Journal of Market Access & Health Policy

8 pages, 425 KiB

Open AccessPerspective

Adoption of a Societal Perspective in Economic Evaluations of Musculoskeletal Disorders: A Conceptual Paper

by Francis Fatoye, Tadesse Gebrye, Leo Nherera and Paul Trueman

J. Mark. Access Health Policy 2024, 12(3), 216-223; https://doi.org/10.3390/jmahp12030018 - 12 Aug 2024

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Economic evaluations are used to compare the costs and consequences of healthcare interventions, including those for musculoskeletal (MSK) disorders, which are very common and a major source of morbidity and absence from work. Reimbursement decisions for interventions for MSK disorders by decision-makers rely [...] Read more.

Economic evaluations are used to compare the costs and consequences of healthcare interventions, including those for musculoskeletal (MSK) disorders, which are very common and a major source of morbidity and absence from work. Reimbursement decisions for interventions for MSK disorders by decision-makers rely on the findings of economic evaluations, the design and results of which depend largely on the perspective adopted. Despite methodological advancements in economic evaluations, there are no clear guidelines on the perspective to adopt. This paper explores the adoption of a societal perspective in economic evaluations of MSK disorders. Within health economics evaluations, the most commonly used perspectives include the payer perspective, the healthcare perspective, and the societal perspective. To facilitate optimal resource allocation decisions in order to reduce the significant economic burden of MSK disorders and improve the health outcomes of individuals with these disorders, all costs and benefits associated with interventions for them should be included. Thus, the societal perspective is arguably a preferable option to the others for economic evaluations of interventions for MSK disorders. Full article

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7 pages, 203 KiB

Open AccessCommunication

Patient Experience and Satisfaction with Orthopedic Services at a Community (Rural) Setting Hospital—How Is It Different from Urban Setting

by Khalid Hasan and Shahin Kayum

J. Mark. Access Health Policy 2024, 12(3), 209-215; https://doi.org/10.3390/jmahp12030017 - 5 Aug 2024

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Abstract

Patient experience and satisfaction are the keystones in evaluating the effectiveness of clinical care in musculoskeletal medicine. Although all orthopedic settings work on the same principles of providing safe and quality health care, community hospitals represent a unique environment. There may be key [...] Read more.

Patient experience and satisfaction are the keystones in evaluating the effectiveness of clinical care in musculoskeletal medicine. Although all orthopedic settings work on the same principles of providing safe and quality health care, community hospitals represent a unique environment. There may be key differences with regard to patient experience between these settings. Accessibility to care, choices of provider, personalized care, availability of and access to resources, cultural and social variances, and waiting times are a few of the many elements that may impact patient experience and satisfaction. This narrative review aims to explore the core differences in these settings and how they can reflect on patient experience and satisfaction. Full article

10 pages, 510 KiB

Open AccessArticle

Valuation of Medical Innovation Handling with Uncertainty and Risk

by Mark Nuijten and Stefano Capri

J. Mark. Access Health Policy 2024, 12(3), 199-208; https://doi.org/10.3390/jmahp12030016 - 1 Aug 2024

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Abstract

Background: The purpose of this paper is to address how to handle uncertainty when performing an economic valuation of a medical innovation R&D project in orphan diseases from the perspective of the investor. Methods: We describe the specific uncertainty related to cash flows [...] Read more.

Background: The purpose of this paper is to address how to handle uncertainty when performing an economic valuation of a medical innovation R&D project in orphan diseases from the perspective of the investor. Methods: We describe the specific uncertainty related to cash flows and the cost of capital for innovation in orphan diseases. The uncertainty in cash flows relates to sales, manufacturing and R&D costs, and probabilities of failure for each phase in the clinical trial program. We consider different net present values (NPVs) and higher standard deviations for orphan drugs compared to non-orphan drugs. Results: Numerical case base examples showed the differences in trade-off by an investor for R&D projects with differences in NPV and level of uncertainty. The investor will transfer the additional uncertainty in cash flows in a higher cost of capital. An alternative approach is the application of an “acceptability curve” based on a probabilistic sensitivity analysis, which displays the cumulative probabilities at a range of different values for the NPV. Finally, we consider uncertainty in the cost of capital itself by applying the Capital Asset Pricing Model (CAPM). Conclusions: In this paper, we described various types of uncertainty and explored various approaches to how to handle uncertainty in the economic valuation of medical innovation in orphan diseases. The bridging of health economics with economic valuation theory in the healthcare market is to our knowledge a novel approach for the valuation of medical innovation by investors. Full article

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18 pages, 1169 KiB

Open AccessArticle

Market Access Challenges and Solutions in Cell and Gene Therapy in The Netherlands

by Rimma Velikanova, Sharon Wolters, Hinko S. Hofstra, Maarten J. Postma and Cornelis Boersma

J. Mark. Access Health Policy 2024, 12(3), 181-198; https://doi.org/10.3390/jmahp12030015 - 30 Jul 2024

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Abstract

With the increasing pipeline of cell and gene therapies (CGTs) and the expected surge in the number of approvals, understanding the market access landscape becomes crucial for timely patient access. This study evaluates the challenges Dutch stakeholders encounter in CGT market access, offering [...] Read more.

With the increasing pipeline of cell and gene therapies (CGTs) and the expected surge in the number of approvals, understanding the market access landscape becomes crucial for timely patient access. This study evaluates the challenges Dutch stakeholders encounter in CGT market access, offering insights for improving time-to-patient access. A traditional literature review was conducted to identify market access challenges and solutions for CGTs. Based on the findings, participants for semi-structured interviews, designed using an interview guide adapted to the Dutch context, were selected to capture diverse perspectives on market access. This review included 124 relevant articles out of 2449, covering several aspects of market access of CGTs. Subsequently, interviews with 16 stakeholders from academia, patient advocacy groups, manufacturers, health insurers, payers, hospital pharmacists, healthcare practitioners, and the Association of Innovative Medicines were conducted. Stakeholders identified challenges and proposed solutions for reimbursement package management, clinical trials, health economics, payment models, and procedural and organisational aspects. Thematic analysis revealed unique country-specific challenges and solutions in the Netherlands. This research provides insights into these challenges and potential solutions, emphasising the need for collaborative efforts among stakeholders to develop practical and multidisciplinary measures to improve the market access landscape for CGTs in the country. Full article

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12 pages, 244 KiB

Open AccessArticle

Comparative Efficacy of Finerenone versus Canagliflozin in Patients with Chronic Kidney Disease and Type 2 Diabetes: A Matching-Adjusted Indirect Comparison

by David Cherney, Kerstin Folkerts, Paul Mernagh, Mateusz Nikodem, Joerg Pawlitschko, Peter Rossing and Neil Hawkins

J. Mark. Access Health Policy 2024, 12(3), 169-180; https://doi.org/10.3390/jmahp12030014 - 25 Jul 2024

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Abstract

This study aimed to close an evidence gap concerning the relative efficacy of finerenone versus SGLT2is in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Canagliflozin was selected as a proxy for the SGLT2i class. Patient-level data of two randomized [...] Read more.

This study aimed to close an evidence gap concerning the relative efficacy of finerenone versus SGLT2is in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Canagliflozin was selected as a proxy for the SGLT2i class. Patient-level data of two randomized controlled trials (RCTs) of finerenone (FIDELIO-DKD and FIGARO-DKD) were used alongside aggregated data from CREDENCE, an RCT of canagliflozin. To account for meaningful between-study heterogeneity between each finerenone trial and CREDENCE, a matching-adjusted indirect comparison of a range of efficacy outcomes was undertaken for each finerenone study versus CREDENCE. These results were meta-analyzed, enabling the estimation of the relative effects of finerenone against canagliflozin. For the cardiorenal composite endpoint, the hazard ratio (HR) comparing finerenone to canagliflozin was 1.07 (95% CI: 0.83 to 1.36). The corresponding HRs for all-cause mortality, end-stage kidney disease and cardiovascular death were 0.99 (95% CI: 0.73 to 1.34), 1.03 (95% CI: 0.68 to 1.55) and 0.94 (95% CI: 0.64 to 1.37), respectively. The absence of statistically significant differences was consistent throughout the main analysis and a range of sensitivity analyses. Based on this study, using a large sample of data and adjusted for meaningful differences between the baseline characteristics of the included RCTs, there was no statistically significant evidence indicating a difference in the efficacy of finerenone compared to canagliflozin in the treatment of CKD in patients with T2D. Full article

11 pages, 1374 KiB

Open AccessArticle

Expanding the Availability of Scalp Cooling to All Patients at Risk of Chemotherapy-Induced Alopecia

by Portia Lagmay-Fuentes, Andrea Smith, Shannon Krus, Laurie Lewis, Asma Latif, Tiffany Gagliardo and Manpreet Kohli

J. Mark. Access Health Policy 2024, 12(3), 158-168; https://doi.org/10.3390/jmahp12030013 - 10 Jul 2024

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Abstract

Alopecia is an undesirable side effect of cancer chemotherapy. The mitigation of alopecia is a desirable adjunct treatment for patients with cancer. FDA-cleared scalp cooling (SC) devices have been successfully used to prevent or reduce chemotherapy-induced alopecia (CIA). This paper provides an understanding [...] Read more.

Alopecia is an undesirable side effect of cancer chemotherapy. The mitigation of alopecia is a desirable adjunct treatment for patients with cancer. FDA-cleared scalp cooling (SC) devices have been successfully used to prevent or reduce chemotherapy-induced alopecia (CIA). This paper provides an understanding of the implementation and value of the new Insurance-Based Billing Model used in the USA for SC and its benefits compared with the original self-pay model. This improved compensation change will result in all patients in need, including underserved and disadvantaged populations, receiving equitable healthcare by allowing access to this valuable supportive care technology. Full article

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14 pages, 983 KiB

Open AccessArticle

Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative

by Zilke Claessens, Michiel Lammens, Liese Barbier and Isabelle Huys

J. Mark. Access Health Policy 2024, 12(3), 144-157; https://doi.org/10.3390/jmahp12030012 - 9 Jul 2024

Viewed by 568

Abstract

National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU [...] Read more.

National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry’s internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration’s potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape. Full article

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16 pages, 2109 KiB

Open AccessArticle

The Role of Medical Societies and the Relevance of Clinical Perspective in the Evolving EU HTA Process: Insights Generated at the 2023 Fall Convention and Survey of the European Access Academy

by Elaine Julian, Oriol Solà-Morales, Maria João Garcia, Francine Brinkhuis, Mira Pavlovic, Carlos Martín-Saborido, Robin Doeswijk, Rosa Giuliani, Anne Willemsen, Wim Goettsch, Bernhard Wörmann, Urania Dafni, Heiner C. Bucher, Begoña Pérez-Valderrama, Renato Bernardini, Fabrizio Gianfrate, Carin A. Uyl-de Groot and Jörg Ruof

J. Mark. Access Health Policy 2024, 12(3), 128-143; https://doi.org/10.3390/jmahp12030011 - 22 Jun 2024

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Abstract

Background: This work aimed to determine the role and action points for the involvement of medical societies in the European Health Technology Assessment (EU HTA) Methods: An online pre-convention survey was developed addressing four areas related to the EU HTA: (i) medical societies’ [...] Read more.

Background: This work aimed to determine the role and action points for the involvement of medical societies in the European Health Technology Assessment (EU HTA) Methods: An online pre-convention survey was developed addressing four areas related to the EU HTA: (i) medical societies’ role; (ii) role of clinical guidelines; (iii) interface with the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS); and (iv) approaching ‘best-available evidence’ (BAE). A descriptive analysis of questionnaire outcomes was conducted to inform the European Access Academy (EAA) Fall Convention 2023. Within the working groups (WGs), action points were identified and prioritised. Results: A total of 57 experts from 15 countries responded to the survey. The WGs were attended by (i) 11, (ii) 10, (iii) 12, and (iv) 12 experts, respectively, representing a variety of national backgrounds and stakeholder profiles. The most relevant action points identified were as follows: (i) incorporation of clinical context into population, intervention, comparator, outcomes (PICO) schemes, (ii) timely provision of up-to-date therapeutic guidelines, (iii) ensuring the inclusion of MCBS insights into the EU HTA process, and (iv) considering randomized controlled trials (RCTs) as the gold standard and leveraging regulatory insights if development programs only include single-arm trials. Conclusions: The involvement of medical societies is a critical success factor for the EU HTA. The identified key action points foster the involvement of patient associations and medical societies. Full article

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J. Mark. Access Health Policy, Volume 12, Issue 3 (September 2024) – 8 articles

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