Generating Pharmaceutical Sales before Marketing
Authorization
Released on = February 6, 2005, 4:53 pm
Press Release Author = Dr. Gene Emmer/Med Services Europe B.V.
Industry = Healthcare
Press Release Summary = 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. This presents drug-makers with an opportunity to generate
revenues while development is still in-progress.
Press Release Body = 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. Med Services Europe conducts business development for
Pharmaceutical, Diagnostic, Biotech and Medical Equipment manufacturers. We
specialize in building and managing distributor networks for medical manufacturers
in Eastern and Western Europe. www.MedServicesEurope.com +31648566707
Web Site = http://www.MedServicesEurope.com
Contact Details = www.MedServicesEurope.com
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