Medicare plans to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, a major policy shift that could make it easier for patients to access new treatments entering the US market.

The proposal would abolish the current Medicare policy nationwide. Currently, the Seniors Program will cover one PET scan per age for patients participating in clinical trials.

Medicare’s proposal would allow regional organizations, called Medicare Administrative Contractors, to decide whether to cover the diagnostic tool. These regional contractors make coverage decisions based on whether the service is “reasonable and necessary” for a diagnosis.

Chiquita Brooks-LaSure, president of the Centers for Medicare and Medicaid Services, said in a statement Monday that the proposed policy “fulfills CMS’s commitment to allow broader coverage of this diagnostic test.” A CMS spokesperson said a final decision could come within 90 days.

Positron emission tomography scans are an important diagnostic tool that detects the presence of a protein amyloid in the brain associated with Alzheimer’s disease. Screenings are the most common way to help diagnose patients.

People on Medicare generally pay 20% of the cost of a PET scan after the deductible is met. The cost of a one-time scan would be about $313 per patient, according to one estimate in a study published in the medical journal JAMA Internal Medicine.

doctor. It’s possible for regional contractors to come to different coverage decisions for PET scans, said Sean Tunis, CMS’ former chief medical officer. But these organizations generally work together on key issues and there’s no reason to think their policies on PET scans will differ widely across the United States, said Tunis, now a consultant at Rubix Health.

Medicare’s coverage of PET scans should make it easier for patients to access new treatments like Leqembi, which was approved by the Food and Drug Administration earlier this month.

Medicare agreed to cover Leqembi’s treatment for Eisai and Biogen’s Alzheimer’s, but requires patients diagnosed with mild cognitive impairment or mild Alzheimer’s disease with documented evidence of amyloid on the brain.

Most patients choose positron emission tomography to confirm the presence of amyloid because imaging is less invasive than alternative diagnostic tools such as spinal taps. Blood tests are also in development, and some are already in use, but not yet widely deployed.

Medicare said it would also cover other antibody therapies for Alzheimer’s with the same terms if they receive approval from the Food and Drug Administration. Eli Lilly The US Food and Drug Administration (FDA) expects to make a decision on its treatment, donanimab, by the end of the year.

The Alzheimer’s Association, a pressure group that advocates for people living with the disease, said the new policy proposed by Medicare would remove unnecessary barriers for patients. Maria Carrillo, the consortium’s chief scientific officer, called the decision “a huge step forward”.

Uninsured Americans pay an average of nearly $98 for a bottle Eli Lillygeneric insulin, even after the company pledged to lower the product’s list price to $25 per vial, according to a report released Thursday by the senator. Elizabeth Warren.

Eli Lilly pledged earlier this year to lower the list price of the generic insulin, Lispro, from $82.42 per vial starting May 1. The Indianapolis-based pharmaceutical company is one of the largest insulin manufacturers in the world.

The Massachusetts senator’s report surveyed more than 300 pharmacy chains and independents in the United States between June 9 and 28 to determine whether the price reduction announced by Eli Lilly “translated into real patient relief.”

The survey found that a third of pharmacies charge uninsured patients $164 or more for a bottle of Eli Lilly’s Lispro.

Seven pharmacies charged $200 per bottle or more, and two sold the product for more than $300.

Chain pharmacies charged uninsured customers an average of $123 per vial for generic insulin, compared to an average of $63 at independent pharmacies.

Eli Lilly did not immediately respond to CNBC’s request for comment on the poll.

The study findings indicate that “Eli Lilly’s promises of affordable insulin have not been delivered to uninsured patients across the country,” Warren said in a statement.

She said the data also shows that Congress needs to take more steps to rein in excessive pricing, such as capping insulin fees at $35 per month for all patients, regardless of their insurance status.

President Joe Biden’s Inflation Reduction Act currently sets co-insulin amounts at $35 per month for people covered by Medicare.

“My new report confirms that far too many uninsured Americans do not have access or cannot afford to pay astronomical prices for life-saving universal insulin — lawmakers need to step up and take action,” Warren said in a press release.

Insured Americans usually pay a fraction of the list price of insulin. But uninsured people often have to pay the full cost, which could force them to ration or stop taking a life-saving diabetes treatment.

Nearly 30% of uninsured diabetics reported skipping insulin doses, taking less than prescribed or delaying purchases within the past year, Warren said, citing a 2022 study conducted by researchers from Harvard University and other institutions.

“No American should ever be forced to choose between life-saving medications, such as insulin, and their ability to pay for food, shelter, and their daily needs,” Warren said.

Earlier this year, Eli Lilly, Sanofi And Novo Nordisk is committed to reducing the list prices of the most commonly prescribed types of insulin by at least 70% later in 2023.

Eli Lilly and Sanofi also set monthly insulin costs at $35 for people with private insurance.

The three companies together control 90% of the global insulin market.

Their commitments were met with praise from lawmakers and Biden, who was pleased that the companies were finally heeding the calls to help make diabetes care more affordable in the United States.

But the Warren poll raises questions about the effectiveness of cost-cutting efforts.

About 37 million people in the United States, or 11.3% of the country’s population, have diabetes, according to the Centers for Disease Control and Prevention.

The American Diabetes Association said nearly 8.4 million people with diabetes are insulin dependent.

Pfizer On Monday, it said it would stop development of an experimental obesity and diabetes pill, called lutigliprone, because of elevated liver enzymes in patients who took the drug once daily in clinical studies.

These elevated enzymes often indicate damage to liver cells, but the pharmaceutical giant said no patients experienced liver-related symptoms or side effects.

Pfizer shares closed down 3.6 percent on Monday.

New York-based Pfizer said it would instead focus on its other oral obesity drug, danoglipron, which is in fully registered phase II clinical trials.

That study found that body weight decreased after patients with type 2 diabetes took high doses of danuglipron twice daily for 16 weeks, according to Pfizer results released last month.

The company expects to complete plans for a Phase 3 clinical trial program for danuglipron by the end of 2023. Pfizer added that it is also developing a version of danuglipron that patients take once a day instead of twice.

“We look forward to analyzing danuglipron’s Phase 2 results and selecting the dose and titration schedule that will maximize therapeutic benefits, safety, and tolerability,” William Sessa, Pfizer’s chief scientific officer for internal medicine, said in a press release.

Pfizer CEO Albert Bourla said the obesity pill could eventually bring in $10 billion each year for the company.

Lotiglipron, danuglipron, and Novo NordiskThe popular weight loss injections Ozempic and Wegovy are part of a class of medications called glucagon-like peptide-1 agonists.

They mimic a hormone produced in the gut called GLP-1, which sends signals to the brain when a person is full.

Medications can also help people manage type 2 diabetes because they stimulate the release of insulin from the pancreas, which lowers blood sugar levels.

Oral medications such as danuglipron from Pfizer can offer an advantage over frequent injections. Novo Nordisk and Eli Lilly They are also developing their own experimental pills for obesity and diabetes.

The new class of obesity drugs is sparking public interest and causing the weight-loss industry to go gold. But there is still uncertainty about its accessibility, and questions remain about how long patients need to take the drugs to shed unwanted weight.

Some people who stop taking medications complain of a return of weight that is difficult to control.

More than 2 in 5 adults are obese, according to the National Institutes of Health. About 1 in 11 adults is obese.

Analysts believe Eli Lilly’s pill has an edge over Pfizer’s danuglipron.

Pfizer’s decision to compete in the oral weight-loss drug space with danuglipron will be challenging given the strong data on Eli Lilly’s experimental pill orforglipron, Wells Fargo analyst Mohit Bansal said in a research note Monday.

Overweight or obese patients who took orforglipron once a day lost 14.7% of their body weight after 36 weeks, according to clinical trial results released by the company on Friday.

Bansal added that doctors generally prefer a one-a-day pill such as orforglipron over twice-daily danuglipron: “Depending on convenience, tolerability, and volume of weight loss, Forglipron is likely to be the factor to overcome,” Bansal added.

Leqembi’s new Alzheimer’s antibody treatment could cost Medicare up to $5 billion a year, according to research published in a leading medical journal this week.

Medicare will spend about $2 billion annually if about 85,700 patients test positive for the disease and are treated with Esay And Biogen Leqembi product, according to research published in JAMA Internal Medicine on Thursday.

According to the study, the program for seniors would spend $5 billion if about 216,500 patients became eligible for the staggering treatment.

The authors said the estimated costs for Medicare are conservative, and spending on Leqembi may increase more than expected depending on demand and other factors.

The researchers who conducted the JAMA study included physicians, along with Public health and policy experts. They are affiliated with the University of California Los Angeles, the Rand Corporation, Harvard Medical School, and Beth Israel Deaconess Medical Center in Boston, among other institutions.

Eisai and Biogen have priced twice-monthly antibody injections at $26,500 per year.

There are also an estimated $7,300 in additional annual costs per patient associated with neurologist visits, MRI exams, PET scans, injection administration, and monitoring and treatment for potential side effects, according to the researchers.

The study assumed that Medicare would cover 80% of the costs with patients left to pay the remaining 20% ​​in whole or in part depending on whether they had supplemental insurance.

Patients may face an annual bill of about $6,600 per year depending on which state they live in and whether they have supplemental insurance, according to the study. Some low-income people who qualify for Medicare and Medicaid will pay nothing out of pocket.

The Alzheimer’s Association, which lobbies on behalf of patients living with the disease, estimates that Alzheimer’s and other forms of dementia will cost $345 billion this year. Those costs could rise to $1 trillion by 2050, according to the association.

“This is the case without a cure. Prevention and treatment are the only way to reduce this cost over time,” Robert Egge, the federation’s chief of public policy, said in a statement.

“But it’s not the cost that should determine whether people have access to life-enhancing care — it’s about the impact on people,” Egge said. “Therapies taken in the early stages of Alzheimer’s disease can mean a better quality of life.”

Leqembi had a positive effect on patients with early-onset Alzheimer’s disease in clinical trial results published in the New England Journal of Medicine in January.

The expensive treatment is not available to the vast majority of patients right now because Medicare has severely restricted antibody coverage.

Medicare has promised broader coverage for Leqembi if the US Food and Drug Administration (FDA) grants full approval of the treatment in July. Leqembi received emergency approval from the Food and Drug Administration in January.

The Alzheimer’s Association, members of Congress and state attorneys general are pressing for Medicare to repeal its restrictions and fully cover Leqembi.

Antibody therapy, which targets brain plaques associated with the disease, slowed cognitive decline by 27% in the Eisai clinical trial.

There are currently no other medications on the market that have shown this level of effectiveness in slowing Alzheimer’s disease. Eli Lillydonanemab showed promising clinical trial results earlier this month. The company plans to apply for full FDA approval this quarter.

Leqembi and donanemab both carry serious risks of brain swelling and bleeding.

CEOs of the three pharmaceutical companies that control 90% of the global insulin market will testify May 10 before the Senate Health Committee on price cuts for diabetes drugs, according to committee chair Sen. said Bernie Sanders on Friday.

Those companies — Eli Lilly, Novo Nordisk and Sanofi — announced in March that they would cut prices of their most widely used insulin products by 70% or more.

On Friday, Sanders called the move an important step forward that was the result of “public outrage and strong grassroots efforts.”

But the Vermont Independent added that Congress must ensure insulin, which has increased in price by more than 1,000% since 1996, is affordable.

“We must, however, make sure that those price cuts take effect in a way that results in every American getting the insulin they need at an affordable price,” Sanders said in a statement announcing the scheduled testimony of Eli Lilly CEO David Ricks. Paul Hudson, CEO of Sanofi, and Lars Froergaard Jørgensen, CEO of Novo Nordisk.

Sanders noted that corporate versions of insulin cost at least $275 before the announced price cuts.

Eli Lilly declined to comment when asked about the scheduled hearing. A Sanofi spokesperson said the company supports efforts to reduce costs and believes other parts of the healthcare system need to do more to help patients. Novo Nordisk said its CEO looks forward to a “productive and collaborative discussion on this important issue.”

CEOs of the three major pharmacy benefits directors CVS Healthand Express Scripts Optum Rx Also testifying, according to Sanders’ office, those executives are David Joyner, president of CVS Health Pharmacy Services. Adam Kautzner, President, Express Scripts; and Heather Cianfrocco, CEO, Optum Rx

Pharmacy benefit managers are the middlemen who negotiate drug prices with manufacturers on behalf of health insurance plans. PBMs have been criticized for inflating drug prices and not giving consumers all the discounts they negotiate.

The Department of Health and Human Services estimates that 17% of patients using insulin in 2021 had to ration the drug due to rising costs.

About 19% of insulin users with private insurance metered the drug, and 29% of uninsured insulin users did, according to HHS.

The drug companies’ decision to lower insulin prices came a month after President Joe Biden called in his State of the Union address to Congress for a cap on insulin prices at $35 per month.

The Biden Inflation Act capped people on Medicare, the government-run health coverage program primarily for seniors, but the law did not cover people with private insurance.

According to HHS, more than two million patients with diabetes who take insulin are privately insured.

The department says about 150,000 patients taking insulin will not have insurance.

On Thursday, two senators, Jane Shaheen, D-NH, and Susan Collins, R-Maine, introduced bipartisan legislation that would require private health insurance to set prices at $35 per month for at least one of every type and dose of insulin. The bill includes other measures to reduce prices.

Types of insulin include rapid, short, intermediate, and long-acting, as well as pre-mixed. Dosage forms include vials, pens, and inhalers.

CNBC’s Jim Cramer on Wednesday told investors to consider adding stocks of well-established consumer packaged goods companies to their portfolios.

“No one is defending what actually works: the old consumer packaged goods names we all know,” he said.

Cramer highlighted the latest quarterly results of three companies as examples of why investors should have such stocks on their shopping lists:

“I bet we get something similar from him Bristol MyersAnd the coca cola And the Eli Lilly [when they report earnings]” He said.

Kramer also reiterated two points he’s made throughout this year: investing in boring companies with strong balance sheets and avoiding money-losing companies likely to struggle in a recessionary environment.

“The stocks that historically have held up best in downturns have lost in cabinet reshuffle—high-quality companies, good capital with good balance sheets, big buybacks, and meaningful dividends.” He said.

Disclaimer: Cramer’s Charitable Trust owns shares in Procter & Gamble, Johnson & Johnson, and Eli Lilly.

Drugmaker Eli Lilly, one of Indiana’s largest employers, said a new state law restricting abortions would cause the company to grow away from its native land.

Lilly said in a statement Saturday that she recognizes abortion as a “highly contentious and personal issue and there is no clear consensus among Indiana citizens.”

“Despite the lack of agreement, Indiana chose to swiftly adopt one of the most restrictive anti-abortion laws in the United States,” said Eli Lilly. “We are concerned that this law will impede Lilly’s – and Indiana’s – ability to attract diverse scientific, engineering and business talent from around the world. Due to this new law, we will have to plan for further employment growth outside of our home state.”

The Indiana state legislature on Friday became the first in the country to pass new legislation restricting access to abortions since the US Supreme Court overturned Roe v. valley. The state was among the earliest Republican-run state legislatures to debate stricter abortion laws after a June Supreme Court ruling that removed constitutional protections for the procedure.

Lilly employs approximately 10,000 people in Indiana, having been headquartered in Indianapolis for more than 145 years.

Cummins, an engine maker that also employs about 10,000 people in Indiana, spoke out over the weekend against the new law as well.

“The right to make decisions about reproductive health guarantees women the same opportunities as others to participate fully in our workforce and the diversity of our workforce,” a company spokesperson said in a statement.

“There are provisions in the law that conflict with this, affect our employees, and impede our ability to attract and retain the best talent and influence our decisions as we continue to grow our footprint with an emphasis on choosing welcoming and inclusive environments,” a Cummins spokesperson said.

The two companies join a growing list of companies, including tech giant Apple and retailer Levi Strauss, that provide their employees with reproductive care resources in states where restrictions have been imposed.

Eli Lilly noted Saturday that although the drug company has expanded its employee health plan coverage to include travel for reproductive services, “that may not be enough for some current and potential employees.”

An abortion ban in Indiana is expected to go into effect on September 1. 15. Comes with some exceptions, including cases of rape or incest and protection of the mother’s life.

The administration of President Joe Biden also condemned Indiana’s decision. White House press secretary Karen-Jean-Pierre called it a “devastating move.”

“It’s another drastic step by Republican lawmakers to usurp women’s reproductive rights and freedom, and to put personal health care decisions in the hands of politicians, not women and their doctors,” she said in a statement.