The Role of HTA in Health Care DecisionMaking

1
The Role of HTA in Health Care Decision-Making

• Panos Kanavos Ulf Persson
• 12 March 2008

2
HTA in assessing value of new technologies

• A policy-makers perspective
• 1. Scientific criteria assessment of
  therapeutic benefit
• What is a novel therapy?
• What type of criteria are used to assess
  therapeutic potential?
• 2. Economic criteria
• Budgets
• Assessment of cost effectiveness
• 3. Industrial policy (good citizenship approach)
• RD
• Employment
• Exports

3
HTA currently used most frequently in assessing
value of medicines and less so of medical devices
and other health care technologies there is
significant potential in using HTA across all
health care technologies, including medical
devices, procedures and e-health technologies
4
How does HTA fit into the regulatory environment
for new medicines?

• Regulatory approaches to pricing medicines
• 1. Rate of Return (RoR) Regulation
• 2. Price Setting
• 3. Value-based pricing/Cost-effectiveness
  pricing/HTA
• 4. Controlling use through price volume agreements

5
Value-based/cost effectiveness pricing/HTA in
EU/Switzerland, 2007

• Under preparation or rising in influence
• France
• Greece
• Poland
• Spain
• Hungary
• Slovenia
• Czech Republic
• Slovakia

• Current practice
• Denmark
• Switzerland
• Sweden
• Finland
• The Netherlands
• England Wales NICE
• Portugal
• Norway
• Baltic states (Estonia, Latvia, Lithuania)
• Italy

6
Using HTA/Value Based Pricing (VBP)
Heterogeneity of existing HTA bodies reflects the
differentiated environments of European health
care systems.
7
Current and future issues and challenges in HTA
across health care technologies - I

• To determine (extent of) price premium
• Explicit versus implicit
• Ex ante versus ex post
• What perspective?
• What costs?
• What data/outcomes?

8
Current and future issues and challenges in HTA
across health care technologies - II

• The use of HTA has increased significantly in the
  past decade in most study countries and it is now
  an integral part of the formal decision-making
  process
• Despite the potential applicability of HTA across
  a wide range of medical technologies, including
  drugs, devices and procedures, it is currently
  applied to drugs in most countries. Nevertheless,
  there are significant opportunities to expand the
  role of HTA to include new technologies, beyond
  drugs, but this is, among others, an issue of
  methods as well as priorities/funding at national
  level.

9
Current and future issues and challenges in HTA
across health care technologies - III

• Stakeholders (patient groups, medical sector,
  industry) need to have the opportunity to
  actively participate in person in HTAs, submit
  evidence, as well as comment on draft reports and
  be able to access the rationale for the final
  decision this is not always the case
• A products impact on health and the health care
  system emerge over time through exposure to the
  market consequently, manufacturers should be
  able to submit health outcomes information to the
  relevant government bodies throughout a products
  lifecycle. This evidence should receive
  appropriate attention from HTA authorities and
  although this is not occurring at the moment,
  there are signs in some countries that this is
  beginning to be the case.

10
Current and future issues and challenges in HTA
across health care technologies - IV

• Few countries actively consider or promote HTAs
  of public health interventions, or, indeed,
  include the public health impact of different
  technologies when considering such technologies
  for coverage.
• Currently, decision-makers consider mostly
  evidence available prior to the launch of new
  technologies (ex-ante) this poses the problem
  that effectiveness data is not available to
  decision-makers or manufacturers at the time of
  launch. As a result, post-launch assessments
  (ex-post) may be preferable due to greater
  availability of more robust data nevertheless,
  the precise specifications of such assessments
  need to be clear from the outset and may be
  dependent on or associated with the ethos of the
  health care system in which they take place.
• Both old and new technologies should be assessed,
  whichever have a significant impact on cost,
  service delivery or patient outcome. This implies
  disinvestment of older and less efficacious
  technologies, but there is a feeling that direct
  disinvesment is still to come.

11
Current and future issues and challenges in HTA
across health care technologies - V

• In certain cases classic RCTs may be unnecessary,
  unethical, inappropriate or impossible. Other
  alternative forms of assessment, including
  observational studies such as registry data,
  should therefore be accepted by HTA assessors.
  There is some resistance in accepting such data
  in some countries and this needs to be addressed.
• While HTA in terms of using economic evidence-
  takes into account the static efficiency
  considerations from investing in innovation, it
  does not necessarily take into account the
  dynamic efficiency implications and the risk
  incurred by suppliers when undertaking investment
  under uncertainty in various forms of medical
  technology.