Next week we should get the European recommendation to approve T-DM1 for Europe, I believe actual approval takes roughly 2 months after the recommendation comes in, but it would definitely be seen as a positive. In addition, Roche is expected to state what sales in the past quarter were, many are looking at $60 million plus but I believe it may be substantially higher and really surprise the market.
The real question is just how much off label use will come from the many other trials producing positive data which almost certainly will lead to label expansion. Insurance companies normally will pay for treatment as long as their is solid substantiation for the treatment, I believe they can find it in all the more advanced trials for the drug. Doctors can use a drug in any way they wish after it's approved for any use, but insurance companies often must be convinced to pay. I'm no expert, but I believe in some cases they may not initially pay, but if the drug proves effective, will pay after the fact.
It's my belief that in time T-DM1 will replace Herceptin in every application. Why? Because by being more effective, it can shorten the treatment if a cure remains a possibility and may result in achieving a cure in patients where not treating with it early may result in sustained treatment as a cure is deemed no longer possible. Cancer cures have certainly increased over the years, but not nearly as much as our ability to sustain life with a reasonable quality of life. T-DM1 will achieve some cures in people who otherwise wouldn't have been cured, but clearly it is sustaining lives, perhaps indefinitely, without actually achieving a cure. For some patients the lives may be sustained long enough that another drug achieves the cure. I'm no expert, but I believe T-DM1 is probably effectively killing the cancerous cells, but it's not necessarily killing the stem cells that are creating the cancerous cells, that's where another drug comes in.
Gary |
