Integration of new technology into clinical practice after FDA approval.

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

The Effects of Catheter Ablation Therapy on Medication Use and Expenditures in Patients with Atrial Fibrillation.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. Catheter ablation has become an important treatment option for many AF patients. Catheter ablation has been hypothesized to reduce the need for continued medical therapy for patients with AF, but there are few empirical data which demonstrate this. Objective: The objective of this study was to estimate the impact of catheter ablation on antiarrhythmic drug (AAD) utilization and total drug expenditures among AF patients. Methods: A retrospective analysis using the Truven Health Analytics MarketScan® Research Database was performed. Patients with AF and a catheter ablation procedure who had continuous enrollment in the database 6 months prior to their first ablation and a minimum of 1-year follow-up post first ablation were compared to AF patients who were treated with AADs and not ablation. Propensity matching was used to account for baseline differences between groups, and multivariable regression models adjusted for patient characteristics and baseline healthcare resource utilization. Sub-analyses were performed for patients age ≥65. Results: AF patients treated with catheter ablation had significantly lower AAD utilization and total prescription drug costs than those treated with AADs only. These results persisted for the subset of patients age ≥65. The effects were strongest in the matched sample, where approximately 30% of ablation patients discontinued use of rhythm medication after receiving catheter ablation. Per-patient total medication expenditures were reduced by $800 to $1,200 per year in the matched sample. Conclusion: Catheter ablation for AF reduced AAD utilization and total prescription drug expenditures in a sustainable fashion up to 3 years post ablation. This reduction was consistent and significant in both the non-Medicare and Medicare populations.

Healthcare utilization and expenditures in patients with atrial fibrillation treated with catheter ablation.

AIM: The aim was to estimate the impact of catheter ablation on short- and long-term healthcare utilization and expenditures among atrial fibrillation (AF) patients in general and Medicare populations. METHODS: Data were analyzed from The MarketScan(®) Databases. MarketScan data contain deidentified patient-level records from employer-sponsored and public health insurance plans. Multivariable regression models for utilization and expenditures were built for all patients, with subanalyses performed for patients ≥65 years. Results were compared to preablation figures and reported for 5 time groups, based on duration of available postablation follow-up: 6-12 months; 12-18 months; 18-24 months; 24-30 months; and 30-36 months. RESULTS: A total of 3,194 patients were identified who had undergone catheter ablation for treatment of AF, had continuous enrollment in the database 6 months prior to first ablation, and had at least 1-year follow-up postablation. Compared to the 6 months prior to ablation, there were significant reductions in the number of outpatient appointments, inpatient days, and emergency room visits in the total study population and in the subset ≥65 years. There was a statistically significant (P < 0.01) decrease in total healthcare expenditures across 4 of the 5 6-month time periods, with annual savings ranging from $3,300 to $9,200. For patients ≥65 years, annual savings ranged from $3,200 to $9,200. Drug utilization also significantly declined (P < 0.01), with average annual medication savings ranging from $670 to $890, and from $740 to $880 for patients ≥65 years. CONCLUSION: Catheter ablation for AF reduced healthcare utilization and expenditures up to 3 years postablation. This reduction was consistent, significant, and had implications for general and Medicare populations.