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New Cholesterol Drugs/PCSK9: PBM Deals
  CVS Health executives were predicting $150 billion in annual sales for the class.
Perhaps tired of watching Express Scripts in the vanguard, CVS Health recently inked a deal with Amgen that could save end payers billions. America's second largest pharmacy benefit manager will add Amgen's Repatha to its commercial formularies, while excluding Repatha's only competitor, Praluent, which is made by Sanofi and Regeneron.
No one doubts the ability of these drugs to help difficult patients reach their cholesterol goals. What is in question is whether they actually help people avoid heart attacks. For one of these therapies we'll have an answer soon.
Express Scripts has agreed to pay for both Repatha and Praluent. Rather than forcing the competition, it's planning to protect its clients' interests by severely limiting their sale with spending caps while playing wait-and-see with ongoing outcome studies.
Amgen and Sanofi are both running enormous outcome studies for their respective PCSK9 therapies. In a nutshell, these trials will measure how long patients on or off therapy live without a cardiac event, such as stroke or heart attack. These studies take a long time, but a statistically significant cardiac benefit would be an enormous advantage for either drug.
This summer, when Amgen announced enrollment completion for its 27,500-patient Fourier trial, the company said it would need to wait "no later than 2017" for results. That deadline -- or at least the accrual of events -- has since been moved up to midyear 2016.
There are lots of reasons to speed up an outcome trial, and favorable data is a common one. If this is the case, it would be a big boost to CVS Health and Amgen. Sanofi and Regeneron just announced full enrollment in Praluent's 18,000-patient outcome study, with data expected in 2017. If Amgen can claim a significant cardiac benefit for Repatha, Sanofi wouldn't be able to counter it for at least half a year.

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