Cost-Effectiveness Analysis of Triptorelin, Goserelin, and Leuprolide in the Treatment of Patients With Metastatic Prostate Cancer: A Societal Perspective.

OBJECTIVES: Metastatic prostate cancer is the most common malignant cancer and the second leading cause of death due to various types of cancer among men after lung cancer. This study aimed to analyze the cost-effectiveness of triptorelin, goserelin, and leuprolide in the treatment of the patients with metastatic prostate cancer from the societal perspective in Iran in 2020. METHODS: This is a cost-effectiveness study in which a 20-year Markov transition modeling was applied. In this study, local cost and quality-of-life data of each health state were gathered from cohort of patients. The TreeAge pro 2020 and Microsoft Excel 2016 software were used to simulate cost-effectiveness of each treatment in the long term. The one-way and probabilistic sensitivity analyses were also performed to measure robustness of the model outputs. RESULTS: The findings indicated that the mean costs and utility gained over a 20-year horizon for goserelin, triptorelin, and leuprolide treatments were $ 13 539.13 and 6.365 quality-adjusted life-years (QALY), $ 18 124.75 and 6.658 QALY, and $ 26 006.92 and 6.856 QALY, respectively. Goserelin was considered as a superior treatment option, given the estimated incremental cost-effectiveness ratio. The one-way and probabilistic sensitivity analyses confirmed the robustness of the study outcomes. CONCLUSIONS: According to the results of the present study, goserelin was the most effective and cost-effective strategy versus 2 other options. It could be recommended to policy makers of the Iran healthcare system to prioritize it in clinical guidelines and reimbursement policies.

Cost-Effectiveness Comparison between Ticagrelor and Clopidogrel in Acute Coronary Syndrome in Iran.

Background: The present study aimed to determine the cost-effectiveness of ticagrelor compared with clopidogrel in Iranian patients with acute coronary syndrome (ACS). Methods: A 1-year decision tree model combined with a 20-year Markov transition model was used to simulate the long-term cost and effectiveness of both ticagrelor and clopidogrel in Iran based on an Iranian payer's perspective. Clinical efficacy data were extracted from the PLATO trial and other published studies. Costs were estimated based on local prices in public sectors. Deterministic and probabilistic sensitivity analyses were used to test the robustness of base-case results over the uncertainties of model inputs. All calculations, analyses, and modeling were done in TreeAge 2011 and Microsoft Excel 2013. Results: Compared with clopidogrel, the treatment of Iranian ACS patients with ticagrelor for 20 years resulted in an additional cost of US$ 2.39 in a hypothetical cohort of 1000 patients. However, ticagrelor led to 7.2 quality-adjusted life-years (QALYs) gained per 1000 hypothetical patients. Accordingly, the estimated incremental cost-effectiveness ratio for this analysis was US$ 332.032 per 1 QALY gained. Conclusion: Ticagrelor was a cost-effective antiplatelet medicine compared with clopidogrel in Iranian patients with ACS. This could help Iran's policymakers to allocate resources more efficiently to ACS.

Determinants and economic burden of HIV/AIDS in Iran: a prospective study.

BACKGROUND: Since the start of the AIDS outbreak, the human immunodeficiency virus (HIV) has infected about 84.2 million people, and approximately 40.1 million people have died due to AIDS-related diseases. So, this study aims to provide a comprehensive population-based description of patient costs and the economic burden of HIV/AIDS in Iran. METHODS: The study population of this cross-sectional cost-of-illness study consisted of HIV-infected patients who were receiving services in Mashhad and were under the supervision of BIDCC. There are four BIDCC centers in Mashhad, we considered all patients referred to these centers. Costs data were evaluated from a social perspective with a bottom-up approach and as a prevalence based. The data from 157 individuals were included in the study. For collecting data on direct and indirect costs belonging to patients and their families, a questionnaire was developed. Also, the Demographic characteristic of participants and the stage of the disease and Transmission category were analyzed. RESULTS: In this study, 57.32 of the subjects were Male. The majority of participants in this study were in the age group 30-59 years (n = 124,78.98%). Based on where the patients live, the majority of patients have lived in the urban region (n = 144, 91.72%). The most common way to transmit this disease is through unprotected sex (30.57%) and then Infected spouse (28.03%), and then injecting drugs (21.02%). The highest cost of this disease is attributed to medicine (10339.32 $ for 6 months), after medicine, the cost of tests was 9101.22 $. CONCLUSION: It seems that to reduce costs for patients with disease HIV/AIDS, the focus should be on diagnostic tests and care. Early diagnosis and rapid initiation of antiviral treatments can be effective in preventing serious and debilitating diseases.

Availability and affordability of cardiovascular medicines in a major city of Afghanistan in 2020.

PURPOSE: Affordable access to quality medicines is a critical target of global efforts to achieve universal health coverage. The aim of this study is to measure the affordability and accessibility of cardiovascular medicines in the city of Herat, Afghanistan. METHODS: The price, affordability, and availability data for 18 most sold generic (MSG) and lowest priced generic (LPG) products were collected from public and private pharmacies located in Herat city in Afghanistan in 2020, which in each area, six pharmacies were randomly selected from a combination of public and private ones based on the standardized methodology developed by WHO/HAI. According to this methodology on Medicine Prices, Accessibility, and Affordability, the minimum daily wage of an unskilled governmental worker, and the price of each type of cardiovascular medicines for one-month use were calculated separately. If the cost of the treatment was more than the minimum daily wage, the medicine was considered unaffordable. RESULTS: The mean availability score for lowest price generic (LPG) in public and private pharmacies and based on the countries of origin including Iran, Pakistan, and India was 60%, 46%, and 31%, respectively. Of the 18 medicines surveyed, just Atenolol (Iranian brand) was found in all 30 pharmacies on the day of data collection. All Indian- brand medicines were less than fifty percent available in any of the surveyed public and private pharmacies. Among the medicines exported to Afghanistan, the population of Herat used more medicines made by Pakistan compared to India and Iran (MSG). Indian medicines were the most expensive ones and the Iranian medicines were the cheapest. A wage of less than one day was enough to afford one-month supply of generic medicines at the lowest price. CONCLUSION: Access of patients to cardiovascular medicines in Afghanistan was 46% in this study which is regarded as low access. Most of available cardiovascular medicines in the market of this country were made in Iran, Pakistan and India. Although the Iranian ones were the cheapest, but people used more Pakistani medicines. LPG products were affordable to the studied population.

Evaluation of COVID-19 Treatments in Iran in Comparison with Local Therapeutic Recommendations: A Population-Level Study on Utilization and Costs of Prescription Drugs.

Objective: In this study, we assess population-level data of COVID-19 treatments in Iran compared to Ministry of Health (MOH)-published guidelines to gain a better insight into the quality of care for this disease. Methods: National sales data of each recommended and nonrecommended COVID-19 medicine were used to proxy utilization between March 21, 2020, and March 21, 2021, or Iranian year 1399. COVID-19-attributed sales volume and number of patients were estimated by adjusting sales data with pre-COVID-19 average growth rate, recommended dose, and duration of treatment. Next, they were compared with the MOH guidelines in outpatient and inpatient settings. Furthermore, the list of top 10 molecules of the market and top 10 COVID-19-indicated molecules in terms of values were extracted to assess the economic burden of COVID-19 prescription drugs and their share. Findings: The estimated number of patients receiving COVID-19 treatments in some outpatient medicines such as recommended hydroxychloroquine was over 2.2 million. Favipiravir and remdesivir were collectively about two inpatient medicines 260,000; however, neither of these two medicines was recommended in the MOH guidelines. In some fewer specific medicines such as dexamethasone, prednisolone, azithromycin, and naproxen, the estimated number of COVID-19-attributed patients were incomparable with the officially announced number of confirmed cases in the year of study, which could be related to nonconfirmed diagnosed cases, irrational use, or prescribing, or limitations of our data and study. The total COVID-19-attributed market of candidate medicines was over 15 trillion IR Rials (almost 4.3% of the total market). Remdesivir, with over 60% of the total COVID-19 attributed market, followed by favipiravir, was among the highest value medicines. Conclusion: Despite the release of the COVID-19 guideline by Iran MOH, misalignment in the enforcement of decisions was a serious weakness (cases of favipiravir and remdesivir). This weakness led to some economic burden on the health-care system and raised ethical concerns.

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.

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.

Social accounting matrix and the effects of economic reform on health price index and household expenditures: Evidence from Iran.

Background: Socioeconomic indicators are the main factors that affect health outcome. Health price index (HPI) and households living costs (HLC) are affected by economic reform. This study aimed at examining the effect of subsidy targeting plan (STP) on HPI and HLC. Methods: The social accounting matrix was used to study the direct and indirect effects of STP. We chose 11 health related goods and services including insurance, compulsory social security services, hospital services, medical and dental services, other human health services, veterinary services, social services, environmental health services, laundry& cleaning and dyeing services, cosmetic and physical health services, and pharmaceutical products in the social accounting matrix to examine the health price index. Data were analyzed by the I-O&SAM software. Results: Due to the subsidy release on energy, water, and bread prices, we found that (i) health related goods and services groups' price index rose between 33.43% and 77.3%, (ii) the living cost index of urban households increased between 48.75% and 58.21%, and (iii) the living cost index of rural households grew between 53.51% and 68.23%. The results demonstrated that the elimination of subsidy would have negative effects on health subdivision and households' costs such that subsidy elimination increased the health prices index and the household living costs, especially among low-income families. The STP had considerable effects on health subdivision price index. Conclusion: The elimination or reduction of energy carriers and basic commodities subsidies have changed health price and households living cost index. Therefore, the policymakers should consider controlling the price of health sectors, price fluctuations and shocks.

Cost-Effectiveness Analysis of Tocilizumab in Comparison with Infliximab in Iranian Rheumatoid Arthritis Patients with Inadequate Response to tDMARDs: A Multistage Markov Model.

OBJECTIVES: To analyze the cost-effectiveness of two common treatment strategies in Iran, comparing infliximab plus methotrexate with tocilizumab plus methotrexate in patients with rheumatoid arthritis with inadequate response to traditional disease-modifying antirheumatic drugs. METHODS: A multistage Markov decision model was applied to assess the incremental cost-effectiveness ratio (ICER) of a tocilizumab-containing regimen versus an infliximab-containing regimen over a 5-year time period. In the case of no response, we assumed that patients switched to the next treatment (adalimumab, rituximab, or supportive care) in sequence for each strategy. We considered major cost items, such as direct medical costs and direct nonmedical costs, from a payer (patients and third-party payers) perspective. A deterministic sensitivity analysis was conducted to assess the robustness of the model results over the uncertainty of key parameters. RESULTS: In the base-case analysis, the ICER of the tocilizumab-containing regimen was US $60,800 per quality-adjusted life-year as compared to the infliximab-containing regimen. In the sensitivity analysis, changes in the price of the drugs by generic substitution, in utility scores, and in discount rate did not change our overall conclusions. Among all inputs to the primary study and the sensitivity analyses, however, the price of tocilizumab had the most impact on the ICER. CONCLUSIONS: Although tocilizumab and methotrexate provide a larger gain in quality-adjusted life-years, their current price is quite high as compared with those of our other interventions. Therefore, a regimen containing tocilizumab is not cost-effective as compared with an infliximab-containing regimen for patients with rheumatoid arthritis in Iran.

A Cost-Utility and Cost-Effectiveness Analysis of Different Oral Antiviral Medications in Patients With HBeAg-Negative Chronic Hepatitis B in Iran: An Economic Microsimulation Decision Model.

BACKGROUND: Although hepatitis B infection is the major cause of chronic liver disease in Iran, no studies have employed economic evaluations of the medications used to treat Iranian patients with chronic hepatitis B (CHB). Therefore, the cost-effectiveness of the different treatment options for this disease in Iran is unknown. OBJECTIVES: The aim of this study was to compare the cost utility and cost-effectiveness of medication strategies tailored to local conditions in patients with HB e antigen (HBeAg)-negative CHB infection in Iran. METHODS: An economic evaluation of the cost utility of the following five oral medication strategies was conducted: adefovir (ADV), lamivudine (LAM), ADV + LAM, entecavir (ETV), and tenofovir (TDF). A Markov microsimulation model was used to estimate the clinical and economic outcomes over the course of the patient's lifetime and based on a societal perspective. Medical and nonmedical direct costs and indirect costs were included in the study and life-years gained (LYG) and quality-adjusted life-years (QALY) were determined as measures of effectiveness. The results are presented in terms of the incremental cost-effectiveness ratio (ICER) per QALY or LYG. The model consisted of nine stages of the disease. The transition probabilities for the movement between the different stages were based on clinical evidence and international expert opinion. A probabilistic sensitivity analysis (PSA) was used to measure the effects of uncertainty in the model parameters. RESULTS: The results revealed that the TDF treatment strategy was more effective and less costly than the other options. In addition, TDF had the highest QALY and LYG in the HBeAg-negative CHB patients, with 13.58 and 21.26 (discounted) in all comparisons. The PSA proved the robustness of the model results. The cost-effectiveness acceptability curves showed that TDF was the most cost-effective treatment in 59% - 78% of the simulations of HBeAg-negative patients, with WTP thresholds less than $14010 (maximum WTP per QALY). CONCLUSIONS: The use of TDF in patients with HBeAg-negative CHB seemed to be a highly cost-effective strategy. Compared with the other available medication options, TDF was the most cost-saving strategy. Thus, TDF may be the best option as a first-line medication. Patients can also be switched from other medications to TDF.

Is Taurolidine-citrate an effective and cost-effective hemodialysis catheter lock solution? A systematic review and cost- effectiveness analysis.

BACKGROUND: Prevention of catheter-related infection is of prime importance,. However, because of the risks caused by the leakage of circulating antibiotics and development of resistance to antibiotics, they are replaced by lock solutions. The aim of this study was to evaluate the efficacy and cost- effectiveness of taurolidine-citrate as a hemodialysis catheter lock solution compared to other common alternatives in Iran. METHODS: To evaluate the efficacy of taurolidine-citrate, a systematic review was conducted by searching electronic databases. The outcomes of interest for cost-effectiveness analysis were as follows: "Catheter-related bacteremia episodes"; "catheter-related bacteremia-free survival"; "catheter thrombosis rate" for efficacy evaluation and "reduction of catheter-related infection". For evidence synthesis, a meta-analysis was conducted on the extracted efficacy data. To evaluate the cost of treatments, direct medical costs were included, and the incremental cost-effectiveness ratio was calculated for each comparison. The payers' (patients and insurance companies) perspectives were used for cost analysis. RESULTS: After carrying out the systematic process, three articles were included in the analysis. Considering 95% confidence interval, the relative difference was -0.16 (-0.25 to -0.07) for catheterrelated bacteremia episode, indicating that the rate of catheter-related infections in hemodialysis patients who used taurolidine-citrate was 16% less than in those hemodialysis patients who received heparin. Considering 95% confidence interval, the relative difference was 0.13 (-0.06 0.32) for catheter thrombosis, showing that the rate of catheter-related thrombosis in hemodialysis patients who used taurolidine-citrate was 13% more than in hemodialysis patients who received heparin. The results of this analysis indicated that taurolidine-citrate, compared to heparin, was more effective in preventing catheter-related infection; therefore, it could be considered as a superior strategy. Nevertheless, compared to heparin-gentamicin combination, taurolidine-citrate is an inferior strategy because of its higher cost and lower infection prevention. CONCLUSION: Compared to heparin, taurolidine-citrate is a superior option, but it is an inferior strategy compared to heparin-gentamicin combination. The clinical evidences on taurolidine-citrate, heparin and gentamicin/heparin are not sufficient for making confident decisions.

Wealth-related Inequality in Utilization of Antihypertensive Medicines in Iran: an Ecological Study on Population Level Data.

BACKGROUND: We aim to evaluate the trend of national and sub-national (provincial) utilization pattern of antihypertensive medicines in the Iranian population in the past decade and evaluate whether there is any wealth-related inequality in utilization of these medicines among different provinces. METHOD: Either fixed effect or random effect linear panel data model was used to check the effect of wealth index on utilization of all antihypertensive medicines and each class, adjusting for other covariates including years of schooling, urbanization, mean age, and food type of provinces. The principal component analysis was applied to make summery measures for covariates using available national datasets. RESULTS: The effect of wealth category on the utilization of all antihypertensive medicines among Iranian provinces was positive and significant (0.84; 95% CI: 0.09, 1.59). Accordingly as subgroup analysis, in BBs and CCBs classes, the effects of wealth category on utilization of medicines were positive and significant (0.36; 95% CI: 0.12, 0.60 and 0.27; 95% CI: 0.07, 0.40, respectively). However in ACEIs and Diuretics classes, the effects of wealth category were positive but not significant. In ARBs class, the effect of wealth on utilization was negative and not significant (-0.04; 95% CI: -0.27, 0.18). CONCLUSION: According to this study, an inequality could be observed in Iran related to wealth category in utilization of total antihypertensive medicines between provinces.

Comparison of two data mining techniques in labeling diagnosis to Iranian pharmacy claim dataset: artificial neural network (ANN) versus decision tree model.

BACKGROUND: This study aimed to evaluate and compare the prediction accuracy of two data mining techniques, including decision tree and neural network models in labeling diagnosis to gastrointestinal prescriptions in Iran. METHODS: This study was conducted in three phases: data preparation, training phase, and testing phase. A sample from a database consisting of 23 million pharmacy insurance claim records, from 2004 to 2011 was used, in which a total of 330 prescriptions were assessed and used to train and test the models simultaneously. In the training phase, the selected prescriptions were assessed by both a physician and a pharmacist separately and assigned a diagnosis. To test the performance of each model, a k-fold stratified cross validation was conducted in addition to measuring their sensitivity and specificity. RESULT: Generally, two methods had very similar accuracies. Considering the weighted average of true positive rate (sensitivity) and true negative rate (specificity), the decision tree had slightly higher accuracy in its ability for correct classification (83.3% and 96% versus 80.3% and 95.1%, respectively). However, when the weighted average of ROC area (AUC between each class and all other classes) was measured, the ANN displayed higher accuracies in predicting the diagnosis (93.8% compared with 90.6%). CONCLUSION: According to the result of this study, artificial neural network and decision tree model represent similar accuracy in labeling diagnosis to GI prescription.

Cost-effectiveness analysis of adding low dose ribavirin to peginterferon alfa-2a for treatment of chronic hepatitis C infected thalassemia major patients in iran.

BACKGROUND: The prevalence of hepatitis C in Iran is 1% and 18% in general population and thalassemia patients respectively. The cost effectiveness analysis of adding Ribavirin to Peginterferon alfa-2a (PEG IFN alfa-2a) as a combination treatment strategy of chronic hepatitis C in thalassemia patients in comparison with monotherapy could help clinicians and policy makers to provide the best treatment for the patients. OBJECTIVES: In this study we aimed to assess whether adding Ribavirin to PEG IFN alfa-2a is a cost effective strategy in different genotypes and different subgroups of 280 patients with chronic hepatitis C infection from the perspective of society in Iranian setting. PATIENTS AND METHODS: A cost effectiveness analysis including all costs and outcomes of treatments for chronic hepatitis C infected thalassemia major patients was conducted. We constructed a decision tree of treatment course in which a hypothetical cohort of 100 patients received "PEG IFN alfa-2a" or "Peg IFN alfa-2a plus Ribavirin." The cost analysis was based on cost data for 2008 and we used 9300 Iranian Rials (IR Rial) as exchange rate declared by the Iranian Central Bank on that time to calculating costs by US Dollar (USD). To evaluate whether a strategy is cost effective, one time and three times of GDP per capita were used as threshold based on recommendation of the World Health Organization. RESULTS: The Incremental Cost Effectiveness Ratio (ICER) for combination therapy in genotype-1 and genotypes non-1 subgroups was 2,673 and 19,211 US dollars (USD) per one Sustain Virological Response (SVR), respectively. In low viral load and high viral load subgroups, the ICER was 5,233 and 14,976 USD per SVR, respectively. The calculated ICER for combination therapy in subgroup of patients with previously resistant to monotherapy was 13,006 USD per SVR. Combination therapy in previously resistant patients to combination therapy was a dominant strategy. CONCLUSIONS: Adding low dose of Ribavirin to PEG IFN alfa-2a for treatment of chronic hepatitis C patients with genotype-1 was "highly cost effective" and in patients with low viral load and in previous monotherapy resistant patients was "cost effective."

Cost-effectiveness analysis review of exemestane in the treatment of primary and advanced breast cancer.

INTRODUCTION: Exemestane was approved in 2005 for adjuvant treatment of breast cancer. In this study, we aimed to assess whether it is cost-effective in comparison to available alternatives. MATERIAL AND METHODS: To evaluate the efficacy of exemestane, a systematic review was conducted by searching electronic databases. The outcomes of interest were "clinical benefit", "overall response" and "disease-free survival rate". To evaluate the cost of treatments, costs of both domestic generic and imported brand medicines were taken into account, and the incremental cost-effectiveness ratio (ICER) was calculated for each comparison. RESULTS: Regarding primary breast cancer, based upon available evidence, exemestane could not be considered as a cost-effective medicine either in generic or brand form compared with placebo (ICER: 119,100 and 215,525), with tamoxifen after 2-3 years of therapy (ICER: 35,150 and 82,400) and with sequential treatment by tamoxifen and exemestane (dominated because of lower effectiveness and higher cost). In metastatic breast cancer, exemestane was not considered a cost-effective treatment compared with both anastrozole and megestrol acetate (dominated) and was highly cost-effective compared with tamoxifen (ICERs: 2,208 and 4,326 dollars per one more patient with an overall response for generic and brand medicines) although even in this case it was not cost-effective in terms of the 1-year survival rates (dominated). CONCLUSIONS: Regarding current evidence and related costs in terms of Iranian pharmaceutical market prices, exemestane could not be considered a cost-effective treatment in primary and advanced breast cancer compared with available alternatives. However, more evidence is still needed for more certain decisions.

A systematic cost-effectiveness analysis of pregabalin in the management of fibromyalgia: an Iranian experience.

INTRODUCTION: Fibromyalgia is a neuropathic syndrome which is more common in adult females. Pregabalin is the first medicine which was approved by the United States Food and Drug Administration for treatment of fibromyalgia. In this study we aimed to evaluate the cost-efficacy of pregabalin in the treatment of fibromyalgia in Iran. MATERIAL AND METHODS: To evaluate the efficacy of pregabalin, a systematic review was carried out by conducting a wide literature search for the main outcomes of interest that were pain score reduction from the baseline and the percentage of patients with more than 50% pain reduction. To evaluate costs of treatment, only the direct medical costs were considered. The calculated incremental cost-effectiveness ratio (ICER) were compared with one and three times the gross domestic product (GDP) per capita as the threshold to evaluate the economic condition of treatment to be "highly cost-effective", "cost-effective" or "not cost-effective". RESULTS: Out of 4012 searched reports, only four reports were included in the study, all of which were randomized controlled trials with placebo controls. The calculated ICERs for pregabalin 450 mg/day and 600 mg/day with both available forms of brand and generic medicines in the country were in the range of 44-1170 US dollars (USD) and 48-814 USD, which in all cases could be considered as highly cost-effective. Pregabalin 150 mg/day based on available evidence does not have significant efficacy in comparison to placebo. But for pregabalin 300 mg/day, no decision can be made based on current data. CONCLUSIONS: Our analysis indicated that generic pregabalin in the treatment doses of 450 mg/day and 600 mg/day is highly cost-effective.

Assessment of the vaccine industry in Iran in context of accession to WTO: a survey study.

BACKGROUND: The vaccine industry is one of the most important health-related industries. It can be affected by accession to the World Trade Organization (WTO) because of probable dramatic changes in the business environment. Iran has already initiated accession negotiations. PURPOSE OF THE STUDY: In this paper, we investigate the position of, challenges to, and opportunities for vaccine manufacturing in Iran with regard to accession to the WTO. METHODS: This is a qualitative and cross sectional study. To collect information, we designed a questionnaire and interviewed some of the vaccine industry's key opinion leaders in Iran. Before the interviews were conducted, the questionnaires were sent to these individuals by email. RESULTS: According to the interviewees, the country's main challenges with regard to accession to the WTO are the lack of firm internal intellectual property (IP) rules, not being recognized as pre-qualified by the World Health Organization (WHO), the use of old equipment, and a lack of cooperation with global vaccine companies. MAJOR CONCLUSIONS: Iran's local vaccine industry, with a long history and international reputation that could be used as an advantage, is faced with several challenges, such as problems with keeping up with Current Good Manufacturing Practice (cGMP), a lack of adequate and meaningful investment in research and development (R&D), and limitations on private sector participation in the production of vaccines.Gradual privatization of the industry, improved international relations, utilization of the R&D power of small hi-tech companies, consistent education of human resources, and modernization of infrastructures and equipment are among the suggested solutions.