1. How (Much) Should We Pay for TAVI?
David J. Cohen, M.D., MSc
Director of Cardiovascular Research Saint-Luke’s Mid America Heart Institute
Professor of Medicine University of Missouri-Kansas City

2. Disclosures Grant Support/Drugs Grant Support/Devices
Eli Lilly/Daiichi-Sankyo - Merck/Schering Plough
Eisai Pharmaceuticals - Astra Zeneca
Grant Support/Devices
MedRAD - Boston Scientific
Edwards Lifesciences - Abbott Vascular
Medtronic
Consulting/Advisory Boards
Medtronic - Eli Lilly/Daiichi-Sankyo
Cordis - Boehringer-Ingelheim
DJC: 2/11

3. Standard Approach: “Pay what it costs”
Manufacturer sets the price for the device, taking into account production costs, R+D, ROI, etc
Reimbursement covers device cost plus implantation costs
Coverage policy used to control overall budget by restricting use to well-defined indications where benefit is well-defined (“treatment is reasonable and necessary”)
Strengths
Hospitals recover appropriate costs
Payers control budget and off-label use
Limitations
May restricts innovation in delivery
Financial risk shifts to providers

4. Alternate Approach #1: It’s a valve… pay for it like a valve!
Advantages
Prosthetic valves are established technology and have an established market and reimbursement structure
Approach similar to rest of world
Disadvantages
Discourages innovation since companies cannot charge a premium to recapture R+ D costs
In the current economic environment, is innovation an important goal of our healthcare system?
May be unnecessary since costs will come down eventually as competitors enter marketplace (e.g., DES)

5. Alternate Approach #2: “Fee for Benefit”
Concept originally proposed by G. Diamond
Reimbursement should be proportional to the with level of expected health benefit
Advantages
Encourages innovation in areas of greatest unmet need
Strong incentives to provide highly beneficial and cost-effective care
Disadvantages
Level of benefit varies considerably with patient population (e.g., no option, high risk, low/intermediate risk) challenging to administer

6. Alternate Approach #3: Pay for it like an analogous treatment
Hazard Ratio 0.52 (95% CI ) D 1-Year Survival = 20%
Hazard Ratio 0.52 (95% CI ) D 1-Year Survival = 27%
LV Assist Device
Medical Therapy
PARTNER Cohort B
1-Year Survival = 20%
Valve Cost = ????
Hospitalization = ????
REMATCH Trial
D 1-Year Survival = 27%
LVAD Device ~$80,000
Hospitalization ~$150,000

7. What should TAVI reimbursement be?
It depends on the priorities of the healthcare system
The most “rational” approach (fee for benefit) has substantial disadvantages in terms of administration and operations
The most likely approach (pay what it costs) will likely result in increased healthcare spending due to the high cost of the valve technology
Stay Tuned Formal cost-effectiveness analysis of the PARTNER trial will be presented at ACC (Opening Plenary Session, Sunday April 3- 9:30 a.m.)