Journal of Market Access & Health Policy

5 pages, 159 KiB

Open AccessOpinion

Public Health Decision-Maker Perspective on Joint Clinical Assessments in Central European EU Member States

by Gergő Merész, Dávid Dankó and Márk Péter Molnár

J. Mark. Access Health Policy 2025, 13(1), 10; https://doi.org/10.3390/jmahp13010010 - 4 Mar 2025

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The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint [...] Read more.

The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint assessment. Challenges related to the timelines, differences between assessment scopes, and diverging guidance may jeopardize the full potential of the HTA R in Central European EU member states. However, these are more likely to be related to the commitment and vigilance of local competent authorities. We attempt to address these opportunities and mark some challenges imposed by the application of the HTA R by taking the perspective of public health decision-makers in Central European EU member states. We conclude that the foundations for capitalizing on the opportunities offered by the HTA R are already laid in the region, and we foresee policymakers and payers sharing the responsibility of acting as drivers of change in health policy to reduce the duplication (or multiplication) of efforts by HTDs, as well as to increase the efficient use of HTA bodies’ resources. Full article

(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))

12 pages, 763 KiB

Open AccessArticle

Ensuring the Efficiency and Effectiveness of Joint Clinical Assessment in National HTA Decision-Making: Insights from the 2024 CIRS Multi-Stakeholder Workshop

by Ting Wang and Neil McAuslane

J. Mark. Access Health Policy 2025, 13(1), 9; https://doi.org/10.3390/jmahp13010009 - 3 Mar 2025

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Abstract

Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, [...] Read more.

Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, and decision-making across Europe. The study aimed at identifying key measures for an efficient and effective JCA process to enable national rollout. Methods: A survey was conducted with international pharmaceutical companies, followed by a multi-stakeholder workshop that expanded on the findings. The survey and workshop focused on key areas such as time to market, submission strategies, and the role of JCA in national decision-making processes. Descriptive and qualitative analyses were performed to identify recommendations for measuring and improving the JCA process. Results: 13 companies responded to the survey, respondents were generally prepared for the JCA process (readiness rated 6–7/10), but concerns persist about timeline uncertainties and timely JCA report delivery. In the short term, success for the HTAR from the company perspective is measured by positive recommendations across EU jurisdictions. Long term, the focus shifts to aligning HTA methodologies and evidence requirements across the EU. Establishing metrics to assess the efficiency and effectiveness of the JCA is a key step in the HTAR’s ongoing learning journey. To enhance the efficiency of the JCA process, a list of metrics is recommended for continuous improvement, as well as establishing training programs to strengthen member states’ capabilities, fostering open dialog for sharing technology-specific insights, and creating open-source tools to support companies. Additionally, research should be conducted to understand agencies’ expectations of the JCA and how they will use its reports, grouping agencies by archetype to identify trends. A key recommendation is the development of a product-based scorecard to evaluate JCA submissions and reviews from various perspectives, ensuring the process meets stakeholders’ needs and can be effectively utilized in national decision-making. Conclusions: The JCA process offers a significant opportunity to streamline HTA decision-making across Europe. This study highlights several key measures and consideration for its successful rollout, including the need for clearer communication about the role of JCA in national decisions, measurement of rollout time components, and the development of quality evaluation frameworks. A collaborative, iterative approach, where stakeholders continually refine the system, will be essential for its effectiveness. Addressing these challenges will enable the JCA to enhance efficiency, consistency, and ultimately improve access to treatments for patients. Full article

(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))

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14 pages, 255 KiB

Open AccessPerspective

The Integration of Social and Health Sectors in Scotland: An Analysis from the Prism of Different Public Policy Models

by Ricardo Correia de Matos, Generosa do Nascimento, Adalberto Campos Fernandes and Cristiano Matos

J. Mark. Access Health Policy 2025, 13(1), 8; https://doi.org/10.3390/jmahp13010008 - 27 Feb 2025

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Abstract

The integration of health and social care has been a key focus in Scotland, driven by demographic changes, rising healthcare costs, and the need for more efficient service delivery. The Public Bodies (Joint Working) (Scotland) Act 2014 sought to formalise this integration by [...] Read more.

The integration of health and social care has been a key focus in Scotland, driven by demographic changes, rising healthcare costs, and the need for more efficient service delivery. The Public Bodies (Joint Working) (Scotland) Act 2014 sought to formalise this integration by restructuring governance and service provision to improve coordination between health and social care sectors. Despite these efforts, challenges remain in fully achieving the intended outcomes of the integration. This study analysed Scotland’s integrated health and social care through the theoretical frameworks of public choice, institutionalism, and functionalism. The objective was to examine policy drivers, structural mechanisms, and governance implications, providing insights into the broader impact of integrated care reforms. A qualitative research approach was employed, synthesising data from peer-reviewed literature, government publications, and policy documents. The findings on integration were systematically examined through the lens of each public policy model, allowing for a nuanced analysis of how Scotland’s approach to integration aligns with and diverges from these frameworks. A literature search was performed on PUBMED, Google Scholar, and Scottish government portals. While integration improved coordination and service delivery in some areas, limitations in funding allocation, workforce distribution, and governance autonomy limited its overall success. Scotland’s integrated care model demonstrates potential benefits in reducing service fragmentation and improving patient-centred care; however, persistent challenges such as funding constraints, workforce shortages, and governance conflicts indicate that integration alone is not sufficient to resolve systemic healthcare inefficiencies. This study provides a perspective on Scotland’s health and social care integration, offering valuable lessons for other European countries facing similar demographic and healthcare challenges. Full article

21 pages, 1392 KiB

Open AccessReview

Healthcare Resource Utilization (HCRU) and Direct Medical Costs Associated with Long COVID or Post-COVID-19 Conditions: Findings from a Literature Review

by Elżbieta Łukomska, Krzysztof Kloc, Malwina Kowalska, Aleksandra Matjaszek, Keya Joshi, Stefan Scholz, Nicolas Van de Velde and Ekkehard Beck

J. Mark. Access Health Policy 2025, 13(1), 7; https://doi.org/10.3390/jmahp13010007 - 12 Feb 2025

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Abstract

Approximately 10–20% of individuals suffering from COVID-19 develop prolonged symptoms known as long COVID or post-COVID condition (LC). This review aimed to assess healthcare resource use (HCRU) and healthcare costs associated with LC. Because LC is not clearly defined and often remains undiagnosed, [...] Read more.

Approximately 10–20% of individuals suffering from COVID-19 develop prolonged symptoms known as long COVID or post-COVID condition (LC). This review aimed to assess healthcare resource use (HCRU) and healthcare costs associated with LC. Because LC is not clearly defined and often remains undiagnosed, studies reporting on long-term follow-up of individuals with a COVID-19 diagnosis were also included. Among the 41 publications included, 36 reported on HCRU and 16 on costs. Individuals with LC had significantly elevated HCRU and healthcare costs vs. controls without a COVID-19 diagnosis over ≥15 months, with a 7.6–13.1% increase in total healthcare costs per person per month as assessed by difference-in-difference analysis. Among studies that did not specifically refer to LC, having a COVID-19 diagnosis was associated with a significant 4–10% increase in long-term total HCRU over 6–8 months and a 1.3- to 2.9-fold relative increase in total healthcare costs over 6 months. Due to the heterogeneity of the included studies, high-quality evidence is needed to better understand the economic burden of LC. In the absence of effective treatments, prioritizing the prevention of acute COVID-19, e.g., through vaccination, may be crucial for preventing LC and the associated long-term HCRU and medical spending. Full article

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17 pages, 1547 KiB

Open AccessArticle

Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy

by Elaine Julian, Tom Belleman, Maria João Garcia, Maureen Rutten-van Mölken, Robin Doeswijk, Rosa Giuliani, Bernhard J. Wörmann, Daniel Widmer, Patrick Tilleul, Ruben Casado Arroyo, Valentina Strammiello, Kate Morgan, Marcus Guardian, Michael Ermisch, Renato Bernardini, Fabrizio Gianfrate, Stefano Capri, Carin A. Uyl-de Groot, Mira Pavlovic and Jörg Ruof

J. Mark. Access Health Policy 2025, 13(1), 6; https://doi.org/10.3390/jmahp13010006 - 10 Feb 2025

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Abstract

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with [...] Read more.

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States. Full article

(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))

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3 pages, 656 KiB

Open AccessEditorial

Agenzia Italiana del Farmaco (AIFA): Developments and Strategy in a Transitioning European HTA Landscape

by Robert Nisticò

J. Mark. Access Health Policy 2025, 13(1), 5; https://doi.org/10.3390/jmahp13010005 - 5 Feb 2025

Viewed by 638

Abstract

The Agenzia Italiana del Farmaco (AIFA) is the national public body that regulates medicines for human use in Italy [...] Full article

(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))

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9 pages, 220 KiB

Open AccessCommunication

Musculoskeletal Magazine Advertising Focuses on White Individuals and Overlooks Minority Consumers

by Wei Shao Tung, Kelsey A. Rankin, Robert John Oris, Adithi Wijesekera and Daniel H. Wiznia

J. Mark. Access Health Policy 2025, 13(1), 4; https://doi.org/10.3390/jmahp13010004 - 4 Feb 2025

Viewed by 587

Abstract

Introduction: Demographic disparities in musculoskeletal (MSK) health exist in the US. Racial representation in advertising has been shown to influence consumer behavior and buying patterns. Direct-to-consumer advertising that does not target a racially diverse audience may exacerbate MSK disparities by failing to reach [...] Read more.

Introduction: Demographic disparities in musculoskeletal (MSK) health exist in the US. Racial representation in advertising has been shown to influence consumer behavior and buying patterns. Direct-to-consumer advertising that does not target a racially diverse audience may exacerbate MSK disparities by failing to reach minorities. We explore the hypothesis that minorities are underrepresented in direct-to-consumer MSK advertisements in this cross-sectional analysis. Methods: Using magazines from four databases, eight health-related magazine types were selected and advertisement categories were established. Racial distribution was analyzed using Pearson’s Chi-squared and Chi-squared tests. Fisher’s Exact test was used when >20% of cells had expected frequencies <5. Significance was set at α = 0.05. Results: Of the advertisements featuring at least one model, 68.5% featured a white-presenting model, followed by 17.6% with a black model. Further, 92.7% of advertisements were monoethnic or monoracial with an overrepresentation of white models (p < 0.001). Black models were overrepresented as athletes (p < 0.001) and underrepresented in advertisements for pain relief (p < 0.001). Hispanic/Latinx and Asian models were underrepresented across all advertisement categories (p < 0.001). Discussion: The causes of musculoskeletal health disparities are multifactorial. One potential influence is adjacent industries such as MSK health-related advertisements. When controlling for US population demographics, white models were overrepresented and minority race models were underrepresented, demonstrating racioethnic disparities in MSK advertising. Improving the racial and ethnic diversity of models within MSK advertisements may serve to improve patient perceptions of orthopaedic products and services and improve MSK disparities. Full article

6 pages, 537 KiB

Open AccessOpinion

The EU Health Technology Assessment Regulation Halo Effect: Are Cross-Functional Teams Ready?

by Sian Tanner, Rebecca Coady, Ana Lisica, Edel Falla and Anke van Engen

J. Mark. Access Health Policy 2025, 13(1), 3; https://doi.org/10.3390/jmahp13010003 - 30 Jan 2025

Viewed by 906

Abstract

The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical nature of market access [...] Read more.

The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical nature of market access in ensuring innovation reaches patients, it should be no surprise that the EU HTAR will have impacts far beyond this function. Here, we utilize published EU HTAR guidance, a pragmatic literature review, internal analysis, and insights from engagements with manufacturers, to outline some of the key cross-functional considerations arising from JSC and JCA, and how manufacturers should account for these in their EU HTAR readiness plans. Full article

(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))

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9 pages, 198 KiB

Open AccessOpinion

Multi-Year Multi-Indication Agreements for Supporting Patient Access to Oncology Medicines with Multiple Indications: An Experimental Approach or Here to Stay?

by Hannah Armstrong, Angelina Petrova, Tim Wilsdon, Henriette Homoki and Alexander Roediger

J. Mark. Access Health Policy 2025, 13(1), 2; https://doi.org/10.3390/jmahp13010002 - 24 Jan 2025

Viewed by 758

Abstract

Over the past decade, an increasing number of oncology medicines with indications for multiple cancer types have been delivering benefits to patients. To ensure these products reach patients, pricing and reimbursement systems have had to adapt to address the value assessment, time-to-access, affordability, [...] Read more.

Over the past decade, an increasing number of oncology medicines with indications for multiple cancer types have been delivering benefits to patients. To ensure these products reach patients, pricing and reimbursement systems have had to adapt to address the value assessment, time-to-access, affordability, and budget uncertainty challenges this creates. Multi-year multi-indication (MYMI) agreements are made between payers and manufacturers and aim to ensure that patients have access to effective treatments for multiple conditions over time; this includes future indications of the treatment. MYMI agreements were first introduced as a solution in several European countries in 2017, offering a range of potential benefits. MYMI agreements have since demonstrated evidence of success in mitigating many of the challenges associated with assessing and reimbursing multi-indication products, time-to-patient access, and budget impact. The purpose of this article is to discuss the recent progress made with MYMI implementation across countries and provide a view on whether it is delivering for patients, healthcare systems, and innovators. We find that MYMI is not a one-size-fits-all solution but a model that needs to be adapted to the unique needs and characteristics of different healthcare systems. The intended benefits of MYMI to patients (speed and breadth of access to new indications) appear to have been realised in practice in some countries but not all. However, the administrative burden associated with MYMI implementation in some countries risks jeopardising the intended efficiency benefits. Payers and policymakers can also benefit from improved budget predictability and sustainability. Full article

19 pages, 705 KiB

Open AccessArticle

Assessing the Value of Further Investment in R&D Using Mixed Methods: A Case Study of Biosensor-Integrated Arteriovenous Grafts

by Samuel Owusu Achiaw, Neil Hawkins, Olivia Wu and John Mercer

J. Mark. Access Health Policy 2025, 13(1), 1; https://doi.org/10.3390/jmahp13010001 - 15 Jan 2025

Viewed by 951

Abstract

This study illustrates the utility of a mixed-methods approach in assessing the value of an example novel technology—biosensor-integrated self-reporting arteriovenous grafts (smart AVGs). Currently in preclinical development, the device will detect arteriovenous graft stenosis (surveillance-only use case) and treat stenosis (interventional use case). [...] Read more.

This study illustrates the utility of a mixed-methods approach in assessing the value of an example novel technology—biosensor-integrated self-reporting arteriovenous grafts (smart AVGs). Currently in preclinical development, the device will detect arteriovenous graft stenosis (surveillance-only use case) and treat stenosis (interventional use case). The approach to value assessment adopted in this study was multifaceted, with one stage informing the next and comprised a stakeholder engagement with clinical experts to explore the device’s clinical value, a cost–utility analysis (CUA) from a US Medicare perspective to estimate pricing headroom, and an investment model estimating risk-adjusted net present value analysis (rNPVs) to determine commercial viability. The stakeholder engagement suggested that it would currently be difficult to establish the current value of the surveillance-only use case due to the lack of well-established interventions for preclinical stenosis. Based on this, the CUA focused on the interventional use case and estimated economically justifiable prices at assumed effectiveness levels. Using these prices, rNPVs were estimated over a range of scenarios. This value assessment informs early decision-making on health technology R&D by identifying the conditions (including clinical study success, potential market size and penetration, market access strategies, and assumptions associated with CUA) under which investment may be considered attractive. Full article

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J. Mark. Access Health Policy, Volume 13, Issue 1 (March 2025) – 10 articles

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