Generating Pharmaceutical Sales Before Marketing Authorization
When a patient has a serious illness and there is no approved drug available, the physician may want to try one which has not been authorized for marketing by national health authorities but has shown promise in clinical trials.This presents drug-makers with an opportunity to generate revenues while development is still in-progress.
Amsterdam, The Netherlands (PRWEB) October 26, 2004 -- When a patient has a
serious illness and there is no approved drug available, the physician may want
to try one which has not been authorized for marketing by national health
authorities but has shown promise in clinical trials. European Named Patient
Programs, like US compassionate use programs, offer physicians access to
pharmaceuticals which have not yet been licensed. However, there is one
important difference: in Europe an unlicensed drug can be reimbursed. This
presents drug-makers with an opportunity to generate revenues while development
is still in-progress.
Significant Revenues Are Possible
The
additional revenues can be considerable. For example, Pharmion, a US based
company focusing on Oncology and Hematology reported dramatic increases in its
Thalidomide sales from $1.9 million in 2Q ‘03 to $15.3 million in 2Q ‘04,
primarily due to named patient sales in Europe for Multiple Myeloma. Thalidomide
sales accounted for approximately 75% of Pharmion’s total revenues for the first
half of 2004, according to company sources, and were generated while the product
awaits marketing approval for this indication. Before receiving European
Marketing Approval, Shire’s Argylin® for essential thrombocythaemia generated
about 5% of its total sales from its European named patient
program.
Though thalidomide and Agrylin were licensed in the USA for some
indications, pharmaceutical companies do set-up named patient programs and
receive full reimbursement for drugs that are not licensed for any indication in
any market. Examples include: Insmed’s SomatoKine® authorized for named patient
use for Primary Lateral Sclerosis, Growth Hormone Insensitivity Syndrome (GHIS)
and Severe Insulin Resistance and Protherics’ ViperaTAb™ authorized for named
patient use for adder snake bites.
Other Benefits of Named Patient
Programs
A named patient program can speed uptake after official launch.
Physicians, who have had experience before launch, via clinical trials or named
patient programs, often become early adopters and references for other
physicians once the drug is freely circulating.
Named patient programs,
like US compassionate use programs, can increase good-will toward the company
because they simplify the process of gaining access for patients in critical
need. Smaller companies often can not afford the administrative time and costs
of shipping drugs around the world before launch. This can lead to frustration
and resentment towards a company that many physicians will remember long after a
drug is officially on the market. Creating a formal channel eliminates the
unfortunate need of denying requests and risking ill-will later.
A named
patient program should be considered an important part of a pre-launch program.
It increases awareness to a pharmaceutical’s existence, creates excitement,
generates good-will and speeds penetration of the product after
launch.
Frequent Communication is Necessary
If one of the objectives
is to generate revenues, setting up a named patient program is just the
beginning. In order to achieve success, physicians need to be aware of the
product and what they need to do to get it. Typical methods of informing
physicians, such as sales rep visits and ads, may not be appropriate because a
license is necessary to market a drug. While physicians are used to simply
writing a prescription and being done with it, named patient programs require
paper-work that some find tedious. Therefore the company needs to create an
appropriate communication plan and work closely with the targeted medical
community to keep them informed and simplify the process.
Issues to
Consider
You have decided to make a named patient program part of your
pre-marketing plan, what now?
• Administration: Do you
“go it alone” or work with a company that is experienced at administering named
patient programs?
There are several experienced organizations that can
assist your company by gaining approval, setting-up the program, doing
administration and taking care of physical distribution. If your organization is
well resourced and has a pipe-line of products that will require named patient
programs, it might be worthwhile acquiring the expertise internally. However, if
you have few appropriate products or a stream-lined organization, it is probably
best to consider outsourcing.
• Communication: You’ve
set up the program, how do you optimize it?
If you do not have an
experienced European marketing group, an organization that is familiar in sales
and marketing of pharmaceuticals in Europe can help you to maximize
participation in the named patient program. A communication plan, if properly
developed and implemented can increase product awareness, but communication
concerning an unlicensed product must be done appropriately. This plan should
ensure that your entire target group:
• Is fully aware
of the product AND the program
• Knows what needs to be
done to take advantage of the program
• Has an advocate
available to guide them through the process
The Author, Dr. Gene Emmer,
is President of Med Services Europe B.V., a European-based consultancy focused
on Sales, Marketing and Business Development of Pharmaceutical and Medical
Products. www.MedServicesEurope.com +31648566707
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Source : http://www.prweb.com/releases/2004/10/prweb171741.htm