Pharmaceutical Commerce - May/June 2017 - 18

Market Access
Ma ny o f t h e p hy s i c i a n s we co n t a c t
in research today have difficulty
differentiating the drugs or even assigning
the right molecule to its appropriate
mechanism of action," says Kaman of ZS
Associates. In this context, developers
w ill have to find alternative ways to
differentiate beyond just proselytizing
their data."
"Manufacturers have an opportunity
to play a strong leadership role," Kaman
adds. "Leading manufacturers must work
in partnership with payers, hospitals and
physicians to run pragmatic trials and
generate real-world evidence that shows
where these therapies work the best and
where they do not."
Meanwhile, the visible role of so many
competing value frameworks w ithin
oncology-such as those developed by the
Institute for Clinical and Economic Review
(ICER), the National Comprehensive
Cancer Network (NCCN), Memorial Sloan
Kettering Cancer Center, and the American

Society of Clinical Oncology (ASCO) -
is also helping to shape the topography
within the I/O space. John Doyle, SVP,
Real-World Insights, QuintilesIMS (New
York, NY) notes that many of today's
value frameworks are more amenable to
meeting with drug developers earlier in
the process, to have conversations about
competing methodologies that may help
to demonstrate value. "The conversation
goes increasingly beyond just clinical
attributes (safety, efficacy, administration)
and cost issues-drug developers are
thinking about many other aspects of the
patient experience, including humanistic
elements, and baking them into the
clinical-development program earlier in
the process," he [Doyle] notes. "In fact,
we're seeing clinicians, epidemiologists
and I/O statisticians on clinicaldevelopment programs, all worrying about
the parameters that the value frameworks
value, and simulating what that will look
like as early at Phase II, to maximize the

probability of success with FDA and EMA.
This is all very new-and I've been in the
oncology space for more than 20 years."
When it comes to showcasing an I/O
therapy's full value proposition, Doyle of
Quintiles says he finds it fascinating that
some pharmacos are actually simulating
what the potential "value framework"
scores might be for their new I/O therapies
much earlier in the process-as early in
Phase II. Such efforts can help to shape
future clinical development work, to
better showcase safet y, efficacy and
administration in the I/O space, helping
drug developers to study things that
don't show up in the clinical trials, such
as patient costs, societal costs and nontraditional patient metrics, in parallel, so
the companies have all the evidence they
need to tell holistic story right from the
"Similarly, there are concerns around
the perception that 'you must try I/Os on
patients to see if they truly work' which

usually necessitates a 90-day trial at a
substantial cost," says John Kalada, a senior
director at Xcenda. "The case for trying
it is made stronger when an approved
biomarker is present-then the plans are
generally more confident they are getting
appropriate value for their investment via
a very targeted approach."
"At present, there are 190 oncology
practices and 16 payers participating in
the risk-reward-bearing Oncology Care
Model (OCM)," says Kalada. "The recent
clarification around FDA's FDAMA-114
statute [which was designed to allow
companies to more readily disseminate
healthcare economic information
(HCEI) to those who need it during
formulary development] will create an
open environment for greater use and
dissemination of this level of real-world
evidence that is focused on clinical and
financial outcomes."

Future look: The Impact of Biosimilars on Oncology
Marketing strategies will adjust with the advent of biosimilars
By Ben Curtis and Katherine Seay, inVentiv Health

In 2016, no topic
generated more
interest and attention
from payers than
o n c o l o g y. A c l o s e
Now, t h e s e p o i n t s
of payer focus are
c o nve r g i n g . A s n e w
oncolytic and supportive
care biosimilars begin
to emerge in 2017, the
impact these products
can make w il l be an
important priority for
health plans and manufacturers alike. [1]
What can we plan for and expect from
biosimilars in oncology? Through our
analysis of data on existing biosimilars,
upcoming launches in oncology and
supportive care, and proxies from other
conditions showing how biosimilars have
impacted therapy and sales, we will provide
information to help plan for this uncharted
Understanding payer expectations
US payers are seeing data that promise
potentially dramatic cost reductions
through the adoption of biosimilars. These
data show combined overall savings in the
US and Europe ranging from $56 to $110
billion through 2020. [2] Payer expectations
on savings are high, so when it comes to
oncology, biosimilars will become a core
focus for future plans. Zarxio, a biosimilar
version of filgrastim, has been on the market
in the US since 2015, and biosimilar versions

of the oncology therapies bevacizumab,
trastuzumab, as well as supportive care
therapy pegfilgrastim are under review by
FDA. Also a Biologics License Application
submission for rituximab is expected this
US-based payers are keenly monitoring
the uptick of biosimilar use in Europe to
anticipate what may happen in the United
States. For instance, use of biosimilar
filgrastim, which is used in chemotherapy
patients for the treatment of infection and
neutropenic fevers, rose more than 40%
since 2009 and now outsells the originator
in some countries, including the United
Kingdom. [3]
Payers watching these products may
also be considering the influence of policy.
Between 2009 and 2014, overall use of
filgrastim in the UK increased by 104%
(Fig. 1). This is primarily due to a number
of UK Strategic Health Authority guideline
updates allowing for first-line use of the antiinfection medicine in cancer patients based
on the availability of the filgrastim biosimilar,
which made it possible to treat more patients
in a more cost-effective manner.
In Europe, there is considerable variation
in price across the drug class (originator
as well as biosimilar) in different countries.
For example, the observed price reduction
of filgrastim in 2015 varied from 14%
in France to 27% in Germany, and there
was actually a 1% increase in the filgrastim
price in Spain. [4] This significant variability
makes it difficult to predict how prices in the
US will be impacted. Zarxio, the US
filgrastim biosimilar, launched with a 15%

18 Visit our website at May | June 2017

discount and, after a slow start, has surpassed
the reference product in volume market
share. [5]
Biosimilar uptake may not be quick
When considering speed of uptake, it
should be noted that price and uptake are
not well correlated. In a 2016 report, IMS
Institute found that high biosimilar market
share did not necessarily equate to the
greatest price reductions in the European
Economic Area. This finding was consistent
across four classes of drugs, including
epoetins, granulocyte colony-stimulating
factor, human growth hormone and antitumor necrosis factor. [6]
This further reinforces what we saw
with filgrastim in the United Kingdom-
that guideline shifts were the primary
trigger for uptake-and underscores that
physician acceptance is essential. It is
reasonable to expect that biosimilar use
will increase significantly once physicians
grow accustomed to them. Manufacturersponsored education initiatives will be
important as individual physicians may
not seek out information about biosimilars
themselves; however, information from
other sources, such as guidelines and
regulatory bodies, may be seen as more
impartial. [4]
Difficulties of biosimilar pricing
It is no secret that the general public, as
well as politicians, are concerned about the
rising cost of health care and have focused
particularly on the rising cost of drugs. The
public demand is for quality medications at

lower prices. Biosimilars have the potential
to meet this demand, but the topic of
biosimilar pricing is complex and the path
forward can be unclear.
Development costs are much higher for
biosimilars than for conventional generics,
due to more stringent requirements for
regulatory approval. These costs range
from $100 to $250 million compared with
generics at $1 to $4 million. With higher
development costs and active promotion
resulting in a greater investment in patient
support and marketing services, it's not
surprising that biosimilars are offering
more modest cost savings than those
achieved with generic products. While
generic savings have ranged from 50% to
90%, anticipated savings with biosimilars
might be just 15% to 30%. [7]
Stakeholders in the
pharmaceutical marketplace
There are multiple stakeholders involved
with the distribution of and payment for
drugs. These stakeholders generate revenue
in various and sometimes conflicting ways.
It is important for biosimilar manufacturers
to consider all of these stakeholders when
setting prices.
Wholesalers, as an example, need to cover
their operational costs and generate revenue
on pharmaceutical transactions. They do
At InVentiv Health, Ben Curtis is EVP,
Director of Integrated Strategic and Creative
Services, and Katherine Seay is VP, Managed
Markets Content Expert.

Table of Contents for the Digital Edition of Pharmaceutical Commerce - May/June 2017

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Pharmaceutical Commerce - May/June 2017 - Cover4