25
Lifecycle Management Through the Rx-to-OTC Switch
and will want to begin top-to-top discussions
about the Rx-to-OTC switch up to two years
before launch, which means initiating retailer
conversations before the NDA is filed. In each
case, however, additional retail display provides
opportunities for more in-store signage.
After shelves are stocked, a variety of
mechanisms may be used to bring attention to
the newly available Rx-to-OTC switch product
and to educate consumers without pharmacist
intervention, including overhead signage, shelf
talkers, floor talkers, undershelf signage, and even
interactive video displays.
It is critical for retail pharmacists to be
engaged in the launch. Pharmacists serve as a key
reference in the Rx-to-OTC switch process and
need to know what to recommend to patients
when their prescription product is discontinued
due to the switch. Furthermore, pharmacists need
to know how to help consumers find the newly
available OTC product at shelf. Pharmacists
require a more scientific tone in communication
materials than consumers and also need to be
able to answer FAQs, particularly about con-
traindications and side effects, especially if the
consumer does not have a primary care phy-
sician to ask. Similarly, clinics located in retail
pharmacies also should be engaged in launch
communications.
Assessing Rx -to-OTC Switch
Value—A High Performing Team
The value of a switch can best be maximized with
an experienced, high-performing team. Rx-to-
OTC switch is a hybrid process: it contains some
elements of an Rx approval and launch, some
elements of OTC monograph launches, and
some elements that are unique to switch. This
combination makes it more complicated than a
pure Rx or OTC project.
In addition, almost all switches are subject to
“us” versus “them” thinking. Nearly all switches
involve a transfer of power from a pharmaceu-
tical division to a consumer healthcare division
or are a joint venture between a pharmaceutical
company and an OTC partner. Furthermore,
many Rx-to-OTC switches operate with both
global and local teams, despite geographic
regulatory differences. Therefore, it is important
to employ best practices with regard to alliance
management, especially effective communication,
to achieve alignment of expectations and goals.
If partnering with a pharmaceutical company,
the Rx team members will need appropriate
recognition or, alternatively, some type of reward
for providing effective help. Even without an
external partner, the core team (R&D, marketing,
manufacturing/supply chain, project manage-
ment) needs to acknowledge the efforts of all
extended team members.
A cohesive, creative, and collaborative
team is therefore crucial to Rx-to-OTC switch
success for a $100 million Rx-to-OTC switch
brand, every week lost represents $2 million
in missed revenue. And missed timing for a
seasonal product could represent an entire year of
lost sales.
Implications for Strategy
With all of the work and investment required to
develop and implement the Rx-to-OTC switch
development plan, including the additional
activities required to develop and implement a
plan to ensure commercial success, organizations
must carefully consider the value that a switch
can generate. Rx-to-OTC switch may not be an
appropriate lifecycle management strategy for
all prescription drugs. A prescription drug that
is the fourth (or fifth) in its therapeutic class to
switch, does not offer additional, meaningful
consumer benefits, and has little to no brand
equity may not be worth the investment, even if
the Rx-to-OTC switch pathway is straight-for-
ward and well-defined.
Even for a “simple” switch, the investment
plan should consider the initial switch and
also the potential requirement to develop new
primary packaging and an innovation plan (novel
dosage forms, etc.).
A key strategic decision in the lifecycle plan
is timing. Switches, particularly those that are
first-in-class or the subject of a partnership, can
take five years or more to plan and execute, not
including the time to find a switch partner and
negotiate a deal. Teams need to determine the
value of exclusivity, either via remaining patent
Lifecycle Management Through the Rx-to-OTC Switch
and will want to begin top-to-top discussions
about the Rx-to-OTC switch up to two years
before launch, which means initiating retailer
conversations before the NDA is filed. In each
case, however, additional retail display provides
opportunities for more in-store signage.
After shelves are stocked, a variety of
mechanisms may be used to bring attention to
the newly available Rx-to-OTC switch product
and to educate consumers without pharmacist
intervention, including overhead signage, shelf
talkers, floor talkers, undershelf signage, and even
interactive video displays.
It is critical for retail pharmacists to be
engaged in the launch. Pharmacists serve as a key
reference in the Rx-to-OTC switch process and
need to know what to recommend to patients
when their prescription product is discontinued
due to the switch. Furthermore, pharmacists need
to know how to help consumers find the newly
available OTC product at shelf. Pharmacists
require a more scientific tone in communication
materials than consumers and also need to be
able to answer FAQs, particularly about con-
traindications and side effects, especially if the
consumer does not have a primary care phy-
sician to ask. Similarly, clinics located in retail
pharmacies also should be engaged in launch
communications.
Assessing Rx -to-OTC Switch
Value—A High Performing Team
The value of a switch can best be maximized with
an experienced, high-performing team. Rx-to-
OTC switch is a hybrid process: it contains some
elements of an Rx approval and launch, some
elements of OTC monograph launches, and
some elements that are unique to switch. This
combination makes it more complicated than a
pure Rx or OTC project.
In addition, almost all switches are subject to
“us” versus “them” thinking. Nearly all switches
involve a transfer of power from a pharmaceu-
tical division to a consumer healthcare division
or are a joint venture between a pharmaceutical
company and an OTC partner. Furthermore,
many Rx-to-OTC switches operate with both
global and local teams, despite geographic
regulatory differences. Therefore, it is important
to employ best practices with regard to alliance
management, especially effective communication,
to achieve alignment of expectations and goals.
If partnering with a pharmaceutical company,
the Rx team members will need appropriate
recognition or, alternatively, some type of reward
for providing effective help. Even without an
external partner, the core team (R&D, marketing,
manufacturing/supply chain, project manage-
ment) needs to acknowledge the efforts of all
extended team members.
A cohesive, creative, and collaborative
team is therefore crucial to Rx-to-OTC switch
success for a $100 million Rx-to-OTC switch
brand, every week lost represents $2 million
in missed revenue. And missed timing for a
seasonal product could represent an entire year of
lost sales.
Implications for Strategy
With all of the work and investment required to
develop and implement the Rx-to-OTC switch
development plan, including the additional
activities required to develop and implement a
plan to ensure commercial success, organizations
must carefully consider the value that a switch
can generate. Rx-to-OTC switch may not be an
appropriate lifecycle management strategy for
all prescription drugs. A prescription drug that
is the fourth (or fifth) in its therapeutic class to
switch, does not offer additional, meaningful
consumer benefits, and has little to no brand
equity may not be worth the investment, even if
the Rx-to-OTC switch pathway is straight-for-
ward and well-defined.
Even for a “simple” switch, the investment
plan should consider the initial switch and
also the potential requirement to develop new
primary packaging and an innovation plan (novel
dosage forms, etc.).
A key strategic decision in the lifecycle plan
is timing. Switches, particularly those that are
first-in-class or the subject of a partnership, can
take five years or more to plan and execute, not
including the time to find a switch partner and
negotiate a deal. Teams need to determine the
value of exclusivity, either via remaining patent