Interview with Lara Wolfson and Anders Gorst-Rasmussen

Why You Should Listen:

✔ EU HTA is becoming reality: Joint Clinical Assessments begin soon with oncology/ATMPs and will expand to all medicines over the next years.

✔ Statisticians are central: Re-analyses, indirect comparisons, RWE, and quality-of-life analyses will be required—often beyond what regulatory trials were designed for.

✔ Timelines are tight: From EMA Day 120 scoping to dossier deadlines and final JCAs just 30 days post-marketing authorization.

✔ Transparency and resources matter: Joint assessments will be public, and both companies and agencies face capacity and clarity challenges.

✔ You can prepare now: Incorporate HTA needs into trial design, analysis planning, and cross-functional collaborations.

Episode Highlights:

00:00 – 02:30 | I introduce the episode and explain why EU HTA is such a critical topic

02:30 – 05:30 | Lara and Anders introduce themselves and their HTA work at MSD and Novo Nordisk

05:30 – 10:45 | Regulatory vs. HTA: safe & effective vs. how good, for whom, and at what cost

10:45 – 18:30 | Europe’s patchwork: national differences in comparators, standards of care, and access

18:30 – 23:45 | The EU regulation: joint clinical assessments, economic modeling, and what’s changing

23:45 – 32:30 | What it means for us as statisticians: re-analyses, ITCs/NMAs, RWE, QoL, and capacity issues

32:30 – 36:00 | Why “transparency” can’t just be 50,000-page PDFs—clear, reproducible evidence matters

36:00 – 45:00 | The PSI HTA SIG’s role, current activities, and how you can get involved

45:00 – end | Our final takeaways and a call for statisticians to engage now

Links:

🔗 Join the PSI HTA Special Interest Group and watch for their newsletter and training.

🔗 Review EUnetHTA 21 methodological drafts—they are shaping the future of JCAs.

🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.

🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.

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Glossary:

HTA – Health Technology Assessment

EU HTA / JCA – Joint Clinical Assessment forming the evidence base for national HTA decisions

EMA / CHMP – European Medicines Agency / Committee for Medicinal Products for Human Use

RWE – Real-World Evidence; NMA/ITC – Network/Indirect Treatment Comparison

QoL/HRQoL – (Health-Related) Quality of Life measures

PSI HTA SIG – PSI Special Interest Group on HTA

EFPIA – European Federation of Pharmaceutical Industries and Associations

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