Pharmaceutical Commerce - September/October 2017 - 8

Top News
The under-regulated world of patient services
Pharma needs better internal policies to manage its increasing patient interaction
It's axiomatic that the trend toward
specialty pharmaceuticals is expanding the
range of patient-oriented services that the
pharma industry is involved in: the very
definition of a specialty pharmaceutical
includes ones that require patient support.
This has also been one of the drivers
of outsourced hub ser v ices-hir ing
independent providers to help navigate the
prior authorization process, reimbursement
support, nursing and other health
maintenance activities.
But, according to a survey recently
conducted by Helio Health (Hoboken,
NJ), there is trouble brewing in the patient
support world: a lack of well-understood
operating standards is creating dramatic
risks in violating a variety of federal laws
and regulations, including anti-kickback
statutes, False Claims Act and HIPAA
patient-privacy violations (Fig 1). The topic
Key Risks of Patient
Services Team Activities

monetary obligations, such as our entering
into a corporate integrity agreement (CIA),"
the company wrote in its latest 10-Q
statement.
United Therapeutics' plight is certainly
not the first such enforcement action, and
it's very likely not to be the last, given some
of the Helio Health findings: While twothirds of the respondents could identify
an individual responsible for compliance
around patient services, the other third
could not. Fewer than half of patient
support teams had staff using call scripts
when engaging with patients (which could
imply improper communications); 19% of
respondents also noted that patient services
support could be performed for off-label
situations.
Patient privacy is an area rife with
violation risks. Federal rules limit who can
have access to patient data; the rules extend
to "business associates" who in turn must
have their own protections in place. But
the survey found that 17% of respondents
allows patient data to be seen by sales reps,
and 10% of respondents did not have
privacy firewalls in place, while a further
third were "uncertain" about the firewalls
(Fig. 2).
"People expect black-and-white rules
for these patient support activities, but they

Does your company use internal or
external resources for
Patient Service program(s)?

Fig. 3. "External resources" (outsourced
hub programs) are used partially or
wholly by manufacturers for 89% of
patient support programs

find that there are instead many gray areas,"
notes Manny Tzavlakis, managing partner
at Helio, adding that the worst situation is
to leave these regulatory areas unaddressed
by internal policies. "On a 0-100 scale of
nonexistent to full readiness for managing

patient support programs, I'd say the
industry is around 10-15."
Agg spending days
Tzavlakis, who worked in the past as a
senior partner at Huron Consulting in life
sciences compliance, likens the situation
to the early days of aggregate-spend
reporting, where industry downplayed
reporting requirements and ignored thirdparty payments. "Now all this is regularly
reported in the annual Open Payments
system; industry put in policies and made
this something of a routine." By instituting
internal practices and safeguards-and
auditing or monitoring the resulting
activity-the problems could be reduced.
All this is happening while the industry
is still resolving how deeply it wants to be
involved in patient support. The Helio
survey shows (Fig. 3) that just under a third
of respondents use an external hub services
provider only, while another 11% only
handle it through internal staff, and the
majority (nearly 60%) do both. Whether
internal or external, patient support
teams now include call center personnel,
reimbursement specialists, nurse educators
and case managers. Just over 40% of
companies site their patient support teams
within a brand or commercial team.

Are there data privacy firewalls at your company regarding patient data?

Fig. 1. At least four federal laws, plus
regulations on adverse-event reporting, can
impact the conduct of a patient support
program. Credit: Helio Health

received a jolt of attention this summer
when United Therapeutics announced a
$210-million set-aside to address a potential
DoJ settlement over its copay assistance
programs. "We expect any such settlement
will include a settlement payment to the
government, and it may also include non-

Fig. 2. While 40% of manufacturers have a data firewall between sales reps and patients,
others have no barrier or have indefinite restrictions

ODA-designation application to approval in 19 days
for Curtana Pharmaceuticals
Company is targeting a treatment for glioblastoma; Phase I to begin next year
It's not certain that it's a recordsetting pace, but the success of Curtana
Pharmaceuticals, a Texas startup, in
winning orphan drug designation is one of
the fastest ever. The action comes shortly
after FDA Commissioner Scott Gottlieb
announced a new FDA effort to speed up
Orphan Drug Act (ODA) designations; he
committed the agency to reduce review
times from 180 days to 90 or less, and set

up a go-team to clear out a backlog of some
200 applications that had been pending.
(Did it help that the disease-gliomas and
glioblastomas-Curtana is targeting is the
very disease Sen. John McCain is suffering?
These days in Washington, who knows?)
O DA d e s i g n a t i o n i t s e l f d o e s n' t
necessarily get a drug through the approval
process faster, but it does "highlight the
potential value" of the drug, according to

8 Visit our website at www.PharmaceuticalCommerce.com September | October 2017

Laurie Halloran, CEO of Halloran Group,
which is the company Curtana worked
with to submit the ODA application. ODA
designation can accelerate finding clinical
trial patients when the testing reaches
that stage; serves to reassure early-stage
investors in a startup, and gets that startup
experienced in developing the clinical data
FDA will ultimately look for.
In parallel with the ODA application,

Curtana has held a pre-IND meeting with
FDA, which provided "general acceptance"
of Curtana's Phase I plan, according to
Stein. The company expects to file its IND
application in the first half of 2018.
Halloran Group has handled 20 IND
applications in the past few years, according
to COO Greg Dombal, and roughly half of
those involved ODA designations. ODA "is
becoming a specialty for us," he says.


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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
Pharmaceutical Commerce - September/October 2017 - 5
Pharmaceutical Commerce - September/October 2017 - 6
Pharmaceutical Commerce - September/October 2017 - 7
Pharmaceutical Commerce - September/October 2017 - 8
Pharmaceutical Commerce - September/October 2017 - 9
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Pharmaceutical Commerce - September/October 2017 - 11
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Pharmaceutical Commerce - September/October 2017 - 17
Pharmaceutical Commerce - September/October 2017 - 18
Pharmaceutical Commerce - September/October 2017 - 19
Pharmaceutical Commerce - September/October 2017 - 20
Pharmaceutical Commerce - September/October 2017 - 21
Pharmaceutical Commerce - September/October 2017 - 22
Pharmaceutical Commerce - September/October 2017 - 23
Pharmaceutical Commerce - September/October 2017 - 24
Pharmaceutical Commerce - September/October 2017 - 25
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Pharmaceutical Commerce - September/October 2017 - 27
Pharmaceutical Commerce - September/October 2017 - 28
Pharmaceutical Commerce - September/October 2017 - 29
Pharmaceutical Commerce - September/October 2017 - 30
Pharmaceutical Commerce - September/October 2017 - 31
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Pharmaceutical Commerce - September/October 2017 - 33
Pharmaceutical Commerce - September/October 2017 - 34
Pharmaceutical Commerce - September/October 2017 - Cover3
Pharmaceutical Commerce - September/October 2017 - Cover4
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