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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 sales@upperquadrant.com.