Insurers won’t cover new Alzheimer’s treatment for some customers

UNDATED (AP)- Some private insurers are balking at paying for the first drug fully approved to slow mental decline in Alzheimer’s patients. Insurers selling coverage in North Carolina, Pennsylvania and New York, among other states, told The Associated Press they won’t cover Leqembi with insurance offered on the individual market and through employers because they still see the drug as experimental. Their decision stands in contrast to Medicare. The federal coverage program mainly for people ages 65 and older announced last month that it will cover Leqembi shortly after the Food and Drug Administration gave the treatment full approval.

UNDATED (AP)- Some private insurers are balking at paying for the first drug fully approved to slow mental decline in Alzheimer’s patients.

Insurers selling coverage in North Carolina, Pennsylvania and New York, among other states, told The Associated Press they won’t cover Leqembi with insurance offered on the individual market and through employers because they still see the $26,000-a-year drug as experimental.

Their decision stands in contrast to Medicare, which will wind up covering most patients who take the drug. The federal coverage program mainly for people ages 65 and older announced shortly after Leqembi received full approval last month that it will cover the treatment while still tracking its safety and effectiveness.

Leqembi is the first medicine that’s been convincingly shown to slow the cognitive decline caused by Alzheimer’s disease, though only modestly. The U.S. Food and Drug Administration approved the IV drug for patients with mild dementia and other symptoms caused by early Alzheimer’s.

That approval came after regulators reviewed data from a large study in which the drug slowed memory and thinking decline by about five months in those who got the treatment compared with those who got a dummy drug. Some Alzheimer’s experts say the delay is likely too subtle for patients or their families to notice.

Alzheimer’s mainly affects the elderly. About 76% of the people taking Leqembi will be covered by Medicare, according to the Japanese drugmaker Eisai, which developed the drug and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.

But people under 65 — even, rarely, as young as their 30s — also can get diagnosed. They are more likely to have commercial coverage.

“That’s why we’re just dumbfounded that commercial plans are not covering it,” said Christine Mann, chief operating officer of the Buffalo, N.Y.-area Dent Neurologic Institute, which will provide the IV drug to patients. “It’s almost like discrimination against these patients.”

The full picture on commercial insurance is still emerging in the patchwork U.S. system of coverage.

Companies saying no so far include Highmark, which provides Blue Cross and Blue Shield coverage in New York, Pennsylvania, Delaware and West Virginia; Blue Cross and Blue Shield of North Carolina, which has about 1.8 million commercial customers; and Philadelphia-based Independence Blue Cross.

Highmark and the North Carolina plan say they are still monitoring Leqembi and could re-evaluate their decision.

Independence Blue Cross made its decision after reviewing published, peer-reviewed studies and publicly available FDA materials.

“That re-evaluation made it clear to us that the existing evidence does not allow for conclusions to be drawn about the safety and effectiveness of Leqembi,” said Dr. Heidi Syropoulos, a medical director with the insurer.

A Highmark spokesman said that company made its decision after also consulting with specialists to determine if the drug’s benefit outweighs its side effects, which include brain bleeding and swelling.

Prominent insurers that will cover the drug for commercial plans include Kaiser Permanente and Elevance Health, the largest provider of Blue Cross-Blue Shield plans in the United States. A spokesman for another big health insurer, UnitedHealthcare, declined to comment when contacted by AP.

Because Medicare covers the drug, patients with privately run Medicare Advantage plans will receive coverage, said Juliette Cubanski, of the non-profit KFF, which researches health care issues.

Many other insurers say they have yet to make a decision.

Most insurers will probably cover the drug but heavily restrict its use through things like requiring pre-approval, said Greg Warren, a health actuary and member of the Society of Actuaries.

For commercial coverage, insurers often pay for treatments that have full FDA approval. But that is not guaranteed.

Tufts Medical Center in Boston maintain a database that includes more than 11,000 commercial insurance coverage decisions on specialty drugs. In 2% of the decisions, insurers did not cover the FDA-approved use, said researcher James Chambers.

Chambers said they have found that the decision to not cover a drug largely happens when the evidence supporting the drug is considered questionable.

The denials for Leqembi don’t surprise Jack Hoadley, a health policy researcher with Georgetown University’s Center on Health Insurance Reforms.

He noted Leqembi’s serious side effects and high cost. The price doesn’t include the cost for repeated brain scans patients need to check for side effects.

But Hoadley said insurers also may have a hard time explaining themselves.

“It’s going to be a harder-to-justify decision for them if they know that Medicare has made a decision to cover it,” he said.

Patients who don’t get coverage through a commercial plan may eventually receive it through Medicare or state- and federally funded Medicaid programs.

But waiting is risky. Those who advance out of early-stage Alzheimer’s may no longer qualify for Leqembi.

Bonnie Bortz has been caring for her 38-year-old daughter, Jaime, who has early-onset Alzheimer’s like her father did.

Bortz, who lives in the Buffalo suburb of Cheektowaga, is confident Jaime will get help paying for Leqembi because she will soon start on Medicare, which is available to some people under 65 with Alzheimer’s. Still, that hasn’t happened yet, and Bortz is anxious for treatment to begin.

She’s watched Jaime progress from repeatedly losing her phone and keys to struggling to help her 7-year-old daughter with homework.

“I don’t want to get to the next stages of all this,” Bonnie Bortz said. “I want more time.”

JULY 20, 2023:

WASHINGTON (AP) — New research shows another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening. Patients given monthly infusions of Eli Lilly and Co.’s donanemab declined about four to seven months more slowly than those given dummy infusions in a large study. If U.S. regulators approve, the drug would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease — after rival Leqembi. Both drugs pose a serious safety concern — brain swelling and bleeding. Lilly’s data was presented at an Alzheimer’s Association international meeting Monday (July 17, 2023) and published in the Journal of the American Medical Association.

WASHINGTON (AP) — Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months, researchers reported Monday.

Eli Lilly and Co. is seeking Food and Drug Administration approval of donanemab. If cleared, it would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease — after the recently approved Leqembi from Japanese drugmaker Eisai.

“Finally there’s some hope, right, that we can talk about,” Lilly’s Dr. John Sims told reporters Monday at the Alzheimer’s Association International Conference in Amsterdam.

“We don’t cure the disease,” he said. “Diabetes doesn’t have a cure either — it doesn’t mean you can’t have very meaningful treatments for patients.”

Lilly announced in May that donanemab appeared to work, but on Monday the full results of a study of 1,700 patients was published by the Journal of the American Medical Association and presented at the Alzheimer’s conference.

Both donanemab and Leqembi are lab-made antibodies, administered by IV, that target one Alzheimer’s culprit, sticky amyloid buildup in the brain. And both drugs come with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths.

Scientists say while these drugs may mark a new era in Alzheimer’s therapy, huge questions remain about which patients should try them and how much benefit they’ll really notice.

“The modest benefits would likely not be questioned by patients, clinicians or payers if amyloid antibodies were low risk, inexpensive and simple to administer. However, they are none of these,” Dr. Eric Widera of the University of California, San Francisco, wrote in a JAMA editorial accompanying Lilly’s new data.

Lilly’s study enrolled people ages 60 to 85 who were in early stages of Alzheimer’s. Half received once-a-month infusions of donanemab and half dummy infusions for 18 months.

The study had a few twists. Patients were switched to dummy infusions if enough amyloid cleared out — something that happened to about half within a year. And because amyloid alone doesn’t cause Alzheimer’s, researchers also tracked levels of another culprit in the brain — abnormal tau. More tau signals more advanced disease.

The results: Both groups declined during the 18-month study but overall those given donanemab worsened about 22% more slowly. Some patients fared better — those with low to medium tau levels saw a 35% slower decline, reflecting that the drug appears to work better in earlier stages of the disease.

How much difference does that make? It means donanemab slowed patients’ worsening by about four to seven months, the JAMA report concluded.

Another way of measuring: Among the donanemab recipients with lower tau levels, 47% were considered stable a year into the study compared with 29% of those who got the dummy version.

The main safety concern is brain swelling or bleeding, which often causes no symptoms but sometimes can be serious, even fatal. About a quarter of donanemab recipients showed evidence of that swelling, and about 20% had microbleeds.

Scientists already know that patients getting any amyloid-targeted therapy need repeat brain scans to check for those side effects — a costly and time-consuming hurdle.

Widera noted that the possibility of stopping donanemab treatment at least temporarily in people who respond well would help limit some of those challenges. For comparison, Leqembi is given by IV every two weeks and researchers didn’t test a similar stoppage.

It’s too soon to know if some patients might need to resume donanemab, said Lilly’s Dr. Mark Mintun. But the amyloid “doesn’t come back with any sort of vengeance,” he said, speculating that might take several years.

Another concern: More than 90% of the study’s participants were white, leaving little data about how other populations might respond, Alzheimer’s specialist Jennifer Manly of Columbia University wrote in JAMA.

Scientists have long tried and failed to slow Alzheimer’s with amyloid-targeting drugs — and the FDA’s contentious 2021 conditional approval of a drug named Aduhelm soon fizzled amid lack of evidence that it really worked. The approval of Leqembi and promising data for donanemab have reignited interest in attacking amyloid buildup.

But Mintun acknowledged additional approaches are needed, saying Lilly expects results of a late-stage study of a tau-fighting drug next year.

UNDATED (AP)- The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away. Experts say scant coverage of the drug and a long setup time needed by health systems are two main factors behind the slow debut. The U.S. Food and Drug Administration approved Leqembi from Japanese drugmaker Eisai in early January 2023. It was approved for patients with mild or early cases of dementia tied to Alzheimer’s disease. Patients take the drug by IV every two weeks. A year’s treatment will run about $26,500, making coverage important for access.

UNDATED (AP)- The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away.

Two big factors behind the slow debut, experts say, are scant insurance coverage and a long setup time needed by many health systems.

Patients who surmount those challenges will step to the head of the line for a drug that delivers an uncertain benefit. Here’s a closer look.

THE SITUATION

The U.S. Food and Drug Administration approved Leqembi, from Japanese drugmaker Eisai, in early January 2023. It’s for patients with mild or early cases of dementia tied to Alzheimer’s disease.

Regulators used the FDA’s accelerated pathway, which allows drugs to launch before they’re confirmed to benefit patients. In studies, Leqembi modestly slowed the fatal disease, but doctors aren’t sure yet how that translates into things like greater independence for patients.

Patients get the drug by IV every two weeks. Eisai says the company has shipped Leqembi to U.S. specialty drug distribution centers. From there, it can be delivered overnight to hospitals or medical centers.

Eisai spokeswoman Libby Holman said prescriptions for the drug have been written, and they expect patients to start receiving it “very soon.”

COST AND COVERAGE

A year’s treatment will run about $26,500. Patients who can afford that without insurance will be able to start the treatment if they are deemed a candidate for Leqembi and they find a doctor and health care system prepared to help them.

There are currently few options outside self-pay. Most of the patients who may be candidates for this drug are on Medicare, and the federal program’s coverage is narrow so far. It has said it will cover treatments like Leqembi only for patients enrolled in certain research trials designed to test the drug.

There are no such studies currently accepting new patients.

“There’s a theoretical door (to coverage) that’s completely slammed shut,” said Robert Egge, chief public policy officer for the nonprofit Alzheimer’s Association.

Medicare made that coverage decision last year when another Alzheimer’s drug, Biogen’s Aduhelm, hit the market.

Health insurers, which run Medicare Advantage coverage, have been sticking to that decision, said a spokesman for the trade group America’s Health Insurance Plans.

The Centers for Medicare and Medicaid Services, which oversees Medicare, said after Leqembi’s approval that it may reconsider its coverage stance, something the Alzheimer’s Association has urged it to do.

Coverage also is likely to change if the drug receives full approval from the FDA. That could happen later this year.

In the meantime, Eisai has an assistance program that provides Leqembi for free to some patients, including those on Medicare. It’s based partly on financial need.

DIAGNOSING

It can take anywhere from several months to more than a year for doctors to diagnose a patient and then figure out if that person is a candidate for Leqembi, according to Dr. Sarah Kremen, a neurologist with the Cedars-Sinai health system in Los Angeles.

That can depend on where a patient lives and the physician’s expertise.

First, a doctor must determine whether a patient has mild dementia.

Then the doctor has to decide what caused the condition. It could stem from Alzheimer’s, Parkinson’s disease, a stroke or a brain injury.

If it’s related to Alzheimer’s disease, doctors must determine whether the patient’s brain has an amyloid protein. The new drug aims to slow the progression of Alzheimer’s by removing that protein.

After all that, some doctors may hesitate to prescribe Leqembi because they don’t have a good idea yet for how the drug will help the patient or affect their everyday life, Kremen said. They have to consider that uncertainty against the brain swelling and bleeding that can develop in patients taking it.

“I think this benefit versus harm issue is going to weigh heavily,” she said.

DELIVERING TREATMENT

Health systems must first develop plans for delivering drugs like Leqembi before they start offering it. That can take months, although some may have started before regulators approved the drug.

This planning might include training nurses on how to give the drug and making sure prescribing doctors know how to recognize candidates for it. Care providers also need a plan for how patients will be monitored once they start taking it.

Patients need repeated brain scans to check for side effects.

Doctors may want to know that such a plan is in place before they feel comfortable writing a prescription, Kremen noted.

Hospital systems also will have to figure out how many patients might come to them for this drug and be able to cover all the costs tied to it. Those might include clinic, nursing, radiologist and pharmacy fees.

“Frankly, the hospital systems are going to have to decide if they want to offer it,” Kremen said. “Is it worth the cost?”

Eisai estimates that about 100,000 people will be diagnosed and eligible to receive Leqembi in the United States by 2026. Representatives of the drugmaker declined to estimate how many people might receive it this year.