Pharmacy Benefit Manager Market Concentration for Prescriptions Filled at US Retail Pharmacies.

This study analyzes pharmacy benefit manager market concentration for commercial insurance, Medicare Part D, and Medicaid managed care in the US.

Medicare Part D Plans Greatly Increased Utilization Restrictions On Prescription Drugs, 2011-20.

Drug utilization management tools can be employed to ensure that medicines are prescribed cost-effectively, but they can also be implemented in ways that reduce adherence and harm patient health. We examined trends in the prevalence of utilization restrictions on non-protected-class compounds in Medicare Part D plans during the period 2011-20, including prior authorization and step therapy requirements as well as formulary exclusions. Part D plans became significantly more restrictive over time, rising from an average of 31.9 percent of compounds restricted in 2011 to 44.4 percent restricted in 2020. The prevalence of formulary exclusions grew particularly fast: By 2020, plan formularies excluded an average of 44.7 percent of brand-name-only compounds. Formulary restrictions were more common among brand-name-only compared with generic-available compounds, among more expensive compounds, and in stand-alone compared with Medicare Advantage prescription drug plans.

Cancer Drug Trastuzumab And Its Biosimilars Compete On Price For Market Share.

Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.

Estimation of the Share of Net Expenditures on Insulin Captured by US Manufacturers, Wholesalers, Pharmacy Benefit Managers, Pharmacies, and Health Plans From 2014 to 2018.

Importance: Recent US media and policy attention on insulin affordability has focused on the role of manufacturers in setting prices; however, the role of other drug distribution intermediaries in determining prices has received less attention. Objective: To estimate the share of net expenditures on insulin captured by manufacturers, wholesalers, pharmacy benefit managers, pharmacies, and health plans from 2014 to 2018. Design Setting and Participants: This cross-sectional study of the US insulin market was conducted in 2020 using 2014-2018 data from multiple sources, including list and estimated net prices from SSR Health for 32 insulin products, mean use weights from a commercial pharmacy claims database, mean acquisition costs and reimbursements from the Centers for Medicare & Medicaid Services, mean spread and share of rebates retained by pharmacy benefit managers from state Medicaid and drug transparency reports, and profit margins from the public filings of distribution system participant companies. Participants were insulin manufacturers, drug wholesalers, pharmacies, pharmacy benefit managers, and health plans. Main Outcomes and Measures: Mean list and net insulin prices, mean net expenditures on insulin, share of expenditures retained by each distribution system participant. Results: Between 2014 and 2018, mean list prices of 32 insulin products increased by 40.1% (from $19.60 to $27.45), while mean net prices received by manufacturers decreased by 30.8% (from $10.53 to $7.29). Net expenditures per 100 units of insulin increased by 3.2% (from $15.11 to $15.59) while the share of a hypothetical $100 insulin expenditure accruing to manufacturers decreased by 33.0% (from $69.71 to $46.73) and the share accruing to health plans decreased by 24.7% (from $13.82 to $10.40). The share of insulin expenditures retained by pharmacy benefit managers increased by 154.6% (from $5.64 to $14.36), the share retained by pharmacies increased by 228.8% (from $6.21 to $20.42), and the share retained by wholesalers increased by 74.7% (from $4.63 to $8.09). Conclusions and Relevance: Results of this cross-sectional study of the distribution of insulin expenditures suggest that policies to control insulin costs should consider all entities throughout the insulin distribution system. Manufacturers represented a decreasing share of insulin expenditures, and pharmacies, pharmacy benefit managers, and wholesalers accounted for a growing share; all entities play a role in increasing insulin costs.

Provider differences in biosimilar uptake in the filgrastim market.

OBJECTIVES: To identify differences in biosimilar uptake across providers and to examine the association between provider biosimilar uptake and observable practice-level characteristics. STUDY DESIGN: A retrospective analysis of 100% of a commercial medical claims database from June 2015 to June 2018. METHODS: We focused on providers of biologic (Neupogen) and biosimilar (Zarxio) filgrastim. We compared trends in biosimilar uptake across 2 dimensions: provider's place of service and provider's prescribing exclusivity. We then used multivariate regression analysis to estimate the association between any biosimilar uptake and practice-level characteristics, controlling for geography and time fixed effects. RESULTS: Relative to hospital-based providers, office-based providers were earlier and quicker adopters of the biosimilar filgrastim. Across all places of service, providers predominantly prescribed either the biosimilar or biologic, exclusively, for all their patients. Any biosimilar uptake was more common among providers in office-based settings, providers with larger practice sizes, and providers with a higher share of health maintenance organization patients, nonwhite patients, and younger patients. CONCLUSIONS: This study uncovers important associations between provider practice characteristics and biosimilar uptake. Our findings suggest that provider awareness and incentives can be important levers to strengthen US biosimilar market penetration and competition.

Evaluating HCV screening, linkage to care, and treatment across insurers.

OBJECTIVES: We examined how a population susceptible to hepatitis C virus (HCV) moves through the HCV screening and linkage-to-care (SLTC) continuum across insurance providers (Medicare, Medicaid, commercial) and identified opportunities for increasing the number of patients who complete the SLTC process and receive treatment. STUDY DESIGN: Discrete-time Markov model. METHODS: A cohort of 10,000 HCV-susceptible patients was simulated through the HCV SLTC process using a Markov model with parameters from published literature. Three scenarios were explored: baseline, in which each step required a separate visit and all infected saw a specialist; reflex, which reflexed antibody and RNA testing; and consolidated, which reflexed antibody, RNA, fibrosis staging, and genotype testing into 1 step, with an optional specialist visit. For each scenario, we estimated the number of patients lost at each stage, yield, and cost. RESULTS: Streamlining the SLTC process by reducing the number of required visits results in more patients completing the process and receiving treatment. Among antibody-positive patients, 76% of those with Medicaid and 71% of those with Medicare and commercial insurance are lost to follow-up in baseline. In reflex and consolidated, these proportions fall to 26% and 27% and 4% and 5%, respectively. The cost to identify and link 1 additional infected patient to care ranges from $1586 to $2546 in baseline and $212 to $548 in consolidated. Total cost, inclusive of treatment, ranges from $1.0 million to $3.1 million in baseline and increases to $3.8 million to $15.1 million in reflex and $5.3 million to $21.0 million in consolidated. CONCLUSIONS: Reducing steps in the HCV SLTC process increases the number of patients who learn their HCV status, receive appropriate care, and initiate treatment.

Innovation in Heart Failure Treatment: Life Expectancy, Disability, and Health Disparities.

OBJECTIVES: The goal of this study was to illustrate the potential benefit of effective congestive heart failure (CHF) treatment in terms of improved health, greater social value, and reduced health disparities between black and white subpopulations. BACKGROUND: CHF affects 5.7 million Americans, costing $32 billion annually in treatment expenditures and lost productivity. CHF also contributes to health disparities between black and white Americans: black subjects develop CHF at a younger age and are more likely to be hospitalized and die of this disease. Improved CHF treatment could generate significant health benefits and reduce health disparities. METHODS: We adapted an established economic-demographic microsimulation to estimate scenarios in which a hypothetical innovation eliminates the incidence of CHF and, separately, 6 other diseases in patients 51 to 52 years of age in 2016. This cohort was followed up until death. We estimated total life years, quality-adjusted life years, and disability-free life years with and without the innovation, for the population overall and for race- and sex-defined subpopulations. RESULTS: CHF prevalence among 65- to 70-year-olds increased from 4.3% in 2012 to 8.5% in 2030. Diagnosis with CHF coincided with significant increases in disability and medical expenditures, particularly among black subjects. Preventing CHF among those 51 to 52 years of age in 2016 would generate nearly 2.9 million additional life years, 1.1 million disability-free life years, and 2.1 million quality-adjusted life years worth $210 to $420 billion. These gains are greater among black subjects than among white subjects. CONCLUSIONS: CHF prevalence will increase substantially over the next 2 decades and will affect black Americans more than white Americans. Improved CHF treatment could generate significant social value and reduce existing health disparities.

Economic study of the value of expanding HCV treatment capacity in Germany.

BACKGROUND: Today's highly efficacious, low-toxicity interferon-free treatment regimens for chronic hepatitis C virus (HCV) can cure most patients with HCV in 12-24 weeks. The aim of this study was to understand how the introduction of shorter duration treatment regimens for HCV will impact the capacity for treatment and value to society. METHODS: A Markov model of HCV transmission and progression was constructed, incorporating nationally representative data on HCV prevalence, incidence and progression; mortality, treatment costs, medical expenditures, employment probabilities and disability payments in Germany. The model was stratified by HCV genotype and exposure route (1-time healthcare exposure, injection drug use and sexual activity). Treatment scenarios were based on German treatment guidelines and projected treatment capacity. The impact of different treatment scenarios on disease transmission and prevalence, quality-adjusted life years (QALYs), treatment costs, medical expenditures, employment and disability expenditures was calculated. RESULTS: Depending on their adoption profile, new treatment regimens and protocols introduced over the next several years will increase HCV treatment capacity in Germany by 8-30%, reducing disease transmission and prevalence, increasing QALYs and adding €94-310 million in discounted social value (QALYs plus medical savings net of treatment costs) over a 30-year horizon. Additional social value in the form of higher employment and lower disability would also result. CONCLUSIONS: The introduction of shorter HCV treatment regimens and the resulting increased treatment capacity in Germany would result in large gains to society by reducing disease transmission and prevalence, resulting in longer, healthier, more productive lives for current and future generations.

Broad Hepatitis C Treatment Scenarios Return Substantial Health Gains, But Capacity Is A Concern.

Treatment of hepatitis C virus, the most common chronic viral infection in the United States, has historically suffered from challenges including serious side effects, low efficacy, and ongoing transmission and reinfection. Recent innovations have produced breakthrough therapies that are effective in more than 90 percent of patients. These treatments could dramatically reduce the virus's prevalence but are costly. To quantify the benefit of these treatments to society, including the value of reduced transmission, we estimated the effects of several hepatitis C treatment strategies on cost and population health. Treating patients at all disease stages could generate $610-$1,221 billion in additional quality-adjusted life-years, plus an additional $139 billion in saved medical expenditures over fifty years, and minimize the disease burden, but up-front treatment costs would exceed $150 billion. An intermediate scenario--treating 5 percent of the infected population annually, regardless of patients' disease stages--would also return substantial benefits and would be much more affordable under current financing schemes.

Reforming medicare's dialysis payment policies: implications for patients with secondary hyperparathyroidism.

OBJECTIVE: To demonstrate how expanding services covered by a "bundled payment" can also expand variation in the costs of treating patients under the bundle, using the Medicare dialysis program as an example. DATA SOURCES/STUDY SETTING: Observational claims-based study of 197,332 Medicare hemodialysis beneficiaries enrolled for at least one quarter during 2006-2008. STUDY DESIGN: We estimated how resource utilization (all health services, dialysis-related services, and medications) changes with intensity of secondary hyperparathyroidism (sHPT) treatment. DATA EXTRACTION METHODS: Using Medicare claims, a patient-quarter level dataset was constructed, including a measure of sHPT treatment intensity. PRINCIPAL FINDINGS: Under the existing, narrow dialysis bundle, utilization of covered services is relatively constant across treatment intensity groups; under a broader bundle, it rises more rapidly with treatment intensity. CONCLUSIONS: The broader Medicare dialysis bundle reimburses providers uniformly, even though patients treated more intensively for sHPT cost more to treat. Absent any payment adjustments or efforts to ensure quality, this flat payment schedule may encourage providers to avoid high-intensity patients or reduce their treatment intensity. The first incentive harms efficiency. The second may improve or worsen efficiency, depending on whether it reduces appropriate or inappropriate treatment.

The association between employee obesity and employer costs: evidence from a panel of U.S. employers.

PURPOSE: To estimate the employer costs associated with employee obesity. DESIGN: The study used cross-sectional analysis of employee health-risk assessment, disability, workers' compensation, and medical claims data from 2006 to 2008. SETTING: The study took place in the United States from 2006 to 2008. SUBJECTS: A panel database with 29,699 employees drawn from a panel of employers and observed for 3 years each (N = 89,097) was used. MEASURES: Workdays lost owing to illness and disability; the cost of medical, short-term disability, and workers' compensation claims; and employees' adjusted body mass indices (BMI) were measured. ANALYSIS: We model the number and probability of workdays lost from illness, short-term disability, and workers' compensation events; short-term disability and workers' compensation payments; and health care spending as a function of BMI. We estimate spline regression models and fit results using a third-degree fractional polynomial. RESULTS: Probability of disability, workers' compensation claims, and number of days missed owing to any cause increase with BMI above 25, as do total employer costs. The probability of a short-term disability claim increases faster for employees with hypertension, hyperlipidemia, or diabetes. Normal weight employees cost on average $3830 per year in covered medical, sick day, short-term disability, and workers' compensation claims combined; morbidly obese employees cost more than twice that amount, or $8067, in 2011 dollars. CONCLUSION: Obesity is associated with large employer costs from direct health care and insurance claims and indirect costs from lost productivity owing to workdays lost because of illness and disability.

Strategic impact of a new academic endocrine surgery program.

BACKGROUND: A minority of medical centers possess a dedicated endocrine surgery program. Here we assess the short-term impact of a new endocrine surgery program on institutional case volumes and financial endpoints. METHODS: We studied all endocrine procedures performed over a 5-year period spanning the inception of the endocrine surgery program at UCLA. Institutional and state-level data on patient geographic origin, discharges for endocrine diagnosis-related groups (DRGs), and hospital-side charges and costs were examined. RESULTS: Total endocrine case volume increased 112% (264 to 559 cases annually) over the study period. The relative increase was greater for parathyroid (56 to 196, 250%, P < 0.0001) and adrenal (11 to 31, 181%, P = 0.06) procedures compared to thyroid procedures (317 to 442, 39%). The endocrine case volume of nonspecialist surgeons remained stable over the study period. Growth in referrals arose from previously unrepresented zip codes and was associated with an increase in the mean distance traveled for care (2006, 44 miles vs. 2009, 92 miles, P < 0.01). In each DRG, UCLA attained the top market position within one year of the program's inception, corresponding to an overall 27% increase in regional market share. Total hospital charges for endocrine DRGs rose 161% to $14.7 million annually, while the cost of parathyroid surgery fell 34% (P < 0.001). CONCLUSIONS: The establishment of an academic endocrine surgery program can cause fundamental shifts in referral patterns within a competitive, densely populated metropolitan environment. Hospitals should consider the inclusion of an endocrine surgery program in strategic planning initiatives.

Burden of illness of diabetic macular edema: literature review.

OBJECTIVE: To provide an overview of the literature on the burden of diabetic macular edema (DME) in the United States and selected European countries. RESEARCH DESIGN AND METHODS: Computerized searches of English-language literature were conducted in PubMed/MEDLINE (1980-2009). The searches were supplemented with electronic and manual searches of relevant society/association proceedings and bibliographies of electronically identified sources. Abstracts were reviewed for relevance to any of the following topics: epidemiology, including prevalence and incidence; health outcomes; resource use and treatment patterns; and economic and humanistic burden associated with DME. Relevant full text articles were retrieved and major findings were synthesized and compared within and across countries. RESULTS: A total of 400 citations were included in the initial review. After abstract screening, 47 articles were deemed pertinent and summarized in this review. The prevalence of DME among diabetic patients ranged from 0.85% to 12.3% across the countries studied. The prevalence and incidence of DME vary depending on type of diabetes (1 vs. 2), insulin- vs. non-insulin-dependence, and duration of disease (years since diagnosis). Although literature findings are limited and indicate a need for further investigation, a synthesis of the available results indicates that DME has a negative impact on patients' health-related quality of life. In addition, patients with DME consume significantly more healthcare resources and incur higher costs compared to diabetic patients without retinal complications. CONCLUSIONS: There remains a need for consistent data capture and assessment within and between countries included in this analysis. Despite the limited evidence, DME appears to be a costly disease that has a negative impact on patients' quality of life.