An efficient and effective ambulatory service model for severe hemophilia-A patients; an introduction to a novel home care model.

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.

Health status and quality of life in patients with severe hemophilia A: A cross-sectional survey.

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 Health Score (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 HRQoL in hemophilia patients was considerably low. Pain, anxiety/depression, and motion limitations were the main causes of the disutility for these patients respectively.

Health care resource utilization and cost of care for haemophilia A and B patients in Iran.

BACKGROUND: Despite the fact that the total therapeutic expenditure of haemophilia is paid by the national health system in Iran, a limited number of research has been performed to evaluate the economic burden of haemophilia. It is even more important when considering the fact that "prophylaxis" has never been used as the main treatment protocol in haemophiliacs in the country, causing high arthropathy rates. The aim of this study is to evaluate the cost drivers in the treatment of haemophilia A and B patients in Iran. METHODS: The national registry database of Ministry of Health (MoH) was queried to identify total number of individuals characteristics diagnosed with Factor VIII and IX deficiency. The service package defined by the department for special diseases was used as the reference for the type and frequency of health care utilization in haemophiliacs in Iran. The direct medical costs including prescription, medical intervention, inpatient, outpatient and diagnostics services and arthroplasty were considered. The prices were extracted from Iranian medical tariff book 2014-15. Medication cost was obtained from the Iranian Food and Drug Organization. RESULTS: Among 8,337 patients registered with bleeding disorders, 3,948 and 848 were identified with haemophilia A and B respectively, of whom 856 (18%) patients had inhibitor at any time in the past. In the two groups, 2,328 (59%) and 452 (53%) patients suffered from severe, 686 (17%) and 186 (22%) from moderate and 902 (23%) and 185 (22%) from mild type of haemophilia. The average annual health care cost for every patient was USD 15,130, mostly allocated to medication USD 10,180 (67%), followed by therapeutic services USD 4,775 (32%) while diagnostic services stood third USD 177 (1%). CONCLUSIONS: There is an urgent need for developing clinical practice guidelines for treatment protocols, procedures and supportive care in haemophilia management in Iran.

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.

Cost analysis of childhood asthma in Iran: A cost evaluation based on referral center data for asthma and allergies.

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.

Cost-effectiveness of adding-on new antiepileptic drugs to conventional regimens in controlling intractable seizures in children.

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.