Another Treatment Option

Yesterday, the FDA approved Actemra for use in the treatment of Systemic-Onset Juvenile Idiopathic Arthritis.  Also known as Still’s Disease, I’ve written about this before.

You might be saying, “I don’t have Still’s, so why would I care?”  I think it matters, because it’s an important step and might be the start of a new trend.

So many times drug companies get their initial approval and then move on to new pastures.  Often this doesn’t matter because once the FDA has approved a drug, doctors can prescribe it for other uses (known as off-label prescribing).  The pharmaceutical company has their medication approved, doctors prescribe the medicine, patients feel better; everyone’s happy.

The catch is that the person taking the medication often isn’t the one paying for the medication, and with the more expensive drugs (such as biologics) the third-party might decide not to pay.  Insurance companies understandably don’t want to shell out $2000 per month if there’s a way to get out of it.  One way is to deny coverage of off-label medications.

If a biologic is approved for use in RA, but not in USpA or MCTD, insurance won’t pay for it even though the medication would be a great help.  Drug companies could make a lot more money if they’d do the extra work to get extra uses added to the label, but they don’t often make the effort.  Thus, I am very excited to see the expanded labeling for a biologic – and hope that other pharmaceutical companies follow suit.

Not only is yesterday’s announcement exciting for kids with SJIA, it holds out hope for all of us for expanded uses of biologics to treat other forms of autoimmune arthritis.

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2 thoughts on “Another Treatment Option

  1. This is all new info to me, Socks. THANK you for gumshoeing it and sharing it with us.

    By the by, here’s hoping that you’re feeling better these days. Have a great Sunday and an even better week. ;)

  2. Good info. Actrema needs a few years of use to know how effective it’s going to be.

    Unfortunately, lawyers find off-label use a handy target for claims of malpractice when results of treatment are poor, and some lobbyists are pushing legislation to restrict such use, and prescribe penalties for any violation.

    This makes some of us very cautious about being involved in off-label use…especially when the use is new or has not yet been fully validated. Even patients will often push you to prescribe when prudence says, “Not proven, not yet.”

    Historically, off-label can be harmful. The decongestant, phenylpropanolamine, which was used as an appetite suppressant is one example. The use of levothyroxine for weight loss is another.

    For me, it’s a matter between a patient and their doctor. Both should understand the nature of the treatment, the plausibility and evidence for its use, and the implications of a lack of regulatory approval.

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