Cadth 2015 c3 panel presentation evidence decision-making disconnect final
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Cadth 2015 c3 panel presentation evidence decision-making disconnect final
- 1. The Evidence/Decision-Making Disconnect. Evidence is often not enough Shahira Bhimani B.Sc.PT, MSc. HTA Manager, Strategic Initiatives HTX – The Health Technology Exchange
- 2. Panelists • Dr. Don Juzwishin – Director Health Technology Assessment and Innovation, Alberta Health Services • Dr. Zayna Khayat - Director, MaRS EXCITE • Dr. Janet Martin – Director, Medical Evidence, Decision Integrity and Clinical Impact (MEDICI) - LHSC, Associate Professor, Schulich School of Medicine and Dentistry, Western University • Mr. John Soloninka – President/CEO, HTX, The Health Technology Exchange
- 3. Agenda • The problem – The PVP journey • Aligning HTA and commercialization mandates • Minimizing the evidence/decision-making divide – Pre-market HTA – Hospital HTA – Innovation procurement via ‘bridge-financing’ • Q/A
- 5. • Technology: Photo-selective Vaporisation of the Prostate (PVP); a minimally invasive surgical ablation tool used to manage Benign Prostate Hyperplasia (BPH) • Technology Indication: BPH is a non-cancerous enlargement of the prostate. It is the most common age-related disorder affecting men, affecting over > 80% of men over the age of 80. • Medical Management: Lifestyle mods/ Pharmaceuticals Surgery Province-specific Adoption Processes An Illustrative Canadian Example
- 6. 2003 20142004 20102006 Independent HTA done by Alberta HC approval HQO firmly supports PVP 2007 PVP field evaluation by OHTAC in anticipation for increased diffusion in ON A Look at Prostate Photovaporization Adoption in Canada 2 Units adopted (ONT) 3rd unit adopted (Alb.) 2011 First unit installed in QC 20112010 2011 CUA supports PVP 2007 Alb. HTA Result: SAFE hospitalization stay and catheterization, Similar f-up care as TURP $3.01 million in avoided costs over 5 years Result: Similar health benefits to TURP costs to the HC System vs. TURP Avoidance of $14 million and 28,000 in-patient days
- 7. SO what really happened?... Overall market penetration (2011) • Canada - Laser accounts for approx. 7.6% of total BPH surgeries • US - TURP represents < 40% of the BPH procedures - If evidence is not enough, then what is?? Manitoba New Brunswick BC ON/ QC/ Alb 20% 6-9% 15% 13% Distribution of Laser procedures in Canada
- 8. The evidence/decision-making disconnect; If evidence is not enough – what is? Don Juzwishin PhD FCCHL Director Health Technology Assessment & Innovation Alberta Health Services
- 9. Research and Development Experimental Technology Innovative Technology General Use Obsolescence/ Replacement Use Time HTA and Diffusion of Health Technologies HTA HTA HTA Medical Device Licensing Innovation Disinvestment Obsolescence
- 10. CERTAINTYOFEVIDENCE EFFECTIVENESS Evidence certain Effective Uncertain evidence Not effective Evidence certain Not effective Uncertain evidence Effective Promising technology Ineffective technology Technology to be adopted 2. Reassessment 4. Innovation 3. Access with Evidence Development 5. Education & Dissemination Certainty of Evidence and Effectiveness
- 11. HTA and the Health Technology Commercialization process Health Technology Assessment • Deliberate and evidenced-based • Rigorous evaluation of evidence to ensure effectiveness and cost- effectiveness • Risk averse process to ensure opportunity costs are surpassed Technology Commercialization • Rapid and market driven • Decision-making dependent of extending market share and generating shareholder value • Risk tolerant process to ensure profits are generated Traditionally HTA and Technology commercialization processes have had competing objectives
- 12. Resource scarcity Health care systems are characterized by a limited supply of resources. Therefore, provision of care is constrained by available budgets. Two central challenges in health technology adoption
- 13. HTA and the Health Technology Commercialization process Public Institutions Societal Perspective Opportunity Cost Expected Gain > Benefit Foregone ICER Private companies Shareholder Perspective Return on Investment Projected revenue > Projected Expenses DCF Buy Side Sell Side CommercializationHTA Innovation Due to misalignment of objectives successful technology adoption occurs haphazardly when offering matches need Can this degree of alignment be improved?
- 14. HTA and the Health Technology Commercialization process Private companies Shareholder Perspective Return on Investment Projected revenue > Projected Expenses DCF Sell Side Commercialization Buy Side Public Institutions Societal Perspective Opportunity Cost Expected Gain > Benefit Foregone ICER HTA
- 15. HTA and the Health Technology Commercialization process Integration of HTA into the Technology Commercialization process can improve alignment between health systems and companies, facilitating permeation of new products into health systems Product Development Uncertainty Product Adoption time lag Mechanism
- 16. Don Juzwishin PhD FCCHL Director Health Technology Assessment & Innovation Alberta Health Services
- 17. April 2015 MaRS Excellence in Clinical Innovation and Technology Evaluation program CADTH Symposium April 14, 2015 Zayna Khayat I zkhayat@marsdd.com I @ZaynaKhayat
- 18. The Case for a new way for HTA …. EXCITE • Innovation defines us as a civilization. It is also an easy victim of neglect • Innovation/industry - part of the health system, not apart from it • New evidence to “police” adoption following regulation - too much, too late, expensive, inefficient, stifles innovation • Harmonized pre-market process that addresses regulatory, coverage and other concerns more efficient. Regulation and coverage processes are discrete and occur sequentially • Time for change: “Insanity is doing the same thing over and over again and expecting different results.” Albert Einstein • EXCITE – emerging from proof of concept 18
- 19. January 2015 Concept RegulationTIME U Pre-Market Post-Market Cost Effectiveness (CE) Systematic review Effectiveness Obsolescence Diffusion Yes Unconditional No • Efficacy Safety • Value (CE) Affordability • Ethical & societal • Post-market conditions E f f e c t i v e n e s s Cost Effectiveness Systematic review • Efficacy Safety • Value (CE) Affordability • Ethical & societal • Post-market conditions Reimbursement
- 20. April 2015 The EXCITE Collaboration Model • Dr. Les Levin, CSO • Dr. Zayna Khayat, Director • Adel Aziziyeh, Project Manager • Lily Lo, Coordinator • Advice on science, methodology • Allocation of projects • Heads of 5 methodology centres • Dr. Les Levin, CSO • Advise prioritization of technologies • Advice on clinical study design • Support in conditions of adoption • Comprised of implementation sub- committee of OHTAC Management Board • Advice, oversight, direction • Approve technologies, protocol, budget • Senior reps: health, economic development, HTA, AHSCs, industry • Review protocols for safety • Chair Tony Easty • Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitals • Contracted in by EXCITE • Design study with industry; • Execute and publish the study • Early advice on design of the evidence package and study Methodology Centres
- 21. • Since April 2012, 49 companies applied in 7 Calls for Innovation • Technologies selected: - 9 currently active (1 multinational, 2 US, 1 BC, 5 Ont) - 6 under review (to be approved at April 23 board) • Publicly discloseable projects are: - Home sleep apnea test - Renal denervation for hypertension (discontinued) - Rna disruption for early prediction of clinical response to chemo in breast cancer - Electrical stimulation for voluntary upper limb movements in stroke Current state of the EXCITE program November 2014
- 22. What’s next? 1. Conditions of Adoption To read the full report visit www.ohic..ca April 2015 Projected Adoption Rates Infrastructure Readiness Reimbursement Considerations Economic Projections Knowledge Translation Procurement EXCITE + Office of Health Innovation to work collaboratively to prepare the system
- 23. What’s next? 2. International collabortion April 2015 EXCITE International Planning Summit (March 27 2015) • UK – NICE, NHS, regulators, AHSN • US – FDA, BCBS, Kaiser, Mayo, MDIC … • Canada – Health Canada, Industry Canada, DFATD, Federal Innov. Panel • Ontario – MoHLTC, CAHO • Industry – small and multinational (Can, US, UK, NZ)
- 24. On the horizon … Paying for outcomes? April 2015
- 25. April 2015 Zayna Khayat Director zkhayat@marsdd.com Lily Lo Associate llo@marsdd.com Adel Aziziyeh Project Manager aaziziyeh@marsdd.com Les Levin Chief Scientific Officer llevin@marsdd.com For more information visit www.excite.marsdd.com Twitter: #MaRSEXCITE Or contact us at:
- 26. Evidence is Often Not Enough! Innovation Adoption and Diffusion… The Missing Link in the Chain. John Soloninka, PEng MBA President and CEO, HTX jsoloninka@htx.ca
- 27. Changing Perceptions and Building Capacity for Innovation Procurement • Procurement Challenges • Coalescing Adoption Initiatives • “REACH”- Innovation Procurement
- 28. CBoC – Innovation Procurement Survey • erere Innovation is Important! We don’t tell the Market what we need. We minimize cost… …But we Don’t Procure it.
- 29. MEDEC Industry Data Survey Ability to sell at home in Canada/Ontario is a Challenge HTX/MEDEC Survey – Fall 2013 Baylis Medical’s Innovative, Atrial Fibrillation Access Catheter, Developed in Ontario. Market Share: • 30% Japan • 20% Germany • 1% Canada! Ontario needs to more rapidly adopt its own home-grown, world-class technology! Ontario: One of the Most Challenging Markets to Enter! Sub-optimizing ROI on R&D Investment Any market seemed easier than Ontario!
- 30. Medtech is a Small Fraction of Health Spend…But Can Have Major Impacts. (Canadian Health Policy Institute Report - Courtesy of MEDEC) CDA per capita spend on Medical Devices ranks 22nd in OECD top 25 $170 per capita 3% of total per capita spend
- 31. Coalescing Initiatives, Aligning Incentives HTX REACH
- 32. REACH: A New Innovation Procurement Program. Resources for Evaluation, Adoption and Capitalizing on Healthcare Technology Technology/Product Development/ Validation Maturing/ Evidence Generation Scale: Diffusion/ Export - Local, Global Intake (Pipeline) Ontario Sales $ MNEs SMEs Academic Spinoffs US EU ROC China Ont US EU Rest of Canada China Ontario HTX REACH Traditional Innovation Support Pre-Market Development Post-Market Evaluation and Adoption Foreign Market Access
- 33. REACH Highlights • Seeking innovation procurement projects solving high-priority health system problems • Methods – Facilitated Partnering Workshops – 2 Calls for Innovation – Subsidies • $300K-$1M per project, requiring 50% or greater matching. • Pilots or Innovation Procurements • Unique/Innovative Ontario and non-Ontario solutions. – Innovative Technology Registry – Health System Problem Registry
- 34. REACH Partners Ontario Healthcare Providers/Innovators….and
- 35. John Soloninka, PEng MBA President and CEO, HTX jsoloninka@htx.ca
- 36. - Q/A - • Shahira Bhimani - Manager, Strategic Initiatives, HTX – The Health Technology Exchange • Dr. Don Juzwishin – Director Health Technology Assessment and Innovation, Alberta Health Services • Dr. Zayna Khayat - Director, MaRS EXCITE • Dr. Janet Martin – Director, Medical Evidence, Decision Integrity and Clinical Impact (MEDICI) - LHSC, Associate Professor, Schulich School of Medicine and Dentistry, Western University • John Soloninka – President/CEO, HTX, The Health Technology Exchange
Editor's Notes
- Cash constrained health care systems around the world cannot keep up with the pace of innovation and making tough choices around adoption, procurement, disinvestment are becoming increasingly difficult The chasm between clinician and hospital administrator priorities is widening Clinicians cutting-edge technologies maximized clinical outcomes and patient benefits Health care systems/hospital administrators The threshold for both willingness to pay and willingness to accept risk is rising! Increasing emphasis on economic metrics Value for $ LOS Readmission rates Comparative effectiveness of new technology vs. current standard care Unique Canadian HC system challenges – capped global budget – no product specific reimbursement scheme ? Managing high cap-ex equipment ? Manage cross-silo costs that get incurred at an institutional level yet positively impact community care centres ? Proving out a business case for reimbursement – innovator challenges
- PVP is a minimally invasive procedure used to treat benign prostatic hyperplasia (BPH). Technology Type: Surgical ablation tool, with single use laser fibers Setting of Care: PVP is designed to be used as a rapid alternative to Transurethral Resection of the Prostate (TURP), with fewer complications, thus oriented better to the out-patient setting Among the novel laser therapies, HoLEP and GreenLight vaporization (PVP) are the only procedures that have demonstrated equivalent outcomes compared to TURP in randomized clinical trials. Furthermore, due to the minimal invasive nature of surgery and associated shorter hospital stay, fewer side effects and fewer complications, these novel laser modalities provide a more attractive treatment option for the medical management of BPH.
- OHTAC Study - Goal: Evaluate clinical and cost effectiveness of PVP vs. TURP Alb Study - Goal: assess safety, efficacy and effectiveness of PVP as compared to TURP assess potential social, fiscal and economic factors involved in providing PVP as a funded service in Alberta. CUA guideline summary: TURP remains the gold standard for care PVP referenced as “a suitable treatment option for most men considering surgical alternatives, particularly for those on anticoagulation”.
- Image 1 Between 2007 and 2012, approximately 20000 TURP procedures were conducted in Canada. In contrast minimally invasive laser-based approaches grew from 767 interventions in 2007 to only 1559 in 2011. Image 2 Laser treatment accounted for up to 20% of BPH procedures in Manitoba, 15% in New Brunswick and 12.7% in British Columbia. In Ontario, Quebec and Alberta, the majority of the Canadian market, laser technology only represented 6% to 9% of total BPH procedures performed in 2011. Laser treatment accounted for up to 20% of BPH procedures in Manitoba, 15% in New Brunswick and 12.7% in British Columbia. In Ontario, Quebec and Alberta, the majority of the Canadian market, laser technology only represented 6% to 9% of total BPH procedures performed in 2011. IF EVIDENCE IS NOT ENOUGH, THEN WHAT IS??
- Pre-Market Partnership formed April 2012 between government, OHTAC, the health system, regulators, academia, clinicians and industry in selection by the health system and protocol design by all Studies funded by industry Streamlines path to adoption of disruptive technologies through a single harmonized process that meets regulatory and reimbursement requirements Process includes evaluation, systematic review, economic analysis and “conditions of adoption” analysis Housed at MaRS, a neutral innovation space (MaRS) which provides flow-through of funds, secretariat, coordinating and quality support Executed by 4 academic Methodology Centres working with 24 Research Hospitals
- MCs are academic units that have demonstrated experience and excellence in clinical trials methodology, health technology assessment and in conducting complex, multi-centre trials with proven capacity for data collection, synthesis and reporting 6 MCs are engaged by EXCITE They are responsible for overseeing the design and execution of EXCITE studies, sometimes in collaboration with one or more other institutions that have the appropriate capabilities/experience to complete evaluations successfully.