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mcbio

11/23/13 5:01 PM

#170447 RE: genisi #170446

I do expect docs to want to treat patients with simeprevir+sofosbuvir off label but think just the more advanced ones

Simeprevir's actual label says the drug is "indicated as a component of a combination antiviral treatment regimen." That is written broadly enough to where it's not clear that simeprevir+sofosbuvir use would necessarily be deemed off-label.

I honestly don't see how they will overcome reimbursement issue.

I certainly don't think it's going to be an issue in those advance stage patients, which are admittedly a much smaller part of the overall market. However, given the broad language in the label, it's possible insurers may well be more apt to reimburse the combo in less advanced patients, particularly given any rebates that JNJ may well be inclined to offer to participate in such combo sales.