Evidence That Regulatory And Market Forces Are Driving Adoption Of Biosimilars.

Biosimilars present a key opportunity to contain the growing cost of biologic drug spending and to make essential medications more affordable. However, the lackluster performance of the US biosimilar market in its first decade was met with disappointment and concern for its future viability. To evaluate the evolution of the biosimilar market, we reviewed key distinctions in medication classes and the financial stakeholders involved in each.

Age-related structural and functional changes of the intracardiac nervous system.

Background: Although aging is known to be associated with an increased incidence of both atrial and ventricular arrhythmias, there is limited knowledge about how Schwann cells (SC) and the intracardiac nervous system (iCNS) remodel with age. Here we investigate the differences in cardiac SC, parasympathetic nerve fibers, and muscarinic acetylcholine receptor M2 (M2R) expression in young and old mice. Additionally, we examine age-related changes in cardiac responses to sympathomimetic and parasympathomimetic drugs.

Increasing emergency department visits for anaphylaxis in very early childhood: A canary in the coal mine.

Aim: The incidence of anaphylaxis is increasing globally in tandem with changing environmental and lifestyle factors. There is very limited data on very early childhood presentations. We aim to assess changes in rates, characteristics and management of infant anaphylaxis in a paediatric ED over a 15-year period.

Health Care Utilization and Spending in Medicare Advantage vs Traditional Medicare: A Difference-in-Differences Analysis.

Importance: Medicare Advantage (MA) has entailed a major expansion of government-financed, privately administered health insurance in the US. As policy makers consider options to expand Medicare further, it is informative to compare the performance of traditional Medicare (TM) and MA.

Objective: To assess whether MA is associated with differential changes in health care utilization and spending for beneficiaries entering Medicare from commercial insurance compared with beneficiaries entering TM.

Mucus concentration-dependent biophysical abnormalities unify submucosal gland and superficial airway dysfunction in cystic fibrosis.

Cystic fibrosis (CF) is characterized by abnormal transepithelial ion transport. However, a description of CF lung disease pathophysiology unifying superficial epithelial and submucosal gland (SMG) dysfunctions has remained elusive. We hypothesized that biophysical abnormalities associated with CF mucus hyperconcentration provide a unifying mechanism.

Coverage Denials: Government And Private Insurer Policies For Medical Necessity In Medicare.

Little is publicly known about coverage denials for medical services that do not meet medical necessity criteria. We characterized the extent of these denials and their key features, using Medicare Advantage claims for a large insurer from the period 2014-19. In this setting, claims could be denied because of traditional Medicare's coverage rules or additional Medicare Advantage private insurer rules.

Incidence and Estimated Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Among Persons Tested in US Retail Locations, May 1 to August 7, 2021.

This case-control study evaluates the estimated vaccine effectiveness against infection changes over time to help inform public health policy and clinical practices.

Measuring the Scope of Prior Authorization Policies: Applying Private Insurer Rules to Medicare Part B.

Importance: Health insurers use prior authorization to evaluate the medical necessity of planned medical services. Data challenges have precluded measuring the frequency with which medical services can require prior authorization, the spending on these services, the types of services and clinician specialties affected, and differences in the scope of prior authorization policies between government-administered and privately administered insurance.

Objectives: To measure the extent of prior authorization requirements for medical services and to describe the services and clinician specialties affected by them using novel data on private insurer coverage policies.

Aetna's Compassionate Care Program: Sustained Value for Our Members with Advanced Illness.

In 2004, Aetna, a national health insurer, launched the Aetna Compassionate Care Program (ACCP) targeting members diagnosed with an advanced illness with a view to increase access to palliative care and hospice services. The objective of this study is to evaluate the impact of ACCP on health care utilization and hospice enrollment among enrolled members. This was a retrospective cohort study comparing participants in ACCP to a matched control group using a propensity score method.

Serum vitamin C levels modulate the lifespan and endoplasmic reticulum stress response pathways in mice synthesizing a nonfunctional mutant WRN protein.

Werner syndrome (WS) is a premature aging disorder caused by mutations in a RecQ-family DNA helicase (WRN). Mice lacking part of the helicase domain of the WRN ortholog exhibit several phenotypic features of WS. In this study, we generated a Wrn mutant line that, like humans, relies entirely on dietary sources of vitamin C (ascorbate) to survive, by crossing them to mice that lack the gulonolactone oxidase enzyme required for ascorbate synthesis.

Increased Use of Adrenaline in the Management of Childhood Anaphylaxis Over the Last Decade.

Background: We recently determined that allergy training programs have improved physician recognition and diagnosis of pediatric anaphylaxis in the last decade.

Objective: To investigate for changes in management, in particular the appropriate use of adrenaline for the treatment of anaphylaxis in a tertiary pediatric emergency department (PED).

Methods: We conducted a retrospective case note study including children aged 0 to 16 years coded and verified for anaphylaxis comparing cases in years 2003/2004 with 2012.

Automatable algorithms to identify nonmedical opioid use using electronic data: a systematic review.

Objective: Improved methods to identify nonmedical opioid use can help direct health care resources to individuals who need them. Automated algorithms that use large databases of electronic health care claims or records for surveillance are a potential means to achieve this goal. In this systematic review, we reviewed the utility, attempts at validation, and application of such algorithms to detect nonmedical opioid use.

Mast cell inhibition as a therapeutic approach in fibrodysplasia ossificans progressiva (FOP).

Background: Episodic flare-ups of fibrodysplasia ossificans progressiva (FOP) are characterized clinically by severe, often posttraumatic, connective tissue swelling and intramuscular edema, followed histologically by an intense and highly angiogenic fibroproliferative reaction. This early inflammatory and angiogenic fibroproliferative response is accompanied by the presence of abundant mast cells far in excess of other reported myopathies.

Results: Using an injury-induced, constitutively-active transgenic mouse model of FOP we show that mast cell inhibition by cromolyn, but not aprepitant, results in a dramatic reduction of heterotopic ossification.

Home infusion: Safe, clinically effective, patient preferred, and cost saving.

Background: As the U.S. healthcare payment system shifts from volume to value, identifying care approaches that improve outcomes while lowering costs are essential.

Economic value of pharmacist-led medication reconciliation for reducing medication errors after hospital discharge.

Objectives: Medication discrepancies at the time of hospital discharge are common and can harm patients. Medication reconciliation by pharmacists has been shown to prevent such discrepancies and the adverse drug events (ADEs) that can result from them. Our objective was to estimate the economic value of nontargeted and targeted medication reconciliation conducted by pharmacists and pharmacy technicians at hospital discharge versus usual care.

Predicting 1-Year Statin Adherence Among Prevalent Users: A Retrospective Cohort Study.

Background: Attempts to predict who is at risk of future nonadherence have largely focused on predictions at the time of therapy initiation; however, these users are only a small proportion of all patients on therapy at any point in time. Methods to predict nonadherence for established medication users, which have not been previously described in the literature, would be helpful to guide efforts to enhance the use of evidence-based therapies.

Objective: To test approaches for adherence prediction among prevalent statin users, namely the use of short-term filling behavior, investigator-specified predictors from medical and pharmacy administrative claims, and the empirical selection of potential predictors using the high-dimensional propensity score variable selection algorithm.

Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial.

Importance: Forgetfulness is a major contributor to nonadherence to chronic disease medications and could be addressed with medication reminder devices.

Objective: To compare the effect of 3 low-cost reminder devices on medication adherence.

Design, Setting, And Participants: This 4-arm, block-randomized clinical trial involved 53 480 enrollees of CVS Caremark, a pharmacy benefit manager, across the United States.

Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014).

Objectives: To assess the impact of CVS Health's discontinuation of tobacco sales on cigarette purchasing.

Methods: We used households' purchasing data to assess rates at which households stopped cigarette purchasing for at least 6 months during September 2014 to August 2015 among 3 baseline groups: CVS-exclusive cigarette purchasers, CVS+ (CVS and other retailers), and other-exclusive (only non-CVS retailers). In state-level analyses using retailers' point-of-sale purchase data, an interrupted time series compared cigarette purchasing before (January 2012 to August 2014) and after (September 2014 to April 2015) tobacco removal in 13 intervention states with CVS market share of at least 15% versus 3 control states with no CVS stores.

Can purchasing information be used to predict adherence to cardiovascular medications? An analysis of linked retail pharmacy and insurance claims data.

Objective: The use of retail purchasing data may improve adherence prediction over approaches using healthcare insurance claims alone.

Design: Retrospective.

Setting And Participants: A cohort of patients who received prescription medication benefits through CVS Caremark, used a CVS Pharmacy ExtraCare Health Care (ECHC) loyalty card, and initiated a statin medication in 2011.

Longitudinal Patterns of Spending Enhance the Ability to Predict Costly Patients: A Novel Approach to Identify Patients for Cost Containment.

Background: With rising health spending, predicting costs is essential to identify patients for interventions. Many of the existing approaches have moderate predictive ability, which may result, in part, from not considering potentially meaningful changes in spending over time. Group-based trajectory modeling could be used to classify patients into dynamic long-term spending patterns.

An Insurer's Care Transition Program Emphasizes Medication Reconciliation, Reduces Readmissions And Costs.

Adverse drug events and the challenges of clarifying and adhering to complex medication regimens are central drivers of hospital readmissions. Medication reconciliation programs can reduce the incidence of adverse drug events after discharge, but evidence regarding the impact of medication reconciliation on readmission rates and health care costs is less clear. We studied an insurer-initiated care transition program based on medication reconciliation delivered by pharmacists via home visits and telephone and explored its effects on high-risk patients.

Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.

Background: The incidence of opioid-related death in women has increased 5-fold over the past decade. For many women, their initial opioid exposure will occur in the setting of routine medical care. Approximately 1 in 3 deliveries in the United States is by cesarean, and opioids are commonly prescribed for postsurgical pain management.