The Cost of Oncology Drugs: A Pharmacy Perspective, Part 2.
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ABSTRACT:
SUBMITTER: Dahl BJ
PROVIDER: S-EPMC6366568 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
Publications
The Cost of Oncology Drugs: A Pharmacy Perspective, Part 2.
Federal practitioner : for the health care professionals of the VA, DoD, and PHS 20160701 7
Guidance documents, the Pharmacy Benefits Management Services, and the VA National Formulary help clinicians and pharmacists decide whether to administer high-cost cancer treatments. ...[more]
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Project description:ImportancePrescription drug spending in the US requires policy intervention to control costs and improve the value obtained from pharmaceutical spending. One such intervention is to apply cost-effectiveness evidence to decisions regarding drug coverage and pricing, but this intervention depends on the existence of such evidence to guide decisions.ObjectiveTo characterize the availability and quality of cost-effectiveness studies for prescription drugs with the greatest Medicare Part D spending.Design, setting, and participantsIn this national cross-sectional analysis, publicly available 2016 Medicare drug spending records were merged with 2016 US Food & Drug Administration Orange Book data and the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. All studies published through 2015 that evaluated the cost-effectiveness of the 250 drugs for which Medicare Part D spending was the greatest in US-based adult patient populations were included. Data were analyzed from September 2018 to June 2020.Main outcomes and measuresThe presence and quality of published cost-effectiveness analyses for the 250 drugs for which Medicare Part D spending was greatest in 2016 were assessed based on the inclusion of key cost-effectiveness analysis elements and global ratings by independent reviewers for the Tufts CEA Registry.ResultsMedicare Part D spending on the 250 drugs in the sample totaled $122.8 billion in 2016 (84.1% of total spending). Of these 250 drugs, 91 (36.4%) had a generic equivalent and 159 (63.6%) retained some patent exclusivity. There were 280 unique cost-effectiveness analyses for these drugs, representing data on 135 (54.0%) of the 250 drugs included and 67.0% of Part D spending on the top 250 drugs. The 115 drugs (46.0%) without cost-effectiveness studies accounted for 33.0% of Part D spending on the top 250 drugs. Of the 280 available studies, 128 (45.7%) were industry sponsored. A large proportion of the studies (250 [89.3%]) did not meet the minimum quality requirements.Conclusions and relevanceIn this cross-sectional study, a substantial proportion of 2016 Medicare Part D spending was for drugs with absent or low-quality cost-effectiveness analyses. The lack of quality analyses may present a challenge in efforts to develop policies addressing drug spending in terms of value.
| S-EPMC8214163 | 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:To assess patients' attitudes towards the community pharmacist's role and determine their negative and positive reactions towards community pharmacists in Lebanon.A cross-sectional study, conducted between January and April 2016, was designed to assess the general public satisfaction with the services provided by the community pharmacies. It was carried out, using a proportionate random sampling of Lebanese community pharmacies from each district. Two sided statistical tests were used to compare between group percentages, Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution, and Student's t-test for quantitative variables of normal distribution and homogeneous variances. The ANOVA test was used to compare between three groups or more, and Pearson correlation coefficient were used to correlate between quantitative variables.a total of 565 participants completely answered the survey questions with a response rate of 94%. The bivariate analysis showed that the patient perception index was positively and significantly correlated with the patient level of expectation index, the overall pharmacy experience and the patient's reason for visiting the pharmacy (p<0.001 for all 3 variables) but was negatively correlated with the barriers for asking questions significantly (p=0.032). On the other hand, this perception index was significantly and positively associated with the number of pharmacy visits, the age categories, the level of education and the family monthly income (p<0.05 for all variables).Public perception and attitude toward community pharmacist in Lebanon is poor despite highly qualified pharmacists. Aspects of pharmacy services most relevant to patients were respect, empathy, a friendly staff, listening carefully, giving quality time, responding quickly to their needs and respecting their privacy. The ministry of Health in Lebanon, along with the Lebanese Order of Pharmacists should educate the pharmacist about working on the different issues patients are complaining about in order to play a more important role in the society and become the number one trusted health care professional.
| S-EPMC5499345 | biostudies-other
Project description:ImportanceIncreasingly, cost-effectiveness analyses are being done to determine the value of rapidly increasing oncology drugs; however, this assumes that these analyses are unbiased.ObjectiveTo analyze the characteristics of cost-effectiveness studies and to determine characteristics associated with whether an oncology drug is found to be cost-effective.Design, setting, and participantsThis retrospective cross-sectional study included 254 cost-effectiveness analyses for 116 oncology drugs that were approved by the US Food and Drug Administration from 2015 to 2020.ExposuresEach drug was analyzed for the incremental cost-effectiveness ratio per quality-adjusted life year, the funding of the study, the authors' conflict of interest, the threshold of willingness-to-pay, from what country's perspective the analysis was done, and whether a National Institute for Health and Care Excellence cost-effectiveness analysis had been done.Main outcomes and measuresThe main outcome was the odds of a study concluding that a drug was cost-effective.ResultsThere were 116 drug approvals with 254 studies and country perspectives. Of the country perspectives, 132 (52%) were from the US. Forty-seven of 78 drugs with cost-effective studies had been shown to improve overall survival, whereas 15 of 38 of drugs without a cost-effectiveness study had been shown to improve overall survival. Having a study funded by a pharmaceutical company was associated with higher odds of a study concluding that a drug was cost-effective than studies without funding (odds ratio, 41.36; 95% CI, 11.86-262.23).Conclusions and relevanceIn this cross-sectional study, pharmaceutical funding was associated with greater odds that an oncology drug would be found to be cost-effective. These findings suggest that simply disclosing potential conflict of interest is inadequate. We encourage cost-effectiveness analyses by independent groups.
| S-EPMC8603079 | biostudies-literature
Project description:ImportanceThe US Department of Health and Human Services (HHS) has proposed to reform drug pricing in Medicare Part B, which primarily covers physician-administered drugs and biologic agents. One HHS proposal would shift coverage of certain drugs from Medicare Part B to Part D, which is administered by private prescription drug plans.ObjectiveTo estimate the association of changes of a shift in Medicare Part B to Part D with total drug spending and patient cost-sharing.Design, setting, and participantsRetrospective drug cohort study of the 75 brand-name drugs associated with the highest Part B expenditures among fee-for-service Medicare beneficiaries in 2016.Main outcomes and measuresEstimated total Medicare spending in Part B and Part D; annual out-of-pocket costs in Part B and under the standard 2018 Part D benefit; and proportion of drugs in Part D's protected drug classes (immunosuppressants for prophylaxis of organ transplant rejection, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics).ResultsAt 2018 prices, total Medicare Part B spending for the 75 brand-name drugs with the highest Part B expenditures was estimated to be $21.6 billion annually. Under the proposed policy, total Part D drug spending for these drugs was estimated to range between $17.6 billion and $20.1 billion after rebates, corresponding to a 6.9% to 18.3% decrease in drug spending in Part D compared with Part B. Of the 75 drugs studied, 33 (44.0%) drugs, accounting for $9.5 billion (43.9%) in Part B spending, were in protected Part D classes where plans must cover essentially all drugs. For 67 drugs with available information, the prices for 65 (97.0%) were a median of 45.8% to 59.7% lower in comparator high-income countries than Part B drug prices. Median patient cost-sharing in Part B for all 75 brand-name drugs was $4683 (interquartile range [IQR], $1069-$9282) per year. Shifting Part B drugs to the 2018 standard Part D benefit was projected to decrease out-of-pocket costs by a median of $860 (IQR, -$3884 to $496) among Medicare beneficiaries without Medicaid or Part B supplemental insurance (Medigap). For beneficiaries who would qualify for the low-income subsidy program in Part D, cost-sharing would be lower in Part D than in Part B for all drugs. For beneficiaries with Medigap insurance, estimated Part D out-of-pocket costs exceeded average Medigap premium costs by a median of $1460 for those with Part D coverage and by a median of $1952 for those without Part D coverage.Conclusions and relevanceAlthough the HHS proposal to shift certain drugs from Medicare Part B to Part D may reduce total drug spending, it may increase out-of-pocket costs for some Medicare beneficiaries, including those with Medicare supplement insurance. The Department of Health and Human Services should ensure that the proposed reforms benefit both patients and payers.
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Project description:ObjectivesTo determine the use and expenditure associated with cystic fibrosis (CF) modulator therapies in Ireland since their reimbursement in 2013.DesignA retrospective analysis of a national drug claims database.SettingThe data included in this study are nationally representative (Ireland).ParticipantsData on all persons receiving CF modulator therapies were included.MethodsWe obtained national claims data for CF therapies from the Health Service Executive's Primary Care Reimbursement Service. We determined the use and expenditure associated with CF therapies from January 2012 to March 2020.ResultsThe increased prescribing of CF modulator therapies was associated with an approximate fivefold increase in expenditure from €23 million in 2013 to €113 million in 2019. Many patients who initiated lumacaftor/ivacaftor in 2017 went on to receive symptomatic therapies, and subsequently initiated tezacaftor/ivacaftor in 2019.ConclusionDespite none of these modulator therapies demonstrating value for money when subjected to health technology assessment, the associated Irish expenditure reached €113 million in 2019 alone.
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Project description:BackgroundStructured reporting and standardized criteria are increasingly recognized as means of improving both radiological and clinical practice by allowing for better content and clarity. Our aim was to examine oncologists' opinions and expectations concerning the radiologist's report to identify general needs in daily practice and ways to improve interdisciplinary communication.MethodsA 19-question survey was sent to 230 oncologists from three different countries (France, Romania, Switzerland) identified on the online web pages of different hospitals and private clinics. The survey was sent by electronic mail with an online survey program (Google Forms®). All recipients were informed of the purpose of the study. The data were collected by the online survey program and analysed through filtering the results and cross-tabulation.ResultsA total of 52 responses were received (response rate of 22.6%). The majority of the respondents (46/52, 88%) preferred the structured report, which follows a predefined template. Most of the respondents (40/52, 77%) used RECIST 1.1 or iRECIST in tumour assessment. Nearly half of the oncologists (21/52, 40%) measured 1-3 cases per week. On a 10-point Likert scale, 34/52 (65%) oncologists rated their overall level of satisfaction with radiologists' service between 7 and 10. In contrast, 12/52 (19%) oncologists rated the radiologists' service between 1 and 4. Moreover, 42/52 (80%) oncologists acknowledged that reports created by a radiologist with a subspecialty in oncologic imaging were superior to those created by a general radiologist.ConclusionStructured reports in oncologic patients and the use of RECIST criteria are preferred by oncologists in their daily clinical practice, which signals the need for radiologists also to implement such reports to facilitate communication. Furthermore, most of the oncologists we interviewed recognized the added value provided by radiologists specializing in oncologic imaging. Because this subspecialty is present in only a few countries, generally in large clinics, further training might become a challenge; nevertheless, intensive efforts should be made to enhance expertise in cancer imaging.
| S-EPMC8620527 | 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:ObjectiveThe study quantitatively investigated the related research progress in pharmaceutical sciences/pharmacy education from a bibliometric angle and provided feasible suggestions to facilitate the development of pharmaceutical sciences/pharmacy postgraduate education.MethodsBibliometric analysis was conducted using the database of Web of Science Core Collection. The literature published in 1985-2021 was screened and selected. The overall profile description, citation analysis, and research hotspot mining were performed using the citation report of Clarivate Analytics, bibliometrics online platform, and VOSviewer software. The bibliometric results and profiles were plotted and illustrated.ResultsThe bibliometric analysis of 485 papers of interest showed that the research frontier was continuously expanding; especially the institutions from the USA were the main contributors. The numbers of citing papers have been ascending, and a considerable part of citations were from the areas other than the education research. Mining results showed that the in-school and residency education of pharmacy postgraduates was a research hotspot, as well as interprofessional training and new education styles for Coronavirus Disease 2019 (COVID-19) therapy were the emerging trends in the field.ConclusionThrough the analysis of the studies, it was found that encouraging relevant research programs, establishing financial supports, and launching specified publication sources could be helpful to boost the development of pharmaceutical sciences/pharmacy postgraduate education. Besides, the results suggested that this was a less discussed topic and was worthy for the investigators to pay more attention to such an issue.Supplementary informationThe online version contains supplementary material available at 10.1007/s12247-021-09611-z.
| S-EPMC8782704 | 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