Toward 2015

Global Digest
November 2014
www.pharmexec.com
Pharm Exec
Global
Digest:
The Year
of Living
Openly
Changes to our
format in the New
Year
Europe and
transparency in 2015
Brazil:
Revising
Growth
Forecasts
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Toward 2015
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‘Warehousing’
and the HCV
Treatment
Landscape
Stricter EU
Guidelines
for 2015
Upcoming regulatory
developments in Europe, stalling
growth in Brazil, and innovations
in data-driven decision making.
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Cloud Technology
and the Industry:
A Five-Year Outlook
Upcoming
pharma
conferences
around the world
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Pharm Exec
Global in 2015
Changes are afoot at PEGD Towers, but it’s business
as usual and we’re all set to provide a faster, smoother
reader experience in 2015.
A
s of next month
(December 2014),
Pharm Exec Global
Digest will cease to be a digital
magazine and will go forward
as a monthly e-newsletter,
known as Pharm Exec Global
Direct. (Long-term readers of
this publication will know that
we like to change its title at
least once every two years.)
The digital magazine format
has been an interesting one to
work with, but with the pace
of our online world becoming
ever more ‘breakneck’, we are
keen to make access to our
new content as speedy and as
convenient as possible.
The move to the e-newsletter
format will enable readers
to link more rapidly to the
Contents
WORLD CLASS R&D MEETS
WORLD CLASS R&R.
From the
Editor
Transparency
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articles, blogs, events, longform features and other new
content on our Pharmexec
site, which, in tandem with
PEGD’s changing format, is
being revamped for launch in
December. The new site, long
in the making, will be faster
and smoother and geared to
improving and enhancing the
user experience.
I hope you’ll contine to
enjoy our offering. Here’s to a
successful 2015!
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Julian Upton
Editor
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2015: The Year of Living
Openly
Regulators
underscored
transparency and
harmonization in
2014, and 2015 is
likely to see the
trend intensify.
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From the
Editor
Transparency
in Europe
Dakshayini Kulkarni looks at the regulators’ new emphasis on transparency and
harmonization.
T
he past year has
brought significant
changes not only
in regulatory mandates
and guidances but also
regarding a broader overall
emphasis on coordination of
information and processes.
The regulators have
prioritized transparency and
harmonization for some time
but underscored them to an
even greater degree in 2014,
and 2015 is likely to see the
trend intensify.
Improvement in the
oversight of companies’
pharmacovigilance systems
will also be a priority in the
year ahead. Regulators have
again taken steps aimed at
improving patient safety —
and, indeed, at encouraging
patients to become moreactive participants in their
own health.
And companies will have to
determine how to respond to
some of those developments.
Perhaps one of the paramount
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Regulators will be
expecting stricter
integration of data...
A meeting of minds
Since June 2014, companies
have been working to meet
the requirements of the
eXtended EudraVigilance
Medicinal Product Dictionary
(XEVMPD). They have had
approximately six months
— from mid-June until the
end of December 2014 — to
update their records and must
begin maintaining their data
immediately after submitting
it.
The XEVMPD is about
the transparency and
harmonization of data by
requiring that companies
submit and maintain their
product information so as
to be able to provide the
European Medicines Agency
(EMA) with an inventory
of all of their medicines
authorized in the European
Union (EU). It also requires
closer communication and
tighter synchronization
between regulatory affairs
and pharmacovigilance, with
a view to describe the process
for identifying, collecting,
and verifying product
information and then loading
the product information into
the XEVMPD, as well as for
processing acknowledgements
received from the XEVMPD
system.
In addition to continuing
to maintain their product
data for the XEVMPD during
2015, companies will also
have to prepare to respond
to the Identification of
Medicinal Products (IDMP).
That response must include
consumer health
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themes of the year — one that
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All of those trends require
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they manage regulatory
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details regarding where and
how to source their data
and what processes and
technologies they’ll need for
supporting data collection
and archiving.
The IDMP will see
regulatory affairs and
pharmacovigilance activities
become more entwined by
virtue of its being a set of
global standards that create
a harmonized and neutral
data model for describing
product information.
Without greater
collaboration between safety
and regulatory, there is the
potential for uncertainty in
the assessment of signals,
which could result in
regulators’ issuing warnings.
Furthermore, the IDMP
could be used in inspections
and in chemistry,
manufacturing, and
controls and could involve
information not generally
found in a dossier, further
emphasising the need for
internal harmonization and
process integration.
The IDMP will be a major
focus in 2015, especially
if companies are to take
a strategic approach to
adoption and use it as an
opportunity to improve the
management of corporate
data for broader purposes.
By the middle of 2015,
implementation guides
from the International
Organization for
Standardization and the
European Medicines
Agency will start to become
available, but even before
then, companies will need to
prepare their solutions and
processes for managing the
IDMP.
In addition to having
internal processes and
regulatory information
management solutions
in place, companies
will want to improve
their interdepartmental
collaboration to make sure
data can be accessed and
shared seamlessly.
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The year ahead will bring
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one of the major regulatory
requirements to the fore: the
pharmacovigilance system
master file, or PSMF.
Implementing the
PSMF has posed
challenges...
A PSMF is a detailed
description of the
pharmacovigilance system
used by the marketing
authorization holder with
respect to its authorized
medicinal products. The
purpose of the PSMF is
to improve the oversight
and accountability of
pharmacovigilance data.
Many companies have already
had some experience with
the PSMF because it’s been a
requirement for new Marketing
Authorization Applications
since July 2012, but its
influence will become most
widely felt from July 2015, when
it becomes a requirement for
all marketing authorizations.
The PSMF helps companies
improve oversight of their
pharmacovigilance systems,
but implementing it has
posed challenges — in part
because its requirements
affect many company
functions and procedures
and because its maintenance
is resource intensive.
However, the PSMF is
both a requirement and
a good tool for providing
oversight for inspectors and
the qualified person for
pharmacovigilance (QPPV).
Other regulator actions
further characterize the
ongoing focus on safety
and accountability. In
September 2014, the
Medicines and Healthcare
Products Regulatory Agency
announced it was leading a
consortium in a three-year
project to develop new ways
of gathering information
on suspected adverse drug
reactions. The idea behind
the project is to develop
a mobile app so that both
healthcare professionals
and the public can report
suspected adverse drug
reactions to national EU
regulators.
In its second year
of operation,
EudraVigilance
received 35,600
patient reports,
compared with
21,600 the previous
year...
In early October 2014, the
European Medicines Agency
began making available
through a single website
certain information on
the suspected side effects
of a further, 1,700 active
substances contained in
drugs. The information
includes products authorized
by national authorities in the
EU. Until the announcement,
the website contained
suspected-side-effects
information on only centrally
authorized products. Rollout
of public access to lists of the
suspected side effects of all
medicines available in the EU
is expected to occur during
the next few years.
Since July 2012, the new
EU pharmacovigilance
legislation has required that
all adverse drug reactions
from medication errors at
the EU level be reported
to EudraVigilance, the EU
database of adverse drug
reactions. Since then, the
number of side effects
reported directly by patients
to national regulatory
authorities or pharmaceutical
companies within the
European Economic Area has
increased significantly.
In the second year of
operation of the legislation,
EudraVigilance received
35,600 patient reports,
compared with 21,600
in the year preceding
the legislation. That was
in addition to reports
received from healthcare
professionals.
The agency is also making
it easier for patients to
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report side effects directly
to the authorities in the EU
member states by publishing
information leaflets in all
official EU languages. The
legislation demonstrates a
clear commitment to public
transparency and patient
engagement.
Beyond regulations,
EMA has been
working hard
to improve
transparency and
dialogue with
industry.
Clearer, more open
processes
On April 2, 2014, the
European Parliament
approved the new European
Union Clinical Trials
Regulation, which is expected
to come into force in May
2016. The regulation will be
binding in all EU member
states without the need for
any national implementing
legislation, thereby ensuring
consistent execution of the
directive throughout all
member states.
One aspect of the
directive aims to increase
transparency, with all results
— including negative ones
— to be published in the
European Clinical Trials
Database. Information
regarding clinical trials with
paediatric and nonpaediatric
participants as well as
protocol-related and resultsrelated information would
be made accessible to the
public.
As important, though,
is the need to improve
the clinical trial process.
According to the European
Commission, 2007 to 2011
saw a 25% reduction in the
number of clinical trial
applications; and delays
in the launching of trials
rose by 90% during those
years. The new regulation
is envisaged to be less
bureaucratic and is intended
to simplify and harmonize
the administrative
provisions for clinical
trials of investigational
medicinal products across
the EU. The European
Commission estimates that
all of the changes could save
researchers €800 million a
year.
The new authorization
procedure has a centralized
system for the approval of
clinical trials; the sponsor
will have to submit an
application via a single
portal, which in turn will be
linked to an EU database.
Regardless of the number of
participating member states,
the sponsor has to submit
only a single application for a
clinical trial.
The new regulation will
also follow a risk-based
approach; trials deemed to
be low risk will be subject
to lighter regulation. This
will benefit trials involving
existing medicines if their
use in the trial is either in
accordance with the terms of
the marketing authorization
or based on published
scientific evidence of safety
and efficacy.
Regulators are also
tightening the laws
around medical
device stand-alone
software...
Beyond regulations, the
EMA has been working hard
to improve transparency
and dialogue with
industry. Recently, the
agency introduced several
initiatives to demonstrate
its commitment to sharing
information, including
holding quarterly meetings
with industry stakeholder
organizations on key
pharmacovigilance issues
and issuing a newsletter to
keep QPPVs informed.
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Beyond pharmaceuticals
While regulations for
pharmaceutical products
have been tightening for
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many years, medical devices
have seen very little change.
Directive 98/79/EC — In
Vitro Diagnostic Medical
Devices (IVDMD) — has
been in its present form
since 1998 and has not kept
pace with state-of-the-art
regulatory requirements and
developments in technologies
related to in vitro diagnostic
medical devices.
Around 40,000
existing lab tests
Europe wide will
have to undergo
a new conformity
assessment.
That changes with the new
EU IVDMD regulation,
which comes into effect
around 2016. When it does,
80% of in vitro diagnostic
devices will have to undergo
conformity assessment by
a notified body under a risk
classification mechanism.
(Currently, most such devices
are self-certified.)
The regulation is likely
to make conformity
assessment procedures more
stringent and introduce
new requirements for
notified bodies. Both new
and existing devices will
have to comply with the
requirements, which for
many manufacturers implies
time-consuming and costly
tasks. Around 40,000 existing
lab tests Europe wide will
have to undergo a new
conformity assessment.
Regulators are also
tightening the laws around
medical device standalone software, including
apps. There are a number
of categories for classifying
software as a medical device,
including where it is used
for diagnosis; prevention;
monitoring of treatment;
alleviation of disease or
injury or handicap; for
investigation, replacement, or
modification of the anatomy
or of a physiological process;
or to control conception.
Companies’
commitment to
open and clear
processes will
become all the more
important...
Any software or app that
performs a calculation or
interprets or interpolates
data wherein the raw data
is not reviewed by a healthcare professional may be
considered a medical device.
Such so-called decision
support and decision-making
software and apps will have
to undergo the conformity
assessment process before
being allowed on the market.
information, their data
transparency, and their
commitment to open and
clear processes will become
all the more important and
will determine their ability to
respond to change.
About the author
Dakshayini (Daks) Kulkarni
is Senior Pharmacovigilance
Officer at ProductLife Group.
From the
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Making progress
In light of significant
regulatory and
pharmacovigilance
requirements in the year
ahead — in particular, the
IDMP and the PSMF — the
ways companies manage,
access, and share their
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Cloud of Dreams — Industry
Outlook through 2020
“Pharma
commercial teams,
doctors, and
patients will benefit
from getting the
right information at
the right time...”
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New innovations in cloud technology will enable faster time to market for new therapies,
evolving business models, and new ways to support physicians and patients, say Matt
Wallach, Brian Longo, Dan Goldsmith, Guillaume Roussel, and Jan van den Burg.
W
atson, meet George
Jetson.
Four years
ago, IBM’s “Watson”
supercomputer famously
outplayed human competitors
on television game show,
Jeopardy.
Today, Watson’s power
is derived from the cloud
and 24 times faster, 2,400%
smarter and 90% smaller …
and, consequently, being
put to more practical use. In
2014, Sloan Kettering Cancer
Center developed the first
Watson-based cognitive
computing innovation for
oncology — clinicians taught
Watson how to process,
analyze, and interpret the
meaning of complex clinical
information. Since then,
Watson has ingested more
than 600,000 pieces of medical
evidence and two million
pages of text from 42 medical
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journals and clinical trials in
the area of oncology research.
It also has the power to sift
through 1.5 million patient
records representing decades
of cancer treatment history,
such as medical records and
patient outcomes, and provide
physicians with evidencebased treatment options, all in
a matter of seconds.
The once far-away notions
of the future depicted in the
1960s-era cartoon, The Jetsons,
no longer seem so space-age.
For certain, the Jetsons’ robot
maid is nothing compared
to Watson — thanks, in part,
to cloud computing. What
else does this revolutionary
technology have in store for the
life sciences industry? Midway
through the decade, the cloud
is no longer a pipe dream.
Now proven, it’s delivering
unprecedented agility and
innovation.
Below, experts from Veeva
Systems forecast what’s next
for the cloud and how it
will impact the life sciences
industry over the next five
years.
“Data derived from
across the industry
will provide a trueto-life picture
of customers’
preferences...”
1. The cloud will remove the
barriers to collaboration
“The life sciences industry
has operated in siloes for
decades, with teams and
functional areas isolated by an
array of client/server systems.
Inherently social, humans do
well when in collaboration,
and business processes
naturally span areas and
people.
Yet technological
limitations have created
disjointed processes and
workflows, keeping teams
disconnected and limiting
progress. Cloud technology
will eliminate traditional
boundaries. New systems
will support how we
collaborate and communicate
innately … not the other
way around. End-to-end
connected solutions powered
by the cloud will finally
bring together actionable,
aggregated data, compliant
content, and real-world
interactions with customers,
including patients.
Since the cloud is a service,
all the back-end processing
and integrations are handled
‘behind the curtain’ —
shielding the complexity
from users. Just like with
Amazon and Google, pharma
commercial teams, doctors,
and patients will benefit from
getting the right information
at the right time, without
having to manage how it all
comes together. And what’s
most profoundly different
is how software evolves;
it just keeps getting better
and better over time. It will
all just happen seamlessly
in the cloud, empowering
companies with a foundation
for easy knowledge sharing,
unimpeded collaboration,
and continuous innovation.”
— Matt Wallach
2. The cloud will deliver
derived customer data
“Life sciences companies are
driving toward an integrated,
multichannel customer
engagement strategy, but
the definition of ‘customer’
has expanded. It now
includes payers, physicians,
administrators, pharmacists,
and even patients, so it’s
difficult to pinpoint customer
needs and preferences.
With the cloud, life sciences
companies will be able to
finally capture this data
accurately and gain insight
about how the industry as a
whole is interacting across
all customer types and
channels, based on real-world
actions … not inferences
from extrapolated surveys or
limited data sets. Data derived
from across the industry will
provide a true-to-life picture
of customers’ preferences so
companies can interact with
them on their terms.
With data no longer buried
inside each company’s own
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database, it can be amassed
industry-wide to provide
insight based upon actual
behavior. No more conjecture
or extrapolations. Instead,
the industry will leverage
the cloud to derive data and
craft precise communications
that are timely, relevant, and
meaningful to doctors and
patients, ultimately resulting in
better patient outcomes.”
— Brian Longo
3. The cloud will usher in an
era of total transparency
“The EFPIA Disclosure Code
will drive the life sciences
industry toward greater
visibility of key data across the
value chain.
“In a world where every
speaker fee, conference ticket,
or consulting engagement is
documented and disclosed
to the public, data quality
is paramount. Cloud-based
master data management
systems will not only
deliver full-value transfer
transparency across all
touch points to comply with
EFPIA, but also provide life
sciences companies with the
opportunity to aggregate data
and insight immediately for
better, more informed, and
targeted customer interactions,
based on a holistic view of
customer behavior.
“With the cloud providing
global and readily accessible
information, the ‘game’
will drastically change. A
central, authoritative source
of customer data will allow
easy, agile information sharing
across teams and geographies,
empowering customer-facing
groups with the actionable
data needed to make the right
decisions.
“Spend transparency is
just the start of this journey.
These initiatives will trigger
a shift in mindset, spurring
all business areas across
life sciences to proactively
improve transparency.
Life sciences companies
will continue to invest in
process streamlining and
automation, further enabling
themselves to manage the
challenges of global expansion
in an increasingly complex
commercial landscape.”
— Guillaume Roussel
“A central,
authoritative source
of customer data
will allow easy, agile
information sharing
across teams and
geographies...”
4. Global analytics will drive
communications worldwide
“The cloud will bring a
new generation of global
insight, allowing companies
to scrutinize brand
performance, determine
content effectiveness, and gain
customer insight from across
the world.
“On the macro level, these
analytics will facilitate
marketing strategies
tailored to an aggregated
global insight. On the micro
level, predictive, real-time
analytics will be used to
orchestrate better customer
experiences by anticipating
and influencing individual
interactions.
“Ultimately, global cloudbased analytics will drive a
seismic shift towards dataand insight-led marketing and
sales, guiding both the content
and the audience for customer
engagement worldwide.”
— Jan van den Burg
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Cloud
Technology
5. Life sciences IT will move
as fast as the business
“Historically within life
sciences, IT has lagged 9–18
months behind business
innovation. IT was inherently
limited by the technology
that was available. Every time
there was a new business
need, market shift, or change
in regulatory requirements,
the enterprise was forced to
wait for IT to catch up because
systems were difficult to
implement and change. As a
result, the IT function became
reactionary.
“Ultimately, this has slowed
the pace of innovation and
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marginalized the impact of
technology in life sciences.
“Being constantly
connected in
the cloud, from
anywhere, will fuel
real-time, data-driven
decisions.”
“The cloud, however,
supports agility and rapid
change so IT can stay current
and even get ahead of the
business to inspire new
approaches. In fact, what
used to take 18 months can
now be accomplished in just
a couple of months or weeks
by leveraging the cloud.
Many global life sciences
organizations like J&J, Eli
Lilly, and AstraZeneca are
realizing the tremendous
advantage of shorter
innovation cycles thanks to
cloud computing.
Over the next few years,
the entire industry will move
a magnitude faster, and IT
capabilities will grow in
unison with the business
for a significant surge in
novel, life-enhancing drug
therapies.”
— Dan Goldsmith
6. The cloud will drive
innovation at 5G speeds
“Mobile ‘offline’ applications
are all the rage these days,
but they will one day be
obsolete. Fundamental
to this disruption is the
ability to reliably link any
device to the Internet and
ensure connectivity at all
times. This may seem farfetched when two-thirds of
the world’s population still
lacks Internet access, and
even in developed nations,
consistent, seamless online
access is a challenge.
“Major developments that
leverage advancements in
technology and materials
science are being made to
change that. Google’s Project
Loon, for example, is an array
of high-altitude balloons that
form a wireless network to
provide Internet access to
people in remote areas and in
the wake of natural disasters.
“Ubiquitous connectivity
eliminates the necessity
for offline applications — a
huge advantage. And being
constantly connected in the
cloud, from anywhere, will
fuel real-time, data-driven
decisions.”
— Brian Longo
Sources
1. PharmaVOICE, “IBM’s
Watson and Healthcare,”
September 2014 by Robin
Robinson.
2. Fox News, “IBM’s Watson
Helps Mayo Clinic Match
Cancer Patients with Clinical
Trials,” September 11, 2014 by
Brian Mastroianni.
3. Markets and Markets,
North American Cloud
Computing Market —
Predictions through 2018.
Manager of Commercial
Cloud; Jan van den Burg,
VP, Commercial Strategy,
Europe; and Guillaume
Roussel, Director of Strategy,
Veeva Network, all at Veeva
Systems.
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About the Authors
Matt Wallach is President and
Co-Founder; Dan Goldsmith
is General Manager, Europe;
Brian Longo is General
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‘Warehousing’ in the HCV
Treatment Landscape
The battle against
hepatitis C (HCV) is
a relatively new and
highly dynamic one.
From the
Editor
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Chris Smith and Sarah Brown discuss the HCV treatment landscape and explore why
‘warehousing’ is defining the battle against HCV.
T
he battle against hepatitis
C (HCV) is a relatively
new and highly dynamic
one. The viral disease was only
discovered in the 1980s and,
according to WHO estimates,
some 3% of the world’s
population are now infected
with HCV, with more than 170
million chronic carriers.
Through the evolution of the
disease, different ‘strains’ —
known as genotypes — have
achieved varying prevalence
across different regions;
genotype 1 prevails in the
USA and Europe, genotype
4 dominates in North Africa
and the Middle East, and
genotype 3 affects the majority
of patients in India and many
other Asian countries.
A dynamic treatment
landscape
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From initial discovery of the
disease to the present day, the
approaches used to treat HCV
have changed dramatically.
The very first non-target13
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specific therapies of interferon
and ribavirin (from Roche
and Merck) had low cure rates
(otherwise known as sustained
virological response or SVR
rate), long treatment durations
(24–48 weeks depending on
the genotype) and a poor side
effect profile. Today, we have
drugs that target specific
stages of the HCV life cycle
and which have also started to
overcome the aforementioned
challenges.
At the same time, overall
HCV treatment remains
low. Many carriers remain
undiagnosed. Another
contributory factor is the
high proportion of diagnosed
patients with unconventional
lifestyles, e.g. drug users. The
other explanation lies in the
nature of the disease itself.
HCV is a slow-progressing
disease and can take 10–20
years to show symptoms and
do damage. This can result in
the lack of a sense of urgency to
treat. Given the drugs’ highly
unpleasant side-effects and
the prospect of newer, more
efficacious HCV drugs in the
pipeline, some patients and
their doctors choose to wait
for better treatments. This is
known as ‘warehousing’.
Some patients
and doctors
choose to wait for
better treatments.
This is known as
‘warehousing’.
The warehousing
phenomenon
Back in 2011, Vertex/Janssen’s
Incivek and Merck’s Victrelis
— the first-generation protease
inhibitors or PIs — changed
the HCV treatment landscape
and proved the occurrence
of warehousing beyond a
doubt. As the first new HCV
treatments to enter the US
market in 9 years, they were
responsible for a dramatic
increase in treatment rates
— e.g. in the US, a rise from
19% to 28% in a single quarter
(Q4 2011), according to Ipsos
Healthcare’s HCV Global
Therapy Monitor.
Then in 2013, Gilead’s
NS5B inhibitor, Sovaldi, and
Janssen’s second generation
PI, Olysio, arrived on the
US market. In the year prior
to these launches, US HCV
treatment rates had been
showing a quarter-on-quarter
decline, dropping to just 11%
by the time of launch. The
period immediately after
launch saw treatment rates
rise to 17% (Q1 2014). Again,
this is a clear indication that
doctors were warehousing
their patients in anticipation of
better treatments. Ipsos’ data
also confirms that Sovaldi and
Olysio have since delivered
significantly higher SVR rates
than ever before (c90% of
treated patients) and far fewer
side effects than with older
regimens.
A global trend
Although the approval dates
for the aforementioned
treatments have varied on
a global scale, the trend of
warehousing patients prior
to product launches has been
mirrored in key markets.
Looking first at France and
Germany (where local market
approval processes mean acute
changes in treatment choice),
we have observed some slight
variances versus the US, but
the same overall warehousing
activity. Immediately after the
first PIs were made available,
treatment rates rose but
rapidly stabilised and then
declined again. Since then,
the proportion of warehoused
patients has been growing
over time. In the lead up to
the Sovaldi launch, it peaked
at two in three untreated
genotype 1 patients in France
and one in two in Germany.
Following the approval of
Sovaldi, treatment rates
significantly increased.
Turning to Asia and more
specifically Japan (where
we typically see faster new
product approvals than in
the EU5), similar trends can
be seen in spite of market
nuances. Up until July 2014,
the proportion of patients
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on treatment had remained
relatively unchanged over
time. However, in the run-up
to the launches of Daklinza
and Sunvepra (also from BMS),
the proportion of untreated
patients “waiting for better
treatments” increased for both
genotype 1 and 2 patients.
A third round of
warehousing?
So against this backdrop,
what is the state of play today?
Is it record HCV treatment
levels given the availability
of more efficacious and more
tolerable products than ever
before? Not quite. Returning
to our US example, whilst we
saw a sharp rise in treatment
after last year’s Sovaldi/Olysio
launches, it did not equal the
2011 upsurge following the
launch of the first generation
PIs. This same trend can be
seen in other markets, for
example in France with the
launches of both Sovaldi and,
more recently, BMS’ Daklinza.
The question is, why haven’t
they? The answer is, almost
certainly, further warehousing.
Despite the growth
of warehousing,
it is not always a
smooth transition
to treatment once
new products are
launched.
Around the time of the
Sovaldi / Olysio launches,
a number of new HCV
treatments were in the final
stages of the US new products
approval process — namely,
Gilead’s Harvoni (Sovaldi +
ledipasvir), BMS’s Daklinza
(already launched in Japan
and France), and AbbVie’s
3D regimen. All of these
offer the possibility of an alloral treatment for shortened
durations and with very
tolerable side effect profiles.
It appears that doctors are
now using the latest products
to treat those patients with the
most urgent needs, e.g. those
with advanced liver damage, or
who are strongly motivated to
undergo treatment and obtain
a cure.
Meanwhile, they are still
warehousing those patients
able to delay treatment, e.g.
those with no or little liver
damage and slow disease
progression. Once again,
this is in anticipation of the
plethora of products currently
in development. US doctors
state they are looking towards
an all-oral regimen, greater
efficacy, and a shortened
length of therapy (which the
pipeline of HCV treatment is
likely to provide in the near
future), while in Japan and EU5
the top attribute doctors are
looking for is “greater efficacy
than PIs”.
Accordingly, when we
analysed the untreated pool
of patients immediately
after the launches of Sovaldi
and Olysio, we saw that the
proportion of patients stated
as not being treated due to
“waiting for better treatment”
had significantly declined.
Following this initial decline,
however, the proportion
of patients now being
warehoused prior to Gilead’s
Harvoni rises to one in two.
Issues and considerations
Despite the growth of
warehousing, it is not always
a smooth transition to
treatment once new products
are launched. A key challenge
that doctors and patients face
when evaluating new treatment
options is, unsurprisingly,
cost. Harvoni, for example, is
priced at $94,500 for a 12-week
regimen in the United States.
This initial outlay could save
healthcare systems significant
sums by preventing later
expenditure on treating the
complications of a long term
hepatitis C infection (the CDC
estimates that HCV-related
mortality may increase two to
three fold in the next 10 years
as patients’ disease advances,
which can be prevented with
effective treatment). Timely
treatment also removes the
possibility of transmission.
However, it is difficult for
healthcare providers to see
the benefits of this investment
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when the return is only
gathered gradually over a
lifetime.
The cost debate has led to
a degree of push-back from
payers, the latter requiring
qualifiers to grant access to
treatment — e.g. advanced
fibrosis, abstinence from
substance abuse for more
than 12 months, and doctors
needing extensive experience
in treating HCV. Patients
may also be influenced by
cost considerations, with 17%
of untreated patients in the
US, 23% in the EU and 33%
in Japan cited to be refusing
treatment at this time.
An interesting area to
observe closely in the near
future will be the pricing
strategy of the upcoming
pipeline drug launches. With
comparable efficacy and side
effect profiles, how will the
new entrants capture market
share? At this time, it is unclear
how these products will be
priced, but a price war could be
on the cards — with patients
and payers likely to gain some
benefit from the intensified
competition. A comprehensive
cost/benefit analysis is needed
to ensure that treatment is
optimally deployed.
The future outlook
Despite new therapies only
coming to market very
recently, we have treatment
rates that have never reached
a maximum threshold before
stabilizing. The proportion
of patients now waiting for
better treatment is increasing,
indicating a third round of
warehousing.
To date, warehousing
has helped create
a substantial pool
of patients now
available for newer
market entrants.
In summary, all signs indicate
that warehousing to date has
helped create a substantial
pool of patients now available
for newer market entrants.
This will no doubt contribute
to what is likely to be a recordbreaking post-launch uptake
for Harvoni (launched in the
US on October 10th).
With several all-oral
regimens still awaiting
imminent approval —
providing doctors with
more choice, extremely high
efficacy, low pill burden, and
shorter treatment durations
— we are likely to see the
treatment rate change once
again. With some promising
products still further down
the pipeline, namely Merck’s
combinations and Achillion’s
NS5A and NS3 inhibitors,
will we see a fourth round of
warehousing? Or a stunted rise
until HCV treatment has all the
ingredients available on the
market?
Our view is that Harvoni
et al have the attributes that
doctors are looking for. They
may seek shorter treatment
durations, but with such good
SVR they are likely to accept a
12-week regimen. So, we may
not see further warehousing
in its traditional form (simply
waiting for better treatments),
but a shift to cost- and accessbased warehousing, which
would certainly put healthcare
systems in a challenging
position. Overall, it is unlikely
that treatment rates will
soar, but the 25% levels we
saw following the first gen
PIs are probably a realistic
expectation.
As in all things, only time
will tell.
Unless otherwise sourced,
all treatment data comes
from Ipsos HealthcareÕs HCV
Global Therapy Monitor. US
and EU5 data are collected
quarterly (online) and Japan
data annually (pen and paper).
Doctor/patient sample sizes are
as follows: US Ð 150 / 2100; EU5
Ð 240 / 3360; Japan Ð 80 / 800.
About the Authors
From the
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Chris Smith is a Senior
Manager and Sarah Brown
is Research Director, Global
Antiviral Therapy Monitors,
both at Ipsos Healthcare.
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Moderation in
local industrial
production and
a slower inflow of
foreign capital are
causing Brazil’s
economic boom to
cool off.
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Brazil’s Economic Boom
to Slow in 2015
From the
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The Brazilian economy is being impacted by internal and external factors, and forecast
figures are being quickly revised downwards, writes Hellen Berger.
T
he Brazilian economy
is being impacted by
internal and external
factors, and forecast figures
are being quickly revised
downwards. Market research
released by Brazil’s Central
Bank revised average
analysts’ projections for
economic growth in 2014
down to 0.70% from 0.90%
four weeks earlier(1). In
June 2014, the Hong Kong
Trade Development Council
(HKTDC) stated that the
local economy was projected
to grow by 1.8% in 2014.
Projection figures keep
slipping on a weekly basis (2).
The HKTDC research
identifies moderation in local
industrial production and
a slower inflow of foreign
capital as reasons for Brazil’s
economic boom cooling off
after recording growth levels
of 7.5% in 2010.
The research shows,
however, that because there
are signs of worldwide
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economic recovery and
sustained commodity
demand, the economy could
see growth of approximately
2.1% in 2015, “as the world
economy improves”(2).
After hosting the
World Cup in 2014, the
country’s presidential
election in October 2014,
and the planning of
the Summer Olympics
in 2016, the economic
situation has become
unstable, unpredictable,
and uncomfortable for
companies, consumers, and
investors. These players all
await political, social, and
economical clarification to
go forward with start-ups,
investments, and acquisitions,
including the pharmaceutical
sector.
Reasons to be cheerful
Analysts believe the sector
will continue its growth
pattern, however, because of
the country’s strong domestic
demand and large foreign
reserves, as well as wide
potential for growth as the
Brazilian population ages and
becomes wealthier.
Specialist Rodrigo Leifert,
intelligence analyst at São
Paulo-based consulting
company Tendências
Consultoria Integrada, expects
pharmaceutical production to
grow approximately 3.8% in
2014, and to maintain a similar
growth pattern for the next
five years, considering Brazil’s
Statistics and Geography
Institute (IBGE) projections for
the sector.
The sector will
continue its growth
pattern, however,
because of Brazil’s
strong domestic
demand and large
foreign reserves...
Renato Tamarozzi,
executive director of the
Brazilian Association of
Pharmaceutical Commerce
(ABCFARMA), is optimistic
for the future of retail sales.
Tamarozzi told PharmTech
that he expects retails sales
of pharmaceutical products
to grow approximately 12%
in 2014 and believes the twodigit pattern should continue
for the next five years. He says
Brazil’s growth potential in
terms of retail sales could lie in
the poorer areas of the country,
as these needy areas tend to
grow faster than the richer
southeast where access to
pharmaceutical drugs is easier
and the competition is fierce.
Public figures from
Visiongain’s Brazilian
Pharmaceutical Market Report
predicts that the country’s
pharma market would reach
$41.3 billion in 2017, with fast
expansion, and by 2024 will be
contributing strongly to world
medical revenues(3).
References
3. Visiongain, Brazilian
Pharmaceutical Market Report
(Nov. 21, 2013).
About the Author
From the
Editor
Hellen Berger is a business
correspondent based in São
Paulo, Brazil.
For the full version of this
article, click here.
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1. Brazil Central Bank, Market
Report (Aug. 25, 2014).
2. HKTDC, HKTDC Emerging
Markets Research (June 11,
2014).
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From the
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PHARMACEUTICAL COMPLIANCE CONGRESS 2015
January 27–28, 2015: Washington, DC
Widely recognized as the most
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ONCOLOGY
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February 24–25: San Francisco, CA
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10TH ANNUAL SUMMIT ON
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