Hi guys!
As you may know, Genentech, Tercica/Ipsen and Insmed formally amended the settlement agreement - and Iplex will be allowed to be distributed to PALS on a named patient basis. They notified Team Iplex of their decision Saturday 11/8/08 - and pushed their press release 11/10/08.
While this was a significant victory towards the final objective, there still remains hurdles to cross. Insmed now has to produce the drug. They will have to satisfy varied regulatory requirements, and establish protocol for the named patient program. I hope and pray that this process is done with great urgency.
Many questions remain, and unfortunately, I do not have answers to most. Many have asked about insurance, cost, etc. There are 19 states in America that mandate that private insurance pays for "off label" drugs, and many insurance carriers do so without being mandated to. Medicare is a different entity, and I have no clear idea on how that will be handled. As information comes in, I will readily share it.
It has been a long road, certainly not one I did alone. Team Iplex, as we have come to call ourselves, has been a growing international group of Pals/Cals determined to have the right to try Iplex. What we were able to do, as a unified voice, without central leadership or even organization, was truly remarkable. We faced some pretty heavy resistance, and still do. But, in our hearts, we have all believed that at the very least we deserve the right to access the drug and try it for ourselves.
The past 11 months have been a very strange journey. It was here that I was told to get Jim to an ALS neuro ASAP....gosh, some of you must remember how scared and naive I was. To think that was only January of this year. Here it is - November, 11 short months after onset of symptoms. Jim's progression has been relentless, he has a PEG, can no longer walk, or do any of his own basic care. This monster is like no other I have ever seen. I can't believe how much I have learned and done .... even going to DC. It was so scary, Jim is confined to a wheelchair... so I carefully read Quadbliss's web site, followed his instructions, and off to DC Jim and I went! Tiring, scary, but also wonderful. We are truly living with ALS. (Although at 4am my temper tantrum was less than attractive today).
Thinking of you all... haven't been here much, been busy as heck - but hoping things will settle down in the coming weeks regarding Iplex. We are also taking a Thanksgiving cruise for 7 days to Mexico... should be interesting at the very least!
Andrea - wife of Pals Jim
