Evidence-Based Oncology

Immunotherapy in Cancer Care: Understanding the Impact of Shifting Treatment Paradigms in the Managed Care Setting | Page 2

Published Online: March 20, 2014
Part Two
Dr Salgo continued the discussion by asking how payments are made; questions such as is it a single payer, is there a committee that decides, is it practice-driven? He also asked the panelists to discuss the influence of the 12-month review by the Centers for Medicare & Medicaid Services (CMS) on Provenge and other immunotherapies on managed care.

Dr Kolodziej: The situation varies by payer. We have an evidence shop that adjudicates the evidence. We do pay attention to bodies like the NCCN (National Comprehensive Cancer Network) as we make our determination. It’s interesting because that particular committee is actually firewalled off from the coverage policy committee and the pay committee. So the evidence shop is all about evidence, but they do respect what other people say….As for the CMS review, I wasn’t at Aetna then, but I don’t think the review had much influence.

CMS had already decided they were going to pay for it, and then they opened the national coverage decisions. Additionally, the FDA had approved the drug and there was already a coverage policy in place. I don’t think that it didn’t make people feel that they got it right.

Dr Kolodziej pointed to the example of bevacizumab in breast cancer treatment. The FDA withdrew approval, but CMS still pays for it and NCCN still recommends it.

Dr Salgo continued the discussion on decisions made on the cost of treatment. One treatment may cost $100,000, while another may cost less initially but must be taken over several years, with possible hospital admissions and treatment for side effects....

He asked whether the actual cost of treatment had been estimated for Provenge, ipilimumab, tumor-infiltrating lymphocytes (TIL) for melanoma, transduced T-cell therapy, and other high-attention agents.

Dr Weber: Well, they’re going to be very different with TIL, which is essentially a 1-time treatment. The approved regimen for ipilimumab is 4 doses over 12 weeks. Maybe you’ll get reinduced somewhere in the future but usually not. Some targeted drugs are taken every day forever until you progress, and if the BRAF/MEK combination has a 2-year median survival, that means

half the patients will be on for a year or more. So that could get even more expensive because if it’s $100,000 a year and you’re on for 3 years, now it’s $300,000.

Dr Kolodziej: Leave cost out of this for a second, okay? How many drugs are available for renal cell cancer? Six?

Dr George: Seven.

Dr Kolodziej: Seven oral agents? I suspect, and I did a lot of genitourinary medicine when I was in practice, if you start with drug A and then give drug B, that may be different than starting with drug B and then giving drug A. However, if you talk to people who do renal cell, they will come to you and say, I intend to use every drug, every single one, as long as the patient can tolerate it….

Now, is that the right thing to do? I don’t know. In some cases it’s futile. But we actually don’t know the answer to that question.

Dr Weber: It’s a testable question. All the more reason why Aetna should be supporting that kind of research.

Dr Kolodzieij: It is a testable question. The data that are required to do that is, it may sound simple, but it’s not so simple. So this is the heart of comparative effectiveness. And we will come to a point where those questions are going to get answered.

Dr Kolodziej said comorbidities make such answers complex, and costs may be spread in many places. But he agreed with Dr George that the real questions are: how much does it cost to take care of a patient with cancer, and what is the timeline? Patients who respond live longer and live better. Dr George said these questions affect how patients are selected for clinical trials.

Dr Salgo then specifically asked Dr Weber to explain some of the factors that would determine a product’s cost versus benefit.

Dr Weber: Well, the cost is obviously set by the pharmaceutical company; as Dr Kolodziei said, the process is ambiguous. Although, my gut, by the way, is it’s whatever the market will bear, and we do live in a capitalist economy. The FDA explores this extensively because they’re always thinking risk-benefit. That’s the charge of the FDA and the Code of Federal Regulations.…However, we think about this as oncologists. Can I take an 85-year-old and give him ipilimumab if he’s got Crohn’s disease? Well, that’s probably not going to happen. So I have to always make the assessment, as all of us do as physicians, of will a patient be able to tolerate a drug, does the drug have more than marginal benefit, and what’s the likelihood it’s going to prolong survival with a decent quality of life?

Dr Salgo then asked the panelists to define meaningful improvement. What is reasonable improvement if the length and quality of life is weighed against the cost of treatment?

Dr Weber: Well, I think most people in the business would say, as a rule of thumb, if you have a prolongation in survival with a hazard ratio of 0.75, meaning you have a one-third increment in survival over the control group, that’s probably meaningful. However, if that increment is weeks or a month, forget it. If that increment is months added to a baseline of a year, then yes.

If someone said we’d like you to do this, you’d live a year with the control, 15 months with the drug, which is a 25% or a 30% increase, I’d say, that’s reasonable.

It’s marginal benefit, and Americans are willing to pay a certain amount of money in general per year of qualityadjusted life gained. And that turns out to be $50 to 150,000. If I told you, as the consumer, that, well, we’re going to give you this therapy to prolong your life by 6 months but it’s going to cost $500,000 and there were a couple of hundred thousand of you in a survey, you’d probably give it thumbs down.

Dr Salgo asked whether the government or the provider is obligated to honor the patient’s decision to follow up on an expensive treatment. Where do you draw the line?

Dr Weber: It’s not clear to me whether I am obligated to honor that as a physician.

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