Translation Pathway for Coronary Stent Development
Chuck Simonton, MD
Coronary revascularization with drug-eluting stents (DES) is widely accepted as the standard of care and reimbursement is well established globally. However, there are important country-specific differences on how these procedures are paid or reimbursed. For example, in the United States, hospitals receive payment for each percutaneous coronary intervention procedure performed, and this is intended to cover all hospital costs related to the procedure, including the implanted stent(s). In contrast, Canadian hospitals operate under global annual budgets allocated across all procedures, which in France, hospitals may receive a technology-specific supplemental payment, in addition to the procedure payment.
In countries where reimbursement is consistent across all coronary stents or for a stent category (i.e., DES vs. bare-metal stent), opportunities to receive differentiated reimbursement for a new product may be limited. However, in countries where reimbursement is linked to specific product type or brand within a stent class, differentiated payment may be approved, if it is clearly associated with significant clinical improvement, cost savings, and/or cost benefit relative to currently available products.
For truly novel technologies that fall outside the scope of existing reimbursement coverage, manufacturers may seek a new reimbursement category after demonstrating comparative effectiveness in populations representative of the real-world patient population. This is often accomplished with the support of professional medical societies in consultation with local payers or reimbursement authorities. Additional reimbursement may also require positive technology appraisals by national health technology assessment (HTA) agencies, such as the the United Kingdom’s National Institute for Health and Clinical Excellence or the Institute for Quality and Efficacy in Healthcare in Germany, or private HTA agencies such as the Center for Medical Technology Policy in the United States.
In situations where regulatory approval is obtained for a novel technology but the local reimbursement authority or payer determines that the clinical evidence generated through the regulatory approval process is insufficient for reimbursement coverage, the technology may receive coverage conditional on addressing evidence gaps. In the United States, for instance, Medicare may approve reimbursement through coverage with evidence development, where the use of a technology is reimbursed as a part of post-approval clinical studies or registries to collect additional evidence.
Whether the objective is to obtain reimbursement coverage for a new technology or increase market adoption where reimbursement is already established, it is becoming increasingly important to demonstrate economic value of medical technologies. This can be accomplished though economic evaluations such as cost-effectiveness, cost-minimization, or budget-impact analyses. When performing these analyses, it is essential to clearly identify the appropriate stakeholder perspective from which the analysis is performed, as well as ensure the cost/value metrics and time horizon are relevant to stakeholders. In the United States, cost savings to the payer may not translate into cost savings for the hospital or physician. Although this is starting to change with the launch of value-based payment models by the Centers for Medicare and Medicaid Services such as Hospital Readmissions Reduction Program, Value Based Purchasing, and Bundled Payments for Care Improvement, U.S. hospitals are still largely concerned with reducing periprocedural costs rather than lowering long-term or follow-up costs that may take years to accrue.
The increased focus on controlling health care costs has led to a shift in the market access landscape that is now strongly influenced by payers and hospital purchasers, as well as physicians. Successful, widespread adoption of new technologies now requires coverage and reimbursement, and a demonstration of economic value, in addition to proving clinical safety and efficacy.