Fabrice Smieliauskas

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.

Impact of Negative Clinical Trial Results for Vertebroplasty on Vertebral Augmentation Procedure Rates

BACKGROUND Vertebroplasty and kyphoplasty are procedures for treating vertebral compression fractures (VCFs). In August 2009, 2 randomized trials in the New England Journal of Medicine found that vertebroplasty did not reduce pain or disability relative to a sham procedure among patients with osteoporotic VCFs. STUDY DESIGN We evaluated quarterly trends in per capita rates of vertebroplasties and kyphoplasties using the Florida hospital inpatient discharge and ambulatory surgery center databases from 2005 to 2012, supplemented with physician specialty and population data. We reported trends by procedure type, patient diagnosis, and physician specialty. We modeled the procedures as interrupted time series with a break when the clinical trials were published, and estimated changes in procedure rates and health expenditures resulting from the trials. RESULTS The trials led to a 51.5% decline in the per capita vertebroplasty rate and a 40.0% decline in the kyphoplasty rate (both results p < 0.010) compared with what procedure rates would have been without the trials. Vertebroplasty rates for interventional radiologists displayed no significant change; rates for surgeons and other specialists declined by 73.1% (p < 0.010). Overall, these changes imply nationwide health expenditure savings of just over

A review of economic impact of targeted oral anticancer medications

1 billion per year. CONCLUSIONS Publication of negative clinical trial results led to moderate reductions in vertebroplasties and kyphoplasties for osteoporotic VCFs. However, vertebroplasty and kyphoplasty continue to be widely used to treat patients with osteoarthritis. Substantial differences in response across physicians suggest an important role for specialty society clinical guidelines in modulating how clinical evidence is incorporated into routine practice.

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

There has been a rapid increase in the use of targeted oral anticancer medications (OAMs) in the past decade. As OAMs are often expensive, economic consideration play a significant role in the decision to prescribe, receive or cover them. This paper performs a systematic review of costs or budgetary impact of targeted OAMs to better understand their economic impact on the healthcare system, patients as well as payers. We present our review in a summary table that describes the method and main findings, take into account multiple factors, such as country, analytical approach, cost type, study perspective, timeframe, data sources, study population and care setting when we interpret the results from different papers, and discuss the policy and clinical implications. Our review raises a concern regarding the role of sponsorship on findings of economic analyses as the vast majority of pharmaceutical company-sponsored studies reported cost advantages toward the sponsors drugs.

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

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.

Interrupted time-series analysis: studying trends in neurosurgery.

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

The Relationship Between Reported Staffing and Expenditures in Nursing Homes

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.

Health Economics and the Management of Degenerative Cervical Myelopathy

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 trends 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 ITSAs 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 interventions 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.

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

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.