J. Mark. Access Health Policy, Volume 13, Issue 4 (December 2025) – 8 articles

Background: Stakeholders’ perception plays a crucial role in shaping pharmaceutical strategies. Stakeholders are groups interested in pharmaceutical companies’ success and outcomes. Stakeholders’ perceptions are multifaceted and impact pharmaceutical strategies, from shaping research to enhancing market access, pricing, and corporate reputation. Understanding and actively managing stakeholders’ perceptions is vital for pharmaceutical companies to succeed in an increasingly complex and competitive industry. Methods: In this case study, knowledge contributions from stakeholders offered insights and strategies for application in the pharmaceutical sector. Results: Qualitative, exploratory research was conducted, which included the participation of sixteen stakeholders from different countries in Latin America, who responded to a semi-structured interview script, whose data were understood through lexical analysis in the Interface de R pour les Analyses Multimensionnelles de Texts et de Questionnaires (IRaMuTeQ). Conclusions: The results of this study underscore the importance of regulatory knowledge for professionals’ support and implementation of international strategies. Regulatory knowledge provides professionals with tools and insights to navigate complex regulatory environments, make informed decisions, and enhance organizational performance in global markets. Full article

Type 2 diabetes (T2D) constitutes a major health problem, reaching alarming rates over the last decades, especially due to contemporary lifestyle and associated obesogenic environments, as well as the aging population. Diabetes not only causes social consequences but also leads to increasing healthcare costs, posing a significant challenge for the health system. This paper applies a five-step approach for estimating T2D-related costs in Greece. The approach initially estimates the T2D-related ICD10 prevalence and the target population. Next it applies the appropriate therapeutic protocols to identify the most appropriate treatments. Subsequently, it calculates the total cost of medical treatments for each target population, based on the distribution of patients between the different treatments and treatment lines. Finally, based on the diagnostic and treatment protocols, it calculates the annual direct costs associated with the cost categories. Using the estimated future population of the country, the proposed methodology can also project the budget required, under certain conditions, to deal with T2D. The analysis estimated that T2D-related costs in 2021 under rational use of resources were EUR 1,397,871,172.55 billion and EUR 1,512,934,947.63 billion projected in the year 2030 considering the aging effect, per cost category, and in total, presenting an increase of approximately 115 million euros in 2030 compared to 2021. The term “rational use of resources” in this study refers to the use of internationally recognized, evidence-based diagnostic and therapeutic protocols, as adopted by the Greek Ministry of Health. This scenario represents an idealized standard of care rather than actual real-world adherence and is used to estimate the potential resource needs under optimal medical practice conditions. An inflation rate of 4.2% was applied to costs between 2021 and 2030. The analysis showed that the highest percentage (39%) of the total T2D-related healthcare expenditures is associated with complications that occur in T2D patients. Despite a comparatively modest prevalence of T2D in Greece relative to other European and Mediterranean countries, the economic burden associated with its management remains high. The aging of the population will lead to an increase in the total cost of T2D. The applied methodology of estimating budgets by aggregating categories of expenses under a specific disease (ICD10), instead of dividing budgets into categories of expenses, can successfully lead to the optimization and rationalization of expenses according to actual needs. The findings underline the significant economic burden of T2D in Greece, particularly due to complications and population aging. These results emphasize the urgent need for health policy strategies focusing on prevention, early intervention, and the efficient allocation of healthcare resources. The methodology applied can serve as a decision-making tool for forecasting healthcare budgets and optimizing expenditures under different population and treatment scenarios. Full article

The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonizing health technology assessments (HTAs) across EU member states. This article explores the implications of JCA, particularly in oncology, for member states who utilize cost-effectiveness (CE) analysis and health technology developers (HTDs) who produce this evidence. The JCA framework attempts to standardise the assessment of relative clinical effectiveness and safety across the EU to input into national appraisals. Importantly, it excludes economic evaluations that may be required nationally, necessitating HTDs to align their CE models with the JCA PICO (Population/Intervention/Comparator/Outcome) parameters outlined by member states. This article discusses the challenges and opportunities for aligning JCA and CE modelling outcomes, contrasting evidence requirements between JCA and CE frameworks. It highlights the potential increase in complexity due to the diverse comparators in PICO surveys, necessitating the use of indirect comparison methodologies. It further underscores the importance of early communication between HTDs and HTA bodies to ensure timely, relevant, and pragmatic decision-making. By sharing national PICOs upfront to support national evidence generation, the JCA framework’s potential to aid high-quality decision-making and improve patient access to innovative medicines can be maximised. Full article

Access to home- and community-based services (HCBSs) varies substantially between states. Yet, it is unknown how state-level policies and administrative factors impact consumer-reported unmet service needs, an important indicator of HCBS access and quality. Using the National Core Indicators—Aging and Disability Adult Consumer Survey (2016–2019; n = 13,654 community-dwelling older adults, 13 states), we examined associations between unmet HCBS needs with four state-level factors: HCBS spending relative to institutional care spending, HCBS spending per client, percentage of Medicaid beneficiaries in managed care, and Medicaid expansion; and funding program. In the adjusted logistic regression model, the odds of overall unmet HCBS needs were lower with higher percentage Medicaid beneficiaries in managed care (adjusted odds ratio [aOR], 0.92; 95% confidence interval [CI], 0.89–0.96) and Medicaid expansion (aOR, 0.80; 95% CI, 0.73–0.87) but greater with higher HCBS spending relative to institutional care spending (aOR, 1.19; 95% CI, 1.11–1.28). Compared to Medicaid waiver, odds of unmet HCBS needs were significantly lower among consumers in Managed Long-Term Services and Supports (aOR, 0.67; 95% CI, 0.61–0.74) and Program of All-Inclusive Care for the Elderly (PACE; aOR, 0.39; 95% CI, 0.31–0.49). State policies and administrative factors are important place-based determinants of HCBS consumers’ unmet HCBS needs/access; and warrant consideration in HCBS quality assurance and improvement. Full article

Vaccination has resulted in substantial public health benefits for human populations worldwide since it was first introduced more than a century ago. This article presents an overview of the history of vaccine development, its implementation, and price setting, the latter mainly from a developed world perspective. It considers potential issues and challenges. Over time, vaccine development and production has evolved to a market-driven approach, conducted largely by private commercial entities. The complex processes of identifying potential vaccine targets and developing and producing vaccines at scale have now become more efficient. However, vaccine pricing is an emerging concern. The elements that maximize the overall health benefit of vaccination include high volume, high coverage, and rapid initial implementation to achieve the high coverage with the vaccine as quickly as possible. It therefore requires substantial initial investment. Consequently, the price set for the vaccine should be reasonable to avoid limiting the coverage given the available budget. Suboptimal coverage leads to suboptimal benefit if herd protection is not fully achieved. This may disappoint health authorities and may result in program discontinuation. Conventional cost-effectiveness analysis is therefore not ideally suited to vaccine price setting, as it is based on the concept of ‘more for more’, i.e., higher health gain achieved at a higher reimbursement cost that does not account for limited budgets. Constrained optimization (CO) combines value assessment with constrained budget allocation into one analysis method and may therefore be the better option for vaccine pricing. Full article

Long-term intravenous therapies often necessitate the use of peripherally inserted central catheters (PICCs). Antimicrobial-coated PICCs have been introduced to minimize central line-associated bloodstream infections (CLABSIs). A decision-analytic cost-effectiveness model was developed from a societal perspective, utilizing real-world data concerning PICC-related complications and costs from Class 3A hospitals and community hospital settings in China. The analysis compared the quality-adjusted life years (QALYs) for patients receiving antimicrobial-coated PICCs versus standard PICCs, with catheter-associated costs included. Incremental cost-effectiveness ratios (ICERs) were calculated in Chinese Yuan (CNY) per QALY gained. Patients with antimicrobial-coated PICCs experienced slightly fewer complication-related events, leading to significantly lower costs for managing complications. In the Class 3A hospital setting, the average total cost per patient was lower with antimicrobial-coated PICCs (CNY 62,800) compared to standard PICCs (CNY 102,900), primarily due to the reduced expenses for treating CLABSIs and related unknown fever. The ICER demonstrated that the coated PICC was the strongest option, showing a negative ICER (cost-saving of approximately CNY 4 million per QALY gained in the base-case Class 3A hospital scenario). In community hospital care scenarios, the cost advantage of antimicrobial-coated PICCs remained. Thus, the antimicrobial-coated PICC strategy was cost-saving, providing equal or improved health outcomes at lower costs in China’s medical center and community hospitals, making it a more efficient choice for long-term vascular access. Full article

Wound infection significantly hinders the healing process. Clinical signs and symptoms (CSS) of infection are used to assess the presence of infection and guide whether to intervene. However, CSS may not be dependable, lacking sensitivity and specificity, and may not accurately reflect bacterial load. The interpretation of CSS can be subjective and can vary between clinicians since they depend on patient characteristics, type of wound, and stage of infection. In addition, conditions such as peripheral vascular disease or diabetes can mask the signs and symptoms of infection. Inaccurate or late diagnosis of infected wounds can be costly to the patient and to healthcare systems. Fluorescence imaging (FLI) provides a safe, objective, highly sensitive approach to detect clinically significant bacterial levels in wounds. This information allows individualized treatment plans and a way to monitor bacterial burden and wound healing longitudinally. This publication reviews the evidence for point-of-care FLI as a means of improving wound identification with a high bacterial burden and the clinical and healthcare economic benefits of earlier and more accurate detection of bacteria. Full article

The implementation of the European (EU) Health Technology Assessment (HTA) Regulation 2021/2282 (EU HTAR) offers many opportunities, aimed at harmonizing HTA procedures and improving access to innovations; it also represents a significant challenge for the European healthcare system. Within the 2024 Health Policy Forum Italy meeting, different actors, stakeholders, and institutions had the opportunity to discuss major criticism and opportunities coming from the EU-HTA Regulation addressing future developments in the healthcare sector. Two groups, EU & Italy Pharmaceuticals and EU-Italy Medical Devices, worked distinctively on the EU HTAR by highlighting key issues that may pose challenges at both European and national levels, proposing potential solutions. The allocation of participants into two groups, according to their affiliation with either the pharmaceutical or the medical device sector, enhances the diversity of professional backgrounds and institutional perspectives, thereby fostering a more comprehensive and informed discussion. The recommendations highlighted by the two groups emphasize the need to promote cooperation among Member States, strengthen training for decision-makers, and develop a monitoring system to evaluate EU HTA’s impact. Full article