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by THE ASSOCIATED PRESS
Some insurers, such as Medicare, would not pay for the medication until its full approval.
The Federal Government approved an Alzheimer’s Drug on Thursday. Medicare, and other insurance policies will now be able to cover it.
Leqembi IV, a new drug approved by FDA for mild Alzheimer’s and related symptoms, is now available to patients. This medicine is the first to be shown as a modestly slowing the cognitive decline that comes with Alzheimer’s.
Eisai, whose early testing suggested Leqembi was clearing a plaque in the brain linked with Alzheimer’s, received FDA conditional approval from January.
These findings were confirmed after the FDA reviewed data from a more extensive study of over 1,800 patients in which the medication slowed down cognitive decline by approximately five months as compared to placebo.
Teresa Buracchio of FDA’s Neurology Drug Director said in a release that the study confirms the drug’s effectiveness and safety.
Leqembi, in very rare circumstances, can cause brain bleeding or swelling, which are both dangerous. On the label it is noted that other Alzheimer drugs also have similar problems.
The FDA’s approval process isn’t given much notice. Alzheimer patients and advocacy groups have been lobbying government officials since Medicare officials said last year that the agency would not cover Leqembi for regular use until it had FDA approval.
Leqembi’s price is about $26,500, for a full year of intravenous (IV) treatments. These are administered every two-weeks. The program was worried that the price of Alzheimer’s medications targeting plaques would be too expensive.
Leqembi & Aduhelm will not be covered by any private insurance companies until FDA approves them.
FDA’s decision on whether or not to approve Aduhelm as a whole will likely take several years.
Chiquita LaSure stated that Medicare is going to start paying once the FDA approves the drug. In addition, Medicare will begin paying for the drug once it is approved by the FDA.
Brooks LaSure explained that the Medicare program would pay for this drug in full while gathering information to better understand its effects.
Medicare Patients may pay 20 percent or more of Leqembi costs depending on their Medicare plans, coverage and details.
The hospital or clinic may suggest that the patient needs time to get used.
Leqembi must only be prescribed if doctors are certain that the patients’ brains have the lesion targeted by the medication. The drug must not only be administered by trained nurses, but patients also need to undergo repeated brain scans to check for any swelling or bleeding. Additional costs to hospitals for administration and imaging are incurred in addition to drug prices.
Eisai says that by 2026 approximately 100,000 Americans are likely to be diagnosed with Leqembi and become eligible for the drug. Biogen, based in Cambridge Massachusetts is the parent company of Biogen.
Alexander Scott, vice president of Eisai stated: “We will ensure that the product only reaches patients who are eligible.” “.
Eisai used a scale measuring basic skills such as memory, cognition, and reasoning to assess people suffering from mild or early diseases. Leqembi participants showed less decline after 18-months than did those on a placebo infusion – a difference that was only half a mark.
In June, in a public hearing, federal health experts recommended that FDA accept the full approval of the drug, despite its slight delay. Patients or their family members are unlikely to notice the subtlety.
