Pharmacoeconomic evaluation of insulin aspart and glargine in type 1 and 2 diabetes mellitus in Iran.

Purpose: The higher costs of insulin analogs including short-acting insulin aspart (IAsp) and long-acting insulin glargine (IGla) have restricted their widespread uptake despite having improved pharmacokinetic and pharmacodynamic properties and patient convenience. This study aims to evaluate the cost-effectiveness of IAsp versus Regular Insulin (RI) and IGla versus NPH Insulin in type 1 and 2 diabetes from the perspective of the Iranian healthcare system. Methods: Clinical data including HbA1c levels, hypoglycemia, weight gain, and health-related quality of life were derived from the included systematic review and meta-analysis studies. Different methods of pharmacoeconomic evaluation were used for an annual time horizon. Utility decrements for diabetes-related complications were extracted from the literature. Direct medical costs were calculated in 2022 prices. A one-way sensitivity analysis was also performed. Results: In type 1 diabetes, IAsp was associated with more costs and effects in terms of reducing HbA1c compared with RI. An incremental cost of $83 was estimated to obtain an additional 1% reduction in HbA1c per patient per year. Similarly, an incremental cost of $16 was estimated for IGla compared with NPH. In type 2 diabetes, IAsp and RI were associated with equal efficacy and safety. For IGla versus NPH, the incremental cost-effectiveness ratio was calculated at $1975 per quality-adjusted life-year. The robustness of the result was confirmed through sensitivity analysis. Conclusion: Insulin analogs, IAsp and IGla, are cost-effective for type 1 diabetes versus human insulins, RI and NPH. For type 2 diabetes, IAsp is not cost-effective when compared with RI. For IGla versus NPH, however, the incremental cost-effectiveness ratio seems to be within the accepted thresholds.

A cost-effectiveness analysis of linagliptin add-on to insulin treatment for patients with type 2 diabetes mellitus and chronic kidney disease in Iran.

Purpose: With the high prevalence of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM), determining optimal treatment strategies has become a major concern. Linagliptin is aDPP-4 inhibitor that does not require dose adjustment in patients with renal impairment. This study evaluates the cost-effectiveness of adding linagliptin to insulin therapy in patients with T2DM and mild (stage 2) or moderate (stage 3) CKD from a health system perspective in Iran. Methods: We developed a cost-utility model using a decision tree and ran it separately for T2DM patients with mild or moderate CKD. Clinical outcomes and health-state utility values were extracted from published studies. Direct medical costs were obtained from national tariffs in Iran in 2021. We adopted an annual time horizon and calculated the difference in costs and quality-adjusted life-years (QALYs) to obtain the incremental cost-effectiveness ratios (ICER). To capture parameter uncertainties, one-way sensitivity analyses were also performed. Results: In T2DM patients with mild CKD, the linagliptin add-on strategy was associated with an additional $23.69 cost and 0.0148 QALYs per patient, resulting in an ICER of 1600.37 USD/QALY. In moderate CKD, the strategy was associated with $22.59 more costs and 0.0191 more QALYs, and the ICER was estimated at 1182.72 USD/QALY. In both populations, the ICER was mainly driven by the impact of HbA1c on utility, cost of linagliptin, and the reduction in insulin usage by adding linagliptin to the treatment. Conclusion: With a cost-effectiveness threshold of $1550 USD/QALY in Iran, adding linagliptin to insulin is cost-effective in patients with T2DM and moderate CKD. However, for those with mild CKD, it seems that the associated costs outweigh the expected benefits. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01243-z.

A scoping review on patient heterogeneity in economic evaluations of precision medicine based on basket trials.

INTRODUCTION: Considerable challenges in the economic evaluation of precision medicines have been mentioned in previous studies. However, they have not addressed how an economic assessment would be conducted based on basket trials (novel studies for evaluation of precision medicine effects) in which the included populations have specific biomarkers and various cancers. Since basket trial populations have remarkable heterogeneity, this study aims to investigate the concept of heterogeneity and specific method(s) for considering it in economic evaluations through guidelines and studies that could be applicable in economic evaluation based on basket trials. AREA COVERED: We searched PubMed, Web of Science, Scopus, Google Scholar, and Google to find studies and pharmacoeconomics guidelines. The inclusion criteria included subjects of patient heterogeneity and suggested explicit method(s). Thirty-nine guidelines and 43 studies were included and evaluated. None of these materials mentioned disease types in a target population as a factor causing heterogeneity. Moreover, in economic evaluations, patient heterogeneity has been considered with four general approaches subgroup analysis, individual-based models, sensitivity analysis, and regression models. EXPERT OPINION: Type of disease is not considered a contributing factor in population heterogeneity, and the probable appropriate method for this issue could be individual-based models.

Cost-utility analysis of Macitentan Vs. Bosentan in pulmonary atrial hypertension.

OBJECTIVE: Endothelin (ET) receptor antagonists (ERAs) have considerable improvements in pulmonary arterial hypertension (PAH) patients' symptoms. Macitentan, a novel ERA, has more significant positive effects like reduction of morbidity and mortality in PAH patients by 45% and decreases PAH hospitalization. Besides, macitentan was able to improve both the physical and mental aspects of patients' lives. This study aimed to evaluate an incremental cost-utility analysis of macitentan compared with bosentan in PAH patients in the Iranian health care system. METHODS: We developed a hybrid model consisting of a decision tree in which PAH patients would take and continue either macitentan or bosentan with different probabilities. Subsequently, each patient would enter one of the 4 Markov's, each consisting of 5 states, PAH fraction I, PAH fraction II, PAH fraction III, PAH fraction IV, and death. The cycles and time horizon were considered 3 months and lifetime, respectively. We assessed the impact of each medicine on patients' quality-adjusted life-years (QALYs) and costs, consequently calculated the ICER (Incremental Cost-Effectiveness Ratio). The costs were measured in the dollar (1 dollar is equal to 42000 rials) with the perspective of the payer. The discount rates were assumed 3% for utility and 5% for costs. In addition, a sensitivity analysis was conducted. RESULTS: The costs are about 14163 dollars for bosentan and 13876 dollars for macitentan for each patient in a lifetime. The QALY produced per patient by macitentan was 0.81 more than that of bosentan. The calculated ICER was -357.47 which means that for each incremental QALY, the payer is charged less. CONCLUSION: Macitentan is preferable to and dominant over bosentan in both effectiveness and expenditure. Thus, the therapeutic regimen containing macitentan is introduced as a favorable treatment strategy.

Impact of Protocol Implementation on Rationalization of Albumin Use in a Tertiary Care Teaching Hospital in Tehran, Iran.

OBJECTIVE: With respect to the high cost and limited availability of albumin, its use must be restricted to indications strongly supported by solid scientific evidence. It was anticipated that with the implementation of the National Health Reform Plan (NHRP), the consumption of albumin would increase as the result of decreasing patients' out-of-pocket costs. This study aimed to evaluate the efficacy of protocol implementation on the rationalization of albumin use in surgery wards of Cancer Institute of Imam Khomeini Hospital Complex, Tehran, Iran. METHODS: This pre-post interventional study was conducted in 32-month phases from January to November 2014 in an Iranian University hospital. The first phase was before the implementation of NHRP, the second phase was after NHRP, and the last one was after the intervention. The first and second phases were conducted retrospectively. Data extraction was performed by a hospital pharmacist. During the third phase, the physicians were mandated to adhere to a local albumin protocol which had been prepared by clinical pharmacy service and approved by drug and therapeutic committee. Appropriateness of prescriptions regarding indication, dose, and duration based on local guideline was compared among groups. FINDINGS: Although hospital bed-days of care remained consistent among phases, albumin was prescribed for 40, 45, and 8 patients during first, second, and third phases, respectively. This shows about 80% reduction of drug prescriptions in the last phase. The mean duration/dose of albumin in inappropriate indications reduced significantly from 11.3 ± 8.2 days/24.7 ± 21.2 vials in the second phase to 2.6 ± 1.7 days/5.6 ± 3.5 vials in the third phase, respectively (P = 0.001 and P = 0.003). CONCLUSION: Interactive collaboration through guideline implementation seems effective in rationalizing the use of high-cost medications such as albumin.

Efficacy of a telephone-based intervention among patients with type-2 diabetes; a randomized controlled trial in pharmacy practice.

Background Pharmacists' interventions to improve outcomes of diabetes management have been promising. However, evidence on using telephone-based interventions in pharmacy practice are limited, particularly in developing countries. Objective To evaluate the efficacy of a telephone-based intervention to improve care and clinical outcomes in type-2 diabetes. Setting A referral community pharmacy and drug information center. Method We conducted a two-armed randomized controlled trial on 100 patients with type-2 diabetes. The intervention consisted of 16 telephone calls in 3 month by a trained pharmacist working in an academic drug information center, while the control group received usual care. Before random allocation, patients attended a live education session delivered by pharmacists to learn the basics of diabetes care and to confirm the eligibility criteria. Assessments were performed at baseline, month-3 (after intervention), and month-9 (follow-up). Main outcome measure Hemoglobin A1c (HbA1c). Results Eighty four patient completed the trial. Baseline variables were comparable between the two groups and the baseline value of hemoglobin A1c was 8.00 ± 1.44 in the study population. HbA1c was significantly improved in both groups at month-3 (6.97 ± 1.41 vs. 7.09 ± 1.78) and remained steady at month-9 (6.96 ± 1.44 vs. 7.26 ± 1.85). Lipid profile showed small improvements in the intervention group but was not significant. The adherence score and self-care score improvement was significantly higher in the intervention group at month-3 and were maintained at month-9. Conclusion Medication adherence and self-care significantly improved in the telephone-based intervention group. However, the improvement of clinical outcomes might have been diluted due to the live diabetes education session.

Effect of a community pharmacist-delivered diabetes support program for patients receiving specialty medical care: a randomized controlled trial.

PURPOSE: The purpose of the study was to investigate the efficacy of a community pharmacist-delivered diabetes support program for patients receiving specialty medical care in a middle-income country (Iran). METHODS: A randomized controlled trial was conducted on 101 patients who received diabetes care from an endocrinologist. A qualified community pharmacist educated patients about medications, clinical goals, self-care activities, and self-monitoring of blood glucose. The pharmacist trained patients in the intervention group for 5 months (5 follow-up visits and 5 phone calls) and recommended physician visits when necessary. The primary outcome was A1C, and the secondary outcomes included self-care activities, medication adherence, blood pressure, and body mass index. Satisfaction and willingness to pay was assessed in the intervention group. RESULTS: Eighty-five patients completed the study, and baseline A1C was similar between groups (intervention: 7.6 ± 1.6 [59 mmol/mol] vs control: 7.5 ± 1.9 [58 mmol/mol]). No significant difference was observed between study groups at the end of the trial period; however, the amount of A1C reduction was higher in the intervention group (1.0% ± 1.5% vs 0.5% ± 1.5%). Self-care activity was improved in general diet, blood glucose monitoring, and foot care subcategories in the intervention group. Medication adherence and body mass index were significantly improved in the intervention group at the end of study. CONCLUSIONS: A community pharmacist intervention improved self-care activity, medication adherence, and body mass index in patients receiving specialty medical care. Baseline A1C values and the presence of specialty medical care should be considered in the interpretation of clinical findings.