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DewDiligence

06/09/15 6:33 PM

#192328 RE: DewDiligence #192323

PCSK9 drugs: A nightmare for US healthcare system?

http://healthaffairs.org/blog/2015/02/17/in-the-debate-about-cost-and-efficacy-pcsk9-inhibitors-may-be-the-biggest-challenge-yet/

…with this potential patient population, how much is the bill for the [US] health care system? The math is simple. If we assume costs of $10,000 per year, familial hypercholesterolemia and severe hypercholesteremia alone would represent a $16 billion market, dwarfing initial Sovaldi costs. Statin intolerant patients would add an additional $20 billion set of costs. And those with a history of coronary disease could add as much as $150 billion annually.

Even if we limit this latter group to those for whom statins are ineffective (patients who do not reach LDL goals from previous guidelines) the price tag would be somewhere between $50 and $100 billion. And this leaves aside what is likely the eventual target for the manufacturers, primary prevention.

As this is chronic therapy, PCSK9 sales could be expected to persist and grow over time, and will likely be the highest selling class of medications in history.

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DewDiligence

06/10/15 9:34 AM

#192335 RE: DewDiligence #192323

ESPR -23% on yesterday’s SNY/REGN panel. REGN -5%.
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DewDiligence

07/24/15 10:00 AM

#193672 RE: DewDiligence #192323

SNY/REGN—CHMP approves Praluent (PCSK9):

http://www.reuters.com/article/2015/07/24/us-sanofi-regeneron-cholesterol-idUSKCN0PY18L20150724

The indication is: i) patients unable to control their cholesterol despite taking optimal doses of a statin; or ii) patients who are statin-intolerant.

The EU Commission will rubber stamp the CHMP decision in 2-3 months.