Papers by Ramiro Gilardino
Journal of Comparative Effectiveness Research, Aug 16, 2023
Value in Health, Dec 1, 2022
Value in Health, Jun 1, 2023
Value in Health, Jul 1, 2022
Value in Health, Jun 1, 2023
Value in Health, Jun 1, 2021
Value in health regional issues, Oct 1, 2019
Value in health regional issues, Oct 1, 2019
Objectives: Real-world evidence (RWE) complements safety and efficacy data generated from randomi... more Objectives: Real-world evidence (RWE) complements safety and efficacy data generated from randomized controlled trials and reflects real-life use of health technologies in clinical practice. In developed markets, regulators are accelerating access to new interventions, and payers can utilise RWE to manage uncertainty around the value of new products. However, the use of RWE in emerging markets is less clear. We investigated current practices for RWE use and its impact on reimbursement processes for pharmaceutical products. Methods: Targeted searches of grey literature and websites of health-technology assessment (HTA)/reimbursement agencies in England (National Institute of Health and Care Excellence; NICE), Australia (Pharmaceutical Benefits Advisory Committee; PBAC) and Canada (Canadian Agency for Drugs and Technologies in Health; CADTH) were conducted to identify policies for RWE use in HTA and reimbursement processes. Evidence exemplifying the impact of RWE on reimbursement processes was also extracted. Results: Formal policies for RWE use in reimbursement decision-making were identified in three areas: scoping before assessment (NICE, CADTH), during HTA assessment to address clinical and cost effectiveness and manage uncertainty through conditional reimbursement (NICE, PBAC, CADTH), and after technology assessment to inform reassessments and confirm value (NICE, PBAC, CADTH). Examples, predominantly from developed markets, of the direct impact of RWE on reimbursement processes were identified during reimbursement decision-makingincluding in pharmacoeconomic analysis, conditional reimbursement and to support the release of full payment-and after reimbursement, to counter formulary exclusion and to provide evidence for disinvestment. Initiatives for RWE generation and use, and challenges and potential solutions for use of RWE in reimbursement processes were also identified. Conclusions: In developed markets, RWE influences all stages of the reimbursement decision-making process, however policies for RWE use differ between HTA/reimbursement agencies in different countries. A more consistent policy approach could be valuable and could inform development of procedures for RWE use in emerging markets.
Value in Health, 2016
A267 year of 2006 and at 2012 to see if these states experienced an increase in transplants that ... more A267 year of 2006 and at 2012 to see if these states experienced an increase in transplants that may be attributable to the law. The 14 later adopting states and the four non-adopting states were analyzed in the same manner Results: The early adopting states experienced no statistically significant difference in the number of organ transplants between 2006 and 2012. This suggests that the 2006 UAGA has not achieved its goal of increasing the number of organ transplants. A brief discussion of reasons why this may be the case follows. ConClusions: Other methods of organ procurement must be considered, including those that would fundamentally change the U.S. system of voluntary donation.
Revista Brasileira De Terapia Intensiva, 2022
Revista Brasileira De Terapia Intensiva, 2022
Revista Argentina de Terapia Intensiva, May 3, 2021
Frontiers in Medicine, 2021
Value in Health Regional Issues, 2018
Assessment Council held roundtables focused on Latin America to discuss health technology assessm... more Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.
Value in Health, 2015
A807 los pacientes con resultado positivo de un estudio electrofisiológico. En el análisis para l... more A807 los pacientes con resultado positivo de un estudio electrofisiológico. En el análisis para los pacientes no isquémicos la costo efectividad depende del escenario escogido, superando algunas veces el umbral y otras no. En general, los resultados son sensibles a cambios en variables como el horizonte temporal, las probabilidades de muerte y el precio del CDI.
International Journal of Health Policy and Management, 2020
During this coronavirus disease 2019 (COVID-19) global pandemic, nations are taking bold measures... more During this coronavirus disease 2019 (COVID-19) global pandemic, nations are taking bold measures to mitigate the spread of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in order to avoid the overwhelming its critical care facilities. While these "flattening the curve" initiatives are showing signs of impeding the potential surge in COVID-19 cases, it is not known whether these measures alleviate the burden placed on intensive care units. Much has been made of the desperate need for critical care beds and medical supplies, especially personal protective equipment (PPE). But while these initiatives may provide health systems time to bolster their critical care infrastructure, they do little to protect the most essential element – the critical care providers. This article examines bolder initiatives that may be needed to both protect crucial health systems and the essential yet vulnerable providers during this global pandemic.
Value in Health Regional Issues, 2018
End-stage renal disease, the last and most severe stage of chronic kidney disease, represents a m... more End-stage renal disease, the last and most severe stage of chronic kidney disease, represents a major and rising concern for countries in Latin America, driven in large part by aging populations and the nearepidemic rises in diabetes, obesity, and hypertension. This places a great clinical, economic, and social burden on the region's health systems. During the ISPOR 6th Latin America Conference held in Sao Paulo, Brazil, in September 2017, an educational forum debated on value-based decision making in the treatment of end-stage renal disease in Latin America. We summarize the current state and how to build strategies and implement actions to move to a more patientcentered, outcomes-based approach for renal care in the region, taken from the discussions in the conference and also from a literature review. Models of renal care used in Ontario (Canada), Colombia, and a Chilean hospital stress the importance of empowering and supporting patients and their families, allowing for a better coordination between primary care providers and specialists, providing financial incentives to health units, and establishing an entity that holds insurers and providers accountable for health outcomes and costs of treatment. The study uses the framework of value-based health care for the evaluation of different dialysis options-peritoneal dialysis, hemodialysis, home dialysis, and so forth-and calls for the countries to adopt an integrated care model. We emphasize that countries in Latin America need to recognize the chronic kidney disease challenge and develop health systems and efficient renal care models to be able to reduce the burden of the disease.
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Papers by Ramiro Gilardino