been lost. One of the most frequently requested
pieces of information by formulary committees
and reimbursement agencies is, ‘What is the
impact on my budget?’ and from patients is
‘What will be the impact on me? Will I feel better?’
It is tempting to ignore pharmacoeconomics under
the guise of ‘it is not required by the agency’ or ‘it
will slow things down’.
The challenges associated with successfully
incorporating pharmacoeconomic components
into a clinical development program include mak-
ing sure the right people are involved early enough,
so that delays do not occur. Adding pharmacoeco-
nomic components to clinical development pro-
gramsdoes nothave to be rate-limiting, butwill
automatically be so when the project team fails to
bring the pharmacoeconomist into the project at an
early stage, that is phase I. Early involvement will
enable the pharmacoeconomist to understand the
characteristics of the investigational drug and the
targeted conditions, and as the trial program is laid
out, pharmacoeconomic components can be
selected that are the most appropriate for the stu-
dies in the program. A thoughtful and documented
pharmacoeconomic development plan should be
made available at the same time as the clinical
and marketing development plans. Only then will
all the three plans be coordinated and support one
another.
23.4 Value-added versus
traditional clinical
development programsThe magnitude of the challenge of incorporating
pharmacoeconomics into a traditional clinical
development program will depend on the type of
program being studied, the willingness of the
research team to be open to new types of outcome
measures and the capability of the pharmacoeco-
nomist. As research-orientated companies avoid
‘me-too’ products, and forge new areas of unmet
medical needs, the need for value-added develop-
ment programs with scientifically valid pharma-
coeconomic outcome data will increase. When the
need to demonstrate value has been discussed long
enough, the real debate should be why toexclude
pharmacoeconomic measures, not whether to
includethem. Including pharmacoeconomic mea-
sures should be the default.
Training and experience of the pharmacoecono-
mistwill impact the conduct of how well value is
added to a drug development program. Does the
pharmacoeconomist understand the clinical trial
process? Is the goal to have a pharmacoeconomic
message useful to marketing? Does the pharmacoe-
conomist understand what messages a sales repre-
sentative can communicate and what materials can
be disseminated as promotion? Has the pharmacoe-
conomic scientist interacted with the FDA and other
regulatory agencies? Will he/she be able to develop
a pharmacoeconomic strategic plan that will com-
plement the clinical and marketing plans and fulfill
the goals of the company? All these questions
shouldbeaskedbeforeselectingastafforconsultant
pharmacoeconomist and embarking on a value-
added development program.23.5 Pharmacoeconomic baseline
The important first step in developing a pharma-
coeconomic strategic plan is to start by finding out
what is currently known about the disease and the
economic and humanistic burden that it has on
patients, payers and providers. The best place to
start is with a review of the literature and the
Internet to determine what has already been
accomplished. This may entail a review of the
epidemiology and clinical aspects of the condition
to verify that pharmacoeconomic components
would be a worthwhile addition to a clinical pro-
gram. After this review the pharmacoeconomist
should then formulate the plan for measuring
economic and humanistic outcome, and this will
ultimately become a component of the full devel-
opment plan.
If adequate baseline measures do not exist, then
an important part of the strategic plan will be to
research and document the baseline burden of ill-
ness as it is currently being treated (or not treated, if
this is the case). This can be done separately from
the clinical trials that are taking place, although
placebo-treated patient measures may also be23.5 PHARMACOECONOMIC BASELINE 295