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New FDA-Approved Alzheimer’s Drug Reqs. Raises Alarms

Alzheimer’s advocacy organizations have praised the Food and Drug Administration’s approval of the new treatment for the debilitating disease, but they have equally condemned the Centers for Medicare and Medicaid Services for attaching significant burdens to access the care.

The Centers for Medicare and Medicaid Services announced on Thursday that, for Medicare to cover these expensive treatments, Medicare patients must be diagnosed with amyloid plaques on the brain and be treated by a physician who would be required to upload patient information into a federal database to monitor the real-world efficacy of the treatments.

After granting accelerated pathway approval for Biogen and Eisai’s drug, Leqembi, in January, the FDA announced full approval of the infusion treatment that clinical trials demonstrate slows cognitive decline caused by Alzheimer’s disease progression in mild, early onset patients by 27%. Leqembi, which is called lecanemab-irmb generically, works by reducing amyloid plaques in the brain, which is a key feature of the disease.

As with many new drugs in high demand, the commercial cost of Leqembi is a staggering $26,500 annually for the drug itself. Added to this cost is the amount of time and travel costs to receive the treatment at licensed infusion centers. CMS promised earlier this year that it would explore coverage options upon the FDA granting full approval.

Coverage for Leqembi falls under Medicare Part B, as the treatment is administered in a facility, with a 20% patient co-pay depending upon the patient’s supplemental insurance, making the out-of-pocket costs for the treatment over $5,000 annually.

Testing for amyloid plaques also involves expensive, invasive procedures, both of which have serious complication risks. Although there are new advances in blood tests detecting the presence of amyloid plaques, existing protocols to test for these include functional PET brain scans or spinal taps to extract cerebral fluid.

The Alzheimer’s Association announced that, although it applauds the FDA’s approval of Leqembi and CMS’s steps to cover the drug, Medicare needs to do more to ease access to life-altering care for those with this terminal illness. Of chief concern is the mandatory participation in the federal registry.

“We were disappointed, however, that CMS did not take this opportunity to initiate the formal process to reconsider their National Coverage Determination policy. This reconsideration is extremely important and long overdue,” Robert Egge, the chief public policy officer of the Alzheimer’s Association, said.

“Registries — an important tool to gather much-needed real-world evidence to transform and improve patient care — should not be a requirement for coverage of a FDA-approved treatment,” read the Alzheimer’s Association press statement.

“The scientists at FDA are in the best position to determine whether a drug is safe and effective,” UsAgainstAlzheimer’s Vice President Stephanie Monroe said. “Now that FDA has made their decision, it is not appropriate for CMS to second-guess that decision.”

The Alzheimer’s Association estimates that more than 6.7 million people in the United States who are age 65 or older have Alzheimer’s disease — or nearly 11% of the Medicare-eligible population. By 2050, the organization estimates that 12.7 million Americans could be living with the disease.

  • Pat says:

    “The scientists at FDA are in the best position to determine whether a drug is safe and effective,” UsAgainstAlzheimer’s Vice President Stephanie Monroe said. “Now that FDA has made their decision, it is not appropriate for CMS to second-guess that decision.”

    After the last 3+ years of lies coming out of the FDA, CDC, NIAID, this is the stupidest comment ever!!

  • Wayne Wettemann says:

    Sounds like it’s being rushed to market before it’s been fully tested. That’s the need for the national registry. As for the cost, it’s typical to charge the weakest and poorest the highest. They’re counting on their victims, sorry patients, being sickly and guaranteed to break their insurance deductibles.

  • ThePeopleArePissed says:

    $26,500 annually? Some meds, such as biologics, are that much PER DOSE, yet ask the manufacturing pharma company how long the biologic was tested prior to FDA approval & they won’t give an answer.

  • Tamirose170 says:

    I seriously doubt that this med was fully tested through Phase I-IV Clinical Trials as that takes 7-10 years. Phase i is on healthy people w/no disease. I dug a little on this meds and see that they tested it on 80 (Eighty) for Pharmacokinetics. Phase II is short-term studies, weekend confinements to study the affects with continual blood draws, urine catches to see how it is processed, etc. (It was tried on a little bit over 550 people with Alzheimers, 105 also had SCLC) Phase III is when it is given to people who have the disease you are hoping the medication will help, and it can takes YEARS to find the Principal Investigators and then enroll the right patients (must meet specific study criteria) and then those will last 6-18 months or so and they continue until you have enough patients fully through the process. You’ll do weekend confinements, where they all eat the same food, same environment, same temperature, same activities. In between Phase I, II, III you provide the Pharmaceutical Company with all the data you have collected on each study participant and they start compiling data to see cross-overs with side effects (such as increased sun sensitivity) as that may appear not during confinement but during weekly/monthly visit – Headaches etc. During Phase III, you’ll run various trials – Double Blind, Placebo Controlled (meaning neither the PI nor the Pt knows if they are getting placebo pills or real study drug) – Randomized Study – where a patient may get the study drug for week 1-8 and then placebo weeks 9-18 and all different various ways to gather information and how the body processes the study medication and what impact it has on starting it, stopping it, how long after stopping is it retained – TONS and TONS of information is gathered in Phase III – – it takes a LONG time. I dug a little deeper, see that this drug got ACCELERATED Approval in Jan 2022, to go into Phase III and even online, it talks about continuing Phase III Studies. I then read, where 865 early onset Alzheimer patients were followed for 79 weeks and it was that data that was given to the FDA for “Approval” – – So a whopping 79 weeks is all the data; that’s hardly LONG-Term. One of the side effects: Swelling & Bleeding in the Brain! ~ Dear Lord, what has the FDA done with their Strict and Stringent Guidelines they used to operate under? I have to wonder if when Trump signed off on “Right to Try” if that is what they are operating under now underhandedly. . He agreed to that so that doctors could try ANYTHING to save a life during COVID – say perhaps a drug only known for Malaria, perhaps meds well-known & safe like Ivermectin & Hydroxychloroquine. I truly have to believe HE KNEW what they were doing, but didn’t have the power to supersede the CDC, NIH, FDA, or get word to all of us since they silenced him on Twitter. It was 1 man against MSM & Social Media saying something opposite! IF there are no other treatment protocols, ONLY then can Big Pharm get the EUA which J&J, Moderna and Pfizer got with their clot shot and BILLIONS was made by many of them (with ZERO short-term or long-term studies). IF Ivermectin & Hydroxychloroquine were used by docs in the Hospitals, and Patients would have been saved…. as those 2 meds were found to be effective, then those VAX would never have been eligible. ~ Reading this over & over, then digging online, I truly believe they are now going to use legit patients again as lab rats! I read that they gave them Accelerated-Rapid Approval because it is a medication that there is nothing like it on the market, to treat Alzheimer’s, the disease, not just the symptoms. So since there is no other treatment or medications FOR THAT – they stepped on the gas and approved it without all of the necessary data – because – Well giving them something is better than not, plus no doubt they purchased stock in Jazz Pharmaceuticals, Palo Alto, CA

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