RESUMEN
Background The number of orphan drug approvals is currently increasing globally. This creates a significant burden on payers and healthcare systems. This study aimed to create a multi-criteria decision analysis (MCDA) tool for evaluating orphan drugs within the United Arab Emirates (UAE). The intended result of the tool is to provide evidence-based guidance to decision-makers in reimbursement and procurement decisions. Methods We conducted a literature search and local expert interviews to identify relevant preliminary criteria for the MCDA tool. Then we conducted a structured consensus-building session for healthcare experts and decision-makers in the UAE to develop the Emirati MCDA tool for orphan drugs. The experts voted for the criteria to be included in the tool and their ranking according to importance, as well as the weight of each criterion and its scoring function. To improve understanding and facilitate the voting process, experts were provided with a brief illustration of similar tools conducted in other countries before the voting sessions. Finally, the tool was developed in a Microsoft Excel sheet (Microsoft Corporation, Redmond, Washington, United States), and it was validated and tested based on real case studies, then it was fine-tuned accordingly based on the experts' discussions. The final tool was provided to the attendees to guide their decisions in the reimbursement and procurement of orphan drugs. Results The created tool provides a score for each analyzed orphan drug based on its value. Ten criteria were included in the final MCDA tool. These were cost-effectiveness (25.1% of the weight), magnitude of health gain (20.1%), availability of therapeutic alternative (14.3%), disease severity (11%), budget impact (7.9%), disease rarity (5.6%), strength of clinical evidence (5.6%), burden on households (4.5%), indication uniqueness (3.2%), and patients' age (2.6%). Conclusions Implementation of evidence-based healthcare necessitates assessing the fair value of each health technology. Addressing the high unmet medical needs and improving healthcare for patients with rare diseases are priorities within the UAE. The created Emirates MCDA tool for orphan drugs has the potential to help decision-makers implement value-based and evidence-based reimbursement decisions for orphan drugs.
RESUMEN
Purpose: Asthma is a common, chronic respiratory disorder associated with substantial societal and economic burden globally, despite the availability of different treatment modalities. GSK has developed a once-daily single-inhaler triple therapy (SITT), comprised of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI); a combination of inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting ß2-agonist for patients with uncontrolled asthma. A budget impact analysis was conducted to determine the financial impact of introducing FF/UMEC/VI SITT from the perspective of the Dubai Academic Healthcare Corporation (DAHC). Methods: A budget impact model was constructed using an epidemiology-based approach and used to estimate the expected 5-year budget impact of including FF/UMEC/VI for the treatment of eligible patients within the DAHC in the United Arab Emirates (UAE). The model included both pharmacy and efficacy-related costs. The perspective of the DAHC healthcare payer was adopted, thus only direct payer costs were included in the analysis. A one-way sensitivity analysis was conducted to test the robustness of the model structure, assumptions, and input parameters. Results: The total budget impact was estimated to save 1 million United States Dollars (USD) over 5 years, with budget impacts of 0.08 million USD in Year 1; 0.14 million USD in Year 2; 0.22 million USD in Year 3; 0.28 million USD in Year 4; and 0.33 million USD in Year 5. The overall budget impact per patient was estimated to save 12.2 USD over 5 years. In one-way sensitivity analyses, the budget impact was most sensitive to changes in the market uptake of FF/UMEC/VI. Conclusion: Healthcare payers may consider FF/UMEC/VI in the management of uncontrolled asthma which would save costs and reduce healthcare resource use in the UAE.
RESUMEN
Background: Dubai Health Authority currently recommends sequential administration of 13-valent pneumococcal conjugate vaccine (PCV13) followed by (â) 23-valent pneumococcal polysaccharide vaccine (PPV23) to prevent pneumococcal disease among adults at elevated risk of illness. Despite recommendations, disease burden and associated costs remain substantial. A new 20-valent pneumococcal conjugate vaccine (PCV20) recently received regulatory approval in the United Arab Emirates and has the potential to further reduce burden of pneumococcal disease. Objectives: To evaluate budget impact of use of novel PCV20 compared with current recommendations (ie, PCV13âPPV23) among expatriates in Dubai aged 50 to 99 years and those aged 19 to 49 years with risk factors. Methods: A deterministic model depicted 5-year risks and costs of invasive pneumococcal disease and all-cause nonbacteremic pneumonia. Each year of the modeling horizon, persons could be vaccinated with either PCV20 or PCV13âPPV23 or remain unvaccinated; persons vaccinated during the modeling horizon were not eligible for vaccination in subsequent years. Annual vaccine uptake was assumed to be 5% in base cases analyses; higher uptake was considered in scenario analyses. Costs were discounted at 3.5% annually and reported in US dollars. Results: In base case, use of PCV20 alone would prevent an additional 13 cases of invasive pneumococcal disease, 31 cases of inpatient all-cause nonbacteremic pneumonia, 139 cases of outpatient all-cause nonbacteremic pneumonia, and 5 disease-related deaths compared with PCV13âPPV23. Medical care costs would be reduced by $354,000, and total vaccination costs would decrease by $4.4 million. PCV20 would therefore yield net budgetary impact of -$4.8 million, resulting in savings of $2.47 per-person per-year over 5 years. In scenarios with higher vaccine uptake, PCV20 prevented more cases and deaths and yielded greater budget savings (vs PCV13âPPV23). Conclusions: PCV20 would reduce burden and economic costs of pneumococcal disease among expatriates in Dubai compared with PCV13âPPV23 and would therefore be budget saving for private health insurers who cover the majority of this population.
RESUMEN
BACKGROUND: This study attempts to estimate the cost-effectiveness of the antiviral remdesivir, as recommended in the 2021 COVID treatment guidelines for the United Arab Emirates, compared to standard of care (SOC), but also favipiravir (FAVI), which was also recommended for the treatment of hospitalized COVID patients. METHODS: A cost-effectiveness model was built using published efficacy data for RDV, FAVI and SOC as well as local epidemiology data. The outcomes measured included hospital bed days averted, mortality, costs and cost per outcome over one year. One-way, probabilistic and scenario analyses were undertaken to reflect uncertainty in the estimates. RESULTS: When modelled over one year, the results indicated that treatment of adults in need of supplemental oxygen with RDV + SOC could result in 11,338 fewer general ward bed days, 7,003 fewer ICU days and 5,451 fewer ICU + MIV bed days compared to SOC alone and similar results when compared with FAVI + SOC. The model results also showed that there were 374 fewer deaths associated with the use of RDV + SOC compared to SOC alone. The model also estimates substantial potential cost-savings associated with RDV + SOC treatment compared with SOC alone (USD 3,454 per patient). The results of the one-way sensitivity analysis showed that the model was sensitive to estimates of length of stay and the cost of hospitalization. Despite this, the model predicted cost-savings in all scenarios versus all comparators. CONCLUSIONS: The model estimated that using RDV + SOC could result in substantial reductions in HCRU and cost savings regardless of the comparator. However, it should be noted that reliable clinical information on FAVI was limited therefore it is challenging to interpret these results. All the potential benefits modelled here for RDV + SOC can have implications not only for the health of the UAE population but for improving hospital capacity to deal with other conditions.
Asunto(s)
COVID-19 , Adulto , Humanos , Análisis Costo-Beneficio , Emiratos Árabes Unidos , Hospitalización , Antivirales/uso terapéuticoRESUMEN
BACKGROUND: Pneumonia is a significant cause of morbidity and mortality among adults globally. This retrospective cohort analysis assessed the pneumonia burden and related healthcare resource utilization and costs in the at-risk (low, medium, and high-risk) adult patients in Dubai, United Arab Emirates (UAE). METHODS: The claims data from January 1, 2014 to June 30, 2019 were extracted from the Dubai Real-World Claims Database for patients, aged ≥18 year, having at least 1 pneumonia claim. Data for the inpatient, outpatient and emergency visits were assessed for 12-months, before (pre-index) and after (follow-up) a pneumonia episode. Healthcare costs were calculated based on dollar value of 2020. RESULTS: Total 48,562 records of eligible patients were analyzed (mean age = 39.9 years; low [62.1%], medium [36.2%] and high [1.7%] risk cohorts). Mean all-cause healthcare costs were approximately >45% higher in the follow-up period (1,947 USD/patient) versus pre-index period (1,327 USD/patient). During follow-up period, the mean annual pneumonia incidence rate was 1.3 episodes, with a similar pattern across all cohorts. Overall, mean claims and costs (USD) per patient (all-cause) were highest in the high-risk cohort in the follow-up period (claims: overall, 11.6; high-risk, 22.0; medium-risk, 13.9; low-risk, 9.9; costs: high-risk, 14,184; medium-risk, 2,240; low-risk, 1,388). Similarly, the mean pneumonia-related costs (USD) per patient were highest for the high-risk cohort (overall: 1,305; high-risk, 10,207; medium-risk, 1,283; low-risk, 882), however, the claims were similar across cohorts (claims/patient: overall: 2.0; high-risk, 1.9; medium-risk, 2.2; low-risk, 1.9). Most all-cause and pneumonia-related costs were due to inpatient visits (4,901 and 4,818 USD respectively), while outpatient (1,232 and 166 USD respectively) and emergency visits (347 and 206 USD respectively) contributed significantly lesser. CONCLUSIONS: Pneumonia imposes a significant healthcare burden in the UAE, especially in the high-risk patients with severe comorbidities. These findings would guide clinicians and policy makers to make informed decisions.
Asunto(s)
Reclamos Administrativos en el Cuidado de la Salud/estadística & datos numéricos , Costo de Enfermedad , Costos de la Atención en Salud/estadística & datos numéricos , Aceptación de la Atención de Salud/estadística & datos numéricos , Neumonía/economía , Adolescente , Adulto , Bases de Datos Factuales/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Neumonía/epidemiología , Neumonía/terapia , Estudios Retrospectivos , Emiratos Árabes Unidos/epidemiología , Adulto JovenRESUMEN
Introduction: In recent periods the United Arab Emirates (UAE) has strengthened economic measures in its pharmaceutical policy by promoting local manufacturing and facilitating the use of generic medicines. International examples indicate the importance of quality control elements in the implementation of cost containment policies. Multicriteria Decision Analysis (MCDA) is increasingly used in health care to facilitate health care decision based on multiple objectives. Our objective was to develop a pilot MCDA tool for repeated use to support the value-based purchasing of generic medicines in the UAE. Methods: An international evidence framework was adapted to UAE in a multistakeholder workshop organized by Dubai Health Authority. After validating the relevance of nine criteria in the local jurisdiction, participants decided the ranking and weight of each criterion by anonymous voting. Results: The top four criteria focused on quality elements starting with real-world clinical or economic outcomes (with 19.8% weight), followed by the quality assurance of manufacturing (17.3%), then evidence on the equivalence with the original product (14.8%), and drug formulation and stability (12.3%). The pharmaceutical acquisition cost criteria ranked fifth with 9.4% weight. The bottom four criteria, including reliability of drug supply, macroeconomic benefit, pharmacovigilance and added value services related to the product had similar weights in the range of 5.5-7.7%. Conclusion: Policy-makers in Dubai put high emphasis of value-based health care by incentivizing manufacturers of off-patent pharmaceuticals to generate additional scientific evidence compared to the mandatory minimum and acknowledging efforts to improve quality standards. The MCDA tool is considered suitable to improve the transparency and consistency of decision making in UAE for off-patent pharmaceuticals, and subsequently for other health technologies.