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Lies, Damned Lies and Cost-Effectiveness: Open-Source Models

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The issue of open-source models in the cost-effectiveness and disease-level (collaborative) models has been brewing for many years. There has been a marked growth in open science, and funding bodies and publishers increasingly require that research data be made available. As mentioned in our previous Issue Panel, “cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Open-source models, then, would encourage greater transparency in pharmacoeconomic modeling and the reuse and updating of the best/most useful models; they are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, and allow for faster access to critical knowledge. The ISPOR-SMDM guidelines and the EUnetHTA joint action projects, are supportive of these views on collaboration, transparency, confidentiality, processes and consistency offered by the availability of open-source models to improve decision-making around health care and reimbursement. With openness and sharing, however, come issues of copyright and access and a need to define how model sharing can be achieved in a fair and equitable manner. There is, therefore, a need to develop an ongoing dialog on openness, especially where the research may be considered precompetitive and not worthy of IP investment. The pros and cons of open source models and the proposed mission of the Open Source Model SIG to curate an ongoing dialog regarding issues around creating, disseminating, sharing, evaluating, and updating open source cost-effectiveness and comparative effectiveness models will be debated amongst SIG members.

Author(s) and affiliation(s): Nancy Risebrough, Senior Principal, ICON plc, Toronto, Canada Jeroen P Jansen; Innovation & Value Initiative; Precision Medicine Group; and Stanford University Lotte Steuten, Vice President & Head of Consulting, Office of Health Economics, UK Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA

Event: ISPOR 2019 Annual Meeting

Date: 20/05/2019

Published in: Data & Analytics
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Lies, Damned Lies and Cost-Effectiveness: Open-Source Models

  1. 1. Lies, Damned Lies and Cost- Effectiveness: Open-Source Models, the SIG Monday, May 20, 2019 12:30PM – 1:45PM, Rooms 391-392
  2. 2. Antitrust Compliance Statement • ISPOR has a policy of strict compliance with both United States, and other applicable international antitrust laws and regulations. • Antitrust laws prohibit competitors from engaging in actions that could result in an unreasonable restraint of trade. • ISPOR members must avoid discussing certain topics when they are together, including, prices, fees, rates, profit margins, or other terms or conditions of sale. • Members have an obligation to terminate any discussion, seek legal counsel’s advice, or, if necessary, terminate any meeting if the discussion might be construed to raise antitrust risks. • The Antitrust policy is available on the ISPOR website, under “Policies & Legal.”
  3. 3. Agenda • SIG Mission Statement, Background, Goals, Rationale and Priority (10 minutes) • Presentations ( 12 minutes each, 10 minutes discussion at end) – Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA – Lotte Steuten, PhD, MSc, The Office of Health Economics, London, United Kingdom – Jeroen P Jansen, PhD, Innovation & Value Initiative, Los Angeles, CA, USA – Nancy Risebrough, BA, ICON plc, Toronto, ON, Canada – Discussion and questions • SIG key and member engagement projects (5 minutes) – Interest in taking on immediate Book of Terms update – Overall discussion and questions from Members
  4. 4. 10 Open Source Model SIG Working Mission Statement • The mission of the Open Source Model SIG will be to curate an ongoing dialog regarding issues around • Creating • Disseminating • Sharing • Evaluating • Updating • opensource cost-effectivenessand comparativeeffectivenessmodels.
  5. 5. Background 1
  6. 6. 6 Marked growth in open science requires that research data be made available • Private and public entities are already undertaking development of platforms to build and/or display models for examination, but this is being done in a vacuum that may be better served being led or at least examined by the preeminent organization dedicated to advancing HEOR science--ISPOR
  7. 7. Why Open Source Models? • “Cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Follow on to an Issue Panel, presented at ISPOR 2018, Baltimore, MD, chaired by Neil Hawkins, MD, with Renée Arnold, PharmD and Jaime Caro, MD as panelists, entitled Lies, damned lies and cost- effectiveness: Open-source models are essential if cost- effectiveness analyses are to be widely accepted
  8. 8. Open Model SIG Goals, Rationale, and Priority 2
  9. 9. Goals • Definethe issuessurroundingopensourcemodels • Developpossiblesolutionsto these issues • Have an ongoingdialog to discussthese issuesand advance thescience. • Should ISPOR govern/curate a repository or other means of model representation to ensure its longevity? • If yes, should ISPOR or others assess its success? 9
  10. 10. Rationale and Priority: Impact of the SIG on HEOR • Important to have accurate,vetted,timely models on which to base reimbursement for new technologies. • The SIG’smissionwill be to improvemodel transparency, updating,idea exchange, currencyand policydevelopment. 10
  11. 11. Rationale and Priority: Why should this topic be a priority for ISPOR? • Topic of discussion in the peer-reviewed literature for at least 10 years • Open-source models are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, allow for faster access to critical knowledge and to “promote trustworthy, reproducible, validated, comparative and flexible health economic models” [Dunlop et al and many others]. • ISPOR-SMDM guidelines and EUnetHTA joint action projects supportive of these views • ISPOR, as the leading HEOR organization, has developed numerous guidances in the field and is well-positioned to explore these ideas via the proposed SIG 11
  12. 12. Presentations 3
  13. 13. Summary of Presentations • Lotte Steuten will provide a general introduction and overview from the UK, Europe and the US. • Jeroen P Jansen will discuss the rationale and logical consequences of open source models, using his NSCLC model as an example • Nancy Risebrough will present the pros and cons of having developed a COPD open source model from various stakeholder perspectives 10
  14. 14. What are we talking about? Transparency Validity Efficiency Vemer P et al., Pharmacoeconomics. 2016;34(4):349-61. Husereau D et al., Value Health. 2013 Mar-Apr;16(2):e1-5. Eddy DM et al., ISPOR−SMDM Modeling Good Research Practices Task Force. Value Health. 2012;15(6):843-50. AdViSHE Tool ISPOR-SMDM Modeling Good Research Practices CHEERS Statement
  15. 15. 30,000 feet view: models for rheumatoid arthritis Decision TreesMarkov Models Discrete Event Simulation Individual Sample Methods n = 58 publications, 1996 to 2012 Decision tree, n=13 Markov, n=25 Individual sampling, n=13 DES, n=7 Bold letters represent the original model within a tree of references - Scholz S and Mittendorf T, Health Econ Rev, 2014
  16. 16. A deeper dive: breast cancer models 40-fold difference ICERs Frederix GW et al. Value Health. 2013;16(6):1100-2
  17. 17. View from the UK
  18. 18. Organisational structures Processes Accountability Methodology Legislation 30 countries 80+ organisations
  19. 19. ICER Pilot Transparency Project
  20. 20. Description of Transparency Pilot Project • Contracting/Fees – Manufacturers contract & pay fee to ICER’s academic collaborators to cover time needed to produce sharable executable files and all supporting documentation • Ownership/Use requirements – To protect IP of researchers and institutions, models shared under confidentiality or licensing agreements – Unable to keep or alter model for their own purposes • Security/NDA – Signed non-disclosure/confidentiality agreements – Secured access (e.g., Dropbox) • Access/Support infrastructure – Access for limited timeframe, with no saving or retention of materials – Confined to team of individuals responsible for review – Support via initial orientation, follow-up email/phone contacts (limited), in-person workshops • Expectation is that reviews will inform written public comments on our draft reports Chapman RH, Kumar VJ. Manag Care Spec Pharm. 2019 May;25(5):521-524.
  21. 21. Transparency Pilot: Results/Lessons Learned • Feedback received from manufacturers and other stakeholders will help determine ICER’s future approach to sharing economic models associated with other evidence reviews • Bridges – Model access provided to manufacturers/consultants – Technical support processes developed – Contracting, sharing infrastructure developing models • Walls – Timing for contracting, review, etc. – Level of support expected (e.g., level & number of interactions), model changes over time – Financial barriers to access for non-manufacturer stakeholders – Confidential/redacted data Chapman RH, Kumar VJ. Manag Care Spec Pharm. 2019 May;25(5):521-524.
  22. 22. Final considerations • Need to get more precise when we talk about ‘transparency’ – Of what, for whom? • Nurture existing incentive structures to facilitate model sharing and stimulate building collaborative networks that – save time and money to industry and HTA-bodies – enable all stakeholders to have a more complete view of relevant models – create safe space for decision modellers to share the content of their models • Better understand the disincentives as well as trade-offs for different stakeholders including patients and society – Consider the wider societal costs and benefits of sharing vs. not sharing Thanks to Chris Sampson, The Office of Health Economics, for sharing his thoughts and insights.
  23. 23. Key Project/Member Engagement Projects 4
  24. 24. WorkingGroups • KeyProject • Type: Identification of Issues Surrounding and Possible Solutions for Making Open Source Models Available • Issues to address: model creation, access, trust, intellectual property rights, model ownership and oversite, payment, storage, maintenance, updating and incentives, resources and legal remedies available to develop and maintain models • Deliverables: • Value in Health manuscript • Part of a short course on issues in model building24 • MemberEngagement • Types/deliverables: • At least annual webinar to the SIG and/or open to the ISPOR population around cost-effectiveness, comparative effectiveness and disease models • SIG group discussion, during at least one major ISPOR conference per year, on one or more forums/webinars • Possible very short-term project to comment on terms related to our SIG in the ISPOR Book of Terms, including defining the terms, providing references and related terms
  25. 25. Immediate Next Steps of the SIG • Determination of SIG Key Project and Member Engagement Co-Chairs • Members solicited to work on webinar, SIG group discussion and manuscript • Develop and refine webinar content outline and possibly present webinar; develop pre-webinar questions for ISPOR audience • Develop and refine detailed outline of ViH manuscript • Develop and refine SIG group discussion outline for ISPOR US, May 2020 • Book of Terms?
  26. 26. ISPOR Special Interest Groups (SIGs) 5
  27. 27. Special Interest Groups • Mission: To provide an opportunity for ISPOR members to identify current and trending topics and initiate platforms that focus on such topics. • Composition: Any ISPOR member interested in a specific topic. A SIG must be multi-stakeholder and geographically diverse. • Goal: To engage ISPOR members within the topic area to advance health economic and outcomes research and the use of this research in health care decisions. • Objectives: To develop area topics into educational and/or scientific work products. To monitor and share information relating to area topics
  28. 28. Special Interest Group New Structure SIG Members Special Interest Group Leadership Member Engagement Working Group Key Project Working Group Special Interest Group Leadership • Chair-elect • Chair • Past chair Each position is a 1-year term, resulting in a 3 year commitment
  29. 29. 29 Special Interest Group Responsibilities of Chair-elect, Chair, Past Chair • Provide overall direction and leadership • Identify the topics SIG members would like to address • Categorizing topics into long, short term projects • Identify the appropriate platforms for delivery • Work with the Working Group co- chairs to ensure the timeliness of the key project • Address any issues within the group • Provide quarterly updates to the SIG membership • Current activities, new developments in field • Report the progress of the SIG projects • Via the yearly business and project plan to HSPC • Recruit new SIG members
  30. 30. 30 Special Interest Group Each SIG will have at least 2 Working Groups Key Project Working Group • Manuscript in Value in Health or Value Outcomes & Spotlight • Short Courses • Tools for Website Member Engagement Working Group • Webinars • Journal Club • Presentation at ISPOR meetings or other organization meetings • Encouraged communication
  31. 31. 31 Working Group Co-Chairs Responsibilities Key Project • Serve until the project is complete (average 24 months) • Lead the project • Ensuring adherence to ISPOR processes and working group deadlines • Address any conflicts or issues Member Engagement Projects • Serves for at least the year • Work with SIG chairs to identify member engagement topics • Identifying speakers, articles, topics for member engagement activities • Ensuring that all member engagement activities occur Those interested in leadership positions, please contact apavlock@ispor.org or opensourcesig@ispor.org.
  32. 32. 32 Special Interest Group Next Steps Identify: • A list of Potential Topics to be developed as: – Key Project – Member Engagement Project • Members interested in developing those topics into projects (Leadership group) • Leadership group to complete Business plan – Reviewed by Scientific and Health Policy Team – Submitted to Health Science Policy Council
  33. 33. Divider Slide 1 SECTION
  34. 34. ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field. ISPOR’s community of more than 20,000 individual and chapter members from 120+ countries includes a wide variety of healthcare stakeholders, including researchers, academicians, regulators and assessors, public and private payers, healthcare providers, industry, and patient representatives. The Society’s leadership has served as an unbiased resource and catalyst for innovation in the field for more than 20 years.

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