Negative Pressure Wound Therapy: Reimbursement situation of this medical device 15 years after entering the European Market

Abstract

Getting adequate reimbursement for new and innovative medical devices is crucial for a successful uptake of the product in the market. However in the last years payers and authorities pushed for more detailed evaluations of the actual benefits of new medical devices before granting reimbursement. These assessment are often based on established Health-Technology-Assessments methods developed for pharmaceuticals. But as medical devices and pharmaceuticals differ in many ways these processes often do not work as smoothly as hoped and necessary. The history and current reimbursement situation of Negative-Pressure-Wound-Therapy (NPWT) is an example for these issues. Despite being on the market for over fifteen years in Europe and backed up by clinical and economic studies only Germany, Switzerland, Netherland, Sweden and Slovakia do have a dedicated reimbursement for NPWT in the inpatient sector. In the outpatient sector the reimbursement situation is even bleaker as only Switzerland and Austria have a fully functioning reimbursement in place. In Germany reimbursement decision are taken on a case-by-case base while in England only the dressings are reimbursed but not the equipment itself. In France only usage in the home hospitalisation sector is reimbursed. This situation cannot be satisfying for patients, physicians, payers and manufacturers. In order to improve the uptake of new medical devices manufacturer need to focus earlier on creating solid clinical evidence while payers also have to adapt their health-technology-assessments and take the differences of medical devices compared to pharmaceuticals into account.