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Strategy
Cedar Associates LLC assists a company’s decision
makers -- from regulatory, clinical, commercial, and
reimbursement teams -- to develop an effective strategy
for commercializing a new product. Our emphasis is
primarily on the economic and reimbursement strategy,
and our experience reveals that it must be informed from
input of other teams.
We
have experience from early-to-late phase development in:
(1) reviewing the economic and reimbursement
landscape,
(2) assessing key regulatory, clinical,
commercial, and reimbursement objectives,
(3) determining the deliverables that are
needed to achieve objectives, and
(4) generating a prioritized list of projects
to complete deliverables.
Our approach stems from the core fundamentals of decision analysis
(e.g., "Value-Based Thinking" Raiffa, 1996).
We start by undertaking to fully understanding the
economic and reimbursement landscape. This involves
review of practice patterns, incentives of key
stakeholders (e.g., patients, providers, payers), the
regulatory environment, and the economic environment. We
then assess with the team their key objectives, looking
especially as to whether the reimbursement/economic
objectives align with regulatory, clinical, and
commercial objectives. The third step involves
determining the deliverables that will be most needed to
achieve objectives; e.g., studies that address specific
knowledge gaps about burden of illness, use of existing
products, quality of life, economic forecasts. We then
undertake to identify all potential projects to help the
team and company reach its objectives (i.e., effective
brainstorming). We assess the potential for each project
to achieve its goals and its feasibility and costs. (Dr.
Hornberger has published on the topic of conducting
cost-effective studies.) We assist in coordinating input
and discussion of the pros and cons of each proposed
project.
It is important to realize that not all projects have
required our full involvement in each of these steps.
With this process, we have found that at the end, the
team and management has a well-referenced, reliable, and
credible summary of strategic options and realistic
expectations about the potential costs of implementing
each strategy and its potential for success.
Our approach has been applied successfully in (1)
influencing study design for Phase II and Phase III
trials, (2) deciding on adjunctive analyses of existing
trials, and (3) designing and implementing new studies
that complement pivotal regulatory trials.
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