Hello! Wegovy, the blockbuster weight reduction treatment from Novo Nordiskis at the highest of the list of medicine that would soon be a part of the second round of price negotiations between manufacturers and Medicare.

That is loud a paper published last week within the Journal of Managed Care & Specialty Pharmacy. By February, the federal government will announce the subsequent 15 most costly Medicare Part D drugs that will probably be the topic of discussions for price changes that may take effect in 2027.

The Biden administration last month announced recent negotiated prices for the primary 10 Medicare Part D drugs chosen for talks. Those prices will take effect in 2026.

Drugs that contain the identical lively ingredient and are made by the identical company are considered a single drug for the talks, based on guidelines from the Centers for Medicare & Medicaid Services. For that reason, researchers expect all three of Novo Nordisk's brand-name drugs that contain semaglutide — Wegovy, the diabetes injection Ozempic and an older diabetes pill called Rybelsus — to be chosen as a single product for the talks.

This could be a big deal for older adults who use these treatments, each of which carries a price tag of about $1,000 monthly before insurance. However, it remains to be unclear how much Medicare could reduce these costs – and the way much patient costs would decrease after insurance and reimbursements are deducted.

The Biden administration, lawmakers and patient advocates have long criticized the Danish pharmaceutical company for the high list prices of its obesity and diabetes drugs. Novo Nordisk's CEO Lars Fruergaard Jørgensen faced a Senate hearing on Tuesday about those prices.

While Jørgensen didn’t commit to lowering prices for Wegovy and Ozempic, he vowed to work with pharmacy profit managers “on anything that provides access and affordability for patients.” He also dismissed price negotiations with Medicare when asked concerning the potential choice of Wegovy and Ozempic, calling the talks “price fixing” that can have negative consequences for drug innovation.

Medicare Part D doesn’t cover weight-loss treatments unless they’re approved and prescribed for an additional condition. But Wegovy could make the list for negotiations since it is now approved to cut back the chance of significant cardiovascular complications, making it likely that some Part D plans have begun to cover the treatment, the researchers said.

Under CMS guidelines, drugs should be in the marketplace for at the very least seven years without generic competitors before Medicare can select them for price negotiations. Semaglutide can have been in the marketplace for seven years and one month in February and has no generic equivalents.

Other researchers and Wall Street analysts consider Ozempic will probably be subject to negotiations because of the high cost of Medicare Part D for the treatment.

The program spent greater than $5.6 billion on semaglutide drugs in 2022, reflecting only spending on Ozempic and Rybelsus because Wegovy was not covered on the time, the paper said. The researchers also projected that Medicare Part D would spend nearly $7.5 billion on Ozempic and Rybelsus in 2023, $3 billion greater than spending on the second-highest reimbursable drug.

They identified that they’d probably “underestimated” their projected spending on semaglutide.

Other drugs which might be expected to be subject to cost negotiations include GSKTrelegy Ellipta, a prescription inhaler used to treat asthma and chronic obstructive pulmonary disease, and Xtandi, a rheumatoid arthritis drug from Astellas Pharma.

However, researchers said the ultimate list of medicine chosen will rely on whether generics come to market before February.

We will probably be closely following the subsequent round of Medicare drug price negotiations, so stay tuned for our coverage.

Please send suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

The data startup Particle Health filed a Antitrust lawsuit against Epic Systems, a software provider that manages medical records of around 280 million patients within the United States

Particle alleges that Epic is using its dominance within the electronic health records space to stifle competition in other markets that use that data. The suit was filed within the Southern District of New York.

Oracle and Meditech are other major players within the electronic health record space, and patient data is usually stored with multiple providers. Still, Epic is a serious competitor. The company has the most important market share within the acute care space within the U.S., covering greater than half of all acute care beds in multiple specialties, based on a report by KLAS ResearchIn addition, Epic is the one provider to see a net increase on this market share in 2023, the report said.

Particle's lawsuit comes after the 2 firms clashed earlier this yr over their data-sharing practices. Epic and Particle are each a part of an interoperability network called Carequality that allows large-scale sharing of patient information.

Epic filed a proper objection to Carequality in March, saying it was concerned that Particle and its participating organizations “may misrepresent the purpose of their data requests.” To join the Carequality network, organizations should be approved to share patient data and cling to “permissible purposes,” which generally relate to treatment.

In its 81-page criticism, Particle claimed Epic's dispute was “constructed” and that Epic had claimed some Particle customers, not Particle itself, had improperly obtained data. Particle said Epic had used its “outsized influence” over Carequality to acquire a positive end result and argued it was harmed by Epic's conduct.

“Unless there are consequences, Epic will have an incentive to reapply this playbook the next time a competitor emerges,” Particle said in a press release on Monday.

Epic said it will “vigorously defend itself against Particle's baseless claims” and proceed to guard patient privacy.

“Particle's claims are without merit. This lawsuit seeks to divert attention from the real issue: Particle's unlawful actions on the Carequality health information exchange network violated HIPAA privacy protections,” an Epic spokesperson said in an announcement to CNBC on Tuesday. “Particle's complaint misrepresents Carequality's decision, which in reality proposes to suspend Particle customers who accessed patient data for improper purposes.”

It will likely be some time before there may be a final ruling, as antitrust cases often crawl. Google, for instance, lost an antitrust case last month that was originally brought in 2020. A U.S. federal judge ruled that the corporate illegally held a monopoly on text promoting and search.

You can read the complete Particle criticism against Epic Here.

Feel free to send suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

The Biden administration on Thursday reached a milestone in Democrats' decades-long effort to make use of Medicare to lower prescription drug costs by announcing latest prices for the primary 10 drugs negotiated between the federal program and drugmakers.

But the announcement is just the start of a contentious, multi-step process that might save taxpayers and older Americans more cash and, over time, put more pressure on drug corporations. It's a key provision of the inflation-fighting bill signed by President Joe Biden, which took effect almost exactly two years ago.

The agreed priceswhich can take effect in 2026, set a precedent for the subsequent round of negotiations starting next yr. These talks are more likely to affect the costs of dozens of other widely used drugs made by the world's largest pharmaceutical corporations in the approaching years.

“I think people should assume this is just the beginning. These are just the first 10 drugs,” says Leigh Purvis, a drug policy director on the AARP Public Policy Institute, an arm of the influential lobbying group that represents people over 50 and advocates for Medicare negotiating powers.

“Sometimes people get upset that their medication is not on the list, even though it will be on the list at some point in the future if they are taking a medication that has a high cost,” Purvis added.

It's unclear how much lower the negotiated prices are than the present net prices of the primary ten drugs heavily discounted by Medicare Part D plans. These net prices aren't publicly available, making it difficult to know the way much a Medicare plan and patient would actually save on a specific drug when negotiated prices take effect in 2026. Copayments could also vary depending on a patient's Part D plan.

“It's hard to know the starting point because … those numbers are not publicly available,” said Tricia Neuman, executive director of the Medicare Policy Program on the health policy research organization KFF, referring to net prices after rebates.

Nevertheless, the Biden administration estimates that the renegotiated drug prices will end in net savings of about $6 billion for the Medicare program and out-of-pocket savings of $1.5 billion for beneficiaries in 2026 alone.

Negotiations “seemed to go relatively smoothly — the overall savings are pretty impressive,” Neuman said. She added that the quantity of savings will increase over time as prices for extra drugs are negotiated in future rounds.

Price negotiations could also put pharmaceutical corporations under greater pressure in the approaching years. Patent protection for a lot of drugs in the primary round of negotiations will soon expire. This will open up the market to cheaper generics, which in turn will result in a lack of sales.

For example, Bristol-Myers SquibbThe pharmaceutical company's blood thinner Eliquis is ready to lose its patent protection within the USA on April 1, 2028. In certain EU markets, patent protection for the successful drug may even expire in 2026.

But over time, drugs which might be much further along of their lack of market exclusivity could also be chosen for future rounds of negotiations, Leerink Partners analyst David Risinger said in a research note on Thursday.

From February 2025The Biden administration will select as much as 15 additional drugs to be subject to the subsequent round of price negotiations, with the brand new prices taking effect in 2027. Manufacturers have until the tip of February to come to a decision whether to take part in this system – a no brainer for the businesses, as they otherwise face high excise taxes or lack of access to the federal Medicare and Medicaid programs.

“It's only going to get more painful as time goes on,” Jeff Jonas, portfolio manager at Gabelli Funds, said in a press release on Thursday. He noted, for instance, that the subsequent round of price negotiations will likely include: Novo Nordisk's best-selling diabetes drug Ozempic.

Jonas added that there was “some speculation that the government had been lenient with pharmaceutical companies this year because, on the one hand, it is an election year and this is the first time they have done something like this.”

After the second round, the Centers for Medicare and Medicaid Services will have the opportunity to barter prices for 15 more drugs that may take effect in 2028. Starting in 2029, that number will rise to twenty per yr.

CMS will select only those drugs for Medicare Part D which might be covered in the primary two years of negotiations. For the round that takes effect in 2028, it is going to add more specialty drugs which might be covered by Medicare Part B and are typically administered by physicians.

This could pose a greater threat to the pharmaceutical industry because prices for drugs under Medicare Part B will not be as high as those for drugs under Part D.

“Because the discounts are limited, I expect they will continue to decline compared to the heavily discounted Part D drugs,” Risinger said in an interview with CNBC, referring to drugs covered by Part B.

Jonas noted that negotiations on price changes in 2028 could include some vital cancer drugs, akin to Merck's blockbuster chemotherapy Keytruda.

Vice President Kamala Harris, the Democratic presidential candidate, will likely attempt to expand the negotiating room and “probably be more aggressive on the discounts” if elected, Jonas said.

But Neuman said it is going to rely upon which party controls the House and Senate whether or not they can pass laws to strengthen that policy. Harris herself needed to solid a tie-breaking vote within the Democratic-dominated Senate to pass the unique bill.

“There is some interest from Democrats in Congress to get this done, but of course the law will depend on which party is in control,” Neuman said.

The pharmaceutical industry argues that the negotiations could lead on to a lack of sales and profits in addition to a lack of innovation in the long run.

For example, Steve Ubl, CEO of PhRMA, the pharmaceutical industry's largest lobby group, said in a press release on Thursday that price negotiations could lead on to a discount within the variety of treatments for cancer, mental illness, rare diseases and other conditions because they “fundamentally change” the incentives for drug development.

Medicare can begin negotiating prices for small molecule drugs as early as nine years after FDA approval, in comparison with 13 years for biologics. Small molecule drugs are made out of low molecular weight chemicals, while biologics are derived from living sources akin to animals or humans.

The industry argues that this distinction will discourage corporations from investing in small molecule drugs.

Good afternoon! The Biden administration's first round of Medicare drug pricing negotiations is almost complete, with two necessary deadlines looming.

President Joe Biden's Anti-Inflation Act gave Medicare the authority to barter drug prices directly with manufacturers for the primary time within the federal program's nearly 60-year history. This process is meant to make expensive drugs more cost-effective for older Americans, however the pharmaceutical industry argues it poses a threat to their revenues, profits and drug innovation.

The government and the manufacturers have been in talks since February, when Medicare submitted its first price offer for every of the ten chosen drugs almost a yr ago. These include diabetes drugs from Merck, AstraZeneca and Boehringer Ingelheim and blood thinners from Johnson & Johnson And Bristol-Myers Squibbincluding medications.

The negotiation phase officially ends next Thursday. Medicare will publish the ultimate agreed prices for the drugs in early September, but the precise timing remains to be unclear.

These prices will come into effect in 2026.

Both the federal government and the pharmaceutical corporations have remained largely silent on the progress of the negotiations. However, the businesses have stated that they’ve factored any impact of the worth negotiations into their long-term financial forecasts.

“We have received the final numbers from the government. We are not disclosing them at this time,” said Jennifer Taubert, J&J's global chair of progressive medicines, during a conference call last week. “While we do not agree with the [Inflation Reduction Act] and the pricing process, those numbers were incorporated into the forecast we presented last year… that still looks very good for us today.”

Meanwhile, Merck and Novartis And Novo Nordisk Lawsuits challenging the negotiations await district court decisions. In each case, the claims overlap with lawsuits filed by AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb and J&J that have been dismissed in recent months.

After this first round of talks, Medicare can negotiate prices for 15 more drugs for 2027 and another 15 in 2028. Starting in 2029, that number increases to 20 negotiated drugs per year.

Vice President Kamala Harris, the leading candidate to succeed Biden as the Democratic presidential nominee after he dropped out of the 2024 presidential race on Sunday, would likely seek to expand negotiating space if elected, experts told CNBC.

Please send tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Nurses are increasingly becoming accustomed to artificial intelligence tools.

Epic Systems, Abridge and Mayo Clinic on Tuesday announced They are developing a brand new AI-powered solution to automate among the notes that nurses must take.

Like doctors, nurses also need to take care of a mountain of administrative tasks comparable to paperwork, and the workload contributes to a high Burn out throughout the healthcare system. At the Mayo Clinic, for instance, which cares for greater than 1.3 million patients worldwide every year, documentation is one in every of the largest problems for nurses, says Ryannon Frederick, chief nursing officer on the Mayo Clinic.

“Right now, in our current environment, they're spending lots of time doing work that's mandatory but doesn't necessarily use their full skills,” Frederick said in an interview with CNBC.

“We need to find ways to make their jobs easier so that we can use their skills, expertise and intelligence where patients need them most,” Frederick added.

Founded in 2018, Abridge originally developed an AI documentation tool for physicians, which it uses in healthcare systems such as Sutter Health, Yale New Haven Health System, Emory Healthcare, and others. When physicians meet with a patient, they can use Abridge to consensually record their conversations and automatically convert them into clinical notes and summaries.

In March, Abridge CEO Dr. Shiv Rao said the company was saving some doctors up to three hours per day. The natural next step is to adapt the technology and make these benefits available to caregivers.

“We say there may be a public health emergency related to clinician burnout and staff shortages, but nowhere is that public health emergency more acute, for my part, than on the nursing side,” Rao said in an interview with CNBC.

Abridge's technology integrates directly with Epic, a healthcare software provider that manages the medical records of more than 305 million people worldwide. Garrett Adams, vice president of research and development at Epic, said the two companies collaborated on the new care tool last year as part of Epic's “Workshop” program. Microsoft's Nuance Communications, which offers a competing AI documentation tool, can also be participating in this system.

Frederick said the Mayo Clinic has seen some early prototypes of Abridge's care tool and tested it in a simulation center, but it surely's still early days. It's necessary to be certain the answer actually solves their staff's problems, she said, so the Mayo Clinic will proceed to check and evaluate it before rolling it out on a bigger scale.

Abridge plans to make its nursing documentation tool available to other healthcare organizations in the longer term.

Feel free to send suggestions, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

A federal judge in New Jersey refused on Monday Johnson & Johnson's and Bristol Myers SquibbThe administration mounts legal challenges to the Biden administration's Medicare pricing negotiations, ruling this system is constitutional.

The decision is one other victory for the White House in a bitter legal battle with several drugmakers over price negotiations. The ruling also weakens the drug industry's strategy of looking for separate rulings in lower courts scattered across the U.S., which could lead to the matter moving to the Supreme Court.

Medicare drug price negotiations are a key measure under President Joe Biden's Inflation Reduction Act, which goals to make expensive drugs more cost-effective for seniors. This could reduce drug manufacturers' profits. Final negotiated prices for the primary round of negotiated drugs, which include one each from J&J and Bristol Myers, will take effect in 2026.

J&J plans to appeal the choice, a spokesperson said in an announcement to CNBC.

“This is a disappointing decision for patients and America’s leadership in medical innovation,” they added.

Bristol Myers Squibb didn’t immediately reply to requests for comment on the ruling.

In separate lawsuits, the drugmakers argued that the negotiations constituted an unconstitutional government seizure of their drugs and a violation of their right to free speech. They also argued that the interviews were an unconstitutional requirement for participation within the Medicaid and Medicare programs.

But Judge Zahid Quraishi of the District of New Jersey wrote in a 26-page opinion that participation in price negotiations and the Medicare and Medicaid markets is voluntary.

The negotiations didn’t require drugmakers to “defer, hold, or otherwise reserve their drugs for use by the government or Medicare recipients,” he wrote. Quraishi added that the talks wouldn’t force manufacturers to physically transport or transport drugs at a renegotiated price.

“Selling to Medicare may be less profitable than it was before the program was implemented, but that doesn’t make sense.” [J&J and Bristol Myers Squibb’s] “The decision to participate is less voluntary,” Quraishi wrote. “For the reasons presented, the court concludes that the program does not result in either physical ingestion or direct appropriation” of medicines from the 2 drug manufacturers.

J&J, Bristol Myers Squibb, Novo Nordisk and Novartis presented their oral arguments before Quraishi through the same hearing in March.

That same month, a federal judge in Delaware rejected AstraZeneca's separate lawsuit difficult the negotiations. In Texas, a 3rd federal judge dismissed a separate lawsuit in February.

A federal judge in Ohio also issued a ruling in September rejecting an injunction from the Chamber of Commerce, one in all the country's largest lobbying groups, that sought to dam price negotiations before Oct. 1.