When you consider that this medicine is prescribed to heart patients who are most likely to eventually die from a cardiovascular event, a money‐back guarantee is pretty mind‐boggling no matter how the agreement is constructed.
There was a time when a company solely focused on getting an FDA approval for its new drug. Once that approval was in hand, commercial success was a reasonable probability. That is no longer sufficient for a new medical breakthrough. Payers now have a big seat at the table. They can make or break a new product. It is a new world.
REFERENCES
1 1. LaMattina, J.L. (2009). Drug Truths: Dispelling the Myths About Pharma R&D, 16–22. Wiley. Chapter 2.
2 2. Mangan D.; Tirrell, M. (2015). Pricey new cholesterol Rx covered by big drug plan, but…. CNBC.com. 6 October.
3 3. Kaufman, T.M., Duell, P.B., Purnell, J.Q. et al. (2017). Application of PCSK9 inhibitors in practice. Circulation Research 121: 499–501.
4 4. Kolata, G. (2017).Cholesterol‐Slashing Drug Can Protect High‐Risk Heart Patients, Study Finds. New York Times. 17 March.
5 5. Herper, M. (2017). Amgen Drug Prevents Heart Attacks, Not Deaths, Disappointing Experts. Forbes.com. 17 March.
6 6. Schwartz, G.G., Steg, P.G., Szarek, M. et al. (2018). Alirocumab and cardiovascular outcomes after acute coronary syndrome. New England Journal of Medicine 379: 2097–2107. 29 November.
7 7. Rockoff, J.D. and Hufford, A. (2016). Pfizer cuts outlook, ends development of cholesterol drug. Wall Street Journal 1 November.
8 8. LaMattina, J.L. (2017). Amgen’s Money Back Guarantee For Its Cholesterol Drug, Repatha. Forbes.com. 4 April.
9 9. Beasley, D. (2018). Amgen cuts price of cholesterol drug Repatha by 60%. Reuters. 24 October.
10 10. Herper, M. (2019). Regeneron and Sanofi cut Praluent price 60%, as low‐selling drugs become a drug pricing laboratory. STAT. 11 February.
11 11. Ray, K.K., Landmesser, U., Leiter, L.A. et al. (2017). Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. New England Journal of Medicine 376: 1430–1440. 17 March.
12 12. LaMattina, J.L. (2018). The Medicine Company CEO, Dr. Clive Meanwell on the Impact of ODYSSEY Outcomes For Heart Patients. Forbes.com. 20 March.
13 13. Ray, K.K., Wright, R.S., Kallend, D. et al. (2020). Two phase 3 trials of Inclisiran in patients with elevated LDL cholesterol. New England Journal of Medicine 382: 1507–1519. 16 April.
14 14. Novartis Press Release (2019). Company for USD 9.7 bn, adding inclisiran, a potentially transformational investigational cholesterol‐lowering therapy to address leading global cause of death, 24 November.
15 15. LaMattina, J.L. (2022). It Was To Be the Cholesterol Drug for the Masses. Novartis Changed That. 3 January.
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