The Trump administration has signaled that it will require drugs’ list prices to be included in direct-to-consumer advertising. Are there any legal complexities with this proposal?

The administration’s TV drug pricing proposal—we’re going to be hearing about for a while, I think. It’s clear that the industry came out the day that the plan was rolled out in saying that they were going to challenge it legally&mdash;pharma did. And there’s certainly grounds for a first amendment challenge, to be seen whether it’s a challenge that will be upheld. But one can say that the proposal, which is actually a rule that has been put out there, will be attacked for saying that it puts out information that is misleading. It doesn’t tell people what they really need to know about the actual pricing of drugs.

So, if you look at other mandatory pricing, like, for example, gas stations which have to post prices, there you really know what am I going to pay for a gallon of gas, whether it’s credit or cash, which is always funny because you know, the cash is always such a discount.

But, will this proposal ever see the light of day? It’s a rule, so it has to go through the regulatory process—in other words, comments, and then be finalized before it takes effect. That process…you can be fast-tracked but it usually takes a couple years so you know, it’s out there, it can be pointed to [by] the administration as a way that they’re taking action, but we’re a long way from seeing it being implemented. I can imagine that if it were to be made a final rule that the industry at that point is going to try to seek an injunction to get the court case heard prior to anything going into effect.

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James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses HHS’ proposal to require that drugs’ list prices appear in direct-to-consumer advertising. 

James Shehan, JD: List Prices in Drug Advertising

Do anticancer biosimilars have a role in bringing down the cost of oncology care?

The role of biosimilars and the cost of cancer care remains to be determined. There is little doubt that the introduction of generics in the small molecules made a tremendous difference in terms of reducing the cost of cancer care. It was counterbalanced by the introduction of predominantly new biologics.

So that was the last 10 years, and now we’re entering a phase where the equivalent of “generic” biologics is starting to make an impact on the market. What we saw in the small-molecule generic was discounts ultimately as high as 80% or 90% as the third or fourth generic drug came to market. It has been argued that we will never see that kind of a discount in the biosimilar market because the compounds are far too complicated to manufacture and the regulatory burden on manufacturers to meet FDA muster is substantially greater, and that’s undoubtedly true.

But let’s remember that if you look at the cost of care over the last 10 years—the rise in the cost of cancer care related to drugs&mdash;are actually due to 2 classes of agents, 1 being oral specialty pharmacy agents where the increase is by far the greatest, but the second are the biologics.

So, even a 10% or 15% discount for a biosimilar agent that is embraced by the clinical community could mean millions or even billions of dollars for a payer. So, the answer is yes.

Now the fascinating thing is this week*, Coherus announced they were going to come in at 33% lower than the reference product, which is Neulasta. That has rocked the market a little bit and may wind up being a bellwether for what we’re going to see as we see other biosimilars, including the big therapeutic biosimilars which we’re going to see coming in the next couple of years—biosimilars for Herceptin and Rituxan&mdash;we will see.

 reduce the cost of care. The question is how much.

Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, Inc, discusses how much anticancer biosimilars will impact the cost of cancer treatment.
 

Michael Kolodziej, MD: Anticancer Biosimilars and the Cost of Cancer Care

In your work with the World Health Organization (WHO), have you seen a positive impact of biosimilar availability for patients in countries with limited resources?

In 2015, WHO approved trastuzumab as an essential medicine for cancer. That was the first expensive, patented medicine that they put on their essential medicines list for cancer. Our hope was that that would help to drive the price down, and that’s not in fact happened.

In most of the places that I’m aware of, in sub-Saharan Africa, or areas of the Caribbean or South America, trastuzumab is still not available. It’s still not affordable and we’re not close to making it affordable. I think WHO has played its role in this, companies have picked up the biosimilar torch and have developed their own products, but we still need some effort to bring the price down or find other funding mechanisms that can make drugs like trastuzumab, which can be life-saving, make them affordable to a larger portion of the world’s population.

Lawrence Shulman, MD, deputy director for clinical services and director of the Center for Global Cancer Medicine at the Abramson Cancer Center at the University of Pennsylvania, discusses the global impact of biosimilar trastuzumab.

Lawrence Shulman, MD: The Global Impact of Biosimilar Trastuzumab

Well, the way payers are going to approach biosimilars depends a little bit on the behavior of the reference product manufacturers.

Let’s say that the reference product manufacturers decide that they don’t really want to compete on price. In which case, I will predict that the commercial payers particularly—and that includes Medicare Advantage&mdash;will institute a policy similar to that around the use of generics. That is, they will require the use of the biosimilar first unless there’s a reason you can’t use a biosimilar.

But of course, in today’s world, we have the potential for manufacturers to undercut the price of the biosimilar product by offering a rebate. That is in fact already happening quite extensively in the inflammatory disease space; we will see what happens in the oncology space.

Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, Inc, discusses how payers are planning for biosimilars.
 

Michael Kolodziej, MD: How Payers Are Preparing for Biosimilars

Trastuzumab has been one of the great advances in breast cancer care over the last several decades. When it was approved in 2005 as an adjuvant therapy for patients who had HER2-positive breast cancer, the mortality rate for those patients went down by almost 50%. There are very few things that we’ve done in cancer medicine that have had such a dramatic effect on overall survival.

But it’s a very expensive drug, and the estimates are that it’s about $40,000 for a course of adjuvant therapy, and that’s a strain on the health system and it’s certainly a strain on patients and their families as well.

Biosimilars have started to come on the market, and I think they’ve been brought on the market very responsibly. The companies have done good trials to show that the effectiveness and the toxicity protocols and profiles are equivalent to what we’re seeing with the native Herceptin from Roche and Genentech. On the other hand, the biosimilars have not dropped the price substantially.

While we’re anxious to see them come on the market and we’re looking forward to competition driving the price down some, we’ve really not seen that effect yet in the [United States] or elsewhere in the world.

Lawrence Shulman, MD, deputy director for clinical services and director of the Center for Global Cancer Medicine at the Abramson Cancer Center at the University of Pennsylvania, discusses the arrival of biosimilar trastuzumab.

Lawrence Shulman, MD: Preparing for Biosimilar Trastuzumab

What types of reforms would you like to see in the US patent system?

So the types of reforms we would like to see in the patent system, what I would like to call inventions, I believe the patent system has conflated innovation with invention. Those are 2 distinct concepts. Innovation has all sorts of ingredients in it; it could be marketing or just commercializing existing technology.

So what we would like to see is returning back to what is a higher bar, in our opinion, of inventiveness, and we believe the patent system has, at least in the US, lowered the bar so that we get more patents coming through, and we believe that there’s a desire to increase investment, but those are different issues when it comes to dealing with monopolies.

Our first real concern is how do we raise the bar and how do we improve the standards of patentability so that we are getting real, genuine inventions and not these low-bar little minor, marginal changes which really, in my opinion, fit the description of innovation but are not inventive for the purpose of getting a 20-year monopoly.

Secondly, we believe, and we’ve seen this across the 12 top-selling drugs in our studies and particularly with Humira, is patent applicants or patentees can keep filing the same applications over and over again. These are called continuation applications, and essentially what you end up with is a system where the company is never refused a patent, and if the USPTO, the US Patent and Trademark Office, refuses an initial application, the applicant can keep refiling it in a slightly different claim form and keep getting those applications; essentially, it’s a war of attrition. And so you keep filing these, and what these continuation applications can also do strategically is, if you see a competitor coming to the market with a slightly different formulation or different method of use, you can slightly tweak your existing patent application as it lingers in the system, even if it may be even 10 years after the original patent is filed.

And so these are all strategic behaviors that branded companies have adopted in order to delay competition, and we believe that the continuation system should be, if not removed, at least severely restricted so that companies don’t abuse it and keep stacking up these patents to delay and extract litigation.    

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses ways to reform the patent system in the United States.

Tahir Amin: Reforming Drug Patents

Are there policy changes that would make the United States a better market for biosimilars?

Definitely we need policy changes, but how quickly we can implement what needs legislation, what needs regulations…all of those are delays, so I think what it comes down to is people understanding better what biosimilars offer; that as an economic matter they are essentially generics, and realizing because they’re approved by the FDA they are of the same quality and will have the same clinical outcomes as their reference. There are questions being raised that make it very, very difficult for biosimilars to penetrate. Plus, it takes a significant investment—about $500 million, a hundred times a generic—to get them to market. So, there needs to be a return on investment and yet, they’re being treated like brands, expected to be cheaper but costing more to produce. And so it’s a serious uphill battle.

Gillian Woollett, MA, DPhil, senior vice president of Avalere, discusses policy and biosimilars in the United States.

Gillian Woollett, MA, DPhil: Policy and Biosimilars

What are the implications of the recently passed law to have the Federal Trade Commission (FTC) and Department of Justice (DOJ) review settlements between brand manufacturers and biosimilar developers?

Having the DOJ and the FTC review settlements is the norm already in the small-molecules world, so it won’t be anything unexpected or different for the biologics world. As a policy it’s been enforced quite strictly; in fact, since that policy had taken place for small molecules there’s been over 12 challenges by the FTC against individual settlements. 

So, there’s been a very aggressive tack. I will add on here at the P4 conference this year an FTC representative came to speak and she explained that the FTC will be continuing to be aggressive in all settlement enforcements for anything of value and just a launch date, and I expect that the same will stay true for biologics.

Imron Aly, JD, partner at Schiff Hardin LLP, discusses a recent law that will involve new regulatory oversight of biologics settlements. 

Imron Aly, JD: FTC and DOJ Involvement in Biologics Settlements

What are practices doing to prepare for the arrival of anticancer biosimilars, and how are nurses in particular being educated?

Well from our practice, we have a very large pharmacy, our own in-house pharmacy Rx to Go. They are preparing by meeting with the pharmaceutical companies and trying to find the best options payable as well as delivering the drug.

Then we work with the pharmacists there who give us education. For our care management department, we rolled that out in webinars to our nurses so that they’re well aware of the side effects and how to manage the patient.

Beth Wittmer, RN, OCN, senior manager of care management at Florida Cancer Specialists, addresses how nurses are being educated about biosimilars. 

Beth Wittmer, RN, OCN: How Nurses Are Preparing for Anticancer Biosimilars

How are you seeing biosimilars impact the world of specialty pharmacy?

I think that the promise of biosimilars to bring down the cost of drugs is certainly out there based on the experience that we’ve had with generics. I’m not sure that we’re really seeing the impact as great, though, because the prices of the biosimilars are not that much lower than the other drugs—so, maybe 25% to 35% reduction.

I think also, in some cases, I think providers are not—they might be a little bit more reluctant to switch in the case of a therapeutic agent until there’s more clinical evidence of efficacy. And that’s not the case necessarily with supportive therapy, where it’s much easier to make that switch.

So, impact there, promise still there, I think there could be some pricing advantages to the providers that have a “buy and bill” program or they pay a little bit lower price for the acquisition of the drug. Then, if it’s reimbursed at [average sales prices, ASP] plus 6%, they just have a lower cost basis on a drug, so there’s some economic advantages too.

Charles Saunders, MD, CEO of Integra Connect, discusses the promise of biosimilars in specialty pharmacy.
 

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