Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development

Brockmann, Rouen; Nixon, Joanna; Love, Bryan L.; Yunusa, Ismaeel

doi:10.1016/j.lana.2023.100467

Cited by 15 publications

(15 citation statements)

References 17 publications

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“…Given the age distribution in the Down syndrome group and low employment rates, 26 we can assume most are eligible under the intellectual disorder SSDI determination. With the increased importance of Alzheimer's disease services and treatments in the Medicare population, 27 the Medicare system is more generous in coverage surrounding Alzheimer's drugs and care. For instance, the Centers for Medicare and Medicaid Services has announced that Medicare will broadly cover Alzheimer's drugs with appropriate FDA approval 28 ; such coverage in Medicaid would be determined by states and subject to coverage restrictions, 27 potentially exacerbating inequities 29 …”

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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Medicare, Medicaid, and dual enrollment for adults with intellectual and developmental disabilities

Rubenstein,

Tewolde,

Levine

et al. 2024

Health Services Research

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ObjectiveGiven high rates of un‐ and underemployment among disabled people, adults with intellectual and developmental disabilities rely on Medicaid, Medicare, or both to pay for healthcare. Many disabled adults are Medicare eligible before the age of 65 but little is known as to why some receive Medicare services while others do not. We described the duration of Medicare enrollment for adults with intellectual and developmental disabilities in 2019 and then compared demographics by enrollment type (Medicare‐only, Medicaid‐only, dual‐enrolled). Additionally, we examined the percent in each enrollment type by state, and differences in enrollment type for those with Down syndrome.Data Sources and Study Setting2019 Medicare and Medicaid claims data for all adults (≥18 years) in the US with claim codes for intellectual disability, Down syndrome, or autism at any time between 2011 and 2019.Study DesignAdministrative claims cohort.Data Collection and Abstraction MethodsData were from the Transformed Medicaid Statistical Information System Analytic Files and Medicare Beneficiary Summary files.Principle FindingsIn 2019, Medicare insured 582,868 adults with identified intellectual disability, autism, or Down syndrome. Of 582,868 Medicare beneficiaries, 149,172 were Medicare only and 433,396 were dual‐enrolled. Most Medicare enrollees were enrolled as child dependents (61.5%) Medicaid‐only enrollees (N = 819,256) were less likely to be white non‐Hispanic (58.5% white non‐Hispanic vs. 72.9% white non‐Hispanic in dual‐enrolled), more likely to be Hispanic (19.6% Hispanic vs. 9.2% Hispanic in dual‐enrolled) and were younger (mean 34.2 years vs. 50.5 years dual‐enrolled).ConclusionThere is heterogeneity in public insurance enrollment which is associated with state and disability type. Action is needed to ensure all are insured in the program that works for their healthcare needs.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Medicare, Medicaid, and dual enrollment for adults with intellectual and developmental disabilities

Rubenstein,

Tewolde,

Levine

et al. 2024

Health Services Research

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“…This supports the amyloid cascade theory, suggesting that Aβ aggregation precedes and exacerbates p-tau pathology in AD. However, two FDA-approved immunotherapies targeting Aβ, aducanumab and lecanemab, show modest reductions in Aβ levels and cognitive decline in some patients with mild cognitive impairment (MCI) or early AD and a 30% risk of brain swelling or bleeding ( Brockmann et al, 2023 ). Therefore, other mechanisms must contribute to AD development and progression.…”

Section: Introductionmentioning

confidence: 99%

Epigenetic modifications of DNA and RNA in Alzheimer’s disease

Martinez-Feduchi,

Jin,

Yao

2024

Front. Mol. Neurosci.

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Alzheimer’s disease (AD) is a complex neurodegenerative disorder and the most common form of dementia. There are two main types of AD: familial and sporadic. Familial AD is linked to mutations in amyloid precursor protein (APP), presenilin-1 (PSEN1), and presenilin-2 (PSEN2). On the other hand, sporadic AD is the more common form of the disease and has genetic, epigenetic, and environmental components that influence disease onset and progression. Investigating the epigenetic mechanisms associated with AD is essential for increasing understanding of pathology and identifying biomarkers for diagnosis and treatment. Chemical covalent modifications on DNA and RNA can epigenetically regulate gene expression at transcriptional and post-transcriptional levels and play protective or pathological roles in AD and other neurodegenerative diseases.

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“…Up until recently, the management of AD has been limited to symptomatic treatment and supportive care [ 11 – 13 ], in addition to non-pharmacological multidomain lifestyle-based prevention strategies [ 14 ]. Recently, two disease-modifying treatments (DMTs), aducanumab and lecanemab, received accelerated approval in the United States (US) by the Food and Drug Administration (FDA) [ 15 , 16 ]; however, the Centers for Medicare & Medicaid Services (CMS) restricted its coverage to patients enrolled in approved clinical trials [ 17 , 18 ]. More recently, in July 2023, lecanemab received traditional FDA approval, and subsequently, CMS made a national coverage determination to provide treatment coverage for patients enrolled in a CMS-approved registry for real-world data collection [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer’s disease

Jönsson,

Ivkovic,

Atri

et al. 2024

Alz Res Therapy

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Background The clinical meaningfulness of the effects of recently approved disease-modifying treatments (DMT) in Alzheimer’s disease is under debate. Available evidence is limited to short-term effects on clinical rating scales which may be difficult to interpret and have limited intrinsic meaning to patients. The main value of DMTs accrues over the long term as they are expected to cause a delay or slowing of disease progression. While awaiting such evidence, the translation of short-term effects to time delays or slowing of progression could offer a powerful and readily interpretable representation of clinical outcomes. Methods We simulated disease progression trajectories representing two arms, active and placebo, of a hypothetical clinical trial of a DMT. The placebo arm was simulated based on estimated mean trajectories of clinical dementia rating scale–sum of boxes (CDR-SB) recordings from amyloid-positive subjects with mild cognitive impairment (MCI) from Alzheimer’s Disease Neuroimaging Initiative (ADNI). The active arm was simulated to show an average slowing of disease progression versus placebo of 20% at each visit. The treatment effects in the simulated trials were estimated with a progression model for repeated measures (PMRM) and a mixed model for repeated measures (MMRM) for comparison. For PMRM, the treatment effect is expressed in units of time (e.g., days) and for MMRM in units of the outcome (e.g., CDR-SB points). PMRM results were implemented in a health economics Markov model extrapolating disease progression and death over 15 years. Results The PMRM model estimated a 19% delay in disease progression at 18 months and 20% (~ 7 months delay) at 36 months, while the MMRM model estimated a 25% reduction in CDR-SB (~ 0.5 points) at 36 months. The PMRM model had slightly greater power compared to MMRM. The health economic model based on the estimated time delay suggested an increase in life expectancy (10 months) without extending time in severe stages of disease. Conclusion PMRM methods can be used to estimate treatment effects in terms of slowing of progression which translates to time metrics that can be readily interpreted and appreciated as meaningful outcomes for patients, care partners, and health care practitioners.

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Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer's disease: patient outcomes, healthcare costs, and drug development

Cited by 15 publications

References 17 publications

Medicare, Medicaid, and dual enrollment for adults with intellectual and developmental disabilities

Medicare, Medicaid, and dual enrollment for adults with intellectual and developmental disabilities

Epigenetic modifications of DNA and RNA in Alzheimer’s disease

Progression analysis versus traditional methods to quantify slowing of disease progression in Alzheimer’s disease

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