The Food and Drug Administration officially approved the Alzheimer’s medicine Leqembi on Thursday, a significant step that will increase access to the costly drug for older Americans. Medicare said shortly after the FDA clearance that it will now fund the antibody treatment for patients participating in the senior insurance programme, subject to certain criteria. Leqembi is the first Alzheimer’s antibody treatment to be approved by the FDA. It is also the first such medicine to get broad Medicare coverage. Leqembi is not a treatment. During Eisai’s clinical trial, the medication delayed cognitive deterioration from early Alzheimer’s disease by 27% over 18 months. The antibody, which is given twice a month by intravenous infusion, targets a molecule called amyloid, which is linked to Alzheimer’s disease.
Medicare coverage is an important step towards assisting older Americans with early Alzheimer’s disease in paying for treatment. With a median salary of around $30,000, most Medicare recipients cannot afford Eisai’s $26,500 yearly price for Leqembi without insurance coverage. Before the treatment’s accelerated clearance in January, Medicare had only consented to fund Leqembi for individuals participating in clinical studies. This policy drastically limited the drug’s availability. Patients must be registered in Medicare, have moderate cognitive impairment or mild Alzheimer’s disease, and have a doctor who participates in a data-collection system set up by the federal government to study the treatment’s benefits and hazards.
Leqembi offers limited benefits for Alzheimer’s patients but carries risks
Joanna Pike, president of the Alzheimer’s Association, the lobby group that advocates on behalf of people living with the disease, said although Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, conduct their daily lives, and spend more time with their families. “This gives people more months of recognizing their spouse, children and grandchildren,” Pike said in a statement Thursday. “This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.” However, the treatment entails significant risks of brain swelling and haemorrhage. Eisai’s study claimed the lives of three patients. According to FDA investigators, it is uncertain whether Leqembi played a role in these deaths. (www.losaltosresort.com)
According to the FDA, Alzheimer’s disease is the most prevalent cause of dementia in older persons and the sixth greatest cause of mortality in the United States. Dr David Knopman, a neurologist at the Mayo Clinic in Minnesota who specialises in Alzheimer’s disease, said Leqembi exhibited a benefit to patients in Eisai’s trial, though he cautioned that the treatment’s efficacy was limited. According to Knopman, adequately diagnosed and informed patients should be able to decide for themselves whether they wish to take Leqembi after assessing the treatment’s benefits and hazards, as well as the potential practical obstacles of finding a venue to receive the twice-monthly infusions.
Medicare coverage
To be eligible for coverage, patients must identify a healthcare provider that is a member of a registry system that collects real-world data on the drug’s benefits and hazards. The system is divisive. The Alzheimer’s Association and some members of Congress are concerned that this restriction would obstruct treatment. There are fears that the number of healthcare professionals who will participate in such registries will be restricted, forcing residents in rural towns and other underserved places to travel considerable distances to find such a physician.
The Centres for Medicare and Medicaid Services has established a countrywide site to make it simple for healthcare professionals to provide the necessary data on patients getting Leqembi. The free portal went live shortly after the FDA’s approval on Thursday. In a letter to CMS last month, Rep. Anna Eshoo of California, the leading Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan, D-Calif., expressed worry that patients would struggle to find a doctor who participates in the system.
Medicare policy limits PET scans; potential wait times for Leqembi treatment
Alzheimer’s disease is often diagnosed via a PET scan to detect the amyloid protein linked to the disease, or, in some cases, a spinal tap. Currently, Medicare only pays one PET scan for dementia per lifetime. It is unclear whether the programme intends to change this policy. There is also fear that if Leqembi is widely accepted as a treatment and patient demand for the antibody is great, there will be insufficient expert physicians and locations to deliver the infusions.
Depending on demand, several studies indicate that wait periods for antibody treatments like Leqembi could range from months to years over the next decade. Tomas Philipson, who advised the FDA commissioner and CMS administrator during the second Bush administration, believes the register is superfluous and that Medicare should delete it, but he does not believe the requirement will impede patients from getting Leqembi.
If there is a strong demand for Leqembi, doctors will have an incentive to engage in the registry, and drug companies will want to help, according to Philipson, a healthcare economist at the University of Chicago. He is unsure how popular Leqembi will be, he says. Families who are concerned about the serious adverse effects may choose not to take the treatment, while others will decide the benefits outweigh those risks, he said.