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Costs and benefits of early access to new cancer drugs through the US Food and Drug Administration's accelerated approval pathway: retrospective observational study and economic evaluation.

OBJECTIVE: To evaluate the survival gains and additional Medicare spending associated with early access to new cancer drugs granted accelerated approval by the US Food and Drug Administration (FDA), compared with access to cancer drugs following completion of confirmatory trials. DESIGN: Retrospective observational study and economic evaluation. SETTING: US Medicare programme, which provides health insurance for adults aged 65 years and older. PARTICIPANTS: Medicare beneficiaries who received new cancer drug indications from the time of FDA accelerated approval to conversion to regular appr

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… Medicare part B drug spending dashboard. https://data.cms.gov/tools/medicare-part-b-drug-spending-dashboard Available. Accessed. 37. Ballreich J, Socal M, Bennett CL, et al. Medicare Spending on Drugs With Accelerated Approval. Ann Intern Med. 2022;175:938–44. doi: 10.7326/M21-4442. 38. …

The Impact of Biosimilar Use on Total Cost of Care and Provider Financial Performance in the Medicare Oncology Care Model: A Population-Based Simulation Study.

IntroductionPayment for oncology care is increasingly moving from fee-for-service to value-based payment (VBP). VBPs are agreements in which providers are held accountable for total cost of care (TCOC) through risk-sharing arrangements with payers that tie reimbursement levels to TCOC benchmarks. Oncology biosimilars may play an important role in managing financial risk in the VBPs like Medicare's Oncology Care Model (OCM), but there has been limited research in this area. The objective of this study is to estimate the impact of biosimilar adoption on TCOC and oncology provider financial perfo

Provider billing margin and cancer treatment selection: population based cohort study.

ObjectiveTo estimate the association between the billing (profit) margin and clinical benefit of cancer treatments and use by oncologists.DesignRetrospective population based cohort study SETTING: Population based sample using fee-for-service Medicare claims data.ParticipantsMedicare beneficiaries with an incident cancer diagnosis from 2015 to 2020; included all patients with cancer treatment indications for which the available treatment options varied in clinical benefit and billing margin.Main outcomes and measuresThe primary outcome was the cancer treatment each patient received among treat

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… Medicare Part B Drugs: Trends in Spending and Utilization, 2006-2017 . Assistant Secretary for Planning and Evaluation, Office of Health Policy; 2020. … Chapter 5: Medicare Part B Drug and Oncology Payment Policy Issues. MedPac; 2016. Accessed 23 Nov 2017. https://www.medpac.gov/docs/default-source/reports/chapter-5-medicare-part-b-drug-and-oncology-payment-policy-issues-june-2016-report-.pdf? …

Estimating Out-of-Pocket Savings From Medicare Site-Neutral Payments on Colon, Lung, Ovarian, and Prostate Cancer Patients.

Site-neutral payment reforms seek to align Medicare reimbursement rates for common outpatient services across care sites. Recent reports have assessed the composite impact of site-neutral payment policies on beneficiaries, federal savings, and the commercial market. This analysis builds on such work, focusing on the potential patient-level savings of site-neutral reform for high-utilizing Medicare beneficiaries facing common chronic cancers. We compiled the outpatient services of standard treatment regimens for a typical lung, ovarian, prostate, and colon cancer patient over their first year o

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… In addition to the out-of-pocket savings, although we do not include it in our estimates here, patients would also expect to see a separate reduction in their Medicare Part B premium rates. … November 8, 2024. https://www.cms.gov/newsroom/fact-sheets/2025-medicare-parts-b-premiums-and-deductibles 26. Ellis P. Estimated Savings from Adopting Site-Neutral Payment Policies for Medicare. Ellis Health Policy. Blue Cross Blue Shield. …

Изменения в охвате части D программы " Медикэр " в конкурентоспособных классах в контексте Закона о сокращении выбросов после инфляции: 2024 - 2026 годы.

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Global Budget Revenue Model and Care for Patients Receiving Chemotherapy.

ImportanceMaryland's Global Budget Revenue (GBR) model provided fixed global payments to hospitals, aiming to control revenue growth while improving care quality. The implications of GBR implementation in 2014 for cancer care have not been robustly evaluated.ObjectiveTo examine the association between GBR implementation and subsequent changes in episode-based Medicare payments, hospital utilization, and quality of care among Medicare beneficiaries undergoing systemic therapy for cancer.Design, setting, and participantsThis cohort study used a difference-in-differences approach to compare chang

Trends in Medicare reimbursement for end-stage renal disease: 1974-1979.

This article presents detailed analyses of the trends in Medicare expenditures for persons with end-stage renal disease. Program expenditures increased at an annual rate of 30.5 percent from 1974 to 1981. Three-fourths of this increase was a result of increases in enrollment. Per capita reimbursements for dialysis patients increased at a 5.2-percent annual rate and per capita reimbursements for transplant patients increased at a 10.5-percent annual rate. In 1979, per capital reimbursements for home dialysis patients were $5,000 less than for in-unit dialysis patients. Patient characteristics s

Перспективы пациентов в отношении стоимостных и качественных показателей лечения рака на основе ценностей.

Перспективные перспективы и предпочтения имеют важное значение при установлении качественных и стоимостных показателей для моделей выплат на основе стоимости (ВБП), с тем чтобы обеспечить увязку услуг по лечению раковых заболеваний с учетом интересов пациентов и стимулов в отношении ПВП. Были собраны сведения о моделях оказания помощи на основе стоимости (ВБК) от пациентов с системой " Медикэр " и one В процентах 4 Обычные раковые заболевания (многообразная миелома, мочевой пузырь, лёгкие и простаты), включенные в усовершенствованную онкологическую модель Medicare. Это исследование в

Cost Implications of Comorbidity for Autologous Stem Cell Transplantation in Elderly Patients with Multiple Myeloma Using SEER-Medicare.

Comorbidity is more common in older patients and can increase the cost of care by increasing toxicity. Using the SEER-Medicare database from 2000 to 2007, we examined the costs and life-year benefit of Auto-HSCT for MM patients over the age of 65 by evaluating the difference over time relative to comorbidity burden. One hundred ten patients had an Auto-HSCT in the early time period (2000-2003) and 160 in the late time period (2004-2007). Patients were divided by a Charlson Comorbidity Index (CCI) of 0 or greater than 1 (CCI1+). Median overall survival was 53.5 months for the late time period p

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… The Patient Entitlement and Diagnosis Summary (Medicare enrollment information), the Medicare Provider Analysis and Review (MEDPAR) (inpatient Medicare Part A claims), the National Claims History (NCH) file (provider Medicare Part B claims), and the Outpatient (institutional Medicare Part B claims) files …

Disparities in clinical trial participation among older adult Medicare beneficiaries with hematologic malignancies from 2006 to 2019: A SEER-Medicare analysis.

BACKGROUND: Clinical trials (CTs) are essential for expanding treatment options across hematologic malignancies (HM) and providing access to novel treatments. However, older adults with HM are often underrepresented in CTs, and a national-level evaluation of factors influencing their participation is lacking. METHODS: The authors conducted a retrospective cohort study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, identifying patients ≥66 years old diagnosed with HM between 2006 and 2018 (follow-up to December 2019). CT participation was defined by Medicare cl

Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial.

BackgroundImproving the health of chronically ill older adults is a major challenge facing modern health care systems. A community-based nursing intervention developed by Health Quality Partners (HQP) was one of 15 different models of care coordination tested in randomized controlled trials within the Medicare Coordinated Care Demonstration (MCCD), a national US study. Evaluation of the HQP program began in 2002. The study reported here was designed to evaluate the survival impact of the HQP program versus usual care up to five years post-enrollment.Methods and findingsHQP enrolled 1,736 adult

Estimated number of prevalent cases of metastatic bone disease in the US adult population.

BackgroundThe prevalence of metastatic bone disease in the US population is not well understood. We sought to estimate the current number of US adults with metastatic bone disease using two large administrative data sets.MethodsPrevalence was estimated from a commercially insured cohort (ages 18-64 years, MarketScan database) and from a fee-for-service Medicare cohort (ages ≥65 years, Medicare 5% database) with coverage on December 31, 2008, representing approximately two-thirds of the US population in each age group. We searched for claims-based evidence of metastatic bone disease from Januar

Расовые различия в лечении и выживании пожилых пациентов с множественной миеломой.

С течением времени эволюционировали фоновые характеристики миеломы (ММ) и улучшили выживание MM. Несмотря на то, что расовые различия в лечении MM и прогнозах между неиспаноязычными афроамериканцами (NHAA) и неиспанскими белыми пациентами (NHW) хорошо зарекомендовали себя, неясно, сохранялись ли они после внедрения новых агентов. 1 год после диагностирования и оценки результатов выживаемости среди бенефициаров программы " Медикэр "≥66 ) с диагнозом MM от 2007 в адрес 2017. Мы применили многовариантные модели пропорциональных рисков кокса для оценки связи между расой и выживанием и пр

US Budget Impact Model for Selinexor in Relapsed or Refractory Multiple Myeloma.

OBJECTIVE: To estimate the budgetary impact of adopting selinexor (XPOVIO; Karyopharm Therapeutics, Inc.) for the treatment of adult patients with penta-refractory multiple myeloma (MM) from the perspective of a third-party payer in the United States (US). METHODS: A budget impact analysis was conducted in one-year increments for the first 3 years after the introduction of selinexor for a private payer or Medicare Part D. Total annual treatment costs (2018 US dollars) were calculated as the sum of drug costs, costs of adverse events (AEs; grade ≥3), along with ongoing best supportive care cos

A review of the first year of Medicare coverage of erythropoietin.

Recombinant human erythropoietin (rHuEPO) is a new drug for treating anemia associated with end stage renal disease (ESRD). In a study of rHuEPO diffusion, costs, and effectiveness, we analyze ESRD program data and all claims submitted to Medicare for reimbursement of rHuEPO administered to ESRD dialysis patients. Access to rHuEPO was rapid and extensive during the first year of Medicare coverage. Dosing of rHuEPO and achieved hematocrit were lower than expected based on the results of clinical trials. rHuEPO cost Medicare $144 million in its first year. The analysis of insurance claims data a

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… Perhaps fewer black patients receive rHuEPO because black people are less likely to obtain coinsurance to cover the 20 percent patient copayment associated with all Medicare Part B services. The burden of the Part B copayment associated with receiving rHuEPO is likely to be considerable. …

Validation of the Medicare-Enhanced Laboratory and Demographics (MELD™) Dataset: A Comprehensive Psychometric, Epidemiologic, and Predictive-Utility Assessment of a 60-Million-Patient Real-World Evidence Resource.

BackgroundReal-world evidence studies increasingly rely on integrated data resources that combine Medicare fee-for-service claims with electronic medical records (EMRs), laboratory results, and patient-reported outcomes. The Medicare-Enhanced Laboratory and Demographics (MELD™) dataset, developed by Columbia Data Analytics, spans 2020 through 2024 and contains 60 million unique patients, roughly 1 billion visits, and more than 241 000 clinicians. Its data-quality properties must be characterized before regulatory-grade use.ObjectiveTo provide a preregistered, multidomain validation of MELD, qu

Более широкие соображения в отношении интеграции медицинских и стоматологических данных

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Socioeconomic Factors and Survival of Multiple Myeloma Patients.

BackgroundOutcome of Multiple Myeloma (MM) patients has improved as the result of the introduction of novel medications and use of autologous hematopoietic cell transplantation. However, this improvement comes at the expense of increased financial burden. It is largely unknown if socioeconomic factors influence MM survival.MethodsWe used the National Cancer Database, a database that houses data on 70% of cancer patients in the US, to evaluate the effect of socioeconomic factors on the survival of 117,926 MM patients diagnosed between 2005 and 2014.ResultsPatients aged ≥65 years who were privat

Наблюдение за финансовыми трудностями пациентов с множественной миеломой и хронической лимфоцитической лейкемией, проходящих лечение в онкологических клиниках США (Alliance A231602CD).

ЦЕЛИ: Оценка доли и корреляции финансовых трудностей, о которых сообщают сами пациенты с множественной миеломой (ММ) или хронической лимфоцитической лейкемией (КЛ). Вечеринка: Sixty-six Общинная практика США и практики меньшинств в области онкологии связана с Программой общинных онкологических исследований Национального института раковых заболеваний (НКОРП). Участники: в целом 521 (больные)≥18 С согласия MM или CLL и 416 :: ответы на опрос (процент завершения)79.8%). Респонденты имели диагноз MM (MM-диагностика)74.0%), степень бакалавра или выше (53.4%), белые (или белые).89.2%), застрахованны

Phase-Specific and Lifetime Costs of Multiple Myeloma Among Older Adults in the US.

ImportanceHealth care costs associated with diagnosis and care among older adults with multiple myeloma (MM) are substantial, with cost of care and the factors involved differing across various phases of the disease care continuum, yet little is known about cost of care attributable to MM from a Medicare perspective.ObjectiveTo estimate incremental phase-specific and lifetime costs and cost drivers among older adults with MM enrolled in fee-for-service Medicare.Design, setting, and participantsA retrospective cohort study was conducted using population-based registry data from the 2007-2015 Su