HOW COMMON ARE DIGITAL WRAP-AROUND PRODUCT TIE-INS WITH FDA-APPROVED NEW MARKET ENTRANTS?

Author(s)

Navaratnam P1, Friedman H2, Navaratnam A2
1DataMed Solutions LLC., New York, NY, USA, 2Sygeny Ltd, Helsinki, Finland

OBJECTIVES: The objective of this study was to evaluate the extent by which the life sciences industry develops and promotes digital wrap-arounds that tie-in with new FDA-approved product introductions in order to optimize patient adherence, monitoring and health outcomes. METHODS: A review of recent novel product approvals in 2016 and the presence of digital wrap-arounds associated with these product introductions was conducted. We defined digital wrap-arounds as any digitally-based mechanism such as a web-enabled device, platform or mobile applications intended to improve patient outcomes, adherence, and treatment costs through enhanced monitoring, education, support and/or a feedback loop to providers. Literature review of scientific and medical literature; product package inserts; and lay media sources (Internet, trade journals, tech websites, etc.) were scrutinized to determine if there were any mentions of a digital wrap-around that was promoted concurrently with new product approvals. Key words and phrases using terms such as ‘digital’, ‘mobile’, ‘apps’, ‘connected devices’, ‘internet of things’, e-health’, ‘mobile health’, and ‘m-health’ along with generic names of the drugs was utilized in these searches. RESULTS: A total of 22 new and novel product approvals were identified from the FDA website (www.fda.gov). Based on the search strategy described above, we found that there were just two specifically designed digital wrap-arounds associated with these compounds; primarily educational mobile apps associated with product patient support programs. CONCLUSIONS: While there has been a lot of interest in ‘wrapping’ new therapeutic products with digitized tools to enhance outcomes, improve adherence and reduce costs; these efforts appear to be promising but largely unfulfilled.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHS105

Topic

Epidemiology & Public Health, Organizational Practices, Patient-Centered Research, Real World Data & Information Systems

Topic Subcategory

Academic & Educational, Health & Insurance Records Systems, Patient Behavior and Incentives, Public Health

Disease

Multiple Diseases

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