OK to further add on to what anchorman said:
I just called Vertex to speak with them about doctor's prescribing Kalydeco off-label.
Here is what I learned~
Any doctor, any where can write a script RIGHT NOW for Kalydeco for any patient with CF regardless of mutation. They (vertex) do not require proof of mutation...that is only important if you have G551D and vertex can help get financial assistance for the drug. The form docs sign is to help G551d get insurance coverage, that is all!!!!
<strong>Vertex is bound by legal obligation to only help (financially) patients who are G551D. There is actually very little they can say to a CF patient who is not G551D because of FDA REGULATIONS because the approval of the drug only covered G551D. They cannot tell you if it might be beneficial (even if it works great in vitro on your mutation) because it is against the LAW and they will get in troulble.</strong>
<strong>However, I was informed that if your doc thinks it is an important drug to try and might be helpful, they are absoltuely allowed to prescribe it off-label. At that point, your pharmacy will do what it can to get the drug covered by insurance.</strong>
If your clinic has a problem with that, have them call this number at vertex:
<span>877-752-5933 Option 2
<span>PLEASE PASS THIS INFO ON TO YOUR DOCTORS!
I just called Vertex to speak with them about doctor's prescribing Kalydeco off-label.
Here is what I learned~
Any doctor, any where can write a script RIGHT NOW for Kalydeco for any patient with CF regardless of mutation. They (vertex) do not require proof of mutation...that is only important if you have G551D and vertex can help get financial assistance for the drug. The form docs sign is to help G551d get insurance coverage, that is all!!!!
<strong>Vertex is bound by legal obligation to only help (financially) patients who are G551D. There is actually very little they can say to a CF patient who is not G551D because of FDA REGULATIONS because the approval of the drug only covered G551D. They cannot tell you if it might be beneficial (even if it works great in vitro on your mutation) because it is against the LAW and they will get in troulble.</strong>
<strong>However, I was informed that if your doc thinks it is an important drug to try and might be helpful, they are absoltuely allowed to prescribe it off-label. At that point, your pharmacy will do what it can to get the drug covered by insurance.</strong>
If your clinic has a problem with that, have them call this number at vertex:
<span>877-752-5933 Option 2
<span>PLEASE PASS THIS INFO ON TO YOUR DOCTORS!