Medicine Information

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. 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, Diagnostic and Medical Products. http://www.MedServicesEurope.com +31648566707


MORE RESOURCES:
This RSS feed URL is deprecated, please update. New URLs can be found in the footers at https://news.google.com/news


Aljazeera.com

Shortage of medicine, drinking water for Kerala flood survivors
Aljazeera.com
"They also need medicine for diarrhoea, rehydration powders and wipes to clean things." The Indian government has pledged $71m for victims of what state chief minister Pinarayi Vijayan called "the worst floods in 100 years". Randeep Kumar Rana of the ...
Kerala Floods: Over six lakh in relief camps; focus on food, medicine as fear of disease arisesNews Nation

all 4,895 news articles »


Good News Network

Top School of Medicine is Now Paying Tuition for All of Its Med Students
Good News Network
The NYU School of Medicine just announced that it is offering full-tuition scholarships to all current and future students in its MD degree program regardless of need or merit—a bold effort to simultaneously address the rising costs of medical ...
NYU to take care of Tuition fees of Medicine studentsThe Siasat Daily
NYU School of Medicine Offers Full-Tuition Scholarships to All New & Current Medical Studentsnyulangone.org
New Research Shows Increasing Physician Shortages in Both Primary and Specialty Care - AAMCNewsAAMCNews
University of Houston -Pew Research Center -The Campaign for Free College Tuition
all 63 news articles »


Lewiston Morning Tribune

Thomas Medicine Elk Kenoras
Lewiston Morning Tribune
Thomas Medicine Elk Kenoras (Simseh — “Obsidian Sub Chief”/Ahtukka “Goose”), affectionately known as “Lil Tom” or “Goose,” entered the world on Nov. 11, 1997, to Lucy (Medicine Elk) and Bleu Jaye Kenoras at Clearwater Valley Hospital in Orofino.



WBUR

The Doctors Without MDs: What Makes Osteopathic Medicine Different?
WBUR
McQuain is a doctor of osteopathic medicine, or DO, the other type of medical doctor in the United States. And while osteopathic physicians are fully licensed doctors with the same prescribing privileges as MDs, the American Osteopathic Association ...



africanews

China/Africa health cooperation enhances medicine
africanews
“Through technological innovation in bioengineering and production, as well as in the efficiency of the whole supply chain, we can effectively improve the ways of drug research development and reduce the cost of future medicine production,” Qiyu said.
Africa needs to make more medicine, health ministersThe New Times

all 30 news articles »


Daily Telegraph

Nine million Aussies use a prescription medicine each day
Daily Telegraph
A survey of more than 1000 adult Australians conducted by YouGov Galaxy for NPS Medicinewise has found two in three parents have difficulty remembering how often to give their children medicine and half worry whether they are administering medicines ...

and more »


The Independent

Why land expropriation without compensation is the wrong medicine for South Africa's economic ills
The Independent
I wonder what goes through the mind of South African president Cyril Ramaphosa each morning. I imagine him sipping coffee, planning how he's going to get the country back to work. He must shake his head, marvelling in revulsion, at the scale of the ...

and more »


VinePair

I Love You, Doc: A Brief, Boozy History of Alcohol as Medicine
VinePair
Ancient Egyptians and Chinese are among the earliest adopters of booze as medicine; though in their cases, alcohol more as a vehicle for medicine, the way Red Bull is (why) a vehicle for vodka. According to Patrick McGovern, the UPenn professor who ...



Health IT Analytics

Precision Medicine Researchers Identify New Alzheimer's Genes
Health IT Analytics
Researchers expect that these findings will help enhance the understanding of the genetic factors that lead to Alzheimer's development, which is a critical step toward eventually achieving effective and scalable precision medicine treatment. “Many of ...



Forbes

How Retail Mental Health Could Be Medicine's Next Frontier
Forbes
Throughout his residency and his last three years as a physician in psychiatry training at Mather Hospital in New York, Dr. Tamir Aldad saw upfront how thousands of mental health patients each year were sent home from the emergency room knowing they ...


Google News

home | site map | Dr. Thad Thomas
© 2006