Administrative process and criteria ranking for drug entering health insurance list in Iran-TOPSIS-based consensus model

The purposes of our study were to identify a drug entry process, collect, and prioritize criteria for selecting drugs for the list of basic health insurance commitments to prepare an "evidence based reimbursement eligibility plan" in Iran. The 128 noticeable criteria were found when studying the health insurance systems of developed countries. Four parts [involving criteria] formed the first questionnaire: evaluation of evidences quality, clinical evaluation, economic evaluation, and managerial appraisal. The 85 experts [purposed sampling] were asked to mark the importance of each criterion from 1 to 100 as 1 representing the least and 100 the most important criterion and 45 out of them replied completely. Then, in the next questionnaire, we evaluated the 48 remainder criteria by the same45 participants under four sub-criteria [Cost calculation simplicity, Interpretability, Precision, and Updating capability of a criterion]. After collecting the replies, the remainder criteria were ranked by TOPSIS method. Softwares "SPSS" 17 and Excel 2007 were used. The ranks of the five most important criteria which were found for drug approval based on TOPSIS are as follows: 1-domestic production [0.556], 2-duration of using [0.399], 3-independence of the assessment group [0.363] 4-impact budgeting [0.362] 5-decisions of other countries about the same drug [0.358]. The numbers in parenthesis are relative closeness alternatives in relation to the ideal solution. This model gave a scientific model for judging fairly on the acceptance of novelty medicines

Applying a simple model of cost Effectiveness study of HPV vaccine for Iran

HPV vaccine has been recently added to the Iran Drug List, so decision makers need information beyond that available from RCTs to recommend funding for this vaccination. Modeling and economic studies have addressed some of those information needs. We reviewed cost effectiveness studies to find a suitable model for Iranian population to determine the potential cost effectiveness of HPV vaccine program based on domestic available epidemiologic data. Articles were obtained from an extensive literature search to determine the cost effectiveness of implementing an HPV vaccination program with routine cervical cancer screening. A total of 64 studies were included in this review. Although the studies used different model structures, baseline parameters and assumptions [either a Markov, Hybrid, or Dynamic model]. Most of the proposed cost effectiveness models need to model the probability of HPV acquisition, the possible progression from HPV infection to CIN I, CIN II, CIN III and cervical cancer, the probability of HPV transmission which are not available in Iranian epidemiologic data. Based on the available epidemiologic data in Iran, the simplified and it requires substantially fewer assumptions than the other more complex Markov and hybrid models, therefore we decided to use this model for the evaluation of cost effectiveness of HPV vaccine in Iran

Drug literacy in Iran: the experience of using "the single item health literacy screening [SILS] tool"

Drug and health literacy is a key determinant of health outcomes. There are several tools to assess drug and health literacy. The objective of this article is to determine drug literacy level and its relationships with other factors using a single item screening tool. A cross- sectional survey was conducted among 1104 people in Qazvin province, Iran. Based on the proportional-to-size method, participants over 15 years old with ability to read were recruited randomly from 6 counties in Qazvin province and were interviewed directly. To determine drug literacy relationship with other variables, Chi-Square and t-test were used. Also, logistic regression model was used to adjust the relationship between drug literacy and other relevant variables. Response rate in clusters was 100%. Findings showed that inadequate drug literacy in Qazvin province is 30.3% and it was in association with [1] age [p = .000], [2] marital status [p = .000], [3] educational attainment [p = .000], [4] home county [p = .000], [5] residing area [p = .000], [6] type of basic health insurance [p = .000], [7] complementary health insurance status [p = .000], and [8] family socioeconomic status [p = .000]. After adjusting for these variables using logistic regression model, the association between [1], [3], [4], [5] and [8] with drug literacy level was confirmed. The analysis also showed that this method can also be used in other health care settings in Iran for drug and health literacy rapid assessment

Cost-effectiveness evaluation of quadrivalent human papilloma virus vaccine for HPV-related disease in Iran

Human Papilloma Virus [HPV] vaccine has been added recently to the Iran Drug List. So, decision makers need information beyond that available from RCTs to recommend funding for this vaccination program to add it to the National Immunization program in Iran. Modeling and economic studies have addressed some of those information needs in foreign countries. In order to determine the long term benefit of this vaccine and impact of vaccine program on the future rate of cervical cancer in Iran, we described a model, based on the available economic and health effects of human papilloma virus [HPV], to estimate the cost-effectiveness of HPV vaccination of 15-year-old girls in Iran. Our objective is to estimate the cost-effectiveness of HPV vaccination in Iran against cervical cancer based on available data; incremental cost-effectiveness ratio [ICER] calculations were based on a model comparing a cohort of 15-year-old girls with and without vaccination. We developed a static model based on available data in Iran on the epidemiology of HPV related health outcome. The model compared the cohort of all 15-year old girls alive in the year 2013 with and without vaccination. The cost per QALY, which was found based on our assumption for the vaccination of 15-years old girl to current situation was 439,000,000 Iranian Rial rate [IRR]. By considering the key parameters in our sensitivity analysis, value varied from 251,000,000 IRR to 842,000,000 IRR. In conclusion, quadrivalent HPV vaccine [Gardasil] is not cost-effective in Iran based on the base-case parameters value

Costs of treatment after renal transplantation: is it worth to pay more?

The present study aimed to provide an estimation of the current financial burden of renal transplantation therapy for insurance organisations. An Excel-based model was developed to determine the treatment costs of current clinical practice in renal transplantation therapy [RTT]. Inputs were derived from Ministry of Health and insurance organizations' database, hospital and pharmacy records, clinical trials and available literature. A one-way sensitivity analysis and Monte-Carlo simulation were performed to illustrate total cost changes made by cost components and to test the reliability of model probabilities respectively. According to the model, 2200 patients received RTT in the study year which resulted in the first year total treatment cost of almost $14,000,000. These costs corresponded to annual total cost per patient of almost $6500 for the payers. According to the results of the study, treatment cost per patient in RTT is almost $6500 for the payers in Iran. Although RTT is almost fully reimbursed by government in Iran, an improvement in insurance decision making especially regarding new effective immunosuppressive drugs is quite necessary for controlling growing trends of OOP expenditures in these patients. The present study aimed to improve efficiency in budget allocation by providing insurance decision makers with an estimation of financial impact of current clinical practice in RTT, making it possible for them to compare current financial burden of the disease with the future cost burden of including newly submitted drugs to their formulary in RTT and also provided practical policy making recommendations in the end

Situation analysis of R and D activities: an empirical study in Iranian pharmaceutical companies

As global competition intensifies, research and development [R and D] organizations need to enhance their strategic management in order to become goal-directed communities for innovation and allocate their resources consistent with their overall R and D strategy. The world pharmaceutical market has undergone fast, unprecedented, tremendous and complex changes in the last several years. The pharmaceutical industry is today still one of the most inventive, innovative and lucrative of the so-called "high-tech" industries. This industry serves a dual role in modern society. On one hand, it is a growing industry, and its output makes a direct contribution to gross domestic product [GDP]. On the other side, drugs, this industry's major output, are an input in the production of good health. The purpose of this study is to evaluate R and D activities of pharmaceutical companies, and also to highlight critical factors which have influential effect on results of these activities. To run this study a valid questionnaire based on literature review and experts' opinion was designed and delivered to 11 pharmaceutical companies. Empirical data show there is not acceptable situations considering of the factors that should be taken in to account by managers including; management commitment, human resource management, information technology and financial management. Furthermore, we concluded some interesting results related to different aspects of R and D management. In conclusion, managers must be aware about their performance in R and D activities, accordingly they will able to take a comprehensive policy in both national and within the company

impact of intellectual capital efficiency on market value: an empirical study from Iranian pharmaceutical companies

The increasing gap observed between market value and book value of many companies has taken into account towards investigating the impact of intellectual capital [IC] on business performance. IC has been widely considered as a critical tool to deliver the business successfully in an intensive competitive environment. Various models have been suggested to measure the numerous aspects of IC, i.e. the Skandia navigator, Tobin's Q, and value added intellectual coefficient [VAIC]. The aim of this study is to examine the relationship between intellectual capital and market value of pharmaceutical companies, using the VAIC developed by Ante Pulic [2000]. Six-year data was obtained from audited financial reports in Iranian Exchange Stock, and used to calculate human capital, structural capital, and capital-employed efficiency of pharmaceutical companies. The results obtained using correlation and multiple regression analysis failed to support the impact of IC on market value. Practically, IC efficiency can be applied as a benchmark and strategic indicator to assess firm value. This study is a pioneering attempt in Iran to measure the impact of IC efficiency on market value using cross sectional time series data

Acute and subacute toxicity of teucrium polium total extract in rats

Teucrium Polium L. [TP] is widely used in traditional medicine of many countries including Iran. There are various reports about pharmacological properties of TP such as calcium antagonist, anti- ulcer, anti - diabetic. There are a few reports about possible toxicological effects of this plant. In the present study we designed to evaluate the subchronic toxicity of Teucrium Polium total extract in rats. Sprague Dawley rats [40 males, 40 females] were divided into four dose groups [10 animals/dose/sex] and were gavaged daily with either 100, 300 or 600 mg/kg of the total extract for 44 days. Control group was received normal saline. Body weight and food consumption was monitored daily. After 45 days animal was sacrificed and hematological and biochemical parameters, as well as weight of left kidney and liver were measured. There was no significant difference in hematological parameters in both sexes as compared to their respective Controls. In biochemical parameters, a significant increase [p<0.05] was seen in both ALT and AST enzyme activities in female rats receiving 300 mg/kg TP. There was also a significant increase in liver weight of male rats receiving 600 mg/kg. No other significant changes in any other parameter were observed. Present data suggests that female rats are more sensitive to higher doses of TP and that liver could serve as a target organ toxicity of this extract

T2-toxin hepatotoxicity in the in situ rat liver model

T-2 toxin, a trichothecene mycotoxin, is considered to be one of the most toxic compounds that are produced by molds, particularly the Fusarium species. Fusarium species have been recognized as a great agricultural problem. They occur worldwide on a variety of plant hosts and cereal grains. The aim of this study was to investigate T-2 toxin-induced liver injury using in situ perfused rat liver. The in situ perfused rat liver [IPRL] was chosen because it permits studies of liver function in a system that resembles normal physiology. Elevation of aminotransferase activities have shown to be a good indicator of hepatocellular damage. In addition, glutathione levels have also shown to be an indicator of liver damage through lipid peroxidation. Male Sprague-Dawley rats [6-8 weeks] weighing 250-300 g were used in this study. They were randomly divided into 5 groups of 3-4 rats per cage. In group 1, liver was perfused by Krebs-Henseleit buffer alone [Control]. Groups 2-5 received different concentration of T-2 toxin [4, 9, 21, 43 [rho]mol/L] in Krebs-Henseleit buffer and biochemical changes in the liver were examined within 2 h. There was a significant increase in both ALT and AST activity in all dose levels compared with the control group [p<0.01 and p<0.05]. T-2 toxin treatment enhanced lipid peroxidation in the liver, as indicated by the increased MDA content in liver homogenates. The MDA level was maximal 2 h after the T-2 toxin challenge [p<0.01 and p<0.05]. The results also show that T-2 toxin causes an increase in lipid peroxidation while causing a decrease in glutathione [GSH] content in bile secretion [p<0.01]. This result suggests that both lipid peroxidation and glutathione [GSH] depletion play a role in T-2 toxin liver induced damages