RESUMO
INTRODUCTION: The capsaïcine 8% cutaneous patch (Qutenza®) was recently approved for the management of patients with peripheral neuropathic pain (PNP). Considering its limited clinical efficacy data, its improvement of medical benefit was determined to be 5 which was insufficient to support its reimbursement in addition to diagnosis related groups'tarifs. Nevertheless its commercialization was associated with a marked interest considering the unmet therapeutic needs for patients with PNP. OBJECTIVES: Our objectives were to assess the effectiveness, the safety, and the economic impact of Qutenza® in real-life conditions. METHODS: An observational cost-consequences study was launched under the aegis of the Drug Committee of our hospital. Medical charts and prescriptions of all patients who received at least one patch application were analyzed. Effectiveness and safety were assessed after 12-week and 24-week of follow-up. The economic impact was measured within the Hospital and Health Insurance perspective and with limitation to direct costs. RESULTS: From March 2012 to October 2013, 91 patients (54.3 ± 14.1 years; 52.7% of male) received at least one application. The average follow- up duration was 188.3 ± 86.4 days. The PNP etiologies were mainly post-surgery (42.9%) and post-traumatology (20.8%). A therapeutic response (decrease of ENS score of least 30%) after 12 weeks and 24 weeks was observed in 27.9% and 37.1% of patients respectively. The SF-36 mental score was significantly improved. The safety profile was good. The application of the patch resulted in incremental costs of 154 euros per hospital stay without impact on outpatient-prescription drug expenditures. CONCLUSION: This study confirms the interest of Qutenza® for heavily pretreated, refractory patients with PNP. The clinical profile of responders has to be further investigated in large observational studies.