Pharmaceutical Commerce - November/December 2016 - 18

Therapy Focus
Pharma seeks growth in eyecare
New industry entrants aim at expanding patient volumes even while drug compounding limits some therapy classes
By Frank Celia, Contributing Editor

Relative to other disease states,
like cancer, diabetes or cardiovascular,
ophthalmology is both smaller and less
contentious. A relatively small number
of pharma companies have significant
franchises in it, namely, Allergan, Alcon
(a subsidiary of Novartis) and Bausch +
Lomb (a subsidiary of Valeant). With overall
drug expenditures in the US of around $20
billion, the field doesn't light up the radar
screens of many payers looking for ways to
clamp down spending.
Ophthalmologists admit few patients
to hospitals, and their surgeries lack the
high technical and facility fees hospital
administrators seek in full-time employees.
Nor has the specialty shown much interest
in healthcare reform pursuits, such as
transitioning to value-based reimbursement
or joining accountable care organizations.
The result is a workforce whose worldview
remains pretty much unchanged since the
20th century: independent; prone to DIY
clinical solutions; and, with less outside
review, quick to embrace innovation.
However, the times are changing. A
relative shortage of ophthalmologists
(there are about 18,000) has led to
"c o - m a n a g e m e n t" w i t h o p t o m e t r y
practices; optometrists (depending on
state regulations) write nearly as many
prescriptions as their physician colleagues.
(1). Everyone is getting busier as the US
population ages; eyecare expenditures for
the over-65 demographic are nearly nine
times as high for younger demographics.
Meanwhile, a wider array of eyecare
conditions-many of them qualifying as
rare diseases-are now targets of drug
de velopment. One company-Shire
Pharma-is gearing up to be a major player
in the field; another is Akorn Pharma, which
added three branded ophthalmic products
from Merck to its portfolio in 2013. Growth
rates of 5%/year are being predicted for the
Yet one more factor differentiates the
field, and one that constrains some pharma
industry growth: the widespread use of
compounded pharmaceutical products.
Ophthalmologists are, in fact, one of the
leading medical professions supporting
wider access to compounded products.
Enter newcomer Shire Pharmaceuticals
(Dublin, Ireland), with bold plans to
compete at almost every level of prescription
ophthalmic drug therapy, and hopes to
revitalize an entire industry. "There are
really only a few companies that have a
major presence in this space, so I think that
has really, from a standpoint of Shire as a
new entrant into the space, allowed us very
quickly to build up our awareness and make
some significant inroads," Robert Dempsey,
head of Shire's Ophthalmic Products
business unit, tells Pharmaceutical Commerce.
Shire's portfolio consists of rare disease

and specialty pharmaceuticals, mostly in
gastrointestinal, internal medicine and
neuroscience spaces-but until recently no
eyecare drugs. When Flemming Ornskov
became CEO in 2013, he knew from his
years as an executive at Bausch + Lomb that
the sector contained a great deal of patient
need. He also knew much of that need took
the form of rare diseases. For example, the
retinal pigment epithelium alone can be the
site of more than 200 rare maladies, most
of them incurable. It seemed a perfect fit
for Shire. Within a year, he had appointed
Allergan veteran Robert Dempsey to head up
the newly created Ophthalmic Business Unit.
Since then, the company has been laying
groundwork, cooperating with professional
organizations, sponsoring medical education
and grants, working with key opinion
leaders, and making a strong commitment
to ophthalmic R&D. By the end of 2016,
Dempsey estimates that Shire will have spent
about $850 million on the ophthalmology
move, even before launching a single drug.
This summer, the company received its
first ophthalmic FDA approval, for Xiidra
(lifitegrast), a dry eye drug. The launch
of Xiidra will be closely watched, as it
challenges Allergan's dry eye blockbuster
Restasis (cyclosporine), which generated
$1.3 billion last year. There are an estimated
16 million dry eye patients in the US, many
undiagnosed. The potential market might
be big enough to allow Xiidra to achieve
blockbuster status without encroaching
much on Allergan's market share, some
forecasters believe.
In addition, Shire has investigational
products for other conditions in various

18 Visit our website at November | December 2016

stages of development, including glaucoma,
retinal disorders and infectious conjunctivitis
(pink eye). Promotional materials indicate
the company hopes to target "the anterior
and posterior segments and rare ophthalmic
diseases," or, in other words, pretty much
everything ocular.
Taking a page from Allergan's Restasis
launch strateg y, Shire is planning a
comprehensive dire c t-to-consumer
advertising campaign. It recently signed
Jennifer Aniston as a celebrity endorser. Few
remember it now, but Restasis was not an
instant success when it launched in 2002.
Former Allergan employee Denise Sheehan,
who now serves as the global marketing
lead for retina at Santen, recalls that "it
was not until after Allergan made some
strategic investments in direct-to-consumer
advertising, also with a celebrity endorser,
that the brand really took off."
Achilles' heel
The consumer choice element in dry
eye is unusual for ophthalmology, which
tends to be dominated by specialty drugs
marketed to physicians. Currently, the most
dynamic area here has been in the retinal
field, driven by the success of anti-VEGF
therapies. (Anti-vascular endothelial growth
factor is a component of treating eye
conditions as well as reducing tumor growth
in cancer.) Anti-VEGF therapies effectively
treat a number of serious, vision-threatening
retinal conditions, including age-related
macular degeneration (AMD), diabetic
macular edema (DME), and central retinal
vein occlusion (CRVO) among others.
Developed by Genentech (San

Fig. 1

Francisco, CA), the first highly successful
agent, Lucentis (ranibizumab), arrived
in 2006 (Fig. 1). Before that, however,
ophthalmologists got wind of the promising
trials and began using a similar Genentech
product purchased through compounding
pharmacies, Avastin (bevacizumab), offlabel (Fig. 2). Avastin produced similarly
positive outcomes and costs only $50 per
dose, compared to more than $1,000 for
Lucentis. When the company took steps to
limit Avastin's availability to compounding
pharmacies, ophthalmologists cried foul.
Eventually, the company backed down, but
the lingering animus within the profession
ac tual ly resulted in the heig htened
popularity of the off-label option, many
observers say.
To this day, despite the addition of
Eylea (aflibercept) by Regeneron Pharma
in 2011, Avastin remains a staple among
retinal surgeons, who may use it when other
options fail or in cases of financial need.
Occasionally an insurance plan will require
Avastin as a first-line therapy, but for the
most part, prescribing decisions have been
left to clinicians. One reason is Avastin's offlabel status for eyecare. "While compounded
Avastin is lower cost, it does require
manipulation of an injectable product which
will ultimately be injected into the patient's
eye," explains Andy Behm, VP of clinical
evaluation and policy at the pharmacy
benefit manager Express Scripts. "It's
challenging to mandate if the prescribing
physician is uncomfortable with the product
or the dispensing pharmacist has little to no
experience in compounding it."
Even so, if the profession has a financial
Achilles' heel, injectable retina drugs are
it. Experts believe some form of cost
curtailment could emerge from CMS
rather than private payers since Medicare
covers most anti-VEGF patients. "Last
year Medicare Part B spent $8.4 billion
on claims by ophthalmologists," notes
Kevin Corcoran, COE, a consultant in
San Bernardino, CA. "Of that amount,
$2.7 billion was supplies, and almost all of
that money was spent on just two items:
Lucentis and Eylea. So in other words, 32%
of all the money ophthalmology received
from Medicare was for just two drugs. And
that number keeps rising every year." In
the long run, he concludes, such numbers
are unsustainable.
DIY antibiotics
Economists blame a small market and
increased competition for recent shortages
and price hikes among generic drugs. A few
examples: Acetazolamide, an oral glaucoma
drug, which once sold for less than $50
for a bottle of 100 pills, now costs $350.
Carbachol, a drop used for glaucoma and
certain eye surgeries, is no longer available.
Echothiophate powder, used to create

Table of Contents for the Digital Edition of Pharmaceutical Commerce - November/December 2016

Table of Contents
Pharmaceutical Commerce - November/December 2016 - Cover1
Pharmaceutical Commerce - November/December 2016 - Cover2
Pharmaceutical Commerce - November/December 2016 - Table of Contents
Pharmaceutical Commerce - November/December 2016 - 4
Pharmaceutical Commerce - November/December 2016 - 5
Pharmaceutical Commerce - November/December 2016 - 6
Pharmaceutical Commerce - November/December 2016 - 7
Pharmaceutical Commerce - November/December 2016 - 8
Pharmaceutical Commerce - November/December 2016 - 9
Pharmaceutical Commerce - November/December 2016 - 10
Pharmaceutical Commerce - November/December 2016 - 11
Pharmaceutical Commerce - November/December 2016 - 12
Pharmaceutical Commerce - November/December 2016 - 13
Pharmaceutical Commerce - November/December 2016 - 14
Pharmaceutical Commerce - November/December 2016 - 15
Pharmaceutical Commerce - November/December 2016 - 16
Pharmaceutical Commerce - November/December 2016 - 17
Pharmaceutical Commerce - November/December 2016 - 18
Pharmaceutical Commerce - November/December 2016 - 19
Pharmaceutical Commerce - November/December 2016 - 20
Pharmaceutical Commerce - November/December 2016 - 21
Pharmaceutical Commerce - November/December 2016 - 22
Pharmaceutical Commerce - November/December 2016 - 23
Pharmaceutical Commerce - November/December 2016 - 24
Pharmaceutical Commerce - November/December 2016 - 25
Pharmaceutical Commerce - November/December 2016 - 26
Pharmaceutical Commerce - November/December 2016 - 27
Pharmaceutical Commerce - November/December 2016 - Cover4