Pharmaceutical Sales Before Marketing Authorization
When a patient has a serious illness and there’s no approved drug available, the physician might consider using a drug that has not been authorized for marketing but has shown promise in clinical trials. European Named Patient Programs, similar to US compassionate use programs, provide access to unlicensed pharmaceuticals. An important difference is that in Europe, unlicensed drugs may be reimbursed, allowing drug-makers to generate revenue while development is still in progress.
Significant Revenues Are Possible
The additional revenues from named patient programs can be considerable. For example, Pharmion, a US-based company specializing in Oncology and Hematology, reported a dramatic increase in Thalidomide sales from $1.9 million in Q2 '03 to $15.3 million in Q2 '04, primarily due to named patient sales in Europe. Thalidomide sales accounted for about 75% of Pharmion's total revenues in the first half of 2004.
Other Benefits of Named Patient Programs
A named patient program can speed up uptake after the official launch. Physicians who have experience with the drug before launch often become early adopters. Additionally, these programs can increase goodwill toward the company by simplifying access for patients in critical need.
Frequent Communication is Critical
To achieve success, it’s essential that physicians are aware of the product and know how to access it. A strong communication plan is necessary to keep the target health professionals informed.
Issues to Contemplate
If you decide to include a named patient program in your pre-marketing plan, consider whether to administer it internally or partner with an experienced organization. Proper administration can enhance program effectiveness and ensure compliance with regulations.
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