Budget impact analysis of heparin-bonded polytetrafluoroethylene grafts (Propaten) against standard polytetrafluoroethylene grafts for below-the-knee bypass in patients with critical limb ischaemia in France.

Objectives: To evaluate the budget impact of progressive replacement of standard polytetrafluoroethylene (PTFE) grafts by heparin-bound PTFE (Propaten) for below-the-knee (BTK) bypass in patients with critical limb ischaemia (CLI).

Design: From a review of the scientific literature, we calculated a theoretical BTK primary patency for Propaten grafts. Using the French hospital expenditure database (PMSI), we retrospectively estimated a rehospitalisation rate for standard PTFE grafts. From these data, a model was created to assess the budget impact of a progressive replacement from standard PTFE grafts to Propaten grafts over a 5-year horizon. We performed an univariate sensitivity analysis to assess the robustness of our results.

Setting: French National Health Insurance (FNHI) perspective.

Participant: Patients with CLI.

Main Outcome Measures: Budget impact analysis.

Results: Data extraction from the PMSI revealed that 656 patients were treated with PTFE grafts in 2011 in French public hospitals for a BTK bypass. Assuming a 2-year survival rate of 76.8%, observed reinterventions rate for standard PTFE grafts at 24 months from the PMSI was 35.1%. The mean rehospitalisation cost was €10 689. The budget impact analysis based on these data found a net cumulative 5-year payer budget reduction of €112 420 in favour of Propaten, under the assumption of a 75.6% primary patency for Propaten grafts for a projected population of 3215 patients of which 801 received a Propaten graft.

Conclusions: Our budget impact analysis showed a positive impact on the national health insurance budget of the replacement of standard PTFE grafts by Propaten grafts for BTK bypass in patients with CLI in France. This supports the enactment of a reimbursement policy by the FNHI.