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To assess the feasibility of implementing multi-criteria decision analysis (MCDA) and to select the criteria for preparing a national MCDA framework for health technology assessment of orphan drugs in the Kingdom of Saudi Arabia (KSA). The study was conducted in 3 phases. In phase I, a targeted literature review was performed to gather relevant information on the implementation of MCDA in healthcare decision making. Phase II was a cross-sectional survey, conducted to obtain insights from different stakeholders and key opinion leaders on specific topics from the KSA perspective. Phase III included a round-table discussion involving experts to validate the results obtained in the phase II survey and further elaborate on specific requirements that may be critical for developing the first national MCDA framework in the KSA. All the key opinion leaders involved in the study acknowledged the importance of implementing MCDA in the KSA. The Ministry of Health was assigned the responsibility of chairing the MCDA decision process. The experts selected the quantitative, qualitative, and economic criteria to be considered for the MCDA framework. The stakeholders decided to initiate a pilot phase using the deliberative MCDA methodology for the assessment of orphan drugs based on the selected criteria for a period of 1 year and then reevaluate the need to adapt the pragmatic MCDA model. This article describes the novel initiative that examined the feasibility and process required for the development of the first MCDA framework in the KSA to support healthcare decision making. • Multi-Criteria Decision Analysis (MCDA) complements existing healthcare technology assessment tools and offers a higher degree of transparency, accountability, and consistency to decision makers. The Kingdom of Saudi Arabia (KSA) has also recognized the need to adopt MCDA in healthcare decision making. Thus, the study aimed to provide a roadmap for the development of a differentiated MCDA framework for orphan drugs, tailored to the unique context of the KSA. • This study is the first step toward understanding the need and defining the criteria necessary for developing the first national MCDA framework. A 3-phased approach, including a targeted literature review, survey, and discussion among relevant stakeholders and key opinion leaders, was used to reach a consensus. • Through this study, a remarkable decision was taken by the Ministry of Health, KSA, to initiate a pilot phase for orphan drugs based on the deliberative MCDA approach for a period of 1 year and then reevaluate the need to adapt the pragmatic MCDA models. In the KSA, the successful implementation of the MCDA framework has the potential to optimize resource allocation, enhance patient outcomes, and contribute to the overall efficiency of the healthcare system. [ABSTRACT FROM AUTHOR]

We aimed to evaluate the cost effectiveness of Favipiravir treatment versus standard of care (SC) in moderately to severely ill COVID-19 patients from the Saudi healthcare payer perspective. We used the patient-level simulation method to simulate a cohort of 415 patients with moderate to severe COVID-19 disease who were admitted to two Saudi COVID-19 referral hospitals: 220 patients on Favipiravir and 195 patients on SC. We estimated the incremental cost-effectiveness ratio (ICER) of Favipiravir versus SC in terms of the probability to be discharged alive from hospital and the mean time in days to discharge one patient alive. The model was performed twice: first, using unweighted, and second, using weighted clinical and economic data. Weighting using the inverse weight probability method was performed to achieve balance in baseline characteristics. In the unweighted model, base case (probabilistic) ICER estimates favored Favipiravir at savings of Saudi Riyal (SAR)1,611,511 (SAR1,998,948) per 1% increase in the probability of being discharged alive. As to mean time to discharging one patient alive, ICERs favored Favipiravir at savings of SAR11,498 (SAR11,125). Similar results were observed in the weighted model with savings using Favipiravir of SAR1,514,893 (SAR2,453,551) per 1% increase in the probability of being discharged alive, and savings of SAR11,989 (SAR11,277) for each day a patient is discharged alive. From the payer perspective, the addition of Favipiravir in moderately to severely ill COVID-19 patients was cost-savings over SC. Favipiravir was associated with a higher probability of discharging patients alive and lower daily spending on hospitalization than SC. [ABSTRACT FROM AUTHOR]

To perform a cost of control analysis of glucagon like peptide-1 receptor agonists (GLP1RA) in Saudi Arabia (SA) and determine the economic impact of adopting GLP1RAs. A budget impact model that captures the cost of control model was constructed to simulate hypothetical patient on six treatment options: a current mix of 60% liraglutide and 40% dulaglutide, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide. We estimated the relative amounts of SAR spend to achieve HbA1c targets (≤6.5% or < 7.0%). For each treatment option, annual treatment cost, proportion of patients achieving HbA1c targets, and cost to treat major adverse cardiovascular events (MACE) were aggregated to estimate the cost of control per patient per year (CCPPPY) over 5-year horizon (2021–2025). Probabilistic sensitivity analysis (PSA) was performed as a confirmatory analysis. The CCPPPY to achieve HbA1c ≤ 6.5%/<7.0% using current mix, semaglutide, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 17,097/SAR 14,113, SAR 12,889/SAR 11,123, SAR 15,594/SAR 12,892, SAR 19,184/SAR 15,940, SAR 580,211/SAR 380,936, and SAR 246,570/SAR 143,759, respectively. The relative amounts of SAR spend to achieve HbA1c ≤ 6.5%/<7.0% relative to 1 SAR on semaglutide in case of adopting current mix, liraglutide, dulaglutide, exenatide, and lixisenatide were SAR 1.42/SAR 1.18, SAR 1.30/SAR 1.07, SAR 1.60/SAR 1.33, SAR 48.33/SAR 31.73, and SAR 20.54/SAR 11.97, respectively. These results were confirmed in the PSA. Semaglutide 1 mg once weekly was the most economically favorable GLP1RA; associated with the least CCPPPY, and amount of SAR spent to achieve HbA1c of ≤6.50%/<7.00% versus all other GLP1RAs. [ABSTRACT FROM AUTHOR]

Background: Multimodal and multidomain strategies are currently recommended for the management of chronic pain. However, there is little information available on how individuals (opioid users versus nonusers) with chronic pain use multimodal strategies in pain management.Methods: This cross-sectional study used questionnaire data from a sample of pharmacists with chronic pain. The questionnaire collected data on demographics, pain characteristics, pain management strategies, and pain management outcomes. The association between the number of strategies used and opioid use were evaluated by linear regression. Differences between the groups in nonsteroidal anti-inflammatory drugs (NSAIDs) use and types of strategies used in managing the pain were analyzed using logistic regressions. A hierarchical logistic regression was performed to identify potential predictors differentiating opioid users from nonusers.Results: Fifty-seven opioid users and 100 nonusers with chronic pain completed the questionnaire. Opioid users reported higher levels of pain at baseline (7.6 ± 1.7 vs. 6.7 ± 2.2; P = 0.011); however, pain levels after treatment were comparable (2.9 ± 1.9 vs. 3.2 ± 2.4; P = 0.33). Although there was no significant difference in the total number of strategies, the number of pharmacologic strategies was significantly higher in opioid users (P = 0.007). The type of pain management strategies and the use of NSAIDs were similar in both groups after adjusting for potential confounders. The significant predictors of opioid use from hierarchical logistic regression analysis were: lower use of over-the-counter NSAIDs (odds ratio [OR] 0.4; 95% CI 0.2-0.9), using more interventions (OR 1.2; 95% CI 1.1-1.3), reliance on pharmacologic strategies (OR 10.8; 95% CI 2.1-55.7), using combination of pharmacologic and nonpharmacologic strategies (OR 3.7; 95% CI 0.9-15.8), and less interference with daily activities after treatment (OR 0.2; 95% CI 0.1-0.9).Conclusion: Opioid use was primarily related to the use of prescription pharmacologic strategies, but not to age or gender. Posttreatment pain levels were similar between opioid users and nonusers; however, opioid users used more nonopioid medications than nonusers did. [ABSTRACT FROM AUTHOR]

To estimate a Saudi-specific value set for the EQ-5D-5L questionnaire using the EuroQol Valuation Technology program and the EuroQol Group's standard protocol. Participants were quota-sampled from the Saudi adult population based on residency location, age group, gender, education level, and employment status. The participants were guided through the completion of composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks by trained interviewers using EuroQol Valuation Technology software. Quality control (QC) measures were used to ensure good data quality. Random intercept and Tobit models analyzed the cTTO data, as well as models correcting for heteroskedasticity. DCE data were analyzed using conditional logit models, whereas hybrid models were used to analyze the cTTO and DCE data jointly. To evaluate model performance, prediction accuracy, logical consistency, significance level, and goodness of fit were used. The valuation study included a representative sample of the Saudi population (N = 1000). The hybrid heteroskedastic model without a constant was chosen as the preferred model for generating the value set. The predicted values ranged from −0.683 for the worst health state ("55555") to 1 for the full health state ("11111"). Pain and discomfort had the largest impact on health-state preference values, whereas usual activities had the least. The value set for the Kingdom of Saudi Arabia is the first value set for the EQ-5D-5L for any country in the Middle East. The value set can be used in Saudi health system economic evaluations and decision making. • The absence of a Kingdom of Saudi Arabia (KSA)-specific EQ-5D-5L value set prompted the Ministry of Health to develop a value set specific for the country. • The objective of this study was to generate the EQ-5D-5L value set for the KSA based on the EuroQol Valuation Technology protocol. • This is the first value set for EQ-5D-5L generated for the KSA and countries in the Gulf Cooperation Council. This value set will be crucial to economic assessments, health technology assessments, and clinical research in the region. [ABSTRACT FROM AUTHOR]

Purpose The findings from the observational studies comparing the effectiveness and safety of non–vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban). Methods The main data sources included PubMed/MEDLINE, EMBASE, Web of Science, CINAHL, and Scopus from January 1, 2005, to February 15, 2016. We searched for Phase III RCTs and observational studies comparing NOACs versus VKAs. The primary outcomes were stroke/systemic embolism (SE) for AF; recurrent VTE/fatal pulmonary embolism (PE) for VTE; and major bleeding for both conditions. Secondary outcomes included stroke and myocardial infarction (MI) for AF, recurrent deep vein thrombosis (DVT)/PE for VTE, and mortality, intracranial hemorrhage (ICH), and gastrointestinal bleeding for both conditions. Pooled hazard ratios (HRs) were reported by using inverse variance–weighted random effects models. Findings A total of 13 RCTs and 27 observational studies (AF, n = 32; VTE, n = 8) were included. For AF, dabigatran and VKAs were comparable for stroke/SE risk in 1 RCT (HR, 0.77 [95% CI, 0.57–1.03]) and 6 observational studies (HR, 1.03 [95% CI, 0.83–1.27]). Rivaroxaban had a 20% decreased risk of stroke/SE in 3 RCTs (HR, 0.80 [95% CI, 0.67–0.95]) compared with VKA, but the effect was nonsignificant in 3 observational studies (HR, 0.78 [95% CI, 0.59–1.04]). Apixaban decreased stroke/systemic embolism risk (HR, 0.79 [95% CI, 0.66–0.95]) compared with VKA in 1 RCT, but edoxaban was comparable to VKA (HR, 0.99 [95% CI, 0.77–1.28]) in 1 RCT (no observational studies available for apixaban/edoxaban). Dabigatran, apixaban, and edoxaban decreased the risk of hemorrhagic stroke, mortality, major bleeding, and ICH by 10% to 71% compared with VKAs but not rivaroxaban. For VTE, NOACs and VKAs were comparable for recurrent VTE/fatal PE/DVT/PE risk in 7 RCTs and 1 observational study. The 7 RCTs demonstrated a 32% to 69% decreased risk of major bleeding for dabigatran, rivaroxaban, and apixaban compared with VKAs. No difference was shown in 1 rivaroxaban observational study (HR, 0.77 [95% CI, 0.40–1.49]) and 1 edoxaban RCT (HR, 0.84 [95% CI, 0.59–1.20]). Except for dabigatran, the NOACs had a 61% to 86% decreased risk of ICH and gastrointestinal bleeding. Implications Overall, NOACs were comparable or superior to VKAs. Although no observational studies are currently available for apixaban/edoxaban, a few notable inconsistencies exist for dabigatran (ischemic stroke, MI) and rivaroxaban (stroke/SE, major bleeding in VTE) between RCTs and observational studies. Individualizing NOAC/VKA therapy based on benefit/safety profiles and patient characteristics is suggested. [ABSTRACT FROM AUTHOR]