BACKGROUND: Breast cancer is the second leading cause of death among women in the United States. The high cost of oral oncology drugs in breast cancer treatment impacts Medicaid budgets and potentially threatens access to therapies for patients and clinical outcomes. OBJECTIVE: To examine the trends in utilization, pharmacy reimbursement, and prices of oral breast cancer therapies in the US Medicaid-covered population from 2008 to 2019. METHODS: We conducted a retrospective drug utilization study. Pharmacy data and reimbursement of brand-name and generic oral therapies for breast cancer were extracted from the Centers for Medicare & Medicaid Services Medicaid state drug utilization data between 2008 and 2019. Those oral therapies included protein kinase inhibitors, aromatase inhibitors, pyrimidine analogs, and antiestrogens. For each brand-name and generic drug included in the study, we calculated the annual prescription counts and reimbursement amounts, and estimated the annual average drug price by calculating the average reimbursement per prescription. RESULTS: The annual generic drug use increased from 68,213 prescriptions in 2008 to 589,506 in 2019, whereas spending increased from $2.2 million in 2008 to $43 million in 2019. For brandname drugs, the number of prescriptions decreased by 59% from 143,009 in 2008 to 58,272 in 2019; however, spending increased significantly by 819%, from $72.5 million in 2008 to $666.3 million in 2019, in part as a result of recently marketed expensive therapies, such as protein kinase inhibitors. The cost per prescription as a drug price proxy for most brand-name drugs increased over the study period. For example, the cost of Afinitor increased by 219% from $5280 in 2009 to $16,868 in 2019. Nevertheless, the price per prescription for generic therapies declined over time as a result of patent expirations. CONCLUSIONS: A significant increase in Medicaid spending on oral breast cancer medications was observed during the 12-year study period with the increase in drug use, and a competition occurred between generic and brand-name oral breast cancer drugs in the Medicaid market. Our study highlights the importance of implementing cost-containment strategies, such as drug utilization review programs and mandatory generic drug substitution, to control the economic burden of breast cancer therapies on the Medicaid budget.
Background Multiple sclerosis (MS) is a progressive autoimmune disorder of the central nervous system characterized by symptoms including reduced mobility, pain, fatigue, and spasticity. MS affects nearly 1 million people in the United States, with significant negative impact on a patient's quality of life, and an average lifetime cost of care in excess of $4 million. The cost-effective management of patients with MS faces several challenges. Objective To review the challenges to the cost-effective management of patients with MS, and to offer healthcare stakeholders a roadmap to address them. Discussion The cost-effective management of patients with MS, which is driven largely by how quickly a patient receives effective medication therapy, is challenged by a paucity of between-office-visit clinical data, variability of provider expertise with magnetic resonance imaging (MRI), MRI machine quality, lack of standards for MRI machines and reports, misaligned financial incentives, the limited number of available Current Procedural Terminology (CPT) codes for brain MRI, the complexity of disease-modifying therapy (DMT) selection, poor patient adherence to treatment plans, poor communication among providers, and a lack of objective measures of disease progression. Conclusion Insurers, neurologists, researchers, and patient advocacy groups must address the needs of patients with MS holistically. These efforts should include establishing standards for MRI machines and reports, matching patients with MS specialists, aligning financial incentives, including creating a new CPT code for complex brain MRI, streamlining prior authorization processes of DMTs, using technology to gather patient data and improve coordination of care, and developing better measurement tools of disease activity.
OBJECTIVE: To evaluate the cost-effectiveness of de novo simvastatin plus standard therapy versus standard therapy alone in patients with sepsis during a 1-year period.METHODS: A total of 145 critically ill patients were recruited in an open-label, randomized, con-trolled clinical trial. Of these, 80 patients received standard therapy according to Surviving Sepsis Campaign Guidelines 2012, and 65 received oral simvastatin plus standard therapy. The outcomes assessed include survival at the end of 1-year follow-up and intensive care unit (ICU) length of stay. Per protocol analysis was used.RESULTS: The ICU length of stay was significantly decreased in the simvastatin group (P = .001). At 1 year, 46% of patients in the simvastatin group survived compared with 35% in the standard therapy group, although this was not significant (P = .173). However, a Kaplan-Meier curve showed a significant difference that favored the standard arm (P = .01). Simvastatin was the dominant treatment option based on lower total direct costs versus the standard group. Savings related to ICU length of stay was the main determinant of the cost-saving results of simvastatin. Incremental cost-effectiveness ratio was negative and thus was not calculated. Probabilistic sensitivity and one-way sensitivity analyses were done, and results were robust to change.CONCLUSION: de novo simvastatin as an adjunct to standard therapy in ICU patients with sepsis lowered the overall cost by shortening ICU length of stay and its associated costs, but generaliza-tion to patients with different magnitudes of sepsis severity and to different ethnic groups requires further investigation.
BACKGROUND: Biosimilars, highly similar versions of biologic agents, can offer patients equivalent efficacy at reduced costs, which could help expand medication access to more patients. Market uptake and adoption of biosimilars in the United States have been relatively slow, however. This summary aims to explore the challenges and opportunities in healthcare systemwide adoption of biosimilars based on a roundtable discussion including multistakeholder healthcare providers. OBJECTIVES: To identify barriers that contribute to slow market uptake and adoption of biosimilars in the United States and suggest strategies to mitigate such barriers. DISCUSSION: The article systematically examines factors affecting biosimilar adoption and offers insights into potential solutions and system-based strategies to facilitate the adoption and implementation of biosimilar agents in healthcare systems. Misinformation and knowledge gaps among providers and patients continue to hinder the adoption of biosimilars. External barriers related to payers' incentives, patent litigation, and Medicare policy were also identified as obstacles to the adoption of biosimilars. Strategies can be designed and implemented to overcome many of these barriers and realize the economic and societal benefits of biosimilar drugs. CONCLUSION: Overcoming key barriers to biosimilar adoption may be possible by implementing actionable system-level strategies that enable the dissemination of accurate and timely information to key stakeholders and improve organizational readiness for institutions considering biosimilar implementation. The resulting benefits would help to achieve the goals of reducing cost and thereby improving patient access while simultaneously reducing the historical barriers to broad biosimilar adoption.
BACKGROUND: The economic and societal burdens of chronic obstructive pulmonary disease (COPD) in the United States are substantial and increasing. COPD had projected US costs of $49 billion in 2020, and chronic lower respiratory diseases, including COPD, were the fourth leading cause of death in the United States in 2019. COPD-related hospitalizations for exacerbations are the greatest driver of costs; however, numerous factors shape the current landscape of COPD, and thus multiple opportunities to improve quality of care for patients are being explored. OBJECTIVES: To describe the existing burden, unmet needs, and related economics of COPD in relation to quality of care and to discuss approaches to reduce the cost of managing COPD, including advancements in maintenance therapy. DISCUSSION: Comorbidities are associated with increased hospitalizations and costs, worse outcomes, and reduced quality of life in patients with COPD. The severity of COPD and the rate of exacerbations are important drivers of medical costs, which highlights the importance of early diagnosis, early recognition of exacerbations, and timely initiation of therapy. The reduction of COPD hospital readmissions is of critical importance to reduce costs, per the recommendations of organizations such as the Centers for Medicare & Medicaid Services. Performance measures offered by the Healthcare Effectiveness Data and Information Set are a helpful tool; however, objective data evaluating how improving the quality of COPD care translates to reduced costs to the healthcare system are lacking. CONCLUSION: A comprehensive strategy to reduce COPD mortality and clinical burden will require a multifaceted approach. Key methods include improved patient access to care; early intervention with appropriate, effective treatment, such as single-inhaler triple therapies; proactive adherence monitoring; early recognition of worsening COPD and modification of treatment; disease management strategies, including smoking cessation and pulmonary rehabilitation; and evidence-based metrics to evaluate hospital readmission programs.
BACKGROUND: In the United States, >25% of the entire population are reported to experience episodes of gastroesophageal reflux disease (GERD). Despite widespread access to effective medications for mild-to-moderate GERD, this disorder accounts for more than $24 billion per year in total health expenditures. Patients with chronic, severe GERD can experience adverse effects from GERD medications, are nonadherent, or do not respond to treatment with antacids, hista-mine-2 antagonists, or proton pump inhibitors. For these patients, care strategies to include sur-gical options have evolved since the introduction of the Nissen fundoplication in the mid-20th century.OBJECTIVE: To assess updates to GERD guidelines with evidence-based data since 2005 on evolved surgical options in clinical practice and outline a change in insurance coverage for chron-ic care.DISCUSSION: The latest iteration of transoral incisionless fundoplication (TIF), TIF 2.0, is a routine option employed today. TIF avoids laparoscopic surgery and complications associated with con-ventional antireflux surgical procedures. Studies of the efficacy and safety of this technique con-firm that it significantly diminishes esophageal acid exposure and is associated with lower rates of serious adverse events, thereby offering economic benefits. However, recurrent use of GERD medications and the need for follow-up procedures have been reported. The health economic implications of GERD and TIF have not been fully explored for more than a decade. From the perspective of plans and plan sponsors, several key factors must be considered, including the time horizon chosen for determinations of total cost-effectiveness. Furthermore, the greatest contribu-tor to total expenditures associated with GERD is indirect costs, such as productivity and absen-teeism. In the face of limited economic information, plan sponsors (and health plans and insurers) are still deciding on coverage policy by assessing direct financial risks.CONCLUSION: Careful trend analysis in high-prevalence, chronic disorders such as GERD can reveal potential opportunities for reducing direct and indirect economic risks through optimal coverage policies.
BACKGROUND: Reference pricing establishes a set price an institution agrees to pay for total hip arthroplasty (THA) to all vendors. The hospital financially aligns itself with surgeons and then contracts with vendors to sell implants at newly dictated prices. Orthopedic surgeons may utilize any implant system using their best clinical judgement that has met the reference price.OBJECTIVE: To compare THA implant costs before and after implementation of reference pricing and to determine if prices decreased and vendors and technologies changed.METHODS: We retrospectively analyzed the 12 months before (May 2017-2018) and the most recent 12 months after (March 2019-2020) implementing reference pricing at our institution. We investigated differences in average prices for total implant and component costs. We evaluated cost of implants with respect to surgeon volume, assessed changes in implant utilization, and number of companies purchased from before and after reference pricing.RESULTS: A total of 6199 THAs were included in the study: 3464 arthroplasties before and 2735 after implementation of reference pricing. Overall implant costs decreased by 22.7% (P <.0001). All individual hip components decreased by =21% (P <.0001). No difference in prices was found between surgeons (P = .98). Implant selection did not change (P = .18), and vendor business in-creased by 1 company after reference pricing.CONCLUSION: The strategy of reference pricing significantly reduced costs for THA implants at our institution. The reduction in implant costs was regardless of surgeon volume and did not change surgeon implant selection. We conclude that this strategy represents a significant cost-savings approach for other hospitals.
BACKGROUND: First-line treatment of acute urticaria with an intravenous (IV) antihistamine in emergency departments had previously been limited to first-generation diphenhydramine, which can cause sedation and anticholinergic effects. IV cetirizine, a second-generation antihistamine, was approved in October 2019 by the US Food and Drug Administration for the treatment of acute urticaria. In a phase 3 clinical trial, IV cetirizine demonstrated comparable efficacy in treating acute urticaria based on reduction in 2-hour patient-reported pruritus scores, with shorter duration of emergency department visits and fewer return visits, compared with IV diphenhydramine. OBJECTIVE: To assess the budget impact of treating patients with acute urticaria with IV cetirizine compared with IV diphenhydramine from an emergency department perspective by modeling clinical, facility, and cost parameters for hospital formulary considerations. METHODS: Using data from the pivotal phase 3 clinical trial, federal health agencies, and peer -reviewed literature, our model evaluated a hypothetical emergency department with 50,000 (Case 1) and 100,000 (Case 2) all-cause visits per year with a nationally representative payer mix and age distribution. RESULTS: In Case 1, an estimated 204 visits per year were attributed to acute urticaria. With IV diphenhydramine as the treatment, the estimated annual net revenue to the emergency department was $56,768 (emergency department revenue of $131,056 minus a cost of $74,289). In the scenario with IV cetirizine, the estimated net revenue was $84,644 (emergency department revenue of $196,295 minus a cost of $113,080). Altogether, the adoption of IV cetirizine had a positive net impact on annual budget of $27,876. In Case 2, we found a larger net positive budget impact of $55,752. CONCLUSION: Adoption of IV cetirizine for acute urticaria treatment in the emergency department setting resulted in a positive budget impact. This outcome was driven by the shorter duration of visits, fewer 24-hour return visits, and higher drug revenue associated with IV cetirizine, compared with IV diphenhydramine.
BACKGROUND: Many patients with follicular lymphoma (FL) who receive first-line chemoimmunotherapy eventually relapse. The development of better second-line therapy options to fill current unmet needs remains an important goal of research. OBJECTIVE: To describe real-world treatment patterns and healthcare costs of commercially insured patients with FL with early treatment failure following first-line chemoimmunotherapy. METHODS: Merative MarketScan Research Databases (January 1, 2005-February 29, 2020) were used to identify adult patients with FL with early treatment failure, defined as initiating second-line within 24 months of first-line chemoimmunotherapy initiation. Per-patient per-month (PPPM) all -cause costs were described by line of therapy and by Oncology Care Model (OCM) episode (ie, first 6 months of line of therapy). RESULTS: A total of 644 patients with FL with early treatment failure of first-line chemoimmunotherapy were identified (median age at first-line initiation, 60.0 years; 42.2% were women). Before 2015, the most common first-line chemoimmunotherapy regimens were R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; 35.4%), bendamustine plus rituximab (23.7%), and R-CVP (rituximab, cyclophosphamide, vincristine, and prednisone; 22.7%). In 2015 or later, the use of bendamustine plus rituximab was more prevalent (44.9%), followed by R-CHOP (33.3%) and R-CVP (4.8%). In second-line or later settings, the use of novel therapies (eg, lenalidomide) was more common in 2015 or later, compared with pre-2015 (second-line: 10.9% vs 5.6%; third-line: 24.1% vs 11.0%; fourth-line and later: 46.7% vs 37.6%). Total costs PPPM in-creased with each line of therapy and OCM episode (from $17,218 for first-line to $28,420 for fourth-line and later; from $20,196 in first-line OCM to $31,092 in fourth-and later-line OCM), driven by increasing inpatient costs PPPM (from $2986 in first-line to $11,658 in fourth-line and later; from $3175 in first-line OCM to $12,962 in fourth-and later-line OCM). CONCLUSION: Treatment of relapsed or refractory FL has evolved in recent years with increased use of novel targeted therapies and bendamustine plus rituximab. In this study, failure of first-line chemoimmunotherapy was associated with high costs of care in subsequent lines of therapy, especially if hospitalization was required. With a rapidly growing number of available novel targeted therapies, monitoring costs remains critical.
Background:An enhanced recovery pathway using individualized multimodal pain management with scheduled nonopioid and opioid regimens previously enabled reproducible same-day discharge of Medicare beneficiaries and commercially insured patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA) procedures in the hospital or in ambulatory surgery center settings. Objective:To analyze the migration trends for TKA and THA procedures from a hospital to an ambulatory surgery center facility and to assess perioperative outcomes before and after incorporating liposomal bupivacaine into a multimodal pain management regimen for these procedures. Methods:This retrospective medical chart review study included patients undergoing THA or TKA with an enhanced recovery pathway in a hospital or an ambulatory surgery center between 2013 and 2019. The outcome measures included length of stay at the hospital or the ambulatory center, and opioid consumption. We compared the outcomes before and after the addition of liposomal bupivacaine to surgeon-applied periarticular intraoperative local anesthetic field blocks between in-hospital patients who received and patients who did not receive liposomal bupivacaine in 2013 and 2014, and the impact of liposomal bupivacaine use in the hospital versus the ambulatory center from 2015 to 2019. Results:In 2013 and 2014, the addition of liposomal bupivacaine increased the same-day hospital discharge rate to 32% versus 4% without liposomal bupivacaine (odds ratio, 14.3; 95% confidence interval, 5.9-33.3; P <.0001); the same-day hospital discharge rates increased to 73% in 2015. From 2015 through 2019, 89% of all patients were discharged on the same day from the hospital. In-hospital opioid use was 22% lower in the liposomal bupivacaine cohort than in the patients who did not receive this medication (P = .0035). In 2018 and 2019, same-day discharge from the hospital or the ambulatory surgery center rates were 96% and 100%, respectively, and 84% of the patients used postsurgical opioid prescriptions of 30 or fewer tablets. The complication rates and healthcare resource utilization did not increase with the incorporation of liposomal bupivacaine into the enhanced recovery pathway and increased same-day discharge rates. Conclusion:An enhanced recovery pathway using individualized, scheduled multimodal pain management protocol in patients undergoing THA or TKA facilitated reproducible, high same-day discharge rates and low postoperative opioid consumption. These results suggest that the use of liposomal bupivacaine for intraoperative field blocks supports predictable same-day discharge rates after THA or TKA. This protocol could facilitate same-day hospital discharge and the migration of THA and TKA procedures from the hospital to lower-cost ambulatory surgery centers.
Background:The opioid epidemic and drug abuse are critical public health challenges in the United States. The number of deaths from exceeding the recommended opioid dose is increasing.Objective:To describe the recent trends in utilization, spending, and cost of opioid medications in the US Medicaid population between 1991 and 2019.Methods:This retrospective, descriptive study was designed to evaluate the utilization of, spending on, and cost of opioids from 1991 to 2019 in the Medicaid population. We extracted data from the Centers for Medicare & Medicaid Services national Medicaid pharmacy files. The opioids received included fentanyl, meperidine, morphine, hydromorphone, oxymorphone, hydrocodone, hydrocodone plus acetaminophen, oxycodone, oxycodone plus acetaminophen, tapentadol, and tramadol. The number of prescriptions and reimbursement spending were calculated for each medication per quarter year. The average per-prescription reimbursement as a proxy of drug price was calculated as the reimbursement amount divided by the number of prescriptions per quarter year. The market shares by spending and utilization were also calculated for each opioid medication.Results:The number of all opioid prescriptions in Medicaid increased from approximately 2.1 million in 1991 to approximately 41.6 million in 2015, and then reduced to approximately 19.1 million in 2019. During this 29-year study period, the opioid medications that were used as monotherapy were hydrocodone (246.8 million prescriptions), oxycodone (111.9 million prescriptions), and tramadol (75.2 million prescriptions). The total spending in the Medicaid population on opioids was $19.4 billion, including approximately $7.3 billion spending on oxycodone, approximately $3.7 billion on fentanyl, and approximately $3.3 billion on hydrocodone. The majority of opioid prices increased over time, and the highest average costs per opioid prescription in 2019 were $1188 for oxymorphone, $641 for tapentadol, and $198 for fentanyl.Conclusions:The utilization of and spending on opioid medications in Medicaid increased over time, peaked in 2015, and then declined with the initiation of nationwide programs to combat the opioid epidemic. Effective cost-containment strategies and programs to combat the abuse of opioids are warranted in Medicaid programs.
The article discusses innovations to ensure medication adherence amid COVID-19 in the U.S. Topics include American, health plans and pharmacy benefit managers (PBMs) are facing unprecedented challenges in ensuring their members adhere to their treatment regimens;and COVID-19 pandemic has created a number of barriers to treatment adherence.
BACKGROUND: The purchase of prescription medications via the Internet is a global phenomenon with significant economic, social, and health-related impacts. The growth of online purchasing of prescription medicines is significant and has been amplified by social isolation related to the COVID-19 pandemic, with many patients unable to obtain medicines as they normally would. By contrast, there are licensed, certified, legitimate retail pharmacies that provide significant and vital services to patients. OBJECTIVE: To review the major public health threat from illegal entities that sell any type of prescription medicines to individuals without proper physician oversight. DISCUSSION: Rogue and inappropriate online vendors are providing counterfeit and substandard medications fraudulently with untold impacts on morbidity and mortality globally. This article presents the differentiation between the types of legal and illegal Internet pharmacies, as well as the actions that are currently in play to affect the illegal online purchase of prescription medicines. Much must be done in a collaborative, global effort to address the public health threat of obtaining prescription drugs via the Internet. CONCLUSION: Global, federal, state, health professional, societal, and patient-specific collaborations are necessary to affect the significant threat that is now present via the increasing ease of access to online medication purchases.
