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The New Cholesterol Lowering Drugs Epitomize The Drug Pricing Battles

The second of a potent new class of cholesterol lowering drugs, Amgen’s Repatha, has just been approved by the FDA. Repatha now joins Sanofi/Regeneron’s Praluent as the first PCSK-9 inhibitors available to patients for whom statins (e.g., Lipitor from Pfizer and Zocor from Merck) are not effective enough to get patients with (or at risk of) cardiovascular (CV) disease to their optimal LDL-C levels. The efficacy of these drugs has never been questioned. Nor has their safety been a major issue. While ALL drugs pose some degree of risk, to date, the PCSK-9 inhibitors have not raised red flags.

The big issue facing these drugs, however, has been their anticipated price. These are very effective drugs and they are being priced accordingly. Praluent, the first out of the box, was priced at $14,600/patient/year. In effect, Sanofi/Regeneron set the bar for the value of these drugs that possess unprecedented LDL-C lowering ability. Not surprisingly, Amgen has set the price of the second marketed agent , Repatha, at $14,100. This can’t be surprising to anyone. After all, Amgen believes that Repatha is every bit as good as Praluent, so why should it charge significantly less?

But the real pricing discussions will now begin. When Praluent was first launched, one of the major drug payers, CVS...