Pharmaceutical Commerce - November/December 2016 - 26


Op-Ed

Patient access strategy: specialty pharmacy, hub-or both?
continued from page 6

p h a r m a c i e s f o r d r u g s d i s p e n s e d to
members of insurance companies). In
order to get a paid claim, every pharmacy,
whether your local retailer or a SP, needs
to understand the payment rules of the
insurance company, and thus employ
reimbursement experts to navigate the
process. Additionally, to coordinate delivery
of the specialty drug, SPs need to operate a
call center with patient care coordinators to
get all information needed from the patient
to dispense the medication. A SP considers
success a paid claim and delivery set-up

with a patient. Getting paid claims keeps
pharmacies in business. Indeed, specialty
pharmacies suppor t reimbursement
services just like a hub, but for vastly
different reasons, creating somewhat of a
conflict and challenge if you hire a specialty
pharmacy to be your hub.
So while it is true that specialty
pharmacies do offer some of the
reimbursement services within a hub, their
function and purpose are distinct from a
hub. It would be ideal if hubs and specialty
pharmacies agree to coexist and appreciate

each other's role in the patient journey.
Hubs need to have stellar relationships
with SPs in order to ensure their patients
get set up for medication delivery with
a high degree of urgency. Having strong
relationships with SPs is critical for your
hub, not just for seamless transition to
dispense, but also for data aggregation
a n d a d h eren ce s t r a te g i e s . Fre qu en t
communication and candor between hub
and SP is recommended as a top priority
before product launch and should be
continued throughout the product lifecycle.

Can hubs and SPs coexist? Absolutely!
Frequent communication between your
hub and SPs is key. As the commercial
leader in charge of patient access, it is
your leadership challenge to set a vision
for your patient access strategy, and your
opportunity to communicate your vision
to your hub and SP partners. Consider
your challenge one that helps evolve
commercialization of new pharmaceuticals
with the patient at the center of your goto market str ateg y for new product
adoption.

Top News

New products take the stage at IQPC Cold Chain Forum
continued from page 11

Laminar Medica, which will expand Sonoco's capacity and
scale in Europe. CSafe Global, which markets RKN unit-load
devices for air cargo as well as AcuTemp passive containers,
has acquired Kalibox, a French packaging supplier. Pelican
BioThermal has recently expanded its manufacturing
capacity by 14,000 sq. ft. in its Plymouth, MN facility. In
recent months, both World Courier and Marken, two
leaders in clinical trial logistics, have expanded their resources

in Moscow; Marken has also opened a new operations center
in India.
Even with all this activity and market growth, some IQPC
vendors might be looking with envy at another "cold chain"
company in the news: Yeti Holdings Inc., which supplies ice
chests and insulated cups for outdoorsmen. The Austin, TX
company (whose Tundra 250, a 6.6-cu. ft. chest made with
rotomolded plastic and polyurethane insulation, retails for

$900, and has been "certified" as "bear proof" by something
called the Interagency Grizzly Bear Committee), is about
to be taken public by a private equity firm with a potential
valuation of $5 billion. That price represents roughly a 36X
P/E ratio, according to a Wall Street Journal article. Could be
that if Yeti doesn't move into the life-sciences logistics space,
some IQPC vendors might look into the bear-proof cooler
market!

Manufacturing & Packaging

Active packaging protects oral solid formulations
continued from page 24

technology, outfitted blisters can be customized to
absorb tailored amounts of water vapor. Using scavenger
technology, blisters can absorb oxygen or targeted gases and
impurities, to levels lower than those achieved by purging.
Greater still, these extruded polymers can be engineered
to provide combination management of moisture and
gas. All options can be produced in shapes and sizes to
accommodate nearly any tablet and capsule size.
For pharmaceutical manufacturers and contract
packagers, the cost of incorporating such active scavenging
blister solutions is, typically, more than offset by alternative
measures taken to best ensure premium moisture
protection, especially when compared to purging and
secondary packaging. Further, Activ-Blister solutions may
allow a product to move from larger cold-form packages
to a thermoform that offers a smaller footprint (up to
a 40-60% size reduction) and provides visibility of the
capsule or tablet for the customer.
Holistic approach
Extending shelf life, reducing returns and optimizing
package design is important to any OSD application. All of
these challenges are magnified in Climate Zones III and IV,
making a truly global packaging and supply chain operation
extremely difficult to serve. Many factors must be taken
into account, including headspace at the time of packaging,
ingress, and off-gassing from API and excipients. Often,

there is a pile-on effect that happens throughout the
product's production, shipping and shelf life, and all of
these issues can be exacerbated even further in the high
humidity climate zones.
Simulated modeling can examine the impact of
Activ-Blister solutions with various blister materials and
designs. Attractive options can then be examined through
prototyping and shelf life testing to determine both the
drug product and the desiccant or scavenger performance.
This process can provide relatively quick iterations and data
to optimize package design.
Plus, experience has shown some unexpected benefits of
Activ-Blister technology. In one example, impurities were
seen in an HDPE bottle application and persisted even in a
cold form blister. More interesting, scavenging oxygen and
other gases also did not impact impurity levels. Surprisingly,
it was ultimately found that Activ-Blister technology using
a molecular sieve (MS) desiccant was able to sufficiently
reduce the impurities. Even better, this performance
was achieved in a thermoform design, providing capsule
visibility and minimized footprint capsules. (Fig. 2.)
Conclusion
Utilizing new packaging solutions that actively
scavenge for moisture, oxygen and other gases-as well as
degradation products such as VOCs-in blister headspace,
products that are normally packaged in bottles with

26 Visit our website at www.PharmaceuticalCommerce.com November | December 2016

desiccant sachets can now be thermoformed into blister
cards without sacrificing protection. This move from bottle
to blister can effectively eliminate the added costs associated
with gas flush/purge and secondary packaging with sachets,
etc.
Ac t ive b l i s ter i n g te ch n o l o g y en a b l e s ph a r m a
manufacturers to achieve headspace management
comparable to existing bottle options. It can extend the
shelf life of alu alu and thermoforms by reducing, and in
some instances eliminating, moisture and gases in existing
headspace and from potential ingress throughout the supply
chain. Use of this groundbreaking technology also reduces
packaging complexity and costs by eliminating the need for
purging, secondary and fishbone packaging. Moving from
cold form to thermoform also reduces material costs and
results in a smaller footprint, and its adhesive-free heatstaking helps eliminate associated off-gassing and expense.
About the author
Craig Voellmicke is VP of Business Development for CSP
Technologies, Inc. (www.csptechnologies.com), which focuses
on pioneering new packaging technologies and designs that
ensure product protection and enhance brand recognition.
The company's services include custom product design,
development and manufacturing. Its portfolio of products
falls into four categories: vials, films and blisters, molded
components, and specialized packaging solutions.


http://www.csptechnologies.com http://pharmaceuticalcommerce.com/

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
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Pharmaceutical Commerce - November/December 2016 - Cover4
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