Medtronic has added to the data for its IN.PACT Admiral drug-coated balloon with the presentation of both its formal cost-effectiveness analysis from the US cohort of the IN.PACT SFA trial and clinical results from the in-stent restenosis cohort data from Medtronic’s IN.PACT Global Study. The data were announced during a special late-breaking clinical trials session at VIVA 2015.
David Cohen, Saint Luke’s Mid America Heart Institute in Kansas City, USA, presented the health-economic analysis, demonstrating that IN.PACT Admiral DCB is cost-effective in comparison to standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery lesions. Marianne Brodmann, Medical University, Graz, Austria, presented real-world data from Medtronic’s global study for IN.PACT Admiral drug-coated balloon, where one-year in-stent restenosis data showed safety and effectiveness in treating complex in-stent restenosis lesions.
Health-economic analysis establishes superiority of drug-coated balloon over angioplasty
The prospective, two-year cost-effectiveness study of the IN.PACT Admiral drug-coated balloon, carried out in conjunction with the IN.PACT SFA Trial in the U.S., demonstrated that IN.PACT Admiral drug-coated balloon is more than cost-effective, but actually is an “economically dominant” strategy in treating superficial femoral artery disease compared to angioplasty. Cost-effective strategies generally justify higher costs for improved clinical efficacy, whereas economically dominant therapies provide higher clinical efficacy and lower costs. The pivotal IN.PACT SFA trial was designed to test the safety and efficacy of IN.PACT Admiral drug-coated balloon versus standard angioplasty in patients with superficial femoral artery disease (NCT01566461); two-year clinical data were recently published in the Journal of the American College of Cardiology (JACC). The IN.PACT SFA trial included a prospectively designed economic analysis in order to provide healthcare decision makers with further insight into the economic effectiveness of IN.PACT Admiral drug-coated balloon.
“While the index hospitalisation costs were approximately US$1,100 per patient higher in patients treated with drug-coated balloon compared to standard angioplasty, over the two year follow up period, treatment costs were approximately US$1,200 per patient less with drug-coated balloon than standard angioplasty,” said Cohen. “This net economic advantage for IN.PACT Admiral drug-coated balloon was driven primarily by the significant reduction in target limb revascularisation procedures with drug-coated balloon over two years of follow up.”
Overall, the drug-coated balloon index hospitalisation costs were higher compared to angioplasty (US$8,293 vs. US$7,164, respectively [p=0.03]) but this initial higher cost was offset by a substantial reduction in follow-up costs through two years (US$2,984 vs. US$4,196, respectively [p=0.52]). This led to lower total costs in the drug-coated balloon arm by the end of two years on top of the significantly lower number of revascularisations in the drug-coated arm. The follow-up costs included items such as medications, physician fees, outpatient vascular care and repeat hospitalisations.
The economic substudy analysis was carried out from the perspective of the US healthcare system and included 181 US patients in the IN.PACT SFA trial. The analysis prospectively measured patients’ quality of life using the EQ-5D, and assessed the total peripheral arterial disease-related healthcare costs (target limb only) to assess the incremental cost-effectiveness of drug-coated balloons versus standard angioplasty in terms of the two year cost per quality-adjusted life-year gained. The study, which was sponsored by Medtronic, was conducted independently by the Mid America Heart Institute’s (MAHI) Health Economics and Technology Assessment (HETA) Group.
In addition to the base case analysis which found drug-coated balloons to be economically dominant, a probabilistic sensitivity analysis (PSA) to assess uncertainty of the results demonstrated that IN.PACT Admiral drug-coated balloon has a high probability of being economically attractive (ICER<$50,000 QALY) compared to standard angioplasty, thereby increasing confidence in the robustness of the analysis.
The results from this economic analysis support the positive reimbursement decisions that many healthcare payers around the world have made who are covering this therapy for their populations. In the USA, for example, the superior effectiveness of IN.PACT Admiral DCB was recognized by the US Centers for Medicare and Medicaid Services (CMS) with the approval, earlier this year, of both hospital outpatient and inpatient new technology add-on payments to support access to DCB therapy.
One-year outcomes from the IN.PACT Global Study demonstrate effectiveness in complex ISR lesions in the SFA
The one-year data from the real world IN.PACT Global Study demonstrating the effectiveness of IN.PACT Admiral DCB in the treatment of challenging ISR lesions were presented today.* This cohort from the prospective, multicenter, single-arm study with independent core laboratory and clinical events committee adjudication included 131 patients with pure de novo ISR lesions.
Complex lesion types, including long lesions, chronic total occlusions and ISR, remain challenging to treat with no identified current treatment standards. ISR is estimated to occur in 30 to 40 percent of all stents placed in the SFA. Treatment with standard PTA techniques is associated with poor patency outcomes.
The one-year primary patency rate for this difficult to treat patient subgroup was 88.7 percent, and the CD-TLR rate was a low 7.3 percent, especially considering the mean lesion length of 17.2 + 10.5 cm.
“Results demonstrate effectiveness and safety of the IN.PACT Admiral DCB in the treatment of patients with complex SFA lesions, including challenging ISR lesions,” said Brodmann. “The primary patency is unmatched in this difficult to treat patient subgroup.”
“IN.PACT Admiral DCB is a proven primary therapy for SFA disease. The latest clinical results demonstrating consistency, safety, efficacy and cost-effectiveness will continue to drive a paradigm shift in SFA interventions,” said Brian Verrier, vice president and general manager of the Peripheral franchise, within the Aortic and Peripheral Vascular business at Medtronic. “Another key pillar of Medtronic’s mission is the ongoing pursuit of providing solutions which increase economic value within the healthcare system. We are proud to showcase our commitment to improving outcomes and increasing economic value through IN.PACT Admiral DCB.”
Medtronic will host symposia to provide further analysis and discussion on DCB treatment in the SFA and the impact on patient outcomes at VIVA 2015 this week.
- PACT SFA Trial 2-Year Outcomes: How Will this Evidence Shift the PAD Treatment Paradigm. Speakers: John Laird, M.D., David Cohen, M.D., M Sc, and Renu Virmani, M.D. Monday 12-1:15PM
- Advancing Treatment in Complex Lesions: Gain the Edge with Clinical Evidence.Speakers: Prakash Krishnan, M.D., Marianne Brodmann, M.D., Antonio Micari, M.D., Eric Scott, M.D. Tuesday 12-1:15PM
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