A novel perspective on pharmaceutical R&D costs: opportunities for reductions

References

• Wouters OJ, McKee M, Luyten J. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009–2018. JAMA Network Open. 2020. DOI:10.1001/jama.2020.1166.
   Google Scholar
• Prasad V, Mailankody S. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med. 2017;177(11):1569–1575.
   PubMed Web of Science ®Google Scholar
• DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20–33.
   PubMed Web of Science ®Google Scholar
• Jacobs J, Livestro D, Oosterwaal M; The Cost of Opportunity - A Study on Pharmaceutical R&D Costs.; 2019. https://gupta-strategists.nl/studies/the-cost-of-opportunity.
   Google Scholar
• Hadjivasiliou A, Gardner J Orphan Drug Report.; 2014. http://info.evaluategroup.com/rs/evaluatepharmaltd/images/2014OD.pdf.
   Google Scholar
• Pomeranz K, Urquhart L. Orphan Drug Report 2019.; 2019. www.evaluate.com/OrphanDrug2019.
   Google Scholar
• The Global Use of Medicine in 2019 and Outlook to 2023.; 2019. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf?_=1572797697886%0Ahttps://www.iqvia.com/institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to–2023.
   Google Scholar
• Cohen D. Cancer drugs: high price, uncertain value. Br Med J. 2017October;359:1–4.
   Google Scholar
• Peter G. Peterson Foundation. Why are prescription drug prices rising and how do they affect the U.S. fiscal outlook? https://www.pgpf.org/blog/2019/11/why-are-prescription-drug-prices-rising-and-how-do-they-affect-the-us-fiscal-outlook. Published 2019. 2021 Jun 10.
   Google Scholar
• Godman B, Hill A, Simoens S, et al. Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications. Expert Rev Pharmacoeconomics Outcomes Res. 2021;1–14. 10.1080/14737167.2021.1884546.
   Web of Science ®Google Scholar
• Anderson-Cook A, Maeda J, Nelson L. Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid: an In-Depth Analysis. Congressional Budget Office. 2019;Vol. 02. March. 1–10. www.cbo.gov/publication/55011http://go.usa.gov/xUzd7
   Google Scholar
• Luzzatto L, Hyry HI, Schieppati A, et al. Outrageous prices of orphan drugs: a call for collaboration. Lancet. 2018;392(10149):791–794.
   PubMed Web of Science ®Google Scholar
• Lee M, Ly H, Möller CC, et al. Innovation in regulatory science is meeting evolution of clinical evidence generation. Clin Pharmacol Ther. 2019;105(4):886–898.
   PubMed Web of Science ®Google Scholar
• Berdud M, Drummond M, Towse A. Establishing a reasonable price for an orphan drug. Cost Eff Resour Alloc. 2020;18(1):1–18.
   PubMed Web of Science ®Google Scholar
• Uyl-De Groot CA, Löwenberg B. Sustainability and affordability of cancer drugs: a novel pricing model. Nat Rev Clin Oncol. 2018;15(7):405–406.
   PubMed Web of Science ®Google Scholar
• Defining Value in “Value-Based Healthcare.”; 2019. 10.2875/35471.
   Google Scholar
• Danzon P, Towse A, Mestre-Ferrandiz J. Value-based differential pricing: efficient prices for drugs in a global context. Health Econ. 2015;24(3):294–301.
   PubMed Web of Science ®Google Scholar
• Godman B, Bucsics A, Bonanno PV, et al. Barriers for access to new medicines: searching for the balance between rising costs and limited budgets. Front Public Health. 2018DEC;6:1–21.
   PubMed Web of Science ®Google Scholar
• International Association of Mutual Benefit Societies. A European Drug Pricing Model for Fair and Transparent Prices. 2019;47(June):1–8. https://www.aim-mutual.org/mediaroom/aim-presents-its-model-for-fair-and-transparent-prices-for-pharmaceuticals/.
   Google Scholar
• Zorginstituut Nederland (ZIN). Overzicht patentverloop dure geneesmiddelen. 2020:1–2. https://www.horizonscangeneesmiddelen.nl/nieuws/patentverloop-feb–2020
   Google Scholar
• Brigden G The 3P Project: Accelerating Innovation and Access to TB Medications.; 2017. https://bc.lung.ca/sites/default/files/5-Brigden-The3PProject-AcceleratingInnovationandAccesstoTBMedications.pdf.
   Google Scholar
• Hooker L, Palumbo D. Covid vaccines: will drug companies make bumper profits? BBC Business. https://www.bbc.com/news/business-55170756. Published 2020. Accessed. 2021
   Google Scholar
• Evaluate Pharma. https://www.evaluate.com/.
   Google Scholar
• Medicines: Fair pricing forum. World Health Organisation. https://www.who.int/news-room/q-a-detail/medicines-fair-pricing-forum. Published 2019. 2021 Jun 18.
   Google Scholar
• Workman P, Draetta GF, Schellens JHM, et al. How Much Longer Will We Put Up With 100,000 Cancer Drugs? Cell. 2017;168(4):579–583.
   PubMed Web of Science ®Google Scholar
• Low E, Bountra C, Hwa Lee W. Accelerating target discovery using pre-competitive open science— patients need faster innovation more than anyone else. E Cancer Med Sci. 2016;10:3–6.
   Google Scholar
• Mcgeary M, Hanna KE. Strategies to Leverage Research Funding: guiding DOD’s Peer Reviewed Medical Research Programs Committee on Alternative Funding Strategies for DOD’s Peer Reviewed Medical Research Programs. Vol. 6. 2004;http://www.nap.edu/catalog/11089.html
   Google Scholar
• Wizemann T, Robinson S, Giffin R. Forum on Drug Discovery, Development, and Translation Board on Health Sciences Policy.; 2020. https://www.nap.edu/download/12219#.
   Google Scholar
• Miron-Shatz T, Shatz I, Becker S, et al. Promoting business and entrepreneurial awareness in health care professionals: lessons from venture capital panels at medicine 2.0 conferences. J Med Internet Res. 2014;16(8):e184.
   PubMed Web of Science ®Google Scholar
• Pontes C, Zara C, Torrent-Farnell J, et al. Time to Review Authorisation and Funding for New Cancer Medicines in Europe? Inferences from the Case of Olaratumab. Appl Health Econ Health Policy. 2020;18(1):5–16.
   PubMed Web of Science ®Google Scholar
• Suleman F, Low M, Moon S, et al. New business models for research and development with affordability requirements are needed to achieve fair pricing of medicines. BMJ. 2020;368:10–12.
   Google Scholar
• Connolly MP, Kotsopoulos N, Ustianowski A. Modeling the fiscal costs and benefits of alternative treatment strategies in the United Kingdom for chronic hepatitis C. J Med Econ. 2018;21(1):19–26.
   PubMed Web of Science ®Google Scholar
• Smietana K, Siatkowski M, Møller M. Trends in clinical success rates. Nat Rev Drug Discov. 2016;15(6):379–380.
   PubMed Web of Science ®Google Scholar
• Fair Medicine. www.fairmedicine.eu. 2021 Feb 25
   Google Scholar
• Godman B, Simoens S. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics Biosimilars Initiat J. 2019;8(2):49–70.
   Google Scholar
• van der Schans S, Vondeling GT, Cao Q, et al. The impact of patent expiry on drug prices: insights from the Dutch market. J Mark Access Heal Policy. 2021;9(1):1849984.
   Google Scholar
• Stott K Pharma’s broken business model: an industry on the brink of terminal decline. Endpoints News. https://endpts.com/pharmas-broken-business-model-an-industry-on-the-brink-of-terminal-decline/. Published 2017. 2020 May 29.
   Google Scholar
• Fernandez R, Klinge TJ The Financialisation of Big Pharma: private Gains We Can Ill Afford.; 2020. https://www.somo.nl/wp-content/uploads/2020/04/Rapport-The-financialisation-of-Big-Pharma-def.pdf.
   Google Scholar
• Orphan Drug HA. Pricing and Costs: a Case Study of Kalydeco and Orkambi. Healthc Policy. 2019;15(1):70–80.
   PubMedGoogle Scholar
• Kaiser J. New cystic fibrosis drug offers hope, at a price. Science. 2012;335(6069):645.
   PubMed Web of Science ®Google Scholar