All-Cause Mortality for Life Insurance Applicants with a History of Breast Cancer.

Breast cancer is the most commonly diagnosed cancer worldwide. Breast cancer is also the second leading cause of cancer death among women in the United States after lung cancer with over 40,000 breast cancer deaths occurring each year. The purpose of this research was to determine the all-cause mortality of applicants diagnosed with breast cancer currently or at some time in the past. Life insurance applicants with reported breast cancer were extracted from data covering United States residents between November 2007 and November 2014. Information about these applicants was matched to the Social Security Death Master (SSDMF) file for deaths occurring from 2007 to 2011 and to another commercially available death source file (Other Death Source, ODS) for deaths occurring from 2007 to 2014 to determine vital status. If there was a death from the other death source, then the SSDMF was searched to verify the death. The study had approximately 561,000 person-years of exposure. Actual-to-expected (A/E) mortality ratios were calculated using the Society of Actuaries 2008 Valuation Basic Table (2008VBT), select and ultimate table (age last birthday) and the 2010 US population as expected mortality ratios. Since the A/Es presented in this paper were known to be an underestimate due to the exclusion of the recent SSDMF deaths, comparative analysis of the mortality ratios was done. Since there was no smoking status information in this study, all expected bases were not smoker distinct. Overall, the 35-44 age group had 6.3 times the relative mortality ratio than those in the 65-75 age group. The relative mortality ratio for the 35-44 age group applicants, when cancer severity was accounted for in combination with 3 or more nodes of cancer involvement, was 29.3 times that when compared to those in the 65-75 age group having localized cancer, where no nodes are involved. The 35-44 age group applicants who were diagnosed with cancer within the last year had over 10-fold increase in relative mortality ratios compared to the 65-75 age group, who were over 10 years from diagnosis. Taking the severity of cancer along with time from diagnosis showed over a 12 times relative mortality ratio between the low rate of over 10 years from diagnosis and localized involvement to those diagnosed within the last year having 3 or more nodes with cancer. Applicant age, time since diagnosis and cancer severity were the most significant variables to predict the relative mortality ratios.

All-Cause Mortality for Life Insurance Applicants with a History of Prostate Cancer.

OBJECTIVE: - To determine the all-cause mortality of life insurance applicants diagnosed with prostate cancer currently or at some time in the past. BACKGROUND: - Prostate cancer is common and a frequent cause of cancer death. Both the frequency of prostate cancer in men and its propensity for causing premature mortality require insurance company medical directors and underwriters to have a good understanding of prostate cancer-related mortality trends, patterns, and outcomes in the insured population. METHODOLOGY: - Life insurance applicants with reported prostate cancer were extracted from data covering United States residents between November 2007 and November 2014. Information about these applicants was matched to the Social Security Death Master (SSDMF) file for deaths occurring from 2007 to 2011 and to another commercially available death source file (Other Death Source, ODS) for deaths occurring from 2007 to 2014 to determine vital status. Actual to Expected (A/E) mortality ratios were calculated using the Society of Actuaries 2015 Valuation Basic Table (2015VBT), select and ultimate table (age last birthday) and the 2013 US population as expected mortality ratios. All expected bases were not smoker distinct. RESULTS: - The study covered applicants between the ages of 45 and 75 and had approximately 405,000 person-years of exposure. Older aged applicants had a lower mortality ratio than those who were younger. Applicants 45 to 54 had the highest mortality ratios in the first year after diagnosis which steadily decreased in years 6 to 10 with an increase in the mortality ratio for those over 10 years from diagnosis. Relative mortality rate was close to unity for those with localized cancer across all age groups. The mortality ratio was 2 to 4 times greater for those with cancer in 1 positive node, and much greater with 3 positive nodes. For each time-from-diagnosis category, the relative mortality ratios compared to age were highest in the 45-54 age group. The A/E mortality ratios based on the 2015VBT were consistently 3 to 4 times that of the mortality ratios based on the 2013 US population. CONCLUSION: - The mortality patterns of insurance applicants with prostate cancer were similar to that observed in individuals with prostate cancer in the general population. Applicant age, time to diagnosis and cancer severity were the most significant variables to predict mortality.

All-Cause Mortality for Diabetics or Individuals with Hyperglycemia Applying for Life Insurance.

Diabetics and individuals with lab results consistent with a diagnosis of diabetes or hyperglycemia were extracted from data covering US residents who applied for life insurance between January 2007 and January 2014. Information about these applicants was matched to the Social Security Death Master File (SSDMF) and another commercially available death source file to determine vital status. Due to the inconsistencies of reporting within the death files, there were two cohorts of death cases, one including the imputed year of birth (full cohort of deaths), and the second where the date of birth was known (reduced cohort of deaths). The study had approximately 8.5 million person-years of exposure. Actual to expected (A/E) mortality ratios were calculated using the Society of Actuaries 2008 Valuation Basic Table (2008VBT) select table, age last birthday and the 2010 US population as expected mortality rates. With the 2008VBT as an expected basis, the overall A/E mortality ratio was 3.15 for the full cohort of deaths and 2.56 for the reduced cohort of deaths. Using the US population as the expected basis, the overall A/E mortality ratio was 0.98 for the full cohort of deaths and 0.79 for the reduced cohort. Since there was no smoking status information in this study, all expected bases were not smoker distinct. A/E mortality ratios varied by disease treatment category and were considerably higher in individuals using insulin. A/E mortality ratios decreased with increasing age and took on a J-shaped distribution with increasing BMI (Body Mass Index). The lowest mortality ratios were observed for overweight and obese individuals. The A/E mortality ratio based on the 2008VBT decreased with the increase in applicant duration, which was defined as the time since initial life insurance application.

Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation.

After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Although it is a significant achievement to see the first asset being placed into human trials under an adaptive pathway, there is much to be learned regarding the multinational and multi-stakeholder effort that has driven the growing acceptance of MAPPs as a methodology and concept, as well as the need for continued and increasing international collaboration to foster the wider adoption of MAPPs. Changes in available science and technology, as well as a number of challenges in the current system, outlined in this paper, are transforming approaches to medicines development and approval. It is these challenges that have led directly to the groundbreaking MAPPs collaboration between the Massachusetts Institute of Technology Center for Biomedical Innovation's New Drug Development Paradigms Initiative, the EMA, patient, payer and health technology assessment groups, the European Federation of Pharmaceutical Industries and Associations, and the Innovative Medicines Initiative-a European public-private partnership. This article examines the development of MAPPs, from inception of the concept, to the establishment of this trans-Atlantic initiative, and examines challenges for the future.

Antibiotic resistance-the need for global solutions.

The causes of antibiotic resistance are complex and include human behaviour at many levels of society; the consequences affect everybody in the world. Similarities with climate change are evident. Many efforts have been made to describe the many different facets of antibiotic resistance and the interventions needed to meet the challenge. However, coordinated action is largely absent, especially at the political level, both nationally and internationally. Antibiotics paved the way for unprecedented medical and societal developments, and are today indispensible in all health systems. Achievements in modern medicine, such as major surgery, organ transplantation, treatment of preterm babies, and cancer chemotherapy, which we today take for granted, would not be possible without access to effective treatment for bacterial infections. Within just a few years, we might be faced with dire setbacks, medically, socially, and economically, unless real and unprecedented global coordinated actions are immediately taken. Here, we describe the global situation of antibiotic resistance, its major causes and consequences, and identify key areas in which action is urgently needed.

The role of the pharmaceutical industry in meeting the public health threat of antibacterial resistance.

The established market model for pharmaceutical products, as for most other products, is heavily dependent on sales volumes. Thus, it is a primary interest of the producer to sell large quantities. This may be questionable for medicinal products and probably most questionable for antibacterial remedies. For these products, treatment indications are very complex and encompass both potential patient benefits, possible adverse effects in the actual patient and, which is unique for this therapeutic class, consideration about what effects the drug use will have on the future therapeutic value of the drug. This is because bacteria are sure to develop resistance. The European Federation of Pharmaceutical Industries and Associations (EFPIA) agrees with the general description of the antibacterial resistance problem and wants to participate in measures to counteract antibacterial resistance. Stakeholders should forge an alliance that will address the need for and prudent use of new antibiotics. A variety of incentives probably have to be applied, but having all in common that the financial return has to be separated from the use of the product.

Mortality experience in the elderly in the Impairment Study Capture System.

Using the dataset of the Impairment Study Capture System, we analyzed mortality experience and underwriting on policies issued at ages 70 and up. Policy issue dates were from 1990-1998 and observation ran from 5-12 years. There were 1430 deaths in a total exposure of over 102,000 policy-years. Nearly two thirds of the total exposure was for females. Despite the use of expected mortality differentiated by smoking status, the mortality ratio for smokers was much higher than for nonsmokers. Both the type of underwriting (paramedical and medical compared to nonmedical and simplified) and the underwriting risk class confirmed the intended effects of underwriting. Variation of mortality ratio by duration after issue did not contradict the select period slope of the 2001 VBT.

Mortality study of policies on insured lives with diabetes mellitus known at time of issue.

BACKGROUND: This is an Impairment Study Capture System (ISCS) study of contemporary diabetes mellitus mortality among insured lives. Because the diagnosis and treatment of diabetes has changed during the last 15 years, many applicants may be expected to exhibit more favorable outcomes than in the past. The study covers policy-years durational experience extending to only 10 years. METHODS: We analyzed the total mortality experience of 41,972 insurance policies. The policies were issued at standard or substandard premium rates between 1989 and 2002 policy anniversaries. The number of policies terminated by death (actual deaths) is compared with expected deaths using the 2001 Valuation Basic Table (2001 VBT). Main outcome measures are expressed as mortality ratios (MR %) and excess death rates/1000 (EDR/M). Poisson confidence intervals are used to test the statistical significance of mortality ratios at the 95% confidence limit. RESULTS: The total experience is based on 103,104 policy-years exposure: males 57,888 policy-years (56%) and females 45,216 policy-years (44%). There were 495 policy-deaths 284 male and 211 female. Substandard risks represented the majority of the total exposure, 76,658 policy-years in both sexes combined (male 56%, female 44%). The mean duration of substandard exposure was 2.3 years. Total mortality for all insured age-groups and risk categories combined was 187%. The mortality ratios for policies rated standard had confidence intervals that were consistent with 100% of the 2001 VBT. The mortality ratios for policies rated substandard had confidence intervals that were above 100% of the 2001 VBT. Mortality ratios varied with the type of treatment. They were lowest in those treated with diet alone and highest in individuals treated with diet plus insulin. CONCLUSION: A clinical diagnosis of diabetes continues to demonstrate evidence of increased, but improving, mortality in insured individuals. The underwriting risk appraisal process effectively categorizes the risk, especially for the substandard classes where the ratings assigned to policies were consistent with the mortality results. The lack of significant differences in the mortality ratios between males and females as well as between nonsmokers and smokers indicate that the early duration variations by gender and smoking status in the 2001 VBT account for these differences in early duration diabetes mortality. Subsequent follow-up studies containing longer durations may show these differences emerging. Results must be interpreted with caution because of the small data set, limited number of ISCS participating companies, and durational experience extending to only 10 policy years.

Study of policies on insured lives with elevated blood pressure known at time of issue.

BACKGROUND: The mortality results of policies on insured lives with elevated blood pressure have been the subject of several studies since the early 20th century. This study, which began with issues of 1989, utilizes data from the Impairment Study Capture System (ISCS). Data are also compiled for impairments other than elevated blood pressure in the ISCS for the same study period. A comparison of these 2 sets of data shows the relative severity of elevated blood pressure compared to all other impairments combined. The determination of elevated blood pressure was made on the basis of risk classification due to lack of specific blood pressure readings. METHODS: Mortality results are actual to expected ratios based on the SOA 1990-95 Select Basic Table. The companies participating in this study have completed 3 steps: (1) agreement to have individual reports to the MIB included in the ISCS file; (2) submission of additional policy information, not on the MIB report; and (3) update of in-force status annually. Reports do not include personal identifying information. RESULTS: Based on the limited amount of data contributed by relatively few companies, there has been considerable improvement since earlier studies in mortality among insureds with elevated blood pressure. Some possible reasons for this include: (1) fewer smokers--there were fewer smokers in the population and hence applying for insurance during the period covered by this study as compared to earlier studies; (2) improved treatment, patient awareness and adherence to regimen--a wider variety of medications and current treatment practices compared to treatment in the 1970s and early 1980s may have influenced results. Compared to prior studies, it is likely that more insureds with elevated blood pressure first noted on the insurance examination subsequently have received treatment. In addition, those with elevated blood pressure have become more aware of the importance of adhering to their medication regimen and improving other adverse risk factors; (3) improvement in the treatment of related medical conditions. CONCLUSION: The results of this study must be interpreted with caution. The volume of data is not substantial, and the results may not be representative of non-contributing companies. Going forward, it is hoped that more companies will agree to participate such that future studies will produce data and results of greater utility.