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An editorial focuses on evaluating the validity of using late-stage cancer diagnosis as an alternative endpoint to cancer-specific mortality in clinical trials for cancer screening. It examines the findings of a study, which analyzed the correlation between these endpoints across various cancer types and concluded that late-stage cancer diagnosis is not a reliable substitute for cancer-specific mortality.

The article discusses that which drug prices should Medicare negotiate. It mentions that there are draft pieces of legislation and regulation that take aim at the rising cost of drugs; and also mentions to make selective price negotiation work, Medicare would have to focus on drugs that are on the market solely under accelerated approval.

The high cost of cancer care worldwide is largely attributable to rising drugs prices. Despite their high costs and potential toxic effects, anticancer treatments could be subject to overuse, which is defined as the provision of medical services that are more likely to harm than to benefit a patient. We found 30 studies documenting medication overuse in cancer, which included 16 examples of supportive medication overuse and 17 examples of antineoplastic medication overuse in oncology. Few specific agents have been assessed, and no studies investigated overuse of the most toxic or expensive medications currently used in cancer treatment. Although financial, psychological, or physical harms of medication overuse in cancer could be substantial, there is little published evidence addressing these harms, so their magnitude is unclear. Further research is needed to better quantify medication overuse, understand its implications, and help protect patients and the health-care system from overuse. [ABSTRACT FROM AUTHOR]

The article discusses a national coverage analysis of chimeric antigen receptor T cells (CAR-Ts) therapies performed by the U.S. Centers for Medicare and Medicaid Services (CMS). Topics include information on the two approved CAR-T therapies, how CMS can drive price competition on CAR-T therapy alone, and strategy highlighted by the Medicare Payment Advisory Commission (MEDPAC).

An editorial is presented on the prices of branded specialty drugs in the pharmaceutical industry. Topics mentioned include the incremental cost-effectiveness of statin therapy with ezetimibe or evolocumab, the benefits of treatment and the increase spending on prescription drugs for chronic diseases.

The federal 340B program gives participating hospitals and other medical providers deep discounts on outpatient drugs. Named for a section of the Veterans Health Care Act of 1992, the program's original intent was to help low-income and uninsured patients. But the program has come under scrutiny by critics who contend that some hospitals exploit the drug discounts to generate profits instead of either investing in programs for the poor or passing the discounts along to patients and insurers.We examined whether the program is expanding in ways that could maximize hospitals' ability to generate profits from the 340B drug discounts. We matched data for 960 hospitals and 3,964 affiliated clinics registered with the 340B program in 2012 with the socioeconomic characteristics of their communities from the US Census Bureau’s American Community Survey.We found that hospital-affiliated clinics that registered for the 340B program in 2004 or later served communities that were wealthier and had higher rates of health insurance compared to communities served by hospitals and clinics that registered for the program before 2004. Our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics. [ABSTRACT FROM AUTHOR]

The article discusses how copay assistance may further increase health care costs. Topics covered include the consistent growth in drug spending, the practice by pharmaceutical companies of offering coupons to offset patients' out-of-pocket costs, and the tendency for copay assistance to undermine benefit designs that enable low-cost insurance plans. Also mentioned are the policy changes that should be done to ensure that the equity of copay assistance programs is improved.

National spending on health care presents a central fiscal challenge for the United States. Expenditures for cancer care are expected to increase substantially because of a rapid rise in new cancer diagnoses associated with the aging of the population. In addition, innovations in cancer treatment are expected to increase spending on cancer care. To examine the drivers of rising cancer costs and to evaluate potential strategies to provide affordable, high-quality cancer care to all patients, the Institute of Medicine's National Cancer Policy Forum convened a workshop in October 2012, Delivering Affordable Cancer Care in the 21st Century. This article summarizes presentations and discussion from the workshop, and focuses on the practice-changing strategies that workshop speakers proposed to improve the affordability of cancer care while maintaining or improving the quality of care. [ABSTRACT FROM AUTHOR]

Payments from the pharmaceutical industry to US physicians are common. In determining which payments rise to the level of an illegal kickback under the Anti-Kickback Statute (AKS), the Department of Health and Human Services' Office of Inspector General (OIG) has stated in nonbinding guidance that influencing or "swaying" physician prescribing is key. OIG has highlighted as a compliance standard the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Professions, which stipulates that permissible payments are those that do not interfere with prescribing. However, recent evidence has shown that most payments influence physician prescribing. driving higher prescription drug costs by increasing use of brand-name and low-value drugs. This evidence implies that many payments that are currently commonplace could be subject to prosecution under AKS. Given that these payments increase costs to patients and the health care system, there is a public interest in curtailing them. This article proposes a range of actions available to stakeholders--including industry, providers, regulators, and payers--to mitigate the cost-increasing effect of industry payments to physicians. [ABSTRACT FROM AUTHOR]

The article presents information on the increase in lung cancer in the U.S. A focus is on the reviewing the benefits and harms of screening in lung cancer which uses low-dose computed tomography (LDCT). The self-funded study was conducted by multisociety initiatives which included American Cancer Society, American Society of Clinical Oncology and American College of Chest Physicians. The result of the study showed that LDCT is beneficial for patients at increased risk of lung cancer. The issues related to radiation exposure are also discussed. INSET: Box. Role of Computed Tomography Screening for Lung Cancer....

Long-standing guidelines against screening high-risk individuals for lung cancer may change following the publication of the randomized National Lung Screening Trial (NLST), which shows a benefit of computed tomography compared with chest x-ray screening. Guideline panels will likely also seek additional information from nonrandomized studies of computed tomography screening, such as the Early Lung Cancer Action Project (ELCAP). However, for the ELCAP findings to be incorporated into new guidelines, some inconsistencies in the published data should first be resolved. Specifically, some of the reports from ELCAP appear to contradict others in terms of important endpoints, and several findings from ELCAP appear to be statistically improbable or outliers when compared with analyses and studies by other research groups. Clarification of both internal and external inconsistencies is a prerequisite for evaluation of the body of work published by ELCAP investigators. [ABSTRACT FROM PUBLISHER]

The steady introduction of more and more expensive cancer treatments has prompted policy makers to explore alternative payment approaches that might rein in costs. We propose a framework for "episode-based" payment during chemotherapy treatment, which would cover the costs of drugs and their administration for a predefined period of treatment and would have the potential to reduce costs and improve patient outcomes. Using the example of metastatic lung cancer treatment, we describe an approach that Medicare could pursue in order to test our proposal as a pilot program. If successful, the concept could be expanded to encompass longer time periods, other cancer diagnoses, and additional care components. [ABSTRACT FROM AUTHOR]

Lung cancer risk prediction models hold the promise of improving patient care and streamlining research. The ultimate goal of these models is to inform clinicians as to which interventions their individual patients should receive to reduce lung cancer-associated morbidity and mortality. In this paper, we discuss the history and current state of lung cancer prediction models, focusing on three models: the Bach model, the Spitz model, and the Liverpool Lung Project (LLP) model. We also discuss the prospects for further development of improved prediction models for lung cancer risk. Although current models can identify those smokers at highest risk for lung cancer, these models are presently of limited use in the clinical setting. Nevertheless, lung cancer risk prediction models can be used during study enrollment to select more appropriate study subjects, and may eventually be useful in identifying patients for lung cancer screening or to receive chemoprevention. [ABSTRACT FROM AUTHOR]

Medicare must find new ways to achieve cost control without limiting access to beneficial services. We propose a payment model incorporating comparative effectiveness research to encourage Medicare to pay equally for services that provide comparable patient outcomes. The model would include higher payments for services demonstrated by adequate evidence to provide superior health benefits compared to alternative options. New services without such evidence would receive usual reimbursement rates for a limited time but then be reevaluated as evidence emerged. In spite of the substantial political hurdles to changing Medicare reimbursement, efforts should be made to use comparative effectiveness research to reward superior services, improve incentives for cost-effective innovation, and place Medicare on a more sustainable financial footing. [ABSTRACT FROM AUTHOR]

The article comments on several concerns about hospital efficiency measures and spending that were documented by the Dartmouth Atlas of Health Care. According to the author, Atlas-based analyses are affected by methodological problems, starting from the definition of efficiency. Another problem, he adds, is that Atlas analyses assess the overall hospital efficiency based on costs incurred for nonrepresentative patients and decedents who were enrolled in fee-for-service Medicare.

The article examines the reasons for increases in cancer-drug prices and spending. It focuses on the U.S. social insurance program Medicare and the legislative and regulatory framework that shields cancer drugs from strategies to keep the prices down. Medicare's strategies including control of utilization and encouraging price competition among manufacturers of interchangeable drugs are discussed. The negotiating leverage of drug plans under Medicare's Part D program is also examined. Laws and regulations which inhibit the flexibility of Medicare are discussed, including provisions of the law which affect drug coverage and laws which undo strategies that depend on the interchangeability of cancer drugs.

The author discusses the rising costs of drugs and existing treatments amidst biomedical improvements, referencing the article "Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma" by R.J. Motzer and colleagues which appeared on page 1803 within the issue. Topics mentioned include the problem Medicare beneficiaries face when it comes to cancer care, the lack of upper limit on coinsurance, and cost-effectiveness analysis as a tool for identifying the value of different treatments.

Summary: For screening to be successful in lung cancer, programmes need to identify a precursor of fatal disease that is highly treatable. This precursor is currently presumed to be early-stage lung cancer, and thus our current efforts in lung-cancer screening have focused on finding, and treating, early-stage lung cancer. In other words, our current natural-history model of lung cancer is based on the notion that for a period before a lung cancer becomes advanced and fatal, it is localised and treatable. Empirical findings emerging from studies of lung-cancer screening suggest this notion to be incorrect. These studies all suggest that early-stage histologically confirmed lung cancers identified by screening are not precursors of advanced or incurable disease. If true, these findings have potentially important implications for the development and assessment of new lung-cancer screening approaches. [Copyright &y& Elsevier]

The article presents a study which evaluates the evidence for, and against screening for lung cancer with low-dose computed tomography. Results reveal that studies of lung cancer screening with chest radiograph and sputum cytology have failed to demonstrate that screening lowers lung cancer mortality rates. Such findings allow researchers to recommend that individuals undergo screening only when it is administered as a component of a well-designed clinical trial.

The article presents a medical research study that examined whether computed tomography screening increases the frequency of lung cancer diagnosis and resection and if it reduces the risk of a diagnosis of advanced lung cancer or death from lung cancer. Asymptomatic current and former smokers were screened annually for lung cancer via computed tomography. The authors found that low-dose computed tomography screening can increase the frequency of lung cancer diagnosis and treatment, but that a reduction in advanced lung cancer or death from cancer may not be a result of the screening. The authors conclude that asymptomatic individuals should not be screened outside of clinical research studies. [ABSTRACT FROM AUTHOR]

In this article we address whether studies of care rendered to patients prior to their death (“studies of decedents”) produce an accurate portrait of care provided to patients who are dying. Studies of decedents typically analyze the care provided to patients over a defined interval antecedent to death. Studies of dying patients analyze care provided to patients subsequent to the time that their terminal status is perceived. We address whether 2 fundamental differences between studies of decedents and studies of the dying—the ways that subjects are identified and the time periods that are examined—lead to differences in interpretation of study results. Using examples from population-based cohorts of individuals with cancer, we show that both the differences in subject selection and time period introduce very substantial biases into studies of decedents. We conclude that studying care received prior to death can lead to invalid conclusions about the quality or type of care provided to dying patients. [ABSTRACT FROM AUTHOR]

Study objectives: To develop and validate a model for estimating the risk of lung cancer death in current and former smokers. The model is intended for use in analyzing a population of subjects who are undergoing lung cancer screening or receiving lung cancer chemoprevention, to determine whether the intervention has altered lung cancer mortality. Design/setting/patients: Model derivation was based on analyses of the placebo arm of the Carotene and Retinol Efficacy Trial. Model validation was based on analyses of three other longitudinal cohorts. Measurements: Observed and predicted number of deaths due to lung cancer. Results: In internal validation, the model was highly concordant and well calibrated. In external validation, the model predictions were similar to what was observed in all of the validation analyses. The predicted and observed deaths within 6 years were very similar when assessed in the Johns Hopkins Hospital trial of chest radiography and sputum cytology screening (176 predicted, 184 observed, p = 0.53), the Memorial Sloan-Kettering Cancer Center trial of chest radiography and sputum cytology screening (108 predicted, 114 observed, p = 0.57), and the National Health and Nutrition Evaluation Survey part I (24 predicted, 21 observed, p = 0.52). Conclusions: The number of lung cancer deaths in a population of current or former smokers can be accurately predicted, making model-based evaluations of prevention and early detection interventions a useful adjunct to definitive randomized trials. We illustrate this potential use with a small example. [ABSTRACT FROM AUTHOR]

Lung cancer is the leading cause of cancer death in US women and is responsible for as many deaths as breast cancer and all gynecological cancers combined. Most lung cancer is caused by cigarette smoke. Despite all that is known about the devastating effects of cigarettes, one quarter of women in the United States continue to smoke. Women are targeted in tobacco advertising, and teenage girls are often drawn to cigarette smoking under a variety of social pressures. Following the increase in smoking, the death rate from lung cancer in US women rose 600% from 1930 to 1997. Women may be more susceptible than men to the carcinogenic properties of cigarette smoke. In addition, differences in the biology of lung cancer exist between the 2 sexes with higher levels of DNA adduct formation, increased CYP1A1 expression, decreased DNA repair capacity, and increased incidence of K-ras gene mutations in women. The novel estrogen receptor β has also been detected in lung tumors and suggests that estrogen signaling may have a biological role in tumorigenesis. Given these differences and given the enormous toll this disease has on US women, undertaking sex-specific research in lung cancer is crucial. Finally, disseminating information about this epidemic may prevent a similar epidemic in other parts of the world where women are just now becoming addicted to tobacco. [ABSTRACT FROM AUTHOR]

: BackgroundEfforts to improve surgical outcomes have traditionally focused on improving preoperative patient selection and reducing the risk of postoperative medical complications. Strategies to optimize surgical technique have been less well studied. We sought to assess the relation between complications related to surgical technique and outcomes after esophagogastrectomy for cancer.: Study designMedical records of 510 consecutive patients undergoing esophagogastrectomy for invasive squamous cell carcinoma or adenocarcinoma at Memorial Sloan-Kettering Cancer Center from 1996 to 2001 were reviewed. Data on diagnosis, stage of disease, therapies received, surgical approach, patient comorbidities, technical complications, and postoperative medical complications and outcomes including length of stay and overall survival were determined by one reviewer of the medical records. The primary predictor was surgical complications and the primary outcome was survival.: ResultsOf the 150 patients studied 138 (27%) had complications directly attributable to surgical technique, such as an anastomotic leak, a paralyzed vocal cord, or chylothorax. At 3 years 43 of 138 patients (31%) with technical complications were alive, whereas 179 of 372 patients (48%) without technical complications were alive. Technical complications were associated with increased length of stay (median 23 days versus 11 days, p < 0.001), increased in-hospital mortality (12.3% versus 3.8%, p < 0.001), and a higher rate of medical complications (77.5% versus 47.3%, p < 0.001). After controlling for age, medical comorbidities, use of induction therapy, tumor stage, histology, and location, and completeness of resection the presence of a technical complication was highly predictive of poorer overall survival; the multivariable hazard ratio was 1.41 (1.22 to 1.63, p = 0.008).: ConclusionsTechnical complications have a large negative impact on survival after esophagogastrectomy for cancer. Strategies to optimize surgical technique and minimize complications should improve outcomes in this cancer operation. [Copyright &y& Elsevier]

The objectives were to define the incidence, risk factors, clinical features and outcome of arterial desaturation syndrome following talc pleurodesis in patients with malignant pleural effusions. This retrospective, observational study took place at a tertiary care cancer center in New York. All patients were those with malignancy who underwent pleurodesis with talc in 1998 at Memorial Sloan Kettering Cancer Center. Characteristics of patients are described by using summary statistics. Differences between groups were assessed with the Fisher's exact statistic for categorical variables and Student's t-test for continuous variables. Among patients who were considered to have arterial desaturation syndrome, we evaluated the relation of SaO2/FIO2 pre- and post-talc installation using a paired Student's t-test. During 1998, 120 patients underwent pleurodesis with talc, and 8 (7%) developed arterial desaturation following the procedure. Symptoms included chest pain, dyspnea, fever, and increased need for oxygen supplementation developed typically within 1 day. Three of the eight patients in this series required mechanical ventilation, but all recovered uneventfully after treatment, which included high-dose corticosteroids. Patients with breast and ovarian cancer appeared to be at increased risk for this complication compared to those patients with other types of cancer (p = 0.01). Approximately 7% of patients who have undergone sclerosis with talc for a malignant pleural effusion will develop arterial desaturation with clinically significant hypoxia requiring supplemental oxygen following the procedure. It appears that most patients recover from this complication and that those with breast and ovarian cancer may be at higher risk. [ABSTRACT FROM AUTHOR]

Background: Although there is no proven benefit associated with screening for lung cancer, screening programs are attracting many individuals who perceive themselves to be at high risk due to smoking. We sought to determine whether the risk of lung cancer varies predictably among smokers. Methods: We used data on 18172 subjects enrolled in the Carotene and Retinol Efficacy Trial (CARET)—a large, randomized trial of lung cancer prevention—to derive a lung cancer risk prediction model. Model inputs included the subject's age, sex, asbestos exposure history, and smoking history. We assessed the model's calibration by comparing predicted and observed rates of lung cancer across risk deciles and validated it by assessing the extent to which a model estimated on data from five CARET study sites could predict events in the sixth study site. We then applied the model to evaluate the risk of lung cancer among smokers enrolled in a study of lung cancer screening with computed tomography (CT). Results: The model was internally valid and well calibrated. Ten-year lung cancer risk varied greatly among participants in the CT study, from 15% for a 68-year-old man who has smoked two packs per day for 50 years and continues to smoke, to 0.8% for a 51-year-old woman who smoked one pack per day for 28 years before quitting 9 years earlier. Even among the subset of CT study participants who would be eligible for a clinical trial of cancer prevention, risk varied greatly. Conclusions: The risk of lung cancer varies widely among smokers. Accurate risk prediction may help individuals who are contemplating voluntary screening to balance the potential benefits and risks. Risk prediction may also be useful for researchers designing clinical trials of lung cancer prevention. [ABSTRACT FROM AUTHOR]

Although virtually all individuals with advanced lung cancer succumb to the disease, a substantial portion of individuals diagnosed at an earlier stage can be cured. This dichotomy has provoked interest in lung cancer screening. To date, randomized controlled trials of chest x-ray and sputum cytology have failed to demonstrate that screening with either modality decreases lung cancer mortality; neither of these technologies can be recommended. Early studies of lung cancer screening with low-dose CT (LDCT) appear promising; however, only data from observational studies are available. We recommend that individuals should only be screened with LDCT in the context of well-designed clinical trials. [ABSTRACT FROM AUTHOR]

Study objectives: To review the available data on the early detection of lung cancer, with a focus on three technologies: chest x-ray (CXR), sputum cytology, and low-dose CT (LDCT) scanning. Design, setting, participants: Review of published clinical studies of early detection technologies. The best available evidence on each topic was selected for analysis. Randomized trials were used to evaluate CXR and sputum cytology. Cohort studies, as well as studies providing evidence regarding rates of overdiagnosis and efficacy of initial treatment, were considered in evaluation of LDCT. Study design and results were summarized in evidence tables. Statistical analyses of combined data were not performed. Measurement and results: Five randomized trials of CXR with or without sputum cytology have been conducted, each which reports disease-specific mortality as well as other end points. None of these studies provide support for the use of either CXR or sputum cytology for the early detection of lung cancer in asymptomatic individuals. Eight completed and ongoing trials of LDCT were identified. All of these studies report the frequency and stage distribution of lung cancers found during initial ("prevalence") screening, and several studies also report rates of detection at the time of annual follow-up. No outcome data on survival or treatment are available. A number of studies support the hypothesis of "overdiagnosis"—that some lung cancers detected by LDCT may behave in an indolent manner. Conclusions: The use of either CXR or sputum cytology for the early detection of lung cancer is not supported by the published evidence. The evidence for LDCT appears promising, in that the technology typically identifies lung cancer at an early stage, although corollary studies suggest that these findings in isolation may be misleading. Further high-quality research is needed to better define the role of LDCT in the evaluation of asymptomatic high-risk individuals. [ABSTRACT FROM AUTHOR]

Context: In recent years a theory that cancer biology is different in blacks and whites has gained prominence in reaction to epidemiologic observations that blacks have poorer survival than whites, even when diagnosed with cancer of similar severity. Yet, few studies have evaluated whether lower-quality treatment and shorter overall life expectancy due to a greater burden of other illnesses may explain the survival discrepancy. Objective: To estimate the magnitude of overall and cancer-specific survival differences between blacks and whites who receive comparable treatment for similar-stage cancer. Data Sources: We searched MEDLINE for English-language articles published from 1966 to January 2002 that reported on overall survival for black and white patients treated similarly for cancer. Study Selection: The abstracts or titles for 891 citations were independently examined by 2 authors. The full text was retrieved if the abstract mentioned both black and white patients, made some comment regarding either similarity of treatment received or presented an analysis based on the treatment received, and commented on survival. Studies were included if they included data for at least 10 black and 10 white patients; specified the cohort ascertainment method and what measures were undertaken to minimize loss to follow-up; summarized survival of both blacks and whites using actuarial measures; presented outcomes within stage, adjusted for stage, or based on cohorts with balanced stage distributions; and specified that blacks and whites in the study received similar treatment. We identified 89 unique cohorts in 54 articles that met our inclusion criteria. Data Extraction: Overall survival rates and hazard ratios (HRs) for death for blacks relative to whites were calculated. These were subsequently adjusted for rates of death due to causes other than the cancer under study to determine cancer-specific survival and cancer-specific HRs. Data Synthesis: Results represent 189... [ABSTRACT FROM AUTHOR]

Study objectives: Investigators have been using severity-of-illness indexes such as APACHE II (acute physiology and chronic health evaluation score II) to describe patients with prolonged critical illness. However, little is known about the utility of these indexes for this patient population. We evaluated the ability of four severity-of-illness indexes to predict mortality rates in 182 patients with prolonged critical illness. Design: Retrospective inception cohort study. Setting: A single, urban, long-term, acute-care hospital in Chicago. Patients: One hundred eighty-two patients transferred from 37 acute-care hospital ICUs. Measurements and results: We assessed four indexes: the acute physiology and chronic health evaluation II, the simplified acute physiology score II, the mortality prediction model II, and the logistic organ dysfunction system using variables measured on admission to the long-term acute-care hospital ICU. We found that none of these indexes distinguished well between the patients who lived and the patients who died (area under ROC [receiver operating characteristics] curve < 0.70 for all), nor did they assign correct probabilities of death to individual patients (Hosmer-Lemeshow goodness-of-fit statistics, p < 0.01 for all). Conclusions: Investigators and clinicians should use caution in using severity-of-illness measures developed for acutely ill patients to describe critically ill patients admitted to long-term care units. As clinical practice and research focus more on these latter patients, development of adequately performing severity-of-illness measures appropriate to this patient population will be needed. [ABSTRACT FROM AUTHOR]

Evaluates available data on diagnostic evaluation, risk stratification and therapeutic management of patients with acute exacerbations of chronic obstructive pulmonary disease (COPD). Data sources; Causes of COPD; Predictors of relapse; Approach to the patient with an acute exacerbation of COPD.

The authors discuss the different methods to improve outpatient oncology practice. They outline the findings of the United pilot project published in the "Journal of Oncology Practice" They emphasize the significance of a coordinated definition of patient classifications in the quality improvement efforts for cancer care.

Objectives. This study sought to track changes in US heroin prices from 1988 to 1995 and to determine whether changes in the affordability of heroin were associated with. changes in the use of heroin by users seeking methadone treatment, as indexed by methadone dose levels. Methods. Data on the price of heroin were from the Drug Enforcement Administration; data on methadone doses were from surveys conducted in 1988, 1990, and 1995 of 100 methadone maintenance centers. Multivariabie models that controlled for time and city effects were used to ascertain whether clinics in cities where heroin was less expensive had patients receiving higher doses of methadone, which would suggest that these patients had relatively higher physiological levels of opiate addiction owing to increased heroin use. Results. The amount of pure heroin contained in a $100 (US) purchase has increased on average 3-fold between 1988 and 1995. The average dose of methadone in clinics was positively associated with the affordability of local heroin (P < .01). Conclusions. When heroin prices fall, heroin addicts require more methadone (a heroin substitute) to stabilize their addiction-evidence that they are consuming more heroin. [ABSTRACT FROM AUTHOR]

In this Viewpoint, Peter Bach and colleague Stacie Dusetzina question the assumption underlying a 2019 proposed federal rule change to eliminate drug manufacturer rebates to pharmacy benefit managers (PBMs) as a way to decrease prescription drug prices, and they propose more extensive restructuring, including a cap on out-of-pocket spending for Medicare Part D beneficiaries, to better control drug costs and save patients money. [ABSTRACT FROM AUTHOR]

In this Viewpoint, the authors review Medicare & Medicaid Services 340B Payment program and recent rules to curtail expansion of drug discounts beyond serving poor patients. [ABSTRACT FROM AUTHOR]

Policy PointsPharmaceutical trade organizations and media outlets in the United States regularly point to compulsory licensing—or even its threat—as the mechanism that peer countries use to control the price of prescription drugs.Our comparative analysis shows that compulsory licensing is not frequently employed in high‐income countries outside the United States as a direct response to drug prices. When its use is threatened, a license is rarely issued and even less often does it lead to a price discount. Accordingly, compulsory licensing is unlikely to contribute to price discrepancies between the United States and other developed nations.In fact, of the 21 compulsory licensing petitions we identified outside the United States, over one‐third were made by pharmaceutical companies themselves and only three were threatened by a government authority. Context: Compulsory licensing is a practice whereby national authorities can license a third party to produce a patented product, such as a pharmaceutical drug, effectively enabling the production of a generic before the original patent expires. The policy was designed—and has historically been used—to improve access to essential medicines in low‐income countries and during public health crises. Although it was not intended to impact drug prices directly, the threat of compulsory licensing may indeed contribute to lower drug prices in high‐income countries outside the United States. Our study sought to determine the plausibility of this claim. Methods: We compiled a comprehensive database of compulsory licensing episodes in the United States and 17 comparator nations over the 20 years following the 2001 Doha Declaration, and we recorded the motivation and outcome of each instance. Our search began with publicly available reports compiled by organizations specializing in pharmaceutical intellectual property, expanded to a query of legal proceedings in Westlaw, and concluded with a comprehensive literature review on PubMed. Findings: This strategy yielded 45 unique episodes of compulsory licensing, 24 in the United States and 21 outside. A minority (24%) of petitions outside the United States were motivated by high prices, and in all countries, only three cases were clearly associated with a price discount. Conclusions: We found no evidence to suggest that compulsory licensing is either frequently threatened or successfully implemented by countries outside the United States to secure price discounts for the most expensive pharmaceuticals, those that are newly patented and just entering the market. [ABSTRACT FROM AUTHOR]

The authors discuss the benefits of lung cancer screening with reference to the National Lung Screening Trial (NLST). They report that the risk for the lung cancer death in the high-risk patients reduced by 20 percent after three rounds of annual medical screening with low-radiation-dose computed tomography (CT) in comparison with chest radiography screening. According to them, people who do not meet the criteria for the NLST, experience the reduced benefit of being screened when risk is low.

The article provides commentary on the article "Tobacco Smoking as a Possible Etiologic Factor in Bronchiogenic Carcinoma: A Study of Six Hundred and Eighty-Four Proved Cases," by Ernest L. Wynder and Evarts A. Graham published in a 1950 issue. The author explains that the study was published before the link between lung cancer and smoking was accepted as fact. He notes that Wynder and Graham laid a foundation for tobacco control policy for public health.

The article discusses a paper published within this issue about the implications of overdiagnosis in lung cancer.

The author reflects on the issue of cost sharing for U.S. health care. Particular focus is given to a study which examines the impact of cost sharing on the utilization of screening mammography among patients in Medicare plans and which suggests cost sharing reduces the use of mammography. It is the author's view that financial factors such as low health care costs should guide patients to obtain services that offer more health gains, but that not many shortcuts to do so are likely.

In this Viewpoint, Peter Bach and colleagues distinguish 5 pricing reform proposals implied by the concept of value-based drug pricing and discuss the potential of each to ensure value in response to unsustainable drug price increases. [ABSTRACT FROM AUTHOR]