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The Readout Damian Garde

Is the new Novartis MS drug overpriced? ICER thinks so

Mayzent, the newly approved Novartis drug for multiple sclerosis, is “far out of line” in its pricing, according to an analysis from the Institute for Clinical and Economic Review. The drug doesn't merit the $88,500 list price, ICER says, because the FDA approved it for a different patient population than was studied in late-stage trials. 

A more appropriate price range for the drug, depending on the approval criteria, would range anywhere from $8,000 to $32,000, STAT's Ed Silverman reports.

Some critics, though, aren't so sure, and are using the watchdog’s analysis to push back on the approach it takes to assess the value of new medicines.

Read more.

VA approves (limited) coverage for esketamine

It's been only three months since the FDA approved esketamine, the fast-acting new depression treatment that has many experts excited about its potential, even as others have expressed concern about safety and efficacy.

Now, some veterans may get access to the drug, following a vote by a Department of Veterans Affairs committee.

The committee, however, approved Spravato, as the Johnson & Johnson drug is known, on a “non-formulary” basis, meaning that it will only be available to patients who have not responded to other treatments and who will have to go through an authorization process to get it.

Read more. 

Viagra + Khaleesi = Vyleesi?

<Insert obvious “Game of Thrones” Mother of Dragons reference here ____.>

A second drug designed to enhance women’s libido, Vyleesi, has been approved by the FDA, rekindling a debate around what role pharmaceuticals should play in human sexuality. Vyleesi, or bremelanotide, is the second drug for hypoactive sexual disorder. The first, Addyi, was approved in 2005, and came with a black-box safety warning that prohibited women from drinking alcohol before taking it. That stymied sales of the drug — and analysts don’t think Vyleesi, made by AMAG Pharmaceuticals, will likely do much better. 

Though the new drug doesn’t have the same safety concerns, it has to be injected — and only offers marginal improvements in libido.

Read more.

Alarm over plan for more gene-editing in babies

Two top scientists have condemned plans by Russian scientist Denis Rebrikov to CRISPR a new batch of babies. Former FDA Commissioner Margaret Hamburg, who heads up an international advisory committee on human genome editing, along with Victor Dzau, president of the U.S. National Academy of Medicine, told STAT executive editor Rick Berke that they’re deeply troubled by Rebrikov’s plans to produce gene-edited babies. But they also don't know what their organizations can do to stop him.

“This is crazy — and it worries me tremendously,” Dzau said.

Read more.

More reads

  • FDA nixes Daiichi’s blood cancer drug quizartinib—after Japanese regulators wave it through. (FierceBiotech)
  • The world is full of innovation more important than ad algorithms. (Bloomberg)

Thanks for reading! More tomorrow,

Megan

Monday, June 24, 2019

STAT

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