- •Without reimbursement at branded prices, drug manufacturers would not develop many drugs, and those drugs would never become available at generic prices. Therefore, cost-effectiveness analyses should include generic prices because they represent an anticipated consequence of reimbursement at branded prices.
- •Including price declines in an analysis of inclisiran, a new cholesterol treatment, yields more favorable cost-effectiveness ratios. Assuming displacement of inclisiran with a follow-on drug does not substantially alter this result if we assume that it likewise eventually loses exclusivity and declines in price.
- •To ensure realistic value estimates, cost-effectiveness analyses should account for anticipated life cycle price patterns.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- Generic competition and drug prices. US Food and Drug Administration.https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-pricesDate accessed: June 29, 2021
- Do cost-effectiveness analyses account for drug genericization? A literature review and assessment of implications.Value Health. 2022; 25: 59-68
- Cost-Effectiveness in Health and Medicine.2nd ed. Oxford University Press, Oxford, England2017
- Drug pricing and pharmaceutical patenting practices. Congressional Research Service.https://sgp.fas.org/crs/misc/R46221.pdfDate accessed: August 25, 2021
- What’s holding back market uptake of biosimilars? Forbes.https://www.forbes.com/sites/joshuacohen/2018/06/20/whats-holding-back-market-uptake-of-biosimilars/#1f28a987691aDate accessed: June 29, 2021
- Generic competition and market exclusivity periods in pharmaceuticals.Manag Decis Econ. 2007; 28: 12
- Decline in economic returns from new drugs raises questions about sustaining innovations.Health Aff (Millwood). 2015; 34: 245-252
- Research and development in the pharmaceutical industry. Congressional Budget Office.Accessed July, 2021.)
- CBO’s simulation model of new drug development. Working paper 2021-09.https://www.cbo.gov/system/files/2021-08/57010-New-Drug-Development.pdfDate accessed: October 31, 2022
- Innovation in the pharmaceutical industry: new estimates of R&D costs.J Health Econ. 2016; 47: 20-33
- Determinants of the cost-effectiveness of statins.J Manag Care Pharm. 2003; 9: 544-551
- Cost-effectiveness of cholesterol-lowering therapies according to selected patient characteristics.Ann Intern Med. 2000; 132: 769-779
- Maximizing the cost-effectiveness of lipid-lowering therapy.Arch Intern Med. 1998; 158: 1977-1989
- The fall of the world’s best-selling drug. Financial Times.https://www.ft.com/content/d0f7af5c-d7e6-11de-b578-00144feabdc0Date accessed: June 7, 2021
- For now, PBMs just say no to high-cost PCSK9 inhibitors.Am J Manag Care. 2015; 21Cover-SP457
- Regeneron, Sanofi cut PCSK9 list price, matching earlier move by rival Amgen. Biopharmadive.https://www.biopharmadive.com/news/regeneron-sanofi-cut-pcsk9-list-price-matching-earlier-move-by-rival-amge/548147/Date accessed: June 28, 2021
- PCSK9 inhibitors for treatment of high cholesterol: effectiveness, value, and value-based price benchmarks: final report.https://collections.nlm.nih.gov/catalog/nlm:nlmuid-101672684-pdfDate accessed: October 31, 2022
- Oligonucleotide therapeutics - a new class of cholesterol-lowering drugs.N Engl J Med. 2017; 376: 4-7
- FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year. Novartis.https://www.novartis.com/news/media-releases/fda-approves-novartis-leqvio-inclisiran-first-class-sirna-lower-cholesterol-and-keep-it-low-two-doses-yearDate accessed: October 31, 2022
- Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol.N Engl J Med. 2020; 382: 1507-1519
- Pricey inclisiran is rolling out: a ‘buy-and-bill’ model may smooth its path. tctMD.https://www.tctmd.com/news/pricey-inclisiran-rolling-out-buy-and-bill-model-may-smooth-its-pathDate accessed: October 31, 2022
- Patent term restoration for top-selling drugs in the United States.Drug Discov Today. 2019; 24: 20-25
- Prices of generic drugs associated with numbers of manufacturers.N Engl J Med. 2017; 377: 2597-2598
- Challenging the link between pharma innovation and US drug pricing.Pharmaceutical Technology, 2017https://www.pharmaceutical-technology.com/analysis/featurechallenging-the-link-between-pharma-innovation-and-us-drug-pricing-5813154/Date accessed: October 31, 2022
- Patients’ access to 2018 FDA-approved drugs 1 year post approval.Am J Manag Care. 2022; 28: e153-e156
- Pursuing breakthroughs in cancer-drug development.https://www.mckinsey.com/industries/life-sciences/our-insights/pursuing-breakthroughs-in-cancer-drug-developmentDate accessed: October 31, 2022
- The real cost of “high-priced” drugs. Harvard Business Review.https://hbr.org/2014/11/the-real-cost-of-high-priced-drugsDate accessed: October 31, 2022
- Utilization, price, and spending trends for antidepressants in the US Medicaid program.Res Soc Admin Pharm. 2008; 4: 244-257
- Biosimilar cost savings in the United States: initial experience and future potential.Rand Health Q. 2018; 7: 3
- Why the world is saving too much money for its own good. The Economist.https://www.economist.com/briefing/2022/02/05/why-the-world-is-saving-too-much-money-for-its-own-goodDate accessed: October 31, 2022