In addition, data on total medication sales were obtained from the national regulatory authority database. The data on medication utilization were analyzed according to the Anatomical Therapeutic Chemical Classification (ATC) /Defined Daily Doses (DDD) international system. RESULTS: Based on the findings, Acetylsalicylic acid was the mainstay of treatment with a utilization rate of 191.7 DDD/ patient/ year in 2017, followed by Atorvastatin with 170.0 and Losartan with 115.1. Although there was an increasing trend in the utilization rate of the medications, the rate of Atenolol and Enalapril was constantly declining during the 2013-17 period. On the other hand, Valsartan and Metoprolol were attracting attention. Almost all medication utilization rates increased from the 30-39 age group up to the 80 + age group. Females had a higher utilization rate in each age group during the whole study period. CONCLUSION: The present study reflects that medication utilization patterns were rational, according to the standard treatment guidelines. Utilization patterns of medications that are recommended for both prevention and treatment of CVD in diabetes were observed to be the highest. Implementation of further policies is needed to minimize cardiovascular complications of diabetes.

A comparison between on-demand usage of rFVIIa vs prophylaxis use of emicizumab in high titer inhibitory hemophilia A patients in Iran: A cost-utility analysis.

BACKGROUND: Hemophilia A (HA) is an inherited X-linked bleeding disease with costly treatment, especially for high titer inhibitory patients. Emicizumab, a new humanized bispecific antibody, has been approved for use to prevent or reduce the frequency of bleeding episodes in HA patients with inhibitors. This study evaluated the cost-utility of emicizumab prophylaxis (EP) in comparison with recombinant factor VII activated on-demand treatment in HA patients with inhibitors. METHODS: A life-time Markov model with payer and societal perspectives was developed in different age groups with different annual bleeding rates (ABR). Efficacy of treatments were extracted from HAVEN trials. Utilities were retrieved from published evidence. Costs were calculated based on Iran food and drug administration official website, national tariff book for medical services and hospital data. One-way deterministic sensitivity analysis was performed. RESULTS: EP was dominant choice in comparison with on-demand administration of recombinant factor VII activated in all age groups with ABR 20 and 25, and it remained dominant in patients with age 2 and age 12 at start point with ABR 16 and 17. The reported incremental cost-effectiveness ratio for the group with ABR 18 at the age 20, was 12,936 United States Dollars which is lower than the acceptable threshold of cost-effectiveness in Iran (1-3 gross domestic product per capita) and EP can be considered as cost-effective choice in this scenario. CONCLUSION: EP was found to be a dominant and cost-effective choice for Iranian HA patients with factor VIII inhibitors with ABR 18 and above with considerable cost saving.

Economic Evaluation for Benign Prostatic Hyperplasia in Iran: Surgical Treatment or Dutasteride.

Benign prostatic hyperplasia is a common chronic disease that is age-dependent. There are two main types of interventional treatment, transurethral resection of prostate as a gold standard (TURP) and open prostatectomy (OP); also, there are two pharmacological groups for managing BPH: alpha-blockers and 5-alpha-reductase inhibitors (5-ARIs). In this economic evaluation study, one 5-ARIs, dutasteride and two main surgical treatments are compared as alternatives for treating moderate BPH in Iran. A cost-utility study with an Iranian health provider perspective was conducted. Markov model in a cohort of 1000 patients with BPH with annual cycle length and ten years' time horizon was developed by using MS EXCEL 2013. The effectiveness measure was an improvement in the IPSS score and transformed to the utility. The transition probabilities, utilities and adverse events were extracted from published clinical trials. The direct medical costs were measured in the 2017 US Dollar. One way sensitivity analysis and scenario analysis were conducted.For treating moderate BPH, seventy-year-old men, in the base case scenario, the utility of pharmacotherapy is 18 QALY less than surgery, and the cost of pharmacotherapy is 136,301.1 $ less than surgery. ICER for pharmacotherapy was 7,572.3 $ compared to surgery. In the sensitivity analysis, the model is not sensitive to most variables but the unit cost of dutasteride. Based on scenario analysis conducted for different age groups, pharmacotherapy with dutasteride is preferred to surgery in patients over 60 years of age in Iran. However, for younger adult men between 40-60 years old, surgery is a cost-effective alternative.

Cost-utility and budget impact analysis of adding-on apremilast to biologic therapy in the treatment of moderate to severe plaque psoriasis, an Iranian payer perspective.

BACKGROUND AND PURPOSE: Plaque psoriasis is a chronic inflammatory disease with skin manifestations that affect the patients' quality of life negatively. The prevalence of psoriasis is approximately 2-3% worldwide and appears to be still on the increase. Due to the stigma problems, psoriasis has a significant effect on one's life that is often overlooked. The current study aimed to conduct the cost-utility evaluation and budget impact analysis of adding-on apremilast ahead of biologic therapy in the treatment of moderate to severe plaque psoriasis. The psoriatic patients who did not undergo the conventional systemic therapy were eligible to enter the defined sequences. EXPERIMENTAL APPROACH: An excel-based Markov model with 40 cycles of 3 months, each of which was adopted to compare the outcomes of each exclusively administered sequence in the treatment of moderate to severe plaque psoriasis. Two exclusive therapeutic sequences were considered. In the first sequence, apremilast was followed by biologics and in the second one, biologics were administered initially without apremilast. The results were extrapolated up to 10 years. The designed Markov model was also used in budget impact analysis. The cost-saving potential of the new treatment was accounted for the next 5 years. FINDINGS/RESULTS: Incremental cost and incremental effect were reported in the base case scenario. Using the sequence consisting apremilast provided an additional 0.10 quality-adjusted life years and decreased total costs by about 11,100 USD per patient. These results were in line with the findings from sensitivity analysis. The cost-saving over 5 years is estimated to be around 30 million dollars for the Iran market following the use of the new treatment. CONCLUSION AND IMPLICATIONS: In the treatment of moderate to severe plaque psoriasis, apremilast supplementation prior to biological treatments is more cost-effective than biological treatment alone.

Cost-utility of new film-coated tablet formulation of deferasirox vs deferoxamine among major beta-thalassemia patients in Iran.

OBJECTIVES: Thalassemia is a hereditary disease, which caused economic burden in developing countries. This study evaluated the cost utility of new formulation of deferasirox (Jadenu) vs deferoxamine (Desferal) among B-Thalassemia-major patients from payer perspective in Iran. METHODS: An economic-evaluation through Markov model was performed. A systematic review was conducted in order to evaluate the clinical effectiveness of comparators. Because of chelating therapy is weight-dependent, patients were assumed to be 2 years-old at initiation in first and 18 years-old in second scenario, and model was estimated lifetime costs and utilities. Costs were calculated to the Iran healthcare system through payer perspective and measured effectiveness using quality-adjusted life years (QALYs). One-way sensitivity analysis and budget impact analysis was also employed. RESULTS: The 381 studies were retrieved from systematic searching through databases. After eliminating duplicate and irrelevant studies, 2 studies selected for evaluating the effectiveness. Jadenu was associated with an incremental cost-effectiveness ratio (ICER) of 1470.6 and 2544.7 US$ vs Desferal in first and second scenario respectively. The estimated ICER for Jadenu compared to generic deferoxamine was 2837.0 and 6924.1 US$ for first and second scenario respectively. For all scenarios Jadenu is presumed as cost-effective option based on calculated ICER which was lower than 1 gross domestic product per capita in Iran. Sensitivity analysis showed that different parameters except discount rate and indirect cost did not have impact on results. Based on budget impact analysis the estimated cost for patients using Desferal (based on the market share of brand) was 44,021,478 US$ in 3 years vs 42,452,606 US$ in replacing 33% of brand market share with Jadenu. This replacement corresponded to the cost saving of almost 1,568,872 US$ for the payers in 3 years. The calculated cost of using generic deferoxamine in all patients was 68,948,392 US$. The increase in the cost of using Jadenu for 10% of all patients in this scenario would be 934,427 US$ (1.36%) US$ at the first year. CONCLUSIONS: Based on this analysis, film-coated deferasirox appeared to be cost-effective treatment in comparison with Desferal for managing child and adult chronic iron overload in B-thalassemia major patients of Iran.

Health-Related Quality of Life and Health Utility Values in Beta Thalassemia Major Patients Receiving Different Types of Iron Chelators in Iran.

Background: Thalassemia is a chronic, inherited blood disorder, which in its most severe form, causes life-threatening anemia. Thalassemia patients not only engage with difficulties of blood transfusion and iron chelating therapy but also have some social challenges and health threatening factors. There are some reports on quality of life in thalassemia patients around the world from southeast of Asia to Italy in Europe and United States. In this study, we tried to evaluate and compare Health Related Quality of life (HRQoL) and the health utility in beta thalassemia major patients receiving different types of iron chelators and living in different socio-economical situations. Subjects and Methods: EQ-5D-3L accompanied by a Visual Analogue Scale (VAS) questionnaire was used. The respondents were patients with beta thalassemia major that were at least 12 years old selected from 3 provinces of Sistan-Blouchestan, Fars and Mazandaran. Comorbidities including heart complication, Diabetes Mellitus and Hepatitis and also types of iron chelators (oral, injection, combination of both) were also asked. Cross tab and ANOVA analysis conducted to evaluate each dimension score and health utility differences between provinces, iron chelation methods, comorbidities, age group and gender. Results: 528 patients answered the questionnaires. The health utility of patients that received oral iron chelator were 0.87 ± .01 for oral iron chelators versus 0.81 ± .01 for injection dosage form (p<0.05). Increase in age was accompanied by decrease in health utility. Females faced more usual activity problems, anxiety and depression. Heart problems were more prevalent in males. Conclusion: This study suggests that the quality of life of beta thalassemia major patients is dependent on type of iron chelation treatment which they received, the gender they have, the comorbidities they suffer and socio-economical situations they live in.