Prescription Drug Coverage Research Articles

Age-Specific Prevalence and Incidence of Dementia Diagnoses Among Older US Adults With Schizophrenia

People with schizophrenia are at high risk of receiving a diagnosis of dementia. Understanding the magnitude and timing of this increased risk has important implications for practice and policy. To estimate the age-specific incidence and prevalence of dementia diagnoses among older US adults with schizophrenia and in a comparison group without serious mental illness (SMI). This retrospective cohort study used a 50% random national sample of Medicare beneficiaries 66 years or older with fee-for-service plans and Part D prescription drug coverage from January 1, 2007, to December 31, 2017. The cohort with schizophrenia included adults with at least 12 months of continuous enrollment in fee-for-service Medicare and Part D and at least 2 outpatient claims or at least 1 inpatient claim for schizophrenia during the qualifying years. The comparison group included adults with at least 12 months of continuous enrollment in fee-for-service Medicare and Part D and without a diagnosis of schizophrenia, bipolar disorder, or recurrent major depressive disorder during the qualifying year. Data were analyzed from January 1 to July 31, 2020. Dementia was defined using the Centers for Medicare & Medicaid Services Chronic Conditions Warehouse diagnosis codes for Alzheimer disease and related disorders or senile dementia. Incident diagnoses were defined by at least 12 consecutive eligible months without a qualifying code before meeting dementia criteria. The study population of 8 011 773 adults 66 years or older (63.4% women; mean [SD] age, 74.0 [8.2] years) included 74 170 individuals with a diagnosis of schizophrenia (56.6% women) and 7 937 603 without an SMI diagnosis (63.5% women) who contributed 336 814 and 55 499 543 person-years of follow-up, respectively. At 66 years of age, the prevalence of diagnosed dementia was 27.9% (17 640 of 63 287) among individuals with schizophrenia compared with 1.3% (31 295 of 2 389 512) in the group without SMI. By 80 years of age, the prevalence of dementia diagnoses was 70.2% (2011 of 2866) in the group with schizophrenia and 11.3% (242 094 of 2 134 602) in the group without SMI. The annual incidence of dementia diagnoses per 1000 person-years at 66 years of age was 52.5 (95% CI, 50.1-54.9) among individuals with schizophrenia and 4.5 (95% CI, 4.4-4.6) among individuals without SMI and increased to 216.2 (95% CI, 179.9-252.6) and 32.3 (95% CI, 32.0-32.6), respectively, by 80 years of age. In this cohort study, compared with older adults without SMI, those with schizophrenia had increased risk of receiving a diagnosis of dementia across a wide age range, possibly because of cognitive and functional deterioration related to schizophrenia or factors contributing to other types of dementia. High rates of dementia among adults with schizophrenia have implications for the course of illness, treatment, and service use.

The impact of public coverage of newer hepatitis C medications on utilization, adherence, and costs in British Columbia.

BackgroundSofosbuvir and ledipasvir-sofosbuvir are both newer direct-acting antiviral agents for the treatment of hepatitis C. The high list prices for both drugs have led to concern about the budget impact for public drug coverage programs. Therefore, we studied the impact of public prescription drug coverage for both drugs on utilization, adherence, and public and private expenditure in British Columbia, Canada.MethodsWe used provincial administrative claims data from January 2014 to June 2017 for all individuals historically tested for either hepatitis C and/or human immunodeficiency virus. Using interrupted time series analysis, we examined the impact of public insurance coverage on treatment uptake, adherence (proportion of days covered), and public and private expenditures.ResultsOver our study period, 4,462 treatment initiations were eligible for analysis (1,131 sofosbuvir and 3,331 ledipasvir-sofosbuvir, which include 19 patients initiated on both treatments). We found the start of public coverage for sofosbuvir and ledipasvir-sofosbuvir increased treatment uptake by 154%. Adherence rates were consistently high and did not change with public coverage. Finally, public expenditure increased after the policy change, and crowded out some private expenditure.ConclusionPublic coverage for high-cost drugs for hepatitis C dramatically increased use of these drugs, but did not reduce adherence. From a health policy perspective, public payers should be prepared for increased treatment uptake following the availability of public coverage. However, they should not be concerned that populations without private insurance coverage will be less adherent and not finish their treatment course.

CMS approves Tennessee's Medicaid block grant 1115 demonstration

On Jan. 8, the Centers for Medicare and Medicaid Services (CMS) approved the first 1115 demonstration that would permit Tennessee to transition its Medicaid program to a “block grant” model with a new aggregate cap approach, the Health Center Advocacy Network reported Jan. 19. Instead of receiving a set percentage of federal funding for enrollees' care, the state would receive fixed payments that increase with a rise in program enrollment and inflation. Tennessee will be eligible to qualify for shared savings on an annual basis when it underspends the “without waiver” aggregate cap and meets quality targets. This flexibility allows the state to receive federal matching funds based on savings rather than expenditures for medical assistance provision. Additionally, the 1115 demonstration includes a closed formulary that enables the state to decline specific prescription drug coverage if regulators say it is too expensive.

Opioid use in older adults and Medicare Part D.

To determine whether the introduction of prescription drug coverage under Medicare Part D increased opioid prescriptions, patient care-seeking for pain, and pain diagnoses among elderly Medicare-eligible adults. Office visits by adults aged 18years or older from the 2000-2016 National Ambulatory Medical Care Survey (12375207253 office visits), and respondents from the 2000-2017 Medical Expenditure Panel Survey (4023418681 individuals). We compared care-seeking for pain, provider-assigned pain diagnoses, and opioid prescriptions before and after the Medicare eligibility age of 65, and before and after Part D's implementation using a regression discontinuity, difference-in-differences design. Analyses were adjusted for age, sex, race, and year. Patient care-seeking for pain increased by 11.4 office visits per 100 people (95% confidence interval 2.0-20.8), or 29%, in response to the implementation of Part D. Opioid prescriptions and diagnoses of pain-related conditions did not change significantly, but the financing of opioid prescriptions shifted from private to public payers at age 65. The introduction of Medicare Part D was not associated with increased opioid use among older adults. Rather, opioid use among the elderly has been driven by high levels of opioid use among commercially insured adults who subsequently age into Medicare. Our findings raise the question of whether more judicious prescribing to younger adults coupled with concerted efforts to deprescribe opioids when appropriate may prevent problematic opioid use among the elderly.

Price Is Right: Exploring Prescription Drug Coverage Barriers for Irritable Bowel Syndrome Using Threshold Pricing Analysis.

Prescription drug costs exert profound effects on commercial insurance coverage and access to effective therapy. We aimed to assess threshold pricing to achieve budget neutrality of FDA-approved drugs treating irritable bowel syndrome from an insurance perspective, based on cost-savings resulting in decreased healthcare utilization through effective disease management. We constructed a decision-analytic model from an insurance perspective to assess the budget impact of IBS prescription drugs under usual insurance coverage levels in practice: (1) unrestricted drug access or (2) step therapy in a primary care population of middle-age, care-seeking IBS patients. Budget-neutral drug prices were then calculated which resulted in $0 budget impact to insurers with a short-term, one-year time horizon. If used according to FDA labeling, IBS-D drugs cost between $4778 and $16,844 per year and IBS-C drugs cost between $4319 and $4955 per year. These drug costs often exceed insurance expenditures of $6999 for IBS-D and $3929 for IBS-C if left untreated. Therefore, for drugs to have $0 budget impact to insurers, their prices would need to be discounted 36.7-74.2% for IBS-D drugs and 59.3-82.5% for IBS-C. IBS drugs are already priced to support step therapy "failing one of several common, inexpensive IBS treatments with a responder rate > 30-40%," reflecting the subpopulation with more severe disease and greater healthcare costs. Broader prescription drug coverage for patients failing common, inexpensive IBS treatments to which at least 30-40% of patients would typically respond appears warranted to enable gastroenterologists to offer personalized approaches targeting specific mechanisms of this heterogeneous disease.

Leading Causes of Mortality and Prescription Drug Coverage in Canada and New Zealand.

Introduction: Canada may soon see the introduction of a national pharmaceutical insurance system. New Zealand has a government-funded healthcare system used by all residents that operates within a tight cost-containment budget. The objective of this analysis was to compare the main mortality causes in Canada and New Zealand and examine listings in current Canadian provincial public drug plans and the New Zealand national drug formulary.Materials and Methods: Age-standardized mortality rates from 2000 to 2015 and data on hospital discharges and average length of stay in hospital for Canada and New Zealand were obtained from the Organization for Economic Cooperation and Development's website. Information on insured medications was obtained from Canadian provincial drug plan lists and the New Zealand Pharmaceutical Schedule current in mid-2019.Results: Hospital discharge rates for cardiovascular disorders, malignancies and respiratory disorders and mortality rates for acute myocardial infarction, ischemic heart disease and cerebrovascular disease were higher, on average over the observation period, in New Zealand than in Canada, but mortality rates for malignancies and respiratory disorders were similar. Reimbursement listing rates for cancer drugs and some cardiovascular medications were lower in New Zealand than in Canada.Discussion: Higher hospital discharge and mortality rates suggest poorer patient health in New Zealand compared with Canada. This may be due to lower reimbursement listing rates for some medications in New Zealand. New Zealand's drug coverage system has contained costs, but it restricts or denies access to new innovative medicines with the potential to improve patients' lives. Although a New Zealand-style national pharmacare scheme in Canada would offer the opportunity to restrain drug expenditure, it would likely fail to satisfy patients and healthcare providers and could diminish health outcomes, resulting in higher costs in other healthcare sectors.

Predictors of Long-term Opioid Use After Elective Primary Total Shoulder Arthroplasty

Opioids are prescribed routinely for pain after total shoulder arthroplasty (TSA). This study was designed to characterize opioid use after elective primary TSA and identify predictors of long-term postoperative opioid use. The authors used the MarketScan administrative claims database to identify 5676 adults who underwent elective primary TSA between 2010 and 2015 and had 1 year or more of continuous insurance enrollment, including prescription drug coverage, postoperatively. Long-term postoperative opioid use was defined as filling prescriptions totaling a 120-day or greater supply during the 3- to 12-month postoperative period. The authors performed univariate regression analysis with age, sex, US region, anatomic or reverse TSA, anxiety, chronic obstructive pulmonary disease, congestive heart failure, depression, diabetes, history of drug abuse, hypertension, obesity, osteoporosis, history of myocardial infarction, and current tobacco use. Variables that were significant at P<.05 were included in multivariate logistic regression. Overall, 16% of patients had long-term postoperative opioid use, which was strongly predicted by the multivariate model (area under the curve, 0.77; P<.001). The strongest predictors in the multivariate analysis were preoperative opioid use (odds ratio [OR], 4.7; 95% CI, 4.0-5.5), history of drug abuse (OR, 2.5; 95% CI, 1.3-4.9), depression (OR, 1.9; 95% CI, 1.6-2.3), anxiety (OR, 1.4; 95% CI, 1.2-1.7), surgery performed in the Western United States (OR, 1.8; 95% CI, 1.3-2.4), and reverse TSA (OR, 1.5; 95% CI, 1.2-1.8). Most patients do not have long-term opioid use after elective primary TSA. Strong predictors of long-term postoperative opioid use are preoperative opioid use, history of drug abuse, depression, anxiety, reverse TSA, and surgery performed in the Western United States. [Orthopedics. 2021;44(1):58-63.].

Contrasting Clinician and Insurer Perspectives to Managing Irritable Bowel Syndrome: Multilevel Modeling Analysis.

Insurance coverage is an important determinant of treatment choice in irritable bowel syndrome (IBS), often taking precedence over desired mechanisms of action or patient goals/values. We aimed to determine whether routine and algorithmic coverage restrictions are cost-effective from a commercial insurer perspective. A multilevel microsimulation tracking costs and outcomes among 10 million hypothetical moderate-to-severe patients with IBS was developed to model all possible algorithms including common global IBS treatments (neuromodulators; low fermentable oligo-, di-, and mono-saccharides, and polyols; and cognitive behavioral therapy) and prescription drugs treating diarrhea-predominant IBS (IBS-D) or constipation-predominant IBS (IBS-C) over 1 year. Routinely using global IBS treatments (central neuromodulator; low fermentable oligo-, di-, and mono-saccharides, and polyols; and cognitive behavioral therapy) before US Food and Drug Administration-approved drug therapies resulted in per-patient cost savings of $9,034.59 for IBS-D and $2,972.83 for IBS-C over 1 year to insurers, compared with patients starting with on-label drug therapy. Health outcomes were similar, regardless of treatment sequence. Costs varied less than $200 per year, regardless of the global IBS treatment order. The most cost-saving and cost-effective IBS-D algorithm was rifaximin, then eluxadoline, followed by alosetron. The most cost-saving and cost-effective IBS-C algorithm was linaclotide, followed by either plecanatide or lubiprostone. In no scenario were prescription drugs routinely more cost-effective than global IBS treatments, despite a stronger level of evidence with prescription drugs. These findings were driven by higher prescription drug prices as compared to lower costs with global IBS treatments. From an insurer perspective, routine and algorithmic prescription drug coverage restrictions requiring failure of low-cost behavioral, dietary, and off-label treatments appear cost-effective. Efforts to address insurance coverage and drug pricing are needed so that healthcare providers can optimally care for patients with this common, heterogenous disorder.

Medication cost sharing in low-income elders with chronic disease co-morbidities: Policy implication of PPACA provisions for dual eligibles and parallel systems at national health services

The implementation of the Patient Protection and Affordable Care Act (PPACA) is aimed at addressing patient safety, quality and insurance coverage for patients with co-morbidities in the United States. Chronic disease patients with both Medicare and Medicaid coverage, however, are further impacted, especially for prescription drug coverage. Additionally, the healthcare reform act entails specific provisions that only affect coverage benefits for low-income elders with chronic disease eligible for both Medicare and Medicaid insurance (dual eligibles). This paper will review the impacts on dual eligible beneficiaries prescription drug cost sharing, Part D plan optimisation and Medicare Advantage premiums. It will focus on the impacts of reducing the Part D doughnut hole and prescription drug cost sharing on patients having additional chronic disease co-morbidities, with reference to healthcare management theory of insurance. This paper will also analyse impacts that affect beneficiary quality of care and access. Dual eligible care for chronic disease patients will be summarised in the context of health insurance and management/economic theory. The PPACA provisions concerning dual eligibles Part D cost sharing align with the theory of demand for health insurance and health care. For dual eligibles with chronic disease, reduced medication cost sharing will increase medication adherence and reduce inpatient expenditures with reference to insurance theory.

Medication Therapy Management: 10 Years of Experience in a Large Integrated Health Care System.

Medication therapy management (MTM) was officially recognized by the federal government in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which requires Medicare Part D plans that offer prescription drug coverage to establish MTM programs (MTMPs) for eligible beneficiaries. Even though the term "MTM" was first used in 2003, pharmacists have provided similar services since the term "pharmaceutical care" was introduced in 1990. Fairview Health Services, a large integrated health care system, implemented a standardized pharmaceutical care service system in 1998, naming it a pharmaceutical care-based MTM practice in 2006. To present the clinical, economic, and humanistic outcomes of 10 years of delivering MTM services to patients in a health care delivery system. Data from MTM services provided to 9,068 patients and documented in electronic therapeutic records were retrospectively analyzed over the 10-year period from September 1998 to September 2008 in 1 health system with 48 primary care clinics. Patients eligible for MTM services were aged 21 years or older and either paid for MTM out of pocket or met their health care payer's criteria for MTM reimbursement; the criteria varied for Medicaid, Medicare, and commercially insured enrollees. All MTM was delivered face to face. Health data extracted from the electronic therapeutic record by the present study's investigators included patient demographics, medication list, medical conditions, drug therapy problems identified and addressed, change in clinical status, and pharmacist-estimated cost savings. The clinical status assessment was a comparison of the first and most recent MTM visit to measure whether the patient achieved the goals of therapy for each medical condition (e.g., the blood pressure of a patient with diabetes and hypertension will be less than 130/80 millimeters mercury [mmHg] in 1 month; the patient with allergic rhinitis will be relieved of his complaints of nasal congestion, runny nose, and eye itching within 5 days). Goals were set according to evidence-based literature and patient-specific targets determined cooperatively by pharmacists, patients, and physicians. Cost-savings calculations represented MTM pharmacists' estimates of medical services (e.g., office visits, laboratory services, urgent care visits, emergency room visits) and lost work time avoided by the intervention. All short-term (3-month) estimated health care savings that resulted from addressing drug therapy problems were analyzed. The expenses of these avoided services were calculated using the health system's contracted rates for services provided in the last quarter of 2008. The return on investment (ROI) was calculated by dividing the pharmacist-estimated savings by the cost of MTM services in 2008 (number of MTM encounters times the average cost of an MTM visit). The humanistic impact of MTM services was assessed using the results from the second patient satisfaction survey administered in 2008 (new patients seen from January through December 2008) for the health system's MTM program. A total of 9,068 patient records were in the documentation system as of September 30, 2008. During the 10-year period, there were 33,706 documented encounters (mean 3.7 encounters per patient). Of 38,631 drug therapy problems identified and addressed by MTM pharmacists, the most frequent were a need for additional drug therapy (n = 10,870, 28.1%) and subtherapeutic dosage (n = 10,100, 26.1%). In the clinical status assessment of the 12,851 medical conditions in 4,849 patients who were not at goal when they enrolled in the program, 7,068 conditions (55.0%) improved, 2,956 (23.0%) were unchanged, and 2,827 (22.0%) worsened during the course of MTM services. Pharmacist-estimated cost savings to the health system over the 10-year period were $2,913,850 ($86 per encounter) and the total cost of MTM was $2,258,302 ($67 per encounter), for an estimated ROI of $1.29 per $1 in MTM administrative costs. In the patient satisfaction survey, 95.3% of respondents agreed or strongly agreed that their overall health and well-being had improved because of MTM. Pharmacist estimates of the impact of an MTM program in a large integrated health care system suggest that the program was associated with improved clinical outcomes and cost savings. Patient satisfaction with the program was high. There was no external funding for this manuscript. The 3 authors are employees of Fairview Pharmacy Services. Ramalho de Oliveira had primary responsibility for the concept and design, writing, and revision of the manuscript, with the assistance of Brummel and Miller. Ramalho de Oliveira performed the data collection, and all 3 authors shared equally in data interpretation.

Impact of the Medicare Part D Coverage Gap Closure and Generic Entry on Medication Use

The Affordable Care Act included a provision to eliminate the Medicare prescription drug coverage gap. The policy was phased in by gradually diminishing the gap each year between 2011-2020. This provides a natural experiment to conduct an in-depth study of how the policy affected medication use, which has implications for other benefit designs that vary cost sharing throughout the year. Using 2007-2016 Medicare claims data, we estimate the effects of closing-the-gap policy with a difference-in-differences approach that compares changes in medication use before and after policy between non-subsidized beneficiaries and a subset of Medicare beneficiaries who have not been affected by the policy. To account for the gradual phase-in of policy changes and possible learning effects, we examine the dynamic effects using an event study difference-in-differences model. Importantly, around the same time as the coverage gap closure, several blockbuster drugs that are commonly used by the Medicare population experienced patent expiration and began to see generic entry. To isolate the effect of coverage gap closure from patent expirations, we further use monthly prescription drug event data to more accurately track initial generic entry by therapeutic class. We find that filling the gap significantly reduced individuals’ out-of-pocket spending on branded drugs and increased the number of prescriptions filled for branded drugs. Consistent with the policy design, people who fell in the gap, were at older ages, or had coexisting chronic conditions saw a larger reduction in the amount they paid for prescription drugs. Without controlling for generic entry, the effect of the policy on utilization is underestimated for branded drugs and overestimated for generic drugs.

Predicting High-Cost Health Insurance Members through Boosted Trees and Oversampling: An Application Using the HCCI Database

Using the Health Care Cost Institute data (approximately 47 million members over seven years), we examine how to best predict which members will be high-cost next year. We find that cost history, age, and prescription drug coverage all predict high costs, with cost history being by far the most predictive. We also compare the predictive accuracy of logistic regression to extreme gradient boosting (XGBoost) and find that the added flexibility of the extreme gradient boosting improves the predictive power. Finally, we show that with extremely unbalanced classes (because high-cost members are so rare), oversampling the minority class provides a better XGBoost predictive model than undersampling the majority class or using the training data as is. Logistic regression performance seems unaffected by the method of sampling.

Spillover effects of state medicaid antipsychotic prior authorization policies in US commercially insured youth.

To evaluate spillover effects of Medicaid antipsychotic prior authorization (PA) policies among commercially insured youth. Commercially insured youth residing in nine US states that implemented PA exclusively for antipsychotics in 2011 or 2012 were identified using a 10% random sample of enrollees in the IQVIA PharMetrics Plus database spanning 2007 to 2015. Youth were included if they were ≤18 years, met the age criteria of the PA at the time of dispensing, and had at least 1 month of prescription drug coverage from 2007 to 2015. The primary outcome of interest was the monthly prevalence of antipsychotics. We implemented segmented regression of interrupted time series analysis to estimate changes in the monthly prevalence of targeted medications, overall and stratified by age. Trends were compared in the 4-year period before and the 3-year period after implementation of PA policies. Antipsychotics prescribing significantly decreased 6.74/10 000 (95% CI, -9.04 to -4.44) enrollees per month immediately after PA implementation. However, PA was not associated with significant long-term trend changes (-0.06; 95% CI, -0.16 to 0.03). Antipsychotic prescribing in children <12 years-old significantly decreased 0.14/10 000 (95% CI, -0.21 to -0.07) enrollees per month after PA implementation, while prescribing in adolescents 12 to 18 years-old significantly increased 0.32/10 000 (95% CI, 0.16 to 0.47) enrollees per month. While Medicaid PA polices for antipsychotic oversight did not affect overall prescribing, there were spillover effects in U.S. commercially insured children <12 years-old. This suggests that state-level Medicaid policies intended to improve the quality of care and safe use of antipsychotics can have broad reach.

1131-P: Clinical, Demographic, Provider, and Formulary Characteristics Associated with Initiation of a SGLT2i or GLP-1RA among Medicare Beneficiaries with Type 2 Diabetes on Prior Oral Agents: A Cohort Study

Using 2014-2016 claims data from a random 5% sample of Medicare beneficiaries, we sought to describe characteristics associated with initiation of a SLT2i or GLP-1RA, focusing on measures of plan generosity (e.g., the number of drugs covered with no or minimal copays). Our cohort included beneficiaries with type 2 diabetes who had at least 1 prescription claim for an oral diabetes medication in the 180 days before the start of follow-up (1/1/2015). To identify new initiators of these agents, we excluded beneficiaries who filled any insulin, SGLT2i or GLP-1RA prior to the index date or who died before 12/31/16. We developed multivariable logistic regression models controlling a priori for age, race, region, prior medication use, claims-based measures of diabetes severity and clinical comorbidities, provider specialty and measures of formulary generosity. Of 103,112 eligible beneficiaries (mean age 73, 57% female), 5,076 (4.9%) initiated a SGLT2i or GLP-1RA between 1/1/15-12/31/16. After adjusting for all baseline characteristics, beneficiaries in plans covering 2 or more target drugs in preferred tiers (i.e., 1-3) were more likely (adjusted odds ratio [aOR] 1.18 [95% CI, 1.05 to 1.32]) to initiate one of these medications than patients enrolled in plans covering 0 drugs. Other characteristics associated with higher odds included: age&amp;lt;65 (aOR 1.78 [95% CI, 1.64 to 1.92]), diabetic retinopathy (aOR 1.19 [95% CI, 1.08 to 1.31], obesity (aOR 1.49 [95% CI, 1.38 to 1.62) and having baseline medications prescribed by an endocrinologist (aOR 1.68 [95% CI, 1.49 to 1.89]. Black race (aOR 0.66 [95% CI, 0.60 to 0.73]) and CKD (aOR 0.84 [95% CI, 0.76 to 0.92]) were associated with lower risk of initiation. After controlling for a large number of prespecified covariates, Medicare beneficiaries with type 2 diabetes with more generous prescription drug coverage were more likely to initiate a SGLT2i or GLP-1RA. Disclosure J. Luo: Consultant; Self; Alosa Health. I. Hernandez: None. N. Gabriel: None. W.F. Gellad: None. Funding National Center for Advancing Translational Sciences (KL2TR001856)

Metabolic syndrome, metabolic comorbid conditions, and risk of early-onset colorectal cancer.

1571 Background: The etiology and contributors to the rising incidence of early-onset colorectal cancer (CRC diagnosed under age 50), driven largely by distal and rectal cancer, remain largely unknown. Metabolic syndrome is associated with higher risk of CRC diagnosed at older ages; however, its association with early-onset CRC remains unclear. Methods: We conducted a nested case-control study among participants aged 18-50 years with ≥2 years of enrollment and prescription drug coverage in the IBM MarketScan Commercial Databases (2006-2015). Incident CRC cases were identified using ICD-9-CM diagnosis codes. Controls without any cancer were identified using frequency matching on age, sex, geographical region, and duration of insurance enrollment. Metabolic syndrome was defined using either ICD-9-CM diagnosis codes or the presence of at least 3 of the following: obesity, hypertension, hyperlipidemia, and hyperglycemia/type 2 diabetes. In addition to ICD-9-CM codes, hypertension, hyperlipidemia, and hyperglycemia/type 2 diabetes were also defined based on regular use of medications. Multivariable logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs). Results: A total of 4,673 early-onset CRC and 40,832 controls were included. Metabolic syndrome was associated with increased risk of early-onset CRC (OR: 1.33, 95% CI 1.16-1.52), after adjusting for a range of potential confounders. The number of metabolic comorbid conditions was positively associated with risk of early-onset CRC in a dose-response fashion. Compared to individuals without any conditions, individuals with 1, 2, ≥3 metabolic conditions had a 13% (OR: 1.13, CI 1.04-1.22), 18% (OR: 1.18, CI 1.07-1.31), and 40% (OR: 1.40, CI 1.22-1.61) higher risk of early-onset CRC (Ptrend&lt;0.001), respectively. These associations were driven by proximal (OR for ≥2 vs 0 metabolic comorbid conditions: 1.40, CI 1.15-1.69) and distal colon cancer, OR ≥2 vs 0: 1.25, CI 1.03-1.53), but not rectal cancer (OR≥2 vs 0: 1.07, CI 0.92-1.24). Conclusions: Metabolic syndrome and metabolic comorbid conditions were associated with increased risk of early-onset CRC, largely driven by proximal and distal colon cancer. Metabolic dysregulations may contribute to the rising incidence of early-onset CRC.

Factors Associated with Entering the Prescription Drug Coverage Gap Among Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease.

Patients with chronic obstructive pulmonary disease (COPD) need long-term use of COPD medications to manage their conditions. However, COPD patients enrolling in Medicare Advantage plans (MAPs) may enter the coverage gap, resulting in increasing financial burden. The purpose of this study was to identify characteristics of COPD patients who enter the Medicare coverage gap and the factors associated with time to enter the coverage gap. A retrospective cross-sectional study was conducted using a Texas MAP database between 2011 and 2014. Patients aged ≥65 years with a diagnosis of COPD and taking medication to treat COPD were included. Patients were divided into mainly 2 groups: "no gap" versus "gap," based on their pharmacy outpatient spending. Within "gap," patients were further categorized into "coverage gap" and gap with "catastrophic coverage." Multinomial logistic regression was conducted to identify characteristics associated with reaching "coverage gap" and "catastrophic coverage." Cox proportional hazards were performed to evaluate factors associated with time to reaching "coverage gap." A total of 3142 COPD patients were identified: "no gap" (79%) and "gap" (21%). Among patients in "gap," 51% fell into "catastrophic coverage." Age, low-income subsidy (LIS) level, and Centers for Medicare & Medicaid (CMS) risk score were significant factors associated with entering both "coverage gap" and "catastrophic coverage." Younger age, greater CMS risk score, and higher LIS benefit were associated with a higher hazard ratio of reaching the coverage gap. These characteristics may assist health maintenance organizations to identify beneficiaries who can potentially be provided with services with or without counseling on drug utilization.

Impact of Pharmacy Benefit Managers on Oncology Practices and Patients.

Pharmacy benefit managers (PBMs) are thoroughly integrated into the drug supply chain as administrators of prescription drug benefits for private insurers, self-insuring business, and government health plans. As the role of PBMs has expanded, their opaque business practices and impact on drug prices have come under increasing scrutiny. PBMs are particularly influential in oncology care because prescription drugs play a major role in the treatment of most cancers and an increasing number of patients with cancer are treated with oral oncology agents managed by PBMs. There is concern that some PBM practices may threaten access to high-quality cancer care and may increase the financial and administrative burden on patients and practices. In this article, we review the role of PBMs in prescription drug coverage and reimbursement, discuss the impact of PBMs on oncology care, and present data from the 2018 ASCO Practice Survey assessing the knowledge and attitude of oncology practices toward PBMs.

A clinical study of drugs associated with acute kidney injury in the Chinese population

Purpose: To carry out a study aimed at comprehensive identificat6ion of classes of drugs which cause acute kidney injury (AKI).Methods: A total of 110,508 patients enrolled in Weihai Central Hospital, Weihai, Shandong, China between March 2014 to April 2018 were asked to provide information on comprehensive prescription drug coverage including antivirals, antibiotics, NSAIDs, diuretics and anti-cancer drugs. Only the active user of these classes of drugs were included in the study. Daily prescription dose, duration, date and time of each drug were recorded. Furthermore, the characteristics and other conditions of the patients such as hypertension, congestive heart failure, diabetes, liver disease, angiotensin receptor blockers (ARBs), alpha-receptor blockers, beta-receptor blockers, and calcium channel-blockers were included.Results: A total of 1230 patients presented with AKI during the first 60 days of follow-up, while 1546 (58 %) patients were diagnosed with AKI in the secondary endpoint. Indomethacin, valacyclovir, fluorouracil, levofloxacin, ibuprofen and rofecoxib produced higher frequencies of AKI than the control drug, celecoxib. Indomethacin (OR = 2.97 ; 95 % CI= 1.94 - 3.89) and valacyclovir (OR = 2.85 ; 95 % CI = 1.56 - 3.42) were mostly responsible for AKI, followed by rofecoxib (OR = 2.48 ; 95 % CI = 2.32 - 2.71), fluorouracil (OR = 2.58 ; 95 % CI = 1.94 - 3.11), ibuprofen (OR = 1.68 ; 95 % CI = 1.28 - 2.21) and levofloxacin (OR = 1.58 ; 95 % CI = 1.48 - 2.73), in that orderConclusion: This study has identified various classes of drugs which frequently induced AKI. Therefore, physicians should exercise caution in prescribing these drugs, and should consider other medicines to minimize the risk of AKI.&#x0D; Keywords: Acute kidney injury, Antiviral, NSAID, Toxicity

How does Medicare Part D (prescription drug coverage) compare with no drug coverage or an alternative pharmaceutical coverage arrangement?

How does Medicare Part D (prescription drug coverage) compare with no drug coverage or an alternative pharmaceutical coverage arrangement?

Subsidy Design in Privately Provided Social Insurance: Lessons from Medicare Part D.

The efficiency of publicly-subsidized, privately-provisioned social insurance programs depends on the interaction between strategic insurers and the subsidy mechanism. We study this interaction in the context of Medicare's prescription drug coverage program. We find that the observed mechanism is successful in keeping "raise-the-subsidy" incentives relatively low, acts much like a flat voucher, and obtains a level of welfare close to the optimal voucher. Across a range of counterfactuals, we find that more efficient subsidy mechanisms share three features: they retain the marginal elasticity of demand, limit the exercise of market power, and preserve the link between prices and marginal costs.