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Aim: This study aimed to perform an economic evaluation of Hemophilia ambulatory service delivery model (HASDM) comparing to the traditional home-episodic treatment model. Study Design: Tehran university of medical science, department pharmacoeconomics and pharmaceutical administration, between Jun 2016 and September 2018. Methods: A cost-minimization analysis (CMA) was conducted for evaluating potential savings of HASDM in comparison to the traditional home-episodic treatment model. The main cost of regular episodic service delivery, basic arm, consists of the cost of recombinant factor VIII (FVIII). In the comparator arm, HASDM, the costs of HASDM for 1660 hemophilia A patients (HAPs) in Tehran were calculated. One-way sensitivity analysis was done to investigate the robustness of the results and to investigate the impact of uncertainty in the percentage of mistakes in bleeding sensation. Results: There were 1660 patients with severe Hemophilia A (PWSHA) in Tehran in 2018. The mean utilization of annual per patient FVIII was 44814 international units (IUs) in Iran. The total annual cost of FVIII concentrate for 1660 hemophilic patients in Tehran was estimated at $ 11,001,816. The cost of running HASDM, personal, and equipment is equal to $ 580,956. The cost of FVIII in HASDM would be $ 4,004,661. Therefore, the total cost of HASDM is estimated at $ 4,585,617. The amount of savings was $ 6,416,199. Sensitivity analysis indicated the robustness of the results up to 94.64% of the variation in the model parameters. Conclusions: HASDM, compared to episodic model, can save 58.32% of the funding for controlling bleeding in HAPs annually. This can save more than 38 times of HAPs annual cost over their lifetime.

Introduction: Hemophilia A (HA) is an inherited deficiency in blood coagulation factors. Starting the treatment based merely on patients’ hemorrhage feelings results in more than 63.6% mistakes in joint bleeding diagnosis. This study aimed to design a useful ambulatory service model for Patients With Severe Hemophilia A (PWSHA). Methods: This study was done in 3 steps. In step-I, the current service model to PWSHA in Tehran was evaluated. In step II, an ambulatory service model was proposed according to the existed gaps and their requirement. In step III, the model’s acceptability was assessed from the perspective of clinicians, PWSHA, and healthcare policymakers. Results: There were 1660 PWSHA in Tehran in 2018. The average use of Factor VIII (FVIII) was 44814 IU in Iran. The yearly budget of FVIII in Tehran was 10,627,320 US$ in 2018. We proposed a home care model with five care centers in Tehran. Ten caregivers and three hematologists for each care center were suggested to cover all services per day. The extracted data indicated that the total service demand would be 39 for each center per day. The results of the questionnaires in all groups were supportive and cooperative. Conclusion: The current service delivery model to PWSHA has significant economic and clinical defects. Implementing our model can significantly improve the efficiency of bleeding management in PWSHA. Most of the PWSHA, healthcare managers, and clinicians were satisfied with the proposed model.

Introduction: Remdesivir is an antiviral drug manufactured by Gilead Sciences, Inc., which in-vitro studies have shown positive results in controlling coronavirus infection. Therefore, this drug has been proposed as a possible effective option in the treatment of Covid-19, and although it has not yet received any approval from the countries’ pharmaceutical authorities and has not passed the first and second phases of clinical trials, it is prescribed on a trial basis for patients with Covid-19. Researchers in more than 20 countries are monitoring the results of using the drug in a clinical setting to prescribe Remdesivir to larger populations if patients respond positively. Materials and methods: This article is a rapid review of health technology assessment studies that collects related articles by searching medical databases and tries to create a policy guide for Remdesivir through their analysis. The search was conducted on the MEDLINE and Cochrane Library database using keywords including drug name and disease name. The titles and abstracts of the articles were reviewed, and the studies were selected based on the inclusion and exclusion criteria. In addition, the list of related study references were reviewed and added to the study list in cases where a new related article was found. Inclusion criteria included: studies that examined the safety and efficacy of Remdesivir in the population of patients with Covid-19, studies in Persian or English, and all types of studies. The search of the mentioned databases was carried out on April 21, 2020. In order to identify ongoing clinical trials in Iran and some countries, clinical trial registration systems were also searched. Results: After matching the inclusion and exclusion criteria on the search results, a cohort study was found that declared positive response of Remdesivir efficacy in compassionate use. The study has emphasized that due to design limitations, the results obtained on the efficacy of Remdesivir were not reliable, and only through randomized clinical trials sufficient confidence can be achieved. Among other search results, there were two studies on patients receiving this drug. There is also a letter to the editor that introduces Remdesivir as a good possible treatment for Covid-19. Most of the studies were review studies (25 studies), most of which reported on the course of treatment for Covid-19 disease and devoted part to Remdesivir position in the treatment of this disease. None of these studies were systematic reviews. Also, in search of clinical trial registration systems, 15 phases two and three clinical trials were found, as well as a retrospective observation study that assessed Remdesivir safety and efficacy. Of the 15 trials, 13 were in the patient recruitment phase, one was terminated early, and the other was suspended. The results of the terminated trial have been published in the Lancet journal . This study, which was the first clinical trial to be randomized and controlled with placebo, 237 patients were divided into two groups: placebo and Remdesivir groups. The results obtained on the 28th day of the trial show that; although the rate of recovery in the Remdesivir group was numerically better than the placebo group, this difference was not statistically significant and studies on a higher number of patients were needed to prove the significance of this difference. On the other hand, this drug has not been shown to reduce viral load in samples taken from the upper respiratory tract. This study also showed that the incidence of side effects in the group receiving the drug was higher than the control group. Twelve percent of patients in the Remdesivir group had to discontinue the drug due to serious side effects, while in the control group, it occurred in only 5 percent of patients. Despite the publication of the results of the trial and the ambiguity in the results of other clinical trials, the US Food and Drug Administration (FDA) issued a letter on May 1, 2020, in which it authorized Gilead to distribute its drug under an emergency use authorization (EUA). Under this license, Remdesivir is prescribed only for hospitalized patients with severe Covid-19, including those with SpO2≤94% and requiring supplemental oxygen or mechanical respiratory support, under the supervision of health care professionals and under strict EUA conditions. Conclusion: Based on the results of this study, it was found that the evidence for certain decision about the safety and efficacy of Remdesivir in the treatment of Covid-19 is very limited, and only if clinical trials that have begun extensively in multiple countries are completed, a decision can be made to approve or reject the prescription. Due to the ambiguity in the efficacy of Remdesivir, its prescription in patients with Covid-19 has so far been limited to clinical trials, compassionate use, or emergency use.

Among different groups of hemophiliacs, those suffering from Severe Hemophilia A (SHA) are most vulnerable to the complications of the disease. This study investigated the Health-Related Quality of Life (HR-QoL) among adult patients with SHA. A cross-sectional study was designed to gather demographic and clinical information from adult patients with SHA. Patients with inhibitors were excluded. The remaining were asked to complete the HR-QoL questionnaire after being examined for joint health using the Hemophilia Joint HealthScore (HJHS). The HR-QoL and joint conditions were measured in 38 patients. The mean EQ-5D value scores were 0.46 (SD = 0.23) while the mean Visual Analogous Scale score was 50 (SD = 18.7). The clinical examination of patients indicated that the HJHS were as follows: eight patients had a score of 55–75, 12 patients had a score of 40–55, 7 of them (25–40) and 11 patients had a score of 10–25. The results obtained from this study showed that HR-QoL in hemophilia patients was considerably low. Pain, anxiety/depression, and motion limitations were the main causes of the disutility for these patients respectively.

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.

Objective: Asthma as the most common chronic disease in childhood reduces the quality of life of children and their families. We aimed to estimate the cost of managing childhood asthma in Iran and to examine its variability depending on asthma severity. Methods: The cost of asthma was estimated by building a cost assessment model regarding the factors that influence the cost of asthma in children including age and sex distribution, prevalence of disease severity, level of resource utilization depending on disease severity (3 groups of controlled, partly controlled and uncontrolled were defined). The model was comprised of both medical (cost of medication, physician visit and respiratory tests) and non-medical (transportation and hoteling) costs. Furthermore, the average family income in each category was figured and the share of asthma managing costs from the average income was calculated in different groups. Findings: According to model, the total cost of childhood asthma in Iran was around 516.5 million dollars. Moreover, direct medical cost represented 49% of the total costs, among which 66% accounting for medication cost. Direct non-medical costs were estimated 51% with the majority (93%) expended on transportation. In addition, the mean annual cost per child was approximately 466 dollars. In addition, the results indicate the vast majority of patients (46%) are categorized in the uncontrolled group. Conclusion: The cost of childhood asthma in Iran is extremely high comparing to the average income of Iranian families in all categories of asthma severity. Considering the high amount of transportation cost, the accessibility of asthma treatment does not appear to be acceptable. The major source of costs is found to be related to medicine expenditure. Since it has been proven that using medicine does not necessarily result in a well-controlled disease status, alternative approaches should be considered in asthma management.

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.

Background and purpose of the study Intractable seizures are a subgroup of epileptic disorders challenging the physicians’ skills to become controlled. Showing resistance towards common pharmacotherapy, they demand newer antiepileptic drugs acquired at higher costs. 0.06% of children around the world are estimated to suffer from epilepsy and its consequences. The aim of the present study has been to evaluate the cost-effectiveness of these drugs in the treatment of intractable seizures in children. Methods Clinical and cost data were collected from medical and cost records preserved at a neurologist office and a referral pharmacy respectively. Based on the new AED which are accessible in Iran, regimens were categorized into eight groups. The first group consisting of conventional AEDs was considered as comparator and the effectiveness of other groups was compared with it. Incremental Cost-effectiveness Ratio (ICER) of adding-on each new antiepileptic drug was calculated in terms of Rials per consequence (Rls/consq) and compared with each other. Furthermore ICER of the regimens was compared with the GDP per capita (Gross Domestic Product) of the year (2010). Results the ICER of the adding-on regimens range from negative values for Gabapentin, Levetiracetam and Zonisamide to low values for Lamotrigine (~ 6.4 million Rials/consequence [mil Rls/consq]) and Oxcarbazepine (~7.7 mil Rls/consq) and followed by high values for Topiramate (~21 mil Rls/consq) and Vigabatrin (~43.7 mil Rls/consq) considering the three months of remaining on regimen. By increasing the limit of remaining time to six months, the previously mentioned regimens persist on negative values. However Oxcarbazepine (~28.7 mil Rls/consq) and Lamotrigine (~13.8 mil Rls/consq) show a steep increase. Topiramate (~23.6 mil Rls/consq) displays a less change. Opposite to other regimens, the ICER value of Vigabatrin (~17.26 mil Rls/consq) has shown an important increase. Major conclusions Adding-on new antiepileptics to conventional regimens are cost-effective and justified considering the GDP per capita.