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Steps forward in regulatory pathways for acute and chronic heart failure
Luca Pani1, Sergio Pecorelli1, Giuseppe Rosano1,2,3
1Italian Medicines Agency-AIFA, Rome, Italy.
ESC Heart Failure
|August 24, 2017
Summary
This workshop highlighted the need for patient-centered, multidisciplinary approaches in heart failure medicine development. Future efforts should focus on consensus endpoints and integrating real-world effectiveness for better treatment strategies.
Area of Science:
- Cardiology
- Pharmacoeconomics
- Health Services Research
Background:
- Heart failure medicine development faces challenges in addressing unmet needs and ensuring cost-effective use.
- Current paradigms may overemphasize molecular aspects over holistic treatment regimens.
Purpose of the Study:
- To discuss unmet needs and future directions in heart failure medicine development.
- To advocate for an integrated, multidisciplinary approach incorporating patient perspectives.
- To explore the integration of health technology assessment and payer perspectives.
Main Methods:
- A workshop organized by the Agenzia Italiana del Farmaco (AIFA).
- Discussion among stakeholders on unmet needs and development pathways.
- Focus on patient-reported outcomes and real-world effectiveness.
Main Results:
- An integrated, multidisciplinary approach including patient needs is crucial for effective heart failure treatment.
- Consensus on clinical endpoints and validation of patient-reported outcomes require further work.
- Integrating health technology assessment and payer perspectives is vital for evaluating real-life treatment effectiveness.
Conclusions:
- A shift towards evaluating medicines within the entire healthcare regimen is necessary.
- AIFA aims to establish a template for stakeholder meetings to define future roadmaps for heart failure medicine.
- Collaborative efforts are essential to address unmet needs and improve heart failure care.
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