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Complete Health Reporting: FDA Approval Does Not Prove Efficacy or Justify Price

Complete Health Reporting: FDA Approval Does Not Prove Efficacy or Justify Price

Two of the most vilified groups in health reporting are insurance companies and pharmaceutical firms.

When an insurance company decides to deny coverage for a particular drug, it is easy for the pharmaceutical company to suddenly become David fighting Goliath.

In further examining how to best address the novelty of a treatment, I’m going to pick on MedPage Today, which does great work on a regular basis and often sets a very high bar for scientific accuracy. The outlet ran a short piece as part of a news wrap-up in September 2012 when Aetna decided to stop paying for Questcor’s drug Acthar for anything other than use for infantile spasms from a disorder known as West syndrome.

The story is emblematic of how treatments are often presented as undeniably better even in the face of scant evidence. If you read Russ Mitchell’s piece in Portfolio that I discussed on Friday, you may be surprised by the tone of the MedPage Today piece.

A long-acting repository form of corticotropin (H.P. Acthar Gel) is FDA-approved for dozens of diseases, but the big health insurer Aetna has decided it will pay for the drug in only one indication: West syndrome, a rare seizure disorder in infants.

The lead framed the story as Aetna acting against good science. The FDA has approved the drug for dozens of diseases, right? But Aetna was denying coverage for those diseases? How dare a profit-focused company doubt the good judgment of the federal government.

Then the story put a little meat on the bones:

Repository corticotropin first came on the market in 1952 and works to increase endogenous corticosteroid activity. It is approved for most steroid-responsive conditions in patients who have failed conventional corticosteroid therapy. Nevertheless, Aetna concluded that the drug is not "medically necessary" for any of these conditions, except for West syndrome.

Note the “nevertheless.” The assumption is that the evidence was on the side of the FDA, and that Aetna was ignoring the evidence. But then MedPage finally allowed Aetna to provide a little context for its conclusions:

[Aetna] cited a lack of clinical studies comparing repository corticotropin with standard steroid drugs, as well as a statement in Acthar's label indicating that it "has limited therapeutic value" in conditions for which steroids may be used. In contrast, expert opinion and some clinical studies have found that the product is uniquely helpful in West syndrome babies.

So it appeared that not only were there very few studies supporting Acthar’s broad use but that the company itself had been forced to state on its label that steroids would be a better option when they could be used as treatment. The lack of evidence supporting Acthar as a drug suitable for “dozens of diseaes” was not news. It was something that Mitchell had reported four years prior in Portfolio. But this story didn’t follow Portfolio’s path. Instead, the story went back to the drug-company-as-underdog storyline.

Sixty years of FDA approval notwithstanding, "Aetna considers repository corticotropin experimental and investigational for all other indications because its effectiveness for these indications has not been established," the company said in a policy statement posted on its website last week.

Read that again, “Sixty years of FDA approval notwithstanding.” Essentially, that means, “You dummies over at Aetna should pay attention to the decades of solid research upon which the FDA has based its approvals.” Note, too, that the story never mentions that in 2007, Questcor jacked up the price of Acthar from $1,650 per vial – already pricey – to $23,000.

So what did the FDA look at to approve Acthar for all those uses over 60 years? And how did the company decide that consumers and insurance companies should start paying a 1,300 percent price increase? The New York Times provided some answers last month.

I’ll explain what the Times did differently and what you can do to investigate similar treatments in my next post.

Image by Fried Dough via Flickr

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