- Email: [email protected]
Cost-Effectiveness of Single-Level Cervical Disc Arthroplasty
16S
Proceedings of the NASS 26th Annual Meeting / The Spine Journal 11 (2011) 1S–173S
CONCLUSIONS: There was no difference in results when comparing TDR as the ‘‘new’’ investigational device to which patients were randomized (has been suggested that results were biased due to patients being pleased to get the TDR), patients knowing they would receive the same device as part of a continued access study, or when the same device served as the control, rather than the new investigational device. This study found that the good results reported for TDR are not likely to be related to a euphoric bias created by being randomized to receive the ‘‘newest’’ technology. FDA DEVICE/DRUG STATUS: Charite: Approved for this indication.
lower 95% confidence interval and simultaneously removing the productivity losses resulted in an ICER of AU$27,352 per QALY. CONCLUSIONS: From the perspective of a reimbursement authority, there is a clear argument for use of CDA over ACDF in single-level surgery, with CDA being associated with a lower overall cost and improved quality of life. Worst case assumptions suggest that any incremental cost of CDA is offset by an acceptable incremental increase in quality of life. FDA DEVICE/DRUG STATUS: Bryan Cervical Disc: Approved for this indication; Prestige Cervical Disc: Approved for this indication. doi: 10.1016/j.spinee.2011.08.050
doi: 10.1016/j.spinee.2011.08.049
31. Cost-Effectiveness of Single-Level Cervical Disc Arthroplasty Peter McCombe, MD, FRACS1, Paul Mernagh2, William Sears, MD, FRACS3; 1St. Andrews War Memorial Hospital Brisbane, Brisbane, Australia; 2Health Technology Analysts Pty Ltd, Birchgrove NSW, Australia; 3Sydney, Australia BACKGROUND CONTEXT: Regulators and payers increasingly look at cost-effectiveness analysis, aimed at demonstrating value for money when considering the introduction of technology such as cervical disc arthroplasty (CDA). PURPOSE: Formal economic evaluation of CDA with either the BryanÒ or PrestigeÒ (Medtronic, Memphis, TN) disc versus ACDF in the Australian context. STUDY DESIGN/SETTING: Clinical data from two IDE RCT’s were combined with cost data to produce an economic model assessing the cost-effectiveness of CDA compared to cervical discectomy and fusion (ACDF). PATIENT SAMPLE: 1004 patients from US IDE randomized trials comparing either Bryan or Prestige disc with ACDF. OUTCOME MEASURES: SF36 converted to SF-6D utility weights. METHODS: Outcome measures for each technique were used to estimate quality adjusted life years (QALYs), by transforming unpublished SF-36 data into preference based SF-6D utility weights. A Markov process, with a cohort expected value analysis was performed. The model used monthly cycles and a duration of five years. There were six possible health states: surgery; success; failure; index re-operation; adjacent re-operation and multilevel reoperation, with transition probabilities determined by trial outcome frequency. Billing codes for medical procedures and ancillary services were determined through expert opinion and for ACDF, after averaging across various ACDF techniques using cost weights derived from sales figures for fusion implants provided by Medtronic. The costs of each service, prosthesis, hospital stay and for lost productivity costs due to work absence were sourced from various Australian government databases. Expected per-patient costs were calculated for five years. This data was used in conjunction with the QALY estimate to calculate the incremental costeffectiveness ratio (ICER) of CDA versus ACDF. RESULTS: Accounting for all downstream costs, including productivity loss by work absence, CDA was estimated to cost AU$803 less than ACDF per treated individual over a five year period. Further, the CDA group accrued 0.13 QALYs more than the ACDF group (3.43 QALYs for CDA versus 3.31 QALYs for ACDF). Removal of the impact of re-operations reduced the cost saving offered by CDA but the intervention remained cost-saving overall. Removal of the productivity losses (adopting a health care perspective only), increased the incremental cost of CDA to AU$1200, with an ICER of AU$10,395 per QALY gained. The model also demonstrated that the cost-effectiveness of CDA is sensitive to prosthesis price and overall success rate. Increasing the prosthesis price by 20% leads to an incremental cost of AU$554, with an ICER per QALY of AU$4795, while lowering the probability of overall success in the CDA arm of the model to its lower 95% confidence interval leads to an incremental cost of AU$322, with an ICER of per QALY of AU$4425. Two-way sensitivity analysis assessing the impact of reducing the overall success rate to its
32. Multicenter, Prospective, Randomized, Controlled Investigational Device Exemption Study Comparing Mobi-CÒ Cervical Artificial Disc to Anterior Fusion in the Treatment of Symptomatic Cervical Degenerative Disc Disease Donna Ohnmeiss, PhD1, Michael Hisey, MD2, Hyun Bae, MD3, Reginald Davis, MD, FACS4, Gregory Hoffman, MD5, Kee Kim, MD6, Pierce Nunley, MD7, Daniel Peterson, MD8; 1Texas Back Institute Research Foundation, Plano, TX, USA; 2Texas Back Institute, Denton, TX, USA; 3Spine Institute St. John’s Health Center, Los Angeles, CA, USA; 4 Greater Baltimore Neurosurgical Assoc., Baltimore, MD, USA; 5 Orthopaedics Northwest, Fort Wayne, IN, USA; 6UC Davis School of Medicine, Sacramento, CA, USA; 7Spine Institute of Louisiana, Shreveport, LA, USA; 8Austin Brain & Spine, Austin, TX, USA BACKGROUND CONTEXT: Anterior cervical fusion (ACF) has been long accepted as the standard of care for radiculopathy or myeloradiculopathy associated with degenerated cervical discs. Cervical total disc replacement (TDR) is designed to provide motion and relieve pain. The most viable way to evaluate the effectiveness of TDR in reducing symptoms is to compare it to ACF. PURPOSE: The purpose of this study was to compare the overall clinical effectiveness of TDR to anterior cervical fusion (ACF) for the treatment of degenerative disc disease (DDD) with radiculopathy or myeloradiculopathy at one level between C3 and C7. STUDY DESIGN/SETTING: This was a prospective, randomized, controlled, multi-center trial conducted as a FDA-regulated Investigation Device Exemption (IDE) trial at 24 sites. PATIENT SAMPLE: The study included 245 patients with single-level DDD with radiculopathy or myeloradiculopathy of at least 6 weeks duration who were randomized to TDR or ACF. Diagnosis was based on MRI and clinical evaluation. OUTCOME MEASURES: The primary endpoint of individual subject success was defined as a composite of Neck Disability Index (NDI) improvement, no subsequent surgical intervention, and the absence of major complications. Secondary endpoints included neck and arm pain, subject satisfaction, significant neurological deterioration, quality of life (SF-12), dysphagia, gait, blood loss, operative time, duration of hospitalization, and time to return to work. METHODS: A non-inferiority design with a 2:1 randomization (n5164 TDR: n581 ACF) was used. Patient evaluations were performed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 18, and 24 months. The TDR used was the Mobi-C Cervical Artificial Disc and ACF was done using allograft and an anterior plate. RESULTS: Six percent of patients were lost to follow-up resulting in composite endpoints for 230 patients at 24 months (n5155 TDR and n575 ACF). The individual subject composite success rate for TDR was significantly greater than ACF (73.6% vs. 65.3%; p!.01), establishing non-inferiority between the two groups. Success in the TDR was group was achieved earlier than in the ACF group (see figure). Device-related revisions and reoperations occurred less frequently in the TDR group compared with fusion (1.2% vs. 6.2%). Data for other secondary outcome measures are presented in the table. Outcomes for TDR patients were similar or superior to ACDF patients on each measure shown (see table).
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.
Proceedings of the NASS 26th Annual Meeting / The Spine Journal 11 (2011) 1S–173S
CONCLUSIONS: There was no difference in results when comparing TDR as the ‘‘new’’ investigational device to which patients were randomized (has been suggested that results were biased due to patients being pleased to get the TDR), patients knowing they would receive the same device as part of a continued access study, or when the same device served as the control, rather than the new investigational device. This study found that the good results reported for TDR are not likely to be related to a euphoric bias created by being randomized to receive the ‘‘newest’’ technology. FDA DEVICE/DRUG STATUS: Charite: Approved for this indication.
lower 95% confidence interval and simultaneously removing the productivity losses resulted in an ICER of AU$27,352 per QALY. CONCLUSIONS: From the perspective of a reimbursement authority, there is a clear argument for use of CDA over ACDF in single-level surgery, with CDA being associated with a lower overall cost and improved quality of life. Worst case assumptions suggest that any incremental cost of CDA is offset by an acceptable incremental increase in quality of life. FDA DEVICE/DRUG STATUS: Bryan Cervical Disc: Approved for this indication; Prestige Cervical Disc: Approved for this indication. doi: 10.1016/j.spinee.2011.08.050
doi: 10.1016/j.spinee.2011.08.049
31. Cost-Effectiveness of Single-Level Cervical Disc Arthroplasty Peter McCombe, MD, FRACS1, Paul Mernagh2, William Sears, MD, FRACS3; 1St. Andrews War Memorial Hospital Brisbane, Brisbane, Australia; 2Health Technology Analysts Pty Ltd, Birchgrove NSW, Australia; 3Sydney, Australia BACKGROUND CONTEXT: Regulators and payers increasingly look at cost-effectiveness analysis, aimed at demonstrating value for money when considering the introduction of technology such as cervical disc arthroplasty (CDA). PURPOSE: Formal economic evaluation of CDA with either the BryanÒ or PrestigeÒ (Medtronic, Memphis, TN) disc versus ACDF in the Australian context. STUDY DESIGN/SETTING: Clinical data from two IDE RCT’s were combined with cost data to produce an economic model assessing the cost-effectiveness of CDA compared to cervical discectomy and fusion (ACDF). PATIENT SAMPLE: 1004 patients from US IDE randomized trials comparing either Bryan or Prestige disc with ACDF. OUTCOME MEASURES: SF36 converted to SF-6D utility weights. METHODS: Outcome measures for each technique were used to estimate quality adjusted life years (QALYs), by transforming unpublished SF-36 data into preference based SF-6D utility weights. A Markov process, with a cohort expected value analysis was performed. The model used monthly cycles and a duration of five years. There were six possible health states: surgery; success; failure; index re-operation; adjacent re-operation and multilevel reoperation, with transition probabilities determined by trial outcome frequency. Billing codes for medical procedures and ancillary services were determined through expert opinion and for ACDF, after averaging across various ACDF techniques using cost weights derived from sales figures for fusion implants provided by Medtronic. The costs of each service, prosthesis, hospital stay and for lost productivity costs due to work absence were sourced from various Australian government databases. Expected per-patient costs were calculated for five years. This data was used in conjunction with the QALY estimate to calculate the incremental costeffectiveness ratio (ICER) of CDA versus ACDF. RESULTS: Accounting for all downstream costs, including productivity loss by work absence, CDA was estimated to cost AU$803 less than ACDF per treated individual over a five year period. Further, the CDA group accrued 0.13 QALYs more than the ACDF group (3.43 QALYs for CDA versus 3.31 QALYs for ACDF). Removal of the impact of re-operations reduced the cost saving offered by CDA but the intervention remained cost-saving overall. Removal of the productivity losses (adopting a health care perspective only), increased the incremental cost of CDA to AU$1200, with an ICER of AU$10,395 per QALY gained. The model also demonstrated that the cost-effectiveness of CDA is sensitive to prosthesis price and overall success rate. Increasing the prosthesis price by 20% leads to an incremental cost of AU$554, with an ICER per QALY of AU$4795, while lowering the probability of overall success in the CDA arm of the model to its lower 95% confidence interval leads to an incremental cost of AU$322, with an ICER of per QALY of AU$4425. Two-way sensitivity analysis assessing the impact of reducing the overall success rate to its
32. Multicenter, Prospective, Randomized, Controlled Investigational Device Exemption Study Comparing Mobi-CÒ Cervical Artificial Disc to Anterior Fusion in the Treatment of Symptomatic Cervical Degenerative Disc Disease Donna Ohnmeiss, PhD1, Michael Hisey, MD2, Hyun Bae, MD3, Reginald Davis, MD, FACS4, Gregory Hoffman, MD5, Kee Kim, MD6, Pierce Nunley, MD7, Daniel Peterson, MD8; 1Texas Back Institute Research Foundation, Plano, TX, USA; 2Texas Back Institute, Denton, TX, USA; 3Spine Institute St. John’s Health Center, Los Angeles, CA, USA; 4 Greater Baltimore Neurosurgical Assoc., Baltimore, MD, USA; 5 Orthopaedics Northwest, Fort Wayne, IN, USA; 6UC Davis School of Medicine, Sacramento, CA, USA; 7Spine Institute of Louisiana, Shreveport, LA, USA; 8Austin Brain & Spine, Austin, TX, USA BACKGROUND CONTEXT: Anterior cervical fusion (ACF) has been long accepted as the standard of care for radiculopathy or myeloradiculopathy associated with degenerated cervical discs. Cervical total disc replacement (TDR) is designed to provide motion and relieve pain. The most viable way to evaluate the effectiveness of TDR in reducing symptoms is to compare it to ACF. PURPOSE: The purpose of this study was to compare the overall clinical effectiveness of TDR to anterior cervical fusion (ACF) for the treatment of degenerative disc disease (DDD) with radiculopathy or myeloradiculopathy at one level between C3 and C7. STUDY DESIGN/SETTING: This was a prospective, randomized, controlled, multi-center trial conducted as a FDA-regulated Investigation Device Exemption (IDE) trial at 24 sites. PATIENT SAMPLE: The study included 245 patients with single-level DDD with radiculopathy or myeloradiculopathy of at least 6 weeks duration who were randomized to TDR or ACF. Diagnosis was based on MRI and clinical evaluation. OUTCOME MEASURES: The primary endpoint of individual subject success was defined as a composite of Neck Disability Index (NDI) improvement, no subsequent surgical intervention, and the absence of major complications. Secondary endpoints included neck and arm pain, subject satisfaction, significant neurological deterioration, quality of life (SF-12), dysphagia, gait, blood loss, operative time, duration of hospitalization, and time to return to work. METHODS: A non-inferiority design with a 2:1 randomization (n5164 TDR: n581 ACF) was used. Patient evaluations were performed pre-operatively and post-operatively at 6 weeks, 3, 6, 12, 18, and 24 months. The TDR used was the Mobi-C Cervical Artificial Disc and ACF was done using allograft and an anterior plate. RESULTS: Six percent of patients were lost to follow-up resulting in composite endpoints for 230 patients at 24 months (n5155 TDR and n575 ACF). The individual subject composite success rate for TDR was significantly greater than ACF (73.6% vs. 65.3%; p!.01), establishing non-inferiority between the two groups. Success in the TDR was group was achieved earlier than in the ACF group (see figure). Device-related revisions and reoperations occurred less frequently in the TDR group compared with fusion (1.2% vs. 6.2%). Data for other secondary outcome measures are presented in the table. Outcomes for TDR patients were similar or superior to ACDF patients on each measure shown (see table).
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.