Pharmaceutical: Market | Marketing Authorization | جلب دواء جديد إلى السوق: أهمية ترخيص التسويق

When a patient includes a serious illness and there's no approved drug available, the physician might want to do one which has not been authorized for marketing by a national health authority but has shown promise in clinical trials. European Named Patient Programs, like US compassionate use programs, offer physicians access to pharmaceuticals which haven't yet been licensed. However, there's one important difference: in Europe an unlicensed drug may be reimbursed. This presents drug-makers with a chance to come up with revenues while development remains in-progress.

Significant Revenues Are Possible

The additional revenues are often considerable. as an example, Pharmion, a US based company that specialize in 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 thanks to named patient sales in Europe for myeloma. Thalidomide sales accounted for about 75% of Pharmion's total revenues for the primary half 2004, company sources, and were generated while the merchandise awaits marketing approval for this indication. Before receiving European Marketing Approval, Shire's Argylin® for essential thrombocythemia generated about 5% of its total sales from its European named patient program.

Though thalidomide and Agrylin were licensed within the USA for a few indications, pharmaceutical companies do set-up named patient programs and receive full reimbursement for drugs that aren't licensed for any indication in any market. Examples include: Insmed's SomatoKine® authorized for named patient use for Primary Lateral Sclerosis, human 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 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 corporate because they simplify the method of gaining access for patients in critical need. Smaller companies often can't afford the executive time and costs of shipping drugs round the world before launch. this may result in frustration and resentment towards an organization that several physicians will remember long after a drug is officially on the market. Creating a proper channel eliminates the unfortunate need of denying requests and risking ill-will later.

A named patient program should be considered a crucial a part of a pre-launch program. It increases awareness to a pharmaceutical's existence, creates excitement, generates good-will and speeds penetration of the merchandise after launch.





Frequent Communication is critical

If one amongst the objectives is to get revenues, putting in a named patient program is simply the start. so as to realize success, physicians have to remember of the merchandise and what they have to try to urge it. Typical methods of informing physicians, like sales rep visits and ads, might not be appropriate because a license is critical to plug a drug. While physicians are accustomed simply writing a prescription and being through with it, named patient programs require paperwork that some find tedious. Therefore, the corporate must create an appropriate communication plan and work closely with the targeted health profession to stay them informed and simplify the method.

 

Issues to contemplate

You have decided to form a named patient program a part of your pre-marketing plan, what now? Administration: does one "go it alone" or work with an organization that's experienced at administering named patient programs?

There are several experienced organizations that may 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 encompasses a pipeline of products that may require named patient programs, be worthwhile acquiring the expertise internally. However, if you've got few appropriate products or a stream-lined organization, it's probably best to think about outsourcing.

Communication: You've founded the program; how does one optimize it?

If you are doing not have an experienced European marketing group, a company that's familiar in sales and marketing of pharmaceuticals in Europe can facilitate your to maximize participation within 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 make sure that your entire target group:

Is fully awake to the merchandise and therefore the program.

Knows what has to be done to require advantage of the program.

Has an advocate available to guide them through the method