Adapting to New Market Realities:
Achieving Launch Excellence in Oncology
By Mike Zubey,
Director and Senior
Principal,
Biotechnology and
Yet, all of this potential won’t materialize as
pharmaceutical companies are
easily as it has in the past. In many tumour
paying a high price as the
©areas, the market has evolved from one of
high unmet need to one in which payers can
Gavin Krumenacker, Oncology market is maturing and
afford to be “choosey” and to impose access
Director, Product &
, that the rate of
access is increasingly restricted.
restrictions. d
It oiswalready
nloadclear
Portfolio
n
a
Ironically, the scientific advancesed ugrowth
sers c for oncology
l use products, while still
a
s
i
Management,
n
r
o
o
s
h
r
t
above
the
global
industry average, is slowing.
. Au
that are transforming
for pe
edthe
y
t
i
p
b
i
o
h
c
o
e
IMS
set
out
to
understand what distinr
e pcancers
ingl
Srinivas Pothukuchi, treatment
usof
a sthe
d
and
t
e
n
i
s
r
i
r
p
guishes
successful
oncology
launches in the
an d
Senior Principal,Unautho
w
e
i
v
,
y
prognosis
for
patients
are
pre-launch
phases
by:
a)
interviewing
displa
experts
from
within
leading
oncology
manuIMS Health
presenting new and complex
facturers and from within IMS and b) studycommercial challenges for
ing 16 leading targeted therapy launches.
marketers.
ht
ion
t
g
i
u
r
b
i
y
r
t
p
s
Co
cial Di
rS
o
f
t
o
N
ale
r
e
m
m
or C o
“Maturity,” as British playwright Tom
Stoppard observed, “is a high price to pay for
growing up.” In a twist on this, biotechnology companies and pharmaceutical manufacturers are paying a high price as the oncology market is maturing and access is increasingly restricted. Ironically, the scientific
advances that are transforming the treatment
of cancers and the prognosis for patients are
presenting new and complex commercial
challenges for marketers. Commercial success with an oncology launch is becoming
more elusive. But it is well worth pursuing –
provided that you understand the new “rules
of the game” and the most recent strategies
that have proven to work.
A Pressing Need for Answers
According to a recent IMS Health Launch
Excellence study, oncology will remain the
top therapy area by share value in the
world’s eight leading geographic markets
through 2020. Thus, quite predictably, the
oncology market is of intense interest to
both large and small R&D companies, to
those with existing oncology franchises, as
well as those not yet in the field. Indeed, the
industry’s collective pipeline is brimming
with promise from significant innovation.
Driver #1: Pursue an Optimal
Indication Sequencing Strategy
Reaching “blockbuster” status ($1billion in
annual sales) with an oncology launch is
becoming more elusive, so the first step to
success is having the right indication
sequencing strategy for optimal investment
and maximum return.
Since mode of actions can often be transferred between tumours, managing an oncology agent is like a portfolio in itself.
Managing multiple oncology drugs can,
therefore, become a daunting task. After
Phase I, the available indication choices start
becoming clearer as defined by the mode of
action. Upon entering Phase II, companies
then need to start forming their sequencing
strategy which includes determining:
• How broad a therapeutic footprint they
wish to pursue
• Whether to go for a speed-to-market or
more comprehensive approach
• What sequence of indications will work
best
• How the product can be differentiated –
and what clinical endpoints will be
required
• The level of financial commitment needed in each scenario and whether the risk
needs to be spread out
Canadian Pharmaceutical Marketing / September 2011
25
IMS Brogan Viewpoint
And, just as in other therapeutic areas, all of this must
be evaluated within the context of the forecasted competitive intensity of the market and the size of the available population. Once a sequencing decision has been
made, companies can then determine what tumour indications are worthy of advancing into Phase III.
While large patient populations have historically been
the obvious first area for investment, today, one must
also consider the payers' view of unmet need before
selecting a path.
The next hurdle will be to ensure that the right endpoints are built into the clinical trial plan. The clinical
trial endpoints that will hold sway with payers depend
upon payer perceptions of the unmet need and the number of targeted therapies available to treat a given tumour
type. One common thread is that payers want to see significant improvement in survival; however, the definition
of the word "significant" changes by tumour type. Today,
payers regard response rate and time to progression as
insufficient surrogate endpoints on which to base reimbursement decisions.
Driver #2: Make the Right
Segmentation Trade-Offs
Given how restrictive the market is for some tumour types,
one viable strategy that is gaining ground is to limit one’s
market to a sub-group of patients for whom the product
produces a greater response rate and, hopefully, also a
higher overall survival rate. Using biomarkers to segment
the patient pool in this way, of course, means sacrificing a
larger patient population for a stronger value proposition
that translates into market access and, potentially, premium pricing. Bear in mind that the alternative, aiming for a
larger population, could fail to produce the necessary clinical endpoints and, thus, preclude you from gaining any
market access.
A strong value proposition, hence (easy) market access,
will greatly enhance further indication approvals and possibly result in premium price reimbursement.
The positive acceptance among the medical community will then rebalance the initial limitation of economic
potential due to patient stratification. Therefore, in some
tumour types, developing a biomarker early in the development cycle is a desirable priority, albeit a difficult one.
One company representative likened developing a biomarker to developing another product, meaning that the
process is complex and also adds considerably to the overall cost of development.
Driver #3: Employ Novel Approaches
to Gain Payer Acceptance
Even companies that have adopted successful lifecycle
and segmentation strategies can meet with resistance
from payers on their oncology products. Universally,
Figure 1: Key Success Factors for an Oncology Franchise
26
Canadian Pharmaceutical Marketing / September 2011
• While payers are an important audience, their
influence over prescribing decisions in oncology has
not overshadowed that of physicians, as it has in other
therapeutic areas
• Gaining access to physicians requires having the
“right” talent and mix of medical and business skills
on board. Increasingly, physicians prefer speaking
with medical liaisons, given their deeper
understanding of the science involved. As one person
we interviewed explained, “It’s hard [for sales people]
to get into the oncology scene and understand the
core dynamics”
• Raising public awareness and inspiring brand
advocacy is crucially important. Involvement of
society beyond patient support groups and use of a
battery of media outlets should become standard
operating procedure. The future of oncology lies at a
conceptual, rather than at a drug level; the whole
concept is important, not just the pill
Driver #4: Build a Strong Oncology
Franchise
Conclusion
Another commonality among the successful launches
we studied was the sponsor companies' investment in
achieving a degree of prominence in the therapy area.
They had – or were focused on gaining – a durable
oncology franchise. By this, we mean that they:
• Demonstrated a long-term commitment to oncology
• Pursued ambitious goals
• Developed treatments across tumour types via
multiple products/indications
• Established a reputation as a leading player in the
field (which is perhaps more difficult in oncology
because oncologists themselves are so specialized
that they may not see the breadth of what a company
offers). This, in turn, gave them enviable access to
key opinion leaders (KOLs), prescribers, and
patients for clinical trials
Companies intending to strengthen their oncology
franchises must be mindful of these conditions:
IMS Brogan Viewpoint
payers are struggling to find the balance between their
desire to maintain access for patients and their need to
control costs. On the one hand, they face political sensitivity and public pressure to make oncology treatments available, and they acquiesce. On the other
hand, their budgets are constrained and must cover
other therapy areas as well.
Consequently, a product that is systematically
reviewed across Europe can easily receive different
outcomes from the clinical data analysis. Bayer’s
Nexavar, for example, was recommended for coverage
in France, Poland, Sweden, and the Netherlands (the
latter with limitations), but denied in Denmark and the
UK. What is more, the outcomes of the economic
reviews by the assessors were more disparate.
Companies clearly need to prepare their dossiers to
address the requirements and perspectives of individual countries. Each will have its own idea of what constitutes good value for their money.
Companies with a strategic focus on oncology must
accept the fact that the market has changed, with
many tumours maturing and payers using new criteria to evaluate treatments. Success in oncology
requires new levels of both clinical leadership and
commercial savvy.
From our observation, discussions, and analysis,
we’ve determined that the most successful oncology
launches all share the following characteristics:
• An investment strategy that maximizes returns using
the best entry route and carefully considered
indication sequencing
• A strategy for developing a patient profile that makes
the right trade-offs between the benefits/drawbacks
of targeting large patient populations versus
sub-segments, which will drive the increasing need
for biomarkers
• A realistic understanding of what payers in different
countries are prepared to pay for and a flexible
approach to meeting their criteria to maximize the
possible access by country CPM
• KOLs are themselves, customers. Given the small
pool of oncologists, thought leaders in the field are
more than usually influential, and engaging them in
clinical trial design and expanded access programs is
critical
Canadian Pharmaceutical Marketing / September 2011
27