Health Technology Assessment (HTA): A Primer for Procurement Professionals

Similar documents
December Eucomed HTA Position Paper UK support from ABHI

Issues in Emerging Health Technologies Bulletin Process

HTA Position Paper. The International Network of Agencies for Health Technology Assessment (INAHTA) defines HTA as:

Health Technology Assessment of Medical Devices in Low and Middle Income countries: challenges and opportunities

Reduce cost sharing and fees Include other services. Services: which services are covered? Population: who is covered?

WHO Workshop, Bangkok, Health Technology Assessment

Adaptation of HTA reports: an effective way to use limited resources?

Convergence and Differentiation within the Framework of European Scientific and Technical Cooperation on HTA

A Focus on Health Data Infrastructure, Capacity and Application of Outcomes Data

Patient safety and optimal performance:

Health Technology Assessment (HTA) Dr Hamid Ravaghi

MedTech Europe position on future EU cooperation on Health Technology Assessment (21 March 2017)

CADTH HEALTH TECHNOLOGY MANAGEMENT PROGRAM Horizon Scanning Products and Services Processes

New methods, how could Norway speed up Health Technology Assessment (HTA) to the benefit of health industry, policy-makers, clinicians and patients?

Changing landscape - changing paradigms

Strategies for Knowledge Translation and Mobilization to Inform Hospital Health Technology Use

IP7: CHANGING PARADIGM IN THE EVALUATION OF THE VALUE OF MEDICAL DEVICES: WHAT MUST STAKEHOLDERS EXPECT IN THE NEW DECADE?

Centre for the Advancement of Health Innovations (CAHI)

SURGERY STRATEGIC CLINICAL NETWORK EVIDENCE DECISION SUPPORT PROGRAM. New ideas & Improvements

Andalusian Agency for Health Technology Assessment (AETSA)

13 December A NERA Briefing: Expert Workshop on HTA Workshop Sponsored by Pfizer

EU Cooperation on Health Technology Assessment

Alberta Health Services and Advancing Uptake of HTA & Innovation

Transforming How We Manage Health Technologies in Support of Better Health, Better Patient Experience, and Better Value

Health Technology Assessment: What are the key challenges to assess medical devices? Rosanna Tarricone, PhD Director CERGAS Scientific Director EHTI

Building quality into HTA and Coverage Decision- Making Processes: What are the features of good practice in HTA?

Getting the evidence: Using research in policy making

Canada s Research-Based Pharmaceutical Companies (Rx&D) 2015 Pre-Budget Submission House of Commons Standing Committee on Finance.

Ethical issues raised by big data and real world evidence projects. Dr Andrew Turner

WHO Regulatory Systems Strengthening Program

HTA, the roadmap from investment to disinvestment

Decision Determinants Guidance Document

A stronger system to protect the health and safety of Canadians. Exploring the Future of the Food Regulatory Framework Under the Food and Drugs Act

Patented Medicine Prices Review Board P M P R B GUIDELINES REFORM. 15 th Annual Market Access Summit. Douglas Clark Executive Director PMPRB

ABHI Response to the Kennedy short study on Valuing Innovation

Standing Committee on the Law of Patents

Introducing Foresight Alliance

Summary HTA. Methods for assessment of innovative medical technologies during early stages of development. HTA-Report Summary

An Essential Health and Biomedical R&D Treaty

Pan-Canadian Trust Framework Overview

Global Perspectives on Clinical Engineering Trends Yadin David, Ed.D., P.E., C.C.E., FAACE, FAIMBE

EXPLORATION DEVELOPMENT OPERATION CLOSURE

Protection of Privacy Policy

SHTG primary submission process

Finn Børlum Kristensen, MD, PhD Director, EUnetHTA Secretariat Danish Health and Medicines Authority (EUnetHTA Coordinator) Copenhagen, Denmark

IPv4 Alloca+on Implica+ons

Overview of Health Technology Assessment (HTA) from Asia Pacific Perspective

The One Mind Strategic Plan (OMSP)

Researching children s rights globally in the digital age

TOWARD TRANSPARENCY IN HEALTH TECHNOLOGY ASSESSMENT

Health Technology Assessment and the European Network for HTA

I. Introduction. Cover note. A. Mandate. B. Scope of the note. Technology Executive Committee. Fifteenth meeting. Bonn, Germany, September 2017

DRAFT TEXT on. Version 2 of 9 September 13:00 hrs

Health Technology Strategy 1.0. June 2004

Initial draft of the technology framework. Contents. Informal document by the Chair

Zayna Khayat, PhD., MaRS, Canada

Brief to the. Senate Standing Committee on Social Affairs, Science and Technology. Dr. Eliot A. Phillipson President and CEO

Inventor-Driven Product Development

Early HTA to inform value driven market access and reimbursement planning

Medical Innovation Changing Business Models. Geneva, 5 July 2013

Use of the Graded Approach in Regulation

Processes and mechanisms for contextualizing scientific evidence Moving from HTA to HTPA?

Global Harmonization Task Force

Advancing Health and Prosperity. A Brief to the Advisory Panel on Healthcare Innovation

rof. Dr. Michael Rodi aculty of Law and Economics niversity of Greifswald

SAFETY ASSESSMENT METHODOLOGIES AND THEIR APPLICATION IN DEVELOPMENT OF NEAR SURFACE WASTE DISPOSAL FACILITIES ASAM PROJECT

Using Foresight and Scenarios for Anticipation of Skill Needs

Pharma - Biotech Collaborations: Optimizing Success, Minimizing Risk and Maintaining Alignment

Tool for reducing uncertainties in the evidence generation for specialised treatments for rare diseases

Environmental Protection Agency

The City of the Future Living Lab Sauro Vicini

Interoperable systems that are trusted and secure

Compliance for Eucomed: The Medical Technology Industry s s Perspective

OECD WORK ON ARTIFICIAL INTELLIGENCE

Health Technology Assessment of innovative medical devices

Translational scientist competency profile

Meet The Expert Dr. Mike Reid

Health Technology Assessment in Developing Countries: A Brief Introduction for Vietnamese Health-care Policymakers

Access to Medicines, Patent Information and Freedom to Operate

SAUDI ARABIAN STANDARDS ORGANIZATION (SASO) TECHNICAL DIRECTIVE PART ONE: STANDARDIZATION AND RELATED ACTIVITIES GENERAL VOCABULARY

In-Country Shared Value Creation The Case of Ghana

WHO / HAI Project on Medicine Prices and Availability

The digital and trustworthy evidence ecosystem: how can health industry players join to increase value in health care and capture a global market?

BUREAU OF LAND MANAGEMENT INFORMATION QUALITY GUIDELINES

How can value be measured and assessed?

Twenty-Thirty Health care Scenarios - exploring potential changes in health care in England over the next 20 years

EU s Innovative Medical Technology and EMA s Measures

Medical Technology Association of NZ. Proposed European Union/New Zealand Free Trade Agreement. Submission to Ministry of Foreign Affairs & Trade

TGA Discussion Paper 3D Printing Technology in the Medical Device Field Australian Regulatory Considerations

Foresight for policy-making

Vincent RIALLE. Maître de conférences-praticien hospitalier, Dr GBM, Dr éthique médicale et biologique

Canadian Health Food Association. Pre-budget consultations in advance of the 2018 budget

Article 117 A Notified Body perspective, advice on how and when to engage notified bodies

Implementing Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property in the Eastern Mediterranean Region

HTA in Norway- HTA - international challenges

Reflection Paper on synergies between regulatory and HTA issues. DG SANTE Unit B4 Medical products: safety, quality, innovation

Manufacture of medicinal products in Italy: challenges for the Italian Medicines Agency

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT. pursuant to Article 294(6) of the Treaty on the Functioning of the European Union

Draft Plan of Action Chair's Text Status 3 May 2008

Mapping of HTA in Europe " Regulatory and Reimbursement Atlas"

Transcription:

Health Technology Assessment (HTA): A Primer for Procurement Professionals Dr. Tammy Clifford, Chief Scien+st & Vice President, Canadian Agency for Drugs and Technologies in Health (CADTH) Dr. Fiona A Miller, Associate Professor, Ins+tute of Health Policy, Management and Evalua+on (IHPME), University of Toronto.

HTA & Procurement AN INTRODUCTION TO HTA 2

What is HTA? (Health) technology assessment is a mul+disciplinary field of policy analysis. It studies the medical, social, ethical, and economic implica+ons of development, diffusion, and use of health technology. From INAHTA (Interna+onal Network of Agencies for Health Technology Assessment); www.inahta.org

What is HTA (2)? systema+c evalua+on of proper+es, effects, and/or impacts of health care technology. It addresses the direct, indirect, intended and unintended consequences Its main purpose is to inform technology-related decision-making in health care. HTA is conducted by interdisciplinary groups drawing from a variety of methods. HTAi (www.htai.org)

The Role of HTA Provide basis for informed decisions about: Adop+on/acquisi+on, diffusion, appropriate use, disinvestment/obsolescence HTA is not, in and of itself, the decision Reliable and +mely provision of (synthesized, appraised) evidence: Is it safe? For whom does it work and when? Is it be[er than what we already have/do? Does it provide value for money? Can we afford it? Can we afford not to? What else needs to be considered?

HTA supports evidence-informed decisions Across the lifecycle of a technology Innovation and R&D Adoption Ongoing assessment Appropriate Use Obsolescence

For Whom? Government policy and decision makers Public drug plan managers Regional health authori+es Hospitals and other health care facili+es Health professionals Pa+ents

Mul+ple Factors in Decision Making While HTA incorporates evidence on many facets of a decision (e.g., clinical, economic, ethical, legal, social) Evidence is but one input into a decision And even what is defined as evidence can differ Desire is to reduce uncertainty Not realis+c to eliminate it

The HTA Landscape: Canada

The HTA Landscape: Interna+onal

To be useful to decision makers, HTA must be tailored to the decision nodes of the health-care system and the needs and interests of decision makers at each of these nodes. The OECD Health Project. Health Technology and Decision Making. Paris, France: OECD. 2005.

HTA one size does not fit all Agency/organiza+on Mandate/remit Governance Linkages to other groups/programs Report Processes Who s involved, at what point(s) and to what extent Decision making framework(s)

What s the HTA Process? 1. Priority Setting/Topic Selection 2. Research Question Formulation 3. Identifying the Relevant Primary Research 4. Collect and Appraise the Clinical Evidence 5. Economic Analyses: comparative cost effectiveness, impact on current budget and health systems (VALUE) 6. Evaluation of ELSIs 7. Summarize/disseminate 3 natural pockets of knowledge Systematic Review & Meta-analysis Economic Evaluation Additional aspects

HTA & Procurement TWO SOLITUDES? 14

Same, same HTA & Healthcare Procurement share Roles in adop+on and appropriate u+liza+on The front doors of healthcare systems Public policy a[en+on Fiscal pressure; value for money Principle missions High quality health systems, pa+ent outcomes

but different HTA Scope For clinical technologies At point of adop+on Mostly drugs (outpa+ent) Procurement Scope For clinical & non-clinical products & services Most adop+on, All diffusion

quite different HTA Soc regulatory regime Limited regulatory direc+ves Community of prac+ce Provides guidance to policy Procurement Strict regulatory regime Trade agreements/ statute Finance/ Treasury Board policy Ensures compliance in prac,ce

really, quite different HTA Touchstones Evidence-based medicine Value for money Pa+ent & social values Procurement Touchstones Compe++on, Fairness & Transparency Fraud & Corrup+on Waste

really, quite different HTA Adjudicate compara+ve clinical & cost effec+veness Evidence-based medicine Cri+cal appraisal of relevant clinical evidence Value for money Cost per QALY Pa+ent & social values Pa+ent preferences Ci+zen values Accountability for Reasonableness Procurement Adjudicate transparent, fair & compe++ve process Request for proposals Pre-specified criteria Mandatory requirements Envelope 1: Technical/ Quality requirements (Clinical, Service Level, Device and Product Performance Requirements) Envelope 2: Business/Financial requirements

Working together? (1) For adop+on HTA to evaluate high cost technologies prior to broad use Procurement to follow. Informa+on to flow Business case to be built Recommenda+ons to be usable Relevant issues evaluated Different value proposi+ons of different products iden+fied Comprehensive, not selec+ve, product review

Working together? (2) For op+mal use Procurement to specify need for assessments Planned spend HTA to follow Iden+fy whether products are clinically equivalent within product class Inform business case for technology variants Ex.: Rela+ve value of different colours of intraocular lens implants? Inform decisions about technology use for different pa+ent subgroups Ex.: Pay more for joint replacement technologies for younger pa+ents?

Working together? (3) For shared exper+se and capacity HTA as source of exper+se for procurement For apprecia+ng value, challenging business as usual Procurement as source of exper+se for HTA To understand u+liza+on, for real world outcomes

Two solitudes? HTA & Procurement Share goals, but Operate in very different ways Many ways to work together & value for each Requires strong connec+ons Requires transla+on across significant differences 23

HTA & Procurement OPPORTUNITIES TO CONNECT 24

What does CADTH consider to be a health technology? Pharmaceu+cals (includes blood and vaccines); Diagnos+cs; and Medical, dental, surgical devices and procedures.

28

Opportuni+es to Connect Make a request! Rapid Response Service Evidence reviews tailored to your specific informa+on needs and +meline All reports posted to cadth.ca Suggest a topic For larger assessments (HTA) For technologies that are new/emerging (horizon scan) To find out who s doing what (environmental scan) Connect with your Liaison Officer h[ps://cadth.ca/submit-a-request Check out our website/subscribe 29

Thanks!