There is a disconnect between when market access activities typically begin and when they should ideally begin, take a look at what we have discovered.

1. MARKET ACCESS
IT’S ALL IN THE
TIMING
- US perspectives
COVANCE MARKET ACCESS
Experience Forward Thinking

2. Findings and discussion from a series of market
access symposia conducted across the US in 2017

3. 03
WHEN IS THE RIGHT TIME?
There is currently much discussion about the optimal timing of market access and health economic activities. The generation
of robust evidence and impactful messaging is crucial to maximizing reimbursement and uptake following launch and
throughout a product’s lifecycle. But to be best prepared for launch, when should key activities, such as stakeholder
engagement, modeling and value proposition development, begin? And is there currently a disconnect between when they
would ideally be started and when they begin in reality?
When asked to consider the timing of market access and health economic activities within their organizations, US healthcare
industry professionals1
reported a distinct trend toward these activities starting later in a product’s development than they
would consider ideal (Figure 1). The responses indicate that phases I and II are considered key stages to start activities – with
the ideal time for market access activities slightly earlier than that for health economic activities – but in many organizations
they start later than that, in phase III.
Figure 1. Real vs ideal timing of key activities
Preclinical Phase I Phase II Phase III Peri-launch
0
25
50
Respondents
(%)
Market access activities
Health economic activities
Preclinical Phase I Phase II Phase III Peri-launch
0
25
50
17
15
9
38
26
35 35
10
12
2
11
17
8
23
31
49
36
9
14
2
Respondents
(%)
When the activities currently begin
When activities should ideally begin

4. 04
WHAT ARE THE BARRIERS TO STARTING EARLY?
Although US healthcare industry professionals stated that the ideal time to start market access and health economic activities
was relatively early in a product’s development, this was not reflected in practice, which indicates the presence of barriers to
early initiation. When asked what they considered to be the greatest barrier in their organizations to starting market access
and health economic activities early, respondents reported a variety of obstacles (Figure 2). Lack of funding was the most
commonly cited challenge; however, this was closely followed by several other factors, suggesting that multiple barriers may
operate, potentially in interaction, to hinder early initiation of activities.
Figure 2. Perceived barriers to starting key activities early
Why start early?
It seems instinctive that considering market access early in a product’s development will be beneficial to its commercial
success. What opportunities might be realized with the additional time gained through starting market access activities
sooner?
14%
33%
17%
13%
21%
0 10 20 30 40 50
Conflicting
goals
Lack of
funding
Organizational
structure
Lack of
expertise
Other
Respondents (%)
Clinical trial design can take account of market access considerations, such as the potential positioning of a
product and the evidence requirements of market access decision makers.
Comprehensive landscape assessments can provide a solid understanding of the current therapy
area and how it might evolve in the years to launch. This can help shape the potential positioning of a product and
ensure there is a focus on generating evidence that will differentiate a product in a potentially crowded marketplace.
Early modeling allows for exploration of potential outcomes for a product, and different scenarios can be
considered to identify where the product’s value might lie. For example, ‘what if?’ scenarios can be compared to
prepare an organization for alternative outcomes that depend on clinical trial results.
Value proposition development is an important strategic activity for any product. By starting early,
various positioning scenarios and potential differentiation from competitors can be explored and tested with external
stakeholders. In turn, this can inform evidence-generation activities – for example, which outputs would be relevant
to calculate from a model, or which endpoints could be valuable for inclusion in a trial.

5. 05
Meaningful relationships can be built with key external stakeholders, such as
payers, clinicians and patients and their input can be sought to gain insight into perception
of unmet needs, attributes in a new product that will be considered valuable and evidence
necessary to support them and the potential response to a product’s messaging and
positioning.
External communications to prepare the market can begin before launch,
initiating a dialogue with decision makers and influencers before regulatory approval. To
maximize the impact of these communications, an understanding of product positioning is
important, for example, so areas of disease burden that the product is expected to address can
be highlighted.
By starting early, potential challenges for a product can be identified, allowing time
to take steps to address them. Early market access activities can also help evaluate the overall
business case for a product, providing insight into its commercial viability depending on trial
outcomes and offering the opportunity for informed stop/start decisions during development.
There is synergy between evidence-generation activities, stakeholder engagement, and value proposition
development (Figure 3). They can benefit from and inform each other, and by starting early this interplay
between key activities can be better facilitated than if activities only begin inPhase III and peri-launch
periods, where they typically run in parallel over short timelines.
Figure 3. Interplay between key market access activities
The potential interaction of these activities is complex. For example, Phase I and II clinical data can
feed into aspirational value messages. These, in turn, can form a basis for initial engagement with
key opinion leaders and payers to gauge their response to the messaging and the potential impact on
decision making. The results of this primary research can then inform evidence-generation activities
and message refinement. Repeated over the course of development, this interaction results in validated
evidence and messaging to support market access activities at launch.
EVIDENCE
GENERATION
Clinical
develoment program
Health economic and outcome
modeling
Literature review
and meta analysis
Real-world data
VALUE PROPOSITION
DEVELOPMENT
STAKEHOLDER
ENGAGEMENT

6. 06
CAN TIMING IMPACT MARKET ACCESS SUCCESS?
Although there appear to be many potential benefits of starting market access activities sooner, these will only be meaningful
if they have a tangible impact on a product’s success. Market access success might be measured in various ways, such as Food
& Drug Administration (FDA) approval, preferred formulary status, fast uptake or a large market share. Several measures
of success have a degree of subjectivity – for example, what constitutes fast uptake or a high price? However, one objective
measure of success is FDA approval and, with information on decision-making considerations available in the public domain,
this can provide insight into what influences success. By reviewing common reasons for non-approval of New Molecular
Entities (Figure 4), it is possible to identify factors that contribute to unfavorable decisions.
Figure 4. Common reasons for non-approval of New Molecular Entities, 2000–20122
What can be learned from this, and could starting market access activities sooner influence the factors that contribute to non-
approval? The FDA feedback highlights the importance of market access being considered in the early phases of development
and design of pivotal trials. This is critical in terms of the clinical evidence required by market access decision makers and
also the data available for economic and outcome modeling activities, which are of increasing importance in the US, owing to
the growing need to demonstrate product value. Crucially, clinical trial design is time sensitive – the right decisions need to
be made at critical stages of product development, as making changes later may incur high additional costs and significantly
impact timelines.
The feedback also emphasizes how the design of the clinical development program can benefit from synergy with other
activities, provided there is sufficient time. For example, stakeholders can provide insight into relevant comparators and
measures of effect to ensure that they are clinically relevant. Also, the value proposition can help focus on key areas of
differentiation and ensure the available evidence is best leveraged to support desired product positioning. Realistically,
activities must begin earlier than Phase III and the peri-launch phase to achieve all of these benefits.
DOSING CONCERNS
• Uncertainties around optimal dose to maximize efficacy
and to minimize safety risks
EFFICACY CONCERNS
• Study endpoints not reflective of clinically meaningful
effects
• Study population not reflective of patients who would use
product
• Inconsistent results when different endpoints tested
• Inconsistent results when different trials or study sites
compared
• Poor efficacy versus standard of care
REASONS FOR FDA NON-APPROVAL
SAFETY CONCERNS
• Missed or inadequate clinical or nonclinical
safety studies
• Failure to address theoretical safety risks raised
in animal studies
• Study population too small to characterize risks

7. 07
IS MARKET ACCESS SUCCESS GUARANTEED BY
STARTING ACTIVITIES EARLY?
When considering past product launches, would outcomes have been different if activities had been
started sooner? It is challenging to give a definitive answer, given the complexity of getting a product
to market and launching it successfully. Through the drug development process and associated market
access activities, there will always be challenges. Regardless of effort and planning, there is always the
risk that a drug may not perform as well as expected in a trial, and differentiation can be challenging in
crowded marketplaces. However, there are undoubtedly benefits to beginning activities sooner than they
are typically begun and, in particular, ensuring market access is a consideration throughout the clinical
development program. So, while starting market access activities early might not guarantee success,
it could improve the chances – and help reduce stress in the typically frantic time preceding product
launch.
1. Responses from 63 symposia attendees in several US locations (Boston, MA; Research Triangle Park, NC; San Diego, CA; San
Francisco, CA) who described their function within their healthcare organization to be Executive Management (37%), Market
Access (19%), Health Economics and Outcomes Research (6%), Regulatory (3%), Medical Affairs (8%) and Other (27%).
2. Taken from Sacks LV et al. JAMA 2014;311(4):378–84

8. COVANCE MARKET ACCESS
Experience Forward Thinking
www.covance.com/marketaccess
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