Methods for capturing the patient's voice and payers' perspectives have drastically changed.

Reflecting on 2020

The global pandemic affected how research was conducted in the health economics and outcomes research (HEOR) world. The ICON global HEOR team paused, regrouped, and pivoted to adapt to the changing environment brought on by this pandemic. Capturing both the patient voice and the payer perspective is crucial to a successful drug development program. However, in the setting of a global pandemic, how those voices are being captured had to drastically change.

Face-to-face interviews and focus groups with patients were no longer possible in a world in lockdown. In-person advisory board meetings and interviews with HTA representatives were no longer viable options. Administering clinical outcomes assessments (COAs) to patients during site visits suddenly became impossible, or at least, much more challenging. Additionally, processes related to HTA appraisals and clinical trial programs were delayed in some therapeutic areas, partly as a result of re-prioritizing resources in the race to control the pandemic. Professional conferences, which usually serves as an opportunity to meet and interact with peers in the field, were cancelled or switched to virtual settings, limiting our ability to interact with global colleagues.

However, despite these challenges of living in a pandemic world, our effort to bring new innovative products to market goes on. Evidence planning and generation still needed to be done. Patient-reported outcomes (PRO) data still needed to be collected, health economic evidence still needed to be generated and health technology assessments albeit after a short hiatus still continued. The work of drug development and engaging with patients and payers has to continue. However, the way health economics and outcomes research takes place had to be reassessed and reinvented in 2020.

When in-person research became nearly impossible, innovation through technology stepped in to ensure that the patient and payer voice would still be heard. Through the use of videoconference platforms, our patient interviews and focus groups became virtual, allowing our global HEOR researchers to connect with patients in their own living rooms, at their convenience. Similarly, virtual advisory boards and payer interviews enabled us to talk to payers across the globe without the added expense and time associated with travel. The global HEOR team worked closely with our clients to help manage their shifting priorities and timelines, and adapt to their needs. We also organized multiple webinars and attended many virtual professional conferences to stay connected and continue sharing novel research methodologies and findings with our peers.

Looking ahead in 2021

Looking ahead in 2021, the GHEOR team continues to evolve, adapt and define the “new normal” in the world of health economics and outcomes research.  In 2020, COA experts were called upon to help drug development programs rethink their COA data collection methods. The trend towards completely remote COA data collection continues into 2021, as the pandemic continues. That is, there is increased use of electronic COA (eCOA), and a rising trend in the use of BYOD (bring your own device).

Also, traditionally, the patient and caregiver voice within the context of clinical trials has been limited to the data collected through COAs. However, more recent trends are indicating that the inclusion of qualitative research within the context of clinical trials through embedded interviews and mixed methods research is becoming increasingly more common. This more holistic approach to incorporating the patient/caregiver voice in drug development is looked upon favourably by regulatory bodies, such as the FDA.

Advisory board meetings and other traditional face-to-face meetings continue to be held successfully as remote virtual meetings. We are looking forward to sharing our knowledge and expertise through many exciting upcoming presentations and webinars in 2021.

Meanwhile, other world events and trends impact the HEOR world. There are new HTA processes due to the impact of BREXIT in the UK, newly established processes in Asia-Pac, and new HTA assessment and evidence requirements driven by the pricing and budget impacts anticipated related to new classes of gene/cell therapies which target larger therapeutic areas.

Recently released new Technical Support Documents from NICE provide guidance on navigating increasingly common challenges with flexible survival modelling methods for immune-oncologic therapies and indirect treatment comparisons for disconnected networks including single arm studies. Utilisation of real-world data within the parameters of health technology assessments and the development of economic evidence in particular is a key impact within 2021.

We continue to bring expertise to our collaborations with the flexibility and agility that the shifting global environment requires in 2021.