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- All HBS Web (324)
- Faculty Publications (138)
Show Results For
- All HBS Web (324)
- Faculty Publications (138)
- July 2019
- Article
The Impact of Price Regulation on the Availability of New Drugs in Germany
By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari
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... View Details
Keywords: Regulation; Pharmaceuticals; Healthcare; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Germany
Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.
- August 2003 (Revised August 2024)
- Case
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
By: Regina E. Herzlinger and John McDonough
Many health care innovations appear successful; but fail. This is the first case in the Innovating Health Care course that investigates how to create successful health care innovations. It is part of the first module in the course. This module focuses on how to... View Details
Keywords: Three Pillars; Industry Analysis; Health Care and Treatment; Innovation and Invention; Innovation and Management; Medical Specialties; Health Industry
Herzlinger, Regina E., and John McDonough. "Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment." Harvard Business School Case 304-009, August 2003. (Revised August 2024.)
- 09 Feb 2024
- HBS Case
Slim Chance: Drugs Will Reshape the Weight Loss Industry, But Habit Change Might Be Elusive
what may at first blush appear to be an easier fix: new drugs such as Ozempic, Wegovy, and Mounjaro, says Harvard Business School Professor Regina E. Herzlinger, who has studied the American health care system for decades. Wegovy has been... View Details
- 11 Sep 2019
- Research & Ideas
Germany May Have the Answer for Reducing Drug Prices
to prove that a new medication’s benefits merit a higher price if cheaper, similar drugs are available. The process rewards companies whose drugs are more novel or help patients more, while forcing... View Details
- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling... View Details
Keywords: Pharmaceuticals; Drug Spending; Drug Pricing; Health Care and Treatment; Spending; Price; Markets; Cost Management; United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations... View Details
Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
- January 2009
- Teaching Note
Biocon: Launching a New Cancer Drug in India (TN)
By: Sunil Gupta and Das Narayandas
Teaching Note for [508026]. View Details
- 2008
- Case
Eli Lilly: Recreating Drug Discovery for the 21st Century
By: Rebecca Henderson and C. Reavis
- 2018
- Chapter
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new... View Details
Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
- 22 Feb 2021
- Working Paper Summaries
Private and Social Returns to R&D: Drug Development and Demographics
- November 2019
- Case
The Genesis Lab at Novartis
By: Amy C. Edmondson, Ranjay Gulati, Patrick J. Healy and Kerry Herman
Novartis' Genesis Labs program, launched in 2016 as part of Novartis Institutes for Biomedical Research (NIBR), hosted pitch competitions where teams of NIBR scientists proposed ideas to explore that aimed to revolutionize drug discovery. The goal was to break down... View Details
Keywords: Drug Discovery; Health Care and Treatment; Research and Development; Innovation and Invention; Programs; Management
Edmondson, Amy C., Ranjay Gulati, Patrick J. Healy, and Kerry Herman. "The Genesis Lab at Novartis." Harvard Business School Case 620-007, November 2019.
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded... View Details
Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- 04 Sep 2014
- News
Our focus was to get drug companies to invest money in ALS
prize to identify a treatment that leads to a 25 percent extension in survival rates. “After eight years, in which we have raised over $10 million,” says Kremer, who lives in his native Israel and communicates via Skype and adaptive... View Details
- April 2017
- Supplement
Imprimis (B)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A). It describes the company’s decision to enter into the pharmaceutical compounding business in 2013–2014. Imprimis purchased a compounded ophthalmological medication called Dropless Therapy, which was injected into patients’... View Details
Keywords: Healthcare; Drug Compounding; Drug Development; Pharmaceuticals; Small Business; Decision-making, Business Model; Mark Baum; Imprimis; Decision Making; Strategy; Health Care and Treatment; Policy; Pharmaceutical Industry; United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (B)." Harvard Business School Supplement 717-496, April 2017.
- October 2023
- Article
Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record
By: Anna D Sinaiko, Caroline E Sloan, Mark J Soto, Olivia Zhao, Chen-Tan Lin and Foster R Goss
Keywords: Prescription Drugs; Electronic Health Records; Physicians; Prescription Drug Costs; Health Care and Treatment; Price; Health Industry
Sinaiko, Anna D., Caroline E Sloan, Mark J Soto, Olivia Zhao, Chen-Tan Lin, and Foster R Goss. "Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record." JAMA Internal Medicine 183, no. 10 (October 2023): 1172–1175.
- Article
Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry
By: Leemore S. Dafny, Christopher Ody and Matt Schmitt
The analogy between value-based purchasing in pharmaceuticals and the new frontier of alternative payment models for health care providers is relatively straightforward. Insurers are increasingly demanding steep discounts from providers in exchange for inclusion in... View Details
Keywords: Drug Copayment Coupons; Prescription Drug Policy; Health Care and Treatment; Insurance; Cost; Policy; Pharmaceutical Industry
Dafny, Leemore S., Christopher Ody, and Matt Schmitt. "Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry." New England Journal of Medicine 375, no. 21 (November 24, 2016): 2013–2015.
- Article
Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study
By: Maryaline Catillon
Keywords: Biomedical Research; R＆D; Innovation; Technology; Drug Trials; RCT; Health; Healthcare; Health Care And Treatment; Health Care Policy; Innovation and Invention; Innovation Strategy; Research and Development; Technological Innovation; Health Industry; Pharmaceutical Industry
Catillon, Maryaline. "Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study." BMJ Open 9, no. 9 (September 2019).
- January 2018 (Revised January 2019)
- Case
ZappRx
By: Jeffrey J. Bussgang and Olivia Hull
In October 2015, ZappRx founder Zoe Barry is deciding between two business models for her health technology start-up. Her product, a software application that aims to expedite the prescription fulfillment process for patients with rare diseases, has attracted interest... View Details
- July 2021
- Article
Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance
By: Jon M. Jachimowicz, Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley and Adam D. Galinsky
Poor compliance of prescription medication is an ongoing public health crisis. Nearly half of patients do not take their medication as prescribed, harming their own health while also increasing public health care costs. Despite these detrimental consequences, prior... View Details
Keywords: Prescription Drugs; Medication Adherence; Personal Health Costs; Health; Behavior; Motivation and Incentives; Communication Strategy
Jachimowicz, Jon M., Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley, and Adam D. Galinsky. "Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance." Behavioural Public Policy 5, no. 3 (July 2021): 396–416.