2020 Outlook: 20 HTA Challenges and 20 PSE Solutions

As we embark on a new decade, we here at #PSEconomics have been reflecting on how far the young discipline of HEOR and HTA has evolved in a very short time. CADTH was a trailblazer, established in 1989 as a 3-year pilot program to evaluate medical devices. The year 1995 brought the Association for Pharmacoeconomics and Outcomes Research (APOR), now known as ISPOR. NICE was established in 1999 and issued its first technology appraisal--on wisdom tooth extraction--in 2000. Now, in 2020, health economics is a recognized academic discipline, and every major pharmaceutical company has a team of HEOR experts to guide global and local HTA strategy, supported by external partners who generate and communicate evidence to support market access for life-changing therapies.

Our field has grown quickly, and there are many challenges ahead. In 2020, we plan to share a series of 20 articles on the key challenges in HTA, with expert insights on solutions and strategies. For example:

• Outdated SLRs: Research in oncology is moving fast, meaning that patients can access more innovative treatments than ever before. The speed of discovery does, however, pose challenges for the HTA lead who needs to maintain up-to-date systematic literature reviews.
• Single Arm Comparisons: Recognizing the need to bring drugs to market in a timely and ethical manner, regulatory agencies have been willing to grant approval based on single-arm studies in certain cancers and rare diseases. This type of clinical evidence poses challenges for comparative effectiveness research, often required by HTA bodies.
• GVDs Not User-friendly: The global value dossier (GVD) has become a standard component of value & access, providing a comprehensive review of the evidence supporting product value. Ideally, a GVD is just a short step along the path to HTA submissions. In practice, a GVD can become long and unwieldy, and even the most user-friendly GVD can become outdated quickly in a dynamic market environment.
• "Black-box" BIMs: Budget impact models (BIMs), another core component of a health economic evidence portfolio, can become the target of payer skepticism. How can we ensure that a BIM is methodologically sound and comprehensive while maintaining full transparency on the design and inputs?
• TMI of Conference Presentations: Alongside the growth of online information sources, conferences continue to be important opportunities for professional networking, along with presenting emerging research. Given the lag time from conference presentation to journal publication (if the results are indeed ever published), how can the astute HTA lead stay abreast of information presented at conferences?

These and other challenges present an opportunity for collaborative problem solving. We look forward to engaging in these discussions with you in the coming year. Watch this space!