Racial/Ethnic and Socioeconomic Disparities and Self-reported Work Productivity in Urinary Incontinence Females Using the National Institute of Diabetes and Digestive and Kidney Diseases Data.

OBJECTIVE: To explore the relationship between racial/ethnic and socioeconomic disparities and self-reported work productivity in urinary incontinence females. METHODS: This was a retrospective observational and secondary analysis of the National Institute of Diabetes and Digestive and Kidney Diseases database trials. We included females with stress urinary incontinence and ≥21 years old. The primary outcome was self-reported work productivity evaluated using a proportional-odds regression model. A backward elimination method was utilized to create a final reduced model. The socioeconomic predictors were age, race/ethnicity, education, marital status, personal income, and language. RESULTS: We included 1252 participants with a median age of 52 years old. Whites accounted for 76.2% of total participants, while Hispanics constituted 11.4% only. Work productivity of Hispanic or non-Hispanic other group was greatly affected compared to Whites (OR: 1.771, P value: .0008 and OR: 1.592, P value=.0231, respectively). Work productivity of patients with higher education was less affected compared to less educated patients. Married females were less likely to report being greatly affected in work productivity than nonmarried females (OR 0.663, P-value .0005). Age, income, and language were not predictive of the outcome variable in the final model. CONCLUSION: Our finding showed that racial/ethnic and socioeconomic disparities play an important role in individuals' work productivity. Future research is needed to the influence of social determinants of health not captured by racial and socioeconomic factors.

Factors Associated with Statin Discontinuation Following Metabolic and Bariatric Surgery: A Retrospective Analysis of 2012-2021 Electronic Medical Records Network Data.

BACKGROUND: Bariatric surgery has been shown to improve hyperlipidemia, decreasing the need for statin medications. Although maintaining statin therapy post-surgery for those with a history of atherosclerotic cardiovascular disease (ASCVD) is advised, it is uncertain if discontinuation risks differ between those with and without ASCVD history. AIM: The study aims to analyze the rate and reasons for statin cessation post-bariatric surgery in the US using real-world data. METHODS: Using the TriNetX electronic medical records network from 2012 to 2021, the study involved patients aged 18 or older on statins at the time of bariatric surgery. They were categorized into primary and secondary prevention groups based on prior ASCVD. Statin discontinuation was defined as a 90-day gap post the last statin dosage. The Cox model assessed factors influencing statin cessation. RESULTS: Seven hundred and thirty-three statin users undergoing bariatric surgery were identified, with 564 (77%) in primary prevention. Six months post-surgery, 48% of primary prevention patients and 34.5% of secondary ones stopped statins. Primary prevention patients had a 30% higher likelihood of cessation compared to secondary prevention (hazard ratio, 1.30; 95% CI, 1.06-1.60) as shown by multivariable analysis. CONCLUSIONS: Post-bariatric surgery, primary prevention patients are more likely to discontinue statins than secondary prevention patients.

Utilization, reimbursement, and price trends for Hepatitis C virus medications in the US Medicaid programs: 2001-2021.

Background: Hepatitis C Virus (HCV) remains a challenging health problem worldwide, with increasing incidence despite being curable with Direct Acting Antiviral (DAA) agents. Objective: This study aimed to describe the utilization, reimbursement, and price trends of HCV treatments and evaluate the influence of treatment guidelines and policies. Methods: A retrospective, descriptive drug utilization study conducted using the outpatient pharmacy data extracted from the Centers for Medicaid and Medicare Services State Drug Utilization Data between 2001 and 2021. All HCV treatments approved in the US were included, conventional therapy (CT), and DAA agents. The annual secular trends were calculated for each medication's total number of prescriptions, reimbursements, and prices. The average reimbursement per prescription was calculated and utilized as a proxy of prices. The HCV treatment guideline and policies and legislation were evaluated overtime to measure the impact on the trends. Results: Despite CT having a higher total utilization, DAA agents commanded significantly greater reimbursements, with 4.1 billion USD for CT and 19.45 billion USD for DAA agents. CT utilization increased rapidly and dominated the market until 2011, peaking at 379,696 prescriptions in 2003 but declining afterward. DAA agents' utilization increased rapidly in their first year: i.e., sofosbuvir reached 50,377 prescriptions with 1.3 billion USD in 2014, while ledipasvir/sofosbuvir reached 79,387 prescriptions with 2 billion USD in 2015. The average price per prescription was high for the DAA agents, like 24,992 USD for sofosbuvir and 22,787 USD for ledipasvir/sofosbuvir, compared to CT medications ribavirin, around 500 USD, and pegINF, around 3000 USD. The new DAA agents replaced CT, and initiating market competition among DAA agents. Conclusion: The introduction of multiple DAA agents slightly changed their prescription prices but remained high during the study period. The recent increase in HCV incidence cases indicates accessibility issues for costly and effective DAA agents, with treatment guidelines and policies playing a critical role in shaping these trends.

A novel online survey approach designed to measure consumer sunscreen application thickness-implications for estimating environmental emissions.

BACKGROUND: The effects of ultraviolet (UV) filters in the aquatic environment have been well studied, but environmental exposures remain unclear and understudied. Consumer usage directly influences the amount of sunscreen products, and subsequently UV filters, potentially released into the environment. OBJECTIVE: To conduct a literature review of previous research into sunscreen application thickness, develop a questionnaire protocol designed to semi-quantify sunscreen usage by US consumers, and conduct a large-scale survey to determine a sunscreen application thickness (to face and body) that is more refined than conservative defaults. The United States Food & Drug Administration (US FDA) recommends a sunscreen application rate of 2 mg/cm2. This value is typically used as a worst-case assumption in environmental exposure assessments of UV filters. METHODS: Designed a novel approach to estimate lotion sunscreen application thickness using an online questionnaire protocol employing visual references and self-reported height and weight of the respondents. A literature review was also conducted to collect historical sunscreen usage. RESULTS: Over 9000 people were surveyed in the US, and after the dataset was refined, their sunscreen application thickness was estimated based on calculated body surface area and reported sunscreen amounts. The mean and median values for survey respondents are 3.00 and 1.78 mg/cm2, respectively, for facial application thickness and 1.52 and 1.35 mg/cm2, respectively, for body application thickness. Earlier research from 1985-2020 reported 36 of the 38 values are below the US FDA's recommended application thickness of 2 mg/cm2 (range 0.2-5 mg/cm2). IMPACT STATEMENT: This web-based survey is the first of its kind, designed specifically to quantify sunscreen application in a large and diverse set of consumers. This method provides a greater reach to larger populations thus enabling more granular data analysis and understanding. Exposure assessments of sunscreen ingredients typically use conservative parameters. These data can refine those assessments and allow for more informed and science-based risk management decisions.

The Utilization, Expenditure, and Price of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in the US Medicaid Programs: Trends Over a 31 Year Period.

BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are used for several indications including hypertension. Our aim is to evaluate the utilization, expenditure, and drug price of ACEIs and ARBs in the US Medicaid population. METHODS: A retrospective descriptive trend analysis was conducted using Medicaid State Drug Utilization outpatient pharmacy summary files managed by the Centers for Medicare and Medicaid Services from 1991 to 2021. Study drugs included ACEIs (e.g., captopril) and ARBs (e.g., losartan). Annual reimbursement and utilization were calculated for both classes. The average reimbursement per prescription was calculated as a proxy for drug prices. Market share competition between ACEIs and ARBs was analyzed over time. RESULTS: ACEI and ARB utilization rose by 25% from 1991 to 2021. Brand ACEIs utilization peaked in 2002 with 28 million prescriptions while brand ARBs utilization continued to increase until 2005 with over 23 million prescriptions. However, generic products took the lead and exceeded brand ACEI and ARB utilization in 2006 and 2012 respectively. Medicaid spent over $ 33.7 billion on ACEIs and ARBs over 31-year. Brand ACEIs and ARBs average prices increased sharply to $8,104 and $6,908 respectively in 2021. The total prescription market share for ACEIs was 68% compared to 32% of ARBs over the entire study. CONCLUSION: ACEIs and ARBs utilization increased over the last 31 years. Brand utilization switched over to generic resulting in less reimbursement. The average prices of brand ACEIs and ARBs continue to increase even after generics were introduced to the market.

Safety and cost-effectiveness of ponatinib versus other tyrosine kinase inhibitors as second-line therapy in patients with chronic myeloid leukemia in the United States.

To evaluate the cost-effectiveness of ponatinib compared with second-line TKIs in the treatment of adult patients with CML who failed, or were intolerant to, first-line TKIs. A Markov state transition model was conducted. Model transition, adverse-effect probabilities, utility data and medical costs were obtained from clinical trials and literature. Measurements included medications, follow-ups, adverse events, allogeneic stem cell transplantation and quality-adjusted life years (QALYs). Univariable and Bayesian multivariable probabilistic sensitivity analyses were conducted using Monte Carlo simulations. Dasatinib resulted in an ICER of $79,086/QALY compared to nilotinib. Ponatinib yielded an ICER of $176,278/QALY and $141,563/QALY compared to dasatinib and nilotinib, respectively. Dasatinib was the optimal treatment at a $100,000/QALY threshold. The probability (36%-40%) for ponatinib or dasatinib optimal treatment was associated with thresholds of $160,000-$180,000/QALY. Dasatinib and ponatinib can be considered cost-effective options and provide clinical benefits compared to other second-line TKIs for CML in the US.

Off-label medication use in rare pediatric diseases in the United States.

Many pediatric patients with rare diseases use drugs off-label due to limited data in pediatric patients. Off-label treatment remains an important public health issue for neonates, infants, children, and adolescents, especially for pediatric patients with rare diseases. For patients with rare diseases, the majority of medications have no or limited information in labelling for pediatric use. Children present unique considerations in clinical trials due to ethical and clinical concerns, which have limited and even discouraged testing of drugs in the pediatric population. Numerous legislative measures have been enacted to address barriers in pediatric drug testing. This research reviewed off-label medication use in rare pediatric diseases, evaluated recent medication uses in pediatric clinical practice, discussed key regulations for rare pediatric diseases, and summarized recent drug approvals for rare pediatric diseases. This study demonstrates the ongoing medical need for newly approved medications to treat pediatric rare diseases and revealed the positive impact of regulations from the Orphan Drug Act of 1983 to the Research to Accelerate Cures and Equity (RACE) for Children Act on drug development and off-label medication practice in rare pediatric disease management. This article provides informative historical background and current considerations of off-label use of medications in neonates, infants, children, and adolescents with rare diseases.

Comparative effectiveness and persistence of TNFi and non-TNFi in juvenile idiopathic arthritis: a large paediatric rheumatology centre in the USA.

OBJECTIVE: To evaluate the persistence and effectiveness of TNF inhibitors (TNFi) vs non-TNFi among newly diagnosed JIA patients after initiation of biologic DMARD (bDMARD). METHODS: Using longitudinal patient-level data extracted from electronic medical records in a large Midwestern paediatric hospital from 2009 to 2018, we identified JIA patients initiating TNFi and non-TNFi treatment. Treatment effectiveness was assessed based on disease activity. Inverse probability of treatment weighting of propensity score was used to estimate the treatment effectiveness and Kaplan-Meier analyses were conducted to assess persistence. RESULTS: Of 667 JIA patients, most (92.0%) were prescribed one of the class of TNFi as their initial biologic treatment. Etanercept was the most frequently prescribed (67.1%) treatment, followed by adalimumab (27.5%). Only around 5% of patients were prescribed off-label bDMARDs as their first-course treatment; however, >20% were prescribed off-label biologics as their second-course therapy. Some 7.2% of patients received four or more bDMARDs. The median persistence of the first-course bDMARD is 320 days, with TNFi being significantly longer than the non-TNFi (395 vs 320 days, P = 0.010). The clinical Juvenile Disease Activity Score (cJADAS) reduction of TNFi users (6.6, 95% CI 5.7, 7.5) was significant greater compared with non-TNFi users (3.0, 95% CI 1.5, 4.6, P < 0.0001) at 6-month follow-up visit. CONCLUSION: Persistence was significantly longer among patients initiating TNFi as their first biologic therapy than those receiving non-TNFi. Patients receiving TNF therapy had significant greater reduction of cJADAS at the 6-month follow-up visit compared with patients in the non-TNF cohort.

Prescribing Patterns and Impact of Factors Associated with Time to Initial Biologic Therapy among Children with Non-systemic Juvenile Idiopathic Arthritis.

OBJECTIVE: The aim of this study was to examine patterns of initial prescriptions, investigate time to initiation of biologic disease-modifying anti-rheumatic drugs (bDMARDs), and evaluate the impact of clinical and other baseline factors associated with the time to first bDMARD in treating children with newly diagnosed non-systemic juvenile idiopathic arthritis (JIA). METHODS: Using longitudinal patient-level data extracted from electronic medical records (EMR) in a large Midwestern pediatric hospital from 2009 to 2018, the initial prescriptions and prescribing patterns of bDMARDs, conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), non-steroidal anti-inflammatory drugs (NSAIDs) and glucocorticoids within 3 months of JIA diagnosis were examined. Kaplan-Meier analyses were performed to assess time to initiation of bDMARDs. Cox proportional hazard models were used to identify factors associated with time to first bDMARD. RESULTS: Of 821 children, the proportion of patients with initial csDMARDs increased from 45.3% in 2009 to 60.3% in 2018. Around 57.5% of polyarthritis rheumatoid factor-positive (Poly RF+) patients and 43.2% of polyarthritis rheumatoid factor-negative (Poly RF-) patients received a bDMARD therapy within 3 months of diagnosis, 14.4% as monotherapy and 28.3% in combination with a csDMARD. Among patients who received combination therapy, combination of methotrexate with adalimumab increased from 16.7% in 2009 to 40% in 2018. The proportion of patients treated with adalimumab gradually increased and passed etanercept in 2016. The predictors of earlier initiation of biologic therapy were JIA category enthesitis-related arthritis (ERA) [hazard ratio (HR) vs persistent oligoarthritis 4.82; p < 0.0001], psoriatic arthritis (PsA) (HR 2.46; p = 0.0002), or Poly RF- (HR 2.43; p = 0.0002); the number of joints with limited range of motion (HR 1.02; p = 0.0222), and erythrocyte sedimentation rate (ESR, HR 1.01; p = 0.0033). CONCLUSIONS: There was a substantial increase in the proportion of patients receiving the combination of methotrexate and adalimumab among patients receiving combination therapy. Adalimumab overtook etanercept as the most frequently prescribed bDMARD. Multiple factors affect the time to biologic initiation, including the number of joints with limited range of motion, ESR, and JIA category.

Drug Expenditure, Price, and Utilization in the U.S. Medicaid: A Trend Analysis for SSRI and SNRI Antidepressants from 1991 to 2018.

BACKGROUND: SSRIs and SNRIs are antidepressants that have largely substituted old antidepressants like Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs). They have been widely used since 1987 when the FDA approved the first SSRI Fluoxetine and the first SNRI Venlafaxine in 1993. Since then, several new SSRIs and SNRIs have been approved and entered the market. Utilization, pricing, and spending trends of SSRIs and SNRIs have not been analyzed yet in Medicaid. AIM: To assess the trends of drug expenditure, utilization, and price of SSRI and SNRI antidepressants in the US Medicaid program, and to highlight the market share of SSRIs and SNRIs and the effect of generic drug entry on Medicaid drug expenditure. METHODS: A retrospective descriptive data analysis was conducted for this study. National pharmacy summary data for study brand and generic drugs were retrieved from the Medicaid State Outpatient Drug Utilization Data. These data were collected by the US Centers for Medicare and Medicaid Services (CMS). The study period was between 1991 and 2018. Study drugs include 12 different SSRI and SNRI brands and their generics available in the market, such as citalopram, escitalopram, paroxetine, fluoxetine, sertraline, venlafaxine, desvenlafaxine, duloxetine, and levomilnacipran. Data were analyzed annually and categorized by total prescriptions (utilization), total reimbursement (spending), and cost per prescription as the proxy of the price for each drug. RESULTS: From 1991 to 2018, total prescriptions of SSRI and SNRI drugs rose by 3001%. Total Medicaid spending on SSRIs and SNRIs increased from USD 64.5 million to USD 2 billion in 2004, then decreased steadily until it reached USD 755 million in 2018. The SSRIs average utilization market share was 87% compared to 13% of the SNRIs utilization market share. About 72% of total Medicaid spending on the two groups goes to SSRIs, while the remaining 28% goes to SNRIs. Brand SSRIs and SNRIs prices increased over time. On the contrary, generic drugs prices steadily decreased over time. DISCUSSION: An increase in utilization and spending for both SSRI and SNRI drugs was observed. After each generic drug entered the market, utilization shifted from the brand name to the respective generic due to their lower price. These generic substitutions demonstrate a meaningful cost-containment policy for Medicaid programs. IMPLICATIONS FOR HEALTH POLICIES: Our findings show the overall view of Medicaid expenditure on one of the most commonly prescribed drug classes in the US. They also provide an important insight toward the antidepressant market and the importance of monitoring different drugs and their alternatives.

Current Development and Practice of Pharmacoeconomic Evaluation Guidelines for Universal Health Coverage in China.

BACKGROUND: China has achieved near-universal health coverage (UHC) for 95 percent of its population (>1.3 billion lives) as a result of healthcare reforms that began in 2009. However, one of many remaining issues in the Chinese healthcare system is the need to better optimize the allocation and use of healthcare resources in order to meet growing healthcare demands. OBJECTIVES: The goals are to highlight the components of the China Guidelines for Pharmacoeconomic Evaluations (CGPE) 2020 Edition and discuss its future development for UHC in China. METHODS: We review the development process of the CGPE 2020 edition, discuss the contemporary practice of the CGPE for UHC in China, describe new opportunities and challenges to the CGPE, and provide suggestions on the future development of the CGPE based on the current state of the healthcare system in China. RESULTS: Pharmacoeconomics provides tools to evaluate the health returns and economic costs of pharmaceutical products in a scientific way for the optimal allocation of healthcare resources. Considering the great potential of pharmacoeconomics in China, demonstrated by its rapid development and recognition as a research field in the past decade, the standardization of pharmacoeconomic evaluations has become particularly important to improve the accuracy of evaluation results used for drug selection, price negotiations and adjustments. CONCLUSION: Suggestions are made for the integration of CGPE into current framework of UHC in China, including standardizing the pharmacoeconomic evaluation process and updating CGPE on topics such as ethics and real-world research. The CGPE 2020 edition offers a standard to improve the quality of pharmacoeconomic evaluation research and enhance the value and efficiency of UHC in China.

Economic burden and treatment patterns of gynecologic cancers in the United States: evidence from the Medical Expenditure Panel Survey 2007-2014.

OBJECTIVE: This study estimated nationally representative medical expenditures of gynecologic cancers, described treatment patterns and assessed key risk factors associated with the economic burden in the United States. METHODS: A retrospective repeated measures design was used to estimate the effect of gynecologic cancers on medical expenditures and utilization among women. Data were extracted from the Medical Expenditure Panel Survey (weighted sample of 609,787 US adults) from 2007 to 2014. Using the behavioral model of health services utilization, characteristics of cancer patients were examined and compared among uterine, cervical, and ovarian cancer patients. Multivariable linear regression models were conducted on medical expenditure with a prior logarithmic transformation. RESULTS: The estimated annual medical expenditure attributed to gynecologic cancers was $3.8 billion, with an average cost of $6,293 per patient. The highest annual cost per person was ovarian cancer ($13,566), followed by uterine cancer ($6,852), and cervical cancer ($2,312). The major components of medical costs were hospital inpatient stays (53%, $2.03 billion), followed by office-based visits (15%, $559 million), and outpatient visits (13%, $487 million). Two key prescription expenditures were antineoplastic hormones (10.3%) and analgesics (9.2%). High expenditures were significantly associated with being a married woman (p<0.001), having private health insurance (p<0.001), being from a low- and middle-income family (p<0.001), or living in the Midwest or the South (p<0.001). CONCLUSION: The key risk factors and components were well described for the economic burden of gynecologic cancers. With a growing population of cancer patients, efforts to reduce the burden of gynecologic cancers are warranted.

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG).

On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

Smoking in pregnancy: a cross-sectional study in China.

BACKGROUND: Findings on smoking among pregnant women were mostly from high income countries and were rarely from China. This study aimed to estimate the prevalence of smoking and its influencing factors among pregnant women living in China. METHODS: A cross-sectional analysis was conducted in this study. Data from pregnant women were collected in this study from June to August 2015 from 5 provinces of mainland China. A total of 2345 pregnant women were included in this study, the mean age of the participants was 28.12 years (SD 4.13). RESULTS: About 82.9% of smoking women quit smoking after they were pregnant. The prevalence of smoking among pregnant women was 3.8%. Among the participants, 40.0, 30.7, 1.8, 29.9, 0.8, 31.4, 31.2, and 26.7% had husbands, fathers-in-law, mothers-in-law, fathers, mothers, colleagues, friends, and relatives, respectively, who were smokers. Compared with pregnant women of basic education level (junior middle school or below), those of the higher education level (undergraduate or above) were at higher risk of smoking (OR, 5.17; 95% CI, 2.00-13.39). Compared with pregnant women from rural areas, urban pregnant women were less likely to be current smokers (OR, 0.55; 95% CI, 0.32-0.94). Compared with pregnant women whose mothers-in-law did not smoke, those whose mothers-in-law smoked were at higher risk of smoking (OR, 4.67; 95% CI, 1.87-11.70). However, compared with pregnant women whose husband did not smoke, those whose husband smoked were not significantly at higher risk of smoking (OR, 1.12; 95% CI, 0.73-1.73). CONCLUSIONS: Most of smoking women quit smoking after they became pregnant. Tailored intervention programs to reduce smoking in pregnant women should focus on those with higher education level, from rural areas, and pregnant women whose mothers-in-law smoke.

Biologic Disease-Modifying Antirheumatic Drugs in a National, Privately Insured Population: Utilization, Expenditures, and Price Trends.

BACKGROUND: Spending on biologic drugs is a significant driver of drug expenditures for payers in private health plans. Biologic disease-modifying antirheumatic drugs (DMARDs) are some of the most effective and costly treatments in a physician's arsenal. Understanding the total annual expenditure, the average cost per prescription, and the impact of cost-sharing is important for drug benefit managers. OBJECTIVE: To assess drug utilization, expenditures, out-of-pocket (OOP) cost, and price trends of biologic DMARDs in patients with rheumatoid arthritis (RA) in a large managed care organization. METHODS: We conducted a retrospective database analysis of pharmacy claims data from January 2004 to December 2013 using the Optum Clinformatics Data Mart database, which covers 13.3 million lives. Pharmacy claims for 40,373 patients with RA were identified during the study period. In all, 9 biologic DMARDs approved for the treatment of RA, including infliximab, etanercept, adalimumab, certoizumab, golimumab, tocilizumab, anakinra, abatacept, and rituximab, and 1 nonbiologic oral, small molecule-targeted synthetic drug, tofacitinib, were included in this study. Descriptive statistics were used to analyze the total annual number of prescriptions, the total annual expenditures, the average annual cost per drug (a proxy of drug price), and the average OOP cost (copay plus deductible and coinsurance). All measurements were also stratified by study drugs and by insurance type. RESULTS: Of the 40,373 patients with RA included in the study, approximately 76% were female (mean age, 55 years at diagnosis). Approximately 77% of the patients were white, and almost 48% lived in the South or Midwest region of the United States. Approximately 62% of patients had a point of service insurance plan. Expenditures on biologic DMARDs increased from $166 million in 2004 to $243 million in 2013, and the number of prescriptions and refills increased from 59,960 in 2004 to 105,295 in 2013. Prescriptions for biologic DMARDs increased more than 20% per patient from 2004 to 2013. The average cost per prescription remained relatively unchanged, at approximately $2300 per prescription, but the OOP expenditures increased from $36 (2.5%) per prescription to $128 (7%) during the study period. The OOP expenditures increased the most in HMO plans and in plans categorized as other (284% and 388%, respectively). CONCLUSIONS: Spending on biologic DMARDs has been primarily driven by an increase in prescribing rates, as the average amount reimbursed per prescription remained relatively unchanged over time, despite a regular annual increase to the average wholesale acquisition cost of 2% to 10%. The OOP burden for patients has increased, but this does not appear to have limited the use of biologic DMARDs. The entrance of new biologic and nonbiologic DMARDs into the market in the past few years is eroding the market share for several established drugs, and may lead to different results, warranting a study of new trends.

Antithrombotic Therapy and Direct Medical Costs in Patients with Acute Coronary Syndrome in Shanghai, China.

BACKGROUND: Acute coronary syndrome (ACS) is a leading cause of morbidity and mortality worldwide. OBJECTIVES: To describe patient profile, treatment patterns, and disease burden for patients with ACS. METHODS: A retrospective descriptive cohort study was conducted. Data were obtained from electronic medical records from seven Shanghai medical centers. Patients with at least one primary diagnosis of ACS from 2006 to 2012 were included. Patient ACS-related antithrombotic medication use, laboratory tests, key comorbidities, health care utilization, and direct medical costs were examined. Log-linear regression was conducted to explore factors associated with total direct medical costs. RESULTS: The mean age for the 6601 patients included was 69.7 ± 12.5 years, and most of the patients (73%) were men. Comorbidities included diabetes (18.2%), hypertension (21.2%), and hyperlipidemia (8.6%). Out of these, 6466 (98%) patients had been hospitalized for ACS with an average length of stay of 14.0 ± 16.4 days per hospitalization. A total of 914 (13.8%) patients had emergency room visits. Of these, 93.5% received any antithrombotic therapy, including antiplatelet agents (92.7%) and anticoagulants (20.8%). ACS-related direct medical costs (in yuan renminbi [¥]) were ¥18,421 ± ¥24,741 per hospitalization, including costs for medications (¥6,776) and laboratory tests (¥1,355), and ¥2,894 ± ¥7,060 per outpatient visit, including costs for medications (¥620) and laboratory tests (¥464). The higher direct medical cost was associated significantly (P < 0.05) with age, being male, antiplatelet and anticoagulant use, and several comorbid disease states (diabetes, hyperlipidemia, hypertension, and chronic kidney disease). CONCLUSIONS: Antithrombotic therapeutic treatments were commonly used among patients with ACS in Shanghai, China. Higher treatment costs for patients with ACS in Shanghai, China, involved their antithrombotic medication use and key comorbidities.

Thromboembolic Events Associated with Bevacizumab plus Chemotherapy for Patients with Colorectal Cancer: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Bevacizumab is a recombinant, humanized monoclonal antibody that hinders the proliferation of new blood vessels required for malignant progression. The drug is considered safe and tolerable; however, some controversy remains about whether it is linked to venous and arterial thromboembolic events (TEEs). OBJECTIVE: To evaluate the risk for overall, venous, and arterial TEEs in patients with colorectal cancer (CRC) who are administered bevacizumab plus chemotherapy in randomized controlled trials (RCTs). METHODS: We searched PubMed and CENTRAL databases to extract reports of relevant trials that were published in English between January 1, 2003, and December 31, 2014. All RCTs in which bevacizumab plus chemotherapy was compared with standard chemotherapy or with placebo plus chemotherapy for the treatment of CRC, and TEEs were reported, were included in a meta-analysis. Risk ratios (RRs) with 95% confidence intervals (CIs) of TEEs were calculated for each RCT. Because the between-study heterogeneities (I2) were insignificant, a fixed-effect model was used to determine the effect size of each TEE. A funnel plot was created to assess publication bias, and 2 forms of sensitivity analyses were performed for each outcome. RESULTS: This meta-analysis included 22 RCTs with a total of 13,185 patients. Overall, compared with the control groups, patients with CRC who received bevacizumab were at significant risk for overall TEEs (RR, 1.334; 95% CI, 1.191-1.494; P <.001; I2 = 1.37%). Regarding venous TEEs, a significant risk was observed for patients who received bevacizumab versus control patients (RR, 1.244; 95% CI, 1.091-1.415; P = .001; I2 = 0.0%). Similarly, the risk for arterial TEEs was significant in bevacizumab-treated patients (RR, 1.627; 95% CI, 1.162-2.279; P = .005; I2 = 0.0%). Sensitivity analyses did not affect the level of significance of the effect size for each outcome, and no significant publication bias was observed. CONCLUSION: In all the studies reviewed in this meta-analysis, the risk for venous or arterial TEEs was associated with bevacizumab use in patients with CRC. Healthcare providers are encouraged to consider thromboprophylaxis agents, periodically monitor their patients who receive bevacizumab, and carefully manage patients who are at increased risk for those complications.

Off-label use of oral fluoroquinolone antibiotics in outpatient settings in the United States, 2006 to 2012.

PURPOSE: The aim of this study was to evaluate the practice pattern of off-label use of fluoroquinolones (FQs) in ambulatory settings and to identify the related risk factors. METHODS: The National Ambulatory Medical Care Surveys from 2006 through 2012 was used to identify subjects who received FQ off-label prescriptions. We defined off-label use as the use of FQs for indications other than those in the FDA-approved drug label. Descriptive statistics were calculated by using a series of weighted chi-squared statistics. Multivariate logistic regression was conducted to identify factors associated with off-label FQ drug use. RESULTS: There were 93 million ambulatory visits in which an FQ was prescribed, and 53.16% of these visits involved the prescribing of FQs in an off-label manner. The percentage of off-label prescriptions was the highest among individuals ≥80 years old (61.6%) and male patients (60.9%). The FQ drug prescribed most for an off-label indication in our study was ciprofloxacin (29.5% of the total visits). The multivariate analysis showed that age of ≥80 years and male patient was significantly associated with off-label use of FQs (adjusted odds ratio (OR) 3.66, 1.72-7.80 and OR 3.26, 2.32-4.56, respectively). Medicaid or private insurance versus Medicare were associated with significantly higher off-label prescribing of FQs (OR 2.53, 1.28-5.01 and 1.77, 1.03-3.03, respectively). CONCLUSION: The percentage of visits involving off-label FQs in US ambulatory settings is substantial. Efforts are needed consolidate and evaluate what high-quality scientific evidence is available and what is needed to support the safety and effectiveness of such off-label uses. Copyright © 2016 John Wiley & Sons, Ltd.

Twenty years of triptans in the United States Medicaid programs: Utilization and reimbursement trends from 1993 to 2013.

OBJECTIVE: After sumatriptan was approved by the Food and Drug Administration in 1992, triptans became first-line anti-migraine therapies. Rapidly rising triptan expenditures, however, led payers, including Medicaid, to implement cost-containment policies. We describe triptan utilization and reimbursement trends in Medicaid. METHODS: Using national summary files for outpatient drug utilization, utilization and expenditure data from 1993 to 2013 were extracted and summed for all triptan national drug codes reimbursed by Medicaid. Data were collected separately for tablets, injections and sprays. RESULTS: The number of triptan prescriptions increased from 87,348 in 1993 to 0.9 million in 2004; fell to 0.4 million in 2009; rose to 1 million in 2011; and rose 1.2 million in 2013. In 2013, Medicaid spent $96.8 million on triptans: 74.4%, 18.4% and 7.2% for tablets, injections and sprays, respectively. Average reimbursement per prescription was $54 for tablets, $351 for injections and $235 for sprays in 2013. From 1993 to 2013, sumatriptan was the most widely prescribed among the triptans. CONCLUSIONS: The substantial increase in triptan prescriptions from 2009 to 2011, without being convincingly explained by either rising migraine prevalence or rising Medicaid enrollment, is suggestive of reduced access to these medications prior to 2009. Cost-containment policies may have inadvertently prevented Medicaid migraineurs from obtaining appropriate pharmacotherapy. PRIOR PRESENTATIONS: An earlier version of this paper was presented as a poster at the Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research, Philadelphia, PA, May 2015, where it received a finalist award.