TASKED TO TRANSFORM David Meek CEO, Ipsen - 2019 OUTLOOK DIGITAL PIVOT
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2019 OUTLOOK DIGITAL PIVOT BRAND ENGAGEMENT
TOP TRENDS TO WATCH DATA SCIENCE AS PARTNER ESCAPE THE UNCANNY VALLEY
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JANUARY 2019
COMMERCIAL INSIGHTS FOR THE C-SUITE
VOLUME 39, NUMBER 1
TASKED TO
TRANSFORM
David Meek
CEO, Ipsen
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JANUARY 2019 PHARMACEUTICAL EXECUTIVE From the Editor 3
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Don’t Ignore These Trend ‘Leftovers’
THIS MONTH WE FEATURE OUR ANNUAL INDUSTRY OUTLOOK, culled by discussions with our
illustrious Editorial Advisory Board experts. We had a long, long list of topics, but cut it down to the
eight you can read starting on page 14. But what about those trends that didn’t make the cut? Are
they just not hot? Not the case. What makes the cut is when we think the trend is going to have
significant impact this year. As an example, let’s look at the list we projected for 2018: Patient vs.
Consumer, Pricing, FDA Commissioner, Emerging Markets, EMA on Move, Biosimilars, Diagnostics,
and eEnablement. Clearly, Commissioner Scott Gottlieb is still a force to reckon with at the FDA, but
last year we weren’t sure where he was coming from or what he intended to do, so his appointment
was very important to last year. EMA moving because of Brexit definitely had impact last year and
LISA HENDERSON
continues into 2019 (Brexit does make this year’s list). Patient vs. consumer was very much a hot
Editor-in-Chief
topic last year, and to a degree, certain influencers still press pharma to “get with the consumer lisa.henderson@ubm.com
times,” but the newness of that term and urgency is gone. Let’s look at the trends that did not make Follow Lisa on Twitter:
our list this year. @trialsonline
I
n late January 2018, Amazon, Berkshire therapies, in the end, may not be supported by
Hathaway, and JPMorgan Chase & Co. payers or governments. Ultimately, this was
announced a partnership on ways to address decided to be an ongoing tension among the
healthcare for their US employees, with the stakeholders and will likely not be any more
aim of improving employee satisfaction and impactful in 2019 than it will be in 2021.
reducing costs. Since that time, little headway And our fi nal example is the bifurcation of
had been disclosed until late in November, when the pharmaceutical industry. On one hand, there
the partners named insurance executive Dana is the trend that pharma targets therapies that
Gelb Safran, senior vice president of enterprise are very personalized and tailored, usually fea-
analytics at Blue Cross Blue Shield of Massachu- ture a population with unmet needs or caused
setts, as head of measurement for the initiative. by a gene variant, are delivered in a complex way,
Our EAB said, ultimately, since there is no move- and have high prices. This group of biopharma
ment by any of the players for the immediate doesn’t need extensive launch strategies because
future, it was being tabled until more progress they are targeting very small populations. They
is made. don’t need a wealth of added wearables or IoT
The Institute for Clinical and Economic technology because the therapy itself is the
Review (ICER) was founded in 2006 as an inde- patient engagement tool.
pendent and non-partisan research organization The other side of the divide relies more on
that evaluates the clinical and economic value of prevention and large population healthcare
prescription drugs, medical tests, and other issues, for example, diabetes. These therapies
healthcare and healthcare delivery innovations. feature extensive launches with direct-to-con-
In the intervening 13 years, the institute has sumer advertising; they rely on digital therapeu-
gained in exposure and influence, and this past tics to engage patients in their care, including
August, CVS announced it would allow health their drugs and adherence; and they also feature
plans and insurers using Caremark to refuse to extensive patient education and patient access
cover drugs that didn’t pass ICER review. The programs. Much of the new developments
resulting response was that ICER was trying to around technology and services are geared more
be the “NICE” of the US, but there aren’t more specifically to these larger population therapies.
recent news reports about ICER. The EAB ulti- The EAB decided that this bifurcation is only
mately decided that ICER is but one of many beginning, and the subsequent changes to third-
influencers on pricing and market access that party providers who serve both markets will
pharma executives need to be aware of and it become more fi ne-tuned and not imply that all
didn’t merit its own separate category. technologies and services are the same for all
There is a widening gap of what regulatory manufacturers.
approval looks like and what payers will pay for. Send us an email or tweet at @PharmExec
This speaks to the trend where regulatory and let us know what you think of this year’s
authorities are asking for and providing path- Industry Outlook. All of us here at Pharmaceu-
ways of approval for more innovative and tical Executive wish you the best for a very
patient-centric therapies. But that these same Happy 2019!
4 WWW.PHARMEXEC.COM PHARMACEUTICAL EXECUTIVE JANUARY 2019
VOLUME 39, NUMBER 1
Pharmaceutical Executive’s 2019 Editorial Advisory Board is a distinguished group of thought leaders with expertise in various facets
of pharmaceutical research, business, strategy, and marketing. EAB members suggest feature subjects relevant to the industry,
review article manuscripts, participate in and help sponsor events, and answer questions from staff as they arise.
MURRAY L. AITKEN STEVE GIRLING CHANDRA RAMANATHAN
Senior Vice President, President, Head, East Coast Innovation Center,
Healthcare Insight, IPSOS Healthcare North America Bayer U.S.
QuintilesIMS
ADELE GULFO AL REICHEG
INDRANIL BAGCHI, PhD Chief of Commercial Development, CEO,
Senior Vice President and Head, ROIVANT Sciences Sea Change Healthcare
Global Value Access,
Novartis NICOLE HEBBERT
Senior Vice President, BARBARA RYAN
MICHELLE BARON, MD Head of Patient Services, Founder,
Vice President, Clinical Research, UBC Barbara Ryan Advisors
Chief Medical Officer,
MICHELE HOLCOMB SANJIV SHARMA
Intarcia Therapeutics
Head, Strategy & Corporate Development, Vice President,
FREDERIC BOUCHESEICHE Cardinal Health North America Commercial Operations,
Chief Operating Officer, HLS Therapeutics
BOB JANSEN
Focus Reports Ltd.
Principal Partner, TERESE WALDRON
LES FUNTLEYDER Zensights LLC Director, Executive MBA Programs,
Portfolio Manager, St. Joseph’s University
KENNETH KAITIN
Esquared Asset Management
Director & Professor, PETER YOUNG
JOHN FUREY Center for the Study of Drug Development, President,
Chief Operating Officer, Tufts University Young & Partners
Spark Therapeutics
CARRIE LIASKOS
JAMES J. GALEOTA, JR. (JAY) Vice President,
President and Chief Operating Officer, Market Engagement,
G&W Laboratories Syneos Health
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JANUARY 2019 PHARMACEUTICAL EXECUTIVE Table of Contents 5
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2019 Industry Forecast
8 Tipping Points for Pharma
Pharm Exec’s annual look
at what lies ahead for the
biopharma industry in the
coming months examines
eight key trends, chosen
with input from our
Editorial Advisory Board,
that are seemingly at
tipping points in their
evolution and poised to
shape the life sciences
landscape in 2019.
Data and AI 14
Ipsen’s David Meek: Vertical Integration 16
Tasked to Transform Emerging Biopharma 18
Payment Models 19
By PharmaBoardroom
Pharm Exec partner PharmaBoardroom speaks with American- Fight for Pharmacy 20
born David Meek, today CEO of Paris-based multinational
Ipsen. Meek takes stock of his two-plus years at the helm of Lifecycle Management 21
the specialty-driven drugmaker—where through revamped
leadership, fostering a biotech mindset, and promoting external Brexit 23
innovation, he has helped Ipsen grow in the US and China Digital Therapeutics 24
markets, while looking for ways to boost France’s profile on the
life sciences world stage.
8 Guest Column: Finding the
Right Digital Health Partner 26
By Paul Upham
NEWS & ANALYSIS STRATEGY & TACTICS INSIGHTS
Washington Report Q&A From the Editor
7 Research and Review 27 Building a Medicines and 3 Don’t Ignore These
Issues on Radar at FDA Data Science Company Trend ‘Leftovers’
Jill Wechsler, Washington Correspondent Julian Upton, European and Lisa Henderson, Editor-in-Chief
Online Editor
Back Page
47 Ascending the Uncanny
Valley in Healthcare
By Julia Stern
Country Report: Turkey
30 Go Beyond
Focus Reports, Sponsored Supplement
Despite market access hurdles, Turkey’s pharmaceutical market holds
tremendous growth potential—in both value and volume. But will the country
be able to take that final step in creating a regulatory and economic
environment that is conducive to further upward development?
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6 this month on PharmExec.com PHARMACEUTICAL EXECUTIVE JANUARY 2019
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in the November issue. Topics include cannabis, that has been previously shelved—and share their
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JANUARY 2019 PHARMACEUTICAL EXECUTIVE Washington Report 7
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t will be a challenge for FDA
Drug Research and Review
I to match or exceed its suc-
cess this past year in approv-
ing record numbers of inno-
vative and generic drugs. These
achievements reflect the ability
Issues on Radar at FDA
CDER priorities for 2019: Opioids, quality, safety, and innovation
of biopharma companies to cap-
italize on important advances in
science, as well as strong support comply more fully with good process to better manage prod-
from the regulators in clarifying manufacturing practices (GMPs) uct changes through the drug
requirements and R&D policies. through more targeted inspec- lifecycle.
While FDA’s Center for Drug tions and recalls for those failing
Eva lu at io n a n d R e s e a r c h to meet standards. Accelerating approvals
(CDER) will strive to further Drug compounding pharma- An important goal for Wood-
enhance its operations, it also cies and outsourcing facilities cock is to complete the overhaul
will support initiatives to ensure will remain in the spotlight, as of the new drug review process
that all medicines are safe, effec- FDA inspectors continue to fi nd to better manage CDER’s grow-
tive, and of high quality. violations at these operations. A ing volume of applications. She
A m idst t hese adva nces , related initiative is to continue to recently named Peter Stein direc-
CDER Director Janet Woodcock implement requirements for tor of the Office of New Drugs
cites the importance of address- tracking drugs through the sup- (OND), and long-time CDER
ing the nation’s deadly opioid ply chain to detect unauthorized guru Bob Temple will become
epidemic as FDA’s top priority medicines, an effort designed to OND senior advisor, positioned
for the coming year. The imme- have “a big impact on the gray to address the more controver-
diate need is to reduce the over m a rke t ,” Woodco ck com- sial and difficult drug develop-
200 million outpatient prescrip- mented. CDER’s Office of Phar- ment and review issues. Wood-
tions for these drugs each year. maceutical Quality (OPQ) will cock hopes to fi nalize the OND
Recently enacted legislation continue to seek more timely reorganization by next summer,
instructs FDA to develop evi- inspections of manufacturing but it has been delayed by diffi-
dence-based prescribing guide- facilities, a process that should culties in gaining Congressional
lines and to explore how manu- be facilitated by a new inspec- approval of a new user-fee pro-
facturers can provide pain tion protocol for drugs, begin- gram for improving the regula-
medicines in more secure pack- ning with sterile drug manufac- tion of over-the-counter drugs.
aging, Woodcock pointed out at turing facilities. Modernizing the review pro-
t he F DA /C M S Su m m it i n T h e s e e f f o r t s m ay b e cess will involve implementing
December. At the same time, enhanced by visible progress in new automation tools for man-
FDA will develop guidelines on industry implementing advanced aging drug applications, study
developing non-opioid medicines manufacturing systems. Wood- data, and review documents
for acute and chronic pain to cock noted at the Summit that under a “multi-disciplinary,
improve treatment for patients. five fi rms have filed applications issue-based review document”
with continuous manufacturing system. CDER also will continue
Ensuring quality components, and that generic to carry out provisions of the
Woodcock also aims to advance drugmakers are moving in this 21st Century Cures Act and
the safety and quality of medi- direction. Other federal agencies reauthorized user-fee programs
cines. CDER has launched a support such efforts as a way to to further advance patient-
JILL WECHSLER is
two-year program to improve enhance surge capacity when focused drug development,
Pharmaceutical
oversight of drug safety, featur- additional treatments are needed expanded use of real-world evi-
Executive’s
ing new methods to evaluate the to manage infectious disease out- dence, novel clinical trial design, Washington
more than two million adverse breaks or bioterrorism attacks. and added authorities to hire Correspondent. She
event reports received this year OPQ also aims to launch a more experts needed to carry out can be reached at
on marketed drugs. The agency structured approach to the man- these multiple drug regulatory jillwechsler7@gmail.
is pressing drug companies to ufacturing supplement review programs. com
8 Executive Profile PHARMACEUTICAL EXECUTIVE JANUARY 2019
WWW.PHARMEXEC.COM
The French Connection
American-born David Meek, today CEO of Paris-based multinational
Ipsen, takes stock of his two-plus years at the helm of the specialty-driven
drugmaker—where through revamped leadership, fostering a biotech
mindset, and promoting external innovation, he has helped Ipsen grow in
the US and China markets, while looking for ways to boost France’s profile
on the life sciences world stage
harm Exec partner PharmaBoardroom,
P whose “Country Report” series is regularly
featured in these pages, spoke recently with
David Meek, CEO of Paris-based Ipsen,
where they discussed the pharmaceutical ecosystem
in France, Ipsen’s bold global expansion and R&D
transformation, open innovation as a cultural
driver, and digital health, among other topics.
A New England native, Meek was appointed
CEO of Ipsen in July 2016, relocating to the com-
pany’s headquarters in Boulogne-Billancourt, a
Paris suburb. Meek came over from Baxalta, where
he was executive vice president and president of its
oncology division. Meek began his biopharma
career at Johnson & Johnson and Janssen Phar-
maceutica and also spent seven years with Novar-
tis. He is a former officer in the US Army, and a
graduate of the University of Cincinnati.
PB: You were brought to Ipsen with two specific tasks:
transforming the company’s R&D activity and establish-
ing a presence in new, high-growth markets like the US
and China. What is your assessment of the progress
made on these two fronts?
MEEK: We have blossomed from our base as a
French company into a growing international player
within the areas of oncology, neuroscience, and rare
disease. At the outset, we were very clear in our
minds that we needed to unleash a profound and
ambitious transformation right at the heart of the
company that would equip Ipsen to face the future
with zeal and confidence. This entailed reconfigur-
ing the leadership team, instilling a biotech mindset,
and nurturing a culture of external innovation with
a view to driving our research, development, and
commercialization.
So far our efforts have met with success. Not
only have we proved able to build a global organi-
David Meek, CEO, Ipsen zation and international presence across three hubs
(France, the US, and the UK), we have also achieved
JANUARY 2019 PHARMACEUTICAL EXECUTIVE Executive Profile 9
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therapeutic leadership in our tar- mined by three core variables: new indication every year. That
get areas. Over the past two people, products, and pipeline. has given our team a sense of pur-
years, Ipsen and its partners have When you have the right people pose in bringing drugs to patients
received six FDA approvals, four and the right leaders, positive and treating some of the world’s
European Medicines Agency transformation can occur. What most serious diseases.
(EMA) Committee for Medicinal we have been able to do is recon- Meanwhile, we increased the
P ro duc t s for Hu m a n U s e figure the leadership team, which number of oncology experts
(CHMP) positive opinions, six we knew needed to happen if we across the R&D value chain; and
EM A validations/ European were going to strengthen our also brought oncology expertise
Commission (EC) approvals, and R&D programs and pivot toward onto our radiopharmaceutical
one Medicines and Healthcare assuming leadership in our tar- franchise, alongside nuclear med-
products Regulatory Agency geted therapeutic areas, notably icine expertise. In the neurotoxin
(MHRA) approval. Moreover, specified areas of oncology with business, we’ve also been having
we rank as one of the industry’s high unmet need. These new great success in attracting world-
fastest-moving players. You will leaders, both within our execu- class experts to work on our pro-
struggle to identify many other tive committee and our broader grams at Milton Park in Oxford
drug developers with over $2 bil- global teams, have made sure that (England), a site which has posi-
lion in revenue that are expand- our strategy gets executed. tioned itself right at the vanguard
ing at a pace of over 20% per of designing next-generation
annum. recombinant toxins.
We are very pleased with this We were very clear
growth profile, especially in the PB: Practically, how have you gone
way that we are broadening our
in our minds that about the arduous task of engineer-
reach globally: the US market
now makes up 25% of our overall
we needed to ing a change in company mindset?
MEEK: It really all begins with
business and our Chinese affiliate unleash a the company ethos and collective
is also thriving. Our growth fig- sense of mission. We have a very
ures were over 21% in the fi rst profound and clear vision—Ipsen is a global bio-
half of 2018, with over 40% pharmaceutical company focused
growth in the US. ambitious on innovation and specialty care.
We have simultaneously made This vision inspires the leaders
strides in optimizing our portfo- transformation and the leaders inspire the change.
lio, having successfully launched Ipsen has been a great company
two oncology indications within
right at the heart for many years, but our recent
the past two years, with our third
potential EC approval imminent.
of the company success can be largely attributed
to our newfound resolve and
Even our established products, sense of purpose. When you com-
like Dysport®, which is the num- PB: Presumably, the dynamism and mit your company to being a
ber two neurotoxin on the mar- ambition that Ipsen is currently global leader in biopharma, espe-
ket, and Decapeptyl®, which was exhibiting is helpful when trying to cially innovative care, the entire
launched 30 years ago for pros- attract top talent? workplace really takes it to heart
tate cancer, are bringing signifi- MEEK: That is precisely what is and they enact the change.
cant patient benefit and register- so exciting about working for We distinguish ourselves by
ing very healthy sales growth. Ipsen. Leaders gain the chance to placing the patient front and cen-
come, drive progress, and bring ter. It can be difficult, from the
PB: How easy has it been to reor- game-changing medicines to standpoint of a pharma compa-
ganize your top team? patients. One of my first actions ny’s headquarters, to flip the tri-
MEEK: Overall, I consider the as CEO was to increase our ambi- angle upside down to where the
biggest transformation within tion in terms of R&D productiv- patient is at the top and the cor-
Ipsen has been the people and the ity, raising the bar; so we are now poration is on the bottom.
culture. A pharmaceutical com- shooting for one new NDA (new We need to start every day
pany’s fortunes are often deter- drug application) or meaningful with the patients’ best interests
10 Executive Profile PHARMACEUTICAL EXECUTIVE JANUARY 2019
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in mind. With this kind of mind- “search and evaluate” capabilities panies, as well as the increased
set, the “walls” that could be for scouting out new partnership role of AI as a disruptive techno-
preventing corporate cohesion possibilities with biotechs and logical force in drug discovery.
start to come down and we get academia. By ramping up our hir- There is a change of paradigm
what I call “a one Ipsen” in ing of physicians and PhDs, we whereby one no longer needs to
which we all work for the are now able to deepen our inter- necessarily test a new treatment
patients. Yes, we need each actions with these types of com- to produce data. We can start
department to be functional, but munities. with data through automated bio-
working cross functionally, both Ipsen is completely agnostic as metric processes.
internally and externally—with to where the innovation comes Ipsen’s digital transformation
academic centers, other compa- from. There will be instances has accelerated since 2014, and
nies, etc.—toward what is in the when we realize that somebody the company intends to stand
best interest of the asset and the outside the company has devel- among the leading companies in
company. With that in mind, oped something better: a therapy this area, implementing three sig-
people collaborate more. that can be properly termed “best nificant changes: speeding up
In an era of globalized drug in class.” In such circumstances, drug discover y, improving
development, the “one Ipsen” we need to be comfortable and at patients’ and HCPs’ user experi-
mindset is essential, ensuring a ease with halting our own propri- ence, and inspiring a culture of
spirit of solidarity and joined-up etary program and, instead, going digital innovation.
action takes precedence; this has after the best one because we real- The new digital odyssey
been one of my priorities. ize that the patients, payers, and begins, for us, in drug discovery,
we, ourselves, demand the best. where we are harnessing digital
PB: One of the elements of Ipsen’s Working with external part- means to identify the best drug
R&D transformation has been the ners helps keep us sharp. It ren- targets. Our researchers look at
pivot toward “open innovation.” ders us aware of all the great sci- data collected from various
How has this come about? ence that is going on out there, sources—for instance, real-world
MEEK: We are built around a not just within small biotech com- data collected from providers such
culture of open innovation. This panies, but within the large as Flatiron Health—and identify
approach is making us a partner pharma companies, too. My what molecules or treatments will
of choice from early stage devel- belief is that the industry needs to have the highest impact. We can
opment and academic partner- reach a point in which you can also rely on data to answer some
ships, through to late stage and walk into a room and you don’t scientific questions, which in the
product commercialization. Our really know where anyone works past could be answered only by
external innovation strategy that —and, moreover, you don’t care! key opinion leaders (KOLs) and
we started to roll out a few years Everybody is just trying to do health specialists.
ago explicitly targets the volume what’s right for the patient. I We are simultaneously deploy-
of global partnerships that we think that if patients saw that, ing AI and machine learning in
seek to enter into. While we want they’d be highly impressed. drug development and clinical tri-
to develop our own pipeline, we After all, patients don’t look at als. AI can be a true game-changer
also strive to supplement it with a label of a drug and ask, “where not only in helping developers
external assets. At the same time, is this made?” They just care if it generate a targeted therapy, but
we are keen to help others bring does what it says on the tin. The also in forecasting drug failure.
drugs to the market. In particu- country of origin or the manufac- I am convinced that by
lar, we are ready and able to turer is an irrelevance to them. embracing digital disruption, we
assist companies that may not can massively upgrade and opti-
have the capacity to manufacture PB: How about your commitment to mize our modus operandi for
or commercialize their own new digital innovation and your partner- drug development, diagnosis, pre-
products. ing with actors like IBM Watson? scribing, and care delivery.
So far, we have placed dedi- MEEK: We are increasingly wit-
cated teams in three innovation nessing the incursion into the bio- PB: Furthering “patient centricity”
hotspots—Boston, the UK, and pharma space of tech giants and has become a key tenet of Ipsen’s
Paris—and equipped them with software and gamification com- new vision. What does this buzz-JANUARY 2019 PHARMACEUTICAL EXECUTIVE Executive Profile 11
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word actually mean to you? And an attractive location for the ble readiness to effect change very
how do you measure your perfor- entire industry from big pharma rapidly.
mance on this issue? to small, innovative biotechs and Frankly speaking, contempo-
MEEK: There really isn’t a startups. rary drug development is a tre-
quantitative way to measure our That said, those very same mendously hard task. It is a highly
success with the patient, per se. ingredients can also be found in risky endeavor and the failure rate
The closest you get to such a some other places. The big ques- can be extreme. We, as an indus-
thing is surveying advocacy tion for France going forward is try, cannot develop innovation on
groups. What Ipsen has done, how the country can leverage our own in a vacuum anymore.
though, is to appoint a chief these qualities to the maximum In the old days, a basic research
patient officer, explicitly dedi- and deliver upon its full poten- laboratory and bench scientist
cated to ensuring the primacy of tial. Quite frankly, there are could identify a molecule and
the patient and that the patient is alternative ecosystems out there commercialize it all within one
positioned right at the forefront at the moment that are managing company. That way of operating
of all of our activities. In new to achieve more with a compa- has categorically gone with the
drug development, for example, rable resource base and where advent of cutting-edge, sophisti-
we are attentive to incorporating the pace of advancement has cated biologics. Innovation now
patient feedback loops early on been astonishingly rapid. At the comes from all directions, and
in the process, with a view to ren- end of the day, investment flows companies have to prove open to
dering the delivery mechanisms will always gravitate toward the ideas from anywhere across the
as user-friendly as possible. markets offering the optimal globe. Furthermore, collabora-
As a company with a strong
footprint in specialty care, we are Contemporary drug development is a tremendously
compelled to establish strong
relationships with our advocacy hard task. …We, as an industry, cannot develop
groups. Meanwhile, we have
been working in conjunction with innovation on our own in a vacuum anymore
a coalition of advocacy groups,
key centers, and regulators in try- value proposition, so there is no tion between industry, patients,
ing to establish an infrastructure room for complacency if France, researchers, payers, and other
to support personalized precision or indeed any country, seeks to actors across the care continuum
medicine whereby treatments can remain in the game. is ever more critical as health sys-
be tailor-made to each patient’s tems battle financial constraints
genetic makeup. PB: What steps, then, should France that can only be remedied by act-
take to properly deliver upon its true ing in concert.
PB: You have been in your current potential in life sciences? What we need is for the major
role for over two years now. How MEEK: There is no single, sim- stakeholders to band together
would you describe your first ple way to optimize the system. and lay out a comprehensive
impressions of the French market? There is no magic fix or silver bul- vision for what the French life sci-
MEEK: My overall impression let. There are many different ences community wants to
is that all of the prerequisite types of stakeholders in the mix become. What I, and many of my
ingredients for a great recipe are and genuine collaboration will in-country peers, have in mind is
at hand. France demonstrates admittedly be tough to engineer. for France to assume its place as
great potential for innovation However, if we do not improve, an innovative center of excellence
thanks to the country’s excellent others will continue to pass on a global standard where we
academic centers and hospitals, France by. As we sit, ponder, and develop drugs that benefit the
an educated workforce, a solid deliberate, the world is not wait- entire world. I think that I can
economy, and a strategic geo- ing for France. Believe me, I speak for many of my colleagues
graphic location for business. [recently] came back from a trip in the industry when I say that we
This is a market that enjoys out- to China and they are not waiting are super motivated to bring this
standing underlying fundamen- for anybody. On the contrary, the about. We want the other stake-
tals and, as such, France remains Chinese demonstrate a formida- holders to be equally motivated12 Executive Profile PHARMACEUTICAL EXECUTIVE JANUARY 2019
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What we need is for the major positive mindset in the social
security budget bill for 2019 and
The domestic market, though
important, is only one compo-
stakeholders to band together the forthcoming decisions on nent of our overall business. We
government health policy. have strategically established
and lay out a comprehensive As an industry, we strive to be global hubs in Paris, the UK, and
constructive and are committed the US, and we are continuing to
vision for what the French life to helping to shape the future, but expand across high-growth mar-
as commercial entities, we also kets in Asia. Meanwhile, part of
sciences community wants have to be mindful of our capital my brief is actually to leverage my
allocation and take actions that experience on both sides of the
to become we believe will help us bring great Atlantic to propel the company
and energetic. We are going to products to patients around the to the next level by deepening our
need a serious private-public world as fast as possible. I would presence in the US.
partnership to attain these goals. describe the present mood as
hopeful and there is a general PB: What are your main priorities,
PB: What was your feeling about the appreciation that we have entered hopes, and aspirations looking
vibe at the Strategic Council of a golden window of opportunity ahead?
Health Industries (CSIS) in July, and in which different stakeholders’ MEEK: We remain at a critical
French Prime Minister Edouard objectives are increasingly aligned. juncture in our company’s life
Philippe’s speech on the Macron cycle. Understanding that our
administration’s agenda for the life PB: It is rather rare to find an Amer- future strength is in drug develop-
sciences industry? ican leading a French pharma com- ment, we have set about trying to
MEEK: For me, it’s not about pany like Ipsen. How have you dealt put in place a “light” research
one speech, but the subsequent with being in this situation? organization that recognizes that
actions that ensue. If we follow MEEK: It certainly has placed research can be done externally.
through on the plans that we me in a unique position. I actually We are changing the way that new
make, then we begin to establish hold the distinction of being the treatments are researched, devel-
credibility. Predictability has all only American CEO in the entire oped, and brought to market—
too often been absent from the SBF 120 (Société des Bourses pushing an open innovation
French ecosystem. There have Françaises 120 Index), the stock approach, promoting partner-
been many false dawns. Having index provided by the Paris ships, and involving patients every
a clear sense of the future operat- Bourse. Nonetheless, given my step of the way.
ing environment is not just a pre- global experience with large mul- Right now, we are fi rmly on
condition for an enterprise to be tinationals and biotechs, as well track to meet our 2020 objective
able to formulate business plans as living and working in Italy, for group sales of over €2.5 bil-
and place big-ticket investments, Switzerland, France, and Canada, lion, equating to over 30%
but also for the researchers, the and my familiarity with the growth over the next two and a
academic institutions, and the mindsets and internal dynamics half years. Our intention is to sus-
rest of the life sciences commu- of these markets, I am pretty tain this momentum by bolstering
nity to perform their tasks com- comfortable in such an interna- the internal pipeline and through
petently. If one part of the value tional environment. the acquisition of therapeutic
chain says one thing, but then I am always keen to stress to assets that fit with our strategy.
does something completely dif- people that Ipsen is a global com- Our future is bright. Our lead-
ferent a few months later, it com- pany that happens to have a ership and culture are strong.
promises everyone’s productivity. French headquarters and heritage. Our specialized portfolio of inno-
I think that what was said this We are very proud of our 90-year vative and differentiated assets—
summer at the CSIS was certainly history in France, but we have, combined with our strong clinical
PharmaBoardroom is
encouraging and the posture of over time, established ourselves as and regulatory skillset, will allow
the UK-based, the new administration is rather a multinational entity fit for taking us to continue to expand indica-
independent publisher more collaborative and pro-inno- on the challenges of contemporary tions across existing therapies
of Healthcare & Life vation than its predecessor. We’re drug development, which is an and to bring new treatments to
Sciences Review looking forward to seeing this increasingly globalized endeavor. market.Stay Connected The world is larger than you think — don't get lost. Cultural insight is the key to doing business in a globalized world. Become a global business insider with Pharma Reports and stay connected with the advancements and trends influencing pharmaceutical industries around the world. Pharma Reports provide pharmaceutical executives with an insider's look at innovations shaping the pharmaceutical industries of countries with vibrant, expanding markets. Shop now at industrymatter.com/reports
14 Industry Forecast PHARMACEUTICAL EXECUTIVE JANUARY 2019
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8 Tipping Points
for Pharma
Pharm Exec’s 2019
Industry Forecast
styf - stock.adobe.com
Welcome once again to Pharm Exec’s annual look at what’s ahead for the biopharma industry, where
we hope the eight trends singled out for this year capture the pulse of
change and opportunity impacting leaders and decision-makers in the life OUR TRENDS FOR ’19
sciences the most. From technology and digital health (see accompanying
Data and AI
guest column on page 26), to integration of healthcare delivery, to new— Vertical Integration
and big—competitors at the pharmacy level, to the tenuous countdown Emerging Biopharma
and aftermath of Brexit, these topics, chosen with input from our Editorial Payment Models
Advisory Board, all represent key tipping points of sorts for the industry in Fight for Pharmacy
Lifecycle Management
the coming year. And with some, such as “emerging” biopharma, perhaps
Brexit
already tilted toward definitive change. Whatever the case may be, watching Digital Therapeutics
these areas unfold should be an interesting ride in 2019.
A Deep Learning Curve
Keeping pace with data and AI
roadly, industry’s uptake and optimization change in the way healthcare is delivered” (bit.
B of artificial intelligence (AI) technologies and
data analytics has failed to match the hype
that has surrounded the topic. While a September
ly/2DasYKn).
With the industry moving tentatively into AI,
Pharm Exec tapped into expert opinion that sug-
2018 Frost & Sullivan report predicts that AI and gests company activities in this space over the next
cognitive computing will generate savings of over couple of years could be crucial in forging their
$150 billion for the healthcare industry by 2025, path ahead. Those who are embracing and seeking
it also noted that uptake in healthcare IT has been to understand the true potential of AI and data
slow due to strategic and technological challenges. may see their efforts begin to pay off. Others may
So far, the report said, “only 15%–20% of end find themselves facing that ominous decision:
users have been actively using AI to drive real “Adapt or die.”JANUARY 2019 PHARMACEUTICAL EXECUTIVE Industry Forecast 15
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Making sense of data The hope is that every patient can have a specific
Mark Lambrecht, director of the health and life therapy geared toward their genetic background
sciences global practice at SAS, told Pharm Exec and their disease, and patients can be matched with
that he sees “a lot more realism coming along” the right trial and the right therapies. “These n-of-1
from companies that began establishing in-house trials offer the opportunity to gather a lot of data—
capabilities and data warehouses a couple of years genomics data, proteomics data—and do a lot of
ago, with company efforts now “maturing to the real-time analytics,” says Lambrecht.
point where organizations understand what tech- Indeed, he adds, we are reaching a point when
niques they want to use,” with different architec- no clinical trial will be run without fi rst consulting
tures and technologies in place for different pur- real-world data. “It will be part of the whole clin-
poses. “They are following where the data is ical development effort, from modeling and simu-
coming from and how it can help them move for- lation and predicting where you need to go with
ward with clinical development or gain an under- your trial, in terms of geography and therapeutic
standing of what value their therapy brings to the area, to really understanding what the medicine
market,” he adds. under investigation does for patients.” Using real-
Smaller biotech and pharma companies con- world data generated from an abundance of
tinue to be more innovative, however. For compa- sources—such as video data, demographic data,
nies with smaller budgets, “automation is definitely claims data, fi nancial data—“will help companies
a big driver in making the best use of the data and understand more about the average patient and
AI—whether that’s natural language processing or create therapies that improve patient outcomes and
image analysis or newer techniques.” Small com- are impactful for society,” says Lambrecht.
panies “don’t have armies of people to manually Video data, particularly, will bring more ana-
filter out the meaningful signals,” says Lambrecht, lytics activity, with “streaming analytics becoming
“so they want to deploy AI techniques on those big more pervasive.” Lambrecht explains: “Take a hos-
data sets. That leads to more efficient ways of look- pital that is using a robot for a surgical procedure;
ing at information and helps ensure that their sci- a lot of video data comes from that. Streaming
entists are looking at high-priority problems.” analytics can be applied to that video data to help
While the absence of mature healthcare stan- support the physician as he or she performs the
dards and the global variations in how data is surgery. In a similar manner, streaming analytics
structured and used remain “big problems” for can be used for clinical development. It will help
pharma, there is positive news in that globalizing companies to trim down and keep just the data and
policies are driving harmonization, adds Lam- information that is relevant.”
brecht. “One example is the EU’s GDPR (General
Data Protection Regulation), which is having an AI in drug discovery
effect globally in the way that the people are think- Margaretta Colangelo, partner at Deep Knowledge
ing about patient privacy. One of the downstream Ventures, notes that biopharma companies were
effects will be data harmonization and standard- skeptical of the disruptive potential of AI in drug
ization. Another example is that the FAIR (Find- discovery (AI in DD), but by 2018 were showing
ability, Accessibility, Interoperability, and Reus- “more interest in the sphere.” However, she says,
ability) data principles, initiated in academia, are companies are still moving very slowly in embed-
also becoming more important in the industry.” ding advanced AI technologies into their internal
R&D processes.
AI in clinical development “The majority of biopharma professionals did
Looking at the short-term future of clinical devel- not have AI or well-developed IT technologies inte-
opment, Lambrecht predicts that n-of-1 trials, or grated into their education,” says Colangelo.
single-patient trials—randomized controlled cross- “Although biopharma companies have sufficient
over trials in a single patient—will come further budgets to hire really strong AI specialists to start
to the fore from a data and AI perspective. N-of-1 understanding this field, they are the most resistant
trials investigate the efficacy or side-effect profi les to adopt new AI in DD technologies.”
of different interventions, with the goal of deter- Noting that the industry famously takes a long
mining the optimal or best intervention for an indi- time to make decisions, and even longer to trans-
vidual patient using objective data-driven criteria. form its operating procedures in the face of new16 Industry Forecast PHARMACEUTICAL EXECUTIVE JANUARY 2019
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images and music, in 2017, scientists from Mail.Ru
Group, Insilico Medicine, and MIPT applied a neu-
ral network to create new pharmaceutical medicines
with the desired characteristics.
GANs, Colangelo explains, “grew from an
extremely new, next-generation technology at the
beginning of 2018 to being embraced as the lead-
ing frontier of AI and deep learning—and the de-
facto standard for modern, advanced AI—by the
end of the year.” She predicts that in 2019–2020,
GANs will be surpassed by the next generation of
novel AI technologies, “resulting in new techniques
that are as far advanced in relation to GANs as
GANs are currently to normal recombinant neural
networks.”
So far, only a “select few” AI in DD companies
Source: Deep Knowledge Ventures are applying GANs as a core part of their R&D
advancements and technologies, Colangelo adds, processes, because the high level of expertise
“Biopharma giants are just that—slow and lum- required means hiring very strong AI specialists—
bering entities, incapable of the kind of agility “a scarce resource in the industry right now,” says
shown by the smaller and younger companies.” Colangelo. In order to survive in the coming years,
These smaller companies will continue to push the major biopharma companies will need to
advancements in AI in DD. Deep Knowledge Ven- “reinvent themselves completely,” adopting AI as
tures expects, for example, to see 10–20 new AI the core component of their R&D, allocating sub-
in DD companies emerging in 2019, with the total stantial budgets to hire the best AI specialists and
number increasing from 125 in 2018 to around proactively keeping pace with new AI advance-
140–150 by the end of 2019. ments.
Colangelo points to generative adversarial net- While a few existing biopharma corporations
works (GANs) as the most significant AI technique will prove capable of surmounting this challenge,
to gain widespread traction in 2018. GANs pit a pair “the rest will prove incapable and will be fated to
of neural networks with machine intelligence—one die out as a result,” warns Colangelo. She adds,
generative, the other discriminative—against each portentously, “No area of biotech and healthcare
other in a “competition,” potentially producing out- will be untouched by AI techniques. They will dis-
puts over time that are beyond human capability. rupt all niches entirely.”
While GANs have been used in the generation of — Julian Upton
New Era in Drug Management
Vertical integration of payers, PBMs, and specialty pharma
n early December 2017, CVS Health and Aetna D prescription drug plan business for individuals
I announced their intent to merge in a $69 billion
deal. Soon after, in March 2018, Cigna and
Express Scripts announced their vertical integra-
required by the US Department of Justice. Cigna/
Express Scripts extended its merger deadline from
December 9, 2018, to June 8, 2019, but has also
tion at a $52 billion price tag. As of this writing, gained some state approvals. While the extension
both mergers have yet to close. CVS Health/Aetna now makes the vertical integration of payers, phar-
is much closer, having been approved by a number macy benefit managers (PBMs), and specialty
of state regulators and a divesture of Medicare Part pharma too early to call a homerun 2019 trend,JANUARY 2019 PHARMACEUTICAL EXECUTIVE Industry Forecast 17
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with the forward motion of the merger approvals the public on how the supply chain
and already set-in-motion programs by each of works, how they have to build
these PBMs, the impact of the vertical integrations money back into their list prices
on pharmaceutical manufacturers is well in sight. to account for the rebates. They
Outside of the big two, other integrations include have done a very effective job.”
UnitedHealthcare/OptumRx and Blue Cross Blue But PBMs came back swing-
Shield with Prime Therapeutics. However, because ing at the end of 2018, and seem
Cathy Kelly
Prime is owned by a number of BCBS plans but to be swaying government opin-
not all of them, it is slightly different. ion, if not public opinion. Express Scripts
According to Cathy Kelly, who regularly reports announced that as of Jan. 1, it will offer employ-
on PBMs in her role as senior editor for the Pink ers the option of using a formulary that would
Sheet, the newest mergers are not likely to result prefer lower-cost alternatives to expensive brands
in significantly more members or covered “lives” and would exclude the brands from coverage as
for any of the players. CVS had already been man- a way to effectively lower prices without violating
aging some duties for Aetna’s pharmacy benefit the terms of rebate agreements already in place.
along with its own internal PBM, and Express A press release stated, “The Express Scripts’
Scripts had recently lost Anthem as its largest cli- National Preferred Flex Formulary provides a way
ent, so the addition of Cigna members more or less for plans to cover lower list price products, such
brought them back to equal. as new authorized alternatives that drugmakers
But what the combinations could lead to is a are bringing to the market and reduce reliance on
greater allocation of PBMs managing medical ben- rebated brand products.”
efit drugs, rather than just drugs covered under the The CVS response, announced in early Decem-
pharmacy benefit. Kelly suggests that with their ber, is its new approach to pricing, called guaran-
ability to see the claims coming across the insurers teed net cost pricing, described in a press release as
database, the PBM insight into how to better man- guaranteeing “the client’s average spend per pre-
age or control the costs of the more complicated scription, after rebates and discounts, across each
physician-delivered drug landscape, which is usu- distribution channel—retail, mail order, and spe-
ally in the scope of the specialty drugs, is a poten- cialty pharmacy…with the guaranteed net cost
tial. model, clients continue to have the option to imple-
On the other hand, one challenge for the PBMs ment point-of-sale rebates to provide plan members
involved in the pending mergers is that the combi- visibility into the net costs of their medication.”
nations lose clients because of the actual or per- As Kelly explains, both the Flex Formulary
ceived competition. For example, insurers that don’t and the guaranteed net cost pricing are options
want to use Express Scripts as their PBM because for employers, so the uptake of the programs
of the Cigna relationship. may not be known for some time. “PBMs are
PBMs and manufacturers are bracing for a major usually not forthcoming about clients, but these
disruption in the current system of drug contract- are high-profi le programs, so they may want to
ing, with possible regulatory action coming from put that information out there.” However, the
the Trump administration to restrict the use of net overall effect of the PBM programs, as well
rebates. In the meantime, the major PBMs are intro- as their mega-mergers, will only start to be real-
ducing programs that aim to reduce the reliance on ized this year.
rebates. The most apparent trend emerging that Will PBMs be able to improve their overall pub-
warrants pharmaceutical executive attention are lic perception in 2019? Again, time will tell. As
those programs. Merck & Co. CEO Kenneth Frazier was quoted in
As Kelly told Pharm Exec, “PBMs have been tak- this article, bit.ly/2rXj6Lu, “I mean no disrespect
ing a lot of heat the past couple of years over rebates.” to anyone else in the supply chain, but I know how
And our own Editorial Advisory Board (EAB) sug- hard it is to make my 50 cents on the dollar. I have
gested that the increased pressure on the PBM is lead- to invent something that’s never existed in the his-
ing many to challenge or question PBMs’ power in tory of the world. And I have to ask my sharehold-
the supply chain. Kelly acknowledged that pressure ers to be patient with their capital. I think that the
is due, in large part, to manufacturers’ efforts. “The system has got to change.”
manufacturers have worked very hard on educating — Lisa HendersonYou can also read
