Defining Priorities in Value-Based Cancer Care: Insights From the Alliance for Clinical Trials in Oncology National Cooperative Group Survey.

PURPOSE: We determine how stakeholders prioritize the importance of oncologic outcomes, patient-reported outcomes (PROs), and cancer-related health care costs. METHODS: A survey was distributed to the National Clinical Trials Network Alliance for Clinical Trials in Oncology cooperative group membership from May 14 to June 30, 2022. Respondents were asked to rate (5-point Likert scale) and rank (1-9) evidence-based value domains: overall survival, treatment toxicities/complications, quality of life (QOL), financial toxicity, access to care, compliance with evidence-based care, health system performance, scientific discovery and innovation, and cost to the health care system. RESULTS: A total of 514 members responded, including researchers (24.7%), nurses (19.5%), medical oncologists (17.9%), administrators (9.3%), surgical and radiation oncologists (9.1%), patient advocates (3.1%), and nonphysician providers (16.4%). Participants represented various practice settings including National Cancer Institute-designated cancer centers (29.8%), university-affiliated academic cancer centers (21%), hospital-owned oncology practices (21.8%), and others (27.4%). There was agreement in how respondents prioritized value domains (W = 0.39, P < .001). Respondents ranked patient QOL (mean rank: 2.6 ± 1.9) as most important above all other metrics including survival (mean rank: 3.5 ± 0.3) and access to care (mean rank: 3.5 ± 2.1; P < .001). Members engaged in direct patient care also ranked access to care of higher importance than nonclinicians (P = .026). Cost to the health care system (mean rank: 7.5 ± 2.1) and health system performance (mean rank: 7 ± 2) were ranked as least important (P < .001). Inclusion of PROs into therapeutic assessment (59.3%) was the most frequently selected priority of future cooperative group initiatives. CONCLUSION: Oncology community stakeholders deemed patient-centered value domains as most important and considered patient QOL the highest priority. Inclusion of PROs into clinical trials was endorsed as an important component of therapeutic assessment. These findings can be taken into consideration when creating a value framework for inclusion in cancer clinical trials.

Olanzapine With or Without Fosaprepitant for Preventing Chemotherapy Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial (ALLIANCE A221602).

PURPOSE: A protocol was developed to evaluate the value of an NK-1 receptor antagonist for preventing nausea and vomiting resulting from highly emetogenic chemotherapy when an olanzapine-based antiemetogenic regimen was used. MATERIALS AND METHODS: A221602, a prospective double-blind, placebo-controlled clinical trial, was developed to compare 2 -olanzapine-containing antiemetic regimens, one with an NK-1 receptor antagonist (aprepitant or fosaprepitant) and one without. Trial patients had a malignant disease for which they received intravenous highly emetogenic chemotherapy (single day cisplatin ≥ 70 mg/m2 or doxorubicin plus cyclophosphamide on 1 day). Patients on both arms received commonly administered doses of a 5-HT3 receptor antagonist, dexamethasone, and olanzapine. Additionally, patients were randomized to receive an NK-1 receptor antagonist (fosaprepitant 150 mg IV or aprepitant 130 mg IV) or a corresponding placebo. The primary objective was to compare the proportion of patients with no nausea for 5 days following chemotherapy between the 2 study arms. This trial was designed to test for the noninferiority of deleting the NK-1 receptor antagonist, with noninferiority defined as a decrease in freedom from nausea by less than 10%. RESULTS: A total of 690 patients were entered on this trial, 50% on each arm. The proportion of patients without nausea for the complete 5-day study period was 7.4% lower (upper limit of the one-sided 95% confidence interval was 13.5%) in the arm without an NK-1 receptor antagonist compared with the arm with an NK-1 receptor antagonist. CONCLUSION: This trial did not provide sufficient evidence to support that deletion of the NK-1 receptor antagonist was as good as keeping it, as a part of a 4-drug antiemetic regimen for highly emetogenic chemotherapy (ClinicalTrials.gov Identifier: NCT03578081).

Mixed-methods economic evaluation of the implementation of tobacco treatment programs in National Cancer Institute-designated cancer centers.

BACKGROUND: The Cancer Center Cessation Initiative (C3I) was launched in 2017 as a part of the NCI Cancer Moonshot program to assist NCI-designated cancer centers in developing tobacco treatment programs for oncology patients. Participating centers have implemented varied evidence-based programs that fit their institutional resources and needs, offering a wide range of services including in-person and telephone-based counseling, point of care, interactive voice response systems, referral to the quitline, text- and web-based services, and medications. METHODS: We used a mixed methods comparative case study design to evaluate system-level implementation costs across 15 C3I-funded cancer centers that reported for at least one 6-month period between July 2018 and June 2020. We analyzed operating costs by resource category (e.g., personnel, medications) concurrently with transcripts from semi-structured key-informant interviews conducted during site visits. Personnel salary costs were estimated using Bureau of Labor Statistics wage data adjusted for area and occupation, and non-wage benefits. Qualitative findings provided additional information on intangible resources and contextual factors related to implementation costs. RESULTS: Median total monthly operating costs across funded centers were $11,045 (range: $5129-$20,751). The largest median operating cost category was personnel ($10,307; range: $4122-$19,794), with the highest personnel costs attributable to the provision of in-person program services. Monthly (non-zero) cost ranges for other categories were medications ($17-$573), materials ($6-$435), training ($96-$516), technology ($171-$2759), and equipment ($10-$620). Median cost-per-participant was $466 (range: $70-$2093) and cost-per-quit was $2688 (range: $330-$9628), with sites offering different combinations of program components, ranging from individually-delivered in-person counseling only to one program that offered all components. Site interviews provided context for understanding variations in program components and their cost implications. CONCLUSIONS: Among most centers that have progressed in tobacco treatment program implementation, cost-per-quit was modest relative to other prevention interventions. Although select centers have achieved similar average costs by offering program components of various levels of intensity, they have varied widely in program reach and effectiveness. Evaluating implementation costs of such programs alongside reach and effectiveness is necessary to provide decision makers in oncology settings with the important additional information needed to optimize resource allocation when establishing tobacco treatment programs.

ChicagO Multiethnic Prevention and Surveillance Study (COMPASS): Increased Response Rates Among African American Residents in Low Socioeconomic Status Neighborhoods.

African American (AA) populations experience persistent health disparities in the USA. Low representation in bio-specimen research precludes stratified analyses and creates challenges in studying health outcomes among AA populations. Previous studies examining determinants of bio-specimen research participation among minority participants have focused on individual-level barriers and facilitators. Neighborhood-level contextual factors may also inform bio-specimen research participation, possibly through social norms and the influence of social views and behaviors on neighbor's perspectives. We conducted an epidemiological study of residents in 5108 Chicago addresses to examine determinants of bio-specimen research participation among predominantly AA participants solicited for participation in the first 6 years of ChicagO Multiethnic Prevention and Surveillance Study (COMPASS). We used a door-to-door recruitment strategy by interviewers of predominantly minority race and ethnicity. Participants were compensated with a $50 gift card. We achieved response rates of 30.4% for non-AA addresses and 58.0% for AA addresses, with as high as 80.3% response among AA addresses in low socioeconomic status (SES) neighborhoods. After multivariable adjustment, we found approximately 3 times the odds of study participation among predominantly AA addresses in low vs. average SES neighborhoods (odds ratio (OR) = 3.06; 95% confidence interval (CI) = 2.20-4.24). Conversely, for non-AA addresses, we observed no difference in the odds of study participation in low vs. average SES neighborhoods (OR = 0.89; 95% CI = 0.69-1.14) after multivariable adjustment. Our findings suggest that AA participants in low SES neighborhoods may be recruited for bio-specimen research through door-to-door approaches with compensation. Future studies may elucidate best practices to improve bio-specimen research participation among minority populations.

Cost-effectiveness analysis of a fecal microbiota transplant center for treating recurrent C.difficile infection.

OBJECTIVE: We assessed the cost-effectiveness of establishing a fecal microbial transplant (FMT) unit in Canada for the treatment of recurrent CDI. DESIGN: We performed a cost-effectiveness analysis to determine the number of patients with recurrent CDI needed to treat (NNT) annually to make establishing a FMT unit cost-effective. We compared treating patients for their second recurrence of CDI with FMT in a jurisdiction with a FMT unit, compared to being treated with antibiotics; then sent to a medical center with FMT available for the third recurrence. We used a willingness to pay threshold of $50,000 per quality-adjusted-life-year gained. RESULTS: The minimum annual NNT was 15 for FMT via colonoscopy, 17 for FMT via capsule, and 44 for FMT via enema compared with vancomycin, and 16, 18, and 47 compared with fidaxomicin, respectively. A medical center's minimum catchment area when establishing a FMT unit would have to be 56,849 if using FMT via colonoscopy, or 64,429 if using capsules. CONCLUSION: We report the minimum number of patients requiring treatment annually with FMT to achieve cost-effectiveness, when including start-up and ongoing costs. FMT is cost-effective in Canada in populations with a sufficient number of eligible patients, ranging from 15 to 47 depending on the FMT modality used. This is crucial for medical jurisdictions making decisions about establishing a FMT unit for the treatment of recurrent CDI. The cost-effectiveness can be generalized in other countries.

Cervical disc replacement: examining "real-world" utilization of an emerging technology.

OBJECTIVE: Cervical disc replacement (CDR) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the management of cervical spondylotic pathology. While much is known about the efficacy of CDR within the constraints of a well-controlled, experimental setting, little is known about general utilization. The authors present an analysis of temporal and geographic trends in "real-world" utilization of CDR among those enrolled in private insurance plans in the US. METHODS: Eligible subjects were identified from the IBM MarketScan Databases between 2009 and 2017. Individuals 18 years and older, undergoing a single-level CDR or ACDF for cervical radiculopathy and/or myelopathy, were identified. US Census divisions were used to classify the region where surgery was performed. Two-level mixed-effects regression modeling was used to study regional differences in proportional utilization of CDR, while controlling for confounding by regional case-mix differences. RESULTS: A total of 47,387 subjects met the inclusion criteria; 3553 underwent CDR and 43,834 underwent ACDF. At a national level, the utilization of single-level CDR rose from 5.6 cases for every 100 ACDFs performed in 2009 to 28.8 cases per 100 ACDFs in 2017. The most substantial increases occurred from 2013 onward. The region of highest utilization was the Mountain region (Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, and Wyoming), where 14.3 CDRs were performed for every 100 ACDFs (averaged over the 9-year period of study). This is in contrast to the East South Central region (Alabama, Kentucky, Mississippi, and Tennessee), where only 2.1 CDRs were performed for every 100 ACDFs. Patient factors that significantly increased the odds of undergoing a CDR were age younger than 40 years (OR 15.9 [95% CI 10.0-25.5]; p < 0.001), no clinical evidence of myelopathy/myeloradiculopathy (OR 1.5 [95% CI 1.4-1.7]; p < 0.001), and a Charlson Comorbidity Index score of 0 (OR 2.7 [95% CI 1.7-4.2]; p < 0.001). After controlling for these factors, significant differences in utilization rates remained between regions (chi-square test = 830.4; p < 0.001). CONCLUSIONS: This US national level study lends insight into the rate of uptake and geographic differences in utilization of the single-level CDR procedure. Further study will be needed to ascertain specific factors that predict adoption of this technology to explain observed geographic discrepancies.

Facilities that service economically advantaged neighborhoods perform surgical metastasectomy more often for patients with colorectal liver metastases.

BACKGROUND: Metastasectomy of isolated colorectal liver metastases (CRLM) requires significant clinical expertise and may not be readily available or offered. The authors hypothesized that hospitals that treat a greater percentage of patients from higher income catchment areas are more likely to perform metastasectomies regardless of patient or tumor characteristics. METHODS: Using the National Cancer Data Base, the authors classified facilities into facility income quartiles (FIQs) based on the percentage of patients from the wealthiest neighborhoods (by zip code). Quartile 1 included facilities with <2.1% of the patients residing within the highest income zip codes, quartile 2 included facilities with 2.2% to 15.6% of patients residing within the highest income zip codes, quartile 3 included facilities with 15.7% to 40.2% of patients residing within the highest income zip codes, and quartile 4 included facilities with 40.3% to 90.5% of patients residing within the highest income ZIP codes. Patient, tumor, and facility characteristics were analyzed using a multivariate logistic regression to identify associations between metastasectomy and FIQ. RESULTS: Patients with CRLM were more likely to undergo metastasectomy at facilities in the highest FIQ compared with the lowest FIQ (18% vs 11% in FIQ4; P = .001). This trend was not observed in the resection of primary tumors for nonmetastatic CRLM (rates of 95% vs 93%; P = .94). After adjusting for individual insurance status, distance traveled, zip code-level individual income, tumor, and host, patients who were treated at the highest FIQ facilities were found to be more likely to undergo metastasectomy (odds ratio, 1.29; 95% CI, 1.02-1.72 [P = .03]). CONCLUSIONS: Metastasectomy for CRLM is more likely to occur at facilities that serve a greater percentage of patients from high-income catchment areas, regardless of individual patient characteristics. This disparity uniquely affects those patients with advanced cancers for which specialized expertise for therapy is necessary.

The impact of marital status on health care utilization among Medicare beneficiaries.

To explain prior literature showing that married Medicare beneficiaries achieve better health outcomes at half the per person cost of single beneficiaries, we examined different patterns of healthcare utilization as a potential driver.Using the Medicare Current Beneficiary Survey (MCBS) data, we sought to understand utilization patterns in married versus currently-not-married Medicare beneficiaries. We analyzed the relationship between marital status and healthcare utilization (classified based on setting of care utilization into outpatient, inpatient, and skilled nursing facility (SNF) use) using logistic regression modeling. We specified models to control for possible confounders based on the Andersen model of healthcare utilization.Based on 13,942 respondents in the MCBS dataset, 12,929 had complete data, thus forming the analytic sample, of whom 6473 (50.3%) were married. Of these, 58% (vs. 36% of those currently-not-married) were male, 45% (vs. 47%) were age >75, 24% (vs. 70%) had a household income below $25,000, 18% (vs. 14%) had excellent self-reported general health, and 56% (vs. 36%) had private insurance. Compared to unmarried respondents, married respondents had a trend toward higher odds of having a recent outpatient visit (unadjusted odds ratio (OR) 1.11, 95% confidence interval (CI) 1.04-1.19, adjusted odds ratio (AOR) 1.10, (CI) 0.99-1.22), and lower odds in the year prior to have had an inpatient stay (AOR 0.84, CI 0.72-0.99) or a SNF stay (AOR 0.55, CI 0.40-0.75).Based on MCBS data, odds of self-reported inpatient and SNF use were lower among married respondents, while unadjusted odds of outpatient use were higher, compared to currently-not-married beneficiaries.

The Relationship Between Reported Staffing and Expenditures in Nursing Homes.

Dramatic improvements in reported nursing home quality, including staffing ratios, have come under increased scrutiny in recent years because they are based on data self-reported by nursing homes. In contrast to other domains, the key mechanism for real improvement in the staffing ratios domain is clearer: to improve scores, nursing homes should increase staffing expenditures. We analyze the relationship between changes in expenditures and reported staffing quality pre- versus post the 5-star rating system. Our results show that the relationship between expenditures and licensed practical nurse staffing is weaker in the post-5-star period, overall, and across subgroups; furthermore, there is a weaker relationship between expenditures and registered nurse staffing among for-profit facilities with a high share of Medicaid residents in the post-5-star period. The weaker relationship between staffing expenditures and staffing scores in the post-5-star era underscores the potential for gaming of the self-reported staffing scores and the need for more reliable sources.

Comparison of Anterior Cervical Discectomy and Fusion to Posterior Cervical Foraminotomy for Cervical Radiculopathy: Utilization, Costs, and Adverse Events 2003 to 2014.

BACKGROUND: Surgery for cervical radiculopathy is often approached by either anterior cervical discectomy and fusion (ACDF) or posterior cervical foraminotomy (PCF). ACDF is more common; however, recent single center studies suggest comparable efficacy and significant cost savings with PCF in appropriately selected patients. OBJECTIVE: To compare utilization, adverse events, and costs for each approach from a national perspective. METHODS: Adults undergoing single level ACDF or PCF for cervical radiculopathy were included from a US commercial health insurance claims database spanning 2003 to 2014. Outcomes consisted of mortality, adverse events, length of stay, and total payments to the health provider. Propensity score matching balanced the groups on observed baseline covariates. RESULTS: The PCF cohort comprised 4851 subjects and the ACDF cohort included 46 147. A greater proportion of PCF cases were discharged on the same day (70.6% vs 46.1%; P < .001). Mortality (0.1/1000, P = .012), vascular injury (0.2/1000, P = .001), postoperative dysphagia/dysphonia (14.5/1000, P < .001), cutaneous cerebrospinal fluid leak (0.2/1000, P = .002), and deep venous thrombosis (0.9/1000, P = .013) occurred more frequency in the ACDF cohort. Conversely, wound infections (14.6/1000, P < .001) and 30-d readmissions (9.8/1000, P < .001) were more frequent in the PCF cohort. Mean unadjusted total payments for the PCF cohort were $15 281 ± 12 225 and $26 849 ± 16 309 for ACDF. Matched difference was -$11 726 [95% confidence interval: -$12 221, -$11 232, P < .001] favoring PCF. CONCLUSION: Within the inherent limitations of administrative data, our findings suggest an opportunity for value improvement in managing cervical radiculopathy and indicate a need for large-scale comparative study of clinical outcomes and costs.

Health Economics and the Management of Degenerative Cervical Myelopathy.

Degenerative cervical myelopathy (DCM) is the leading cause of spinal cord impairment worldwide. Surgical intervention has been demonstrated to be effective and is becoming standard of care. Spine surgery, however, is costly and value needs to be demonstrated. This review serves to summarize the key health economic concepts as they relate to the assessment of the value of surgery for DCM. This is followed by a discussion of current health economic research on DCM, which suggests that surgery is likely to be cost effective. The review concludes with a summary of future questions that remain unanswered, such as which patient subgroups derive the most value from surgery and which surgical approaches are the most cost effective.

State insurance mandates and off-label use of chemotherapy.

Access to cancer drugs used off-label is important to cancer patients but may drive up healthcare costs with little evidence of clinical benefit. We hypothesized that state health insurance mandates for private insurers to provide coverage for off-label use of cancer drugs cause higher rates of off-label use. We used Truven MarketScan data from 1999 to 2007 on utilization of 35 infused chemotherapy drugs in private health plans in the United States, covering the period when eight states implemented off-label coverage laws. We studied trends in off-label use of drugs, distinguishing between appropriate and inappropriate off-label use according to drug compendia, and estimated difference-in-difference regressions of the effect of state laws on off-label use. We estimate 41% of utilization was off-label, including 17% of use conservatively defined as inappropriate. Trends show gradual declines in off-label use over time. We also find no discernable effect of state laws mandating coverage of off-label use of cancer drugs on utilization patterns under multiple empirical specifications. Our conclusion is that policymakers should consider shifting away from mandating coverage as a way to ensure access to drugs off-label and towards incentivizing adherence to clinical practice guidelines to improve the quality and value of off-label use.

Rising Prices of Targeted Oral Anticancer Medications and Associated Financial Burden on Medicare Beneficiaries.

Purpose The high cost of oncology drugs threatens the affordability of cancer care. Previous research identified drivers of price growth of targeted oral anticancer medications (TOAMs) in private insurance plans and projected the impact of closing the coverage gap in Medicare Part D in 2020. This study examined trends in TOAM prices and patient out-of-pocket (OOP) payments in Medicare Part D and estimated the actual effects on patient OOP payments of partial filling of the coverage gap by 2012. Methods Using SEER linked to Medicare Part D, 2007 to 2012, we identified patients who take TOAMs via National Drug Codes in Part D claims. We calculated total drug costs (prices) and OOP payments per patient per month and compared their rates of inflation with general health care prices. Results The study cohort included 42,111 patients who received TOAMs between 2007 and 2012. Although the general prescription drug consumer price index grew at 3% per year over 2007 to 2012, mean TOAM prices increased by nearly 12% per year, reaching $7,719 per patient per month in 2012. Prices increased over time for newly and previously launched TOAMs. Mean patient OOP payments dropped by 4% per year over the study period, with a 40% drop among patients with a high financial burden in 2011, when the coverage gap began to close. Conclusion Rising TOAM prices threaten the financial relief patients have begun to experience under closure of the coverage gap in Medicare Part D. Policymakers should explore methods of harnessing the surge of novel TOAMs to increase price competition for Medicare beneficiaries.

Surgery for degenerative cervical myelopathy: a patient-centered quality of life and health economic evaluation.

BACKGROUND CONTEXT: Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health-related quality of life outcomes and financial expenditures is needed to inform resource allocation decisions. PURPOSE: This study aimed to estimate the lifetime incremental cost-utility of surgical treatment for DCM. DESIGN/SETTING: This is a prospective observational cohort study at a Canadian tertiary care facility. PATIENT SAMPLE: We recruited all patients undergoing surgery for DCM at a single center between 2005 and 2011 who were enrolled in either the AOSpine Cervical Spondylotic Myelopathy (CSM)-North America study or the AOSpine CSM-International study. OUTCOME MEASURES: Health utility was measured at baseline and at 6, 12, and 24 months following surgery using the Short Form-6D (SF-6D) health utility score. Resource expenditures were calculated on an individual level, from the hospital payer perspective over the 24-month follow-up period. All costs were obtained from a micro-cost database maintained by the institutional finance department and reported in Canadian dollars, inflated to January 2015 values. METHODS: Quality-adjusted life year (QALY) gains for the study period were determined using an area under the curve calculation with a linear interpolation estimate. Lifetime incremental cost-to-utility ratios (ICUR) for surgery were estimated using a Markov state transition model. Structural uncertainty arising from lifetime extrapolation and the single-arm cohort design of the study were accounted for by constructing two models. The first included a highly conservative assumption that individuals undergoing nonoperative management would not experience any lifetime neurologic decline. This constraint was relaxed in the second model to permit more general parameters based on the established natural history. Deterministic and probabilistic sensitivity analyses were employed to account for parameter uncertainty. All QALY gains and costs were discounted at a base of 3% per annum. Statistical significance was set at the .05 level. RESULTS: The analysis included 171 patients; follow-up was 96.5%. Mean age was 58.2±12.0 years and baseline health utility was 0.56±0.14. Mean QALY gained over the 24-month study period was 0.139 (95% confidence interval: 0.109-0.170, p<.001) and the mean 2-year cost of treatment was $19,217.82±12,404.23. Cost associated with the operation comprised 65.7% of the total. The remainder was apportioned over presurgical preparation and postsurgical recovery. Three patients required a reoperation over the 2-year follow-up period. The costs of revision surgery represented 1.85% of the total costs. Using the conservative model structure, the estimated lifetime ICUR of surgical intervention was $20,547.84/QALY gained, with 94.7% of estimates falling within the World Health Organization definition of "very cost-effective" ($54,000 CAD). Using the more general model structure, the estimated lifetime ICUR of surgical intervention was $11,496.02/QALY gained, with 97.9% of estimates meeting the criteria to be considered "very cost-effective." CONCLUSIONS: Surgery for DCM is associated with a significant quality of life improvement. The intervention is cost-effective and, from the perspective of the hospital payer, should be supported.

Conflicts of Interest in Medical Technology Markets: Evidence from Orthopedic Surgery.

Financial relationships between physicians and industry are vital to biomedical innovation yet create the potential for conflicts of interest in medical practice. I consider an inducement model of the role of financial relationships in health care markets, where consulting payments induce physicians to use more devices of the firms that sponsor them. To test the model, I exploit a policy shock, whereby government monitoring of payments to joint replacement surgeons resulted in declines of over 60% in both total payments and in the number of physicians receiving payments from 2007 to 2008. Using hospital discharge data from three states, I find that the loss of payments leads physicians to switch 7 percentage points of their device utilization from their sponsoring firms' devices to other firms' devices, an effect which is concentrated among surgeons with low switching costs. These results offer support for the inducement model. I also find evidence of an increase in medical productivity following the policy intervention, which suggests conditions under which regulation of financial relationships would be socially beneficial. Copyright © 2015 John Wiley & Sons, Ltd.

Interrupted time-series analysis: studying trends in neurosurgery.

OBJECT Neurosurgery studies traditionally have evaluated the effects of interventions on health care outcomes by studying overall changes in measured outcomes over time. Yet, this type of linear analysis is limited due to lack of consideration of the trend's effects both pre- and postintervention and the potential for confounding influences. The aim of this study was to illustrate interrupted time-series analysis (ITSA) as applied to an example in the neurosurgical literature and highlight ITSA's potential for future applications. METHODS The methods used in previous neurosurgical studies were analyzed and then compared with the methodology of ITSA. RESULTS The ITSA method was identified in the neurosurgical literature as an important technique for isolating the effect of an intervention (such as a policy change or a quality and safety initiative) on a health outcome independent of other factors driving trends in the outcome. The authors determined that ITSA allows for analysis of the intervention's immediate impact on outcome level and on subsequent trends and enables a more careful measure of the causal effects of interventions on health care outcomes. CONCLUSIONS ITSA represents a significant improvement over traditional observational study designs in quantifying the impact of an intervention. ITSA is a useful statistical procedure to understand, consider, and implement as the field of neurosurgery evolves in sophistication in big-data analytics, economics, and health services research.

Trends in the Cost and Use of Targeted Cancer Therapies for the Privately Insured Nonelderly: 2001 to 2011.

PURPOSE: This study sought to define and identify drivers of trends in cost and use of targeted therapeutics among privately insured nonelderly patients with cancer receiving chemotherapy between 2001 and 2011. METHODS: We classified oncology drugs as targeted oral anticancer medications, targeted intravenous anticancer medications, and all others. Using the LifeLink Health Plan Claims Database, we studied and disaggregated trends in use and in insurance and out-of-pocket payments per patient per month and during the first year of chemotherapy. RESULTS: We found a large increase in the use of targeted intravenous anticancer medications and a gradual increase in targeted oral anticancer medications; targeted therapies accounted for 63% of all chemotherapy expenditures in 2011. Insurance payments per patient per month and in the first year of chemotherapy for targeted oral anticancer medications more than doubled in 10 years, surpassing payments for targeted intravenous anticancer medications, which remained fairly constant throughout. Substitution toward targeted therapies and growth in drug prices both at launch and postlaunch contributed to payer spending growth. Out-of-pocket spending for targeted oral anticancer medications was ≤ half of the amount for targeted intravenous anticancer medications. CONCLUSION: Targeted therapies now dominate anticancer drug spending. More aggressive management of pharmacy benefits for targeted oral anticancer medications and payment reform for injectable drugs hold promise. Restraining the rapid rise in spending will require more than current oral drug parity laws, such as value-based insurance that makes the benefits and costs transparent and involves the patient directly in the choice of treatment.

Economic evaluation of therapeutic cancer vaccines and immunotherapy: a systematic review.

Cancer immunotherapy is a rapidly growing field in oncology. One attractive feature of cancer immunotherapy is the purported combination of minimal toxicity and durable responses. However such treatments are often very expensive. Given the wide-spread concern over rising health care costs, it is important for all stakeholders to be well-informed on the cost and cost-effectiveness of cancer immunotherapies. We performed a comprehensive literature review of cost and cost-effectiveness research on therapeutic cancer vaccines and monoclonal antibodies, to better understand the economic impacts of these treatments. We summarized our literature searches into three tables by types of papers: systematic review of economic studies of a specific agent, cost and cost-effectiveness analysis. Our review showed that out of the sixteen immunotherapy agents approved, nine had relevant published economic studies. Five out of the nine studied immunotherapy agents had been covered in systematic reviews. Among those, only one (rituximab for non-Hodgkin lymphoma) was found to be cost-effective. Of the four immunotherapy drugs not covered in systematic reviews (alemtuzumab, ipilimumab, sipuleucel-T, ofatumumab), high incremental cost-effectiveness ratio (ICER) was reported for each. Many immunotherapies have not had economic evaluations, and those that have been studied show high ICERs or frank lack of cost-effectiveness. One major hurdle in improving the cost-effectiveness of cancer immunotherapies is to identify predictive biomarkers for selecting appropriate patients as recipients of these expensive therapies. We discuss the implications surrounding the economic factors involved in cancer immunotherapies and suggest that further research on cost and cost-effectiveness of newer cancer vaccines and immunotherapies are warranted as this is a rapidly growing field with many new drugs on the horizon.

Geographic variation in radiologist capacity and widespread implementation of lung cancer CT screening.

BACKGROUND: Newly released United States Preventive Services Task Force (USPSTF) recommendations for lung cancer screening are expected to increase demand for low-dose computed tomography scanning, but health system capacity constraints might threaten the scale-up of screening. OBJECTIVES: To estimate the prevalence of capacity constraints in the radiologist workforce and resulting potential disparities in access to lung cancer screening. METHODS: We combined information from health interview surveys to estimate the numbers of smokers who meet the USPSTF eligibility criteria, and information from administrative datasets to estimate the numbers of radiologists and the numbers of scans they currently interpret in Health Service Areas (HSAs) nationwide. We estimated and mapped the prevalence of capacity constrained HSAs - those having a greater than 5% or greater than 25% projected increase in scans over current levels from scaling up screening - and used descriptive statistics and logistic regressions to identify HSA characteristics associated with capacity constraints. RESULTS: Scaling up lung cancer screening would increase imaging procedures by an average of 4% across HSAs. Of the 9.6 million eligible smokers, 1,023,943 lived in HSAs with increases of at least 5%. HSAs that were rural, with many eligible smokers, and disproportionately Hispanic or low-income smokers had significantly higher odds of facing capacity constraints. CONCLUSIONS: Disparities in access to lung cancer screening appear likely unless policy makers target HSAs with few radiologists for additional resources. Radiologists should be able to absorb the workload imposed by lung cancer screening in most areas of the country.