Talking PIE, the Act, Before Thanksgiving

AMCP CEO Susan A. Cantrell spoke with Managed Healthcare Executive® about Preapproval Information Exchange (PIC) Act, which would allow drug manufacturers to share information about a drug with payers before the drug is approved. Cantrell says passage of the PIE Act would speed up patient access to new medications.

The Academy of Managed Care Pharmacy (AMCP) has made passage of the Preapproval Information Exchange (PIE) Act a priority. A conversation about legislation named for pie seemed appropriate for the week before Thanksgiving. Managed Healthcare Executive® spoke Susan A. Cantrell, the CEO of AMCP, about the PIE Act, the reasons AMCP is pushing for it and the chances of it passing during the upcoming lame duck session.

This transcript has been edited for length and clarity.

What would the PIE Act accomplish?

ThePreapproval Information Exchange Act of 2022 is intended to facilitate the exchange of information between manufacturers and payers in a proactive manner, in advance of a products approval by the FDA. And traditionally, there have been significant limitations on the ability of manufacturers to share this information, especially proactively.

FDA tried to address that, in some ways with its guidance that was finalized in June of 2018. But it's limited and not explicit that proactive sharing is allowable. We believe that it's very important to codify the ability of manufacturers to do this and provide some additional clarity. We've made great progress since the release of the final guidance, but more needs to be done.

Payers need this information, because they want to provide timely access to their patients to new innovative products that are coming to market. And often what happens is you have a product approved by the FDA, but there's a lag time before payers have the information, clinical evidence, etcetera, that they need in order to make decisions about coverage and formulary placement. So we're trying to close that gap with the ultimate goal of giving patients more efficient and rapid access to these new innovative products.

When we say information in this context, what are we talking about? Are we talking about data from the pivotal clinical trials?

Information in the name of the act is purposely vague. We're talking about really any information that's useful to the payer audience, as the product is making its way through the approval process. And that certainly can be clinical data. We have a number of products that are approved now under expedited approval pathways, breakthrough therapies, for example. So you actually could have the product come to market before there is availability of the phase 3 clinical trial data. So clinical evidence, and data is certainly an important part of the pie — no pun intended.

But there are other things like dosage, type of administration, site of service, for example, if you're dealing with products that have to be infused in a physician's office or ambulatory infusion center. So really information kind of sums up everything that payers are looking for as they begin to evaluate products for coverage and formulary placement.

Isn't there a wealth of information available already? There are presentations at meetings, there are clinical trial results published in the peer reviewed literature.

Payers are always reviewing information. Pipeline tracking is a really, really important effort on behalf of our members that they're engaged in. In fact, if you attend AMCPnational meetings, one of the most well attended sessions that are meeting is the pipeline session that we feature every year. So yes, they're always looking for that. But there's often information that only manufacturers have in advance of approval. That's what we're looking for that key information that will help payers begin to evaluate products in advance of their approval.

Also, let's don't forget the contracting process, we now see some value-based contracting taking place that is quite complex and time consuming. So having certain pieces of information in advance of a product's approval can really allow payers and manufacturers to begin that process, again, with the goal of closing the gap on patient access when the new therapies come to market.

When we talk about information exchange between manufacturers and payers, it would be only certain individuals or certain groups at the payer organizations that would have access to this information, correct? It's not the entire payer organization.

So that's an important piece of this legislation. Certainly, theregulations that would go along with legislation would be really important and setting up the guardrails to ensure that we avoid any type of negative scenarios or unintended consequences. And yes, controlling who can receive this information is important. Who can deliver this information is (also) really important. There would need to be the appropriate guardrails certainly put into place.

We have long argued that payers have within their ranks individuals who have expertise in evaluating clinical studies, in analyzing information in contract negotiations, in pharmacoeconomic analyses — all those types of things. We're looking to make sure the right people have access to the right information, and also that the right people deliver it on the part of the manufacturer. I think we're all completely aligned on that being an important piece of this.

How would those people be identified in the legislation or the regulations?

I can't speculate how FDA might address that in regulation. But it will be important, and it's something that we've spent quite a bit of time speaking with our members and also with pharmaceutical manufacturers about. So more to follow on but certainly those will be important parts of the negotiation as we get into the specifics. We're trying not to jump ahead, though, in advance of passage or the legislation.

If the PIE Act had been enacted when Aduhelm was approved do you think that would have made a difference in coverage decisions?

Well, there are a number of examples of where having this information could be very beneficial in making informed and appropriate decisions about product usage. So that's really what we're striving for here is avoiding a scenario where when a product is approved for marketing, there's insufficient evidence to determine the appropriate patient population, how it should be used, and coverage and reimbursement. So that's exactly what we're trying to make sure that we avoid in the future with very innovative products like that. Giving payers the information and the evidence that they need in a timely manner, so that they, in turn, can ensure their patients have access to innovative therapies as appropriate.

AMCP has been a strong advocate for the PIE act. Why do you have a dog in this fight?

Our members brought this issue to us back in 2016. I remember it well. It's an issue that arose from discussions with our members about their needs as it relates to new therapies coming to market.

You might remember that was a few years after we had seen the hepatitis C drugs come to market, which revolutionizedthe way that we treat that condition and improved the lives of millions of patients. And, of course, we all know the story there. Payers were kind of caught unaware they knew these products were coming (and) had little information about how they would be used and exactly whichpatients (and) what indications might be included in the labeling. They weren't able to plan for these products as they could have otherwise. Our members came to us and said, “You know, we need to make sure that we're avoiding this situation. And one thing that's critical is that we get information from manufacturers, not just in response to an unsolicited request, because quite frankly, in the absence of information, sometimes we don't know the questions to ask. We want manufacturers to be able to share this information with us proactively in advance of a product approval to avoid this type of nightmare scenario, where you have a, you know, life changing —life saving, in some cases — products coming to market.’’

So it came from the members. And as we began, six years ago, to really delve into this, what we found is that there was broad support for this type of communication to take place.

There's always some push and pull, some jockeying for position, some roadblocks to legislation. So who is against, or who is pushing against, the PIE Act?

We were so excited to see the reintroduction of the PIE act on November 15. And it has broad bipartisan support. We have on the House of Representative side, six co-sponsors, three Democrats and three Republicans, so we have, at this point, broad bipartisan support. We are, fortunately, not hearing a lot of opposition. And there are a number of stakeholder groups who are very much in favor of it.