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


The Guardian

Adam Kay: 'If I had kids I would put them off studying medicine'
The Guardian
Kay had enjoyed a longstanding interest in comedy, performing in medical student revues, and later in corporate gigs for pharmaceutical companies. He'd also been on Radio 4 and performed at the Edinburgh festival, so comedy was the obvious way to go ...



Florida Flambeau

FSU College of Medicine hosts World AIDS Day vigil
Florida Flambeau
From 2008 to 2010, there were about 32 new HIV cases and 19 new AIDS cases in Leon County. During this time period, Leon County reported 1,392 cases of gonorrhea, chlamydia and syphilis. Gonorrhea and syphilis rates are higher in this county than ...

and more »


Salt Lake Tribune

Commentary: The Tribune was wrong. Medicine often involves a risk to the patient.
Salt Lake Tribune
(Courtesy of the Utah Department of Health) A health department initiative called Talk to Your Pharmacist placed stickers on bottles to prompt prescribers to talk to their pharmacist about the risk of using opioids. By Lynn Webster | For The Tribune ...



The Hindu

'Exciting careers beyond engineering and medicine'
The Hindu
In a State where a huge chunk of student population go towards engineering and medicine, choosing a course other than the two requires a certain aptitude. It's the aptitude that matters when choosing a career, experts from various fields advised ...



KFSN-TV

New Treatment for Neuropathy: Medicine's Next Big Thing?
KFSN-TV
Thirty percent of all Americans will be affected by peripheral neuropathy, a condition that impacts nerves leading to the arms and legs. (KFSN). KFSN. By Margot Kim. Saturday, December 09, 2017 11:48PM. Thirty percent of all Americans will be affected ...



Rethink Healthcare: Government hospitals must provide quality, affordable medicine
Economic Times (blog)
Delhi government's decision to cancel the licence of Max hospital, Shalimar Bagh, for negligence resulting in the death of a premature newborn – the baby was declared dead by the hospital even though he was alive at the time he was given to his parents ...

and more »


New York Times

What Doctors Should Ignore
New York Times
Those variants are enriched in people of African ancestry. Girish N. Nadkarni, a kidney specialist at Icahn School of Medicine at Mount Sinai in New York City, explained to me that scientists think this may be because those variants protect against the ...



EurekAlert (press release)

Landmark CAR-T cancer study published in the New England Journal of Medicine
EurekAlert (press release)
IMAGE: This is how CAR-T cell therapy harnesses a patient's immune system to fight cancer. view more. Credit: Loyola Medicine. MAYWOOD, IL - Loyola University Medical Center is the only Chicago center that participated in the pivotal clinical trial of ...
Loyola Medicine Oncologist Patrick Stiff, MD, Co-Author of Landmark @NEJM CAR-T Study, Offers Measured ...Newswise (press release)

all 5 news articles »


Daily Mail

HEALTH: Nature's medicine for sore joints
Daily Mail
When financier John Carey, then 35, woke up one night in 2002 with a searing pain in the ball of his left foot, the last thing on his mind was gout. 'I'd been training hard the day before – I practise judo and ran marathons – and thought I must have ...



HuffPost

Medicine And Why Net Neutrality Matters
HuffPost
Recently, the library at Einstein, where I work as a medical librarian, experienced a momentary internet outage. In that instant, everything seemed to stop in its tracks. Medical students preparing to take their STEP 1 Board exams couldn't finish their ...

and more »

Google News

home | site map | Dr. Thad Thomas
© 2006