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Valbenazine Market Access The Centre for Outcomes Research and Economic Evaluation for Health (C2H) is an esteemed department of the National Institute of Public Health in Japan, established in 2018. The organisation conducts rigorous academic research on cost-effectiveness evaluations and plays a crucial role in the official evaluation process. In a nation where public healthcare expenditure is continually increasing, C2H’s work is invaluable. They strive to balance the cost and outcome of healthcare technologies, providing crucial data and materials for […]

The EU Pharma Legislation Review: A Hot Topic The buzz at the ISPOR Europe 2023 conference in Copenhagen was all about the proposed EU pharma legislation review. This legislation, proposed at a potentially turbulent time, aims to reshape the healthcare landscape in Europe. But has encountered significant resistance from the pharmaceutical industry. The industry is also grappling with the simultaneous implementation of the joint Health Technology Assessment regulation (HTAR). Balancing Industry and Health Policies: A Complex Task The panel at […]

How the 340B Program Came Into Existence The 340B Drug Pricing Program was formed in 1992 with the intention of providing financial assistance to hospitals and clinics that are part of the safety net and serve populations that are underserved or have low incomes. The Medicaid Drug Rebate Program underwent certain revisions, which resulted in the birth of this program, which provides patients with discounts on the prices of outpatient medications. These developments led to pharmaceutical companies discontinuing direct discounts […]

The Ongoing Issue of Unapproved Fixed-Dose Combination Drugs in India The regulation of medicines in India, a responsibility shared between the central government and individual states, has been a source of friction and calls for reform. One area of notable concern has been the regulation of Fixed-Dose Combination drugs (FDCs), specifically antibiotic FDCs. Despite regulatory initiatives since 2007, hundreds of unapproved antibiotic FDC formulations remained on the Indian market, Accounting for over 700 million of the 4.5 billion standard units […]

The Potential of AI in the Medical Field The field of healthcare is undergoing a rapid transformation brought on by artificial intelligence (AI), which has the potential to greatly improve patient care. A recent interview that was conducted with Dr. Andrew Bindman, Chief Medical Officer (CMO) of Kaiser Permanente, an industry-leading healthcare organisation, is discussed in this article. The early detection of sepsis and the analysis of social risk factors that effect patients’ health are two examples of how AI […]

Sanofi’s role in Morocco’s Healthcare Transformation Sanofi, a global leader in life science consulting, is making headway in Morocco, Tunisia, and Libya. Spearheaded by Adrien Delamare-Deboutteville, Sanofi’s mission is to enhance access to innovative therapies, reflecting the company’s commitment to value-based healthcare. This initiative aligns with Morocco’s grand vision of universal healthcare, a transformative goal that seeks to double the number of Moroccans covered by health insurance from 22 million to 44 million. The Landscape of Innovation in Morocco Innovation […]

The Importance of Uncertainty Assessment Health Economic Evaluations (HEEs) play a crucial role in reimbursement decisions, particularly in the realm of healthcare technologies. However, these evaluations are often fraught with uncertainty, posing significant challenges to decision-makers. The assessment of uncertainty is a cornerstone of these evaluations, helping to gauge the robustness of results and the potential consequences of uncertainty related to decisions. Yet, there is currently no comprehensive overview of the methods used for uncertainty assessment in HEEs. Exploring the […]

Introducing AI in Cardiovascular Imaging Innovation has always been possible in cardiovascular imaging. The latest game-changer? Artificial Intelligence (AI). Traditional AI used rules-based algorithms, called symbolic or classical AI. AI’s popularity has grown due to machine learning, especially deep learning. Machine learning algorithms use data patterns and inference to learn without programming. A subtype of machine learning, deep learning uses deep artificial neural networks inspired by the human nervous system. Cardiovascular Imaging Deep Learning Deep learning has been applied to […]

The Medicine Accessibility Challenge High-income countries are increasingly struggling to afford medicines. New and established drugs are often too expensive and scarce. Gene and cell therapies, cancer pharmaceuticals, and orphan drugs are expensive and burden individuals and health systems. Broken Pharma Systems Pharmaceutical system fragmentation, especially in Europe, limits equal medicine availability. The outpatient and hospital sectors frequently have separate public bodies for medicine reimbursement and procurement. This distinction can cause differences in inpatient and outpatient medicine, which can have […]

The Regulatory Hurdle Europe’s healthcare system, known for its extensive social security and fair healthcare access, faces a test of strength. Structural barriers in the existing regulatory framework hinder the prompt distribution of vital medical technologies. These technologies are crucial at every patient care stage. The In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR) were designed with the objective of creating a robust, transparent, predictable, and sustainable regulatory system for medical devices. The expectation was that […]

The Rising Cost of Medical Interventions Novel medical interventions have emerged from scientific advancements, offering better quality and extended life for patients with life-threatening conditions. These interventions include gene therapies and tissue-engineered medicines that target various cancers, rare, and ultra-rare diseases. However, the medicines come with an extremely high cost. In 2022, the top ten most expensive medicines ranged from USD 600,000 to over USD 3.5 million per dose. This high cost puts a significant financial burden on households. Consequently, […]

Introduction The European Union stands at the threshold of significant change with its proposed EU pharmaceutical legislation. This initiative, born from the challenges experienced during the COVID-19 pandemic, aims to revitalize the EU’s approach to healthcare, ensuring it’s better prepared for future crises and more responsive to the needs of its citizens. Panelists that spoke on the proposed EU Pharmaceutical legislation included: Gloria Ghequiere, Belgium Federal Government, Brussels, Belgium Neil Grubert, Independent, Basildon, United Kingdom Denis Lacombe, European Organisation for […]

The Rising Challenge of Telehealth and CGM Technology in Diabetes Management As we celebrate World Diabetes Day, we must acknowledge the growing burden of diabetes care. With 37.3 million people in the United States diagnosed with diabetes, the healthcare industry faces a tremendous issue. The number of endocrinologists, or diabetes specialists, is frighteningly low, with a patient-to-endocrinologist ratio of 1:4375. Because of this imbalance, the majority of diabetes care is now provided in primary care settings. However, resources and expertise […]

Embracing the Potential and Challenges of Virtual Wards The National Institute for Health and Care Excellence (NICE) has recently recommended the exploration of virtual wards in healthcare. Virtual care is not a new concept. Recent health crises, like the COVID-19 pandemic, have propelled it into the spotlight. Virtual care, including telehealth and remote patient monitoring, has shown great promise in improving access to care, especially for those in remote or underserved areas. For example, early warning scores, such as NEWS2 […]

The European Health Data Space (EHDS) represents a groundbreaking initiative by the European Commission, poised to advance healthcare data management across the EU. As discussed in the recent ISPOR Europe conference panel, the EHDS is much more than a tool for pharmacovigilance and retrospective cohort studies. It’s a comprehensive framework designed to empower EU citizens with equitable access to healthcare data while ensuring data privacy and fostering participation in intellectual property creation. The EHDS is set to enhance the digitalization […]

The Current State of Health Technology Assessment Health technology assessment (HTA) in medical device procurement has been instrumental in determining the value of medical devices. However, the unique characteristics of these devices, including frequent iterations and user learning curves, make generalising outcomes challenging. Furthermore, the diverse needs of stakeholders often result in varying views on a technology’s value. Despite the wealth of information available on HTA, a knowledge gap exists regarding its use by non-payer, non-HTA stakeholders in their assessment […]