I'm just going to group a series of Dendreon tidbits on several topics into a single post. It's All Dendreon All the Time around here.
First, Dendreon reports that its last facility in the US, in Atlanta, has now received FDA approval for the manufacture of Provenge. This completes Dendreon's network of three US facilities -- the other two beng in New Jersey and Los Angeles. The scale up into all three facilities had been touted as being critical to the company's growth plan with Provenge. However, recent events have shown that issues surrounding physician acceptance and reimbursement are equally important to establishing the product's sales trajectory. In its last earnings announcment, Dendreon retracted its sales forecast of $350 - $400 million in 2011. See Xconomy.
Picking up on the physician reluctance to prescribe issue further, the Pharmalot blog continues with a report detailing physician anxiety with the product. Several factors were cited as inhibiting use of Provenge:
- 68% of oncologists and urologists (N=101) the survival benefit was too low at 4.1 months and needed to be at least 7 months. 30% wanted at least 1 year.
- 68% also reported that they thought they would have problems with reimbursement - at $93,000 a pop even 1 patient not receiving reimbursement was viewed as trouble
- Provider education gaps and the novel nature of the treatment itself were also a barrier and was cited by 41% of the docs
- 68% also cited the co-pay for their patients as a major concern
The triple whammy going here is that docs don't know how to use yet, would like to see better survival benefit and worry about being reimbursed for an expensive treatment.
Finally, firmly in Dendreon's court, we have a report from Seeking Alpha decrying the misinformation out there surrounding Provenge. The report, written by Saul Kerpelman, says Provenge produced the "largest median survival advantage EVER" in hormone unresponsive prostate cancer patients. The post further explains median survival benefit and its meaning.
Provenge's 4.1 months median survival benefit means that 50% of the men in the clinical trial who received Provenge lived 4.1 months longer than 50% of the men in the non-treatment group. So half the men in the non-treatment group died 4 months earlier than half the men in the Provenge group. But, Provenge also reduced risk of death by 22.5% and increased 3 year survival by almost 40%. So many men went on to survive much longer on Provenge. Provenge had 38% more men make it to three years. So the statement that Provenge "extends life on average 4 months" is wrong. And it is equally wrong to say that $93,000 buys you only 4 months. Provenge may give you many more years of life and with fewside effects compared to standard treatments.
Kerpelman says Dendreon needs to hire new PR to challenge erroneous and misleading media reports AND do a lot more on the physician and patient education side. Medicare already fully reimburses for Provenge and just issued a Q code (to speed reimbursement) in July. Better education as to benefit will fix the slow adoption rate.
Posted by Bruce Lehr Aug 30th 2011.