Medicare price negotiation and pharmaceutical innovation following the Inflation Reduction Act

References

Plaintiff’s motion for summary judgment. Merck & Co., Inc., v. Xavier Becerra et al. US District Court for the District of Columbia (11 July 2023).

Duehren, A., Wise, L. & Rubin, R. Democrats reach deal on lowering prescription drug prices. Wall Street Journal (2 November 2021).

Pharmaceutical Research and Manufacturers of America. ICYMI: a Patient, Physician, Biotech Investor and Industry Leaders Warn About the Dangers of Government Price Setting Bill https://catalyst.phrma.org/icymi-a-patient-physician-biotech-investor-and-industry-leaders-warn-about-the-dangers-of-government-price-setting-bill (2022).

Biotechnology Innovation Organization. New Drug Pricing Bill Could Propel Us Light Years Back into the Dark Ages of Biomedical Research https://www.bio.org/press-release/new-drug-pricing-deal-could-propel-us-light-years-back-dark-ages-biomedical-research (2022).

Kolchinsky, P. et al. Healthcare Investors Make a Case for a Simple Fix: Parity of ‘Negotiation’ for All Drugs at 13 Years https://nopatientleftbehind.docsend.com/view/e4cg7sgj6js5qenr (2022).

Buxbaum, J., Chernew, M., Fendrick, A. & Cutler, D. Contributions of public health, pharmaceuticals, and other medical care to US life expectancy changes, 1990–2015. Health Aff.39, 1546–1556 (2020).

Article 

Google Scholar 

Cutlerc, D., Rosen, A. & Vijan, S. The value of medical spending in the United States, 1960–2000. N. Engl. J. Med.355, 920–927 (2006).

United States Government Accountability Office. Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals. GAO-18-40 https://www.gao.gov/products/gao-18-40 (2017).

Dusetzina, S., Huskamp, H., Qin, X. & Keating, N. Prescription drug spending in fee-for-service Medicare, 2008–2019. JAMA328, 1515–1522 (2022).

Article 
PubMed 
PubMed Central 

Google Scholar 

Congressional Budget Office. Estimated Budgetary Effects of Public Law 117-169 https://www.cbo.gov/system/files/2022-09/PL117-169_9-7-22.pdf (2022).

Congressional Budget Office. CBO’s Model of New Drug Development https://www.cbo.gov/publication/57450 (2022).

Philipson, T. & Durie, T. Issue Brief: the Impact of HR 5376 on Biopharmaceutical Innovation and Patient Health https://cpb-us-w2.wpmucdn.com/voices.uchicago.edu/dist/d/3128/files/2021/08/Issue-Brief-Drug-Pricing-in-HR-5376-11.30.pdf (2021).

Gassull, D., Bowen, H., & Schulthess, D. IRA’s Impact on the US Biopharma Ecosystem https://vitaltransformation.com/2023/05/iras-impact-on-the-us-biopharma-ecosystem (2023).

Dickson, S. & Hernandez, I. Drugs likely subject to Medicare negotiation, 2026–2028. J. Manag. Care Spec. Pharm.29, 229–235 (2023).

PubMed 

Google Scholar 

Rome, B. et al. Simulated Medicare drug price negotiation under the Inflation Reduction Act of 2022. JAMA Health Forum4, e225218 (2023).

Article 
PubMed 

Google Scholar 

Reitsma, M. et al. Examining opportunities to increase savings from Medicare price negotiations. JAMA Intern. Med.183, 581–588 (2023).

Article 
PubMed 

Google Scholar 

Schuhmacher, A. et al. The significance of blockbusters in the pharmaceutical industry. Nat. Rev. Drug Discov.22, 177–178 (2023).

Article 
CAS 
PubMed 

Google Scholar 

Evaluate Pharma. World Preview 2022, Outlook to 2028: Patents and Pricing https://info.evaluate.com/rs/607-YGS-364/images/2022%20World%20Preview%20Report.pdf (2022).

Hernandez, I., San-Juan-Rodriguez, A., Good, C. & Gellad, W. Changes in list prices, net prices, and discounts for branded drugs in the US, 2007–2018. JAMA323, 854–862 (2020).

Article 
PubMed 
PubMed Central 

Google Scholar 

Brown, A. The Patent Winter is Coming https://www.evaluate.com/vantage/articles/insights/other-data/patent-winter-coming (2022).

Dixit, R. & David, F. Market watch: trends in pharmaceutical company R&D spending: 2005–2015. Nat. Rev. Drug Discov.16, 376 (2017).

Article 
CAS 
PubMed 

Google Scholar 

Elmhirst, E. COVID Drives a Record Jump in Research Spending for Big Pharma https://www.evaluate.com/node/17806/pdf (2022).

Joint Committee on Taxation. Memorandum: Analysis of Large Pharmaceutical Corporation Tax Data https://www.finance.senate.gov/imo/media/doc/JCT%20-%20pharma%20tax%20data%205.4.23.pdf (2023).

Krieger, J., Li, X. & Thakor, R. Find and Replace: R&D Investment Following the Erosion of Existing Products Working Paper 19-058 (Harvard Business School, 2021).

Ringel, M. What is the right amount to spend on biopharma R&D? Nat. Rev. Drug Discov.16, 597–598 (2017).

Article 
CAS 
PubMed 

Google Scholar 

Yin, W. Market incentives and pharmaceutical innovation. J. Health Econ.27, 1060–1077 (2008).

Article 
PubMed 

Google Scholar 

Blume-Kohout, M. & Sood, N. Market size and innovation: effects of Medicare Part D on pharmaceutical research and development. J. Public Econ.97, 327–336 (2013).

Article 
PubMed 
PubMed Central 

Google Scholar 

Agha, L., Kim, S., & Li, D. Insurance design and pharmaceutical innovation. Am. Econ. Rev. Insights4, 191–208 (2022).

Branstetter, L., Chatterjee, C., & Higgins, M. Generic Competition and the Incentives for Early-Stage Pharmaceutical Innovation Working Paper 20532 https://www.nber.org/system/files/working_papers/w20532/w20532.pdf (NBER, 2022).

Vogel, M., Kesselheim, A., Feldman, W. & Rome, B. Will Medicare price negotiation delay cancer-drug launches? N. Engl. J. Med.389, 1546–1548 (2023).

Article 
PubMed 

Google Scholar 

Congressional Budget Office. How CBO Estimated the Budgetary Impact of Key Prescription Drug Provisions in the 2022 Reconciliation Act https://www.cbo.gov/system/files/2023-02/58850-IRA-Drug-Provs.pdf (2023).

Frank, R., McGuire, T. & Nason, I. The evolution of supply and demand in markets for generic drugs. Milbank Q.99, 828–852 (2021).

Article 
PubMed 
PubMed Central 

Google Scholar 

Vogel, M. et al. Cost of exempting sole orphan drugs from Medicare negotiation. JAMA Intern. Med.184, 63–69 (2024).

Article 
PubMed 

Google Scholar 

Abbott, T. & Vernon, J. The cost of US pharmaceutical price regulation: a financial simulation model of R&D decisions. Manage. Decis. Econ.28, 293–306 (2007).

Article 

Google Scholar 

Kerr, W. & Nanda, R. Financing innovation. Annu. Rev. Financ. Econ.7, 445–462 (2015).

Article 

Google Scholar 

Fougner, C. et al. Herding in the drug development pipeline. Nat. Rev. Drug Discov.22, 617–618 (2023).

Article 
CAS 
PubMed 

Google Scholar 

Bloom, N., Schankerman, M. & Van Reenen, J. Identifying technology spillovers and product market rivalry. Econometrica81, 1347–1393 (2013).

Article 

Google Scholar 

Dranove, D., Garthwaite, C. & Hermosilla, M. Does consumer demand ‘pull’ scientifically novel drug innovation? Rand J. Econ.53, 590–638 (2022).

Byrski, D., Gaessler, F. & Higgins, M. Market Size and Research: Evidence from the Pharmaceutical Industry Working Paper 28858 https://www.nber.org/system/files/working_papers/w28858/w28858.pdf (National Bureau of Economics Research, 2021).

Frank, R., Conti, R. & Gruber, J. International reference pricing in the context of US drug policy. J. Health Polit. Policy Law47, 779–796 (2022).

Article 
PubMed 

Google Scholar 

Conti, R., Frank, R. & Nichols, L. How do commercial insurance plans fare under proposed prescription drug price regulation? JAMA Health Forum2, e214242 (2021).

Article 
PubMed 

Google Scholar 

Adler, L. Cost-Shifting in Drug Pricing, or the Lack Thereof https://www.brookings.edu/articles/cost-shifting-in-drug-pricing-or-the-lack-thereof (2021).

Clemens, J. & Gottlieb, J. In the shadow of a giant: Medicare’s influence on private physician payments. J. Polit. Econ.125, 1–39 (2017).

Article 
PubMed 

Google Scholar 

Dusetzina, S., Keating, N., Huskamp, H. & Mello, M. Medicare’s plan for drug-price negotiation: the importance of defining generic entry. N. Engl. J. Med.389, 97–100 (2023).

Article 
PubMed 

Google Scholar 

Rome, B., Egilman, A. & Kesselheim, A. Trends in prescription drug launch prices, 2008–2021. JAMA327, 2145–2147 (2022).

Article 
PubMed 
PubMed Central 

Google Scholar 

Congressional Budget Office. Re: Additional Information About Drug Price Negotiation. https://www.cbo.gov/system/files/2023-12/59792-Letter.pdf (2023).

Cha, M., Rifai, B. & Sarraf, P. Pharmaceutical forecasting: throwing darts? Nat. Rev. Drug Discov.12, 737–738 (2013).

Article 
CAS 
PubMed 

Google Scholar 

DiMasi, J., Grabowski, H. & Hansen, R. Innovation in the pharmaceutical industry: new estimates of R&D costs. J. Health Econ.47, 20–33 (2016).

Article 
PubMed 

Google Scholar 

Wouters, O., McKee, M. & Luyten, J. Estimated research and development investment needed to bring a new medicine to market, 2009–2018. JAMA323, 844–853 (2020).

Article 
PubMed 
PubMed Central 

Google Scholar 

Frank, R. & Zeckhauser, R. Excess Prices for Drugs in Medicare: Diagnosis and Prescription Working Paper RWP18-005 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3116330 (Harvard Kennedy School, 2018).

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