OVERVIEW
The work of ISPOR members in the design of evidence in the
form of outcomes research and pharmacoeconomics studies and the
communication of the evidence research is critical to these
reimbursement decisions, which in turn can impact both access to
and delivery of quality care. It is increasingly important that
health economics and outcomes studies consider third-party payer
health technology assessment standards and that payers be educated
on design of evidence and how information can be properly used. At
the same time, payer requirements vary by country, while good
outcomes and economic research of any country should be considered
and used world-wide.
By its presence or absence, reimbursement by third-party payers
for a new procedure, drug or medical device can dramatically
affect patient care. Payers will often but not always establish
coverage and appropriate reimbursement based on unbiased clinical
and economic evidence as reflected in sound health technology
assessment methods. Do we as outcomes and economics researchers
know when scientific evidence can and can't be used to reimburse
for new treatments?
Study designs for clinical trials are designed to the
specifications of the regulatory bodies. However, some payers use
various aspects of study designs to make coverage decisions, such
as use of patient inclusion and exclusion criteria as coverage
criteria. Do we understand the impact of clinical study designs on
coverage decisions?
Third-party payers in all countries are seeking better value for
money spent on treatments, drugs and devices, and are therefore
major users of consumers of outcomes and health economics studies.
Do we know if the principles of good outcomes and economics study
design are reflected in payer evidence requirements?
Some influential payers are developing and changing evidence
requirements for coverage. Do we have a mechanism for following
these trends and where necessary adjusting our study designs to
consider or include them?
Some payers may need education on how to understand and use
outcomes research findings in decision making. Can we build a
forum for payers and outcomes researchers to dialogue on these
common interests?
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