EARLY SCIENTIFIC ADVICE AT CADTH – OPTIONS AND RECOMMENDATIONS FOR FUTURE DEVELOPMENT
Author(s)
Husereau D1, Sood AR2
1Institute of Health Economics, Ottawa, ON, Canada, 2Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada
Presentation Documents
OBJECTIVES: : Early Scientific Advice at CADTH was developed in response to a perceived need by innovators and modeled after similar programs internationally. It was developed with the principles that advice on early drug development plans will help produce a more complete package of evidence for reimbursement, and with the goals of reducing uncertainty for payers and providing more timely access for patients. The purpose of this qualitative study was to gauge industry stakeholder awareness of the initiative, and what changes within the scope or mandate of the program may make it more useful and accessible. METHODS: : Semi-structured interviews were conducted with representatives of pharmaceutical companies. Interviews were conducted by a consultant via telephone and written notes were sent back to each participant with instructions to review for accuracy and make modifications as necessary. Comments were aggregated into themes. RESULTS: : Among 26 companies contacted, 16 completed an interview. The interview sample consisted of 4 small companies (≤ 10,000 employees globally), 6 large US-based companies, and 6 large non-US-based companies. Two of the interviewees were global representatives. Most interviewees were aware of the CADTH Scientific Advice program. Major themes that emerged with regards to suggested improvements to the program included the following: expand the scope of the program to include advice after initiation of Phase III trials; provide advice on real-world evidence study designs; allow for disclosure of advice received at the time of submission for reimbursement review; provide quick access to smaller requests for advice; offer parallel advice with a regulator or with other HTA agencies. CONCLUSIONS: : The findings from this study will help inform improvements to the Scientific Advice program at CADTH. They may also inform other HTA agencies with similar existing programs as well as those developing Scientific Advice programs currently.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP244
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases