Rising Drug Costs Research Articles

Public deliberation to assess patient views on biosimilar medication switching for the treatment of inflammatory bowel disease

BackgroundBiosimilars are highly similar, but not identical, versions of originator biologic medications. Switching patients to biosimilars presents an opportunity to mitigate rising drug costs and expand patient access to important biologic therapies. However, decreased patient acceptance and adherence to biosimilar medications have been reported, which can lead to loss of treatment response, adverse reactions, and inefficient resource utilization. Understanding patient perceptions of biosimilars and biosimilar switching is needed to inform patient-centered care strategies that promote efficient resource utilization.MethodsWe used democratic deliberation methods to solicit the informed and considered opinions of patients regarding biosimilar switching. Patients with inflammatory bowel disease (IBD; n = 29) from the Veterans Health Administration (VHA) participated in 5-hour deliberation sessions over two days. Following educational presentations with experts, participants engaged in facilitated small group discussions. Transcripts and facilitators’ notes were used to identify key themes. Participants completed surveys pre- and post-deliberation to collect sociodemographic and clinical features as well as to assess IBD treatment knowledge and attitudes toward care and approaches to biosimilar switching.ResultsFive major themes emerged from the small group discussions in the context of biosimilar switching: 1) concerns about adverse consequences and unclear risk-benefit balance; (2) importance of communication and transparency; (3) desire for shared decision making and patient involvement in treatment decisions; (4) balancing cost-saving with competing priorities; and (5) advocating for individualized care and prioritization based on risk levels. These views led participants to favor approaches that prioritize switching the sickest patients last (i.e., those with poorly controlled disease) and that offer patients control and choices around biosimilar switching. Participants also expressed preferences for combining elements of different approaches to maximize fairness.ConclusionsApproaches to biosimilar switching should consider patients’ desires for transparency and effective communication about biosimilar switching and engagement in their medical decision-making as part of patient-centered care. Incorporating patient preferences around biosimilar switching is critical when navigating the quality and affordability of care in resource constrained settings, both within the VHA and in other healthcare systems.

Adult Pharmacy Costs and Characteristics of Very High-Cost Prescription Drug Users in the United States, 2018–2022

Objective: This study sought to identify: (1) the demographic and clinical characteristics of very high-cost users (defined as patients with pharmaceutical expenditures that were equal to or greater than the 99th percentile), (2) whether or not these characteristics changed over time, (3) sociodemographic and clinical correlates of being very high-cost users, (4) the average pharmaceutical costs of very-high cost users, and (5) the therapeutic classes and medications that contributed to these high costs Background: There are growing public concerns about rising drug costs, in part due to increased availability, greater effectiveness, and market considerations. There is a concentrated portion of patients that accounts for a disproportionately large portion of pharmaceutical expenditures. Methods: A large serial cross-sectional study was conducted with De-identified, member-level pharmacy claims (n = 65,739,791) from a large, national pharmacy benefits manager from January 1, 2018 to December 31, 2022. The main outcome and measures were 2018–2022 pharmaceutical expenditures; amounts were adjusted for inflation to reflect 2022-dollar values. Results: Across the study period, the odds of being classified as a very high-cost user were 1.31 times as high for those 45–64 years old compared with those 18–44 years old (reference category); the odds were 1.42 times as high for males compared with females; 1.13 times as high before those identifying as non-Hispanic Black compared with non-Hispanic white; 1.11 times as high for those enrolled in a health care exchange plan compared with a commercial plan. In addition, very high-cost users lived in areas with higher social needs. Human immunodeficiency virus, inflammatory conditions, multiple sclerosis, and cancer accounted for the largest share of costs among this group. Conclusions: This study identified the unique characteristics of very high-cost pharmaceutical users and identified the top conditions and prescription drugs that drove high pharmaceutical expenditures among this population. These findings are essential to understanding rising pharmaceutical costs in the United States and can help identify the issues and solutions of specific cost drivers within our health care policies.

Economic Trends in Commonly Used Drugs for Spinal Fusion and Brain Tumor Resection: An Analysis of the Medicare Part D Database.

With the incidence of central and peripheral nervous system disorders on the rise, neurosurgical procedures paired with the careful administration of select medications have become necessary to optimize patient outcomes. Despite efforts to decrease the over-prescription of common addictive drugs, such as opioids, prescription costs continue to rise. This study analyzed temporal trends in medication use and cost for spinal fusion and brain tumor resection procedures. The Medicare Part B Database was queried from 2016 to 2020 for data regarding spinal fusion and brain tumor resection procedures, while the Part D Database was used to extract data for two commonly prescribed medications for each procedure. Pearson's correlation coefficient and linear regression were completed for the analyzed variables. The results showed a significant negative correlation between the number of spinal procedure beneficiaries and the cost of methocarbamol, as well as between the annual percent change in spinal beneficiaries and the annual percent change in oxycodone cost. Linear regression revealed that oxycodone cost was the only parameter with a statistically significant model. Moving forward, it is imperative to combat rising drug costs, regardless of trends seen in their usage. Further studies should focus on the utilization of primary data in a multi-center study.

Pharmacotherapy Analysis for Hospitalized Patients with COVID-19 (Prescriptions, Costs, and Outcomes)

Background: The COVID-19 pandemic has caused many economic problems worldwide, in Iran as well, causing Hospitals to face many financial problems. Objectives: Based on documented data on pharmacotherapy, costs, and its effectiveness, this study aimed to analyze the costs and outcomes of hospitalized patients with COVID-19 under pharmacotherapy in Iran. Methods: This research was a retrospective analytical descriptive study. Relevant data of the COVID-19 hospitalized patients’ were extracted from the Hospital’s Medical Records Department. All items of direct medical costs, such as visits, nursing services, consuming materials, laboratories, imaging, medical operations, medications, and beds, were extracted by reviewing COVID-19 hospitalized patients’ files in different wards of the Shohada Ashayer Hospital in Khorramabad city in 2021. Results: A total of 399 patients were examined in this study. The total direct medical costs per patient was 338.63 US$. Of note, the highest cost was related to medicine (32.56%), more than the cost of bed (22.77%). The most commonly used drugs were Lopinavir (95%) and Azithromycin (90%), and the highest medicine cost per patient was related to Immunoglobulin (64.32 US$) and Remdesivir (46.91 US$). Conclusion: Medicine and hospitalization costs accounted for the largest share of the total treatment costs of patients. Therefore, reducing bed costs requires home treatments and outpatient injections. Furthermore, due to rising drug costs, prescriptions should be based on standard treatment protocols.

Attention to price disclosures in direct-to-consumer prescription drug advertising and the impact on drug perceptions.

Mandatory disclosure of the price of prescription drugs within direct-to-consumer pharmaceutical advertisements (DTCA) has been proposed as a potential means of curbing rising drug costs in the United States. While price transparency in DTCA has widespread public support, empirical evidence regarding the effects of such drug prices disclosures remains limited. This study assessed the degree to which a price disclosure was noticed, the individual characteristics associated with price disclosure recognition, and the impact on perceived drug affordability, effectiveness, and safety. A randomized experiment was conducted among 2,138 members of the Amerispeak online panel. Participants were shown a television commercial for a drug treating either type II diabetes, deep vein thrombosis/pulmonary embolism (DVT/PE), or rheumatoid arthritis (RA) that disclosed the list price, disclosed the list price plus the average out-of-pocket cost, or had no price disclosure. Roughly forty percent of participants noticed when a price was disclosed while 20-24% noticed information about individual costs varying (the higher of these percentages occurred when the average out-of-pocket cost was provided). Attention did not vary systematically with the cost amount. Recognition of the different elements of the price disclosure were most predicted by sociodemographic variables such as race, education, and income as well as health characteristics. Price disclosure altered perceived affordability of the advertised medication in a manner consistent with the costs provided, but such consistent significant effects were not found for perceived drug effectiveness and safety. Repeated exposure to price disclosure in television DTCA or supplementary sources of price information may be necessary to increase attention to drug price information, especially among those who are most vulnerable to the burden of drug costs. Price transparency appears useful for adjusting affordability perceptions, but additional research needs to examine how such perceptions factor into healthcare decision-making and drug pricing.

Perks and Pitfalls of Performance-Linked Reimbursement for Novel Drugs: The Case of Sacubitril-Valsartan.

Rising drug costs have increased interest in performance-linked reimbursement (PLR) contracts that tie payment to patient outcomes. PLR is theoretically attractive to payers interested in reducing the risk of overpaying for expensive drugs, to manufacturers working to improve early drug adoption, and to patients seeking improved access. Multiple PLR contracts were developed for sacubitril-valsartan. We evaluated how the characteristics of a PLR contract influence its performance. We used a published cost-effectiveness model of sacubitril-valsartan. We evaluated hypothetical PLR contracts that adjusted drug payment based on observed therapy effectiveness. Ideally, these contracts reduce the uncertainty around the value obtained with purchasing sacubitril-valsartan. By reducing the financial risk in covering an ineffective therapy, PLR incentivizes insurers to increase patient access. We measured the uncertainty in value as the SD of the incremental net monetary benefit (INMB), an estimate of therapy value incorporating costs and clinical benefits. We evaluated the change in INMB SD under a variety of different assumptions regarding contract design, therapy effectiveness, and population characteristics. Over 2 years, sacubitril-valsartan led to 0.042 additional quality-adjusted life-years at an incremental cost of $4916. Using a willingness-to-pay of $150 000 per quality-adjusted life-year, this led to a mean INMB across simulations of $1416 (SD, $1720). A PLR contract that adjusted payment based on cardiovascular mortality reduced the INMB SD moderately by 20.7% while a contract based on all-cause mortality was more effective (INMB SD reduction of 27.3%). A contract based on heart failure hospitalization reduction was ineffective. PLR effectiveness increased with greater uncertainty regarding therapy effectiveness or in sicker cohorts (eg, New York Heart Association Class III/IV heart failure). Contracts required precise estimates of treatment effect in addition to trust or verifiability between manufacturers and payers concerning patient selection. The development of accurate prospective estimates of treatment effectiveness using actual enrollee characteristics will be critical for successful PLR. If able to meet these requirements, PLRs could incentivize insurers to expand access to expensive treatments by reducing financial risk.

Abstract 11520: Cost-Related Medication Nonadherence in Adults with Diabetes Mellitus in the United States

Background: Health-related expenditures due to diabetes mellitus (DM) are rising in the US. Medication nonadherence is associated with worse health outcomes, particularly among individuals with DM who require uninterrupted treatment. We sought to determine whether patients with DM in the US report cost-related nonadherence (CRN), a potential consequence of rising drug costs. Methods: We used the National Health Interview Survey (2013-18), a nationally representative study, to identify participants with and without self-reported DM. Participants were considered to have experienced CRN if during the preceding year they reported skipping doses, taking less medication, or delaying filling a prescription to save money. Results: Of the 20,326 participants with DM, a weighted 14% (or 3 million annually) experienced CRN, including 9.5% skipping doses, 9.9% taking less medicine, and 11.8% delaying prescription filling to save money. Compared to those without DM (N=145,186), participants with DM reported a higher prevalence of CRN, with the largest differences being observed among non-elderly adults (Figure). Among non-elderly adults with DM, a weighted 19.4% (or 2.3 million annually) reported CRN. In multivariable logistic regression models, the main drivers of CRN among participants with DM were lack of insurance (OR 4.34, 95% CI 3.49, 5.39), younger age (OR 3.43, 95% CI 2.65, 4.44), low income (OR 1.82, 95% CI 1.58, 2.09), use of insulin (OR 1.19, 95% CI 1.04, 1.35), and unfavorable risk factor profile (OR 1.53, 95% CI 1.21, 1.93) (Table). Conclusion: In the US, 1 in 7 adults with DM reported CRN, and the burden was highest among non-elderly adults. Cost represents a serious barrier for therapy adherence among individuals with DM in the US, particularly among the most vulnerable. Removing financial barriers to accessing medications may improve adherence to essential therapies among individuals with DM, and ultimately improving outcomes.

Comparison of claims from high-drug cost beneficiaries in Ontario, Canada, and Australia: a cross-sectional analysis.

Background:Globally, payers are struggling with rising drug costs, driven primarily by the increasing number of high-cost medications used by their beneficiaries. We aimed to compare the annual drug spending on claims from high–drug cost beneficiaries in the province of Ontario, Canada, and Australia.Methods:We conducted a cross-sectional analysis of public drug claims in Ontario and Australia from fiscal years 2006 to 2017. We identified the total government costs for prescribed medications per beneficiary. During the study period, public drug coverage in Ontario was provided to all residents 65 years of age and older, those with financial needs, and those living in long-term care or in need of home care. Australia maintains a publicly funded, universal system covering all citizens. Based on annual spending, we divided beneficiaries into 4 cost groups, representing the top 1%, top 5%, top 10% and the remaining 90%. We reported the following for each cost group: medication cost and proportion of total government spending, number of unique drugs dispensed per person and the top 10 most costly drug classes.Results:In Ontario and Australia, the top 1% of beneficiaries accounted for a large and increasing proportion of all government drug costs, growing from 12% ($405 946 197) to 24% ($1 345 977 248) in Ontario, and from 14% ($86 565 586) to 34% ($416 097 984) in Australia between 2006 and 2017. The most costly drug classes among high-drug cost beneficiaries in both jurisdictions were biologics and hepatitis C treatments.Interpretation:In both Ontario and Australia, a small number of beneficiaries accounted for a large proportion of public drug spending, driven largely by the use of expensive medications. The current development of potential national pharmacare strategies in Canada must optimize the use of high-cost drugs to ensure the sustainability of the program.

Eligible but Not Enrolled: Consequences of Forgoing Prescription Drug Subsidies Among Low‐Income Medicare Beneficiaries with Diabetes

Research ObjectiveTo estimate take‐up of the Part D Low‐Income Subsidy (LIS) among Medicare beneficiaries with diabetes, and to examine differences in out‐of‐pocket costs and prescription drug use between enrollees and LIS‐eligible non‐enrollees. The LIS lowers prescription drug costs for Medicare beneficiaries with incomes ≤150% of the Federal Poverty Level (FPL), and caps out‐of‐pocket costs for beneficiaries with incomes ≤135% of FPL. Although a number of recent policy proposals seek to address rising drug costs, the LIS itself remains underutilized. The value of forgoing this benefit among chronically ill beneficiaries has not previously been studied.Study DesignWe used data from the Health and Retirement Study (HRS) to estimate take‐up of the LIS among Medicare beneficiaries with diabetes. Using propensity score‐weighted analyses, we compared out‐of‐pocket costs, prescription drug use, and cost‐related drug non‐adherence among LIS enrollees and eligible non‐enrollees. We stratified the analyses according to whether respondents' income was ≤100% vs. >100% to ≤150% of FPL because of differences in the generosity and take‐up of Medicaid benefits above vs. below 100% of FPL, and because individuals with Medicaid automatically receive the LIS.Population StudiedCommunity‐dwelling HRS respondents surveyed biennially between 2008–2016 who were enrolled in Medicare Part D, had an established diagnosis of diabetes, and were eligible for the LIS (income ≤150% FPL and assets below LIS limit).Principal FindingsAmong Medicare beneficiaries with diabetes, 56.9% of those with incomes >100% to ≤150% of FPL received the LIS, while 90.3% of those with incomes ≤100% received the LIS, reflecting automatic enrollment from Medicaid. Based on these take‐up rates, we estimate that 322,746 LIS‐eligible individuals with diabetes do not enroll in the LIS annually. For those with incomes >100% to ≤150% of FPL, compared to LIS enrollees, eligible non‐enrollees incurred higher annual out‐of‐pocket drug spending ($518, p < 0.001), had 20% fewer fills for diabetes, hypertension, and hyperlipidemia prescription drugs (p = 0.003), and were 9 percentage points more likely to report skipping drugs due to cost (p = 0.04).ConclusionsA substantial proportion of Medicare beneficiaries with diabetes are eligible for but not enrolled in the LIS. Low take‐up was concentrated among beneficiaries with income >100% to ≤150% of FPL. Forgoing the LIS was associated with higher out‐of‐pocket costs and cost‐related non‐adherence, and lower use of medications used to treat chronic conditions. Our findings demonstrate the extent to which out‐of‐pocket costs may be reduced, and use of chronic disease medications increased, if a higher proportion of LIS‐eligible Medicare beneficiaries receive this benefit.Implications for Policy or PracticeProposals to lower out‐of‐pocket drug costs for Medicare beneficiaries often overlook the fact that existing prescription drug subsidy programs are underutilized. Because the LIS reduces cost sharing for all Part D covered drugs and caps annual out‐of‐pocket costs for most recipients, increasing LIS take‐up would likely provide better financial protection for seniors with chronic conditions than a flat subsidy or price caps limited to certain drugs. Policies to streamline or automate LIS enrollment for low‐income Medicare beneficiaries could help to mitigate the impact of rising drug costs in this vulnerable population.Primary Funding SourceAgency for Healthcare Research and Quality.

Looking Ahead to 2030: Survey of Evolving Needs in Pharmacy Education.

In order to keep pharmacy education relevant to a rapidly-evolving future, this study sought to identify key insights from leaders from a broad array of pharmacy and non-pharmacy industries on the future of the pharmacy profession, pharmaceutical sciences, and pharmacy education. Thought leaders representing a variety of industries were surveyed regarding their perspectives on the future of pharmacy practice, pharmaceutical science disciplines, and pharmacy education in seven domains. From 46 completed surveys, top challenges/threats were barriers that limit clinical practice opportunities, excessive supply of pharmacists, and high drug costs. Major changes in the drug distribution system, automation/robotics, and new therapeutic approaches were identified as the top technological disrupters. Key drivers of pharmacy education included the primary care provider shortage, growing use of technology and data, and rising drug costs. The most significant sources of job growth outside of retail and hospital settings were managed care organizations, technology/biotech/pharmaceutical companies, and ambulatory care practices. Needs in the industry included clinical management of complex patients, leadership and management, pharmaceutical scientists, and implementation science. Knowledge gaps were pharmacists not recognizing their value on the health care team, preparation to embrace and lead change, and expertise in data science and analytics. Pharmacy schools will need to address several disruptive trends to future-proof their curricula, including expanding patient management skills, leadership and management training, technology, and data analytics.

What Can Your Pharmacist Do for You? Role of Collaborative Drug Therapy Management in Hospice (QI641)

•Describe and explain the role of collaborative drug therapy management (CDTM) in community and inpatient hospice as it applies to physicians, pharmacists, and nurses.•Illustrate an innovative care model that emphasizes patient-centered, team-based care linking system and patient-level outcomes to manage individualized drug therapy in hospice.•Evaluate reduced pharmacoeconomic expenditures through optimal use of medications in CDTM. American healthcare systems, including community-based organizations, are grappling with rising healthcare costs and medication-related expenditures. Annually, more than 1.5 million preventable adverse events are caused by inappropriate use of medications. This costs our healthcare system $290 billion annually. Rising drug costs and medication safety concerns provide a rationale for increased clinical pharmacist collaborative medication management, especially in the hospice setting. In this poster presentation, we describe our innovative approach of CDTM. The process and requirements for this approach will be presented using a Massachusetts-based hospice as an example. CDTM allows a clinical pharmacist to therapeutically assess and identify patients' medication related needs and act as an extension of the physician. The goal is to optimize medication-related outcomes and includes selection, initiation, monitoring, and adjusting medications as defined in the CDTM agreement. Additionally, this quality improvement project evaluates the benefit of a pharmacist as a member of the interdisciplinary team and thus manage the overall pharmaceutical budget. Telephonic and/or virtual visit medication therapy management will be provided by clinical pharmacist(s) to hospice patients within two teams (n=160). Each patient's medical record will be reviewed and concurrently monitored on admission and subsequent IDT sessions with the entire team. Validity to be measured as a prospective cohort study. The teams that utilize a hospice pharmacist will see an increase in their Consumer Assessment of Heathcare Providers and Systems (CAHPS) scores and overall decrease in medication costs by 25% versus those teams that did not. Additionally, it is anticipated that over 500 drug therapy related matters will be resolved. This tailored care aims to improve quality of patient outcomes by symptom improvement, increase patient satisfaction and quality of life, and manage costs. This study highlighted the role of pharmacists in managing medications for hospice patients and described a clear path for a CDTM.

Association of Rising Cost and Use of Oral Anticancer Drugs With Medicare Part D Spending From 2013 Through 2017

This cross-sectional study weighs the proportional associations of rising drug costs and use with increased Medicare Part D spending for a cohort of oral anticancer drugs used from 2013 through 2017.

PNS164 PHARMACOECONOMIC ASSESSMENT AND DRUG COSTS OF TREATMENTS FOR CANCER AND RARE DISEASES IN IRELAND

Objectives Drug development is increasingly focused on treatments for oncology and rare diseases. This has resulted in rising drug costs with delayed or limited access to these products. This study aimed to compare drug costs for oncology and orphan products with those from other therapeutic areas. Methods Product details from reimbursement submissions to the NCPE were recorded for 2012-2017. The estimated annual/treatment cost per patient and incremental cost effectiveness ratio (ICER) were extracted from the pharmacoeconomic reviews. These indicators for oncology and orphan products (Group A) were compared to all others (Group B) for the study period. The trends for the two groups were also reviewed by contrasting 2012 with 2017. Results 273 reviews were submitted during the study period, excluding repeat submissions, and 103 full health technology assessments (HTA) were commissioned. 108 reviews were for Group A (39.6%) and the majority of HTA’s (62.1%) involved this group. The estimated annual cost per patient for a drug from Group A more than doubled from 2012(€59,500) to 2017(€130,500). A similar increase was apparent for Group B, however, the annual cost for Group A drugs was almost five times higher. This was also reflected in the percentage of Group A drugs (46.3%) with an ICER greater than the Irish Willingness to Pay (WTP) compared to Group B (8.5%). The percentage of Group A drugs which exceeded the threshold increased from 25% to 50% over the study period. Conclusion It is evident from this study that treatments for cancer and rare diseases are considerably more expensive than those from other therapeutic areas. Also, they more frequently require HTA assessment and are increasingly exceeding agreed WTP thresholds. While some countries are addressing these issues, it is necessary to develop health policies at a European level to ensure appropriate access to these medicines.

Effects of rising drug costs on efforts to control overall cost at a large academic cancer center.

2 Background: Value-based payment programs like the Oncology Care Model (OCM) have focused efforts to reduce costly acute care use through improvements in access and coordination rather than targeting the exponential rise in pharmaceutical pricing. We assessed how participation in OCM affected total cost of cancer care at a large academic cancer center. Methods: Using Medicare claims for Yale-Smilow Cancer Hospital, an NCI-designated cancer center with an academic hub and 10 community practices, we identified episodes for chemotherapy initiated during a historical period (pre-OCM, 2012-2015) and performance period (post-OCM, 2016-2017) following OCM criteria to identify total cost of care. We reported frequency of utilization categories, the mean cost per episode, the proportion of total cost attributed to each utilization category and compared pre- and post-participation periods. Results: There were 8,843 episodes during the historical period and 6,679 episodes during the performance period. The mean total cost per episode increased from $28,645 to $32,666, but this was less than the Medicare-defined expected increase (target price). Between the two periods, the percentage of total episodes decreased for emergency department (ED) use from 36% to 33%, inpatient care from 33% to 29%, and post-acute care from 28% to 25% (p < 0.01). Mean costs of drugs per episode increased by 27% between periods, and from 52% to 58% of total cost of care (p < 0.01). While mean cost per episode for ED, inpatient, and post-acute care remained stable, the mean cost per episode for antineoplastics increased 39% from $10,676 to $14,843. Conclusions: After implementing OCM, we beat the Medicare target largely by decreasing acute care use and stabilizing the cost of hospitalizations and ED; however, actual cost increased largely due to pharmaceutical spending. Because drug costs were the largest proportion of overall cost of care, future value-based models must address the rising cost of pharmaceuticals. [Table: see text]

HHS Proposes Plan to Import Lower-Cost Drugs

HHS Proposes Plan to Import Lower-Cost Drugs

Current Value Frameworks—What's New?

Current Value Frameworks—What's New?

The Use of Aerosolized Ribavirin in Respiratory Syncytial Virus Lower Respiratory Tract Infections in Adult Immunocompromised Patients: A Systematic Review.

Introduction: Respiratory syncytial virus (RSV)-associated lower respiratory tract infection (LRTI) is a concern in immunocompromised patients. Aerosolized ribavirin (RBV AER) is used for treatment of RSV LRTI; however, adverse events and rising drug costs remain a challenge for patient management. The purpose of this systematic review is to summarize the efficacy and adverse event profile of RBV AER for the treatment of hospitalized RSV LRTI in immunocompromised adult patients. Methods: A Medline/PubMed, Embase, Google Scholar, Clinicaltrials.gov, and Cochrane Library database search was conducted from 1966 to January 2019 for the use of RBV AER. Search strategy: [(ribavirin OR ICN1229) AND ("administration, oral" OR "oral" OR "administration, inhalation" OR "inhalation)] AND ("respiratory tract infection" OR "pneumonia"). Studies were reviewed if adult patients were hospitalized, immunocompromised, had RSV LRTI, received RBV AER, and included the outcome of mortality and/or adverse reactions. Methodological quality was assessed using the Cochrane Collaboration GRADE approach. Results: A total of 1787 records were identified and 15 articles met inclusion criteria: hematopoietic stem cell transplant (HSCT)/bone marrow transplant (n = 8), other malignancy/neutropenic (n = 2), solid organ transplant (n = 5). All of the trials are observational with a low quality rating; therefore, a meta-analysis was not performed. The 30-day mortality in studies that contain >10 patients with HSCT, malignancy, and transplant range from 0 to 15.4%, 6.3%, and 0 to 27%, respectively. Improved mortality was cited in 4 studies when RBV AER started before mechanical ventilation or within 2 weeks of symptom onset. Only 3 studies had comparative mortality data with RBV AER and RBV PO. Adverse reactions were reported in 5 studies and included psychiatric manifestations (anxiety, depression, feeling of isolation; n = 14), wheezing/bronchospasm (n = 6), snowflakes/hail blowing in face (n = 6), and precipitation in ventilator tubing (n = 5). Conclusion: There is a lack of high quality, comparative trials on the use of RBV AER for the treatment of RSV LRTI in adult hospitalized immunocompromised patients. There may be a mortality benefit when RBV AER is initiated early after diagnosis or prior to mechanical ventilation, but requires further study. Patient isolation and psychological effects must be weighed against the benefit of therapy.

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review.

Newly developed biosimilar agents confer significant cost-saving advantages, yielding the potential to mitigate rising drug costs and expand patient access to care for important biologic therapies. Biosimilar market uptake greatly depends on health care provider willingness to promote, prescribe, and use biosimilars in clinical practice. To perform a systematic review evaluating current U.S. and European health care provider knowledge, perceptions, and prescribing behaviors of biosimilar medicines to assess the need for clinician-directed biosimilar education. An electronic literature search was conducted using journal databases, including PubMed, Embase, and Cochrane Library. Terms related to biosimilar agents, survey questionnaires, and education were used. Two independent reviewers evaluated 158 citations published from January 1, 2014, to March 5, 2018 that were the result of this search. Studies in English were included if they surveyed U.S. or European physician and/or pharmacist knowledge, attitudes, and/or prescribing preferences of biosimilar drugs. Overall trends in prescribing behavior and perceptions were abstracted. A total of 20 studies met inclusion criteria. Three studies originated from the United States and 17 were from Europe. Hospital specialists, gastroenterologists, and rheumatologists were the most frequently surveyed practitioners. The percentage of biosimilar prescribing varied widely between countries and within similar practice fields. If used, biosimilars were predominantly prescribed in biologic treatment-naive patients. An overall lack of biosimilar familiarity in U.S. and European health care settings accompanied concerns about biosimilar safety, efficacy, extrapolation, and interchangeability. Detailed descriptions of biosimilar education programs were lacking within the literature. Findings from this review indicate that U.S. and European health care providers still approach biosimilar medicines with caution, citing limited biosimilar knowledge, low prescribing comfort, and safety and efficacy concerns as main deterrents for biosimilar use. To realize the full cost-saving potential of biosimilar medicines, clinician-directed biosimilar education will be imperative to address gaps in biosimilar knowledge, facilitate prescribing changes, and ultimately increase biosimilar use. No outside funding supported this study. The authors have nothing to disclose.

The Contribution Of New Product Entry Versus Existing Product Inflation In The Rising Costs Of Drugs.

It is unknown to what extent rising drug costs are due to inflation in the prices of existing drugs versus the entry of new products. We used pricing data from First Databank and pharmacy claims from UPMC Health Plan to quantify the contribution of new versus existing drugs to the changes in costs of oral and injectable drugs used in the outpatient setting in 2008-16. The costs of oral and injectable brand-name drugs increased annually by 9.2percent and 15.1percent, respectively, largely driven by existing drugs. For oral and injectable specialty drugs, costs increased 20.6percent and 12.5percent, respectively, with 71.1percent and 52.4percent of these increases attributable to new drugs. Costs of oral and injectable generics increased by 4.4percent and 7.3percent, respectively, driven by new drug entry. The rising costs of generic and specialty drugs were mostly driven by new product entry, whereas the rising costs of brand-name drugs were due to existing drug price inflation.

PMS8 - The Evolving Cost of Illness of Rheumatoid Arthritis: A Systemic Review

Over the past couple of decades, there has been major advances in the management of rheumatoid arthritis (RA). It is now recognised that early diagnosis and intensive treatment can limit disease progression and restore physical function in patients with RA. One of the major developments have been the introduction of disease-modifying antirheumatic drugs (DMARDs) and biolgoics. However, these drugs are expensive, and have transformed the composition of and the total cost of illness of RA. The objective of this study is to synthesise the knowledge about contemporary cost of illness (COI) studies and understand the full burden of patients with recent-onset and established RA. We performed a systematic review of all COI studies of RA, published after the year 2000. Multiple databases using relevant keywords and search filters were searched. We synthesised the data from all relevant studies through a narrative synthesis, with specific focus on the impact of the various settings and methodological approaches used to estimate costs in the studies. There were substantial variations in patient case-mix, healthcare settings, and methodological approaches to estimating COI of RA. The majority of the studies adopted the prevalence-based approach from a societal perspective to estimate an annual cost per patient. Direct costs tended to increase over the past decade mainly because of the introduction of biologics. However, this rising drug costs reached a plateau around 2009 and was subsequently offset by a general reduction in hospitalisation and in productivity loss. Productivity loss was mostly estimated by the human capital approach, accounted for the largest part of total annual cost, (45%-70% of total costs in the Western society). In the management of RA, early and intensive treatment may increase the short-term direct costs, but in the longer-term, this was associated with reduced hospitalisation and productivity loss in the society.