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Health Technology Assessments and their Impact on Benefit Plans, Considering the Patient Perspective

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Title: Health Technology Assessments and their Impact on Benefit Plans, Considering the Patient Perspective


1
Health Technology Assessments and their Impact on
Benefit Plans, Considering the Patient
Perspective
  • Frank DeFelice, MPA
  • Director Global HTA Public Policy,
  • Merck
  • Roundtable Discussion on UHC in Latin Amercia
    the Caribbean Health Benefit Plans
  • December 6, 2013

2
Outline
  • Key Challenges and Considerations for Universal
    Health Coverage (UHC)
  • Underlying Success Factors
  • The Role of HTA in achieving more optimal
    patient-centred health systems
  • Health Plan Experience with HTA
  • Limitations to adopting HTA from other
    jurisdictions and Essential Elements when
    considering HTA development
  • Conclusions

2
3
1. Key Challenges to Achieve Universal Coverage
  • Achieving improved access to appropriate services
    in a fiscally constrained environment
  • Scale of the need for basic health care
  • Demographic changes (e.g. aging)
  • Epidemiological changes such as chronic disease
    burden
  • Emerging health technologies
  • Siloed approach to health technologies, health
    system, societal impacts, and innovation

4
Underlying Success Factors for UHC Local
Tailoring, Partnership Approach and Evaluation
Shared Goal Expanding access while preserving
incentives to innovation and sustainability
  • Every Country is unique and tailored approaches
    are required
  • Progress on UHC will be enhanced by a partnership
    approach on priority policy areas
  • Standardized evaluation metrics to be developed
    for stakeholder monitoring of progress
  • Evidence from Research to underpin approach
  • Enhanced data and health information systems are
    a necessity

5
2. The Role of HTA in Health Benefit Plans
  • HTA has often been seen as a tool to address cost
    concerns in the health system.
  • HTA when done effectively
  • addresses a wide range of elements including
    clinical, patient, and societal impacts.
  • involves stakeholders in key parts of process
    design and implementation
  • takes a cross-health system approach (not solely
    focused on one technology)
  • There are widely accepted best practice
    principles for HTA.
  • Growing use of HTA globally with variation in
    approach (QALY-based v. relative assessment of
    value), application and how utilized (for
    guideline development, inform reimbursement)

6
HTA/CER System Development
6
7
Key HTA Principles How Widely Are They Adopted?
8
  Key Principle CMS(US) NICE(UK) IQWiG (Germany) CADTH (Canada) Anvisa(Brazil) DHTA (Taiwan) HIRA (Korea)
  Structure of HTA program      
1 The goal and scope of the HTA should be explicit and relevant to its use
2 HTA should be an unbiased and transparent exercise
3 HTA should include all relevant technologies
4 A clear system for setting priorities for HTA should exist
  Methods of HTA
5 HTA should incorporate appropriate methods for assessing costs and benefits
6 HTAs should consider a wide range of evidence and outcomes
7 A full societal perspective should be considered when undertaking HTAs
8 HTAs should explicitly characterize uncertainty surrounding estimates
9 HTAs should consider and address issues of generalizability and transferability
Notes signifies that the organization
supported the principle in question in written
guidelines or other form, regardless of whether
they actually follow it. means that the
organization implemented the principle in
published reports, and decisions based on these
reports demonstrate adoption of the specific
principle.
9
  Key Principle CMS(US) NICE(UK) IQWiG (Germany) CADTH (Canada) Anvisa(Brazil) DHTA (Taiwan) HIRA (Korea)
  Processes for conducting HTA
10 Those conducting HTAs should actively engage all key stakeholder groups
11 Those undertaking HTAs should actively seek all available data
12 The implementation of HTA findings needs to be monitored
  Use of HTA in decision making
13 HTA should be timely
14 HTA findings need to be communicated appropriately to different decision makers
15 Link between HTA findings and decision-making processes needs to be transparent and clearly defined
Notes signifies that the organization
supported the principle in question in written
guidelines or other form, regardless of whether
they actually follow it. means that the
organization implemented the principle in
published reports, and decisions based on these
reports demonstrate adoption of the specific
principle.
10
What elements of HTA are being captured? EUnetHTA
Core Model --
11
Achieving more Optimal HTA Patient-Centred
Innovation integrated
a. A focus on the patient is required in health
system design and health policy development and
this extends to HTA programs and processes.
b. Health care policy and program decision-making
needs to factor in innovation impacts.
If carried out in line with best practice
principles, HTA can be a useful tool to achieve
the value to patients and society and to
encourage innovation.
12
Towards More Patient Centred Health Care Putting
the Patient First
Accountability to Patients, Citizens, Society
Informed multi-stakeholder involvement including
patients, providers, industry is essential
13
What Patient Centred should be
  • The experience (to the extent the informed,
    individual patient desires it) of transparency,
    individualization, recognition, respect, dignity,
    and choice in all matters, without exception,
    related to ones person, circumstances, and
    relationships in health care.


Berwick, Don.What patient centred should mean
Confessions of an extremist, Health affairs
March 25,2011
14
What is Patient-Based HTA?
  • HTA Questions HTA Processes

Focus on Patients Problems
Allowing patient participation
Take Patients Perspective
Building on patient-physician partnerships
Accommodate Patients Preferences
Empowering patient to improve their health
Bridges, John F.P, and Jones C,. Patient-based
HTA A vision of the Future, IJHTAHC, 2007
15
Patient Based HTA
Bridges, John F.P, and Jones C,. Patient-based
HTA A vision of the Future, IJHTAHC, 2007
16
How can patients perspectives in HTA be a route
to robust evidence and fair deliberation?
  • Patients and carers can contribute to HTA
  • By providing evidence about their experiences and
    preferences
  • Through participation in the HTA process

Facey et al. International Journal of Technology
Assessment in Health Care, 2010, 334-340
17
Patient and Other Stakeholder Involvement
Recognized
  • High Level Pharmaceutical Forum (Europe)
  • Highlights the key role of stakeholders including
    industry
  • Stakeholder involvement built in to the HTA
    process in Ireland (HIQA), Scotland (SMC),
    England/Wales (NICE).
  • Importance of Stakeholder involvement recognized
    in Canada, Australia, and the US.
  • Patient Centred Focus of the Patient-Centred
    Outcomes Research Institute (PCORI) in the US

18
The full range of perspectives is needed
  • Aim is to have the full range of perspectives
    considered in HTA processes, with objective
    assessment that considers all stakeholders views
    and inputs. This requires a transparent system
    and education for all stakeholders, including
    patient advocates and interested health
    professionals.
  • Most systems invite some stakeholder
    participation but often exclude contribution at
    key stages of the evaluation process

A Comparative Analysis of the Role Impact of
HTA, CRA. Report for EFPIA, PhRMA, EuropaBio,
and Medicines Australia, 2011
19
Quantifying Patients preferences and outcomes in
HTA
  • The number of instruments approaches is
    growing
  • EuroQol EQ5D, SF-36, SF-6D
  • Discrete Choice Experiments
  • Analytic Hierarchy Process (AHP) ranking of
    patient and provider preferences on different
    endpoints and relative weighting applied
  • OxPAQ participation activity measure
  • Increasing call for patient relevant endpoints
    (Patient Reported Outcomes (PROs))
  • Secondary Endpoints e.g. Health Related Quality
    of Life (HRQL), satisfaction, preferences less
    impactful
  • Greater understanding of the data required.
  • Qualitative aspects may need to be taken further
    into account

See Professor Mandy Ryan, Chair in Health
Economics, Aberdeen University Danner, M et al.
Integrating patients views into HTA AHP as a
method to elicit patient preferences (IQWiG
based), IJHTAHC, October, 2011 ISPOR Panel on
PROs Presentation PROs when who, November,
2011
20
Patient Access varies considerably across
HTA-utilizing nations
  • International Positive Reimbursement
    Percentages
  • (Based on all CDR-approved drugs also available
    in other countries)

Source International Report on Access to
Medicines 2009/10, Wyatt Health Management for
RxD
20
21
Summary of Key Considerations
  • A patient focus requires
  • Patient voice in the process
  • Patient Impact Assessed
  • Appropriate value weighting placed on patient
    perspective and outcomes
  • Timely Appropriate Access to Needed New
    Medication
  • Transparency
  • Multi-stakeholder involvement (patients,
    providers, industry) in policy design and
    program implementation
  • Health Literacy (e.g. HTA Patient Training at
    LSE)
  • Cross-health system impacts considered (beyond
    drug budgets)
  • Productivity Societal Impacts captured and
    given sufficient weighting
  • Innovation Impact Value Considered

22
3. Limitations when Considering HTA Development
Based on other countries
  • Transferability. Inappropriate transfer of HTA
    evaluations can result in incorrect decisions,
    patient access delays to medical advances, and to
    less efficient use of health care resources
  • HTA Capacity(technical expertise financial
    resources)
  • Unique country context and priorities
  • Data capacity
  • Differences in Comparator, practice patterns of
    patient population, inadequate reporting
  • Health Information Systems lacking

23
When is Formal HTA Appropriate? Essential
Elements
  • The health care system should be effective in
    providing quality services to all citizens
  • The use of HTA should have a clear objective and
    be predicated on the current capacity in the
    existing health system
  • There should be adequate financial resources to
    establish and sustain the HTA system
  • There should be an adequate HTA workforce
  • There should be well functioning health
    information systems
  • There should be clarity in the purpose and
    process of a proposed HTA system
  • HTA should be tailored to ensure appropriate
    customization to the individual characteristics
    of a country

HTA in Emerging Markets. PhRMA International
Position Paper,May 2013
24
4. Conclusions HTA Development is moving forward
but how it is used varies let best practice
principles guide the way
  • Increased health care spending, health system
    reforms to broaden coverage, and growing need to
    access modern technology gives a strong impetus
    to HTA
  • HTA systems are constantly evolving even amongst
    early adopters
  • Although NICE remains a prominent model, it is
    also a model in transition
  • Some forms of HTA are converging but significant
    methodological issues remain
  • Despite some convergence of approaches, the motto
    appears to be Globalize the evidence, localize
    the decision
  • Adopting widely accepted best practice principles
    is preferable approach when developing HTA.

CRA,Latin America Industry Workshop
Presentation, May 2013
25
Impact of HTA Considering the Patient Perspective
  • Questions or Comments

26
  • Back Up Slides

27
Use of HTA by Private Plans
  • HTA plays an increasing role in translating
    emerging technologies into clinical practice and
    policy.
  • Private payers are important users of HTA whose
    decisions impact adoption and use of new
    technologies.
  • Payers relied more extensively on HTAs for
    reviews of personalized medicine (64) than for
    other technologies.
  • Most payers (82) valued expertise of reviewers
    and rigor of evaluation as HTA strengths
  • Key reported shortcomings for personalized
    medicine were limited availability of reviews
    (73) and limited inclusion of nonclinical
    factors (91), such as cost-effectiveness or
    adoption of technology in clinical practice.
  • (HTA private payers coverage of personalized
    medicine.Am J Manag Care. 201117(5 Spec
    No.)SP53-SP60)

28
Use of HTA among private plans in the US
  • Insurers coverage and reimbursement policies have
    traditionally lacked sufficient transparency
  • The Academy of Managed Care Pharmacy (AMCP)
    produced its first guidance document on evidence
    requirements to support formulary listing in
    2000.
  • WellPoint released a set of evidence requirements
    to improve transparency on the type of data
    required to make value-based, health-care
    decisions on drug therapy for its members.

HTA in Health-Care Decisions in the United
States, Value in Health, S. Sullivan et al, Vol
12, 2009
29
Use of HTA among private plans in the US
  • HTA will continue to evolve to accommodate the
    needs of health insurers.
  • It will always be shaped in part by the political
    landscape that will in turn be influenced by
    public perceptions of HTA as either a system that
    improves patient care or simply restricts access
    to promising medical technologies.
  • Such perceptions will influence the level of
    public financing of HTA, but they will not change
    the real need that payers have for controlling
    health spending at the same time ensuring access
    to effective medical technologies. The medical
    technology industries will need to grapple with
    the seeming paradox of meeting regulatory and
    licensing requirements while building an
    evidence-base necessary to satisfy health-care
    payers.
  • The evidence summary reports by organizations
    such as the Cochrane Collaboration, UK-NICE,
    DERP, and the CADTH now are more similar than
    they are distinct. As a result, decision-makers
    in the United States have begun to rely on these
    sources in their HTA processes, and are thus less
    prone to develop ad hoc or nontransparent
    approaches to evidence appraisal.

HTA in Health-Care Decisions in the United
States, Value in Health, S. Sullivan et al, Vol
12, 2009
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