The Associated Press had an interesting article last week titled “Why So Few Patients Get the New Cholesterol Busters.”  In it, the author examines why the launches of the new PCSK9s (Praulent and Repatha) have been so slow and financially lack-luster.

Certainly the high prices of these medications play a significant role.  But we’ve seen high priced drugs like the Hepatitis C medications Sovaldi and Harvoni perform very well financially for their sponsors.  The big difference here is that the payers are asking for hard evidence that the higher prices ensure additional value – better safety and/or effectiveness than existing (cheaper) options.  That seems like a pretty simple requirement, but one that has been sorely lacking in healthcare for far too long.

In all other consumer transactions, we expect value for money.  The $100,000 car should be better than the $20,000 car.  They both get you to where you’re going, but someone who is paying $80,000 more expects something better about the ride (and a little boost in their ego).  Of course, settling on a proper course of healthcare is not the same as buying a car.  But in certain areas, like lowering cholesterol, there are similarities.  You have multiple choices, each with positives and negatives, and hopefully you can find the one that works best for you.  Of course, the big issue is that as consumers we don’t get to always decide on our own course of treatment – financial realities mean that our health insurers step in and dictate a lot of the decision making.  So it’s not surprising that payers want to know that they are getting value for their money.

Unfortunately proving better effectiveness and safety in a newly launched drug isn’t easy.  Many are waiting on ongoing outcomes-based clinical studies for the new PCSK9s.  Not wanting to wait for that, at least one health system, Harvard’s Pilgrim Health Care, has worked an interesting deal with Amgen whereby, “if Repatha doesn’t lower patients’ cholesterol to levels seen in company trials, they get a rebate.”

See – I told you it’s kind of like buying a car!

Neither of these solutions are ideal – they take a lot of time, money, and effort.  And they confirm what we’ve been saying for years– that the results seen in pre-launch clinical trials do not necessarily properly represent the real world evidence that emerges once a drug is used in a wide, diverse, and less controlled patient population.  It’s nice to see the industry finally coming around to that conclusion too. 

Now the big question is:  What can we do about it?

As data people, we like to believe that these types of problems can largely be solved with data.  Over the past few years, we’ve proven that out on the safety side by developing, validating, and publishing on our ability to accurately predict emerging side effect issues in the post-approval market well before FDA.

Doing something similar with efficacy is very much on our product roadmap.  Earlier this year we launched our clinical evidence module on the Evidex platform that incorporates clinical trials data.  This module provides an initial framework to present and analyze efficacy and outcomes data from those trials.  With the proper real world data, we believe that we can incorporate that framework to look at post-marketed efficacy data and extract the types of outcomes-based evidence payers, providers, and even patients long to see.

It will take time and the ingenuity of the amazing Advera Health team.  And we will certainly have our doubting Thomases along the way.  But we know from tackling the safety side of the equation that this can be done.  And that it should be done.  Patients in need of vital medications shouldn’t have to wait for costly post-approval outcomes studies to get the treatment they need and payers shouldn’t shoulder the economic risk/reward balance on their own.

To see what we’ve already accomplished and to learn more about the path ahead, click here.


 Brian M. Overstreet, President, Advera Health Analytics, Inc.


Topics: Drug / Indication Information

Brian Overstreet

Written by Brian Overstreet