Transcript PHARMACOECONOMICS ON THE INTERNET

PHARMACOECONOMICS
THE ROLE OF
PHARMACOECONOMICS
FROM THE PHARMACOECONOMICS ON THE INTERNET ®SERIES
© Paul C Langley, 2004
Maimon Research LLC
OBJECTIVES
• To consider the key audiences for
pharmacoeconomic (pharmaceutical economic)
studies
• To identify the principal information needs of
each audience
• To consider how the disparate needs of audiences
might be met
• To provide a redefinition of the role and scope of
pharmacoeconomics
CLINICIANS AND
ECONOMISTS
• While pharmacoeconomics is
interdisciplinary by nature there is clearly
tension between those from a clinical as
opposed to an economic background
• The clinical mindset has dominated the field
• Driven by the needs to reimbursers to risk
manage populations and budgets, the focus
is now shifting
WHERE ARE WE GOING?
• Clearly there is a demand for effectiveness
studies - for a more naturalistic approach
which allows inferences to be drawn on
population impacts
• The emerging paradigm is to move away
from clinical, incidence models (and ICOR
claims) to designing studies which allow
population cost and outcome inferences to
be drawn
….AND THE DESTINATION?
• In the next five years we will see, driven by
the needs of reimbursers and health system
managers, a commitment to population
impact trials as part of the drug
development process
• These will build on the notion of
“naturalistic trials” but with the brief to
provide the evidentiary basis for population
risk management claims by manufacturers
LIFE CYCLE STAGES
• Stage 1: Conventional Clinical Phases of
Product Development
• Stage 2: Reimbursement Stage
• Stage 3: Market Entry and Support Stage
STAGE 1: ACTIVITIES
• Identify prevalence and treating prevalence
in disease area for key markets
• Identify treatment patterns, outcomes,
resources used and costs
• Specify potential patient switching and
pricing scenarios
• Agree a sustainable unit price consistent
with company objectives
STAGE 2: ACTIVITIES
• Achieving reimbursement: a sufficient or
necessary condition for market entry?
• Contracting and prescribing constraints
• Preparing market specific reimbursement
submissions
• Budget impacts and sub-population
considerations
STAGE 3: ACTIVITIES
• Generalizability of reimbursement claims
• Prescriber perspectives: total cost versus
silo-budgeting
• Modeling for generalizability
• Naturalistic trials and treatment pattern
assessments
AUDIENCE NEEDS
• Does pharmacoeconomics meet audience needs?
• As presently conducted, pharmacoeconomic
research is dominated by the marketing interests
of drug companies
• Studies are commissioned because they are
perceived to meet the needs of marketing
departments and are typically supportive of the
sponsor’s product
A WIDER AUDIENCE?
• Audience responsible for drug development
and ongoing assessments of market
potential
• Reimbursers and prescribers
• Journal editors and reviewers
BIAS
• A longstanding concern given the pecuniary
interests of sponsors and researchers
• Need seen to meet the gold standards of
evidence based medicine
• Pleas for transparency and access to data
and models
• A failure to appreciate approximate nature
of economic evaluations (?)
PHARMACOECONOMICS
An application of the tools of
microeconomics to the ongoing evaluation
of the impact of new and emerging
technologies in health care systems from
perspectives of (i) manufacturer, (ii)
reimburser and (iii) prescriber
ANALYTICAL FRAMEWORK
• Clearly seen shift away from ‘efficacy’ studies to
‘effectiveness’ studies
• Growing emphasis on a patient population risk
management focus with requests for budget
impact assessments (e.g., resource allocation and
application of a reference case methodology)
• Budget impacts have led reimbursers to request
sub-group analysis as a rationing and limited
access justification
SUMMARY
• Pharmacoeconomics is increasingly being
challenged to demonstrate its relevance to
formulary choice and health system
management
• We face the need to develop new tools in
order to provide a better methodological
basis for assessing the prospective impact of
new technologies