Evidence-Based Oncology

Immunotherapy in Cancer Care: Understanding the Impact of Shifting Treatment Paradigms in the Managed Care Setting | Page 3

Published Online: March 20, 2014
Part Two
Dr Salgo continued the discussion by asking Dr Kolodziej to provide examples of cost effectiveness or quality-of-life data that would aid in these decisions on coverage and reimbursement. Additionally, he asked if money was the major driving force in the decision-making process and whether the benefit of therapies was underestimated.

Dr Kolodziej: As we discussed before, that has typically not been the process,  partly because it’s politically unpalatable.  In addition to poor quality of data, it is a difficult pill to swallow.

If a medicine invented tomorrow could cure cancer, people would get it. We would, as a society, decide it was worth it irrespective of what the price is. The elephant in the room is why do things cost so much money. We’ve heard the excuse that drug development is expensive and maybe that’s right. It’s not my area of expertise. Are we going to get at the ultimate cost of developing a drug? What a fair price is? Is the government going to step in?

Dr Weber: Part of it’s because so many drugs fail.

Dr Kolodziej: We will see. I don’t know where the truth lies, but I don’t think it’s an accident that everything costs $10,000 a month now. You said it yourself. It’s what the market will bear.

Dr George: When you talk to drug companies and ask, “How do you set the price? Why do you set the price so high?” They’ll come back and say, “We have to.” Like Dr Kolodziej says, it’s not

his money. He’s really just being a steward. They’re stewards of their shareholders, and their shareholders will come back and sue them if they don’t price that drug at what it maximally could be priced at. That’s the capitalist society that we have.

Dr Weber: It’s a very simple solution in the capitalist system: if nobody wants to buy your product, it doesn’t matter how much you charge—you’re not going to make any money. But if you drop the price and people start to buy it, then you might start to make some money.

Dr Kolodziej: But we’re going to see a very interesting thought experiment play out over the next 18 months with TKIs (tyrosine kinase inhibitors) and CML (chronic myelogenous leukemia).

Recently there was an article in Blood where the CML researchers went out there and said, these drugs are really, really expensive. We’re not sure why they cost so much more money. The new ones cost more and have small incremental benefit. So what’s the thought experiment? Imatinib goes generic in a year, which means that we’re going to have drugs like dasatinib or nilotinib that cost from $8000 to $10,000 a month and we’re going to have imatinib. And I don’t know what it’s going to cost. Let’s just argue $1000 a month or $500 a month. So should we step? Should we require people get imatinib first? Is there a reason not to do that? Now we have this scurrying going on about trying to define a value proposition for the newer TKIs. Yes, they have a better depth of response and a better molecular profile. The question though is if you start with imatinib, is there any risk to the patient of doing a step?

Dr Salgo furthered the case for immunotherapy by sharing beneficial data on Provenge. This therapy for prostate cancer resulted in fewer hospitalizations (1.2% versus greater than 26%), fewer discontinuations, and fewer deaths than AEs (adverse events) with docetaxel in prostate cancer. These data suggest that Provenge could save money compared to traditional therapy,

and it is only administered once.

Dr Kolodziej: People don’t get either/or. Talk about disingenuous. People know that there’s a lot more toxicity with chemotherapy. People who fail Provenge get chemotherapy later. It’s not the right question.

Dr Salgo: But take it the other way around. People who do well on Provenge don’t, and then it may be much more than cost-effective. Dr Weber?

Dr Weber: The benefit to Provenge is the same way they get docetaxel. The clinical trial that was done, these were clinical trial patients in the United States, and only 50% of them got docetaxel chemotherapy when that was really the only other approved therapy at the time for advanced prostate cancer. So I would just push back on Dr Kolodziej a little bit. I’m not sure that everybody is going to get every therapy with prostate cancer or even kidney cancer. If you look at our registry on kidney cancer, 20% of patients have third-line therapy. So  there’s a drop-off with each of these, and some of that is disease progression and death, and in some cases patients don’t want any more therapy. Considering the heterogeneity in this field, moving some of these therapies, particularly immunotherapies that have demonstrated the greatest value in the long-term survivors, to me makes the most sense. If you’re going to use those treatments, use them in a setting where they have the potential for that patient to live long enough to really get a more absolute benefit, whether it’s due to sequential other therapies or not.

Dr Salgo then asked Dr Weber’s opinion on the impact of the ACA (Affordable Care Act) on the coverage for cancer in terms of immunotherapies.

Dr Weber: Obamacare consists primarily of expanding the equivalent of Medicaid to a larger chunk of the uninsured population, which is a good thing. This country has a huge proportion of uninsured folks; I’m sure we have the highest share in the industrialized world.

That means patients who did not have insurance in the past will now be able to come to Moffitt, which has some modest proportion of charity care, but most everybody we see has some insurance. It means we’ll be able to see more patients, get them on better treatments, get them on trials, which is a plus. There will also be some reasonable guidelines, as there are for can you use ipilimumab, can you put them on a trial? So I don’t have a problem with that.

Dr Salgo: What about ACOs (accountable care organizations), organizational models such as that; are they feasible for oncology reimbursement?Dr Kolodziej: I would agree with Dr Weber. I think the thing that we’re going to see most immediately is the health insurance exchanges and the expansion of Medicaid, which will provide a large number of patients, who previously

had no health insurance, some health insurance.

Dr Salgo: The number is 40 million or so.

Dr Kolodziej: The truth of the matter is that we actually don’t really know how cancer patients are going to be taken off within that construct. Because the benefits design is a very basic benefits design. It’s better than nothing, but I think the question is, so how do you take care of cancer in that universe? I assure you they would pay premiums in the health information exchanges for several years for how much it costs for 1 cycle, 1 treatment of Provenge. So I think its unclear how cancer care is going to happen in that world. Now, that’s the immediate change. The long-term change of course is going from fee-for-service, paying for transactions to paying for value. When I was in practice, I thought, “There’s no way that ACO is going to happen,” and you know what, now I think they’re going to happen.

Dr Salgo pointed out that he did not agree with this. Since a part of the drug cost includes research and development, if the drug manufacturing cost alone is covered, then it might just freeze the system.

Dr Kolodziej: We talked about the possibility that up to 30% might be waste. I’ve always thought of that as the pool of money to pay for innovation. That’s my own perspective, not Aetna’s, but I’ve always thought that’s a lot of money…So the challenge is “Who’s going to be the ACOs?” There are integrated delivery systems like the Mayo Clinic and Geisinger. There are numerous hospitals that aspire to transform themselves to be ACOs. There are a lot of reasons why it’s hospital systems, but let’s just accept the fact that hospital systems are the predominant player in this area. They’ve got to really change the way they’re thinking about care. Keeping beds full is no longer your primary driving force…If we can execute that change, that’s where the money comes from.

Dr Salgo then specifically asked Dr George and Dr Weber how they thought the ACA would particularly impact immunotherapy. In their opinion, would it help or hurt the implementation of immunotherapy and research and development?

Dr George: This is a dynamic area. This is a phased healthcare reform and, as pointed out by Dr Kolodziej and Dr Weber, the first phase is greater access to patient care. Now, these are expensive therapies and to what extent the basic plan, or the Medicaid plan, covers an expensive therapy remains to be seen. But I’m encouraged because patients who are most likely to benefit most from immunotherapy are going to be more likely to have some insurance to allow us to treat them. The societal benefit is that we treat the right patients with the right drugs, and avoid waste.

So the patients that have some coverage now they can get that, and we’ll be able to increase that enrichment strategy.

Dr Salgo: Is the way to carve out your 30% waste that you could put it going forward, is that going to be at the cost of small practices versus large practices, large practices that achieve economies of scale?

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