specialty-drug launch survival guide
TRANSCRIPT
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Specialty-Drug Launch Survival Guide: Why KPIs Will Make or Break Your Plan
INTRODUCTION
The lifecycle of a drug, from discovery to development to patient adoption, is the
culmination of hard work from hundreds of people. The successful launch of a drug
depends on many finely-tuned moving parts, all working seamlessly to conquer a
myriad of goals. Furthermore, each and every department needs to meet or exceed
their milestones for the drug launch to be successful. As a result, there’s a multitude
of types and sources of information that need to be closely tracked:
Many Pharma companies struggle to efficiently collect, analyze, interpret, and report
all of this diverse information. This shortcoming presents a serious problem when it is
time to assess the success of the launch. Our Launch Survival Guide will help to
prioritize and analyze information to eliminate inefficiencies and get the most
coverage, access, and ultimately, sales.
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TODAY’S PHARMA MARKET
In the past couple of years, the
healthcare industry has seen many
changes. The Affordable Healthcare Act
is flooding the market with millions of
new customers, specialty pharmacies
are gaining traction, and healthcare
reform and policy changes now have
the ability to impact access.
Additionally, health-insurance
companies must find new ways to
decrease costs to offset government-
program rebates. Patent expiration— a
thorn in the side of most all Pharma
organizations—is resulting in new
competition, eroding once robust
revenue streams (though competition
hasn’t been as immediate for specialty
drugs and biologics- yet…).
All of these factors have left
pharmaceutical companies reeling to
adapt their business models.
MAXIMIZING LAUNCH SUCCESS
IN TODAY’S MARKET
According to McKinsey & Company,
2/3 of drug launches perform below
their forecasted sales, and those that
do not meet their expected sales the
first year continue to do poorly for
the next 2 years, and beyond.
With robust and constant competition
from other Pharma companies,
effectively managing the lifecycle of a
drug is essential for mitigating any
potential risk to revenue. As a result,
there is most always a sense of urgency
and a necessity to do things correctly
the first time. Clever organizations
know that there are tools and
strategies specially designed to ensure
that their next drug launch meets its
full potential.
Read on to learn how to prime a launch
group up for success, with an efficient,
agile, and adaptable drug launch.
Pre-Launch
Coverage is king. People don’t buy
drugs, insurance companies do.
While marketing drugs to consumers
and doctors is important, if insurance
companies don’t provide favorable
coverage, there will be no customer
base, no matter how great the drug.
Many people can’t, or won’t pay for a
drug that isn’t covered by insurance,
which is especially true for costly
specialty drugs or biologics.
Tracking all aspects of coverage and
access should be a high priority in the
pre-launch stage. Here’s how to
effectively accomplish just that…
DEFINE LAUNCH GOALS
As with any project, without
quantitatively defined goals, it is
impossible to assess success. It is
critical to be as specific as possible
when setting goals to make the most of
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every launch. Is the objective to notify
the top 10% of payers or all National
payers within a certain time frame? If
so, then payers need to be assigned to
appropriate field reps ASAP. Is it
required that a specific number of lives
have access to the drug? Then in this
case, it is critical that the organization
has the ability to track real-time
updates as the field reps capture them.
The best asset for a successful launch
team is feet on the street, talking to
the payers.
While these goals may be different
across business units, going through this
exercise will ensure that everyone on
the team is properly aligned.
PRIORITIZE KPIs
There is a lot to be done before
patients can get prescriptions for a new
drug:
o Notify plans of pending FDA
approval
o Understand the competition,
inside and out
o Determine which payers will
provide coverage for the drug
o Know how favorably payers will
cover the drug, and how
restrictive coverage will be
(e.g., prior authorizations)
o Begin marketing to channels
To avoid getting overwhelmed with
information, prioritize specific KPIs to
be able to quickly analyze success.
Additionally, be sure that all KPIs are
actionable. If it doesn’t help to
mitigate problems or improve
performance, then that KPI is useless,
nothing more than a field in a report.
Having defined KPIs gets the internal
teams speaking the same language
reducing confusion and
miscommunication when reporting
progress and adjusting launch plans.
STANDARDIZE INFORMATION
COLLECTED FROM FIELD
With any drug launch, there is
information that must always be
collected, analyzed, and reported.
Potential data includes payer
marketing, updates from field reps,
access and coverage information, and
contract details. Unfortunately, many
companies rely
on spreadsheets
to collect this
type of data.
There are many
pitfalls in using
spreadsheets to
collect data
across multiple locations and people. In
fact, according to a 2008 University of
Hawaii study, almost 90% of
spreadsheets contain errors. Errors can
be caused by many different factors:
o Simple data entry errors
o Hiding of columns or filtering of
rows within shared spreadsheets
“Every study that has attempted
to measure [spreadsheet]
errors, without exception, has
found them at rates that would
be unacceptable in any
organization.”
University of Hawaii
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o Version control issues: multiple
circulating renditions of the
same spreadsheet
o Personal “My Version” files that
instantly become out of sync
with the live file
o Lockouts between users,
prohibiting access to all
interested parties
Not only can spreadsheets be
inaccurate, but they can also waste a
lot of valuable time.
To put these risks into perspective, a
company recently lost $100 million in a
buy-out deal due to a “spreadsheet mix
up.”
Considering that information can
emanate from hundreds of field reps
and payer marketers across multiple
geographic locations, encompassing
various cultures and languages,
standardizing data collection can be a
huge challenge.
It is crucial to empower field reps with
tools designed to allow easy data input
and instant KPI reporting. Because
having the most recent field
information available will have great
impact when the launch commences.
In addition to the importance of
standardizing the collection of data,
the type of information collected is
key.
First, standardize the actual fields that
are collected, and then define the
payer interaction to track. For
example, standard fields could be:
o Number of plans notified of
(impending) FDA approval
o Number of lives associated with
each payer
o Percentage of Plans covered
o Percentage of Lives with access
o Percentage of Plan/Lives with
favorable coverage, restrictive
or no coverage
Depending on the level of specificity
desired, data can be further refined by
breaking out key channels, such as
commercial, FFS Medicaid, Managed
Medicaid, Medicare Part D, and
Federal.
If the process of collecting launch data
bottlenecks the process, insights will
be inhibited. As a result, the
organization may miss the opportunity
to successfully change course,
jeopardizing the launch strategy.
SECURE SENSITIVE DATA WITH
USER-SPECIFIC PERMISSIONS
Because compliance requirements
often limit who can see what data,
information sensitivity needs to be
considered when standardizing data
collection.
Ideally, each user would be able to
view and edit their data without the
ability to see or alter anyone else’s
information.
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If data access isn’t taken into account,
platform security may compromise
compliance or internal data-protecting
policies, derailing even the best data
collection plan.
A side benefit of restricted access,
those in the field will find it much
easier to input their data if they only
see relevant data that pertains to them
without the noise of other field reps’
information.
SIMPLIFY WORKFLOW FOR
THOSE IN THE FIELD
Everyone in the field hates battling
complicated spreadsheets.
If payer marketers or field reps are
constantly having difficulties inputting
data or waiting to access a shared
spreadsheet, their time is being wasted
on logistics. Or worse yet, they could
simply give up, resulting in incomplete
information.
It seems that everyone in this line of
work has heard nightmare stories of
reps having to wake up at 3 a.m. to
input their daily activity data because
that was the only time when other reps
weren’t using the shared spreadsheet.
Tip: Make collection convenient. Make it
available on the devices your field uses
(laptops, tablets, and smartphones.)
As soon as data collection is
standardized and aligned with the
actual fields, it becomes much easier
for reps to input. Reporting is already
setup to get faster insights, with less
effort. Further to that, a less
cumbersome process greatly enhances
the probability of rep compliance.
Everyone will agree that saving time
and effort is a very good idea. At the
end of the day though, how does this
actually help the success of the launch?
During Launch
Having defined goals and success
measures is a great foundation in
planning a successful drug launch.
Streamlining data collection and
workflow not only takes a big burden
off of employees, but also allows for in-
depth and unprecedented insights.
IDENTIFY TRENDS WITH
REAL-TIME REPORTING
Studies have shown that most launches
do not improve after the initial 6
months, making it imperative that
companies achieve market penetration
as quickly as possible. This leaves a
small window to identify problems, and
subsequently, communicate strategy
changes or adjustments to the field.
Because global market analyses and
forecast models often take months to
compile and don’t take into
consideration any political, cultural or
emotional factors of the payers, it is
unwise to rely solely on external
sources for insight.
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To make matters worse, if the
reporting process takes days or weeks,
valuable time is wasted that could be
otherwise used to adjust launch
strategy and take tactical action. It is
pretty simple, if data is updating in
real-time, shouldn’t the reports?
Knowing what is happening when it is
happening, and being able to
communicate that to the field could be
the edge needed to meet or exceed
launch goals.
TRACK CONTRACT &
COVERAGE CHANGES
A single contract change has the
potential to negatively impact coverage
and access numbers. Often times, field
reps will be the first to hear of
impending changes.
Regardless of which contract model is
being used, it is imperative to record
and track these changes across brands
in a single platform. This allows
straight forward characterization of
payer patterns and history.
For example, if it can be deduced that
a specific payer is consistently re-
negotiating contracts after 6 months,
dynamic reporting can direct an
organization to proactively adjust
pricing or negotiation strategy.
Tip: Input scheduled contract reviews into
the same system to have a holistic view of
contract updates and schedules.
TRACK ISSUES WITH ACCESS
AND REIMBURSEMENT
Even with favorable coverage, high
number of lives with access, and great
market penetration, things can still go
awry. There could be distribution
problems, patients finding that the co-
pay is too high, patient’s benefit design
has changed, challenges with prior
authorization process, or a payer could
change coverage with little notice.
As with contract updates, tracking
access allows full characterization of
patterns, allowing the company to
clearly identify spikes in recorded
issues, and minimize barriers to access.
It is important to track access and
reimbursement services, coverage, and
marketing efforts all in one location.
Additionally, linking to HUB services
data on an ongoing basis for analytical
purposes is key. Only with full
knowledge and understanding of this
data can an organization ensure that
nothing slips through the cracks.
Post Launch
SUMMARIZE AND STANDARDIZE
What worked? What didn’t work?
Reconvening after the first few months
of a launch allows the commercial
team to review lessons learned, and
apply that knowledge to the next
launch.
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Because there are common tasks and
processes that every drug launch
requires, clever and flexible teams can
create a repeatable process that is
much easier to fine tune to specific
projects instead of re-creating the
wheel for each launch.
By eliminating the learning curve by
standardizing pre-launch prep, data
collection, and reporting, teams will
find that they have more time to focus
on the unique factors associated with
each launch.
Conclusion
To thrive in this highly competitive and
evolving market, pharma companies
must prioritize innovation and
adaptability to eliminate barriers to
access and assist with access-related
issues throughout the entire treatment
process, from patient identification
until prescription fulfillment.
Technology exists to bring the myriad
of data types together, resulting in
easy to follow and actionable reports.
Pharma companies that choose to
maximize their success will cut
inefficiencies to the bone, and nimbly
react to launch trends. The smartest
companies will optimize these efforts
by engaging cutting-edge technologies
to give them this critical edge.
Doing more things right is always great,
but sometimes all that is needed is to
do less things wrong.
UQube Pharma
Launch Tracker
UQube Pharma Launch Tracker is a
cloud-based, scalable application suite
that aggregates and provides analytics
on drug launch data across brands in a
centralized location, making tracking
the entire lifecycle of a drug easier for
pharmaceutical companies.
To learn more about UQube for
Pharma, call us at 703-476-1992 or
email [email protected].