Part 1: Christine Simmon Discusses the Individual Mandate and Biosimilars

The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today, on the MJH Life Sciences News Network, The Center for Biosimilars® is pleased to welcome Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM).

Can you tell us a little bit about the Association for Accessible Medicines and your role with them?

Simmon: Hi, Matthew, Thank you for having me today. The Association for Accessible Medicines represents the makers of generics and biosimilars, and our mission really is to provide patient access to these more affordable alternatives to expensive brand medications. So, what we do is we advocate on behalf of the manufacturers and help create a conducive legislative as well as regulatory and legal environment for these manufacturers to produce the products for America's patients.

CfB: What are some key pieces of legislation that the AAM is supporting to advance the use of biosimilars?

Simmon: AAM's work on biosimilars takes place through a division called the Biosimilars Council. So, the Biosimilars Council has a membership and we are pure play biosimilar manufacturers who are out there advancing biosimilar versions of innovator biologics, and we are very active on the advocacy front supporting pieces of legislation generally designed to further incentivize payers and patients to increase biosimilars utilization in the United States.

So, to help get these biosimilars really into the hands of patients, we are trying to, in addition to our usual education efforts, we are using legislative fronts to provide additional incentives for providers to prescribe these medicines to their patients. For example, we want to increase physician reimbursement for Medicare Part B. Right now, providers in Medicare Part B receive an add-on payment of plus 6% of the [reference] biologic’s average sales price (ASP) and we want to increase the add-on payment to 8% of the ASP, but it would only apply if the biosimilar’s price is lower than the [reference] biologic's price.

And so, this piece of legislation, which is called the BIOSIM Act, has bipartisan support in the House and is also included in the Senate Finance package and the Democrat House package, HR-3. We also are trying to eliminate biosimilar cost sharing in Part B.

So, these Part B efforts take precedence because biosimilars that are currently on the market are reimbursed through Part B and they're physician or hospital administered. Eliminating cost sharing would help beneficiary access to biologic treatments and encourage physicians to also prescribe them for their patients.

Right now, in Part B patients pay less for biosimilars compared to [reference] biologics because the ASP for the biosimilar is on average 25% lower than the [reference] biologic ASP. The cost sharing isn't usually enough to drive patient behavior, but we think that eliminating it would help both on the patient and physician side. That bill is called the Access Act. Again, it has bipartisan support in the House, and the Senate version [does as well].

So, those are 2. There are others. There's one around the Purple Book called the Biologic Patent Transparency Act, which Senator Susan Collins [R-ME] initiated. It requires patents to be listed in the Purple Book, which is an FDA document that assists biosimilar developers in trying to assess what patent hurdles they need to overcome to get a biosimilar on the market. Right now, patent thickets, where a [reference] biologic manufacturer tries to extend monopolies by obtaining additional patents around the product, are a big problem for biosimilar competition. Listing patents in the Purple Book would help a biosimilar developer more readily identify the patents that need to be addressed.

There are others around shared savings, which would really provide an opportunity in Medicare Part B for patients and providers to share in the savings that Medicare already recognizes every time a biosimilar is used. And this would be a demonstration project that the CMS Innovation Center could launch to test out the shared savings model, which is another incentive to increase biosimilar uptake. So, those are just a few.

CfB: How do you size up the prospects for approval of these bills?

Simmon: Well, of course, we all know the current environment is very focused, obviously, on the pandemic response and related matters. So, drug pricing legislation had to take a backseat. But the administration has publicly continued to say it's a priority. There is full broad bipartisan and bicameral support for increases in physician reimbursement, for example, so, that's probably the one that's most likely to pass.

CfB: To build off that, how do you see the current election affecting progress for biosimilars?

Simmon: Biosimilars are a really important part of reducing prescription drug costs for Americans and that continues to be, [especially] before the pandemic, the number 1 issue that voters cited as an area of concern. It's always in the top 5 or so. So, certainly the concern and public appetite for solutions to the high cost of prescription drugs isn't going away anytime soon. And no matter who ends up in the White House, it's clear that policymakers need to come together to enact policies that will address that. Biosimilars are a large part of that solution and a really important tool in the toolkit around the issue. So, we think that whatever the election outcome may be, biosimilars will continue to be a big issue.

CfB: The Supreme Court's review of the individual mandate puts the Biologics Price Competition and Innovation Act (BPCIA) in jeopardy. Can you explain the issue of severability and the AAM's position on this important case?

Simmon: So, you're absolutely right. Once again, the Supreme Court is tasked with reviewing a challenge to the Affordable Care Act, also known as Obamacare. And that challenge, like many prior challenges, centers around the constitutionality of the individual mandate of being required to have insurance or pay a penalty. The Affordable Care Act was a large piece of legislation, and it includes the BPCIA, which is the legal pathway that allowed the FDA to review and approve biosimilars.

So, the BPCIA is caught up in this. It was really a piece of legislation that can stand on its own 2 feet, but in order to pass, it was attached to the Affordable Care Act. [This sort of occurrence happens often with] different legislative measures. Because of that, we feel strongly that we can make the case that [the BPCIA] can be severed from the rest of the law, because it [can] stand by itself.

So, AAM and the council filed an amicus brief with the court arguing that because the plaintiffs in the case would not have standing to challenge the BPCIA itself and they would benefit from the savings and public health benefit that the biosimilars pathway provides, that it can be severed. There was a big legislative process around getting the BPCIA drafted, finalized, put into the Affordable Care Act and [getting it to have] bipartisan support. It was written as a free-standing bill, and it would have stood on its own as a legislative document had it not been rolled in. So, it would not be affected by the outcome of the of the actual issue that's being adjudicated by the court [had it not been] included. So, we do think it's severable and that's the argument we made in our amicus brief.

CfB: Based on your experience, what do you expect may result from the court proceedings?

Simmon: Well, it's hard to speculate on what the outcome of litigation will be. Certainly, there is a lot of evidence that we provide in our amicus brief on the need for the BPCIA, the savings it brings to biosimilars, the public health benefit, etc. We have seen many stakeholders such as patient and consumer groups, be very supportive of biosimilars in all kinds of contacts and I think that many of them are looking for ways to engage on this case.

So, I think it will be tied up in the court for a bit of time. The decision and the oral arguments aren't expected until the fall, which means a decision would happen after the election, probably in early summer. And if the Affordable Care Act falls to this challenge, then the BPCIA would need to be reauthorized by Congress as a standalone piece of legislation. I don't think [that] is any anyone's desired outcome, because every time you revisit a piece of legislation, there are always opportunities for interested parties to try and leverage that and ask for more or ask for things that weren't clear to be taken away. So, it's a bit of a challenge and we're very hopeful that it will be severed.

CfB: Thanks, Christine.Simmon: Sure. Thank you.

CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia, thanks for joining us.

You can watch part 2 of this interview here.