You may imagine that your brain is the most amazing part of you. It is entertaining to wonder about how you can think about yourself and the mysteries of consciousness. Self awareness is worthy of awe but the miracle of your body is really your liver. I grew up in the computer industry and consequently I'm not as young as you may have thought. I remember a time when a single person could actually understand everything going on in a computer. Today computer systems are so complex that no one can understand it all. The liver is like that. Thousands of interacting chemicals churning through chains of reactions with a vast number of interlocking functions. If you examine biochemistry in any detail you have to wonder how it is even possible for you to be alive. It seems unlikely that something so complex could persist over time.
I've had the opportunity to look closely at some of the research that is going on with liver disease treatments and I really have to admire the teams that are tackling this problem. The liver cell is rather like a bunch of finely tuned clocks within clocks and if you touch any part of any clock it may stop some other clock from keeping the proper time. This complexity has confounded the development of drugs to treat liver disease forever. The people on the front lines of this research face real challenge. With the success Madrigal has had bringing Rezdiffra to market, we can now see that there will be successes and liver disease need not be the toboggan ride to hell that it has been.
The day to day landscape for patients will be changing from hoping for help to how do you access care and what are the hoops the system will force us to jump through. A current debate is how are treatments paid for. To understand the new game it is useful to remember that up to now the payors didn't have to worry about liver specific drugs for steatotic disease because there weren't any. Now they have a new category of drugs to think about and we all know that their bottom line will come first.
The test of whether payors support treatment is how difficult they make it to approve therapy. In the case of Rezdiffra, we are seeing some worrisome signs. A key question is what proof a patient has to provide to qualify for coverage. We dealt with that extensively with the FDA regarding the label. Would they require a biopsy to allow a patient to receive the drug. The FDA did not conclude that biopsy was necessary. This was a very significant win for the patient community, conceptually making it much easier to qualify.
Now we are seeing the payors weigh in. Remember, in our badly dysfunctional system, the insurance company is the real gate keeper. They don't have to listen to the FDA. They all have committees who decide what they will cover. Early results are mixed. We are seeing a concerning number of payors requiring biopsy or even refusing to cover care. It is still early and results are mixed. These are some of the payors who have made decisions that we believe are flawed.
It makes us crazy that federal systems like the VA are standing in the way of treatment and the Blue Cross Blue Shield decision is very concerning. The good news, in a way, is that the real heavyweights haven't weighed in yet. The major players like CVS, Express Scripts, and Optum will be making decisions soon. We will keep you informed as things develop.
