Biosimilars' Slow Uptake

Hannah Wolf  0:03  
Welcome to Healthcare Policy pop. I'm Hannah Wolf. It's Thursday, October 19 2023. Today's pop topics: uptake for a biosimilar of a popular drug is much lower than anticipated. What does that mean for the market and a quality alternative? We speak with the Co-creator of a different model to see how it might work better. Let's start today with that biosimilar news. An endpoint news article says that nearly a year after Humira biosimilars launched AbbVie, Humira's manufacturer, still controls more than 97% of the US market. Wayne Winegarden is a senior fellow at the Pacific Research Institute, and lays out his initial thoughts when hearing the news. 

Wayne Winegarden  0:51  
The first thought is disappointing. There was hope that biosimilars would get a larger market share faster. It's not completely unexpected. But you know, certainly not the most optimistic scenario that could have happened. 

Hannah Wolf  1:05  
Weingarten says there are a number of reasons why this may be and not all are nefarious. But without a doubt, the system itself in many ways discourages a competitive landscape. 

Wayne Wingarden  1:17  
The competitive landscape isn't as competitive as we would want. There are obstacles things like rebate walls and other types of issues that [affect] the whole rebate system, which kind of stacks the deck against these new competitors, against the biosimilars, that's always been the concern that these types of obstacles will prevent biosimilars from getting the amount of market share that they should. And so toward that end, to the extent that that is the constraint, that's concerning. And that's when we really need to start looking at how do we change the way the current rebate system works. 

Hannah Wolf  1:55  
It takes time for markets to shift and for patients and doctors to get comfortable with biosimilars. But why adoption has not been quicker still needs to be examined. 

Wayne Winegarden  2:06  
The fact that it was approved means that does impact things, if the obstacles we talked about are actually kind of what's preventing it, then it will take five years, right. But if it is more just that doctors need to get used to it, you know, they just need time for it to work, then it could be next year. And along with the delays, I think that will actually give us a lot of information in terms of what is the primary obstacle, and obviously all of these things are playing at once. But what is the binding constraint? What is actually keeping 97% of the market for Humira.

Hannah Wolf  2:40  
Learn more about the Humira biosimilar landscape by using the link in the show notes.

Patients rising now is well on record about the QALY measurement and its discriminatory nature. But what's the alternative to measuring the efficacy and value of treatments. One is the grace model or generalized risk adjusted cost effectiveness model. We spoke with Darius Lakdawalla, a co-author of the grace model. 

Darius Lakdawalla  3:14  
The GRACE model is designed to solve the problem that traditional cost effectiveness appeared not properly coincide with the values of real patients. In particular, a major issue has been that people with very severe illness seem to place more value on treatment, and traditional cost effectiveness seems to suggest they should. And so GRACE is a way of generalizing (that's the G) traditional cost effectiveness in a way that better aligns and reflects the preferences of real human patients. 

Hannah Wolf  3:50  
Lakdawalla says he looked at current measurement tools, they did not reflect his own experience as a patient. So he and a colleague set out to develop a better way. 

Darius Lakdawalla  4:00  
What GRACE does is I think it gives a better and more accurate accounting of how human beings think about risk when they assess healthcare interventions, health technology, and disease, and incorporates risk. One way of thinking about this is that it's much more valuable to me to protect myself against the big risks and a small risk. It's why here in Los Angeles, I have earthquake insurance on my house, but I never buy the extended warranty at Best Buy, because it doesn't matter so much that my $50 toaster breaks down. 

Hannah Wolf  4:35  
How does the GRACE model apply that thinking to health care? 

Darius Lakdawalla  4:39  
It's much more valuable to me to have some way of protecting myself against cancer, Alzheimer's disease, Parkinson's disease, and less valuable to protect myself against seasonal allergies, which I do have, by the way, but it's just a milder disease and the risk is less significant. So that's just an example of how GRACE aligns predictions better. It also helps us understand uncertainty, it helps us account for risky outcomes. 

Hannah Wolf  5:08  
Lakdawalla says even though this is a relatively new model, it's already being used, and it looks like it might be used even more in the future. It has been used by academics and research. It's been used by companies that are bringing drugs to market new drugs to market to understand a different perspective on value. ICER recently announced that they're considering pilot testing grace in a few of their analyses, though, that will be another source of experience. Learn more about the GRACE model using the link in the show notes.

Finally today, Patients Rising Now is working on its latest report. This one is about formulary practices. The report details the history of formularies the impacts of current formulary practices on patients and current reform efforts. It also discusses the intertwining of PBMs and their effects. We will have more on the report in future episodes. That's all for today. We're back on Tuesday for another Health Care Policy Pop, a resource of Patients Rising Now. I'm Hannah Wolf, have a great day.