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1.
Oncologist ; 29(6): 527-533, 2024 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-38484395

RESUMEN

BACKGROUND: Because the markups on cancer drugs vary by payor, providers' financial incentive to use high-price drugs is differential according to each patient's insurance type. We evaluated the association between patient insurer (commercial vs Medicaid) and the use of high-priced cancer treatments. MATERIALS AND METHODS: We linked cancer registry, administrative claims, and demographic data for individuals diagnosed with cancer in North Carolina from 2004 to 2011, with either commercial or Medicaid insurance. We selected cancers with multiple FDA-approved, guideline-recommended chemotherapy options and large price differences between treatment options: advanced colorectal, lung, and head and neck cancer. The outcome was a receipt of a higher-priced option, and the exposure was insurer: commercial versus Medicaid. We estimated risk ratios (RRs) for the association between insurer and higher-priced treatment using log-binomial models with inverse probability of exposure weights. RESULTS: Of 812 patients, 209 (26%) had Medicaid. The unadjusted risk of receiving higher-priced treatment was 36% (215/603) for commercially insured and 27% (57/209) for Medicaid insured (RR: 1.31, 95% CI: 1.02-1.67). After adjustment for confounders the association was attenuated (RR: 1.15, 95% CI: 0.81-1.65). Exploratory subgroup analysis suggested that commercial insurance was associated with increased receipt of higher-priced treatment among patients treated by non-NCI-designated providers (RR: 1.53, 95% CI: 1.14-2.04). CONCLUSIONS: Individuals with Medicaid and commercial insurance received high-priced treatments in similar proportion, after accounting for differences in case mix. However, modification by provider characteristics suggests that insurance type may influence treatment selection for some patient groups. Further work is needed to determine the relationship between insurance status and newer, high-price drugs such as immune-oncology agents.


Asunto(s)
Medicaid , Humanos , Medicaid/estadística & datos numéricos , Estados Unidos , Femenino , Masculino , Persona de Mediana Edad , Antineoplásicos/uso terapéutico , Antineoplásicos/economía , Neoplasias/tratamiento farmacológico , North Carolina , Anciano , Seguro de Salud/estadística & datos numéricos , Adulto
2.
Oncologist ; 29(5): 400-406, 2024 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-38339991

RESUMEN

BACKGROUND: In qualitative work, patients report that seemingly short trips to clinic (eg, a supposed 10-minute blood draw) often turn into "all-day affairs." We sought to quantify the time patients with cancer spend attending ambulatory appointments. METHODS: We conducted a retrospective study of patients scheduled for oncology-related ambulatory care (eg, labs, imaging, procedures, infusions, and clinician visits) at an academic cancer center over 1 week. The primary exposure was the ambulatory service type(s) (eg, clinician visit only, labs and infusion, etc.). We used Real-Time Location System badge data to calculate clinic times and estimated round-trip travel times and parking times. We calculated and summarized clinic and total (clinic + travel + parking) times for ambulatory service types. RESULTS: We included 435 patients. Across all service day type(s), the median (IQR) clinic time was 119 (78-202) minutes. The estimated median (IQR) round-trip driving distance and travel time was 34 (17-49) miles and 50 (36-68) minutes. The median (IQR) parking time was 14 (12-15) minutes. Overall, the median (IQR) total time was 197 (143-287) minutes. The median total times for specific service type(s) included: 99 minutes for lab-only, 144 minutes for clinician visit only, and 278 minutes for labs, clinician visit, and infusion. CONCLUSION: Patients often spent several hours pursuing ambulatory cancer care on a given day. Accounting for opportunity time costs and the coordination of activities around ambulatory care, these results highlight the substantial time burdens of cancer care, and support the notion that many days with ambulatory health care contact may represent "lost days."


Asunto(s)
Atención Ambulatoria , Citas y Horarios , Neoplasias , Humanos , Neoplasias/terapia , Femenino , Masculino , Estudios Retrospectivos , Atención Ambulatoria/estadística & datos numéricos , Persona de Mediana Edad , Factores de Tiempo , Anciano , Adulto
3.
Ann Surg ; 2023 Nov 20.
Artículo en Inglés | MEDLINE | ID: mdl-37982509

RESUMEN

OBJECTIVE: Compare rates and severity of recurrent acute diverticulitis in patients with and without solid organ transplant. SUMMARY BACKGROUND DATA: Immunocompromised solid organ transplant recipients have been considered higher risk for both recurrence and severity of acute diverticulitis. Current guidelines recommend an individualized approach for colectomy in these patients, but these are based on single-center data. METHODS: We identified patients with acute diverticulitis using the Merative MarketScan commercial claims data from 2014-2020. Patients were classified by history of solid organ transplant. The primary outcome was recurrence of acute diverticulitis with an associated antibiotic prescription ≥60 days from the initial episode. Secondary outcomes included hospitalization, colectomy, and ostomy in patients with recurrence. Analyses used inverse probability weighting to adjust for imbalances in covariates. RESULTS: Of 170,697 patients with evidence of acute diverticulitis, 442 (0.2%) had a history of solid organ transplantation. In the weighted cohort, among people who had not been censored at one year (n=515), 112 (22%; 95% CI 20%-25%) experienced a recurrence within the first year. Solid organ transplantation was not significantly associated with a risk of recurrence (HR 1.19; 95% CI 0.94-1.50). There was also no statistically significant difference in the hospitalization rate for recurrent diverticulitis. Restricting the analysis to hospitalized recurrences, there was no statistically significant difference observed in either length of stay or discharge status. CONCLUSIONS: In this national analysis of commercially-insured patients with acute diverticulitis we found no statistically significant differences in recurrence between those with and without a history of solid organ transplant. We do not support an aggressive colectomy strategy based on concern for increased recurrence rate and severity in a solid organ transplant population.

4.
N Engl J Med ; 383(6): 558-566, 2020 08 06.
Artículo en Inglés | MEDLINE | ID: mdl-32757524

RESUMEN

BACKGROUND: Specialty drugs are used to treat complex or life-threatening conditions, often at high financial costs to both patients and health plans. Three states - Delaware, Louisiana, and Maryland - passed legislation to cap out-of-pocket payments for specialty drugs at $150 per prescription. A concern is that these caps could shift costs to health plans, increasing insurance premiums. Estimates of the effect of the caps on patient and health-plan spending could inform future policies. METHODS: We analyzed a sample that included 27,161 persons under 65 years of age who had rheumatoid arthritis, multiple sclerosis, hepatitis C, psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis and who were in commercial health plans from 2011 through 2016 that were administered by three large nationwide insurers. The primary outcome was the change in out-of-pocket spending among specialty-drug users who were in the 95th percentile for spending on specialty drugs. Other outcomes were changes in mean out-of-pocket and health-plan spending for specialty drugs, nonspecialty drugs, and nondrug health care and utilization of specialty drugs. We compared outcomes in the three states that enacted caps with neighboring control states that did not, 3 years before and up to 3 years after enactment of the spending cap. RESULTS: Caps were associated with an adjusted change in out-of-pocket costs of -$351 (95% confidence interval, -554 to -148) per specialty-drug user per month, representing a 32% reduction in spending, among users in the 95th percentile of spending on specialty drugs. This finding was supported by multiple sensitivity analyses. Caps were not associated with changes in other outcomes. CONCLUSIONS: Caps for spending on specialty drugs were associated with substantial reductions in spending on specialty drugs among patients with the highest out-of-pocket costs, without detectable increases in health-plan spending, a proxy for future insurance premiums. (Funded by the Robert Wood Johnson Foundation Health Data for Action Program.).


Asunto(s)
Enfermedad Crónica/tratamiento farmacológico , Seguro de Costos Compartidos/legislación & jurisprudencia , Costos de los Medicamentos/legislación & jurisprudencia , Gastos en Salud/estadística & datos numéricos , Seguro de Servicios Farmacéuticos/economía , Gobierno Estatal , Adulto , Enfermedad Crónica/economía , Seguro de Costos Compartidos/economía , Delaware , Humanos , Seguro de Servicios Farmacéuticos/legislación & jurisprudencia , Louisiana , Maryland , Persona de Mediana Edad , Honorarios por Prescripción de Medicamentos/legislación & jurisprudencia , Estados Unidos
5.
J Urol ; 210(3): 447-453, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37341420

RESUMEN

PURPOSE: Patients eligible for Medicare Part D low-income subsidy have lower cost-sharing for both IV and oral cancer therapies. We evaluated associations between low-income subsidy and treatment choice, treatment initiation, and overall survival in patients with metastatic prostate cancer. MATERIALS AND METHODS: We identified men aged 66 years and older diagnosed with stage IV prostate cancer between 2010 and 2017 included in the Surveillance, Epidemiology, and End Results-Medicare linked data set. Using linear probability models, we evaluated the impact of low-income subsidy on type of first supplementary treatment (oral vs IV) among patients who received nonandrogen deprivation therapy supplementary systemic therapy, and initiation of any nonandrogen deprivation therapy supplementary systemic therapy. Overall survival was estimated with Kaplan-Meier curves. RESULTS: Of the 5,929 patients included, 1,766 (30%) had low-income subsidy. On multivariable analysis, those with low-income subsidy were more likely to receive oral as opposed to IV treatments compared to patients without low-income subsidy (probability difference: 17%, 95% CI 12, 22). However, patients with low-income subsidy were less likely to initiate any nonandrogen deprivation therapy supplementary systemic therapy (oral or IV) compared to those without low-income subsidy (probability difference: 7.9%, 95% CI 4.8-11). Additionally, patients with low-income subsidy experienced worse overall survival than those without low-income subsidy (P < .001). CONCLUSIONS: While low-income subsidy was associated with increased use of more expensive oral therapies in men with metastatic prostate cancer, barriers to accessing these treatments still exist. These findings stress the importance of continued efforts to improve health care access to low-income individuals.


Asunto(s)
Medicare Part D , Neoplasias de la Próstata , Masculino , Humanos , Anciano , Estados Unidos , Neoplasias de la Próstata/terapia , Pobreza , Accesibilidad a los Servicios de Salud
6.
J Urol ; 210(2): 290-298, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37416955

RESUMEN

PURPOSE: Assessments of financial toxicity among patients with metastatic prostate cancer are lacking. Using patient surveys, we sought to identify coping mechanisms and assess characteristics associated with lower financial toxicity. MATERIALS AND METHODS: Surveys were administered to all patients seen at a single center's Advanced Prostate Cancer Clinic over a 3-month period. Surveys included the COST-FACIT (COmprehensive Score for Financial Toxicity) and coping mechanism questionnaires. Patients with metastatic disease (lymph nodes, bone, visceral) were included for analysis. Coping mechanisms were compared between patients experiencing low (COST-FACIT >24) vs high (COST-FACIT ≤24) financial toxicity using Fisher's exact test. Multivariable linear regression was used to evaluate characteristics associated with lower financial toxicity. RESULTS: Overall, 281 patients met inclusion criteria of which 79 reported high financial toxicity. In multivariable analysis, characteristics associated with lower financial toxicity included older age (estimate: 0.36, 95%CI: 0.21-0.52), applying for patient assistance programs (estimate: 4.42, 95%CI: 1.72-7.11), and an annual income of at least $100,000 (estimate: 7.81, 95%CI: 0.97, 14.66). Patients with high financial toxicity were more likely to decrease spending on basic goods (35% vs 2.5%, P < .001) and leisure activities (59% vs 15%, P > .001), as well as use savings (62% vs 17%, P < .001) to pay for their treatment. CONCLUSIONS: In this cross-sectional study, patients with metastatic prostate cancer and high financial toxicity were more likely to decrease spending on basic goods and leisure activities and use savings to pay for care. Understanding the impact of financial toxicity on patients' lives is crucial to inform shared decision-making and interventions designed to mitigate financial toxicity in this population.


Asunto(s)
Neoplasias , Neoplasias de la Próstata , Masculino , Humanos , Costo de Enfermedad , Estrés Financiero , Estudios Transversales , Adaptación Psicológica , Encuestas y Cuestionarios , Calidad de Vida
7.
Med Care ; 61(12 Suppl 2): S153-S160, 2023 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-37963035

RESUMEN

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources.


Asunto(s)
Medicare , Evaluación del Resultado de la Atención al Paciente , Anciano , Humanos , Estados Unidos , Estudios Prospectivos , Evaluación de Resultado en la Atención de Salud , Atención Dirigida al Paciente
8.
J Gen Intern Med ; 38(16): 3482-3489, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37709993

RESUMEN

BACKGROUND: Medication cost conversations occur less frequently than patients prefer, and it is unclear whether patients have positive experiences with them when they do occur. OBJECTIVE: To describe patients' experiences discussing their medication costs with their health care team. DESIGN: Cross-sectional survey. SETTING: Nationally representative survey fielded in the United States in 2022 (response rate = 48.5%). PATIENTS: 1020 adults over age 65. MEASUREMENTS: Primary measures were adapted from Clinician and Group Consumer Assessment of Healthcare Providers Survey visit survey v4.0 and captured patients' experiences of medication cost conversations. Additional measures captured patients' interest in future cost conversations, the type of clinicians with whom they would be comfortable discussing costs, and sociodemographic characteristics. RESULTS: Among 1020 respondents who discussed medication prices with their health care team, 39.3% were 75 or older and 78.6% were non-Hispanic White. Forty-three percent of respondents indicated that their prior medication cost conversation was not easy to understand; 3% indicated their health care team was not respectful and 26% indicated their health care team was somewhat respectful during their last conversation; 48% indicated that there was not enough time. Those reporting that their prior discussion was not easy to understand or that their clinician was not definitely respectful were less likely to be interested in future discussions. Only 6% and 10% of respondents indicated being comfortable discussing medication prices with financial counselors or social workers, respectively. Few differences in responses were observed by survey participant characteristics. LIMITATIONS: This cross-sectional survey of prior experiences may be subject to recall bias. CONCLUSION: Among older adults who engaged in prior medication cost conversations, many report that these conversations are not easy to understand and that almost one-third of clinicians were somewhat or not respectful. Efforts to increase the frequency of medication cost conversations should consider parallel interventions to ensure the discussions are effective at informing prescribing decisions and reducing cost-related medication nonadherence.


Asunto(s)
Cumplimiento de la Medicación , Relaciones Médico-Paciente , Humanos , Estados Unidos , Anciano , Estudios Transversales , Encuestas y Cuestionarios , Encuestas de Atención de la Salud
9.
Curr Cardiol Rep ; 25(6): 577-581, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37097432

RESUMEN

PURPOSE OF REVIEW: Cardiovascular medications improve health and prevent early death. However, high drug prices reduce the use of these medications and strain the health system. The Inflation Reduction Act (IRA) of 2022 allows Medicare to negotiate drug prices with manufacturers and reduces out-of-pocket drug costs for Medicare beneficiaries. This article explores the potential impact that the IRA will have on the treatment of cardiovascular disease. RECENT FINDINGS: Cardiovascular disease medications are likely to be selected for price negotiations under the IRA, leading to savings for patients and for Medicare. Recent work suggests that the IRA's reforms to the Medicare Part D drug benefit will meaningfully reduce out-of-pocket costs for important cardiovascular medications. The IRA is expected to impact cardiovascular disease treatments via price negotiations and through the broader access to medications afforded by improvements to Part D coverage design.


Asunto(s)
Enfermedades Cardiovasculares , Cardiopatías , Medicare Part D , Anciano , Humanos , Estados Unidos , Negociación , Costos de los Medicamentos
10.
J Urol ; 208(5): 987-996, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36094864

RESUMEN

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.


Asunto(s)
Gastos en Salud , Neoplasias de la Próstata , Antagonistas de Andrógenos/uso terapéutico , Andrógenos , Costos y Análisis de Costo , Humanos , Masculino , Neoplasias de la Próstata/tratamiento farmacológico
11.
Support Care Cancer ; 31(1): 3, 2022 Dec 13.
Artículo en Inglés | MEDLINE | ID: mdl-36512134

RESUMEN

PURPOSE: No single pharmacy in an urban zip code is consistently the least expensive across medications. If medication prices change differently across pharmacies, patients and clinicians will face challenges accessing affordable medications when refilling medications. This is especially pertinent to people with cancer with multiple fills of supportive care medications over time. We evaluated if the lowest-priced pharmacy for a formulation remains the lowest-priced over time. METHODS: We compiled generic medications used to manage nausea/vomiting (14 formulations) and anorexia/cachexia (12 formulations). We extracted discounted prices in October 2021 and again in March 2022 for a typical fill at 8 pharmacies in Minneapolis, Minnesota, USA (zip code 55,414) using GoodRx.com. We examined how prices changed across formulations and pharmacies over time. RESULTS: Data were available for all 208 possible pharmacy-formulation combinations (8 pharmacies × 26 formulations). For 172 (83%) of the 208 pharmacy-formulation combinations, the March 2022 price was within 20% of the October 2021 price. Across pharmacy-formulation combinations, the price change over time ranged from - 76 to + 292%. For 12 (46%) of the 26 formulations, at least one pharmacy with the lowest price in October 2021 no longer was the least costly in March 2022. For one formulation (dronabinol tablets), the least expensive pharmacy became the most expensive, with an absolute and relative price increase of a fill of $22 and 85%. CONCLUSION: For almost half of formulations studied, at least one pharmacy with the lowest price was no longer the least costly a few months later. The lowest price for a formulation (across pharmacies) could also change considerably. Thus, even if a patient accesses the least expensive pharmacy for a medication, they may need to re-check prices across all pharmacies with each subsequent fill to access the lowest prices. In addition to safety concerns, directing medications to and accessing medications at multiple pharmacies can add time and logistic toxicity to patients with cancer, their care partners, prescribers, and pharmacy teams.


Asunto(s)
Neoplasias , Farmacias , Farmacia , Humanos , Medicamentos Genéricos , Costos y Análisis de Costo , Neoplasias/tratamiento farmacológico
12.
JAMA ; 328(15): 1515-1522, 2022 10 18.
Artículo en Inglés | MEDLINE | ID: mdl-36255428

RESUMEN

Importance: Prescription 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. Objective: To estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions. Design, Setting, and Participants: Descriptive, 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. Exposure: Calendar year. Main Outcomes and Measures: Net 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). Results: There 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 Relevance: In 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.


Asunto(s)
Planes de Aranceles por Servicios , Gastos en Salud , Medicare , Medicamentos bajo Prescripción , Anciano , Femenino , Humanos , Estudios Transversales , Planes de Aranceles por Servicios/economía , Planes de Aranceles por Servicios/estadística & datos numéricos , Planes de Aranceles por Servicios/tendencias , Gastos en Salud/estadística & datos numéricos , Gastos en Salud/tendencias , Medicare/economía , Medicare/estadística & datos numéricos , Medicare/tendencias , Medicare Part D/economía , Medicare Part D/estadística & datos numéricos , Medicare Part D/tendencias , Medicamentos bajo Prescripción/economía , Estados Unidos/epidemiología , Medicare Part A/economía , Medicare Part A/estadística & datos numéricos , Medicare Part A/tendencias , Medicare Part B/economía , Medicare Part B/estadística & datos numéricos , Medicare Part B/tendencias , Masculino , Persona de Mediana Edad , Anciano de 80 o más Años
13.
J Health Polit Policy Law ; 47(6): 673-690, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-35867545

RESUMEN

Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway. The authors examined how much of Medicaid programs' accelerated approval spending is attributable to products that have demonstrated clinical benefits versus those that have not. Their findings provide support for states' concerns that pharmaceutical companies often fail to complete their required postapproval confirmatory studies within the FDA's requested timeline. But the findings also highlight one issue that policy stakeholders have not yet devoted substantial attention to: the use of surrogate endpoints involved in the postapproval confirmatory studies for most of the products in this study's sample. The granularity of the study's results enabled an analysis of the impact of different policy recommendations on both the accelerated approval pathway and Medicaid programs. These findings inform the current policy debate, suggesting that policy stakeholders might focus attention on products converting their approval on the basis of surrogate outcomes rather than on clinical outcomes.


Asunto(s)
Medicaid , Medicamentos bajo Prescripción , Estados Unidos , Humanos , Aprobación de Drogas/métodos , United States Food and Drug Administration
14.
Oncologist ; 26(9): 771-778, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-33982829

RESUMEN

BACKGROUND: Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received. MATERIALS AND METHODS: We conducted a nested case-control study from August 2013 to December 2018. We manually abstracted membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference-in-differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair. RESULTS: During the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p = .02); this difference did not increase in the year after joining (DiD = $731; p = .45). CONCLUSION: Medical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry. IMPLICATIONS FOR PRACTICE: Oncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less-conflicted panel members.


Asunto(s)
Conflicto de Intereses , Industria Farmacéutica , Estudios de Casos y Controles , Revelación , Humanos , Oncología Médica
17.
J Gen Intern Med ; 36(11): 3311-3320, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-33963508

RESUMEN

BACKGROUND: The quality of end-of-life (EOL) care in the USA remains suboptimal, with significant variations in care by race and across disease subgroups. Patient-provider communication may contribute to racial and disease-specific variations in EOL care outcomes. OBJECTIVE: We examined racial disparities in EOL care, by disease group (cancer vs. non-cancer), and assessed whether racial differences in patient-provider communication accounted for observed disparities. DESIGN: Retrospective cohort study using the 2001-2015 Surveillance, Epidemiology, and End Results - Consumer Assessment of Healthcare Providers and Systems data linked with Medicare claims (SEER-CAHPS). We employed stratified propensity score matching and modified Poisson regression analyses, adjusting for clinical and demographic characteristics PARTICIPANTS: Black and White Medicare beneficiaries 65 years or older with cancer (N=2000) or without cancer (N=11,524). MAIN MEASURES: End-of-life care measures included hospice use, inpatient hospitalizations, intensive care unit (ICU) stays, and emergency department (ED) visits, during the 90 days prior to death. KEY RESULTS: When considering all conditions together (cancer + non-cancer), Black beneficiaries were 26% less likely than their Whites counterparts to enroll in hospice (adjusted risk ratio [ARR]: 0.74, 95%CI: 0.66-0.83). Among beneficiaries without cancer, Black beneficiaries had a 32% lower likelihood of enrolling in hospice (ARR: 0.68, 95%CI: 0.59-0.79). There was no racial difference in hospice enrollment among cancer patients. Black beneficiaries were also at increased risk for ED use (ARR: 1.12, 95%CI: 1.01-1.26). Patient-provider communication did not explain racial disparities in hospice or ED use. There were no racial differences in hospitalizations or ICU admissions. CONCLUSION: We observed racial disparities in hospice use and ED visits in the 90 days prior to death among Medicare beneficiaries; however, hospice disparities were largely driven by patients without cancer. Condition-specific differences in palliative care integration at the end-of-life may partly account for variations in EOL care disparities across disease groups.


Asunto(s)
Cuidados Paliativos al Final de la Vida , Neoplasias , Cuidado Terminal , Anciano , Comunicación , Disparidades en Atención de Salud , Humanos , Medicare , Neoplasias/diagnóstico , Neoplasias/epidemiología , Neoplasias/terapia , Estudios Retrospectivos , Estados Unidos/epidemiología
18.
Gastrointest Endosc ; 94(4): 752-759.e1, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-33862104

RESUMEN

BACKGROUND AND AIMS: Patients with biliary obstruction caused by adenocarcinoma of the pancreas head may require bile duct decompression to treat symptomatic cholestasis and/or permit systemic chemotherapy. ERCP with biliary stent placement is the preferred intervention in such cases. The primary aim of this study was to determine what proportion of patients with surgically unresectable pancreatic adenocarcinoma undergo ERCP and whether this proportion has changed over time. METHODS: We used Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked data to identify a cohort of individuals diagnosed with adenocarcinoma of the pancreas head between December 31, 2000 and December 31, 2015 and who did not receive pancreas surgery. ERCP use was measured in the 30 days before and after cancer diagnosis. Additional covariates of interest were extracted for multiple variable analysis. RESULTS: A total of 14,810 patients met study inclusion and exclusion criteria. Of them, 53% (7034/14,810) underwent ERCP within 30 days of cancer diagnosis. The proportion of patients who underwent ERCP declined from 57% in 2001 to 46% in 2015 (P for trend < .001). Among those who underwent ERCP, the mean number of ERCPs performed per patient over the year after diagnosis declined from 2.3 (standard deviation, 1.6) in 2001 to 1.8 (standard deviation, 1.1) in 2015 (P < .001). Despite decline in ERCP use, adjusted 1-year survival increased over time. CONCLUSIONS: In a SEER-Medicare population between 2001 and 2015, both the proportion of patients with unresectable pancreas cancer who underwent ERCP and the mean number of ERCPs per patient decreased over time. Survival improved over time despite decreased use of ERCP.


Asunto(s)
Adenocarcinoma , Colestasis , Neoplasias Pancreáticas , Adenocarcinoma/epidemiología , Adenocarcinoma/cirugía , Anciano , Colangiopancreatografia Retrógrada Endoscópica , Humanos , Medicare , Neoplasias Pancreáticas/complicaciones , Neoplasias Pancreáticas/epidemiología , Neoplasias Pancreáticas/cirugía , Estudios Retrospectivos , Stents , Estados Unidos/epidemiología
19.
J Health Polit Policy Law ; 46(4): 599-609, 2021 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-33503239

RESUMEN

In January 2021, the incoming Biden administration inherited urgent priorities for curbing health care spending and expanding health care coverage to millions of Americans while also addressing the COVID-19 pandemic and resulting economic downturn. Among these competing priorities is the issue of access to and affordability of prescription drugs. Here, the authors outline Biden's plan for directly lowering prescription drug spending for payers and patients and for expanding access to prescription medications through improved health insurance coverage. These policies could provide important financial protections for Americans against high prescription drug prices. Despite widespread public support for addressing prescription drug prices, many of Biden's plans rely on congressional action, which will be complicated by the narrow majority held by Democrats in the House and an evenly divided Senate. However, there may be other opportunities for reducing prescription drug spending and improving health insurance enrollment among the uninsured. While directly lowering drug prices would provide the most widespread savings for payers and patients alike, any successful effort for increasing the number of Americans enrolled in health insurance or rendering it more affordable will still likely effectively lower patients' out-of-pocket costs and improve access to prescription drugs.


Asunto(s)
Gastos en Salud , Accesibilidad a los Servicios de Salud , Cobertura del Seguro/economía , Seguro de Salud/economía , Medicamentos bajo Prescripción/economía , Humanos , Cobertura del Seguro/legislación & jurisprudencia , Seguro de Salud/legislación & jurisprudencia , Política , Estados Unidos
20.
Cancer ; 126(2): 322-328, 2020 01 15.
Artículo en Inglés | MEDLINE | ID: mdl-31580492

RESUMEN

BACKGROUND: Anti-programmed death protein 1 (anti-PD-1) agents have transformed the treatment of advanced melanoma and other cancers, but the rates of steroid-refractory toxicities and health care utilization are not well described. This study assessed these endpoints in patients with melanoma treated with anti-PD-1 with or without ipilimumab. METHODS: This study retrospectively evaluated 344 patients with metastatic melanoma treated with anti-PD-1 or a combination of ipilimumab and nivolumab at Vanderbilt University Medical Center from 2009 to 2018. The incidence, types, grades, management, and outcomes of immune-related adverse events (irAEs) and hospitalizations for irAEs and disease progression were assessed. RESULTS: Patients on combination therapy were more likely to develop irAEs than those on monotherapy (72% vs 37%; P < .001) and were more likely to require systemic steroids (61% vs 20%; P < .001), steroid dose re-escalation (23% vs 6%; P < .001), and second-line immunosuppressive use (17% vs 2%; P < .001) and to suffer high-dose steroid-refractory toxicities (23% vs 3%; P < .001). Combination-treated patients were more likely to have any hospitalization (32% vs 7%; P < .001) or multiple hospitalizations for irAEs (11% vs 3%; P = .001) and had a longer average time of hospitalization (mean, 1.92 vs 0.62 days; P = .002). Among 176 hospitalizations related to disease progression in patients who died during evaluable follow-up, 69% occurred within the 90 days before death. Early hospitalizations for disease-related reasons portended a very poor prognosis (median time from admission to death, 58 days). CONCLUSIONS: Patients treated with a combination of ipilimumab and nivolumab had higher rates of hospitalization and steroid-refractory toxicities than those treated with anti-PD-1 monotherapy. Disease-associated hospitalizations were similar between the 2 groups, portended a poor prognosis, and mostly occurred in the last months of life.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Melanoma/tratamiento farmacológico , Aceptación de la Atención de Salud/estadística & datos numéricos , Neoplasias Cutáneas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Antígeno CTLA-4/antagonistas & inhibidores , Antígeno CTLA-4/inmunología , Progresión de la Enfermedad , Resistencia a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/tratamiento farmacológico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/inmunología , Femenino , Estudios de Seguimiento , Glucocorticoides/farmacología , Glucocorticoides/uso terapéutico , Humanos , Ipilimumab/efectos adversos , Masculino , Melanoma/inmunología , Melanoma/mortalidad , Melanoma/secundario , Persona de Mediana Edad , Nivolumab/efectos adversos , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Receptor de Muerte Celular Programada 1/inmunología , Supervivencia sin Progresión , Estudios Retrospectivos , Neoplasias Cutáneas/inmunología , Neoplasias Cutáneas/mortalidad , Neoplasias Cutáneas/patología , Adulto Joven
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