Clinical Progress and Coverage Policies in Immuno-Oncology - Episode 16
Michael Kolodziej, MD: The question about how responsive pathways are to the best available evidence, I think, is largely unfounded. In all the years that we managed pathways, we did have occasions where we had updated pathways, regretted it, and had to go back. We never got accused of not being prompt enough, and that’s because we had a structure whereby really game-altering therapies, either presented at a national meeting or more typically published in peer-reviewed literature, would be reflected in the pathways in a very timely fashion. So, people weren’t getting cheated out of access to something that was really going to save their lives.
I think implicit in the question of timeliness is a subtext that physicians should be able to act on “a good idea”, preliminary evidence. And I will say that maybe when I started in oncology, when drugs were very inexpensive and there were few options, what was true then and what is true now is that the therapies are very, very expensive, and speculative prescribing, irrespective of pathways, is something that payers are simply not going to allow. So, what’s the solution? Let’s fix the clinical trials mechanism so that we can get those patients on a trial and they would make a decision very quickly about whether that’s a good idea or a bad idea. This is not the payer’s problem. There’s a lot of really great stuff out there, and I know there’s a great deal of enthusiasm for combining it, so let’s answer the question about whether it makes sense or not.
As we consider the consequences of what I’ve called speculative prescribing, we actually face the same potential costs that we discussed a while ago, which is, number one, its cost of therapy, but number two, its human cost or toxicity cost. Now, you can look at that as human suffering from side effects, or you can look at it as unnecessary spending on inpatient or ICU use. It’s kind of interesting. There’s this impression that somehow immunotherapy is much less toxic than chemotherapy. That may, in fact, prove to be the case.
But, I was recently on a panel with an academic physician from the Northeast, and she said that the current inpatient service at her institution is almost exclusively people hospitalized with immunotherapy toxicity. That’s a very telling statement. There is no question that if you add nivolumab to ipilimumab in melanoma, you increase the toxicity a ton. That’s not arguable. There are costs associated with that. So, I think the health plan, and, honestly, all oncologists should be concerned about that. Is the price, and I use that term in its greatest sense, worth it? Well, we have to find that out.