AJMC®tv Interviews, October 2017

Amanda Forys on How Medicare Will Refine Its Biosimilar Policy

Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team, discusses how Medicare will address and possibly change its biosimilar policies as the FDA offers more guidance and as biosimilars become more prevalent in the market.

How do you think Medicare may refine its biosimilars policy as the FDA releases more guidance and more biosimilars reach the market?

FDA guidance could affect a little bit of what Medicare is doing. The FDA and CMS are going to have some lessons learned moving forward. There are a lot of other really big issues coming up around the Medicare program in general, that could affect biosimilars and could affect all products. A couple of those things, I believe, are going to be hot-button issues, but I’ll start with just biosimilars in general.

Right now, with a biosimilar, the originator product has its own billing code and all biosimilars to that originator product are grouped together into a billing code. In the industry, a lot of members of different biosimilar forums and other councils for biosimilars have not been interested in keeping it that way and have been working very hard to ask that they each get their own code. They’re saying that these are products that are each unique, they are not biosimilar to one another, so grouping them together is quite confusing for providers and was not necessarily the intent of the BPCIA [Biologics Price Competition and Innovation Act] when that legislation was passed. There is a lot of tension there with CMS and people asking for them to split the codes up.

Then you have MedPAC coming in and they are saying we want to simplify the whole system and what we’d like to do is we’d like to see the originator product and the biosimilar grouped together and share a code. When that happens, you are going to see the price of that originator product drop substantially and that will really save the Medicare program money. While, in theory, yes that probably could save money, the intent of the BPCIA isn’t necessarily clear, and that may not be possible, it might not be something you can do legally, by grouping those products together with the way the biosimilar is defined. That’s going to be something that has to be ironed out and you may see some guidance as interchangeables come to the market and the FDA irons out interchangeables you might see them say, how are we going to treat that? Are we going to give that its own code, its own separate billing code? Are they going to be grouped with all of the other biosimilars? Will they even share a code with the originator product because they are an interchangeable? We just don’t know yet. That is something that could be a concern or an issue for biosimilar manufacturers. It’s just really ironing out payment.

Also, to see some of the other pressures to control drug prices, that’s a huge hot topic right now on [Capitol] Hill. Are you going to see CMS suing significant things to change the average sales price base payment methodology that they have for Medicare Part B drugs? Could that happen and, if so, how will that affect the market? I think you’ve got what’s happening in general and then how will that affect biosimilars, just as much as how is the biosimilars market going to change. On the Part D side, we are definitely going to need to see more clarification on [whether] a biosimilar can be considered a brand, that is something that manufacturers are looking for and asking for that clarification, so that they can offer that 50% rebate in the coverage gap for patients. So, that is something that will be defined more and more. MedPAC has recommended that be put in place, so we will see if that actually happens in the future.

Dr Brandon Shank on Biosimilar Naming and Suffixes

Brandon Shank, PharmD, MPH, BCOP, clinical pharmacy specialist, discusses the merits of the current biosimilar naming system.

Could 4-letter suffixes to the names of biosimilars create confusion?

One benefit of the naming system is that you know what the reference product is. Some clinicians, pharmacists included, and patients may assume interchangeability, which may not be inferred by the naming system. It is important to have a way to differentiate these products so that you can know which ones are interchangeable, so that ones with different indications will also be recognized and not be used for the wrong indication. Also, dosing and administration differences in products may also be assumed with the naming system, which is why the suffix will be helpful in those situations.

I also believe that with this naming system, they need to differentiate the products in the computer order systems and be able to have adverse event reporting that distinctly identifies them, which the naming system will with the current suffix system.

Kim Woofter: Data at Point of Care Necessary for Success in Value-Based Models

As the healthcare industry moves increasingly toward value-based payments, practices have a greater need for usable data that can help them succeed in new payment models, said Kim Woofter, executive vice president of strategic alliances and practice innovation at the Advanced Centers for Cancer Care, at OncoCloud ’17, held by Flatiron Health September 16-17, 2017, in Las Vegas, Nevada.

What are the main challenges to implementing value-based payments in oncology?

So many practices do not know exactly what it costs for them to deliver that care, so they can’t get into value-based care if they don’t truly know what it costs them. There’s too much risk involved. And, so, organizations, such as Flatiron Health, [provide] some of the consolidation of data and the ability to look at your patient base over a continuum, so that you can actually go into a value-based model with information or well informed, and that will help you to be successful.

How can practices ensure that all the data they are receiving and have access to are being used at the point of care?

That’s a really good question, because to use data at the point of care, it has to be cleansed and streamlined and it’s a very difficult task to get into the hands of a provider. It takes a larger organization with some real knowledge about the workflow of a practice to actually make that happen. I think you’re seeing that in some of the Flatiron tools that are being developed right now.

Dr Kashyap Patel Discusses Biosimilars and Medicare Part D Drug Pricing

Kashyap Patel, MD, medical oncologist, Carolina Blood and Cancer Care, highlights the potential impact of biosimilar drugs on Medicare Part D drug pricing.

What would be the impact of biosimilars on Part D drug pricing?

So right now, our country is facing a drug price explosion. There’s been a couple of areas where it’s growing fastest—the hematological space, where we’re growing about 12.9% per year in terms of cost, and
in the oncologic space, [which is] growing at 4.9%. So, we don’t have infinite resources, and at some stage, the system with either implode, or we have to look at drug pricing. Biosimilars do have a role. They can help in reducing some of the additional escalation of the expenses. When we go back and look at the European experience, in Europe, in 10 years’ time, drug prices have dropped by about 30% compared to the reference product. So clearly biosimilars do have a significant role that they can play in the Part D drug pricing space, and they also improve access as well, so biosimilars have a very valid and legitimate space in becoming part of the solution for Part D prices.

Robert Cerwinski on Healthcare Reform and the BPCIA

If the Affordable Care Act, the ACA, is repealed, what becomes of the Biologics Price Competition and Innovation Act (BPCIA)?

So, the BPCIA is part of the ACA, and if Congress repeals it lock, stock, and barrel, without having some replacement ready to go, technically the BPCIA goes with

it, right? I don’t think any of us expect that that’s going to happen, but I’ll tell you that with the current administration and with the current Congress, uncertainty seems to be the rule. The BPCIA so far, in all the debate that we have been hearing and monitoring in Congress and in the administration, seems to be flying completely under the radar. It does not appear to be one of the controversial aspects of Obamacare that the president and Congress are really focused on.

From that standpoint, that’s good for biosimilar applicants, but again, because there is this uncertainty, we have at least been watching it. I think I can say that nobody really expects the BPCIA to go away, and we
don’t think it is seriously at risk, but certainly we watch what Congress is doing in this respect.

Dr Bruce A. Feinberg: Biosimilar Labeling and Extrapolation

What are some considerations in the labeling of biosimilars?

The biggest consideration in biosimilar labeling is the fact of extrapolation. Extrapolation relates to the fact that a biosimilar that may have a half-dozen specific disease indications,

will likely only be clinically tested in 1 of those indications. If it is proven to be equivalent by all the different measures the FDA is using, then the FDA appears to be granting, by extrapolation, the expanded label to all indications. So, there is a big difference from a branded drug, which had to have clinical trials in each of the 6, to a biosimilar which is only going to have a clinical trial done in 1 of the 6.

Dr Lee Newcomer on Policy Decisions as New Immunotherapy Agents Are Developed

Lee N. Newcomer, MD, MHA, senior vice president of oncology and genetics at UnitedHealthcare, discusses off-label communications and how coverage determinations are changing along with the production of new immunotherapy agents.

How are coverage determinations being made for newer immunotherapy agents? Are policies being developed for CAR T-cell treatments?

Our policy about making decisions on new technology has never changed. In cancer, we rely on the National Comprehensive Cancer Network [NCCN] guidelines, and so that decision is made actually external to UnitedHealthcare by about 25 of the world’s leading cancer centers. If they tell us there’s enough evidence to approve it, we approve it. CAR T won’t be any different, nor will the new immunotherapies.

You need to develop evidence, the professionals need to recommend them based on that evidence—and that’s how we decide. The one thing about CAR T is that it’s going to be very expensive. Those therapies will cost anywhere from half a million to $2 million per treatment, and so we are organizing both to provide the financing for that and to make sure that the right centers provide that care.

What kind of off-label information would prove useful for payers? What do you think is the impact of off-label communications?

Well again, we rely on the NCCN, so there’s plenty of evidence sometimes for off-label indications. In fact, most of the indications for cancer are o -label, but we’re looking to the NCCN to weigh the evidence to support it. So, it’s their call but the more studies you do and the stronger the studies are, the more likely you are to get a recommendation from the NCCN.

What have been some lessons learned as United Health has implemented value-based contracts with providers? And how is the data you gather being used?

Well, all of this is hard work. The first lesson is, you really do need to half a good comparison database and we’ve spent almost 8 years building that database. So, we now have fee-for-service patients where we have clinical information, enough so that we can match the patients that are being cared for by a medical group in our episode program. If we can do that exact match, then we can compare apples to apples, rather than apples to oranges and it makes for a much fairer comparison and more accurate results. But, building the database it tough.

I think the other big barrier is that physicians and practices have never had internal data systems—they don’t know how to measure their own performance. When we put them at risk, one of the things they learn very quickly is that they need better information inside their practices. We’re helping with that by providing them claims data to help with that area, but it’s not enough to do that just alone. All of us are learning as we go through this experience, and the good thing is that patients are getting better care because of it.

What work do you do with physicians to help them implement things like episode-based payments and educate them?

An episode payment is partnership; we both have the same incentive now. The more we can bring cost down and improve quality, the more we both win. The physicians will make more money and our patients are better served. So, rather than have a conflict here, that we do in fee-for-service, we now have a partnership where we are bringing them data from the claims system to show them what they could do differently. We are bringing them comparison data from other groups to show who’s got maybe a better way of solving a problem. We bring them together every year for a round-table discussion to look at that data and talk among our- selves about what our best practice is. Partnership is key and we are now working together because we have the same common goal.

Download PDF: AJMC^®tv Interviews, October 2017