Wednesday, March 6, 2019

Just out of reach


So close, yet so far…


We’ve already started the process to try to access the triple combo before it gets FDA approval. The first step is for a doctor to reach out to the drug manufacturer, Vertex, and find out whether they are willing to provide the drug. If they are, the doctor then submits an application to the FDA for Individual Patient Expanded Access, which allows patients with an immediately life threatening or serious condition with no other alternative therapies to access investigational treatments. If the FDA approves it, presumably we then try to convince my insurance company to pay for it.

My doctor has already contacted Vertex. However, there’s a hitch: Vertex is not offering expanded access for the triple combo yet. They are currently studying 2 different triple combo treatments, and will only move forward with one of them based on the study results. They won’t provide expanded access until they choose which drug they’re submitting for FDA approval, which could take a few more months.

So now it’s a waiting game. Here’s hoping they finish up the studies and make a decision soon!!

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