Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy
Abstract
:1. Background
2. Methods
3. Results and Discussion
3.1. Social Impact and Costs of the Disease
3.2. VNS Eligibility and Clinical Results
3.3. Quality of Life (QoL), Quality Adjusted Life Years (QALY) and Health-Related Quality of Life (HRQOL) after VNS
3.4. Economic Impact and Productivity Regained after VNS
3.5. Costs of VNS
4. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Abbreviations
AAN | American Academy of Neurology |
ASDs | Antiseizure drugs |
BMP | Best medical practice |
DRG | Diagnosis-related group |
EPC | Epilepsia Partialis Continua |
FDA | Food & Drug Administration |
GDP | Gross Domestic Product |
HTA | Health Technology Assessment |
HRQOL | health-related quality of life |
ICU | Intensive Care Unit |
ILAE | International League Against Epilepsy |
LGS | Lennox Gastaut Syndrome |
LICE | Lega Italiana Contro l’Epilessia |
NICE | National Institute for Clinical Excellence |
QALY | Quality Adjusted Life Years; QoL: Quality of Life |
RSE | Resistant Status Epilepticus; |
SE | Status Epilepticus |
SUDEP | Sudden Unexpected Death in Epilepsy |
VAT | Value Added Tax |
WHO | World Health Organization |
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Author (Ref) | Patients Number | Mean/Range Age at Implantation | Mean/Range Follow-Up | Seizure Free % (n) | Responders % (n) of Patients with ≥50% Seizure Reduction |
---|---|---|---|---|---|
Abubakr [15] | 31 | 14 to 62 years | 4 years | - | 53% (16) |
Gonzales [19] | 1194 | n.d. | 24–48 months | 8% | 63% |
Morris [40] | 481 | n.d. | 1–5 years | n.d. | 55% |
Parain [42] | 10 | 5 to 20 y | 22 months | 0% | 90% |
Janszky [43] | 47 | 22.7 y | 22 months | 13% | n.d. |
Klinkenberg [45] | 41 | 4 to 18 y | 10 months | n.d. | 26% |
Englot [46] | 3321 | n.d. | 3 to 64 months | n.d. | 21 to 50% |
Englot [47] | 4483 1104 | - | 3 months 24 months | - | 44% 56% |
Chrastina [49] | 74 | 18–59 years | 10 years | n.d. | 63.6% |
Kuba [50] | 90 | 36.3 years | 5 years | (5) | (44/85) |
Vonck [51] | 131 | 32 years | 33 months | 7% | 50% |
De Herdt [52] | 138 | 30 years | 44 months | 9% (12) | 13% |
Patwardhan [54] | 38 | 11 months–16 years | 12 moths (10 months–18 months) | n.d. (n 29% >90% reduction) | 68% |
Nakken [55] | 47 | 34.4 years | 2.7 years | 2% (1 pt) | 32% (15) |
Fernandez [58] | 15 | 3 years < | 4.3 years (1.4 years–10.2) | 0% | categorical variable reported 33% “improvement” |
Terra [57] | 36 | up to 18years | 12 months to 4 years | (1 pt) | 55% ≥ 50% seizure reduction |
Orosz [59] | 347 | 6 months to 17.9 years | 24 months | 8% (17/208) | 43.8% |
Kabir [60] | 69 | 10.69 years | 6 months to 10 years | 1.4% (1) | 8.7% (6) Engel II 90% (63) Engel III–IV |
Alexopoulos [61] | 46 | 12 years | 2 years | 10% (5) | 43.5% (20) |
Colicchio [62] | 135 | 5 months to 64 years | 36 months | 5.1% | 49% |
Wang [66] | 1061 | 5–60 years | 6 months–12 years | n.d. | 53.53% |
Ghaemi [68] | 144 | 3 to 65 years | 2 years | (10) | 62% (89) |
Marras [69] | 35 | 6 to 52 years | 36 months | - | 51% (18) |
Amar [90] | 921 CS 3822 Non-CS | 28 years 26 years | 24 months 24 months | 5% 8% | 55% 62% |
Ulate-Campos [91] | 30 | 21 months (1–144) | 6–36 months | n.d. | 50% |
Moro de Faes [92] | 35 | 3–18 years | 3 months to 2–3 years | n.d. | 43% |
Soleman [93] | 45 | 133.9 ± 184.5 months | 72.3 ± 39.8 months | n.d. | 49.9% |
Items | Lazio | Emilia Romagna | Lombardia | National Average |
---|---|---|---|---|
Surgery | EUR 3182 | EUR 5168 | EUR 2204 | EUR 3518 |
VNS device | EUR 21,084 | EUR 21,084 | EUR 21,084 | EUR 21,084 |
Hospital stay | EUR 1327 | EUR 2293 | EUR 2203 | EUR 1941 |
Total costs | EUR 25,593 | EUR 28,545 | EUR 25,491 | EUR 26,543 |
Total costs without device | EUR 4509 | EUR 7461 | EUR 4407 | EUR 5459 |
Health Resources | Min | Max | National Average |
---|---|---|---|
Days of hospitalization/patient (no.) | 3 | 4 | 4 |
Average duration of surgery (hours) | 1 | 3 | 2 |
Duration occupancy operating room (hours) | 2 | 5 | 3 |
Hours of intensive care/patient (no.) | 0 | 0 | 0 |
Items | Min (EUR) | Max (EUR) | National Average (EUR) |
---|---|---|---|
Pre-operative diagnostic tests | 380 | 380 | 380 |
Surgery | - | - | - |
Materials | 38 | 80 | 65 |
Personnel costs | 293 | 931 | 638 |
Drugs | 189 | 199 | 193 |
Operating room | 1684 | 3958 | 2622 |
VNS device | 21,084 | 21,084 | 21,084 |
Total cost of intervention | 23,288 | 26,252 | 24,602 |
Total cost of intervention without VNS device | 2204 | 5168 | 3518 |
Inpatient | - | - | - |
Hospital stay | 1067 | 1869 | 1572 |
Inpatient drugs | - | 5 | 3 |
Personnel costs for inpatient | 233 | 392 | 339 |
Other (e.g., perfusion) | 27 | 27 | 27 |
Total cost of inpatient | 1327 | 2293 | 1941 |
Total cost of VNS implantation stage without pre-operative tests | 24,615 | 28,545 | 26,543 |
TOTAL COST OF VNS IMPLANT | 24,995 | 28,925 | 26,923 |
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Marras, C.E.; Colicchio, G.; De Palma, L.; De Benedictis, A.; Di Gennaro, G.; Cavaliere, M.; Cesaroni, E.; Consales, A.; Asioli, S.; Caulo, M.; et al. Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy. Int. J. Environ. Res. Public Health 2020, 17, 6150. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176150
Marras CE, Colicchio G, De Palma L, De Benedictis A, Di Gennaro G, Cavaliere M, Cesaroni E, Consales A, Asioli S, Caulo M, et al. Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy. International Journal of Environmental Research and Public Health. 2020; 17(17):6150. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176150
Chicago/Turabian StyleMarras, Carlo Efisio, Gabriella Colicchio, Luca De Palma, Alessandro De Benedictis, Giancarlo Di Gennaro, Marilou Cavaliere, Elisabetta Cesaroni, Alessandro Consales, Sofia Asioli, Massimo Caulo, and et al. 2020. "Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy" International Journal of Environmental Research and Public Health 17, no. 17: 6150. https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph17176150