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Volume 11
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10.3390/jcdd11070186
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Perspective

Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases

by
András Inotai
1,2,
Zoltán Kaló
1,2,*,
Zsuzsanna Petykó
1,2,
Kristóf Gyöngyösi
1,2,
Derek T. O’Keeffe
3,
Marcin Czech
4 and
Tamás Ágh
2,5
1
Center for Health Technology Assessment, Semmelweis University, 1091 Budapest, Hungary
2
Syreon Research Institute, 1142 Budapest, Hungary
3
School of Medicine, University of Galway, H91TK33 Galway, Ireland
4
Department of Pharmacoeconomics, Institute of Mother and Child, 01-211 Warsaw, Poland
5
Medication Adherence Research Group, Center for Health Technology Assessment and Pharmacoeconomic Research, University of Pécs, 7623 Pécs, Hungary
*
Author to whom correspondence should be addressed.
J. Cardiovasc. Dev. Dis. 2024, 11(7), 186; https://doi.org/10.3390/jcdd11070186
Submission received: 28 May 2024 / Revised: 18 June 2024 / Accepted: 19 June 2024 / Published: 21 June 2024
(This article belongs to the Section Basic and Translational Cardiovascular Research)
Versions Notes

Abstract

Despite the availability of affordable pharmaceuticals treating cardiovascular diseases (CVDs), many of the risk factors remain poorly controlled. Fixed-dose combinations (FDCs), a form of incremental innovation, have already demonstrated improvements over combinations of single medicines in adherence and hard clinical endpoints. Nevertheless, there are many barriers related to the wider use of FDCs in CVDs. Our aim was to identify these barriers and explore system-level facilitators from a multi-stakeholder perspective. Identified barriers include (i) hurdles in evidence generation for manufacturers, (ii) limited acceptance of adherence as an endpoint by clinical guideline developers and policymakers, (iii) limited options for a price premium for incremental innovation for healthcare payers, (iv) limited availability of real-world evidence, and (v) methodological issues to measure improved adherence. Initiatives to standardize and link healthcare databases in European countries, movements towards improved patient centricity in healthcare, and extended value assessment provide opportunities to capture the benefits of FDCs. Still, there is an emerging need to facilitate the generalizability of sporadic clinical evidence across different FDCs and to improve adherence measures. Finally, healthcare payers need to be convinced to pay a fair premium price for the added value of FDCs to incentivize incremental innovation in CVD treatment.
Keywords: incremental innovation; fixed dose combination; polypill; adherence; pricing; real world data; cardiovascular diseases; medicine; reimbursement incremental innovation; fixed dose combination; polypill; adherence; pricing; real world data; cardiovascular diseases; medicine; reimbursement

Share and Cite

MDPI and ACS Style

Inotai, A.; Kaló, Z.; Petykó, Z.; Gyöngyösi, K.; O’Keeffe, D.T.; Czech, M.; Ágh, T. Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases. J. Cardiovasc. Dev. Dis. 2024, 11, 186. https://doi.org/10.3390/jcdd11070186

AMA Style

Inotai A, Kaló Z, Petykó Z, Gyöngyösi K, O’Keeffe DT, Czech M, Ágh T. Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases. Journal of Cardiovascular Development and Disease. 2024; 11(7):186. https://doi.org/10.3390/jcdd11070186

Chicago/Turabian Style

Inotai, András, Zoltán Kaló, Zsuzsanna Petykó, Kristóf Gyöngyösi, Derek T. O’Keeffe, Marcin Czech, and Tamás Ágh. 2024. "Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases" Journal of Cardiovascular Development and Disease 11, no. 7: 186. https://doi.org/10.3390/jcdd11070186

APA Style

Inotai, A., Kaló, Z., Petykó, Z., Gyöngyösi, K., O’Keeffe, D. T., Czech, M., & Ágh, T. (2024). Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases. Journal of Cardiovascular Development and Disease, 11(7), 186. https://doi.org/10.3390/jcdd11070186

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