The finalist top-10% poster on treatment-resistant depression and vagus nerve stimulation; a budget impact analysis in England

1. The analysis was based on population estimates from a Clinical Commissioning Group
(CCG) in England (N=366,000).
Patient records (year 2018) from five general practices were analysed, to determine a group
of patients eligible for VNS. The cohort was defined based on ICD10 codes (Table 1), age
Introduction
Methods
The total cost per patient of VNS to the NHS, including the device, implantation
procedure, programming, and monitoring was estimated to be £14,484 in the
first year and an additional £335 for subsequent years.
Based on the HES data analysis the average length of stay of completed hospital
episodes was found to be 40 days (range: 6 – 68 days).8
This was estimated to be
reduced to 27 days (32% reduction) after VNS implantation.14
Similarly, using HES data, the average outpatient activity was estimated to be 11
visits per year (range: 4 – 18).8
After VNS use, the number of outpatient appoint-
ments was estimated to be 5 per year (58% reduction).14
The proportions calculated from the CCG data were applied to the total population in
England (56 million), resulting in a total of 38,140 individuals eligible for VNS in 2018.15
When assuming an exponential growth based on the TRD sales forecast of VNS, the
total device cost was estimated at £10.7 million. The savings from hospitalisation and
psychiatric visits reduction was estimated to be £7.7 million and £1.4 million, respectively.
Overall, VNS therapy was associated with a budget impact of £1.5 million over the
years 2019 to 2023. This estimate corresponded to just over £2000 for each patient
implanted with VNS. The addition of future battery replacement costs increased the
budget impact to £1.8 million.
When using linear trend forecasts based on past UK adoption rates of VNS and DBS
for other conditions the introduction of VNS produced total savings (Figure 2).
Further savings are likely in all scenarios from the reduction electroconvulsive
therapy (ECT) for a proportion of these patients.14
When considering all relevant costs and resource use, the introduction of VNS in NHS
England can be a long-term cost-saving option for patients suffering with TRD.
The above results present conservative estimates since further savings, from the reduction of
ECT, were not included in the calculations.16
This work considered national hospitalisation statistics for England. Nevertheless, initial
evidence from individual Health Care Trusts suggested extensive variation in the length
of hospitalisation. This may be down to difficulties in capturing and reporting on activity
that is recorded within the mental health block contract. Therefore, the budget impact
may vary significantly at a local level.
References1. American Psychiatric Association (APA). Practice guidelines for theTreatment of PatientsWith Major Depressive Disorder. 2010; Available from: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/mdd.pdf.
2. Al-Harbi, K.S.,Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Prefer Adherence, 2012. 6: p. 369-88.
3. Eaton,W.W., et al.,The burden of mental disorders. Epidemiol Rev, 2008. 30: p. 1-14.
4. Rizvi, S.J., et al.,Treatment-resistant depression in primary care across Canada. Can J Psychiatry, 2014. 59(7): p. 349-57.
5. Rush, A.J., et al., Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry, 2006. 163(11): p. 1905-17.
6. Conway, C.R., et al., ChronicVagus Nerve Stimulation Significantly Improves Quality of Life inTreatment-Resistant Major Depression. J Clin Psychiatry, 2018. 79(5).
7. Office for National Statistics, Statistical bulletin: Subnational population projections for England: 2014-based. 2014.
8. Department of health, Hospital Episode Statistics for Admitted Patient Care, Outpatient and Accident and Emergency Data. 2017.
9. Department of Health, National Schedule of Reference Costs 2016-17 for NHS trusts and NHS foundation trusts. 2016-2017.
10. Department of Health. NationalTariff: currencies and prices published by NHS improvement. [Website] 2018 [cited 2018 05/10/2018]; Available from: https://improvement.nhs.uk/.
11. National Institute for Health and Care Excellence (NICE), Guide to the methods of technology appraisal 2013., in Process and Methods Guides. 2013, National Institute for Health and Care Excellence.: London.
12. LivaNova, Data on file. 2018.
13. Packer, C., S. Simpson, and A. Stevens, International diffusion of new health technologies: a ten-country analysis of six health technologies. Int JTechnol Assess Health Care, 2006. 22(4): p. 419-28.
14. Sperling,W., U. Reulbach, and J. Kornhuber, Clinical benefits and cost effectiveness of vagus nerve stimulation in a long-term treatment of patients with major depression. Pharmacopsychiatry, 2009. 42(3): p. 85-8.
15. Office for National Statistics, Mid-2016 Population Estimates for Clinical Commissioning Groups (CCGs) in England by SingleYear of Age and Sex - National Statistics. 2016.
16. Aaronson, S.T. and D.J. Kutzer,Vagus Nerve Stimulation in Patients Requiring MaintenanceTherapy After Response to ElectroconvulsiveTherapy: An Eight Case Series, in ENCP. 2017.
1
Symmetron Limited, London, UK; 2
LivaNova PLC, London, UK
The treatment of TRD with vagus nerve
stimulation: a budget impact analysis in England
Diamantopoulos A., MSc1
; Rinciog C., MSc1
; Forsey J., BSc (Hons)2
; Glencorse M., MSc Clin Res2
;
Rizzo E., MPH2
; Murphy J., MBA Life Sciences2
Table 1: ICD10 Code used for filtering patients eligible for VNS and HES data
Severe depressive episode with psychotic symptoms
Recurrent depressive disorder, current episode severe with psychotic symptoms
Recurrent depressive disorder, current episode severe without psychotic symptoms
Severe depressive episode without psychotic symptoms
Recurrent depressive disorder unspecified
Moderate depressive episode
Depressive episode unspecified
Recurrent depressive disorder, current episode moderate
Recurrent depressive disorder, current episode mild
Mild depressive episode
Recurrent depressive disorder, currently in remission
Severe depressive episode with psychotic symptoms
Recurrent depressive disorder, current episode severe with psychotic symptoms
F323
F333
F332
F322
F339
F321
F329
F331
F330
F320
F334
F323
F333
ICD10 Code ICD10 Description
Table 2: Unit costs
£9,941
£7,750
£3,371
£783
£168
£395
£141
Item Unit cost
Device cost11
Device replacement cost9
Device/lead implantation9
Device replacement procedure9
Adult outpatient visits8
Hospitalisation8
Psychiatric consultation8
Figure 1: VNSadoptionratescenariosstartingfromacommonreferenceof14implantsin2018
(18 years and over), history of depression (at least three years from diagnosis), and
repeated treatment referrals (at least four previous antidepressants, referral to
secondary care services, prescribed lithium or aripiprazole or quietiapine).
The model population was assumed to increase in line with the national statistics.7
To estimate the burden of TRD, Hospital Episode Statistics (HES) were used, filtered by
hospital admissions and outpatient activity based on the ICD10 codes in Table 1.8
Unit costs were obtained from NHS reference costs and tariffs (Table 2).9, 10
In addition to
the implantation procedure and device costs, it was assumed that patients, on average,
required seven outpatient visits in the first year and two visits in subsequent years for
programming and monitoring.
VNS would need replacement after 10 years due to battery depletion. To include in the
calculations the future costs of device replacement and re-implantation procedure, it was
assumed that for each patient/implanted device, a loan would be taken by the CCG for
the cost of the new device and re-implantation procedure, with an annual loan
repayment rate of 3.5%.11
Three sales forecast scenarios were explored, projecting adoption of VNS from a common
base of 14 implants in 2018 to 2023 (Figure 1):
• 719 implants based on LivaNova sales forecast for TRD12
• 740 based on historical trends of deep brain stimulation (DBS) diffusion rates for
Parkinson’s disease from years 1994-2004 (assumed linear trend)13
• 137 based on historical trends of VNS adoption rates for epilepsy (assumed linear trend)12
Figure 2: Annual savings using three scenarios of VNS adoption
Abbreviations: DBS, deep brain stimulator; VNS, vagus nerve stimulation
Treatment-resistant depression (TRD) is a term used to describe patients suffering
from major depressive disorder (MDD) who do not achieve a satisfactory therapeutic
outcome following the initial rounds of treatment.1
In the UK, the prevalence of MDD is estimated to be 5-10% of people seen in
primary care settings,2
of which 20-50% will develop TRD.3-5
A recent study has shown a significant difference in response, remission and patient
quality of life with Vagus nerve stimulation (VNS) compared with treatment as usual.6
VNS therapy aims to reduce the effects of depression by stimulating the left
vagus nerve in the neck that carries signals to the brain.
The objective of this analysis was to evaluate the budget impact of introducing
VNS for treating patients with TRD in England.
Results Discussion and limitations
Conclusion