Francesca Bruce

2 days ago | insights.citeline.com | Francesca Bruce

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data RequirementsIn an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements. From the very beginning, rare disease manufacturers need to consider EU-level joint clinical assessment data requirements when designing development programs .

1 week ago | insights.citeline.com | Francesca Bruce

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies Brazil’s drug pricing authorities are planning to introduce a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework. Brazil updates pricing framework for medicines to bring clarity and predictability for companies. (Shutterstock)

1 week ago | insights.citeline.com | Francesca Bruce

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector. Brazil will consult on a new resolution that brings clarity to the pharmaceutical pricing framework. (Shutterstock)

1 week ago | insights.citeline.com | Francesca Bruce

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease DrugsCooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said. Future changes to the joint clinical assessment process could benefit treatments for very rare diseases. (Shutterstock)

1 week ago | insights.citeline.com | Francesca Bruce

What The EMA Can Teach HTA Bodies About Joint Clinical AssessmentsEU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference. The EMA'S approach to non-traditional studies should be echoed in the joint clinical assessment process. (Shutterstock)