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The Readout Damian Garde & Meghana Keshavan

The colossal impact of Aduhelm on Medicare

The FDA’s approval of the Aduhelm, the controversial — and costly — Alzheimer’s drug from Biogen, has the entire health care sector aflame. Not only has it prompted a new Congressional inquiry, announced late Friday, but some experts speculate that the medication’s impact on Medicare could be catastrophic. Biogen projects a target population of 1 to 2 million people, though the actual numbers are unknown. The drug has been approved to treat all forms of the neurodegenerative disease — not just early onset — so it could be used, potentially, by the 5.8 million adults over 65 with Alzheimer’s.  

STAT’s Rachel Cohrs and J. Emory Parker developed an interactive that shows the drug’s impact on Medicare's budget. Currently, the total Medicare spending on drugs administered by doctors is $37 billion. If just one third of seniors with the disease take Aduhelm, the potential cost would be $110.4 billion.

Read more.

Top Operation Warp Speed official set to retire

Gus Perna, the four-star Army general who spearheaded the U.S. coronavirus vaccine program, will retire this summer, STAT reported exclusively. Several of his top deputies have also left their posts in Operation Warp Speed — and seem to be looking for new jobs. Although the initiative is still underway, the Biden administration has also changed its name. It’s now called the Countermeasures Acceleration Group, sources tell STAT’s Nicholas Florko.

It’s not exactly clear why Warp Speed is facing all the turnover, though three sources said the changes in the Department of Defense staff were normal, planned rotations.

Read more.

CRISPR-based gene therapy from Intellia seems to work

A CRISPR-based therapy from Intellia showed some success in treating a genetic nerve disorder in six patients, the company reported Saturday. Preliminary results demonstrate for the first time that CRISPR-based genome editing can be delivered throughout the body, STAT’s Megan Molteni writes. The treatment reduced levels of a disease-causing protein by 87% in the higher-dose cohort, with only mild side effects. 

The medication, which is being co-developed by Regeneron Pharmaceuticals, is aimed at treating transthyretin amyloidosis — a progressive and fatal disease caused by a single gene mutation. It causes the liver to produce misshapen, unstable versions of the protein transthyretin, which ultimately accumulate into toxic plaques in the peripheral nervous system. Intellia’s drug, called NTLA-2001, was able to successfully turn off the faulty gene. 

Read more.

Opinion: Importing European price controls won’t fix health

President Biden has idealistic health goals — with aims to end cancer, HIV, even Alzheimer’s. But he’s also interested in importing European-style drug price controls to the U.S. in new legislation called the Elijah E. Cummings Lower Drug Costs Now Act, writes diplomacy expert James K. Glassman in a new First Opinion for STAT. Glassman argues the legislation would reduce the R&D funds necessary to develop new therapies. 

The most worrisome feature, opines Glassman, is so-called international reference pricing — a policy that would link the prices of hundreds of U.S. drugs to those of six other single-payer countries, whose prices are set by the government. This would cause prices to drop dramatically, which might be good for consumers, but bad for patients in the long term, he says. 

Read more.

More reads

  • As Covid-19 rages in India, Gilead faces pressure to lower the price of a drug that treats a rare, related infection. (STAT)
  • Pharma has ‘hidden’ influence over UK Parliament members through funding. (STAT)
  • Johnson & Johnson agrees to pay $230 million to settle opioid case in New York. (STAT)
  • In an about-face, Health Canada allows a controversial rare disease drug back on the market. (STAT)

Thanks for reading! More tomorrow,

Damian

Monday, June 28, 2021

STAT

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