Over 45 of our scientists and consultants attended the 17th Annual ISPOR European Congress in Amsterdam; below are some of their insights from the conference.
"Adaptive licensing--a staggered approval process that would bring products to market faster for patients with a pressing unmet medical need--was a hot topic at ISPOR and something EMA began piloting in 2014. From a regulatory perspective, this process allows for starting real-world studies in parallel with phase 3, and for manufacturers, it can bring needed drugs to patients quicker. But what would adaptive licensing mean for payers and reimbursement? Would it mean adaptive pricing as well? It's not clear yet what something like this would mean for stakeholders, but I look forward to monitoring it as it unfolds to see what it will mean for our industry."
Kati Copley-Merriman, MS, MBA
Her comment on attending an adaptive licensing ISPOR plenary session
Budget Impact Analysis
"Especially with sluggish economies and aging populations, budget impact analysis is extremely important. With health care budgets being cut all over Europe and other places in the world, it is increasingly important to know how to estimate the budget impact of new health care interventions."
Jo Mauskopf, PhD
VP, Health Economics
Her comment on the sold-out courses she co-taught with Drs. Earnshaw, Brogan, and Wolowacz
"I'm excited to see such interest from the ISPOR community on setting standards and guidance for measuring health state utilities for cost-effectiveness analysis. It's an area of research that is becoming increasingly critical in HTA decision-making."
Sorrel Wolowacz, PhD
Head, European Health Economics
Her comment on her position on the ISPOR Health State Utility Task Force
"Recent examples, particularly with vaccines in low income countries, have shown that current methods for determining price and value are flawed--at least for certain therapies in certain markets. These examples indicate that perhaps we need new approaches for determining the value of pharmaceutical products."
Sandra Talbird, MSPH
Director, Health Economics
Her comment on attending an RTI-HS co-lead workshop about cost effectiveness analysis
"Real-world data (RWD) are especially important in addressing the gaps from RCT-generated evidence such as external validity, generalizability, and determining long-term and rare effects. For example, a recent study suggested that only 4% of the 'real' asthmatic population would qualify for inclusion in RCTs! RWD can also help to inform development of economic models. However, RWD has limitations as well. Biases, data quality and availability, and privacy concerns all lead to methodological challenges. Recent projects like the GetReal public-private consortium aim to address some of the standardization and harmonization issues that RWD researchers face."
Ewa Rupniewska, PhD
Sr. Associate, Market Access and Outcomes Strategy
Her comment on attending several sessions on using RWD in HTA and P&R
"As social media and other online sources are increasingly used to find and share health-related information, how can we (and should we) start to use this information to draw real-world insights? No best practices exist and much work is still needed to understand the regulatory, ethical, and legal issues associated with social media content.”
Kati Copley-Merriman, MS, MBA
Her comment on attending a social media session