Why a New Alzheimer’s Drug Is Slowly Debuting in the US

The first drug proving it slows Alzheimer’s is on the market, but most patients are still months away from treatment.

Experts say the two main factors behind the slow debut are meager insurance coverage and the lengthy set-up time required by many healthcare systems.

Patients who overcome these difficulties will be at the head of the queue for a drug of uncertain benefit. Here’s a closer look.

SITUATION

The U.S. Food and Drug Administration approved Lekambi from Japanese drugmaker Eisai in early January. This is for patients with mild or early cases of dementia associated with Alzheimer’s disease.

Regulators have used the FDA’s fast track, which allows drugs to be launched before they are proven to benefit patients. In studies, Lekambi has slowed the deadly disease slightly, but doctors aren’t sure how that translates into things like greater independence for patients.

Patients receive the drug intravenously every two weeks. Eisai says the company has shipped Leqembi to specialized drug distribution centers in the US. From there, it can be transported overnight to hospitals or medical centers.

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

COST AND COVERAGE

The annual treatment will cost approximately $26,500. Patients who can afford it without insurance will be able to start treatment if they are identified as candidates for Lekambi treatment and find a doctor and healthcare system willing to help them.

Currently, there are several options other than self-pay. Most of the patients who might be candidates for this drug are on Medicare, and the coverage of the federal program is still low. He said he would only cover treatments like Leqembi for patients in certain research trials designed to test the drug.

Currently, there are no studies that accept new patients.

“The theoretical door (to coverage) has been completely shut,” said Robert Egge, chief public policy officer at the nonprofit Alzheimer’s Association.

The story goes on

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

Health insurers that provide Medicare Advantage coverage are sticking to the decision, a spokesman for the America’s Health Insurance Plans trade group said.

The Centers for Medicare and Medicaid Services, which oversees Medicare, said after Lekambi’s approval they may reconsider their position on coverage, as called for by the Alzheimer’s Association.

The coverage is also likely to change if the drug receives full FDA approval. This may happen later this year.

Meanwhile, Eisai has an assistance program that provides free Leqembi to some patients, including those on Medicare. This is based in part on financial need.

DIAGNOSTICS

According to Dr. Sarah Kremen, a neurologist at Cedars-Sinai Health System in Los Angeles, it can take doctors anywhere from a few months to more than a year to diagnose a patient and then find out if that person is a candidate for Lekambi’s treatment. .

This may depend on where the patient lives and the experience of the doctor.

First, the doctor must determine if the patient has mild dementia.

The doctor must then decide what caused the condition. This may be due to Alzheimer’s disease, Parkinson’s disease, stroke, or traumatic brain injury.

If it is related to Alzheimer’s disease, doctors must determine if there is an amyloid protein in the patient’s brain. The new drug aims to slow the progression of Alzheimer’s disease by removing this protein.

After all this, some doctors may hesitate to prescribe Lekambi because they don’t yet have a clear idea of ​​how the drug will help the patient or affect their daily life, Kremen said. They must take into account the uncertainty about cerebral edema and bleeding that may develop in patients taking it.

“I think the question of benefits and harms will be of great importance,” she said.

TREATMENT

Health systems must first develop delivery plans for drugs like Lekambi before they start offering it. This could take months, although some of it may have started before regulatory authorities approved the drug.

This planning may include teaching nurses how to administer medication and ensuring that prescribers know how to recognize candidates for it. Health care providers also need a follow-up plan for patients after they start taking it.

Patients need a repeat brain scan to check for side effects.

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

Hospital systems will also have to figure out how many patients can come to them for this drug and be able to cover all the costs associated with it. These may include expenses for a clinic, nursing, radiologist, and pharmacy.

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

By 2026, Eisai estimates that about 100,000 people will be diagnosed and eligible for Lekambi in the United States. Representatives for the drug maker declined to estimate how many people could get it this year.

___

Follow Tom Murphy on Twitter: https://twitter.com/thpmurphy

___

The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Science and Education Media Group. AP is solely responsible for all content.

Content Source

News Press Ohio – Latest News:
Columbus Local News || Cleveland Local News || Ohio State News || National News || Money and Economy News || Entertainment News || Tech News || Environment News

Related Articles

Back to top button