Coverage with Evidence Development

Hannah Wolf  0:03  
Welcome to Healthcare Policy pop. I'm Hannah Wolf. It's Thursday, October 12 2023. Today's pop topics, coverage with evidence development, or CED, and how it restricts patient access. Kirsten Axelsen is a Senior Policy Advisor with DLA Piper, a global law firm and says the restriction of CBD is troubling.

Kirsten Axelsen  0:28  
I guess the concern I have about some of these approaches that would limit access at launch such as coverage with evidence development, which essentially says, for a certain type of patient enrolled in a certain type of study, you can get access to this treatment will evaluate if it's worth it, that necessarily restricts the patient population to a more artificial setting. Axelsen says it's the opposite of how it should be. 

Kirsten Axelsen  0:52  
So as opposed to starting small and getting the evidence, I would rather see a system that started big and gained the evidence so that you could actually see how these drugs worked across a larger patient population, and then do the evaluation a year or two out. It's a little bit more similar to the process for a new technology add on payment where a drug or a new device is added. And they're sort of a bit of money added on to put that into the bundle.

Hannah Wolf  1:16  
Axelsen also says CED is redundant, since many companies already assess the value of their medicine,

Kirsten Axelsen  1:24  
Biopharma companies do create and produce evidence on the value of their own medicines, health insurers have the ability to do that as well. And often do, you know, the Medicare data is also could be made more broadly available for evaluation, you know, independently, I think, you know, all these things are ways that evidence is collected. The concept behind doing a CED is well, we don't know if it's worth paying for it. So we're going to restrict the population that can get it

Hannah Wolf  1:52  
Axelson adds that data on a drug is important, but it takes time to be complete.

Kirsten Axelsen  1:58  
You know, with medicine, it's always been the case that when a drug or a device is launched, we have the least amount of information about it will ever have. You get information over time and many advances in treatment have occurred because a drug or another treatment was developed and more was learned about it over time and its use was expanded

Hannah Wolf  2:17  
Contradictory messaging from different government agencies also doesn't help patients.

Kirsten Axelsen  2:23  
You know, we have one government agency that is putting forward structures that allow treatments to come on the market as quickly as possible, and with limited evidence, sort of by design. And that's something patient groups who fought very hard to get, and again has been tremendously beneficial in particular to diseases such as cancer. And then we have another government agency that is saying, well, it was approved on this pathway, which means we don't have good evidence, which means I'm not going to pay for it. So that's really kind of like one instead of cancelling out another incentive.

Hannah Wolf  2:54  
You can learn more about Kirsten Axelsen by using the link in the show notes.

Hannah Wolf  3:04  
For the first time, Medicare is going to negotiate the prices of prescription drugs. Now all the companies who manufacture the first 10 drugs have agreed to negotiate. Sounds too good to be true. It kind of is. The companies say they had no choice. They could either agree to participate or face fines or even have their drugs pulled from the Medicare and Medicaid markets completely. You can find a link to an NPR story on this in the show notes. Finally, today a new study published in the Annals of Internal Medicine says that discount card programs could save people money on Out of Pocket drug costs. This study showed that people who use an Amazon Prime or Good RX called discount card potentially could save between 20 and 43% on Out of Pocket payments. But it also caution that these cards might just be quote, temporary relief, the link to the studies in the show notes. 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.