HTAi Interest Sub-Group on HTA-Regulatory Interactions Overview

Overview

There is increasing pressure for Health Technology Assessment (HTA) recommendations and reimbursement decisions to be made closer to the point of marketing authorisation. This means that HTA for coverage decision making is occurring earlier than previously and increasingly relies on evidence that has been developed mainly to suit regulatory agency needs. As a result, there is increased attention on initiatives that aim to improve the relevance of regulatory evidence for HTA and coverage decisions, as well as to align those HTA and regulatory review processes where objectives are complementary.

Less than five years ago there was little discussion between regulatory agencies, HTA bodies and coverage bodies, but the interface between these stakeholders is now evolving at a rapid rate with a variety of activities occurring around the globe. HTA-Regulatory Interactions was the topic of the 2011 HTAi Policy Forum and a key conclusion from this Forum in relation to the increasing dialogue was that ‘this effort should be well directed and focused on the areas of most importance’.

The HTAi Interest Sub-Group on HTA-Regulatory Interactions has been established to provide the HTAi membership and the wider HTA community with a forum for continued discussion that follows on from discussions of the 2011 HTAi Policy Forum and also as a forum for interaction with representatives from regulatory agencies. 

Aims of the ISG

  1. To develop a repository of different activities at the HTA-Regulatory interface in order to signpost ongoing and completed initiatives so that further work can build on this experience, avoid unnecessary duplication, and to explore alignment or synergies with other ongoing or planned initiatives. The repository will also help to identify relevant country context, key trends and patterns, as well as gaps where additional work might be beneficial.

    HTA-Regulatory Interactions repository
     
  2. To identify and share best practice relating to HTA-Regulatory interactions, based on the experience and outcomes of current initiatives and to help identify those areas where the need for improved interaction is most urgent. Best practice interactions are those that are likely to improve the efficiency of pharmaceutical and device development, support timely access to innovative technologies, and facilitate patient access to the best available care.
     
  3. To be a vehicle for informal discussions between representatives of regulatory, HTA and coverage body communities, and the life sciences industry in order to share their views and requirements. Discussions will facilitate greater understanding of the context and remit of regulatory agencies, HTA bodies and coverage bodies internationally (functions, processes, outputs, policy levers, resources, constraints, political drivers, etc).
     
  4. Horizon-scanning to identify future challenges emerging in the HTA-Regulatory interface and to pro-actively discuss how best to respond to such challenges.

Join this ISG

ISG chairs: 

  • Franz Pichler, Chair (Australia)
  • Matthew Brougham, vice-Chair (Canada)

Past-chairs:

  • Mel Walker (UK) 2011-2012

 

All members of HTAi are welcome to participate in this ISG. To join, simply log in to the website and return to this page. A link to join the ISG mailing list will appear automatically.

Non-members of HTAi are also welcome express interest in joining this ISG, with membership pending approval of the ISG chair. For enquiries, please contact the HTAi Secretariat.