This post summarises OHE’s activities at this year HTAi meeting in Oslo, June 2015. Topics include the effect of NICE decisions abroad and a new drug development paradigm.
HTAi’s 12th Annual Meeting, Global Efforts in Knowledge Transfer: HTA to Health Policy and Practice, took place on 15-17 June 2015 in Oslo. Members of the OHE team attended and presented key research. OHE presentations are summarised below.
New Clinical Development Paradigm for Drugs
Sean Tunis (Center for Medical Technology Policy: CMTP),
Adrian Towse (OHE), Sarah Garner (NICE) Franz Pichler (Eli Lilly).
This workshop held on Sunday 14th June combined knowledge from two projects: (i) the New Drug Development Project, undertaken by CMTP and OHE, funded by five companies, which set out development pathways for different drug ‘archetypes’ and (ii) initial findings from the Innovative Medicines Initiative (IMI) ‘GetReal’ Project proposing innovative (more pragmatic) trial designs in pre-and post-launch drug development. In the first part of the workshop on the Changing Environment for Evidence in the US and the EU Adrian Towse presented on CER and the changing environment in the US.
Sarah Garner presented a European Perspective on Developing Relative Effectiveness Estimates for Medicines in Development.
Finally, in this section of the workshop Adrian Towse presented A Comparison of the CER/RE evidence environments in the US and Europe.
In the second part of the workshop Changing the Drug Development Paradigm, Franz Pichler presented Incorporating real-life clinical data into development strategies, setting out the work of the GetReal project.
Adrian Towse then presented The NDDP project – Implications for Drug Development.
Sean Tunis facilitated a discussion at the end of each part of the programme with an audience including drug developers, clinical trial reviewers and methodologists, HTA evidence assessors, and HTA decision makers. The objective was to share knowledge about the likely changes in the type of evidence that is generated in the drug development process and the impact that HTA and payer bodies can have on that process.
Do NICE Decisions Affect Decisions in Other Countries? A Feasibility Study
This poster looks at whether NICE recommendations on the use of a new drug affect recommendations from other bodies in countries outside England and Wales. A basket of 29 drug/indication pairs and a group of 15 countries were studied (Australia, Canada, Denmark, France, Italy, Korea, Netherlands, New Zealand, Poland, Portugal, Spain, Bosnia, Ecuador, Egypt and Ghana). The findings suggest that after the publication of a NICE appraisal there is a higher probability that an HTA is undertaken for the same drug in other countries. The results suggest that the selected agencies are considering NICE decisions as a factor for rejecting or restricting the use of drugs which in other case would be recommended or reimbursed. Results need to be treated with caution given the small sample size.
