EMA Advances Use Of Real-World Data By HTAs And Payers

 
• By Vibha Sharma
  
Generate a summary of this article
Listen to this article
Beta

Results from the first pilot real-world evidence study commissioned by the European Medicines Agency to help HTA bodies and payers characterize patients with multiple myeloma have drawn positive feedback.

Hand holding global network connection on healthcare, telemedicine, wearable devices, health informatics, digital health, technology and futuristic innovations.
The EMA is using RWD to help a diverse range of decision-makers across the medicinal product’s life cycle • Source: Shutterstock

Health technology assessment and payer organizations have begun tapping into the real-world data (RWD) analysis capabilities of the EU medicines network to gain valuable insights for their own decision-making processes.

Key Takeaways

  • The European Medicines Agency has published its second report on the use of real-world evidence (RWE) studies to support medicine regulation.

A new report on real-world evidence (RWE) studies commissioned by EU regulators between February 2023 and February 2024 shows that...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Real-World Evidence

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

 
• By Sue Sutter

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Use AI In Health Technology Assessments Only When Valuable, England’s NICE Tells Pharma Firms

 
• By Eliza Slawther

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

EMA Advances Use Of Real-World Data By HTAs And Payers

 
• By Vibha Sharma

Results from the first pilot real-world evidence study commissioned by the European Medicines Agency to help HTA bodies and payers characterize patients with multiple myeloma have drawn positive feedback.

EU Ocaliva Withdrawal Recommendation Based On ‘Flawed’ Studies

 
• By Francesca Bruce

Overreliance on “problematic” trials while overlooking the value of real-world evidence could affect the development of other rare disease treatments, according to Advanz’s CEO.

More from Clinical Trials

Clinical Trial Diversity Action Plans Need Timely FDA Feedback, Groups Say

 
• By Sue Sutter

The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.

How To Decarbonize Pharma R&D

 
• By Francesca Bruce

As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.

US FDA’s MIDD Program Could Expand Beyond Quarterly Requests, But Needs Resources

 
• By Derrick Gingery

An FDA official said the agency is considering allowing MIDD meeting requests to be submitted more often, but must have a plan to deal with the likely increased demand.