Clinical Progress and Coverage Policies in Immuno-Oncology - Episode 13
Michael Kolodziej, MD: The question about what determines on pathway/off pathway or, more globally, pathway content, it’s been a challenge, I think, for people who work in this area for a very, very long time. And when I was in oncology and part of the pathways group, we had very long, very complicated meetings that went through everything with a fine-tooth comb. When I went to the health plan, I told them I was not going to manage content because that would take up every single minute of my time. So, we chose to go with a vendor, and we delegated content management to that vendor. That vendor, in turn, has a committee of academic and community physicians that contribute to the synthesis of the content. I do not get a vote on those committee meetings. I don’t even attend those committee meetings. We do mandate that the content of the pathways harmonize with our coverage policy, but that’s not hard. The pathway vendor that we use actually licenses NCCN content now because their coverage policy reflects NCCN content. There’s no conflict.
I think different pathways companies, pathways developers, they follow different recipes for determining what the appropriate level of evidence is. But I always say, “You know, if it really works, you’ve got nothing to worry about. It’s going to be on pathway. That’s the way it is.” There is no pathway in the universe, none, that does not have Herceptin first-line, adjuvant, you name it. There’s no pathways company in the world that does not have the PD-1 drugs second-line, irrespective of histology, in non—small cell carcinoma. There just are no pathways that don’t allow those treatments. Why? Because they’re so clearly better than anything else we’ve got. So, people get, I think, a little bent out of shape around the edges, where they ask, “Is that endpoint adequate to make it on pathway versus off pathway?” or “How much are you considering the cost?”, and I have just decided to divorce myself from those discussions because I cannot win.
The consequences of not being on pathway actually vary depending on the payer, and I’ll just tell you how we approach it. The pathways actually have no influence on coverage policy. It’s a really important distinction. Because people got this impression, that is totally wrong, that if you’re off pathway, the treatment is not going to get paid for; the treatment will be paid for if it’s consistent with our coverage policy, and those are publicly available. And if you don’t look it up, then if it’s NCCN 2B or better, you’re on pretty good ground. Okay, so that’s number one. Number two is, because we have chosen to go with aggregate-level reporting in levels of performance, there is a quality performance pool if you achieve a certain threshold. And, in fact, that threshold is graded, so if you are better than 65% compliant, you get something. If you’re better than 75% compliant, you get something extra. And if you’re better than 80% compliant, you get something extra yet. So, there’s a gradation. We do not reward people for being greater than 80% compliant. We do consider the entire book of business when we measure performance compliance.
So, that’s how we do it. I know other people do it other ways. It’s a fair way. It does allow you to, for example, not be punished for a case mix, a distribution of patients that might be particularly challenging to treat on pathway. It allows you to spread that risk over your entire patient population.