ISSUE: Global oncology spending is continuously rising. Simultaneously, drugs are increasingly approved based on less comprehensive evidence to ensure timely access, hampering assessments of their added benefit and often resulting in negative ratings. Concerns are growing regarding the financial strain on health systems and misalignment between incentives in the pharmaceutical market and patient interests, i.e. access to beneficial drugs for critical needs.

OVERVIEW: First, Francine Brinkhuis will present findings (~10 minutes) from a BMJ-published study*, co-authored by herself and Wim Goettsch, revealing that many EMA-approved oncology drugs (1995-2020) lack demonstrated added benefit, especially those approved via expedited pathways. These pathways aim to accelerate access to drugs for unmet medical needs but often lead to expensive drugs without substantial clinical benefits. Further, while revenues seemingly align with added benefit, most oncology drugs recover R&D costs within a few years. All this underscores the policy gap between drug approval/reimbursement and patient/societal benefit.

Next, three panelists share their insights (~10 minutes each), moderated by Wim Goettsch:

• Michael Berntgen discusses regulatory incentives for unmet medical needs. Are current incentives adequate to drive innovation for beneficial drugs? How can regulatory processes be adjusted to prioritize patient/societal value?
• Matteo Scarabelli provides an industry perspective. What are the challenges/opportunities faced by industry under the current regulatory/HTA environment? How can industry incentives be aligned with delivering high-value oncology drugs?
• Bettina Ryll focuses on a patient perspective on access to oncology drugs. What changes are needed to ensure that patient needs are better met?

The panel will then engage in a debate including audience participation, fostering a discussion on the challenges of incentivizing drug development for unmet medical needs and concerns about sustainable health systems. The audience will gain a deeper understanding of the challenges/opportunities within regulatory/HTA frameworks, providing key takeaways for more informed decision-making in oncology drug development/reimbursement.

*https://www.bmj.com/content/384/bmj-2023-077391

https://www.bmj.com/content/384/bmj.q511