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Eisai's Leqembi received FDA approval for Alzheimer's | CMS coverage of Leqembi | ipharmacenter

Eisai's Leqembi received accelerated approval in the US for Alzheimer's Disease; CMS was cautious about coverage.


Eisai and Biogen announced that the United States Food and Drug Administration (FDA) had given accelerated approval to Leqembi (lecanemab) for treating Alzheimer's.

Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody administered via intravenous use and is directed against aggregated soluble and insoluble forms of amyloid beta.

The approval was based on Phase 2 data, demonstrating the reduction in Aβ plaque accumulation in the brain. Eisai is also submitting a Supplemental Biologics License Application (sBLA) based on the Phase 3 Clarity AD trial for approval under the traditional pathway.



Price determination of Leqembi

Eisai announced that the WAC price of Leqembi will be $ 26,500 per year. However, Eisai calculated the per-patient-per-year value to be $ 37,600. The price was determined based on a biweekly 10 mg/kg IV with an average weight of 75 kg. The WAC price of a 500 mg vial is $637.02, and a 200 mg vial is $254.81.

The annual cost per patient was calculated based on the formula:

Annual per-patient value =((QALY gained ×WTP threshold)+Cost offsets)/Time on treatment

Treating with lecanemab was estimated to provide additional 0.64 QALYs versus the standard of care. A WTP threshold of $200,000 was used considering the high burden of the disease ($50,000 to $150,000 is considered a cost-effectiveness threshold for traditional drugs). The cost offsets were estimated to be $7,415, and the average time on treatment is considered to be 3.6 years.

Eisai estimates that nearly 91% of patients will be covered by Medicare with Medigap, Medicare Advantage, Medicaid, and Commercial. The out-of-pocket costs for these patients are expected to range between $0 to a few dollars.


CMS says that it will review the data for coverage

The Centers for Medicare & Medicaid Services (CMS) announced that it recognizes Alzheimer's disease as a devastating illness with high unmet need and continuously reviews the data to cover new products.

CMS stated that it is reviewing the available information and may consider coverage based on the available data. CMS further said it would cover a broader population after the drug receives complete approval from the US FDA.

CMS is seeking more information on

  • If the anti-amyloid mAb will improve health outcomes?

  • Is the harm associated with anti-amyloid mAb, including hemorrhage and edema, associated with the patient's characteristics and treating physicians?

  • Will there be any change in the benefits and harms over time?

CMS is approaching stakeholders to answer the above-mentioned Coverage with Evidence Development (CED) questions.




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