The merger comes amid growing concern that healthcare consolidations among payers and providers are driving up costs.
Elevance Health, Inc. will buy Blue Cross and Blue Shield of Louisiana and put the health insurer under its multistate Anthem umbrella, the payers announced Monday.
Financial terms were not disclosed.
The deal is expected to close this year, pending regulatory approval, and nonprofit BCBSLA, which serves about 1.9 million Louisianans, roughly one-third the state's population, will become an affiliate of Elevance's Anthem Blue Cross Blue Shield network, which now operates plans in 14 states covering about 47 million people.
"Elevance Health and Blue Cross and Blue Shield of Louisiana will combine strengths to provide services unique to the needs of Louisiana to better serve members through a whole health personalized approach," Elevance President / CEO Gail Boudreaux says in a media release.
"As organizations aligned in our missions, we are excited at the opportunity to bring our leading, innovative whole-health solutions to BCBSLA's members as we work together to become a lifetime, trusted health partner," she says.
The proposed merger comes amid growing concern that healthcare consolidation among payers and providers is driving up the cost of healthcare. A 2022 report by the American Medical Association found that “that the majority of health insurance markets in the United States are highly concentrated.”
“Coupled with external evidence on their anticompetitive behavior, this strongly suggests that health insurers are exercising market power in many parts of the country and, in turn, causing competitive harm to consumers and providers of care," the AMA report concluded.
As mergers in the healthcare sector involve larger and larger players, payers and providers blame each other for concurrent rising healthcare costs, each side saying they need a bigger footprint when negotiating prices with one another. Ultimately, of course, it is the consumer who foots the bill.
HealthLeaders' Emails Monday afternoon to Elevance and BCBSLA asking for the financial details and the potential effect on consumers were not returned.
Boudreaux says the acquisition builds on an existing joint ownership the two payers share for Healthy Blue, which serves the Louisiana's Medicaid and Medicare Dual Eligible enrollees.
The payers say the acquisition will also allow BCBSLA to access Carelon, Elevance's healthcare services organization that specializes in behavioral health, complex and chronic care programs, and innovative digital models.
Steven Udvarhelyi, MD, president / CEO of BCBSLA says the sale of the 90-year-old company was needed to "remain strong in today's environment with an ability to provide leading innovations, products and capabilities."
"We concluded that we needed a partner that could help us deliver these faster and better than we could alone," Udvarhelyi says. "Aligning with Elevance Health - a national health care organization that has been our trusted partner since 2017 - will allow us to accelerate our mission of improving the health and lives of Louisianians,"
When the deal is finalized, BCBSLA headquarters will remain in Baton Rouge and keep its workforce of about 3,000 employees.
The payers say the deal will also create "a multibillion-dollar foundation, the Accelerate Louisiana Initiative."
"This foundation is being created to address the unique and complex needs of the people of Louisiana with the mission to improve the health and lives of the people of Louisiana by addressing health inequities and strengthening local communities," the companies say.
Regulators want more evidence that the pricey drug works.
The Food and Drug Administration has rejected fast-track approval for Eli Lilly and Co.'s Alzheimer's drug donanemab, telling the company that it must produce more research showing the pricey drug's efficacy is needed before they'll green light it.
In a media release Thursday night announcing the decision, Indianapolis-based Lilly says the FDA "specifically requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab."
"While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as 6 months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab," Lilly says. "The FDA indicated that the data to meet the exposure expectation would likely need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion."
No other shortcomings in the application were noted by the FDA.
Lilly says an expanded Phase 3 clinical trial for the drug is underway and will be completed this year. The drug maker says it is confident that those results will prove the efficacy of the monoclonal antibody treatment and they plan to resubmit an application for fast-track status.
"We look forward to our upcoming confirmatory TRAILBLAZER-ALZ 2 Phase 3 results and subsequent FDA submission, which we've always seen as the most impactful next steps for patients," Lilly Neuroscience President Anne White says.
"We anticipate this study will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ Phase 2 study and believe that patients and physicians will be well served by having the full Phase 3 data available alongside our Phase 2 data when they need to make treatment decisions," White says.
"We are committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need."
The FDA has already granted limited fast-track approval for two similar Alzheimer's treatments; Biogen and Eisai's aducanumab, and BioGen's lecanemab (Leqembi). The three drugs target beta amyloid protein accumulations in the brains of Alzheimer's patients.
An independent analysis estimates that donanemab would be cost-effective at a price of about $20,000 a year, but with the caveat that the true cost-effectiveness will not be known until at least the results of the Phase 3 trials are completed. Leqembi cost-effectiveness threshold is about $26,500 a year, and aducanumab's is about $23,000 a year.
UsAgainstAlzheimer's COO Russ Paulsen offered a mixed reaction to the FDA's action.
"While we are disappointed this treatment won't be made available to patients sooner, the reason why is encouraging: donanemab worked too well to meet the criteria required by the FDA," Paulsen says.
"The FDA requires a minimum of 100 patients to be on the drug for at least twelve months but, due to donanemab's quick action in some patients, many were able to stop treatment in as little as six months. We are very encouraged by that and look forward to learning even more about donanemab's effectiveness when Lilly releases its Phase 3 trial data later this year in advance of its application for traditional FDA approval."
CEO says layoffs 'a difficult but necessary step' to reduce workforce redundancies and 'transition to more balanced growth of revenue and profitability.'
Telehealth provider Teladoc Health, Inc. says it will cut about 6% of its nonclinical workforce — roughly 300 jobs – as part of a cost-cutting and restructuring plan.
In a letter this week to employees, Teladoc CEO Jason Gorevic, calls the move "a difficult but necessary step" to reduce redundancies in the workforce brought on by recent mergers and "transition to more balanced growth of revenue and profitability."
"At this stage in both our evolution as an enterprise and given the challenged economic environment, we believe that balanced growth is the right step for us as a well-run company," Gorevic says. "And so, after taking several non-people cost-saving actions, including ongoing real estate and systems consolidations, we concluded that today's moves were necessary."
"As some team members leave, we will also be making changes to our organizational structure to streamline our work and best capture the opportunities ahead," Gorevic says, including a "further review of our real estate footprint and return on vendor investments."
In an 8-K filing with the Securities and Exchange Commission, Purchase, New York-based Teledoc says it "incurred approximately $4.4 million in pre-tax charges in Q4 2022, including about $2 million in costs related to employee transition, severance payments, employee benefits, and related costs, and approximately $2.4 million in exit costs associated with the office space reductions.
Under its restructuring plan, Teledoc says it anticipates "approximately $17 million in pre-tax charges in 2023, consisting of $9 million for employee transition, severance payments, employee benefits, and related costs expected to be realized in Q1 2023, and $8 million of exit costs associated with office space reductions expected to occur by Q2 2023."
From its pre-tax charges in 2023, Teledoc expects to incur about $10 million in expenditures related to the layoffs, and a $6 million reduction in stock-based compensation in Q1 2023 from forfeited stock awards.
In his letter to employees, Gorevic says the layoffs "put our company on an improved path to profitability and necessitates our collective focus on our commercial business priorities - Primary 360, chronic care management, mental health and delivering true whole person care – along with continued growth in our BetterHelp consumer brand."
"We know that more than half our commercial buyers want the integrated, whole person strategy that we offer, and delivering value across our businesses is of even greater importance in this economy," he says. "At the same time, we will continue to make significant innovation investments to ensure that our whole person offering is seamless and comprehensive."
"These actions put us on an even stronger financial footing at a time when many of our competitors are questioning their ability to keep their doors open."
The laid-off employees will get: a severance package payout based on years of service and grade level; bonus payments for 2022; subsidized COBRA benefits; access to free therapy from Teledoc's in-house BetterHelp; and job search support.
In his letter to employees, Gorevic concedes that he doesn't know if this week's action "is the beginning of ongoing layoffs or the precursor to further disruption in our company."
"What I can promise you is that today's actions were based on our best assessment of our current business needs, with the sole intent of putting us on a better path to top and bottom-line growth," he says.
Suzan Berro submitted fake reimbursement claims to several drugmakers' co-pay assistance programs.
A Michigan woman has been convicted of wire fraud and related charges for her role in a years-long scheme to steal more than $65 million from several drug co-pay help programs, the U.S. Department of Justice says.
Suzan Berro, 23, of Dearborn, was convicted on Friday after a six-day trial in U.S. District Court in Detroit. She will be sentenced on May 1, when she faces a maximum of 20 years in prison on each count.
According to court documents and evidence presented at trial, Berro submitted fake reimbursement claims to several drugmakers' co-pay assistance programs that provide patients with "coupons" to offset the often-high costs of name brand prescription drugs.
Prosecutors showed that for nearly one year Berro was a biller for multiple pharmacies. She created fake prescriptions for fake patients using addresses from real estate lists, making up names and birth dates, selecting expensive name brand, and then ultimately pairing them with real doctors' names and credentials.
The evidence showed that the conspiracy went to great lengths to make the supposed patients appear real, including ensuring that all three addresses—the real doctor, the fake pharmacy, and the made-up patient—were in close, geographic proximity. However, witnesses said that most of pharmacies only existed on paper, were never opened to the public, nor did they order inventory.
Berro and her co-conspirators submitted bogus claims on behalf of more than 40 pharmacies, totaling over $65 million.
"This was a complicated scheme that abused dozens of programs established to help those who are legitimately unable to afford their medications," says Dawn N. Ison, U.S. Attorney for the Eastern District of Michigan.
Eli Lilly, Novo Nordisk, Sanofi, CVS Caremark, Express Scripts, and OptumRx are accused of overcharging patients.
California Attorney General Rob Bonta on Thursday filed a lawsuit against the nation's biggest insulin makers and pharmacy benefits managers, accusing them of using deceptive, illegal and unfair schemes to drive up the cost of the lifesaving drug.
The 47-page suit, filed in California Superior Court in Los Angeles, accuses drug makers Eli Lilly, Novo Nordisk, and Sanofi, and PBMs CVS Caremark, Express Scripts, and OptumRx, of leveraging their vast market power to overcharge patients, a violation of the state's Unfair Competition Law.
"Insulin is a necessary drug that millions of Americans rely upon for their health, not a luxury good," Bonta says. "With today's lawsuit, we're fighting back against drug companies and PBMs that unacceptably and artificially inflate the cost of life-saving medication at the expense of vulnerable patients."
Bonta is asking the court to order the defendants to stop their unfair business practices outlined in the suit and provide restitution for consumers who have been victimized by the scheme, and issue civil fines of $2,500 for each violation of state law.
More than 3 million Californians are diabetic, about 10% of the state's population, Bonta says, and their insulin is so pricey that many can't afford it, even the insured, and are forced to ration doses, sometimes with deadly consequences.
Those facts are in line with a 2021 report that found that insulin costs roughly 10 times more in the United States than in other countries. Other studies have shown that the high insulin prices disproportionately hurt poor people and communities of color. The California Department of Public Health reports that Hispanic and Black people are much more likely to be diagnosed with Type-2 diabetes than non-Hispanic white people, and much more likely to die as a result of complications from it.
"No one should be forced to ration or go without basic medication that could mean the difference between life or death," Bonta says. "California will continue to be a leader in the fight to ensure everyone has equal access to affordable healthcare and prescription medications they need to stay healthy."
The lawsuit notes that the three drug makers named in the suit produce more than 90% of the global insulin supply, and that the three PBMs manage 80% of insulin prescription claims. Using their market stranglehold, Bonta alleges, the defendants "work in lockstep… to keep aggressively hiking the list price of insulin at the expense of many patients."
The lawsuit asserts that manufacturers and PBMs are complicit in the gouging, with drug makers setting insulin's list price and PBMs negotiating for rebates on behalf of health plans. The rebates are based on a percentage of list price, so manufacturers raise their list prices to get the biggest rebates they can offer PBMs
"PBMs are often paid for their services with a portion of the rebate they have negotiated," the suit says. "This creates an incentive to negotiate a drug with a higher rebate, not necessarily the lowest price for consumers. As a result, the drug becomes unaffordable for uninsured or underinsured patients, who have to pay the full price of insulin. High list prices also make insulin unaffordable for other patients as well, including those with high deductible health plans or coverage gaps."
Defendents Respond
CVS Health issued a statement denying the allegations raised in the suit and saying it will "vigorously defend against this complaint."
"Pharmaceutical companies alone set the list price for their products," the company says. "Nothing in our agreements prevents drug manufacturers from lowering the prices of their insulin products and we would welcome such action. Allegations that we play any role in determining the prices charged by manufacturers are false."
A Novo Nordisk spokesperson says the drug maker does not comment on active litigation. However, the company issued a statement not specific to the suit which claims that Novo Nordisk's net prices for insulin have declined over the past five years "due in large part to the significant rebates and discounts manufacturers pay to ensure access for patients."
The company says that about 100,000 diabetics got free insulin from Novo Nordisk every year, and that more than 1 million get some form of financial assistance from the drug maker. The company has also extended its insulin program with Walmart that sells the drug for $25 per vial, and has seen "meaningful uptake" for its My$99Insulin program.
"However, we know there are people who continue to struggle to afford their insulin and that not one single solution will work for everyone," the statement reads.
Optum Rx issued a statement saying that PBMs negotiate for lower prices on behalf of consumers and "are the only participants in the prescription drug supply chain whose role is to reduce drug costs." The PBM says it has eliminated out-of-pocket costs on several prescription drugs, including insulin,
"Optum Rx welcomes the opportunity to show the California Office of the Attorney General, just as it has with other States Attorneys General, how we work every day to provide people with access to affordable drugs, including insulin," the statement reads.
Quadrupling the price of COVID-19 vaccine would make it too expensive for millions of Americans, the Vermont Independent says.
Railing against "unacceptable corporate greed," U.S. Senate firebrand Bernie Sanders is warning the billionaire executives at Moderna to "reconsider and refrain" from rumored plans to quadruple the price of their COVID-19 vaccine.
In a letter this week to Moderna CEO Stéphane Bancel, Sanders, I-VT, the incoming chairman of the powerful Health, Education, Labor and Pensions (HELP) Committee, expresses alarm about media reports that the drug maker will raise the price of its COVID-19 vaccine by as much as $110 to $130 per dose, more than four times the $26.36 cost that the federal government paid.
Sanders says the price hike is "particularly offensive" because the federal government directly provided $1.7 billion to Moderna's COVID-19 vaccine research and development, and guaranteed the company billions more in sales.
"The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients. Your decision will cost taxpayers billions of dollars," Sanders says in his letter.
"Your outrageous price boost will also increase private health insurance premiums. Perhaps most significantly, the quadrupling of prices will make the vaccine unavailable for many millions of uninsured and underinsured Americans who will not be able to afford it. How many of these Americans will die from COVID-19 as a result of limited access to these lifesaving vaccines?"
Moderna did not respond Wednesday to HealthLeaders' request for comment.
Sanders cites estimates that the cost of producing the vaccine is about $2.85 per dose – 2.2% of what Moderna plans to charge. At the same time, he notes that Moderna has pocketed more than $19 billion in profits off of the COVID-19 vaccine.
Top executives at Moderna have become billionaires off vaccine profits, Sanders notes, citing a Forbes estimates that Bancel is worth $6.1 billion, Moderna Chairman / Co-founder Noubar Afeyan is worth $2.1 billion; Co-founder Robert Langer is worth $2.2 billion; and founding investor Timothy Springer is worth $2.6 billion.
"Further, my understanding is that Moderna approved a $926 million golden parachute for you once you leave the company along with $160 million for Stephen Hoge (Moderna's president) and $53 million for Juan Andres (Moderna's chief technical officer)," Sanders writes. "The purpose of the recent taxpayer investment in Moderna was to protect the health and lives of the American people, not to turn a handful of corporate executives and investors into multi-billionaires."
Sanders says the "profiteering has taken place in the midst of the worst public health crisis in America in 100 years," with COVID-19 claiming 1.1 million Americans over the past three years, and sickening more than 100 million others.
"Now, in the midst of a continuing public health crisis and a growing federal deficit, is not the time for Moderna to be quadrupling the price of this vaccine," he writes. "Now is not the time for unacceptable corporate greed."
In a conference call Wednesday morning with reporters, Health and Human Services Secretary Xavier Becerra says the Centers for Medicare & Medicaid Services will publish the first 10 high-cost Medicare Part D drugs picked for negotiations on Sept. 1. The "negotiated maximum fair prices" for the drugs to be announced on Sept. 1, 2024, and the prices will take effect on Jan. 1, 2026.
Following the outline laid out in the Inflation Reduction Act, CMS will pick another 15 Part D drugs for 2027, 15 more Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year after that.
Lowering the cost of prescription drugs is a key component of the Act, which President Joe Biden signed into law in August, 2022. It gives CMS, for the first time in history, the authority to set drug prices, which Becerra says will lower out-of-pocket costs for millions of Medicare enrollees.
"Thanks to the Inflation Reduction Act, we finally have the authority to get American families the lower prescription drug costs they deserve," Becerra says. "Today we are releasing our plan for how we will implement Medicare drug price negotiation under this landmark law — and we will be transparent and aggressive in implementation every step of the way."
The program is fiercely opposed by the pharmaceutical industry. Pharmaceutical Research and Manufacturers of America (PhRMA) President / CEO Stephen J. Ubl in August blasted HHS’s newly bestowed authority, calling it "a partisan set of policies that will lead to fewer new treatments and doesn’t do nearly enough to address the real affordability problems facing patients at the pharmacy."
"We will explore every opportunity to mitigate the harmful impacts from the unprecedented government price setting system being put in place by this law," Ubl said. "We will continue to advocate for policies that give patients better and more affordable access to lifesaving treatments and for a system that supports innovation."
CMS Administrator Chiquita Brooks-LaSure says the negotiations will not be done in a vacuum, and that her agency "will engage with the public early and often," including Medicare and consumer advocates, drug makers, providers, pharmacies, and Medicare Advantage and Part D plans.
"We are proactively seeking feedback and insights from a broad range of interested parties throughout implementation of this historic law," she says.
Meena Seshamani, MD, CMS deputy administrator and director of the Center for Medicare, says public feedback will play a critical role in the successful implementation of the new law.
"Through this detailed timeline, we offer stakeholders the predictability they need to contribute to our implementation efforts," Seshamani says. "We want the public to know when and how they can make their voices heard on forthcoming policies."
IRA Savings Touted
Becerra also notes that Medicare enrollees are already feeling the financial benefits from several provision of the Inflation Reduction Act, including: free preventive Tdap and shingles vaccines; and a $35 monthly cap on out-of-pocket costs insulin.
In addition, the IRA requires drug makers to provide rebates to Medicare for drug prices that outpace inflation. That mandate took effect on Oct. 1, 2022 for Part D drugs, and Jan. 1, 2023 for Part B.
The IRA also authorized health insurance subsidies during its ongoing Marketplace Open Enrollment that the Biden administration says will enable 13 million people to save an average of $800 a year on health insurance premiums, and which has allowed four-out-of-five Healthcare.gov enrollees to find a plan for $10 or less after subsidies.
In contrast, in-person services for common mental health disorders dropped by more than half after the PHE was declared in 2020.
Telehealth for common mental health issues grew up to 20 fold in the first year of the COVID-19 Pandemic, more than compensating for a concurrent drop in in-person care for a number of conditions, a RAND Corporation study shows.
The RAND study is the first to show that the magnitude of the increased use of telehealth more than made up for the decline in in-person treatment.
An examination of more than 5 million privately insured adults, the researchers found that in-person services for depression, anxiety, bipolar, adjustment, and posttraumatic stress disorders dropped by more than half after the public health emergency was declared in 2020.
In sharp contrast, telehealth use grew steadily during the first year of the pandemic. By December of 2020, tele-mental health treatments for some disorders was 10% to 20% higher than in January 2020, according to the study, which was published in JAMA Health Forum.
“Our findings highlight a remarkable transition in the U.S. mental health system from in-person to virtual care,” says RAND economist Christopher M. Whaley, senior author of the study.
Other studies have documented an elevated level of psychological distress and mental health disorders such as anxiety and depression over the course of the COVID-19 pandemic.
Meanwhile, concerns about the spread of the coronavirus have led many mental health providers to eliminate or reduce in-person services.
In response, many providers switched to providing telehealth mental health services, and both public and private insurance providers expanded coverage for telehealth services.
To examine trends in tele-mental health, researchers looked at claims from commercially insured adults from January to December 2020, as provided by Castlight Health, a health benefit manager for employer-sponsored health insurance plans for about 200 employers in all 50 states.
The study found that the increased use of telehealth was lowest for bipolar disorder and highest for anxiety disorders.
When combining in-person and telehealth service treatment rates, there was an overall increase in care for major depressive disorders, anxiety disorders, and adjustment disorders. The increase in use of mental health services for anxiety disorders during the pandemic was higher for women than for men.
People in rural areas were less likely to use telehealth services, and people over age 46 also had lower rates of services than younger adults.
“While this may be partly due to a lower prevalence of certain conditions among older Americans, the consistency of this trend across different diagnosis categories suggests that factors such as lower digital literacy and less comfort with using telehealth also may play a role,” said Ryan K. McBain, lead author of the study and a policy researcher at RAND.
Support for the study was provided by the National Institutes on Aging and the Robert Wood Johnson Foundation.
The declines varied by regions, with larger drops in the South, Midwest, and West.
After a summer of relative stability, Telehealth use fell 3.7% this past autumn, from 5.4% of medical claim lines in September to 5.2% in October, according to FAIR Health's Monthly Telehealth Regional Tracker.
The declines varied by regions, with larger dips in the South (6.8%), Midwest (4.9%) and West (4.1%), contrasting increased use in the Northeast (1.7%), according to the FAIR data, which includes privately insured population, including Medicare Advantage but excludes Medicare fee-for-service and Medicaid.
Also in the report:
COVID-19 continued to fall among the top five telehealth diagnoses nationally and in most regions in October, as it had in September. Nationally and in the Midwest, COVID-19 fell from third to fifth place in the rankings. In the Northeast, it fell from second to third place, and in the South, it fell from fifth place out of the rankings.
In the West, COVID-19 had already been out of the top five telehealth diagnoses since September.
Acute respiratory diseases and infections climbed in the rankings of the top five telehealth diagnoses in October, following a trend that began in September.
In the Northeast, from September to October, this diagnosis rose from third to second place; in the West, it rose from fourth to second place. Nationally and in the Midwest and South, it remained at second place but increased in percentage share of telehealth claim lines. Nationally, for example, it rose from 3.1% of telehealth claim lines to 4.1%.
The rankings of the top five telehealth specialties did not change nationally or regionally from September to October, as social worker remained the number one telehealth specialty.
From September to October, the rankings of the top five telehealth procedure codes did not change nationally or in any region when compared to the previous eight months. The number one telehealth procedure code nationally and in every region remained CPT®2 90837, one-hour psychotherapy.
The Telehealth Cost Corner spotlighted the cost of CPT 90833, psychotherapy with evaluation and management visit, 30 minutes in October. Nationally, the median charge amount for this service when rendered via telehealth was $126.20, and the median allowed amount was $77.70.
Without insurance coverage, out-of-pocket costs for the drug will average about $26,500 per patient per year.
With the Food and Drug Administration granting fast-track approval on Friday of Eisai/Biogen's new Alzheimer's drug Leqembi, stakeholders are now urging the Centers for Medicare & Medicaid Services to follow suit and cover the pricey treatment.
The Alzheimer's Association called the FDA approval of the new drug for patients with mild cognitive impairment or in the early stages of Alzheimer's disease "a milestone achievement" for patients and their families. However, they warn that the cost of the drug – about $26,500 annually -- will limit access for many of the 6.5 million people in the United States who suffer from the disease. The advocates are pressing CMS to cover the costs.
"What the FDA did today in granting accelerated approval to Leqembi was the right decision. But what CMS is doing by severely restricting coverage for approved treatments is unprecedented and wrong," Alzheimer's Association CEO/President Joanne Pike, DrPH says.
"The FDA carefully reviewed the evidence for Leqembi before granting approval. CMS, in sharp contrast, denied coverage for Leqembi months ago before it had even reviewed this drug's evidence."
"CMS has never done this before for any drug, and it is clearly harmful and unfair to those with Alzheimer's," Pike says. "Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills, and independence. They're losing time."
CMS Administrator Chiquita Brooks-LaSure says the jury is still out on the efficacy of Leqembi, which has shown moderate success during clinical trials.
"We will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes," Brooks-LaSure says.
FDA Approval
The FDA used its Accelerated Approval pathway to approve Leqembi (lecanemab-irmb) saying the drug, which reduces the beta amyloid clumps linked to Alzheimer's, "represents an important advancement in the ongoing fight to effectively treat Alzheimer's disease."
Billy Dunn, MD, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, called the treatment "the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."
The FDA approval follows clinical research that included a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer's disease (three of whom died during the trial, although it's not clear if the drug played a role), and which showed a 27% reduction in cognitive decline over 19 months among patients receiving the 10 milligram/kilogram intravenous dose of the drug every two weeks, when compared with those who received the placebo.
Upon learning Friday that the FDA had fast-tracked Leqembi, Eisai/Biogen immediately submitted a supplemental Biologics License Application to the agency for a traditional approval.
Costs
Leqembi is not cheap, which Tokyo-based Eisai and Cambridge, Mass-based Biogen acknowledge. However, the drugmakers cite an Alzheimer's Association estimate that Medicare, Medicaid, commercial payers and out-of-pocket spending would increase from $267 billion in 2020 to $451 billion in 2030 if no treatments exist to delay the disease.
With effective treatments, however, the drugmakers say they can reduce the average per-person cost of treating Alzheimer's patients from about $37,000 to $26,500 annually, and that the cost could be further reduced to about $15,000 a year for ongoing maintenance once the treatment is underway.
