MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL - PowerPoint PPT Presentation

MEDICAL DEVICE REW a clinician’s perspective INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM (IMDRF) 2017 Harindra Wijeysundera MD PhD FRCPC Vice President Medical Devices & Clinical Interventions, CADTH Associate Professor, Department of Medicine, & Institute for Health Policy, Management and Evaluation (iHPME) University of Toronto Interventional Cardiologist, Schulich Heart Center, Sunnybrook Health Sciences Center Scientist, Sunnybrook Research Institute

OUTLINE 1. Who am I? • Clinician • Researcher • CADTH 2. What is CADTH? 3. Trans-catheter Aortic Valve Replacement • Medical device life-cycle milestones 4. RWE in TAVR – how it happened 5. RWE in TAVR– missed opportunities 1

Who am I A. clinician • Interventional cardiologist at Sunnybrook Health Sciences Center, University of Toronto, since 2008 • Clinical practice is restricted to coronary angiography and angioplasty, and TAVR • TAVR since 2009, with ~150 cases annually (3 rd largest in Canada) 2

Who am I: B. researcher • Health service researcher at the Institute for Clinical Evaluative Sciences • Expertise in administrative data for use in health technology assessment • Health outcomes • Health care costs • Integrating these data as inputs in decision analytic economic/policy models 3

Who I am? Real World Evidence CorHealth Ontario Cardiac Services BC TAVI Registry TAVI Registry 2012-2017 2012-2017 CIHI National Ambulatory Care Reporting Discharge Abstract Database (DAD) System (NACRS) Data: Acute hospitalizations Data: ED visits &Same day surgeries Linked TAVI Registry -patient risk factors & clinical characteristics -wait-time Continuing Care -medications and doses Reporting System Homecare Database -Procedural details -peri-procedural complications Data: complex continuing care Data: homecare services and long term care Ontario Drug Benefit (ODB) Vital Statistics Database (age > 65 years) Ontario Health Insurance Plan (OHIP) & BC Data: Medical services Plan (MSP) BC Pharmanet Date of Death & Location (all patients) Data: physician claims for visits, Data: Outpatient prescriptions dispensed procedures and diagnostic tests 4

Who am I: c. CADTH VP 5

Aortic Stenosis Background • Degenerative valve disease • Prevalence of 13.2% in patients >75 years • Next cardiovascular epidemic in developed countries • Severe aortic stenosis (AS) is the most common valvular condition that requires intervention 11

35 30 30 28 Survival, % 25 5-year survival 23 20 rates 15 12 10 5 4 3 0 Breast Lung Colorectal Prostate Ovarian Severe Cancer Cancer Cancer Cancer Cancer Inoperable AS* 12

Therapeutic Need • Surgical Aortic Valve Replacement (SAVR) • Traditionally ~ 50% of AS patients ineligible due to excessive peri-operative risk 13

TAVR • Majority are awake • Fully percutaneous • Median Length of hospital stay • 2 days 15

Life Cycle of TAVR Guidelines 2017: 2012 2016 Ontario intermediate risk Funding in funds high Ontario risk Guidelines for 2014: inoperable 2011 inoperable only FDA and and high HC risk approval CE Mark 2007 2002 Time 16

RWE in TAVR: how it happened • Pre-regulatory • None • Regulatory approval delayed till publication of landmark PARTNERs trials June, 2011 Oct, 2010 17

RWE in TAVR: how it happened • Pre-regulatory programs had initiated with foundation funds • 10 programs in Ontario • First in 2007 18

RWE in TAVR: how it happened • Post-Regulatory • Funding 2012 • No RWE used in decision • Mandated that precondition for funding would be mandatory data entry into clinical registry to be held by CorHealth Ontario (CCN) • However, – No clear a priori objective for data – No direction on data elements – No funding for data collection 19

RWE in TAVR: how it happened • Canadian Cardiovascular Society (CCS) developed quality indicators for TAVR 20

RWE in TAVR: as it happened 21

RWE Data in TAVR: findings • Data quality: 22

RWE in TAVR: findings • ACCESS 23

ACCESS 24

Canada • April 1 st 2013- March 31 st 2014: 1,136 cases 90 80 70 60 49 50 83 40 34 62 61 30 49 48 42 41 20 36 33 29 25 25 10 20 16 0 British Columbia Alberta Manitoba Ontario Quebec New Brunswick Nova Scotia TAVI/100,000>75 years TAVI/million population Canadian average/100,000 > 75 years Canadian average/million population 25

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RWE: Access • Exponentially increasing demand with limited capacity 27

RWE: Wait-times • Canadian Wait-Time Alliance: • Maximum recommended wait-times for surgical aortic valve replacement • 14 days for urgent cases • 42 days for elective cases 28

Wait-times Balance Increased demand (referrals/cases) = Increased capacity (funding) 29

Wait-time consequences Wait-time hospitalization for heart Wait-time mortality: ~4.5% failure: ~15% 30

Canada ~50% of costs are device related 31

Modifiable Drivers of Costs Factor Rate Ratio P-value Non-transfemoral 1.31 (1.18-1.45) <0.001 Length of stay >3 days 1.42 (1.14-1.78) <0.001 Long ICU stay >4 days 1.30 (1.2-1.41) <0.001 32

RWE in TAVR • Limited impact on regulatory and reimbursement process • Substantial insights into implementation and dissemination 33

RWE in TAVR – missed opportunities Dis-investment? Reallocation of SPECIAL ACCESS 2012 resources from - Earlier initiation Funding in surgery - Define evidentiary Ontario needs for - ?Adaptive pathway inoperable only 2011 FDA and HC approval CE Mark 2007 2002 Time 34

Conclusions • In rapidly changing landscape, early engagement to define the objectives of RWE collection is critical • RWE is resource intensive • Prone to poor quality if front line health care providers are not convinced as to its utility • Iterative re-evaluations of regulatory and reimbursement decisions, informed by RWE will potentially facilitate earlier , and more efficient dissemination and greater access 35

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