Named Patient Program

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Dr. Gene Emmer

Dr. Gene Emmer

Medical marketing and business
development expert describes how pharmaceutical companies can generate
important revenues while drug development is still in progress

Med Services Europe Reveals How a
Pharmaceutical Company Can Sell a Drug Before it is Approved

How can a start-up, cash hungry, biotech
company generate much needed revenues? Dr. Gene Emmer President of Med Services
Europe GmbH
. advises them to consider if a European "named patient program" might
be an option.

A named-patient program allows physicians and their patients access to drugs
which have not yet received approval for marketing by national health
authorities. "European Named Patient Programs, like US compassionate use
programs, offer physicians access to pharmaceuticals which have not yet been
licensed" explained Dr. Emmer, "However, there is one important
difference: in Europe an unlicensed drug is often purchased by National Health
Systems." 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, a source at 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.

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?

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

Dr. Gene Emmer The Author, Dr Gene Emmer, is President of Med Services Europe GmbH, a
European-based company which conducts business development for Pharmaceutical,
Diagnostic, Biotech, Medical Equipment and Medical Device manufacturers. We
specialize in building and managing distributor networks for medical
manufacturers in Eastern and Western Europe. href="" target="_blank"> +41438193681


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