Real Endpoints’ RxScorecard™ Predicted Launch Failure of Major New Anti-Cholesterol Drugs

Analysis from 2015 showed that because PCSK9 inhibitors had not proved more than incremental value for most patients, payers would dramatically restrict their usage. Poor Q4 sales show that’s exactly what happened.

Westport, CT, February 12, 2016 --( In a press release issued July 7, 2015, ( Real Endpoints LLC (RE) predicted that the two soon-to-be-launched PCSK9 inhibitors from Amgen and Regeneron/Sanofi would not get substantial market uptake.

RE based this conclusion on its proprietary tool RxScorecard™, which assesses the relative value of marketed and pipeline drugs from a patient’s and payer’s point of view. RE defines this value as a full assessment of a drug’s efficacy, safety, convenience, adherence and economic attributes in comparison to other therapies in the indication. RxScorecard indicated that while both products offered potential efficacy benefits, they proved for most patients little incremental value because of their lack of meaningful outcomes data at launch and their expected high pricing. As a result RE said last July that “Payers will have an extraordinary opportunity to control costs in this class.”

That’s exactly what they did. Now that Q4 sales are in for both Praluent and Repatha, the magnitude of their launch failure is clear. Praluent sold only $7 million in Q4; Amgen has not released data on Repatha, but Wall Street estimates that its sales are even smaller than Praluent’s. This is in contrast to the company’s and analysts’ predictions that their sales would be more than three times that amount in Q4 (an estimate analysts had much reduced after a poor third quarter) and $10+ billion for the class at its peak.

With Amgen set to release outcomes data in the second half of the year, the picture for these drugs – which are only six months into their launch -- could change. If the drugs do actually reduce cardiovascular events to the same degree they lower LDL cholesterol, patients will benefit enormously and payers will, to a degree, loosen current restrictions. But the weak launch so far has made many payers very comfortable with restricting PCSK9 usage, and unless new data on their outcomes is extraordinary, these products will never achieve the lofty sales once predicted for the category overall. Companies can only launch a product once.

For the industry overall, the story of PCSK9 inhibitors is a wake-up call about the power of payers and other intermediaries to limit access to new drugs that don’t provide value advantages.

RE also believes it teaches six basic lessons:
1. Most existing methods that drug companies, security analysts and other industry observers are using to evaluate the market potential of new therapies are inadequate, and don’t reflect the increasing influence of value-oriented payers, PBMs and providers.
2. Understand the true incremental value your product will provide patients and payers, relative to other drugs on the market and in late-stage development.
3. Develop and communicate compelling data to support this value proposition.
4. Price your product according to the demonstrable value it provides.
5. Build a launch plan that anticipates and effectively answers key payer questions.
6. Manage internal and external expectations concerning your product’s adoption and sales trajectory so as to not cripple it with unrealistic goals.

For more information, contact Viviana Ramos at or 203-517-4769.

About Real Endpoints
Real Endpoints (RE) is a healthcare information and analytics company that prepares healthcare providers, payers and pharmaceutical companies for the value-based healthcare economy. Informa is RE’s exclusive marketing partner to the pharmaceutical industry for RxScorecard. For information on other RxScorecards, contact Viviana Ramos at

About Informa
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Viviana Ramos