Matthew Ong: What were your first thoughts when you read the draft guidance by the subcommittee?
Richard Goldberg: My first thoughts are that it has become a standard part of practice to do NGS on patients. I work in the GI oncology world, and mainly do colon cancer, and we do it on patients at first sign of metastasis, partly because we need RAS testing, but also because we’re looking for tumors that exhibit microsatellite instability, as those tumors are more likely to respond to treatment with immuno-oncology agents.
The main reasons for wanting to do NGS is that if you can find a driver mutation with a specific drug that’s targeted to it, or if you can find that tumors have a high mutational burden and are more likely to respond to an immuno-oncology agent, you can give patient those options. So, I would say that most sophisticated patients and most sophisticated oncologists are doing this testing.
Every week, I have another vendor coming in—you’ve got Caris, Foundation Medicine, Orion, groups that are doing the blood-based assays—there’s huge investment in this technology and a huge marketing effort for it. The utility of NGS is becoming more apparent every year, and the field is changing rapidly so that, looking at the outcomes of analyses that were done in 2015 as was done by the Oregon tribunal, those are recording data that were done before then, at a time when we understood the technology less well, and a time when we had fewer targeted options.
At one point in my life, I ran a new technology assessment committee for Geisinger Health Plan, which is an insurance company, and we had a panel of people who deliberated and tried to decide when something had sufficient evidence to be covered. I’ll give you an example—proton beam therapy for people with prostate cancer, which we wrestled with way back then.
This is sort of a similar circumstance; technology that’s emerging. It is a difficult judgment to determine when it becomes standard or when is it experimental.
Clearly, it was standard enough that the FDA approved of NGS testing from Sloan Kettering and Foundation Medicine technologies and those two panels of genes. NCCN is recommending it, and Medicare is covering it. Those are all significant endorsements of the technology.
Since you say this is the standard of care in colon cancer—solid malignancies—and you use NGS testing routinely for your patients, why would the Oregon subcommittee say that there is no direct evidence of clinical utility in solid tumors?
RG: They cited, as you saw, several studies, all three of them from 2015—two of which show no survival benefit, one of which show there’s survival benefit—and they used that as their database, I think.
Is that database cherry-picked?
RG: I think it is, likely. I have to admit that I haven’t looked at all the data recently, but based on what I know, we are doing this standardly in lung cancer patients, in GI cancer patients, in melanoma patients. It’s a standard of care in the management of patients with advanced disease, particularly as they become refractory to standard therapies.
From your perspective as a director of a cancer center in West Virginia, if this recommendation is enacted in Oregon, what does this mean for low socioeconomic status patients who rely on Medicaid for cancer treatment? Would it harm them? Would this widen disparities?
RG: I do think it will have the potential to widen disparities, because patients with private insurance will often get coverage for this, and therefore, will have more options than those who don’t get this testing done, because they lack insurance coverage of NGS testing. It’s gotten to the point where, for studies like ASCO’s TAPUR, having genotyping done is necessary to be considered for the trial. And so, both on and off trials, this is relevant.
Is it bad science to deny access to NGS testing?
RG: My opinion is that patients should have equal access to technology that is becoming useful in improving outcomes, regardless of which insurer they are covered by. There shouldn’t be disparities between private-paying insurers and government-paying insurers, and government insurers like Medicare vs. those that cover low-income individuals.
I can tell you that every week, we’re doing NGS tests on Medicaid patients in West Virginia as well as on patients with every other kind of insurance.
Has West Virginia’s Medicaid program made a coverage determination for NGS tests?
RG: Not that I’m aware of.
If this becomes real policy in Oregon, does it set a precedent for Medicaid programs in other states, including West Virginia, for instance?
RG: I would think it does, because there is no obligation for a state to follow a national coverage determination, as I understand it. That is because Medicaid is a state-administered and funded program.
Would private insurers also look at something like this and say, “Look, Oregon isn’t paying for it, so that’s our scientific rationale”?
RG: Yes, I think that’s also a possible outcome of this. In the end, these deliberative bodies are made up of people who are educated, but variably expert on the technologies that they are evaluating, in a time when the utility of technologies is evolving extremely quickly.
So, I think it’s reasonable to ask the question, “Did they evaluate the most up-to-date data that’s out there in making their decision, and how different is the data going to be after this year’s ASCO than it was after last year’s ASCO?”
In another interview, someone asked me who Vinay Prasad is and I said he was known this year for the debates at ASCO and AACR…
RG: …who gave the various “no utility to personalized medicine” talks? Yes. I would say that he is not an unbiased evaluator of this technology.
Another oncologist, who is quoted in this story, also said that since Prasad had “pre-formed opinions,” Prasad should’ve recused himself from the conversation. I don’t know if this is the right question to ask, but since he’s not unbiased and believes that precision oncology is “mostly hype,” do you think it’s ethical for him to chair this subcommittee?
RG: I think it’s ethical for him to chair this subcommittee. Whether he should’ve recused himself from this particular deliberation is another question, and I would’ve said, “He should have.”
Because, if nothing else, it’s raising the question of: Is he grandstanding? Or is he being an unbiased judge?
If I were in his situation, I would’ve recused myself.
From this particular deliberation that has real impact on cancer treatment for Medicaid patients in his state.
RG: Right.
Did I miss anything?
It’s a standard of care in the management of patients with advanced disease, particularly as they become refractory to standard therapies.
RG: I would say that, based on my personal experience with findings from NGS, I have made therapeutic recommendations that have been of value to patients. The difficulty with that is individual patients vs. populations of patients, and the relative cost-effectiveness of doing the evaluations.
In my opinion, and that would be in my experience, it is cost-effective, while the Oregon subcommittee made a decision that it wasn’t.
And I believe that there is room for disagreement in this setting, that a person who is a bit of a contrarian about this new technology should have recused himself from this conversation.
