The first drug shows it slows Alzheimer’s, but treatmen. Is still months away for most patients.Two major reasons behind the slow rollout, experts say. Are low insurance coverage and the long setup time many health systemsmuste.Patients who overcome these challenges will be at the top of. The line for a drug that offers an unproven benefit. Here’s a closer look.
The US Food and Drug Administration approved Lekembi. From Japanese drugmaker Isai in early January. It 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 Alzheimer’ to be introduced before they are confirmed to benefit patients. In the study, Lakembi modestly slowed the deadly disease. But doctors aren’t yet sure how that translates into things like greater independence for patients.
Patients receive medication by IV Alzheimer’s every two weeks. Isai said the company sent Lakembi to a U.S. specialty drug distribution center. From there it can be delivered overnight to a hospital or medical center.
Isaias spokeswoman Libby Holman said prescriptions have been written for the drug. And they expect patients to start taking it “very soon.”
Cost and coverage
A year of treatment will run about $26,500. Patients who may be able to start treatment without insurance. Are considered candidates for Lakembi and can find. A doctor and health care system ready to help them.
There are currently few options beyond self-pay. Most patients who may be candidates for this drug are on Medicare, and the federal program’s coverage is still narrow. It said it would only cover treatments like Lekambi for patients enrolled in specific research trials designed to test the drug.
There are currently no studies accepting new patients.
“There’s a theoretical door (to coverage) that’s been completely closed,” said Robert Egge. Chief public Alzheimer’ policy officer for the nonprofit Alzheimer’s Association.
Medicare made that coverage decision last year when anothedrug, Biogen’s Aduhelm, hit the market.
Health insurers, which run Medicare Advantage coverage, stand by the decision. Said a spokeswoman for the trade group Health Insurance Plans of America.
The Centers for Medicare and Medicaid Services, which oversees Medicare. Said it may reconsider its coverage position after Lakembi’s approval, which the Association has urged it to do.
Coverage may also change once the drug receives full approval from the FDA. That could happen later this year.
Meanwhile, Eisai has a support program that provides Lekambi for free to some patients with Medicare. This is partly based on financial need.
Diagnosis
According to Dr. Sarah Kremen, r Alzheimer’s a neurologist at Cedars-Sinai Health System in Los Angeles. It can take months to more than year for doctors to diagnose a patient. And then determine whether that person is a candidate for Lekambi. .
This may depend on where a patient lives and the expertise of the physician.
First, a doctor must determine whether a patient has mild dementia.
Then the doctor has to decide what is causing this condition. It can arise from Parkinson’s disease, stroke or brain injury.
If it is related to disease, doctors must determine whether the patient has amyloid protein in the brain. The new drug aims to slow the progression of Alzheimer’s by removing that protein.
Even so, some doctors may be hesitant to prescribe Lakembi because they don’t yet have. A good idea of how the drug will help patients or affect their daily lives, Kremen said. They have to consider the uncertainty against brain swelling and bleeding that can develop in patients taking it.
“I think this benefit Alzheimer’ versus harm issue is going to weigh heavily,” he said.
Provide treatment
Health systems must first develop a plan to provide. A drug like Lakembi before they can begin offering it. This can take several months, although some may begin before regulators approve the drug.
The plan includes nurses making sure doctors know how to administer medication and 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 exists before they. Feel comfortable writing a prescription, Kremen noted.
Hospital systems also need to determine how many patients can come to them for this drug. And be able to cover all the costs associated with it. This may include clinic, nursing, radiologist and pharmacy fees.
“Frankly, hospital systems have to r Alzheimer’ decide if they want to offer it,” Kremen said. “Is it worth the price?”
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