When $3.9M is fair drug price

A drug price watchdog concluded a forthcoming treatment for a rare, deadly childhood disease is worth up to $3.9 million — more than any medicine in history.

The gene therapy, approved last week as Lenmeldy, cures some babies of an ultra-rare neurodegenerative disease, called metachromatic Leukodystrophy. If given in time, they grow up to live essentially normal lives.

Lenmeldy's price is $4.25 million. That's closer to ICER's fair price, as a percentage, than the vast majority of medicines it reviews. Or as STAT's Jason Mast eloquently puts it: "In other words, in a country defined by irrational, runaway drug spending, many gene therapies live on a rare island of semi-rationality: They cost a fortune, but the return, sometimes, is babies

who get to have childhoods, grow up and become adults." Read more.

MORE DRUG PRICES

Will Bernie Sanders' attack on Ozempic work?

Senate health committee Chair Bernie Sanders (I-Vt.) is demanding lower prices for yet another drug, Novo Nordisk's diabetes and weight-loss drug semaglutide.

Sanders cited new study findings that Ozempic costs less than $5 a month to manufacture. Novo Nordisk charges Americans nearly $1,000 a month for the drug, while the same product sells for $155 a month in Canada and just $59 in Germany. Ozempic is the brand name for the drug when used to treat diabetes. As an obesity drug, it's sold as Wegovy.

Sanders said his committee will do whatever it takes to lower the price of Ozempic and the closer to what other countries pay for it. He's made similar promises before. After he proposed subpoenaing executives of companies that make insulin products, they announced plans to lower prices (though those price drops were likely due to a Medicaid rebate policy). Companies also lowered prices for inhalers after a Sanders investigation (though the same Medicaid rebate dynamic also applied to those products). Medicare is expected to choose Ozempic and Wegovy for price negotiation within the next few years, but it would take a couple more years after that for the negotiated price to take effect.

AGENCIES

Can no one sue the FDA?

That's the question Justice Samuel Alito repeatedly asked the Biden administration's lawyer on Tuesday as the court tussled over the FDA's prescribing standards for the abortion pill mifepristone. And while it's very difficult to do, especially when trying to restrict access, Sarah Owermohle reports that it has been attempted before, albeit in a totally different realm.

Ed Thompson, a longtime pharmaceutical manufacturer, in 2019 sued the FDA to restrict opioid labels to short-term use, ideally barring opioid prescriptions for chronic pain. He wasn't the first to consider it: Others, including opioid policy researcher Andrew Kolodny, mulled that path before abandoning it because policy experts warned it'd be virtually impossible to win.

Unlike the mifepristone and opioid suits, which sought to restrict access, FDA is usually sued by patients demanding more access to a restricted or experimental medicine. More here.

FOOD ADDITIVES

Fight brews over decaf coffee

STAT's Nicholas Florko gives us a fun article about an effort to ban the coffee industry's chemical of choice for making decaf.

Methylene chloride strips paint, though it's long been banned for that application. It also apparently is good for stripping caffeine from coffee beans. Nearly all of the major coffee companies in the U.S. use the chemical. Industry says it's safe to use because none of it remains after the decaffeination process. Those trying to ban the chemical say it's a carcinogen and companies could just use hot water to remove caffeine from the beans. But industry says that process is more expensive and doesn't taste as good.

"True coffee aficionados, in blind tasting, select the methylene chloride decaffeinated coffee as one of the best in class," wrote a global coalition of decaf coffee companies in a recent letter to the FDA. More here.

Rx FOOD

Saving a movement from profiteering

The nonprofit organizations that pioneered the food-as-medicine movement are trying to retake ownership of it and standardize the term before profit-seeking companies undermine it.

Nick got an early look at the Food is Medicine Coalition's draft accreditation standards for their official medical food moniker. The association of community-based nonprofit food providers focuses on one of the most-well established "food is medicine" interventions, medically tailored meals, which are prepared meals cooked for specific conditions, like HIV and heart failure.

The criteria are stringent and expected to draw criticism, especially from food corporations. For starters, the standards require accredited service providers to be nonprofits. That would prevent the slew of food-profit meal providers that have launched in recent years from getting the group's seal of approval. Read more.

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