Rise and shine, everyone, another busy day is on the way. How so? The evidence presented itself early this morning as the official mascots dashed about the grounds to bark about passersby, and a steady parade of driving machines could be seen from our window. All of which is to say that a cup of stimulation is in order. Our choice today is blueberry muffin. As always, you are invited to join us. You are also, by the way, invited to read Adam Feuerstein’s Biotech Scorecard, a new newsletter that launches this week and will be filled with saucy, exclusive stuff just for subscribers. Public service announcements aside, it is time to get cracking. So here are a few items of interest. We hope you have a wonderful day and achieve all of your goals. And do keep in touch. …
The number of abortion pills obtained outside the traditional U.S. health care system spiked considerably in the months after the U.S. Supreme Court overturned Roe v. Wade, The Hill tells us, citing a study in JAMA. There were nearly 28,000 additional doses of pills for “self-managed” abortions in the six months after the fall of Roe, more than four times the number of pills per month that were reported before the decision. In the same six months after Roe ended, there were nearly 33,000 fewer abortions that took place within the formal health care system at licensed facilities and telehealth clinics, so medication abortion nearly offsets that.
Novo Nordisk plans to seek coverage by Germany’s public health insurance scheme for the use of its Wegovy drug to cut the risk of strokes and heart attacks, if the extended indication wins European approval, Reuters notes. German health agency G-BA issued guidance last week saying regulation banning Germany’s health system from paying for weight-loss drugs would not apply in the case of other approved uses, a boost for Novo Nordisk’s efforts to convince governments of its wider medical benefits. Novo added Wegovy would first need European Union approval for use in reducing cardiovascular risks and must “officially fall into the area of reimbursable conditions” in Germany.
Amgen has filed a lawsuit accusing a Colorado state board of violating the U.S. Constitution over a plan to pursue a first-in-the-nation move to cap the cost of a pricey prescription medicine, STAT reports. In its lawsuit, the company argued the mandate for the state prescription drug affordability board is unconstitutional because its actions will conflict with federal law, violate basic requirements of due process, and seek to regulate business outside of Colorado. The move comes one month after the state board — which is designed to function like a rate-setting authority — determined that a big-selling Amgen medication called Enbrel is unaffordable.
AstraZeneca and Pfizer chief executive officers pledged to support expansion of China’s biopharmaceutical industry, even as U.S. lawmakers seek to decouple the tightly entwined supply chains that provide medicine to the world, Bloomberg News says. Both spoke at an event in Beijing organized by the Chinese Ministry of Commerce to attract foreign investment. Meanwhile, the Biosecure Act, designed to reduce U.S. reliance on the Chinese biopharmaceutical industry, makes its way through Congress. The bill would ban Chinese biotech companies “of concern” — and any pharmaceutical companies that work with them — from getting federal contracts in a bid to ensure national security.
Chick-fil-A, one of the largest fast-food restaurants in the U.S., is easing its commitment to using chickens raised without any antibiotics, a step that was criticized over concerns it could increase the risk of spreading antibiotic resistance among humans, STAT writes. In a statement, the company said it will instead switch to chickens that are raised without the use of antibiotics that are considered important to human health. The change will occur this spring at the slightly more than 3,000 Chick-fil-A locations around the U.S, a decade after the chain announced it would implement a “No Antibiotics Ever” policy by 2019.
Philadelphia District Attorney Larry Krasner is suing insulin makers and pharmacy benefit managers that he alleges have artificially inflated the cost of a life-saving diabetes medication, Philly Voice tells us. The lawsuit accuses the companies — Eli Lilly, Sanofi, Novo Nordisk, CVS Caremark, OptumRx, and Express Scripts — of colluding to increase the price of insulin. Krasner alleged the insulin makers and PBMs drove the cost of the diabetes therapy up from roughly $20 per vial in the 1990s to the range of $300 to $700 “to exponentially increase their profits at the expense of health insurance plans and their beneficiaries, as well as uninsured consumers.”
While out-of-pocket caps on insulin indeed cut down on costs for commercially insured patients in the U.S., the policies didn’t do much to increase insulin use, MedPage Today writes, citing a study that examined claims data. After the policies were implemented in eight states, insulin users under age 65 had a 17.4% relative reduction in costs compared with insulin users in others states, a difference that translated to an average $11.46 reduction in monthly costs. But there was no difference in mean 30-day insulin equivalent fills per month from before to after implementation of the caps when compared with states that did not have such programs.
The U.S. Food and Drug Administration is expected to approve a Merck drug for a rare lung disorder called pulmonary arterial hypertension, making available a novel treatment for a deadly condition that has long been challenging to treat, STAT notes. In a large trial published last year, the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting the risk that their condition would worsen, that they would die, and that they would need new treatments. PAH is estimated to occur in 15 to 50 per million people, mostly in women, and the drug, given as an injection every three weeks, is seen to be a key growth driver for Merck.