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

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

Feb 12, 2024 361 likes •752 views

MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM (IMDRF) 2017 Harindra Wijeysundera MD PhD FRCPC Vice President Medical Devices & Clinical Interventions, CADTH Associate Professor, Department of

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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

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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

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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 (3rd largest in

Canada)

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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

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Who I am? Real World Evidence

Linked TAVI Registry

  • patient risk factors & clinical characteristics
  • wait-time
  • medications and doses
  • Procedural details
  • peri-procedural complications

CIHI Discharge Abstract Database (DAD) Data: Acute hospitalizations National Ambulatory Care Reporting System (NACRS) Data: ED visits &Same day surgeries Ontario Health Insurance Plan (OHIP) & BC Medical services Plan (MSP) Data: physician claims for visits, procedures and diagnostic tests Ontario Drug Benefit (ODB) (age > 65 years) BC Pharmanet (all patients) Data: Outpatient prescriptions dispensed Homecare Database Data: homecare services Continuing Care Reporting System Data: complex continuing care and long term care Vital Statistics Database Data: Date of Death & Location CorHealth Ontario TAVI Registry 2012-2017 Cardiac Services BC TAVI Registry 2012-2017

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Who am I: c. CADTH VP

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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

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23 4 12 30 28 3

5 10 15 20 25 30 35

Survival, %

Breast Cancer Lung Cancer Colorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS*

5-year survival rates

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Therapeutic Need

  • Surgical Aortic Valve Replacement (SAVR)
  • Traditionally ~ 50% of AS patients ineligible due to

excessive peri-operative risk

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TAVR

  • Majority are

awake

  • Fully

percutaneous

  • Median Length of

hospital stay

  • 2 days

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Life Cycle of TAVR

Time 2002 CE Mark 2007 2011 FDA and HC approval 2012 Funding in Ontario for inoperable

  • nly

Guidelines 2014: inoperable and high risk 2016 Ontario funds high risk Guidelines 2017: intermediate risk

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RWE in TAVR: how it happened

  • Pre-regulatory
  • None
  • Regulatory approval delayed till publication of landmark

PARTNERs trials

Oct, 2010 June, 2011

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RWE in TAVR: how it happened

  • Pre-regulatory programs had initiated with foundation funds
  • 10 programs in Ontario
  • First in 2007

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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

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RWE in TAVR: how it happened

  • Canadian Cardiovascular Society (CCS) developed quality

indicators for TAVR

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RWE in TAVR: as it happened

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RWE Data in TAVR: findings

  • Data quality:

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RWE in TAVR: findings

  • ACCESS

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ACCESS

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Canada

  • April 1st 2013- March 31st 2014: 1,136 cases

83 41 25 42 49 62 33 61 20 16 29 36 48 25 49 34

10 20 30 40 50 60 70 80 90 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

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RWE: Access

  • Exponentially increasing demand with limited capacity

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RWE: Wait-times

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  • Canadian Wait-Time Alliance:
  • Maximum recommended wait-times for surgical

aortic valve replacement

  • 14 days for urgent cases
  • 42 days for elective cases
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Wait-times

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Balance Increased demand (referrals/cases) = Increased capacity (funding)

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Wait-time consequences

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

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Canada

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~50% of costs are device related

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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

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RWE in TAVR

  • Limited impact on regulatory and reimbursement process
  • Substantial insights into implementation and dissemination

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RWE in TAVR – missed

  • pportunities

Time 2002 CE Mark 2007 2011 FDA and HC approval 2012 Funding in Ontario for inoperable

  • nly

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Dis-investment? Reallocation of resources from surgery SPECIAL ACCESS

  • Earlier initiation
  • Define evidentiary

needs

  • ?Adaptive pathway
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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

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