Can a Dr. in the U.S. write a script for Ocaliva for a NASH patient? Is it prohibited by law &/or employer?

[Troutwhisperer]

Ocaliva & Nash Treatment

[nash2 Partner]

It is approved for PBC so a doctor can order it but insurance probably won't pay for it absent that diagnosis and many docs won't because they may have to answer questions from some agency. You can apply to Intercept directly as a compassionate use if a doc wants to do that for you.

[Troutwhisperer in reply to nash2]

So if a NASH patient has a compassionate doctor willing to contact Intercept directly would it be fair to assume that a patient might likely expect some verifiable benefit unless patient is already experiencing liver failure?

[nash2 Partner in reply to Troutwhisperer]

You would have to be careful about expectations. First, the phase 3 results showed improvement in fibrosis level in a very select group. They had not progressed to advanced cirrhosis so you have to realize that information is still limited. Also, it did not cure anyone and didn't help everyone so there are no assurances that it would help you as an individual. In effect you would become a study in which the number of participants is 1 so it is not done frequently and requires a personal doctor who wants to participate.

[Troutwhisperer in reply to nash2]

Thanks so much for clarifying. I’m greatful for your help. It is comforting also to learn that Intercept is not alone in a quest to succeed with a medication

that will be either the first or even one of several that will have a significant positive impact on the lives of so many.

Sincerely,

Rob