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    • All HBS Web  (347)
      • Faculty Publications  (45)

      Prescription Drug Policy Remove Prescription Drug Policy →

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      • 2022
      • Working Paper

      Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

      By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
      Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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      Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
      • October 2022
      • Case

      mPharma: Scaling Access to Affordable Primary Care in Africa

      By: Regina E. Herzlinger and Ben Creo
      mPharma CEO Greg Rockson is attempting to create the largest pan-African primary healthcare company. He must evaluate a three-year strategy potentially involving three key components: a rapid and extensive expansion of the company's network of 600 retail pharmacies in...  View Details
      Keywords: Africa; Pharmaceutical Companies; Pharmacy Benefit Manager; Health Care; Health Care And Treatment; Health Care Costs; Health Care Delivery; Health Care Entrepreneurship; Telehealth; Health Equity; Corporate Strategy; Social Entrepreneurship; Equity; Growth and Development Strategy; Expansion; Product Launch; Customer Value and Value Chain; Social Enterprise; Multinational Firms and Management; Pharmaceutical Industry; Health Industry; Africa
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      Herzlinger, Regina E., and Ben Creo. "mPharma: Scaling Access to Affordable Primary Care in Africa." Harvard Business School Case 323-033, October 2022.
      • 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
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      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).
      • 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...  View Details
      Keywords: Prescription Drugs; Coupons; Impact; Health Care and Treatment; Markets; Price; Spending; Pharmaceutical Industry; United States
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      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

      A Prescriptive Analytics Framework for Optimal Policy Deployment Using Heterogeneous Treatment Effects

      By: Edward McFowland III, Sandeep Gangarapu, Ravi Bapna and Tianshu Sun
      We define a prescriptive analytics framework that addresses the needs of a constrained decision-maker facing, ex ante, unknown costs and benefits of multiple policy levers. The framework is general in nature and can be deployed in any utility maximizing context, public...  View Details
      Keywords: Prescriptive Analytics; Heterogeneous Treatment Effects; Optimization; Observed Rank Utility Condition (OUR); Between-treatment Heterogeneity; Machine Learning; Decision Making; Analysis; Mathematical Methods
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      McFowland III, Edward, Sandeep Gangarapu, Ravi Bapna, and Tianshu Sun. "A Prescriptive Analytics Framework for Optimal Policy Deployment Using Heterogeneous Treatment Effects." MIS Quarterly 45, no. 4 (December 2021): 1807–1832.
      • 2021
      • Working Paper

      Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?

      By: Eric Barrette, Leemore S. Dafny and Karen Shen
      As of 2016 there were an estimated 2.1 million Americans suffering from opioid use disorder (OUD). To date, most policy interventions have focused on curbing opioid prescriptions and extending insurance coverage to include substance use disorder. However, relatively...  View Details
      Keywords: Opioid Treatment; Medication-assisted Treatment; Substance Use Disorder; Private Insurance; Health Care and Treatment; Health Disorders; Insurance; United States
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      Barrette, Eric, Leemore S. Dafny, and Karen Shen. "Do Policies to Increase Access to Treatment for Opioid Use Disorder Work?" NBER Working Paper Series, No. 29001, July 2021.
      • 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
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      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.
      • 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
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      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...  View Details
      Keywords: Cost-sharing; Impact; Health Care and Treatment; Insurance; Health; Consumer Behavior
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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 (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...  View Details
      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
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      Roscini, Dante, and John Masko. "Hester Pharmaceuticals (A): A Pricing Dilemma." Harvard Business School Case 721-001, January 2021. (Revised June 2021.)
      • January 2021
      • Case

      mPharma (A)

      By: Rembrand Koning, John D. Macomber, Pippa Tubman Armerding and Wale Lawal
      mPharma pioneered electronic prescriptions in Ghana, and aimed to increase drug affordability and accessibility in Africa, but the company remained unprofitable. Following investor concerns about mPharma's business, CEO Gregory Rockson considered alternative business...  View Details
      Keywords: Strategy; Entrepreneurship; Acquisition; Health; Business Model; Health Industry; Technology Industry; Ghana
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      Koning, Rembrand, John D. Macomber, Pippa Tubman Armerding, and Wale Lawal. "mPharma (A)." Harvard Business School Case 721-428, January 2021.
      • January 2021
      • Supplement

      mPharma (B)

      By: Rembrand Koning, John D. Macomber, Pippa Tubman Armerding and Wale Lawal
      mPharma pioneered electronic prescriptions in Ghana, and aimed to increase drug affordability and accessibility in Africa, but the company remained unprofitable. Following investor concerns about mPharma's business, CEO Gregory Rockson considered alternative business...  View Details
      Keywords: Strategy; Health; Entrepreneurship; Business Model; Health Industry; Technology Industry; Ghana
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      Koning, Rembrand, John D. Macomber, Pippa Tubman Armerding, and Wale Lawal. "mPharma (B)." Harvard Business School Supplement 721-429, January 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...  View Details
      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
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      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.
      • Article

      Treatment Of Opioid Use Disorder Among Commercially Insured U.S. Adults, 2008–17

      By: Karen Shen, Eric Barrette and Leemore S. Dafny
      There is abundant literature on efforts to reduce opioid prescriptions and misuse, but comparatively little on the treatment provided to people with opioid use disorder (OUD). Using claims data representing 12–15 million nonelderly adults covered through commercial...  View Details
      Keywords: Opioid Treatment; Medication-assisted Treatment; Substance Use Disorder; Private Insurance; Health Disorders; Health Care and Treatment; Insurance; United States
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      Shen, Karen, Eric Barrette, and Leemore S. Dafny. "Treatment Of Opioid Use Disorder Among Commercially Insured U.S. Adults, 2008–17." Health Affairs 39, no. 6 (June 2020): 993–1001.
      • 2020
      • Discussion Paper

      Acting Now While Preparing for Tomorrow: Competitiveness Upgrading Under the Shadow of COVID-19

      By: Christian H.M. Ketels and Peter Clinch
      This paper aims to provide policy makers, especially those focused on the longer-term growth potential of their countries, with an initial framework to think about their action priorities in the context of the overall COVID-19 response. Our focus is on the...  View Details
      Keywords: Competitiveness; COVID-19 Pandemic; Competition; Government Administration; Health Pandemics; Economy; Supply Chain; Safety
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      Ketels, Christian H.M., and Peter Clinch. "Acting Now While Preparing for Tomorrow: Competitiveness Upgrading Under the Shadow of COVID-19." Discussion Paper, Institute for Strategy and Competitiveness, Boston, MA, US, 2020.
      • 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,...  View Details
      Keywords: Pharmaceuticals; Rebates; Health Care and Treatment; Markets; Price; Analysis; Pharmaceutical Industry
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      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.
      • 2019
      • Book

      Love Your Enemies: How Decent People Can Save America from the Culture of Contempt

      By: Arthur C. Brooks
      To get ahead today, you have to be a jerk, right?

      Divisive politicians. Screaming heads on television. Angry campus activists. Twitter trolls. Today in America, there is an “outrage industrial complex” that prospers by setting American against...  View Details
      Keywords: Political Participation; Political Culture; Moral Sensibility; Government and Politics; Society; United States
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      Brooks, Arthur C. Love Your Enemies: How Decent People Can Save America from the Culture of Contempt. New York: Broadside Books, 2019. (National bestseller.)
      • February 14, 2019
      • Other Article

      We Should Treat Algorithms like Prescription Drugs

      By: Andy Coravos, Irene Chen, Ankit Gordhandas and Ariel Dora Stern
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      Coravos, Andy, Irene Chen, Ankit Gordhandas, and Ariel Dora Stern. "We Should Treat Algorithms like Prescription Drugs." Quartz (February 14, 2019).
      • 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...  View Details
      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
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      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.
      • January 2018
      • Supplement

      BeiGene Supplemental PowerPoint

      By: Willy C. Shih and Jimmy Zhang
      BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window...  View Details
      Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; Biotechnology Industry; China
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      Shih, Willy C., and Jimmy Zhang. "BeiGene Supplemental PowerPoint." Harvard Business School PowerPoint Supplement 618-043, January 2018.
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