FDA Appproval for CIDP

Anonymous
December 21, 2010 at 7:39 pm

The ONLY IVIG to be approved for CIDP is Gammunex.
Carimune is much cheaper, as is Gammagard SD.
Here is the FDA Summary [brand name not mentioned] of the trial:
URLhttp://clinicaltrials.gov/ct2/show/NCT00001287?term=CIDP+AND+IVIG&rank=1URL
And: URLhttp://clinicaltrials.gov/ct2/show/NCT00220740?term=CIDP+AND+IVIG&rank=4URL
To my knowledge? There are NO generics of IVIG. Look under ‘specialty pharmacy’ medications or drugs in your insurance plan to see what the ‘ins’ and ‘out’s’ are… Most neuro or rheumy physician’s offices have someone dedicated to knowing the complicated coding systems that are required to sort these issues out to the Ins. Co’s satisfaction.
When any ADMINISTRATING source substitues The PRESCRIBED brand for another [such as a hospital] THEY MUST notify the physician and the patient promptly… to avoid possible reactions. IF NOT? Think lawsuits…
And… someone correct me here? Since Gammunex IS an FDA approved med or ‘blood product’? It should be covered even under Medicare [tho your co-pays are going to be HUGE].
Yuehan? I’d start calling your prescribing doc’s office, the insurance company and any and all others…including senators and representatives to GET answers. While you mite not like the answers? Getting all resources behind you, and facts in line can help you get better and cheaper treatments!
Good luck and bless you in this exhausting struggle!
I’ll keep my fingers crossed that things work out better than well!
This part of having CIDP and getting older IS the PITS!