Review time of oncology drugs and its underlying factors: an exploration in China
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ABSTRACT:
SUBMITTER: Zhu X
PROVIDER: S-EPMC10654631 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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| S-EPMC10643204 | biostudies-literature
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| S-EPMC11080832 | biostudies-literature
Project description:Healthcare expenditure on pharmaceuticals, especially innovative oncology drugs, is escalating. Current knowledge on this topic is largely limited to studies conducted upon reimbursement of new drugs. We investigated how endogenous factors (e.g., changed reimbursement criteria, such as an expanded indication) and exogenous factors (e.g., competing drugs) affect the level and trends of innovative oncology drug utilization in the Taiwan National Health Insurance (NHI) system, both upon reimbursement and afterward. This retrospective longitudinal study analyzed monthly data (January 2009 to December 2014) from the NHI Research Database on the consumption (prescribing volume) of 15 innovative oncology drugs reimbursed by the NHI between 2007 and 2013. Effects of endogenous and exogenous factors on drug utilization were evaluated using interrupted time series analyses. In segmented regression analyses, changed drug prescribing volume after the indication expanded (endogenous factor) was statistically significant; however, drug volume did not change significantly after prescription restrictions changed. First-competitors and non-first-competitors (exogenous factors) were significantly associated with drug prescription levels or utilization rates. Taking sorafenib as an example, the post-reimbursement drug prescribing volume did not change significantly after its therapy line changed (endogenous factor), whereas the reimbursement of first-competitors (exogenous factor) was significantly associated with a lower level or usage rate of sorafenib. Utilization of innovative oncology drugs in Taiwan changed dramatically after NHI reimbursement, driven largely by expanded indications and new competitors. Drug utilization evaluations should investigate both endogenous and exogenous factors.
| S-EPMC7719368 | biostudies-literature
Project description:BackgroundTo determine the magnitude of difference between manufacturer-submitted and pan-Canadian Oncology Drug Review (pCODR) calculated incremental cost-effectiveness ratios (ICERs), incremental cost (ΔC), and incremental effectiveness (ΔE); to examine whether there is a significant difference in the proportion of ICERs deemed cost-effective; to evaluate trends in the ICERs over time; and to identify methodological issues in manufacturer-submitted economic models.MethodsEconomic guidance reports for all drug indications submitted from July 2011-November 2018 were extracted from the pCODR database. Cumulative distribution plots were constructed to compare the manufacturer-submitted economic values with both the pCODR lower- and upper-reanalyzed estimates. The proportion of drug reviews considered cost-effective at varying willingness-to-pay (WTP) thresholds by the manufacturer and pCODR were calculated. Manufacturer changes in ICERs over time from 2012 to 2018 were determined. Recurring methodological issues with manufacturer submissions were tallied.ResultsThere were 73 unique indications that were included. Manufacturer-submitted ICERs were consistently lower than pCODR estimates for most indications. Manufacturer-submitted ICERs were generally more cost-effective over a range of WTP thresholds. From 2012 to 2018, manufacturer and economic guidance panel (EGP) lower limit reanalyzed ICERs did not change significantly over time. However, EGP upper limit re-analyses did show decreasing cost-effectiveness (increasing ICERs). The two most common issues identified in the manufacturer-submitted models were related to survival time horizon and utility estimates.ConclusionsManufacturers tend to overestimate the cost-effectiveness of their therapies when submitting economic models to pCODR. Although certain methodological issues are still common in manufacturer-submitted models, revision rates are high for most issues raised by pCODR.
| S-EPMC7924399 | biostudies-literature
Project description:PurposeShared decision making (SDM) among the oncology population is highly important due to complex screening and treatment decisions. SDM among patients with cancer, caregivers, and clinicians has gained more attention and importance, yet few articles have systematically examined SDM, specifically in the adult oncology population. This review aims to explore SDM within the oncology literature and help identify major gaps and concerns, with the goal to provide guidance in the development of clear SDM definitions and interventions.MethodsWe conducted a scoping review using the Arksey and O'Malley approach along with the PRISMA Extension for Scoping Reviews Checklist. A systematic search was conducted in four databases that included publications since 2016.ResultsOf the 364 initial articles, eleven publications met the inclusion criteria. We included articles that were original research, cancer related, and focused on shared decision making. Most studies were limited in defining SDM and operationalizing a model of SDM. There were several concerns revealed related to SDM: (1) racial inequality, (2) quality and preference of the patient, caregiver, and clinician communication is important, and (3) the use of a decision-making aid or tool provides value to the patient experience.ConclusionInconsistencies regarding the meaning and operationalization of SDM and inequality of the SDM process among patients from different racial/ethnic backgrounds impact the health and quality of care patients receive. Future studies should clearly and consistently define the meaning of SDM and develop decision aids that incorporate bidirectional, interactive communication between patients, caregivers, and clinicians that account for the diversity of racial, ethnic, and sociocultural backgrounds and preferences.
| S-EPMC9803891 | biostudies-literature
Project description:BackgroundOncology telemedicine was implemented rapidly after COVID-19. We examined multilevel correlates and outcomes of telemedicine use for patients undergoing radiotherapy (RT) for cancer.MethodsUpon implementation of a telemedicine platform at a comprehensive cancer center, we analyzed 468 consecutive patient RT courses from March 16, 2020 to June 1, 2020. Patients were categorized as using telemedicine during ≥1 weekly oncologist visits versus in-person oncologist management only. Temporal trends were evaluated with Cochran-Armitage tests; chi-squared test and multilevel multivariable logistic models identified correlates of use and outcomes.ResultsOverall, 33% used telemedicine versus 67% in-person only oncologist management. Temporal trends (ptrend < 0.001) correlated with policy changes: uptake was rapid after local social-distancing restrictions, reaching peak use (35% of visits) within 4 weeks of implementation. Use declined to 15% after national "Opening Up America Again" guidelines. In the multilevel model, patients more likely to use telemedicine were White non-Hispanic versus Black or Hispanic (odds ratio [OR] = 2.20, 95% confidence interval [CI] 1.03-4.72; p = 0.04) or receiving ≥6 fractions of RT versus 1-5 fractions (OR = 4.49, 95% CI 2.29-8.80; p < 0.001). Model intraclass correlation coefficient demonstrated 43% utilization variation was physician-level driven. Treatment toxicities and 30-day emergency visits or unplanned hospitalizations did not differ for patients using versus not using telemedicine (p > 0.05, all comparisons).ConclusionThough toxicities were similar with telemedicine oncology management, there remained lower uptake among non-White patients. Continuing strategies for oncology telemedicine implementation should address multilevel patient, physician, and policy factors to optimize telemedicine's potential to surmount-and not exacerbate-barriers to quality cancer care.
| S-EPMC9119354 | biostudies-literature
Project description:Corticobasal syndrome (CBS) is an atypical parkinsonian presentation characterized by heterogeneous clinical features and different underlying neuropathology. Most CBS cases are sporadic; nevertheless, reports of families and isolated individuals with genetically determined CBS have been reported. In this systematic review, we analyze the demographical, clinical, radiological, and anatomopathological features of genetically confirmed cases of CBS. A systematic search was performed using the PubMed, EMBASE, and Cochrane Library databases, included all publications in English from 1 January 1999 through 1 August 2020. We found forty publications with fifty-eight eligible cases. A second search for publications dealing with genetic risk factors for CBS led to the review of eight additional articles. GRN was the most common gene involved in CBS, representing 28 out of 58 cases, followed by MAPT, C9ORF72, and PRNP. A set of symptoms was shown to be significantly more common in GRN-CBS patients, including visuospatial impairment, behavioral changes, aphasia, and language alterations. In addition, specific demographical, clinical, biochemical, and radiological features may suggest mutations in other genes. We suggest a diagnostic algorithm to help in identifying potential genetic cases of CBS in order to improve the diagnostic accuracy and to better understand the still poorly defined underlying pathogenetic process.
| S-EPMC7830591 | biostudies-literature
Project description:Recent advances in treatment have transformed the management of cancer. Despite these advances, cardiovascular disease remains a leading cause of death in cancer survivors. Cardio-oncology has recently evolved as a subspecialty to prevent, diagnose, and manage cardiovascular side effects of antineoplastic therapy. An emphasis on optimal management of comorbidities and close attention to drug interactions are important in cardio-oncologic care. With interdisciplinary collaboration among oncologists, cardiologists, and pharmacists, there is potential to prevent and reduce drug-related toxicities of treatments. The cytochrome P450 (CYP450) family of enzymes and the P-glycoprotein (P-g) transporter play a crucial role in drug metabolism and drug resistance. Here we discuss the role of CYP450 and P-g in drug interactions in the field of cardio-oncology, provide an overview of the cardiotoxicity of a spectrum of cancer agents, highlight the role of precision medicine, and encourage a multidisciplinary treatment approach for patients with cancer.
| S-EPMC8984624 | biostudies-literature
Project description:ObjectiveTo estimate patients' elasticity of demand, willingness to pay, and consumer surplus for five high-cost specialty medications treating metastatic disease or hematologic malignancies.Data source/study settingClaims data from 71 private health plans from 1997 to 2005.Study designThis is a revealed preference analysis of the demand for specialty drugs among cancer patients. We exploit differences in plan generosity to examine how utilization of specialty oncology drugs varies with patient out-of-pocket costs.Data collection/extraction methodsWe extracted key variables from administrative health insurance claims records.Principal findingsA 25 percent reduction in out-of-pocket costs leads to a 5 percent increase in the probability that a patient initiates specialty cancer drug therapy. Among patients who initiate, a 25 percent reduction in out-of-pocket costs reduces the number of treatments (claims) by 1-3 percent, depending on the drug. On average, the value of these drugs to patients who use them is about four times the total cost paid by the patient and his or her insurer, although this ratio may be lower for oral specialty therapies.ConclusionsThe decision to initiate therapy with specialty oncology drugs is responsive to price, but not highly so. Among patients who initiate therapy, the amount of treatment is equally responsive. The drugs we examine are highly valued by patients in excess of their total costs, although oral agents warrant further scrutiny as copayments increase.
| S-EPMC2813440 | biostudies-literature
Project description:The biological fingerprint of environmental adversity may be key to understanding health and disease, as it encompasses the damage induced as well as the compensatory reactions of the organism. Metabolic and hormonal changes may be an informative but incomplete window into the underlying biology. We endeavored to identify objective blood gene expression biomarkers for psychological stress, a subjective sensation with biological roots. To quantify the stress perception at a particular moment in time, we used a simple visual analogue scale for life stress in psychiatric patients, a high risk group. Then, using a stepwise discovery, prioritization, validation, and testing in independent cohorts design, we were successful in identifying gene expression biomarkers that were predictive of high stress states, and of future psychiatric hospitalizations related to stress, more so when personalized by gender and diagnosis.
2019-03-15 | GSE125216 | GEO