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- March 2024
- Article
Medicare Price Negotiation and Pharmaceutical Innovation Following the Inflation Reduction Act
By: Matthew Vogel, Pragya Kakani, Amitabh Chandra and Rena M. Conti
The Inflation Reduction Act (IRA) requires Medicare to negotiate lower prices for some medicines with high Medicare spending. Using historical data from public and proprietary sources to apply the IRA's negotiation criteria retrospectively, we identify all drugs that...
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Keywords:
Policy;
Government Legislation;
Health Care and Treatment;
Negotiation;
Price;
Pharmaceutical Industry
Vogel, Matthew, Pragya Kakani, Amitabh Chandra, and Rena M. Conti. "Medicare Price Negotiation and Pharmaceutical Innovation Following the Inflation Reduction Act." Nature Biotechnology 42, no. 3 (March 2024): 406–412.
- January 2024
- Article
Cost of Exempting Sole Orphan Drugs from Medicare Negotiation
By: Matthew Vogel, Olivia Zhao, William B. Feldman, Amitabh Chandra, Aaron S. Kesselheim and Benjamin N. Rome
Importance: The Inflation Reduction Act (IRA) requires Medicare to negotiate prices for some high-spending drugs but exempts drugs approved solely for the treatment of a single rare disease.
Objective: To estimate Medicare spending and global... View Details
Objective: To estimate Medicare spending and global... View Details
Vogel, Matthew, Olivia Zhao, William B. Feldman, Amitabh Chandra, Aaron S. Kesselheim, and Benjamin N. Rome. "Cost of Exempting Sole Orphan Drugs from Medicare Negotiation." JAMA Internal Medicine 184, no. 1 (January 2024): 63–69.
- 2023
- Article
Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation
By: Jan B. Brönneke, Annika Herr, Simon Reif and Ariel D. Stern
Germany’s 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the health care delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital...
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Keywords:
Digital Transformation;
Applications and Software;
Product Development;
Insurance;
Policy;
Health Industry;
Germany
Brönneke, Jan B., Annika Herr, Simon Reif, and Ariel D. Stern. "Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation." International Journal of Technology Assessment in Health Care 39, no. 1 (2023).
- October 2023
- Article
What Does the Inflation Reduction Act Mean for Patients and Physicians?
By: Amitabh Chandra and Benedic Ippolito
The debate around prescription drug measures in the recently passed U.S. Inflation Reduction Act (IRA), which limit some patients’ out-of-pocket costs, has not fully addressed their effect on physicians and patients via their effect on payers. Reducing patients’ costs...
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Chandra, Amitabh, and Benedic Ippolito. "What Does the Inflation Reduction Act Mean for Patients and Physicians?" NEJM Catalyst Innovations in Care Delivery 4, no. 10 (October 2023).
- December 2022
- Article
The Contribution of Price Growth to Pharmaceutical Revenue Growth in the United States: Evidence from Medicines Sold in Retail Pharmacies
By: Pragya Kakani, Michael Chernew and Amitabh Chandra
Context: To what extent does pharmaceutical revenue growth depend on new medicines versus increasing prices for existing medicines? Moreover, does using list prices, as is commonly done, instead of prices net of confidential rebates offered by manufacturers, which are...
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Kakani, Pragya, Michael Chernew, and Amitabh Chandra. "The Contribution of Price Growth to Pharmaceutical Revenue Growth in the United States: Evidence from Medicines Sold in Retail Pharmacies." Journal of Health Politics, Policy and Law 47, no. 6 (December 2022): 629–648.
- October 2022
- Case
Cost Plus Drugs
By: Alexander MacKay and James Barnett
In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....
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Keywords:
Business Ventures;
Decision Making;
Entrepreneurship;
Ethics;
Health;
Markets;
Social Enterprise;
Society;
Strategy;
Health Care and Treatment;
Business Divisions;
Factories, Labs, and Plants;
Health Industry;
Pharmaceutical Industry;
United States;
Texas
MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial...
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Keywords:
Market Entry and Exit;
Price;
Market Timing;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States;
Germany
Blankart, Katharina, Huseyin Naci, and Amitabh Chandra. "Availability of New Medicines in the U.S. and Germany From 2004 to 2018." e2229231. JAMA Network Open 5, no. 8 (August 2022).
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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Keywords:
Biosimilars;
Rebates;
Pharmaceuticals;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- 2022
- Working Paper
How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?
By: Leemore S. Dafny, Kate Ho and Edward Kong
Drug copayment coupons to reduce patient cost-sharing have become nearly ubiquitous for high-priced brand-name prescription drugs. Medicare bans such coupons on the grounds that they are kickbacks that induce utilization, but they are commonly used by...
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Keywords:
Prescription Drugs;
Coupons;
Impact;
Health Care and Treatment;
Markets;
Price;
Spending;
Pharmaceutical Industry;
United States
Dafny, Leemore S., Kate Ho, and Edward Kong. "How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?" NBER Working Paper Series, No. 29735, February 2022.
- 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...
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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.
- 2021
- Working Paper
The Health Costs of Cost-Sharing
By: Amitabh Chandra, Evan Flack and Ziad Obermeyer
We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in...
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Chandra, Amitabh, Evan Flack, and Ziad Obermeyer. "The Health Costs of Cost-Sharing." NBER Working Paper Series, No. 28439, February 2021.
- January 2021
- Case
Value-Based Insurance Design at Onex
By: Joshua Schwartzstein, Amitabh Chandra and Amram Migdal
The operating executives of Health and Benefits for Onex Partners, Megan Jackson Frye and Sam Camens, faced a challenge: Healthcare costs for employees of Onex’s portfolio companies were continuing to rise above the consumer price index, reflecting broader trends...
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Keywords:
Decision Making;
Cost vs Benefits;
Decision Choices and Conditions;
Decisions;
Finance;
Behavioral Finance;
Insurance;
Health;
Health Care and Treatment;
Human Resources;
Compensation and Benefits;
Markets;
Demand and Consumers;
Consumer Behavior;
Social Psychology;
Behavior;
Interests;
Motivation and Incentives;
Perception;
Health Industry;
Insurance Industry;
North America;
United States
Schwartzstein, Joshua, Amitabh Chandra, and Amram Migdal. "Value-Based Insurance Design at Onex." Harvard Business School Case 921-023, January 2021.
- January 2021 (Revised June 2021)
- Case
Hester Pharmaceuticals (A): A Pricing Dilemma
By: Dante Roscini and John Masko
In August 2019, the leadership of Hester Pharmaceuticals (Hester) had a problem. Italy promised to be a key market for their new breakthrough oncology drug Akrozumab, but for almost two years, its single-payer healthcare system had been unable to agree with Hester on a...
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Keywords:
Macroeconomics;
Trade;
Price;
Global Range;
Global Strategy;
Globalized Markets and Industries;
Health Care and Treatment;
Patents;
Monopoly;
Negotiation;
Business and Government Relations;
Risk and Uncertainty;
Human Needs;
Business Strategy;
Commercialization;
Pharmaceutical Industry;
Italy
Roscini, Dante, and John Masko. "Hester Pharmaceuticals (A): A Pricing Dilemma." Harvard Business School Case 721-001, January 2021. (Revised June 2021.)
- July 2020
- Article
Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
By: Victoria D. Lauenroth, Aaron S. Kesselheim, Ameet Sarpatwari and Ariel Dora Stern
Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the U.S., it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been...
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Keywords:
Pharmaceuticals;
Prescription Drug Costs;
Drug Pricing;
Access To Care;
Cost Reduction;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Cost Management;
Germany
Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel Dora Stern. "Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany." Health Affairs 39, no. 7 (July 2020): 1185–1193.
- Working Paper
Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S.
By: Pragya Kakani, Michael Chernew and Amitabh Chandra
Rising list prices are often used to illustrate the burden of prescription drug spending, but payers routinely negotiate rebates from manufacturers that generate differences between list and net prices. List prices are easily available and affect patient cost-sharing,...
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Keywords:
Pharmaceuticals;
Rebates;
Health Care and Treatment;
Markets;
Price;
Analysis;
Pharmaceutical Industry
Kakani, Pragya, Michael Chernew, and Amitabh Chandra. "Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S." NBER Working Paper Series, No. 26846, March 2020.
- 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...
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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.
- 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...
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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.
- August 2018
- Article
The Impact of the Entry of Biosimilars: Evidence from Europe
By: Fiona M. Scott Morton, Ariel Dora Stern and Scott Stern
Biologics represent a substantial and growing share of the U.S. drug market. Traditional “small molecule” generics quickly erode the price and share of the branded product upon entry; however, only a few biosimilars have been approved in the U.S. since 2015, thereby...
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Keywords:
Health Care;
Biosimilars;
Biologics;
Pharmaceutical Competition;
Healthcare Spending;
Innovation;
Health Care and Treatment;
Spending;
Market Entry and Exit;
Competition;
Innovation and Invention;
Pharmaceutical Industry;
United States;
Europe
Scott Morton, Fiona M., Ariel Dora Stern, and Scott Stern. "The Impact of the Entry of Biosimilars: Evidence from Europe." Review of Industrial Organization 53, no. 1 (August 2018): 173–210.
- April 2017
- Supplement
Imprimis (C)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A & B). Set in 2015, it first describes Imprimis’s decision to introduce its own line of compounded eye drop medication called LessDrops. The case then examines the moral dilemma faced by CEO Mark Baum, who was struck by the...
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Keywords:
Health Care and Treatment;
Cost;
Moral Sensibility;
Competitive Strategy;
Decision Choices and Conditions;
Pharmaceutical Industry;
United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (C)." Harvard Business School Supplement 717-497, April 2017.
- April 2017
- Supplement
Imprimis (D)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A, B, & C). It describes Imprimis’s 2015 decision to develop a $1 per pill compounded alternative to Daraprim, the branded drug that had recently undergone an extreme price hike, raising its price to $750 per pill. Imprimis also...
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Keywords:
Decision Choices and Conditions;
Growth and Development Strategy;
Pharmaceutical Industry;
United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (D)." Harvard Business School Supplement 717-498, April 2017.