Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study.

BACKGROUND: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). OBJECTIVES: This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting. PATIENTS AND METHODS: A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors. RESULTS: A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant. CONCLUSION: Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required.

Quality of Life of Family Caregivers of Critically Ill Patients With Cancer Before and After Intensive Care Unit Admission Measured by EQ-5D 3-Level: A Longitudinal Prospective Cohort Study.

OBJECTIVES: Admission to the Intensive Care Unit (ICU) is considered a distress journey with an increased demand and cost for informal caregiving. This study aimed to generate utility values through assessing the quality of life (QoL) of family caregivers using the EQ-5D-3L measure before and after ICU admission of their family members. METHODS: A 1-year prospective cohort study (January 2017 to February 2018) was conducted at a comprehensive cancer center in Jordan. Caregivers of adult patients who were in the ICU for ≥ 24 hours were included. The QoL was assessed using the EQ-5D-3L instrument. Caregivers' health profiles were described, and single summary index value for their health status were calculated before ICU admission and were compared with 1-week, 1-month, and 3-month utility index scores after ICU discharge. Predictors of the change of caregivers' QoL were also reported. RESULTS: During the study period, 126 caregivers completed the QoL assessment at baseline. The mean age ± SD of the cohort was 55 years ± 14, and 52% were males. The mean utility scores ± SD were 0.70 ± 0.32, 0.73 ± 0.29, 0.71 ± 0.31, and 0.78 ± 0.31 at baseline, 1 week, 1 month, and 3 months after discharge, respectively. A significant relationship between the patient's Acute Physiology and Chronic Health Evaluation (APACHE II) score and the change in caregiver's utility score index after 3 months was reported. CONCLUSIONS: Improvement in caregivers' QoL has been seen 3 months after ICU discharge. Patients' APACHE II score at baseline is a predictor of the change of caregivers' QoL 3 months after discharge.

Establishment and implementation of hospital-based health technology assessment at King Hussein Cancer Center: can our model be an example?

OBJECTIVE: To describe the establishment of, and assess the implementation of, a hospital-based health technology assessment (HTA) program in a comprehensive cancer center in Jordan. METHODS: This is a cross-sectional assessment study of the HTA program from 2008 to 2018. We used an indicator-based assessment that included structural, process, and outcome indicators. Structural indicators measured the program's enablers. Process indicators measured activities and outputs, whereas outcome indicators measured the program impact. A data collection form was prepared to collect data related to each indicator. RESULTS: The program met its core structural and process indicators. The Center for Drug Policy and Technology Assessment was established as an organizational entity to conduct assessments. A functional decision-making entity is available. There are competent pharmacists to conduct assessments, including economic evaluation and decision analytical modeling. There is a structured capacity building program that has been implemented within the last 5 years. Specific submission, assessment, and appraisal processes were established and implemented. Reference methodological guidelines for efficacy, safety, and cost-effectiveness assessments were developed and used by assessors. Thirty-one HTA reports were produced from 2012 to 2018 with a 100 percent utilization rate. Twenty-three medications were listed under restriction, and eight were rejected. The prices of twenty-one medications out of the twenty-three listed medications were reduced based on the HTA assessment results. CONCLUSION: The HTA program at the King Hussein Cancer Center (KHCC) in Jordan is functional, is effective with a high utilization rate of produced assessments, and is having a positive impact on price reductions.

Implementation of Health Technology Assessment in the Middle East and North Africa: Comparison Between the Current and Preferred Status.

INTRODUCTION: Implementation of health technology assessment (HTA) is still in an early stage with some heterogeneity in the Middle East and North Africa (MENA). Our objective was to assess the current and future status of HTA implementation in the MENA region by focusing on regional commonalities. METHODS: Preparatory discussions for the first ISPOR conference in the MENA region indicated some potentially generalizable trends of HTA roadmaps. To widen the perspective, a policy survey was conducted among conference participants by applying an HTA implementation scorecard. Discussion group members helped to validate key conclusions during and after the conference. RESULTS: Health policy experts in MENA countries would like to facilitate HTA implementation and expect significant changes with some generalizable directions in 10 years compared to the current status according. HTA capacity building has to be strengthened by more graduate and postgraduate programs. Increased public budget and enhanced institutionalization are necessary success factors of HTA implementation. The scope of HTA has to be extended from pharmaceuticals to non-pharmaceutical technologies and to revision of previous policy decisions. Although cost-effectiveness with explicit threshold remains the most preferred HTA criterion, several other criteria have to be considered, maybe even by applying an explicit MCDA framework. The role of local evidence and data has to be strengthened in MENA countries, which translates to the extended use of local patient registries and payers' databases. Duplication of efforts can be reduced if international collaboration is integrated into national HTA implementation. DISCUSSION: Our results should be viewed as an initial step in a multi-stakeholder dialogue on HTA implementation. Each MENA country should develop its context-specific HTA roadmap, as such roadmaps are not transferable without taking into account country size, economic status, public health priorities and adopted systems of health care financing.