“Marching-In” A Step Too Far

Janson Silvers  0:02  
Welcome to Healthcare Policy pop, I'm Janson Silvers. it's Tuesday December 12 2023. Today's hot topics: The White House has announced unprecedented steps to do what they say will curb high drug prices, but Patients Rising has major concerns and questions, including if it will even actually reduce drug prices. Late last week, The White House announced several regulatory updates, including a framework to enforce the government's march-in authorities on drugs developed with taxpayer dollars. The White House says they would do this if drug makers refuse to make their products quote reasonably available. MacKay Jimeson the Executive Director of Patient Rising, says march-in rights have been around a long time. But this isn't what they were intended to do. 

MacKay Jimeson  0:50  
The idea behind march-in rights is really to solve some kind of problem that may occur with the production of some of these patent protected technologies from government funded research. So an example of that would be, let's say a hurricane took out a manufacturing plant, and the manufacturer of that particular product was unable to continue to deliver that to Americans, and it was very much in the public interest, the government would then use those march-in rights to allow others to manufacture that particular product to make sure that the supply was continue to be available for patients. 

Janson Silvers  1:27  
The White House's proposal, though, is an unprecedented use of march-in authority. 

MacKay Jimeson  1:32  
They have taken a far more hostile approach and specifically have targeted patent protected medicines that may be based on some form of NIH funding to start. And basically this update calls out drug pricing specifically. They don't give a lot of specifics in terms of what that level of cost is was sort of an unacceptable cost. 

Janson Silvers  1:52  
Jimeson says the added prospect of losing your exclusivity to develop a drug will undoubtedly hurt Investment and Development. 

MacKay Jimeson  2:00  
It certainly is another way of eroding. Really what has been working in terms of creating new medicines. This will temper investment. This will create a new level of risk if you're an investor in terms of if we invest in certain technology are we at risk of actually not receiving the benefit from that multimillion dollar billion dollar investment that we're putting into a new treatment? 

Janson Silvers  2:24  
Jimeson says government intervention in this area won't fix drug pricing because competition isn't the issue, the system is. 

MacKay Jimeson  2:32  
Invalidating a patent is no guarantee that you're going to be able to get cheaper medicines for patients. If you look at the biosimilars market, you can actually see what's happening and it's not a function of not having competition, it's a function of these predatory practices that are being used by insurance companies in the pharmacy benefit managers. 

Janson Silvers  2:51  
Jimeson says you have to only look as far as the HUMIRA biosimilar situation to see that competition is far from the problem. We discussed that particular example in an earlier episode of the Healthcare Policy Pop, and we'll put a link to that episode along with the latest on The White House march-in proposal in the show notes.

A reversal on a decision from a large insurer that is actually good for patients. Aetna has reversed course on a previous decision to stop covering some types of virtual mental health and substance use disorder treatment. They had planned to end coverage for virtual intensive outpatient and partial hospitalization program care at the start of December. But Politico is reporting that now the insurer says it will continue to cover such care. Many groups argued it would hurt access to care and contradict many policies CMS and other federal agencies have adopted to promote telehealth access. However, some are saying it is a partial victory as it only applies to self insured plans. You can read the full story by using the link in the show notes. That's all for today. We're back on Thursday for another Healthcare Policy Pop, a resource of Patients Rising Now. I'm Janson Silvers, have a great day.