GLOBAL VALUE DOSSIERS (GVDS)- HOW TO ENSURE THE VALUE ISN’T LOST IN TRANSLATION
Author(s)
Sarnes E, Shields K, Kaufman S, Meyer KL
Xcenda, LLC, Palm Harbor, FL, USA
Presentation Documents
OBJECTIVES: While GVDs are considered a critical component of a new product’s global market access/reimbursement plan, anecdotal evidence suggests variability across organizations in perceptions of purpose and utility. METHODS: A web-based survey was fielded to global and regional employees of pharmaceutical manufacturers with responsibility in developing and/or executing market access strategy for new products. RESULTS: A total of 42 industry employees participated in the survey; regions represented included Europe, North America, and Asia-Pacific. The perceived primary purposes of a GVD were to assist in preparing local health technology assessment (HTA) submissions and/or provide comprehensive disease state and product review (73%); 20% felt the primary purpose was to highlight product value. However, only 50% of respondents indicated that the GVD adequately addressed their purposes. Only 23 of 36 respondents who have developed a local HTA submission reported having a GVD “the last time” they prepared/reviewed a local HTA submission, and only 31% (n=7/23) felt the GVD provided value. Greatest barriers to use were lack of relevancy to country/region (57%), lack of comprehensive content (39%), language (English) (35%), and cumbersome format (30%). Of elements commonly included in GVDs, those most important for local HTA submissions were clinical efficacy (95%), epidemiology (87%), unmet needs (87%), and product description (76%). In comparison, cost-effectiveness (21%) and budget impact (11%) were deemed the least important. Utility of these sections is likely driven by specific country HTA/reimbursement schema, although the sample size was too small to draw meaningful conclusions. Most respondents indicated the most useful time to have a GVD was 6-12 months pre-approval (65%); 20% would prefer earlier (2+ years pre-approval). CONCLUSIONS: One of the greatest challenges with GVDs is balancing comprehensiveness with specificity. Opportunity for improvement remains in the timely provision of valuable data to affiliates responsible for local HTA submissions.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PHP95
Topic
Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Formulary Development, Health Care Research
Disease
Multiple Diseases