The FDA has granted full approval for lecanemab, or Leqembi, to treat Alzheimer’s in people in the early, mild stages of the neurodegenerative condition
to the accelerated approval that it would not cover the $26,500 yearly cost of lecanemab unless people were part of a clinical trial that continues to gather safety and effectiveness data on the medication. CMS said it will only reimburse for the drug outside of studies if the drug receives full FDA approval, which it now has, and peoplethat requires doctors to continue to report safety and effectiveness data for their patients using it.
CMS is expected to provide more details about the registry soon. Based on previous statements, it will likely involve the types of information doctors are collecting already, including reports of side effects such as brain inflammation and results of cognitive tests to verify the patient’s diagnosis of mild Alzheimer’s disease.
Addressing coverage, and therefore access, is critical to better understanding the true impact that disease-modifying drugs like lecanemab can have on Alzheimer’s. “I see this medication as primarily an overdue catalyst for transformational change,” says Dr. Alvaro Pascual-Leone, a professor of neurology at Harvard Medical School and medical director at Hebrew SeniorLife, a non-profit senior health facility in New England. “Dementia care right now is not what it should be.
South Africa Latest News, South Africa Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Call 999 if you see this man as police release CCTV images of missing pensionerCall 999 if you see this man as police release new CCTV images of vulnerable missing pensioner
Read more »
Fiona Phillips reveals why she hid Alzheimer's diagnosis from her two sonsFiona Phillips has spoken about hiding her Alzheimer’s diagnosis from her two sons. The broadcaster bravely shared her diagnosis publicly after receiving the news at the age of 61.
Read more »
Minister puts 'UK to shame' by ordering staff to paint over art for children at asylum centreJenrick’s order to staff at an asylum centre to paint over wall art depicting cartoons and animals to welcome children 'puts Britain to shame', Labour says YvetteCooperMP says it shows the Government has 'lost any sense of common decency or humanity'
Read more »
Llandudno: Great Orme goats roam town centre despite removal plansThe goats have divided opinion - some believe they simply cause damage, others like seeing them.
Read more »
Met Police commissioner defends thin blue line badge banMark Rowley says he is 'cautious' about officers 'showing allegiance to any cause' on their uniform.
Read more »
Met Police commissioner defends thin blue line badge banThe thin blue line badge was created as a 'mark of remembrance and respect' for officers who have died while working.
Read more »