According to the Institute for Clinical and Economic Review (ICER), the beta amyloid-directed monoclonal antibody, lecanemab, must be priced lowerthan $20,600 a year to be cost-effective. Specifically, ICER’s calculations suggest that the Alzheimer’s Disease drug’s demonstrated benefits in a Phase 3 trial – a modest but statistically significant slowing of cognitive decline – are valued at between $8,500 and $20,600 per year.
FILE – This file photo shows a closeup of a human brain affected by Alzheimer’s Disease. Lecanemab, … [+]AP2003
Lecanemab’s PDUFA* date for its potential accelerated approval is January 6th. The product could launch after its approval by the Food and Drug Administration (FDA). And so now the discussion turns to what price it will be launched at, as well as whether it will eventually be reimbursed by Medicare, the predominant payer for a product such as lecanemab.
The January 6th accelerated approval of lecanemab is notbased on the Phase 3 data that was presented in November at the 15th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Francisco. Rather, the accelerated approval is based on a smaller study that is more narrowly focused on the surrogate marker, beta amyloid plaque reduction.
If the Food and Drug Administration (FDA) approves lecanemab on January 6th, this is not likely to impact the Centers for Medicare and Medicaid Services’ (CMS) National Coverage Determination (NCD) regarding coverage of beta amyloid-directed monoclonal antibodies. As a reminder, the NCD issued by CMS in April 2022 restricted coverage of allbeta amyloid-directed monoclonal antibodies to a post-marketing randomized controlled clinical trial (RCT). Medicare will only reimburse a regularly approved product outside of an RCT if the therapeutic agent unequivocally demonstrates cognitive or functional benefits and is considered reasonably safe.
In this trial, at 18 months, lecanemab reduced cognitive decline on a clinical outcomes scale by 27% compared to placebo. About 21% of patients treated with lecanemab experienced brain swelling or brain bleeding that was visible on PET scans. Also, scientists have tied a third clinical trial death to lecanemab.
If lecanemab is approved by FDA at some point in 2023 going the traditional route, this will have implications for the NCD and ultimately reimbursement by Medicare Administrative Contractors and Medicare Advantage Plans.
Lecanemab’s positive Phase 3 data and subsequent regularFDA approval may lead to a loosening of Medicare coverage restrictions that were put in place for beta amyloid-directed monoclonal antibodies. It’s likely that should FDA give the nod CMS will drop the randomized trial requirement, though it could still require the establishment of a patient registry, as way to systematically collect post-marketing evidence on lecanemab’s safety and effectiveness in the real world.
To determine what to do about coverage of lecanemab, the Centers for Medicare and Medicaid Services (CMS) will evaluate whether the incremental increase in efficacy and the findings on safety meet the so-called reasonable and necessary standard. Under the reasonable and necessary standard, CMS is only obliged to reimburse those items, technologies, and medical services the agency deems safe and effective; not experimental; and appropriate for Medicare patients.
In this context it’s important to note that regardless of what price Eisai and Biogen decide upon for lecanemab, it will not(and has not) factor(ed) into CMS’s decision-making at the national level. That is, CMS is prohibited from determining what’s “reasonable and necessary” to reimburse on the basis of price or cost.
It’s not unambiguously clear whether lecanemab meets the litmus test CMS imposed, namely answering the question CMS posed in the NCD in the affirmative: “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”
Also, even if CMS relaxes restrictions, in the end lecanemab’s uptake will also hinge on whether physicians and patients find the data convincing. For example, while some clinical neurologists believe the data posted by the sponsors is promising, others have said they do “not foresee much meaningful change in patients’ lives.” For lecanemab, as for any medicine or healthcare intervention for that matter, statistical significance does not necessarily imply a meaningful drug to individual patients and their caregivers.
