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Clinical and economic evaluation of diaphragm pacing for ventilator-dependent patients: a Public Health System perspective
University of CampinasHealth Secretary of São Paulo StateHeart Institute - University of São Paulo
ADRIANA CAMARGO DE CARVALHO VIVIAN C. ANTUNES DOS SANTOSERICA MIE OKUMURASILVIA YUKARI TOGORO
MIGUEL L. TEDDEEVELINDA TRINDADEANDRÉ DEEKE SASSE
Brazilian Public Health System
Health: right of the population and duty of the government
SUSUnified Health System
Universality
Integrality
Equality
THE PROBLEM
Higher incidence of complications
and discomfort for patients
High costs
Shortage of hospital beds
Elevate number of chronic patients in ICU only for ventilatory support
Surgical procedure to restoringbreathing through direct stimulation ofdiaphragm
Goal: Replace, delay or reduce theneed for mechanical ventilation
Main Indications: hight cervical spinalcord injury and other ventilatorydiseases
CURRENT CONTEXT
A single brand is registered by the Brazilian regulatory agency
Commercial monopoly
Disproportionately high costs
Elevate number of lawsuits
Costly to the public system
Few number of individuals benefited
OUR QUESTION: Is it viable to incorporate DP in the Brazillianpublic health system?
To quantify the added benefit when DP is used compared to the ventilator for patients with chronic respiratory failure
To evaluate the economic impact of DP use versus the use of mechanical ventilation from the Brazilian public health perspective
OBJECTIVES
SYSTEMATIC REVIEW
Clinical trials (randomized or non-randomized),
case series (prospective or retrospective),
HTA informs
Search Strategy updated up until November 2014
Two independent researchers
MEDLINE, EMBASE & Lilacs
Sensitive search strategy
Western idioms
• Population: In ventilator-dependent patients with chronic respiratory
failure...
• Intervention: ...does DP (thoracic or intradiaphragmatic)
• Comparator: ...compared to mechanical ventilation alone...
• Outcome: ... bring benefits in terms of weaning patients off of
mechanical ventilation and/or improve the quality of life?
PICO
Identified 72 articles usingPubMed, EMBASE and Lilacs
16 Full-text articles assessed for elegibility
56 citations removed: did notmeet inclusion criteria
(case reports)
11 studies included in review:
• 6 retrospective estudies• 5 prospective estudies
3 prospective non-randomized2 prospective randomized
5 full-text articles excluded:focus not of interest
and diverse study design
SYSTEMATIC REVIEW
EFFICACY CONCLUSIONS
Quality of data was low.Risks and benefits were difficult to characterise and quantify.
Possible positive effect on weaning patients from mechanical ventilation.
Potential improvement of quality of life level.
It can be considered safe
Phrenic nerve integrity must be proven by neuromuscular tests
The most established indications are for spinal cord injury and Congenital Central Hypoventilation
ECONOMIC ANALYSIS METHOD
ICUHome Care - MVHome Care – DP and MV
Three Different Scenarios
Design
Cost Analysis
Perspective
Brazillian Public Health System (SUS)
Cost – Data Sources
Real costs - Heart Institute - University of São Paulo (USP)Lawsuits - Health Secretary of São Paulo State
Costs - MV in Intensive Care Units
263
1,913
7,820
3,150
3,020
2,576
1,095
0 1000 2000 3000 4000 5000 6000 7000 8000 9000
Hemotherapy
Honoraria
Daily Cost
Diagnostic Tests
Supplies
Drugs
Appliances and Gases
Dollars (US$)
Monthly Average Costs
Total: ~20K (US$)
COSTS - Diaphragm Pacing System
129,3
25
53,87
0
20
40
60
80
100
120
140
Mark IV® (Avery) NeuRx DPS System®(Synapse Biomedical)
Atrostim PNS V2.0®(Atrotech)
Tho
usa
nd
Do
llars
(US$
)
Single brand registered by the Brazilian regulatory agency
Monopolar SystemQuadripolar
System
COSTS – Implantation of DP
318
2,530
450
328
103
0 500 1000 1500 2000 2500 3000
Multiprofessional Honoraria
Fees
Diagnostic Tests
Supplies
Drugs
Dollars (US$)
Surgery Average Costs
Total: 3,730K (US$)
MONTHLY HOME CARE COSTS
4,102
1,176992
495
1,235
3,572
1,176992
213 79
0
500
1.000
1.500
2.000
2.500
3.000
3.500
4.000
4.500
Human Resources EquipamentLeasing
Inputs Gas Therapy Services
MECHANICAL VENTILATION - Total: 8K
DIAPHRAGM PACING + MECHANICAL VENTILATION - Total: 6K
63,6
6 6 6 6 6 6
96,3
0
20
40
60
80
100
120
140
1 2 3 4 5 6 TOTAL
Tho
usa
nd
Do
llars
Months
DP – Home Care
Inicial Cost Monthly Cost Cost in 6 months
20 20 20 20 20 20
120
0
20
40
60
80
100
120
140
1 2 3 4 5 6 TOTAL
Tho
usa
nd
Do
llars
Months
MV-Intensive Care Unit
Monthly Cost Cost in 6 months
AVERAGE COSTS: Current Scenario vs DP Implantation
CONCLUSION – ECONOMIC ANALYSIS
The installation of the DP and the patient transfer to his residence would generate savings of financial resources
Breaking the current monopoly and promoting market opening would also probably reduce the costs of the technology
More appropriate economic models could be developed if there was more and better data on efficacy/effectiveness and quality of life
