Author(s)
Guido Beccagutti, Pharm, D, Health Economics and Reimbursement Specialist1, Furio Zucco, MD, Chief of Department2, Angelo Lavano, MD, Chief of Department3, Marisa De Rose, MD, Student of Medicine3, Paolp Poli, MD, Chief of Department4, GianPaolo Fortini, MD, Medical Doctor5, Laura De Martini, MD, Medical Doctor6, Enrico De Simone, MD, Chief of Department7, Valentino Menardo, MD, Chief of Department8, Piero Cisotto, MD, Medical Doctor9, Mario Meglio, MD, Chief of Department10, Amedeo Costantini, MD, Medical Doctor111Medtronic Italy, Sesto San Giovanni, Italy; 2 Azienda Ospedaliera, Garbagnate Milanese, Milano, Italy; 3 Campus Universitario di Germaneto, Catanzaro, Italy; 4 Azienda Ospedaliera Universitaria Pisana, Pisa, Italy; 5 Ospedale di Circolo e Fondazione Macchi, Varese, Italy; 6 Fondazione Maugeri, Pavia, Italy; 7 Ospedale Maffucci, Avellino, Italy; 8 Ospedale S. Croce e Carle, Cuneo, Italy; 9 Ospedale Regionale S. M. dei Battuti, Treviso, Italy; 10 Azienda Universitaria Policlinico A. Gemell, Roma, Italy; 11 Policlinico SS Annunziata, Chieti, Italy
OBJECTIVES: Failed Back Surgery Syndrome (FBSS) is a chronic neuropathic pain disorder characterized by persistent lower back and/or leg pain after lumbar spine surgery. We are developing a cost-effectiveness study evaluating Spinal Cord Stimulation (SCS) treatment compared to conventional medical management (CMM) in FBSS patients. Here we report the baseline cost and health-related quality of life (HR-QoL) data from a societal perspective. METHODS: A prospective, pre-post, observational study is ongoing in nine Italian centers. Enrolled patients will be followed for two years. A questionnaire was developed to collect clinical (NRS - pain Numerical Rating Scale), economic (visits, drugs, diagnostic-tests, hospitalizations, productivity losses, medical aids), and quality of life (EQ-5D, SF-36 and Oswestry) patient outcomes and productivity losses for caregivers. RESULTS: Eighty patients were enrolled (mean age 58; 58% female). The mean NRS valued in the year before enrolment was 7.6±1.5. The average total cost per patient per month was €287.96: 55% private expenses and 45% charged to NHS. Hospitalizations created the highest burden (22%, NHS) followed by home-care and transport (both private). In the last year 26 patients (33%) varied their occupational status due to pain. Fifty-eight (73%) patients required a caregiver; caregivers were absent from work in 80% of cases. A strong impairment in baseline HR-QoL was documented. Patients reported an average value of 37 in the EQ-VAS (‘pain/discomfort’ and ‘usual activities’ are the most impaired domains), using the UK conversion values the mean utility score was 0.07, using the Catalonian it was 0.10. According to the Oswestry questionnaire, 44% of patients were considered crippled and 39% severely disabled. The physical role was the most impaired dimension as measured with the SF-36. CONCLUSIONS: Our baseline analysis demonstrates FBSS is a very expensive disease that severely impairs HR-QoL. Future analyses will evaluate the cost-effectiveness of SCS and CMM in the treatment of FBSS.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PSY17
Topic
Economic Evaluation
Topic Subcategory
Cost-comparison, Effectiveness, Utility, Benefit Analysis
Disease
Systemic Disorders/Conditions