Related Experiment Video
Updated: Jun 19, 2025

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases
András Inotai1,2, Zoltán Kaló1,2, Zsuzsanna Petykó1,2
1Center for Health Technology Assessment, Semmelweis University, 1091 Budapest, Hungary.
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.
Insights
Fixed-dose combinations (FDCs) improve cardiovascular disease treatment adherence but face barriers. Overcoming these requires better evidence, policy acceptance, and fair pricing to incentivize innovation.
Area of Science:
- Pharmacology and Cardiovascular Medicine
- Health Services Research
- Health Economics
Background:
- Cardiovascular diseases (CVDs) remain poorly controlled despite available treatments.
- Fixed-dose combinations (FDCs) offer incremental innovation, improving adherence and clinical outcomes compared to single-drug regimens.
Purpose of the Study:
- To identify barriers hindering the wider adoption of FDCs for CVD treatment.
- To explore system-level facilitators for FDC implementation from a multi-stakeholder viewpoint.
Main Methods:
- Multi-stakeholder perspective analysis to identify barriers and facilitators.
- Review of evidence generation, clinical guideline development, healthcare payer policies, and real-world evidence availability.
Main Results:
- Identified barriers include evidence generation challenges, limited acceptance of adherence as an endpoint, restricted price premiums for payers, insufficient real-world evidence, and adherence measurement issues.
- Facilitators include standardized healthcare databases, patient-centric healthcare movements, and extended value assessment frameworks.
Conclusions:
- Addressing barriers in evidence, policy, and reimbursement is crucial for FDC utilization in CVDs.
- Standardizing data, enhancing patient centricity, and demonstrating value are key opportunities.
- Convincing payers to offer fair premium pricing is essential to incentivize incremental innovation in FDCs for cardiovascular disease management.
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