I’ve always been interested in pre-approval access because it is at the cutting-edge of bringing science and patients together – and it really is about helping those in need. But research presented today in Baltimore, at CBI’s conference on Pre-Approval Access (sponsored by IDIS), shows that there is a financial return for providing these programs as well.
Based on an eight country, decade-long analysis, Dr. Andree Bates, president of Eularis, reports that named patient programs have a positive effect on revenue.How positive? By observing how 33 drugs performed in cash markets a year after commercial launch, Eularis deemed there was a 1.362 times higher odds of spending $1 on a drug that participated in these pre-launch programs compared with one that did not. (For those of us who are “statistically challenged,” Bates put it another way: Let’s say a pharma company was about to launch a drug and expected a 5 percent market share. If that same company launched the drug, but had run a pre-approval access program, they can expect that market share to be 6.7 percent.)
Across the board, there has been little to no research done on the ROI of named patient programs, probably because the driver of such programs is patient need. Not to mention, the whole idea of named patient programs and financial benefit seems just sticky. Although companies are allowed to charge for drugs that are available pre-launch, many companies elect to charge an artificially low price or not at all – a decision, says Tim Tustin, Shire’s managing director, export, they may regret later on.
“Companies can be accused of seeding the market – of not charging patients until the drug is available commercially, and then having to charge a price,” he says. “Governments can then look at price, and it might not be what they expected.”
The British-born Tustin also remarked on the EU-US divide when it comes to pre-approval access programs. “I now understand the questions my US colleagues ask,” he says. “The US and UK systems for these drugs are diametrically opposed.”
More information on pre-approval access programs can be found here.
Photo by MTSOFAN