HBS Scholarly Articleshttps://nrs.harvard.edu/1/33459302024-03-19T01:24:07Z2024-03-19T01:24:07ZThe Impact Of Price Regulation On The Availability Of New Drugs In GermanyStern, ArielPietrulla, FelicitasHerr, AnnikaKesselheim, Aaron S.Sarpatwari, Ameethttps://nrs.harvard.edu/1/373778222024-03-07T17:28:01Z2019-07-01T04:00:00ZThe Impact Of Price Regulation On The Availability Of New Drugs In Germany
Stern, Ariel; Pietrulla, Felicitas; Herr, Annika; Kesselheim, Aaron S.; Sarpatwari, Ameet
The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate comparator,” and impact price negotiations beyond the first year on the market. Using data on drugs that entered the market from 2012 to 2016, we evaluated benefit assessment findings, subsequent drug exits, and their correlates. We considered 171 drug-indication pairs, corresponding to 138 different drugs. Of these, 66 drug-indication pairs (55 different drugs) were found to have any additional benefit. Almost all drugs with any positive benefit assessment (98%) remained on the market, while drugs without a positive benefit assessment were over ten times more likely to exit (25% vs. 2%). U.S. policymakers considering how to address rapidly increasing drug costs may draw valuable lessons from the German experience.
2019-07-01T04:00:00ZAdvancing Digital Health Applications: Priorities for Innovation in Real-World Evidence GenerationStern, ArielBrönneke, JanDebatin, Jörg FHagen, JuliaMatthies, HenrikPatel, SmitClay, IeuanEskofier, BjoernHerr, AnnikaHoeller, KurtJaksa, AshleyKramer, Daniel BKyhlstedt, MattiasLofgren, Katherine TMahendraratnam, NiroshaMuehlan, HolgerReif, SimonRiedemann, LarsGoldsack, Jennifer Chttps://nrs.harvard.edu/1/373778212024-03-07T17:12:31Z2022-03-01T05:00:00ZAdvancing Digital Health Applications: Priorities for Innovation in Real-World Evidence Generation
Stern, Ariel; Brönneke, Jan; Debatin, Jörg F; Hagen, Julia; Matthies, Henrik; Patel, Smit; Clay, Ieuan; Eskofier, Bjoern; Herr, Annika; Hoeller, Kurt; Jaksa, Ashley; Kramer, Daniel B; Kyhlstedt, Mattias; Lofgren, Katherine T; Mahendraratnam, Nirosha; Muehlan, Holger; Reif, Simon; Riedemann, Lars; Goldsack, Jennifer C
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a “Fast-Track” regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.
2022-03-01T05:00:00ZCybersecurity Features of Digital Medical Devices: An Analysis of FDA Product SummariesStern, ArielGordon, William JLandman, Adam BKramer, Daniel Bhttps://nrs.harvard.edu/1/373778202024-03-07T17:04:29Z2019-06-01T04:00:00ZCybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
Stern, Ariel; Gordon, William J; Landman, Adam B; Kramer, Daniel B
Objectives: To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices. Design: We analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information. Setting: The full set of regulated medical devices, approved over the years 2002–2016 included in the FDA’s 510(k) and premarket approval databases. Primary and secondary outcome measures: The primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas. Results: Among regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%. Conclusions: To ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.
2019-06-01T04:00:00ZWhy Is Dollar Debt Cheaper? Evidence from PeruGutierrez, BryanIvashina, VictoriaSalomao, Julianahttps://nrs.harvard.edu/1/373778192024-03-07T17:00:06Z2023-06-01T04:00:00ZWhy Is Dollar Debt Cheaper? Evidence from Peru
Gutierrez, Bryan; Ivashina, Victoria; Salomao, Juliana
In emerging markets, a significant share of corporate loans are denominated in dollars. Using novel data that enables us to see currency and the cost of credit, in addition to several other transaction-level characteristics, we re-examine the reasons behind dollar credit popularity. We find that a dollar-denominated loan has an interest rate that is 2% lower per year than a loan in Peruvian Soles. Expectations of exchange rate movements do not explain this difference. We show that this interest rate differential for lending rates is closely matched by the differential in the deposit market. Our results suggest that the preference for dollar loans is rooted on the local household preference for dollar savings and a banking sector that is closely matching its foreign assets and liabilities. We find that borrower competitive pressure increases the pass-through of this differential.
2023-06-01T04:00:00Z