Are Current International Pricing Paradigms for an Efficacious Disease‐Modifying Anti‐Alzheimer’s Treatment Equitable? Are Quality‐Adjusted Life‐Years Worth Considering?

Abstract

AbstractBackgroundThe June 2021 approval of aducanumab [Aduhelm], initially priced at $56,000/year, followed by the January 2023 approval of lecanemab [Leqembi], initially priced at $26,500/year, generated renewed debate over reasonable and appropriate pricing for disease‐modifying anti‐Alzheimer’s treatments. For equitable pricing of an anti‐Alzheimer’s treatment, what are the optimal patient‐centered pricing paradigms?MethodA literature search of pricing models for anti‐Alzheimer’s, plus other, medicines indicates there are (at least) seven drug pricing models, with value‐based pricing being the most popular. In many countries new medicines are only compared within a certain indication, which may lead us to unknowingly pay substantially more for equal benefit in one disease versus another(1).ResultIn tandem with Leqembi’s expedited review and approval, there was substantial discussion as to what would be reasonable and appropriate pricing. Analysts at the Institute for Clinical and Economic Review [ICER] reported the drug would be cost‐effective at the $8,500 to $20,600 range; their analyses were based on preliminary data. Eisai analysts reported that lecanemab has a societal medicinal value of approximately $37,000, noting that it slowed cognitive decline by 27% over eighteen months(2). The top five selling drugs for multiple sclerosis have an average annual price of $64,760; the average annual cost for the top five cancer drugs is > $165,000.Measurement of outcomes and costs are essential for value‐based pricing. For dementia, the International Consortium for Health Outcomes Measurement [ICHOM] notes that patient‐centered outcome measures represent the ultimate measure of quality and they are always multidimensional. Quality‐adjusted life‐years [QALYs] seem to be absent from the computation of pricing for anti‐dementia treatments. Although consensus on QALY calculations is evasive, currently extant data are compelling. In Australia, the 2023‐adjusted QALY range is $32,618 to $55,415; United Kingdom $49,631 to $98,158, Germany $25,562 to $82,079, Sweden $51,494 to $59,416 and in Japan $56,819 to $67,643(3‐5). Utilizing an 18‐month treatment‐period, a range of QALY valuations will be presented, plus comparisons with the two other clinical indications.Conclusion The inclusion of QALYs for valuation of Alzheimer’s disease medicines warrants consideration; and, The full value of anti‐dementia treatments may be understated in current pricing models.