WASHINGTON, D.C.—Transcatheter aortic valve replacement (TAVR) proved cost effective in an analysis of data from the US CoreValve High Risk trial. Study investigator Matthew R. Reynolds, MD, MSc, of the Harvard Clinical Research Institute in Boston, discussed the results with Cardiovascular Business.
Reynolds, director of Economics and Quality of Life Research, unveiled the findings Sept. 13 at the Transcatheter Cardiovascular Therapeutics scientific session’s late-breaking clinical trials. The study, which took the perspective of the U.S. healthcare system, showed that at one year high-risk patients treated with the CoreValve system (Medtronic) gained an estimated 0.24 life years and 0.2 quality-adjusted life years (QALYs) compared with patients with severe aortic stenosis treated with surgical aortic valve replacement.
Based on that, the projected lifetime incremental cost-effectiveness ratios with TAVR totaled about $67,000 per QALY gained and $57,000 life years gained. According to a sensitivity analysis, cutting cost of initial TAVR hospitalizations by $2,000 to $4,000 per patient would lower the cost effectiveness ratios to less than $50,000 per QALY or life year, which meets the generally accepted threshold for being of good value.
The Q&A below has been condensed from the exclusive interview.
Q: What did you consider to be the most interesting finding?
A: We wound up right in the vicinity of what we would call high-value therapy. We had this good clinical benefit that we knew but we didn’t know the cost piece. The costs weren’t equal; there was an incremental cost with TAVR but in light of the benefits, the cost effectiveness lands in the vicinity of high value. In a forward-looking way, that is where we think it is heading.
Q: When you say high value, are you looking at the traditional $50,000, and knowing that is from many years ago, we probably should bump that number up?
A: [Other healthcare economists] say it is a 1970s historical standard and it is too low, it is artificially low. If you accept that argument, then the therapy is right there, right now. It is going to come down. How far, we don’t know.
Q: We are talking about patients who are going to be costly to begin with, correct?
A: Yes. The average age is 83 and they have a lot of health problems. They were selected to be in the trial because they were expected to be at high risk for surgery. What we used in our analysis to project cost was the six- to 12-month interval. Theoretically, all the perioperative and periprocedural events are over by then. The cost, if you annualize it in that 12-month interval, was in the range of $20,000 to $25,000 a year. That is after they get their valve fixed.
Q: What would it be for an average octogenarian?
A: I don’t know that number precisely, but it is probably close to $20,000 a year. [One analysis placed it] closer to $30,000 a year.
Q: Who is looking at this information?
A: The consumer we hope is payers. That is who we want to inform. Clinicians look at it, leaders of programs who have to defend their need for resources at their institutions.
Q: What unanswered questions remain?
A: The biggest unanswered question is what happens in even lower risk populations, both cost and clinical. Part of the key of what we presented is that there was this survival benefit, that TAVR was clinically superior. It is OK for something to cost more if it is clinically superior. If it is clinically equivalent and it costs a lot more, [it] raises questions.
Both the clinical results in the lower risk patients and the relative costs will be important to how far this therapy expands. Every new risk group that gets studied, this question will have to be looked at.