Mercedes Carrasco: Thank you, Ellen. And then just to build on the question on potential pricing for vadadustat. How might you be thinking about pricing once the TDAPA period ends?
John Butler: That’s an important question. So, as we talked about TDAPA, you’ve got kind of that two-year window where you’re outside of the dialysis bundle. When TDAP ends in the final rule that came out just a couple of weeks ago, basically the way CMS has looked at it as they look at the overall utilization of a product that was part of TDAPA and then they basically take those dollars and spread it over all of the dialysis sessions that are provided. So, for a product that has very limited use in a very small number of patients, that’s really challenging, right? It doesn’t really provide the dialysis providers the cash, if they have one or two patients that are getting a drug. The great thing for vadadustat is, as we’ve talked about, dialysis — anemia is treated in 90% of dialysis patients and there are significant dollars already in the bundle.
So thinking about that pricing and that post-TDAPA policy is a little bit more straightforward. Now, I don’t think that, that post TDAPA policy really encourages innovation long term. And one of the things being part of the kidney care partner, the lobby and coalition, this is a key area of focus for us and kind of creating a better way to incorporate innovation into treatment of these patients. So, we’re going to continue to lobby on the hill and with CMS to have those dollars follow the patients, and that’s a real opportunity for us. So, if we think about the environment today, though, whatever pricing you have during your TDAPA period, you are going to have to adapt that pricing to kind of what’s in the bundle, moving forward. So, there will be, and we’ll kind of see where our pricing strategy lands, but I do expect that the contracting price will have to become more aggressive post-TDAPA without a change in that post TDAPA policy.
So, stay tuned as that progresses, but that’s the way we’re thinking about that.
Mercedes Carrasco: Great. And on vadadustat, can you help us frame the base case expectation on the label, particularly any differences compared vadadustat and whether that will matter for uptake?
John Butler: So, obviously, we haven’t started labeling discussions with FDA yet. I mean they’re early in their review. But we do think that there are significant differences between the compounds. We know that FDA does frequently have a desire to have class labeling, but there are certain areas that we really believe that the data doesn’t support that. So, we’ve really tried to address that — those particular areas as aggressively as we can and as clearly as we can, maybe it’s a better word in our draft labeling to the FDA. But of course, we will obviously work with the agency to have the product approved, and there’s a point where negotiation ends and you take what you get. But from a compound perspective, we really do think that these are very different products.
And some of the areas, like the four months not using the product until patients been on for four months. If you look at the MACE data from INNO2VATE from incident patients and from the 1,000 patients protect who became dialysis patients during treatment there’s no increase in MACE risk seen in that data. So, we’ve incorporated that into our resubmission. I feel very strongly about that, and that’s the kind of conversation we’re looking forward to having with the agency.
Mercedes Carrasco: Thanks. And then finally, just on the Auryxia side once more, Ellen had provided good commentary on volume expectations for next year. Just curious if that factors in any impact from the availability of tenapanor? Or more broadly, how should we be thinking about the competitive set for Auryxia moving forward?
