Surrogate Endpoints Guidance: New International Report Enhances HTA Practices

By João L. Carapinha

January 24, 2025

The National Institute for Health and Care Excellence (NICE) published a new report that provides surrogate endpoints guidance. This guidance offers best practices for utilizing surrogate endpoints in health economic models to inform health technology assessment (HTA) decisions. The aim is to clarify how surrogate endpoints can predict long-term health outcomes from short-term effects, which is particularly crucial when long-term data is not available. The report results from a collaborative effort among several global health technology assessment agencies.

What you need to know

The new report addresses the previously fragmented guidance on using surrogate endpoints in HTA, providing clarity and support for technology developers and HTA agencies. It outlines methods for selecting, validating, and incorporating surrogate endpoints into health economic models, enhancing predictions of long-term health benefits. This surrogate endpoints guidance results from a collaborative effort among multiple international HTA agencies, including NICE, Canada’s Drug Agency, ICER in the US, and others. The report assists HTA committees in understanding the relationship between short-term surrogate endpoints and long-term health outcomes, which is crucial for evaluating the value of new treatments.

Surrogate endpoints are biomarkers or intermediate outcomes that predict a treatment’s effect on a final clinical outcome. This concept is critical in health technology assessment as it allows the evaluation of treatments based on shorter-term data when long-term outcomes are not yet available. The report aligns with regulatory standards and HTA guidance, drawing from published methods in HTA manuals, regulatory guidelines, and statistical validation. This ensures that the guidance is grounded in established practices and methodologies.

Implications

The new guidance significantly impacts health economics and outcomes research by providing a standardized approach to using surrogate endpoints. This can enhance the accuracy and reliability of cost-effectiveness analyses, which are crucial for decision-making in healthcare resource allocation. By clarifying the relationship between surrogate endpoints and long-term health outcomes, this guidance can lead to more informed decisions about the reimbursement and adoption of new treatments. The long-term effects of many drugs are vital for determining their overall value to patients and health systems. The report may lead to modular updates in HTA methods, ensuring that the guidance remains current and integrated into ongoing HTA processes, further enhancing the evaluation of health technologies.

Reference url

Recent Posts

capivasertib cost-effectiveness
      

Capivasertib Cost-Effectiveness in Advanced Breast Cancer

💡What’s the strategy to bring capivasertib’s price within reach of breast cancer patients?

A recent study evaluates capivasertib, an AKT inhibitor, as a second-line treatment for advanced breast cancer, revealing that its costs significantly outweigh the added health benefits. The analysis indicates that to be cost-effective, a substantial reduction in its price is necessary.

Delve into the economic implications of this treatment and the pressing need for pricing reforms in healthcare.

#SyenzaNews #HealthEconomics #costeffectiveness #oncology

reserve antibiotics benefits
           

Reserve Antibiotics Benefits: G-BA Designates Meropenem/Vaborbactam as Critical Reserve Treatment

🔍 What makes reserve antibiotics crucial in the fight against antimicrobial resistance?

The recent assessment of Meropenem/Vaborbactam by the G-BA highlights its vital role as a reserve antibiotic for severe gram-negative infections, ensuring effective treatment options when others fail. With tight regulations and stewardship in place, its designation underscores the importance of preserving these powerful tools in modern medicine.

Dive into the article to explore the implications for healthcare, economics, and patient safety.

#SyenzaNews #HealthcareInnovation #HealthEconomics

robotic surgery approval
               

NICE Grants Conditional Robotic Surgery Approval to Enhance Patient Care and Address Health Inequities

🤖 Are you ready for the future of surgery?

The recent approval of 11 robotic surgery systems by NICE could improve patient care in the NHS, leading to faster recoveries and minimal invasiveness. With a focus on real-world evidence, this transformative step aims to improve health outcomes while addressing access and equity concerns.

Explore how this innovative approach will shape the landscape of surgical procedures in the coming years!

#SyenzaNews #HealthcareInnovation #MedicalDevices #MarketAccess

When you partner with Syenza, it’s like a Nuclear Fusion.

Our expertise are combined with yours, and we contribute clinical expertise and advanced degrees in health policy, health economics, systems analysis, public finance, business, and project management. You’ll also feel our high-impact global and local perspectives with cultural intelligence.

SPEAK WITH US

CORRESPONDENCE ADDRESS

1950 W. Corporate Way, Suite 95478
Anaheim, CA 92801, USA

© 2025 Syenza™. All rights reserved.