Pharmaceutical Commerce - September/October 2017 - 31

Information Technology
Ohio's rationale for changing the
TDDD rules is to get a better handle on
the sampling of controlled substances;
howe ver, the r ule goes well be yond
controlled substances. And while sampling
is required to be documented nationally
under the Prescription Drug Marketing Act,
some states make the sample part of what
gets reported as an Open Payments-type
transfer of value.
The Open Payments requirements
demonstrate both how many parts of a
pharma company need to track interactions
with HCPS (Fig. 2) and what companies
have been doing to address the need (Fig.
3). QuintilesIMS, which published a "US
Trends in Aggregate Spending" survey last
October, concluded that "manufacturers are
not closing the book on their transparency
initiatives; rather, they are just beginning
the second chapter as the y identify
opportunities to achieve a more efficient
and effective compliance operation."
NPI numbers are just the beginning of
the physician categorizations that today's
MDM systems are achieving. There are
also DEA registration numbers (which
used to be the default numerical ID before
NPI became widely established); state
medical licenses (a significant number of
physicians operate in more than one state);
certifications by medical specialty (which,
under PDMA rules dictates what drugs can
be sampled to which specialties). LexisNexis
touts its sourcing of data from a consortium
of 70 payers (insurers), which generates
1.6 billion medical claims annually, and
whose data is used by CMS itself in tracking
public insurance payments. "A good part
of this work is for the benefit of healthcare
providers," says Schoeller, "but we have the
opportunity to leverage this data to the
pharma industry."
The lion's share of attention is currently
focused on affiliations-which health
systems prescribers belong to, and which
pharmacy benefit managers and health
plans have agreements with those systems.
With the shift to market access teams to
address prescription choices at institutional
as well as individual prescriber levels, these
connections become vital.
According to QuintilesIMS' Busalacchi,
affiliation data (which can also tie into
related topics like formulary decisions
and other factors) can best be addressed
by taking an enterprise information
m a n a g em en t ( E I M ) p er s p e c t ive on
MDM systems. QuintilesIMS calls this
the "orchestrated customer experience,"
and it could include any relevant MDM
data, combined with the claims data that
QuintilesIMS has been providing the
industry for years, and with affiliation
details as well as both structured and
unstructured data (i.e., data that has not
been organized into an integrated fashion).
The orchestrated customer experience is
branded as IMS One, but IMS One has
significant technology components to it.
A key element, says Busalacchi, is a close

European transparency reporting
Looking for the equivalent of the US's
Open Pay ments system-one public
repository where payments to individual
HCPs is revealed and updated annually-
is an eye-watering exercise in Europe. It's
not necessarily that there's less intense
public interest in the topic, but that
the multinational regulatory practices
across the continent allow for differing
procedures, and individual privacy rights
are more strongly guarded. Legislators and
public interest groups who propelled the
transparency initiatives had to engage in
one negotiation with industry, and another
with the professional organizations of
HCPs, and the standards practices of those
organizations.
All members of EFPIA, the European
Federation of Pharmaceutical Industries
and Asso ciat ions (and the memb er
companies in these associations) have
agreed to provide annual reports on
transfers of value to HCPs, but EFPIA does
not attempt to aggregate all companies'
reports. Some countries, notably the UK,

France and several other nations, have a
central repository; in other cases, companies
operating in the various nations report
activity in each nation. EFPIA comprises 33
nations, five more than the EU.
Then there are the standards as to what's
reported. Again, there are variations, but as
far as EFPIA is concerned, the key reporting
on an individual basis is the funding of
meetings and travel to them, speaking
engagements and consulting arrangements.
R&D expenditures are reported in the
aggregate for each organization (other EU
rules on clinical trials require identifying
clinical trial investigators, but the trial
funding and the investigator are apparently
not combined). "Hospitality" expenditures
on meals and drinks are generally not
reported (considered "a disproportionate
administrative burden" by EFPIA), but this
varies by nation, too.
All that being said, data is beginning to
come forward; EFPIA had a June 30 deadline
for member companies to file reports.
In the UK, the Disclosure UK program

is in its second year: in June, it reported
that members of the Assn. of British
Pharmaceutical Industries reported a total
of £454.5 million ($586.3 million) spent
with HCPs and healthcare organizations-a
25% increase from 2015 (£363 million). The
increase is tied to more R&D spending, said
to represent 74% of total expenditures. The
number of HCPs allowing individual data
to be published also increased to 65% (the
increased participation is not directly tied
to the increased announced expenditure,
which is an aggregate figure).
When it comes to individual company
reports, it appears hard to beat Novartis,
which has published transparency
data (mostly tied to organizations, not
individuals) across 38 nations. The reports
are listed on one Novartis webpage,* but in
each country's language and currency.

partnership QuintilesIMS has with Reltio, a
San Francisco, CA company that deploys Big
Data technology to link and then visualize
diverse massive data sets. According to Ajay
Khanna, VP of marketing at the firm (and
a former Veeva employee), one component
of Reltio's offering is a proprietary type of
graphing technology ("graphing" is a term
of art in organizing large data sets).
"Our graphing technology enables a
user of the data to quickly pivot from, say,
a view of a prescriber and that person's
affiliations, to one of the affiliations and
all the other prescribers connected to it,"
he says. "Additionally, a new data set or
dimension can be added and the system
quickly adjusts." With conventional
relational databases-or traditional MDM
technology-such switching could only be
carried out by reprogramming the MDM
software, taking time and effort and making
the maintenance of the reference data
heavily burdensome.
QuintilesIMS is a value-added reseller
of Reltio technology, but IMS One includes
other features that QuintilesIMS is bringing
together to make IMS One a "platform" for
EIM, notes Busalacchi. Specific elements
include Amazon Web Services such as
S3, and the IMS One platform is being
designed to be open to a variety of analytics
services and other data-storage systems
(QuintilesIMS had earlier announced
relationships with Cloudera, a data-storage
technology company, and with Salesforce.
com, whose Force.com platform enables
applications to be built quickly).
Veeva-ever ready to go at QuintilesIMS
it seems-proposes a different approach.
"You don't need to bring complex analytics

tools into MDM to get useful insights
from it," says Veeva's Cushman. "You're not
going to train hundreds of field reps in data
science to get a multidimensional view of
their clients." Veeva offers what is called
"portlet" technology that enables data to
be viewed from the MDM database, rather
than generating integrations to the various
other software applications. Having said
that, however, Veeva's OpenData system
is accessible to those analytics systems
should clients desire it. Veeva's overall data
platform is branded as Veeva Network, and
Network enables easy tie-ins to other Veeva
products, such as its Vault application for
storing and tracking (among other things)
promotional materials.
Both LexisNexis and MedPro have
partnerships with Reltio, and Reltio's
Khanna says that the company aspires to be
an open platform accessible to the growing
array of Big Data resources now on the
market.

data with lifestyle contexts, to get better
insights into patient behaviors," he says.
A way to address patient outcomes
(without identifying specific patients) is the
Systems of Care data service the company
now offers, which is organized around
the "social health" of patients. The service
has been started initially to provide health
systems with better characterization of their
extended services (so that, for example,
helpful lab tests can be targeted for certain
therapy areas). Schoeller says that the
methodology is going to be extended to
patient populations during the coming year,
as a potential boost for adherence programs
Veeva's Cushman (see sidebar) notes
that patient data organized in an MDM
system is providing benefits to fighting
the opioid crisis. And he (and others)
point to the coming of wearable devices
for medical monitoring, and the potential
to interact with patients directly based
on readouts from those devices (whether
this information will flow to pharma
manufacturers remains to be seen).
All of this, of course, threads the needle
carefully with regard to patient privacy and
HIPAA requirements. Reltio's Khanna notes
that the drive toward pay-for-performance
agreements in healthcare, along with valuebased contracting for pharma sales directly,
is opening up channels of communication
and information-sharing among payers,
providers, patients and the pharma industry.
It's worth noting that Amazon Web Services,
as part of its offerings to participants in
healthcare, has already created resources
for healthcare organizations to comply with
HIPAA standards as they convey their data
to cloud-based systems.

Big data for patients
The ease with which large data sets can
now be handled with cloud-based systems
that offer low expense and high availability
opens up another area of opportunity for
the pharma industry: patient data, and
dealing with patients directly.
LexisNexis' Schoeller makes a point
seldom recognized by pharma marketers:
with opt-in systems, the pharma industry
has a direct connection to patients; the
challenge has been, what to do with it?
"There hasn't been a lot of utility to get
more out of these registries than name
and address standardization, but the
opportunity is present to match identity

*https://www.novartis.com/about-us/
corporate-responsibility/doing-businessresponsibly/ethics-compliance/healthcare

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Table of Contents for the Digital Edition of Pharmaceutical Commerce - September/October 2017

Table of Contents
Pharmaceutical Commerce - September/October 2017 - Cover1
Pharmaceutical Commerce - September/October 2017 - Cover2
Pharmaceutical Commerce - September/October 2017 - Table of Contents
Pharmaceutical Commerce - September/October 2017 - 4
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Pharmaceutical Commerce - September/October 2017 - 7
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Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
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