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Printed in the United States.
he title is dry:
“Drug and Device
The draft guidance, part of the
21st Century Cures Act, takes the
language from section 114 of the
20-year-old Food and Drug Modernization Act and updates it in
As Peter Weissberg, group
director, market access, at Intouch Solutions notes in his essay, “Outcomes data enters the
21st century” ( http://www.phar-malive.com/outcomes-data-en-
114 didn’t give much guidance to
the industry on how to present
healthcare economics information to payers.
“With the new guidance, we now
have a much clearer understand-
ing of the types of information that
constitute HCEI; the specifics of
who actually represents a formu-
lary decision maker; and which
information not specifically con-
tained with the approved label is
appropriate for communication,”
Weissberg says. “This should sig-
nificantly assist field, regulatory,
health economics outcomes re-
search (HEOR), market access
better understanding of who can,
and should, deliver HCEI and with
whom they are able to engage.”
These changes are significant
enough that the draft guidance,
also kno wn as Cures 3037, was
the specific focus of two panels
at the International Society for
Research’s (ISPOR) recent inter-
national conference in Boston.
In one of the panels, Bris-
tol-Myers Squibb’s Laurent Car-
ter, VP, head of Strategic Payer
Marketing, says the clarification
has been long needed. “We wait-
ed 20 years for any feedback at
all [on FDAMA 114]; hopefully
we won’t have to wait another 20
years for refinement to this guid-
ance,” Laurent says.
Another panelist, Jan Hansen, VP of the Evidencefor Access Unit within Genentech’s US
Medical Affairs, spoke about the
uncertainty FDAMA 114 created
among manufacturers. For example, at Genentech the old guidance
caused such uncertainty among
the medical, legal,and regulatory
divisions that one piece aimed at
payers went through 50 revisions.
Hansen says “it would be helpful” if FDA created an HCEI review group in light of the guidance, since most reviewers at FDA
are used to evaluating clinical trial
data that is strictly on the label
and aimed at physicians, and do
not have much experience with
real-world evidence data.
Despite the questions about
Cures 3037, manufacturers are
welcoming it. Laurent called the
guidance “a gift” to manufacturers who wants to disseminate
HCEI to payers.
Eleanor Perfetto, Ph. D., from
the National Health Council
and the University of Maryland
School of Pharmacy, came up
with a metaphor that the new
guidance is the equivalent of upping the highway speed limit, but
all the other laws still apply.
“It’s anopportunity for us to go
75 miles per hour, but don’t go
crazy and drive onthe sidewalks,”
The current draft guidance
widens the door that FDAMA
114 opened. Manufacturers have
been communicating information about their products to payers for the past 20 years, but ina
more limited fashion.
Dr. Richard Willke, chief scientific officer for ISPOR, notes
ho w manufacturers were providing this information to payers in
dossiers, in a format created by
the Association for Managed Care
Pharmacy. These dossiers communicate information about the
cost burden of a specific disease
and share economic models extrapolated from clinical trial data.
“All the major companies have
been doing this for awhile,” Willke says. “Smaller companies have
different levels of capabilities. But
by and large, any company with a
product coming out is aware that
this needs to be done and payers
are looking for some compilation
of the evidence around the drug.”
Both FDAMA 114 and Cures
3037 allowed manufacturers to
communicate with payers outside
of the dossiers, but Cures 3037
clarifies what constitutes “
competent and reliable scientific evidence” – what experts say is the
“What constitutes competent
and reliable scientific evidence
has been one of those areas of a lot
of discussion,” Willke says. “Does
this mean replicated studies?
Clinical evidence usually has that
two trials standard.”
ISPOR is trying to set the stan-
dards for good practices in studies
to determinereal world evidence
and health economics, Willketold
Med Ad News.
“How do you conduct a health
economics study?” Willke says.
“How do you report a health economics study? How do you do it
if it’s a model, how do you do it if
it’s real-world data? How do you
have an economicanalysis alongside a randomized clinical trial?
While we cannot force FDA to
define CARSE, we can give them a
grounding for how they see it.”
The draft guidance comes at a
significant time for the pharmaceutical industry. According to te
benchmarking firm TGas Advisors, manufacturers are responding to increasing pressure to
demonstrate value and lower the
cost of pharmaceuticals, “
particularly in today’s uncertain health
This means market access leaders such as Carter and Hansen are
investing more in health economics and outcomes research capabilities and enhanced data and analytics, experts at TGas Advisors
say, and policy is top of mind for
these leaders. “Market access has
become center stage as a strategic
imperative for the pharmaceutical
industry as increased barriers and
pricing pressures limit traditional
approaches to market growth,”
says Rebecca Villari, practice leader at TGas Advisors.
In surveying stakeholders and
analyzing what has changed from
2016, TGaS’ Market Access & Reimbursement practice found:
The impact of government policy and influencers, considered
secondary last year, is now a major
concern. “One respondent noted,
‘We are currently monitoring 44
pieces of legislation in 26 states,’”
The television portion of pharma’s
DTC spend justkeeps rising.
M&A action and clinical success
will be a large swing factor for
the bio sectorin 2017 with the
regulatory environment arguably
at its mostamenable for years.
The 28th annual Manny Awards
event was held on April 20th at
New York City’s Chelsea Piers.
continued onpage 6
TV or not TV
Avewoheuue T ByChristianeTruelove• email@example.com
Manufacturers and their communications agencies see great opportunities in a new
draft guidance from FDA, but the fear of warning letters still shadows the industry.
The 2017 Manny Awards
The driving forces
Manufacturers and their communications
agencies see great opportunities in a new draft
guidance from FDA, but the fear of warning
letters still shadows the industry.
manny awards special feature 16
hba special feature 22
orphan extra feature 24
extra feature 26
dtc special feature 9 The television portion of pharma’s DTC spend just keeps rising.
The 28th annual Manny Awards event
was held on April 20th at New York
City’s Chelsea Piers.
The Healthcare Businesswomen’s Association’s 28th
annual Woman of the Year luncheon was held on May
11th at the New York Hilton Midtown.
The expedited development and subsequent approval
of asfotase alfa re;ects a large and promising trend in the
battle against rare diseases.
If U.S. companies are to successfully
compete on a global stage, we need to
welcome talented immigrants who are
pursuing their American dreams.
bio 10 R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years. annual report