Two New Publications: ‘New Age Decision Making in HTA’ and ‘How Can HTA in Asia-Pacific Respond to Increased Clinical Uncertainty?’

OHE has just published two new briefings entitled ‘New Age Decision Making in HTA’ and ‘How Can HTA in Asia-Pacific Respond to Increased Clinical Uncertainty as a Consequence of Expedited US and EU Regulatory Processes?’. Both publications are reports of panel sessions held at the HTAi 2016 meeting in Tokyo.

OHE has just published two new briefings entitled ‘New Age Decision Making in HTA’ and ‘How Can HTA in Asia-Pacific Respond to Increased Clinical Uncertainty as a Consequence of Expedited US and EU Regulatory Processes?’. Both publications are reports of panel sessions held at the HTAi 2016 meeting in Tokyo.

The first report, New Age Decision Making in HTA, begins with some background on the topic of decision making in HTA, provided by the chair of the panel session, David Grainger (Eli Lilly & Company). He highlighted that existing HTA systems have devoted a significant amount of time and effort to the methodologies and evidence requirements of HTA, but less attention to the actual “decision-making” processes and mechanics.

Next, OHE’s Professor Nancy Devlin, gave an overview of structured decision-making approaches to the inclusion of multiple criteria in HTA. She discussed the potential merits of structured decision making and explained that there is a growing interest in this topic globally, providing several examples of where such structured approaches have been used around the world. Dr Wija Oortwijn (ECORYS) then built on this, sharing the experiences of the Dutch appraisal committee, including the steps taken to find the best way to conduct a “deliberative process” in HTA. Finally, Professor Eui-Kyung Lee (Sungkyunkwan University, Korea) shared experience in and insights into the Korean system and the Korean experience of decision making and HTA.

Download the full report here.

The second panel session, How Can HTA in Asia-Pacific Respond to Increased Clinical Uncertainty as a Consequence of Expedited US and EU Regulatory Processes? , was chaired by Franz Pichler (Eli Lilly & Company). The session began with an introduction to regulatory changes (such as the FDA’s Breakthrough Therapy Designation (BTD) and other EMA initiative such as PRIME (PRIority Medicines) and adaptive pathways) all of which have potential knock-on effects for HTA.

Dr Michelle Mujoomdar (CADTH) explained the issues from a Canadian perspective, and discussed the challenges and opportunities of risk-sharing arrangements as a potential solution. Professor Arnold Chan (Health Data Research Centre) gave a Taiwanese perspective, explaining how conditional approval, with collection of post-marketing data alongside risk-sharing or pay-for-performance, is being explored locally. Finally, OHE’s Professor Adrian Towse explained how performance-based risk-sharing has been used to date, providing examples of such arrangements in the US and Europe, and exploring the implications for the Asia-Pacific region.

The panel discussion touched on issues such as the mechanics of “managed exit”, price flexibilities, and the importance of trust in risk-sharing arrangements.

Download the full report here.

Grant funding was received by OHE from Eli Lilly and Company to produce a record of these panel sessions in the form of these reports.

To see OHE’s presentations from the HTAi 2016 meeting click here; to see OHE’s posters from the meeting click here.