Medicare Spending on Drugs With Accelerated Approval, 2015-2019.
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ABSTRACT:
SUBMITTER: Rome BN
PROVIDER: S-EPMC8796889 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
Publications
Medicare Spending on Drugs With Accelerated Approval, 2015-2019.
Rome Benjamin N BN Feldman William B WB Kesselheim Aaron S AS
JAMA health forum 20211203 12
This article examines the budgetary implications of high-priced accelerated approval drugs by estimating Medicare spending on these drugs from 2015 through 2019. ...[more]
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Project description: Not available
| S-EPMC10334293 | biostudies-literature
Project description:ImportanceState Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on state Medicaid programs.ObjectiveTo identify the number and class of drugs approved through the FDA's accelerated approval pathway and analyze state Medicaid programs' use and spending on these drugs from 2015 through 2019.Design setting and participantsIn this cross-sectional study, biannual FDA reports were used to identify products granted accelerated approval and their associated indications approved between December 1992 and December 2020. State Medicaid Drug Utilization Data files available for 1992 through 2019 were used to estimate national totals for spending and use of outpatient drugs.Main outcomes and measuresNational Medicaid use and gross and net spending on drugs with accelerated approval from 2015 through 2019.ResultsSince the inception of the FDA's accelerated approval pathway in 1992 through 2020, 216 product-indication pairs granted accelerated approval were identified, comprising 149 unique products. The composition of drugs approved through the pathway has changed over time, with 28 of 30 (93.3%) product-indication pairs receiving accelerated approval in 2020 being indicated for cancer. Relative to all outpatient prescription drugs paid for by Medicaid, products with accelerated approval ranged from 0.2% to 0.4% of use (1.3-2.4 million prescriptions annually). Despite their infrequent use, drugs with accelerated approval represented a minimum annual net spending on all drugs covered by Medicaid of 6.4% ($2.2 billion of $34.6 billion) in 2015 and a maximum of 9.1% ($2.5 billion of $27.6 billion) in 2018. Estimated annual gross spending on drugs with accelerated approval ranged from $4.2 billion to $4.9 billion over 2015 through 2019, and estimated net spending from $2.2 billion to $2.6 billion.Conclusions and relevanceIn this cross-sectional study of 216 drugs granted accelerated approval, state spending on drugs approved through the FDA's growing accelerated approval program represented an outsized amount of spending relative to use. Because drugs with accelerated approval have come to market on the basis of trials using surrogate end points, considerable amounts of this spending may have been attributable to products with unproven clinical benefits.
| S-EPMC8727037 | biostudies-literature
Project description:This cross-sectional study uses Centers for Medicare & Medicaid Services payment data to examine use of short-course radiotherapy from 2015 to 2019 among Medicare beneficiaries with indolent lymphoma.
| S-EPMC9250056 | biostudies-literature
Project description: Not available
| S-EPMC8524351 | biostudies-literature
Project description:ImportancePrescription drug spending is a topic of increased interest to the public and policymakers. However, prior assessments have been limited by focusing on retail spending (Part D-covered drugs), omitting clinician-administered (Part B-covered) drug spending, or focusing on all fee-for-service Medicare beneficiaries, regardless of their enrollment into prescription drug coverage.ObjectiveTo estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions.Design, setting, and participantsDescriptive, serial, cross-sectional analysis of a 20% random sample of fee-for-service Medicare beneficiaries in the United States from 2008 to 2019 who were continuously enrolled in Parts A (hospital), B (medical), and D (prescription drug) benefits, and not in Medicare Advantage.ExposureCalendar year.Main outcomes and measuresNet spending on retail (Part D-covered) and clinician-administered (Part B-covered) prescription drugs; prescription drug spending (spending on Part B-covered and Part D-covered drugs) as a percentage of total per-capita health care spending. Measures were adjusted for inflation and for postsale rebates (for Part D-covered drugs).ResultsThere were 3 201 284 beneficiaries enrolled in Parts A, B, and D in 2008 and 4 502 718 in 2019. In 2019, beneficiaries had a mean (SD) age of 71.7 (12.0) years, documented sex was female for 57.7%, and 69.5% had no low-income subsidies. Total per-capita spending was $16 345 in 2008 and $20 117 in 2019. Comparing 2008 with 2019, per-capita Part A spending was $7106 (95% CI, $7084-$7128) vs $7120 (95% CI, $7098-$7141), Part B drug spending was $720 (95% CI, $713-$728) vs $1641 (95% CI, $1629-$1653), Part B nondrug spending was $5113 (95% CI, $5105-$5122) vs $6702 (95% CI, $6692-$6712), and Part D net spending was $3122 (95% CI, $3117-$3127) vs $3477 (95% CI, $3466-$3489). The proportion of total annual spending attributed to prescription drugs increased from 24.0% in 2008 to 27.2% in 2019, net of estimated rebates and discounts.Conclusions and relevanceIn 2019, spending on prescription drugs represented approximately 27% of total spending among fee-for-service Medicare beneficiaries enrolled in Part D, even after accounting for postsale rebates.
| S-EPMC9579917 | biostudies-literature
Project description:ImportanceMedicare Part B drug expenditures have increased in recent years. This trend is likely to persist given the increased use and availability of biologics.ObjectivesTo assess the extent to which Medicare Part B spending growth was associated with changes in price vs quantity, and how these trends interacted with entry of new drugs into the marketplace.Design, setting, and participantsThis cross-sectional study quantified the degree of spending concentration and the association between price and use of Part B drugs among fee-for-service Medicare beneficiaries. Data on use and spending for separately payable Part B drugs were included. Source data were aggregated to the drug-year level and reported from 2016 to 2020. Descriptive decomposition and index analyses quantified the relative association of price and use changes separately for existing single-source drugs, existing drugs that faced competition, and new drugs that entered the market. Data analysis was performed from June to December 2022.Main outcomes and measuresPart B drug spending by the fee-for-service Medicare program and beneficiaries, as well as use, defined as dosage units and beneficiaries using the drugs.ResultsThe study included 535 unique Part B drug products. From 2016 to 2020, 15 or fewer products comprised half of all Part B drug expenditures. The set of 7 drugs that comprised the top 25% of spending was very consistent over time, and all were biologics. Part B drug products that cost $1.85 or less per administration accounted for more than half of the doses administered in 2020. Spending on Part B drugs increased by $15 billion from 2016 to 2020. The entry of new, nonbiosimilar drugs during this period accounted for $12 billion of this increased spending (80%), while shifts in use and price increases among existing single-source brand drugs accounted for the remaining increase in spending. Part B spending decreased among the subset of existing drugs facing generic or biosimilar competition. Among single-source drugs on the market in 2016, the index that varied dosage units exceeded the index that varied price in all years, confirming that changes in use were associated more with spending growth for those drugs.Conclusions and relevanceIn this cross-sectional study of Medicare Part B drug expenditures, spending was found to be concentrated among a small number of drugs. The entry of new products was a key factor associated with recent increases in Part B drug spending. These findings suggest that policies targeting top-selling drugs may have greater potential to curb Part B drug spending than those targeting price growth.
| S-EPMC10492179 | biostudies-literature
Project description:ObjectiveBillions of public dollars are spent each year on biologic disease-modifying antirheumatic drugs (DMARDs), but the drivers of recent increases in biologic DMARD spending are unclear. This study was undertaken to characterize changes in total spending and unit prices for biologic DMARDs in Medicare and Medicaid programs and quantified the major sources of these spending increases.MethodsWe accessed drug spending data from years 2012-2016, covering all Medicare Part B (fee-for-service), Medicare Part D, and Medicaid enrollees. After calculating 5-year changes in total spending and unit prices for each biologic DMARD as well as in aggregate, we performed standard decomposition analyses to isolate 4 sources of spending growth: drug prices, uptake (number of recipients), treatment intensity (mean number of doses per claim), and treatment duration (annual number of claims per recipient), both excluding and including time-varying rebates.ResultsFrom 2012 to 2016, annual spending on public-payer claims for the 10 biologic DMARDs included in this study more than doubled ($3.8 billion to $8.6 billion), with median drug price increases of 51% in Medicare Part D (mean 54%) and 8% in Medicare Part B (mean 21%). With adjustment for general inflation, unit price increases alone accounted for 57% of the 5-year, $3.0 billion spending increase in Part D, while 37% of the spending increase was from increased uptake. Accounting for time-varying rebates, prices were still responsible for 54% of increased spending. Unit prices and spending were lower under Medicaid than under Medicare Part D, though temporal trends and contributors were similar.ConclusionPostmarket drug price changes alone account for the majority of the recent spending growth in biologic DMARDs. Policy interventions targeting price increases, particularly those under Medicare Part D plans, may help mitigate financial burdens for public payers and biologic DMARD recipients.
| S-EPMC6994362 | biostudies-literature
Project description: Not available
| S-EPMC10082405 | biostudies-literature
Project description:This cross-sectional study describes changes in annual Medicare Part B spending for biologic drugs after biosimilar entry, focusing on the first 4 products to experience biosimilar competition: filgrastim, infliximab, epoetin alpha, and pegfilgrastim.
| S-EPMC8796923 | biostudies-literature
Project description:ObjectiveTo estimate lifetime incremental medical spending attributed to incident type 2 diabetes (T2D) among Medicare beneficiaries by age at diagnosis, sex, and race/ethnicity.Research design and methodsWe used the 1999-2019 100% Medicare fee-for-service claims database to identify a cohort of beneficiaries with newly diagnosed T2D in 2001-2003 using ICD codes. We matched this cohort with a nondiabetes cohort using a propensity score method and then followed the two cohorts until death, disenrollment, or the end of 2019. Lifetime medical spending for each cohort was the sum of expected annual spending, a product of actual annual spending multiplied by the annual survival rate, from the age at T2D diagnosis to death. Lifetime incremental medical spending was calculated as the difference in lifetime medical spending between the two cohorts. All spending was standardized to 2019 U.S. dollars.ResultsMedicare beneficiaries with newly diagnosed T2D, despite having a shorter life expectancy, had 36-40% higher lifetime medical spending compared with a comparable group without diabetes. Lifetime incremental medical spending ranged from $16,115 to $122,146, depending on age at diagnosis, sex, and race/ethnicity, declining with age at diagnosis, and being highest for Asian/Pacific Islander and non-Hispanic Black beneficiaries.ConclusionsThe large lifetime incremental medical spending associated with incident T2D underscores the need for preventing T2D among Medicare beneficiaries. Our results could be used to estimate the potential financial benefit of T2D prevention programs both overall and among subgroups of beneficiaries.
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