The Value Agenda in Spine Care Steven D. Glassman, M.D. Professor of Orthopedic Surgery University of Louisville Norton Leatherman Spine Center Past-President, Scoliosis Research Society Medtronic Disclosures Steven D. Glassman, M.D. University of Louisville Norton Leatherman Spine Center Norton Healthcare Royalties, Consulting Research Support Spine Consensus Conference October 1, 2016 Measuring Outcome for Lumbar Spine Primary Outcome Measures Primary Outcome Measures Physician Assessment Complications Fusion Rate fair good very good excellent very excellent Physician Assessment Complications Fusion Rate 1
Primary Outcome Measures Primary Outcome Measures Physician Assessment Complications Fusion Rate Physician Assessment Complications Fusion Rate How should we assess outcome? What is the fusion rate? What is the durability (revision rate)? What is the complication rate? What is the RTW rate? What is the change in Health Status? 1992 Health Related Quality of Life (HRQOL) Ware - Medical Outcomes Short Form 36 SF-36 Outcome Therapy SF-36 2
The Power of Data Patient-based data made an impression 2000 HRQOL Measures SF-36, ODI VAS/NRS back or leg pain ODI SF-36 3
ODI What does this mean? Interpreting HRQOL Scores What is an acceptable outcome? HRQOL Measures Interpreting HRQOL Scores What is an acceptable outcome? HRQOL Measures SF-36 PCS = 0 Δ ODI score = 12.5 Statistical significance MCID Interpreting HRQOL Scores What is an acceptable outcome? HRQOL Measures Interpreting HRQOL Scores What is an acceptable outcome? MCID MCID identifies an improvement that patients recognize as clinically relevant. MCID
Interpreting HRQOL Scores What defines a valuable outcome? Substantial Clinical Benefit (SCB) SCB describes a change that patients identify as a major improvement. 2006 Comparative Effectiveness Is a treatment or technique better than the available alternatives? In June 2006, CMS announced the decision to hold an MCAC meeting to evaluate the evidence regarding: spinal fusion for the treatment of low back pain secondary to lumbar degenerative disc disease (DDD). CMS staff emphasizes need for better evidence to conclusively demonstrate improvement in health outcomes Our Best Evidence Spine Patient Outcomes Research Trial (SPORT) SPORT NIH Funded $23 Million Multicenter Prospective Study RCT and Observational Arms 5
SPORT Sky Diving Outcomes Trial Sky Diving Outcomes Trial Parachute (n=10) No Parachute (n=10) 6 Sky Diving Outcomes Trial Parachute (n=10) No Parachute (n=10) Sky Diving Outcomes Trial Parachute (n=10) No Parachute (n=10) Sky Diving Outcomes Trial Parachute (n=10) No Parachute (n=10) 6 Parachute (n=12) No Parachute (n=8) 12 with chutes 8 without chutes 12 0 8 0 6
Sky Diving As Treated Sky Diving Intent to Treat Parachute (n=1) No Parachute (n=6) Parachute (n=10) No Parachute (n=10) 12 0 8 0 6 6 100% Live 100% Die! Parachute or No Parachute - 0% Die! SPORT SPORT SPORT Excellent quality evidence for the benefit of surgical treatment in well selected patients: Decompression for Spinal Stenosis Decompression for Disc Herniation Decompression and Fusion for Spondylolisthesis The Future of Spine Care Cost Effectiveness Is a treatment or technique more expensive than the available alternatives? 7
How do we define value? Cost vs. Benefit Cost per HRQOL score improvement Cost per QALY gained (Quality Adjusted Life Year) How do we define value? QALY - Health Utility 0 = Death.1.0 = perfect health 0.5 0.6 x 1 year = 0.1 QALY gained How do we define value? Health Utilities Cost/QALY has become the primary currency for Healthcare Economics? EQ-5D Euro-QOL SF-6D Generated from SF-36 cost/qaly $50,000 - $100,000 is generally considered cost effective. How do we define value? cost/qaly Applicable across specialties Measure of patient preference Accounts for efficacy and durability 8
Study Cohort: To determine the cost/qaly gained for singlelevel instrumented posterolateral lumbar fusion over a five year postoperative interval. 80 patients with complete 5 year data 8 females, 33 males Mean age 55.0 yrs (range 19 79 yrs) 1 ICBG, 39 rhbmp-2 Study Design: Treatment costs and HRQOL outcomes were collected over a 5 year post-op interval. Outcome Measures: ODI, SF-36, Back and Leg pain NRS QALYs determined using SF-6D health utility SF-6D calculated from SF-36 Baseline and Subsequent 5 Year HRQOL Scores Time Back Pain Leg Pain ODI SF-36 PCS SF-6D Baseline 8.0 7. 56.1 27.5.500 One Year.0 3.7 31.0 37.0.621 Two Year 3.8.1 29.8 38.5.638 Three Year.1.5 31.2 36.7.630 Four Year.1.2 30.6 36.5.66 Five Year.3.1 28.0 37.6.653 QALY Gained over 5 Year Post-op Interval Time SF-6D Δ SF-6D Baseline.500 One Year.621 0.121 Two Year.638 0.138 Three Year.630 0.130 Four Year.66 0.16 Five Year.653 0.153 Cummulative 0.688 Breakdown of Cost over 5 Year Interval Intervention N Cost Index Procedure 80 $15,720 Post-admission Rx 80 $1,571 Revision 80 $ 3,375 Total $ 20,669 9
Progression of Cost/QALY over 5 Year Interval QALY GAINED cost/qaly 1 0.121 $15,72 2 0.259 $72,827 3 0.388 $50,925 0.535 $38,020 5 0.688 $30,053 Cost Effectiveness of Single Level Posterolateral Lumbar Fusion cost/qaly = $ 30, 000 at 5 yrs post-op (Cost Effective - < $50,000 $100,000) Spine Value Agenda Anticipate similar standards for surgical and nonsurgical treatment. Spine Value Agenda Recognition that RCTs alone will never meet our need for high quality data. Registries Risk Stratification Spine Value Agenda In the absence of data, decisions are still going to be made. Spine Value Agenda Summary 10
The Value Agenda in Spine Care THANK YOU 11