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Generating Pharmaceutical Sales before Marketing Authorization

Posted on July 15, 2022 by Dennis Gage

When a patient has a serious illness and there is no approved drug available, the physician may want to try one that 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 that have not yet been licensed. However, there's 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 earnings can be considerable. By way of example, Pharmion, a US based company focusing on Oncology and Hematology reported dramatic increases in its Thalidomide sales primarily due to named patient sales in Europe for Multiple Myeloma. Thalidomide sales accounted for approximately 75 percent of Pharmion's total revenues for the first half of 2004, according to company sources, and were generated while the item awaits marketing approval for this indication. Before getting European Marketing Approval, Shire's Argylin for essential thrombocythaemia generated about 5% of its total sales from its European named patient program.

Although thalidomide and Agrylin were licensed in the USA for several indications, pharmaceutical companies do setup named patient programs and receive full compensation for medications 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(TM) authorized for named patient use for adder snake bites.

Other Benefits of Named Patient Programs

A named patient program can rate uptake after official launch. Physicians, who have had experience prior to launch, via clinical trials or named patient programs, frequently become early adopters and testimonials for additional physicians once the medication 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 transport drugs around the world prior to 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 ought to be regarded as an important part of a pre-launch program. It increases awareness into a pharmaceutical's existence, creates enthusiasm, generates good-will and rates penetration of this product after launch.

Frequent Communication is Necessary

If one of the goals is to generate earnings, establishing a named patient program is only the start. So as to achieve success, physicians will need to be aware of the product and what they should do to get it. Typical techniques of informing physicians, such as sales rep visits and ads, may not be appropriate because a permit is necessary to market a drug. While physicians are used to simply writing a prescription and being done with it, named patient programs need paper-work that some find dull. 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 procedure.

Issues to Consider

You have opted to make a named patient program part of your pre-marketing plan, what now?

Administration: Can 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 supply. If your organization is well resourced and has a pipe-line of goods that will require named patient programs, it may be worthwhile acquiring the expertise internally. But if you have few appropriate products or a stream-lined organization, it's probably best to think about outsourcing.

Communication: You have set up the program, how can you optimize it?

Should you not have an expert European marketing team, an organization that is familiar in sales and marketing of pharmaceuticals in Europe can enable you to maximize participation from the named patient program. A communication plan, if properly developed and implemented can increase product awareness, but communication concerning an unlicensed product has to 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 this program

* Has an advocate available to guide them through the proces.