Francesca writes about a broad range of policy and regulatory topics, including intellectual property rights. However, her main areas of expertise are pricing and reimbursement and how medicines may or may not make it to patients. She writes about developments in Europe and is also expanding coverage in emerging markets, including Latin America and the Middle East. Francesca writes for Pink Sheet, Scrip and In Vivo.
Latest from Francesca Bruce
The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
The Member State Coordination Group on HTA has also resolved to improve information sharing with drug developers to improve resource planning for EU-level joint clinical assessments.
An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
A new Innovative Health Initiative project will see the German health technology appraisal (HTA) body, IQWiG, work towards ensuring evidence generated in clinical studies meets the needs of HTA bodies and regulators.