1. Practical experiences in the HTA process for
new technologies into Brazilian Public Health System
Murilo Contó
Health Policy – Boston Scientific
IFMBE-HTAD

2. funding by Boston Scientific
Disclosure
Boston Scientific Corporation
(2018 – current) - Health Policy Manager
IFMBE-HTAD
(2018 – current) - Member-elected HTA-Division
PAHO-WHO
(2015–2018) - National Consultant in HTA & HTM
CONITEC - Brazilian National Committee for Health Technology Adoption
(2012–2015) - HTA Consultant - Medical Devices
Ministry of Health of Brazil – Investment Projects
( ) - Medical Equipment Division Manager
Atrial Equipamentos Médicos
( ) – General Coordinator
funding by Boston Scientific
Working to reach the universal health coverage, promoting the access for innovative medical devices to transform lives and improve the patient health.

3. Mandatory points by Law for new technologies
1- Registration at ANVISA - National Health Surveillance Agency
2- Dossier Submission to with minimal requirements
scientific evidences and economic studies from the research question
first assessment about safety and efficacy to get registration and to become available at market
healthcare services (private) can use the technology, if they wants //
Is the technology (I) more cost-effective about the outcome (O) than comparator (C) to treat the patients (P)?

4. Guideline 6 Domains Clinical (scientific evidences)
Economic (modeling, budget impact)
Technician (on-board technology, functions)
Operational (learning curve, infrastructure)
Admissibility (legal framework)
Innovation (real power – disruptive?)
Brazilian MoH Guidelines – Medical Equipment Assessment
Free Access (English, Spanish, Portuguese):

5. Specific features about Medical Devices (1-4)
Needs of infrastructure: Power electric supply, temperature control, shields, humidity, support equipment
specific instrumentation
electric supply
bunker construction
magnetic resonance
cryogen system
environment temperature

6. Specific features about Medical Devices (2-4)
On-board technologies: software, application packages, complementary functions
BIPAP AC
PSV
VCV PS
Angiography
Cardiology
Neurology
Trauma
Cancer
SIMV
CPAP
IMV
PCV
CMV
MMV
APRV
Computed Tomography
Ventilators (ventilation modes)
Management
Planning
IMRT
IGRT
Images Fusion
Elastography
Esophagical
Color Doppler
3D/ 4D
Doppler
Ultrasounds
Linear Accelerator (LINAC)

7. Specific features about Medical Devices (3-4)
Learning Curve: training, expertise, human factors
All medical devices (A or B) depends on the operator expertise (effectiveness)
The higher the complexity of the device (A), the longer the time and cost (a) to achieve a good performance (costs)

8. Specific features about Medical Devices (4-4)
Total Cost of Ownership: all costs related to the device/equipment during the entire life cycle (since the acquisition till the replacement)
acquisition
infrastructure
Procurement
operation
transportation
Cost$$$
maintenance
installation
Using
accessories
training
Cost$$$
disposables
calibration

9. Case 1: Hepatic Elastography (1-2)
P = Diagnosis of hepatic fibrosis in patients with hepatitis
I = Ultrasonic Elastography
C = Liver Biopsy
O = Diagnostic Accuracy (sensibility, specificity)
Technician Domain – search for options
Transient Elastography (TE)
Acoustic Radiation Force Impulse (ARFI)
Real Time Sheare Wave Elastography (SWE)
Strain Elastography (SE)
Operational Domain - reprodutibility
Strain Elastography (SE) doesn’t indicated for liver fibrosis diagnostic due too much operator-dependent and difficulty to reproduce results

10. Case 1: Hepatic Elastography (2-2)
Clinic Domain
TE, ARFI and SWE technologies: sensibility and specificity levels close to gold stand (biopsy). Advantage non-invasive and non-pain procedure
Economic Domain – Budget Impact
Echosens Fibroscan (TE) – US$ 300 K
Philips iU22 – US$ 150 K
Siemens Acuson S2000 – US$ 90 K
possibility to up-grade: US$ 10 K
CONITEC Decision
Adoption the procedure with the same value of regular US and funding the equipment with ARFI and SWE.
Incremental cost: US$ 1.2 Million
Available: conitec.gov.br

11. Case 2: Da Vinci Robotic System (1-2)
P = Radical Prostatectomy
I = Robotic surgery
C = Laparoscopy surgery
O = Urinary incontinence, bleeding, sexual function
Clinic Domain
Time of Surgery: no meaningful differences
Bleeding: no meaningful differences
Urinary incontinence: favor to Robotic surgery
Sexual function: favor to Robotic surgery
Operational Domain – Learning curve
Need of 200 to 250 procedure to reach expertise (400 cases in some studies)
Available: conitec.gov.br

12. Case 2: Da Vinci Robotic System (2-2)
Total Cost of Ownership
US$ 2,877,300
Available: conitec.gov.br
US$ 13,890,152
CONITEC Decision:
Non adoption due the incremental cost

13. Cost-effectiveness ratio
Conclusion
The more precise is the key (research) question (PICO), the better defined will be the ideal technical specification of the adopted equipment.
All specific features related to medical devices, have a direct impact on the costs and effectiveness, affecting the cost-effectiveness ratio.
An adoption process covering all the specific aspects is essential to make a best decision, reducing the uncertainties and seeking to assure an efficient resource allocation.
Facility
Training
Facility
Operation
Training
Acquisition
Operation
Maintenance
Maintenance
On-board technology
On-board technology
Cost
Effectiveness
Cost-effectiveness ratio

14. Thank you Murilo Contó Health Policy – Boston Scientific
Member Elected - IFMBE-HTAD