Introduction: Anterior cervical discectomy and fusion (ACDF) is a standard treatment for cervical spondylosis with radiculopathy or myelopathy refractory to conservative care. i-Factor™ Peptide Enhanced Bone Graft (CeraPedics, Inc., Westminster, CO), a novel synthetic 15-amino acid polypeptide, has been demonstrated efficacious and non-inferior to autograft for single-level ACDF from C3-C7. We evaluated the cost-effectiveness of i-Factor compared to autograft in ACDF for patients with degenerative cervical disc disease.
Methods: Data was from a prospective, randomized, controlled, multi-center clinical trial in North America that investigated the safety and efficacy of i-Factor compared to autograft. Subjects received either i-Factor or autograft in a cortical allograft ring implanted into the interspace before plate placement. SF6D health utilities were used to calculate area under curve, representing total QALY experienced. Change in QALY compared to baseline projection represented QALY gain. Probability of reoperation was estimated using Kaplan-Meier product limit estimates at 6 years. Gross cost estimates were based on 140% Medicare reimbursement multiplier. Cost and QALYs were discounted at 3% annually.
Results: Cumulative estimated QALY gained after 6 years was 0.8323. 6-year projected subsequent surgery rates were 22.6% versus 15.7% in autograft and i-Factor subjects, respectively. Estimated cost/QALY was $31,400.35 and $33,280.46 in i-Factor and autograft subjects, respectively. Estimated total direct costs for initial and subsequent surgeries were $26,135.63 and $27,700.51 in the autograft and i-Factor groups, respectively. The cost difference in favor of i-Factor was $1,564.89; i-Factor was $1,880.11 less expensive per QALY than autograft. One-way sensitivity analysis depicted a cost effectiveness ratio from $28,545.77 and $34,889.28 per QALY in i-Factor subjects and from $30,254.97 and $36,978.29 per QALY in autograft subjects.
Conclusions: ACDF is a cost-effective treatment for cervical spondylosis causing radiculopathy or myelopathy. i-factor and autograft are both cost-effective; however, i-factor is more cost-effective due to a lower subsequent surgery risk.
Patient Care: We evaluated the cost-effectiveness of i-Factor compared to autograft in ACDF for patients with degenerative cervical disc disease.
Learning Objectives: We evaluated the cost-effectiveness of i-Factor compared to autograft in ACDF for patients with degenerative cervical disc disease.