Stanton R.
Mehr, President, SM Health Communications LLC
We’re
often asked when we conduct our mock P&T Committee meeting (P&T
Insight™) whether we can videostream the session to the sponsor’s site. This is
not difficult to do, technologically speaking. Since we are already recording
the meeting for an audio and video file transfer to DVD, most of the equipment
is already in place. However, we strongly recommend that a one-way,
noninteractive videostream is the best choice.
The
mock P&T Committee faculty members know they are being videotaped, and that
at some point in time, the result of their efforts will be viewed by a client.
Yet, the need for blinding of the sponsor is essential to guard against bias in
the Committee’s decisions, which can render the result unreliable and not
applicable to other health plans or systems. The effect of bias can go both
ways. Individual mock P&T Committee members may have had negative
interactions with a drug maker in their own past experience, and it may color
their decision. On the other hand, they may have extremely good relationships
with an account manager from the sponsor, and may subconsciously want to give
that person’s drug a favorable decision.
When
a videostream is requested (regardless of the number of locations to stream is
sent to over an encrypted line), we make sure that there is no interaction
between the viewers and the Committee members during the meeting. If a sponsor
wishes to ask questions after the completion of the meeting, we collect them
via a separate communication line, and our staff presents the questions to the P&T
Insight™ Committee members.
Why
take these precautions? If sponsors interact with the participants, the level
of bias rises to that of an advisory board, which is not what the sponsor has
paid for or desires. The feeling that the sponsor is “looking over their
shoulder” can be palpable, and the discussions cannot be reliably adjusted for
this effect—directly impacting the decisions made by the mock P&T Committee
(encouraging them to approve or reject a new product).
Furthermore,
direct participation and interaction with the sponsor can have implications for
the Sunshine Act reporting. This can prevent some of our best consultants from
participating in the P&T Insight™ process.
When
asking for a videostream for the mock P&T Committee, consider the need to
limit bias in the project. The product team will be happy you did.
SM Health Communications provides writing, consulting, and
innovative market research services for the payer markets. Its proprietary
P&T Insight™ virtual P&T Committee program is the leading mock P&T
Committee product in the field. We’ve participated in many market research
projects involving biosimilar development and launch, from the point of view of
the biosimilar and the innovator drug manufacturer. For more information,
please visit www.smhealthcom.com or
contact Stanton R. Mehr, President, at stan.mehr@smhealthcom.com.
