Practical experiences in the HTA process for new technologies into Brazilian Public Health System

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

2. 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 • (2008-2012) - Medical Equipment Division Manager • Atrial EquipamentosMédicos • (1998-2008) – 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?) BrazilianMoHGuidelines – Medical EquipmentAssessment Free Access (English, Spanish, Portuguese): www.saude.gov.br/rebrats

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 SIMV CPAP IMV PCV Angiography Cardiology Neurology Trauma Cancer CMV MMV APRV Ventilators (ventilation modes) Computed Tomography 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 = UltrasonicElastography C = LiverBiopsy O = DiagnosticAccuracy (sensibility, specificity) TechnicianDomain – searchforoptions Transient Elastography (TE) AcousticRadiation 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 EchosensFibroscan (TE) – US$ 300 K Philips iU22 – US$ 150 K Siemens Acuson S2000 – US$ 90 K possibility to up-grade: US$ 10 K CONITEC Decision Adoptiontheprocedurewiththesamevalueof regular US and fundingtheequipmentwith 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 adoptionduethe incremental cost

13. 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