Healthcare system conversion to a biosimilar: Trials and tribulations

Author(s):  
Simon W Lam ◽  
Kevin Amoline ◽  
Christopher Marcum ◽  
Mandy Leonard

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose While biologic medications have transformed the care and management of millions of patients, they are a large financial strain on the healthcare system. Biosimilar medications present a great opportunity to improve care affordability. However, despite streamlined approval processes and the potential for cost savings, the acceptance and adaptation of biosimilars have been slow. This descriptive report illustrates the preparation for, challenges, and execution of an enterprise-wide biosimilar conversion within a large healthcare system. The 3 phases of biosimilar conversion utilized at our institution included selection of a biosimilar, pharmacy and therapeutics (P&T) committee approval, and implementation. Summary When selecting a biosimilar, clinical data, medication safety, cost, institutional cost savings, payer coverage, patient assistance programs, and additional patient services should be taken into consideration to ensure patient care is not affected. Understanding and endorsement of biosimilar use by physician leadership, care managers, and pharmacists are crucial before implementation. P&T committee approval with clear delineation of the patient population (naive vs experienced), disease states, and whether the biosimilar would be the preferred medication should be obtained. Transparent communication of clear expectations to patients and coordination with the information technology (IT), contracting, and supply chain departments are necessary before the go-live date. Contracting and IT implementations should ideally take potential changes in biosimilar adaptation into consideration and have enough flexibility to account for these changes. Planned evaluations of patients’ experiences with the change to the biosimilar should be incorporated as part of the implementation plan. Conclusion The barriers to biosimilar adaptation are plentiful. Careful planning, clear communication, and coordination with all affected disciplines can ensure successful biosimilar conversion.

2020 ◽  
Vol 9 (13) ◽  
pp. 907-918
Author(s):  
Aseel Bin Sawad ◽  
Fatema Turkistani

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients’ physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers’ coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.


Author(s):  
Mouaz H Al-Mallah ◽  
Owais Khawaja ◽  
Fadi Alqaisi ◽  
David Nerenz ◽  
W Douglas Weaver

Introduction: Smoking is a well established risk factor for acute myocardial infarction (AMI). The potential impact of a nationwide comprehensive smoking ban (CSB) legislation on the incidence of AMI hospital admissions is not known. The aim of this analysis is to determine the impact of a nationwide CSB legislation on the incidence of AMI hospitalizations. Methods: We contacted the department of health at states with no CSB law for information on the total number of AMI discharges (ICD-9-CM 410), length of stay and charges in dollars for 2007. Expected decrease in the number of AMI in the year following a potential implementation of a nationwide CSB was calculated by multiplying the current number of AMI by the pooled relative risk reduction (RRR) obtained from a recent published meta analysis (RR 0.89). Results: In 2007, 37 States had CSB laws. There were 169,043 AMI hospitalizations in states without CSB. A nationwide smoking ban would result in 18,596 less AMI hospitalizations in the year following such a ban. This is associated with more than 92 million dollars in direct cost savings. Conclusion: A nationwide CSB legislation would result in significant reduction in the number of AMI hospitalizations. This is associated with significant cost saving. Further studies are needed to evaluate the impact of CSB on admission from other disease states.


Author(s):  
Satish Munigala ◽  
Margaret Brandon ◽  
Zackary D Goff ◽  
Richard Sagall ◽  
Paul J Hauptman

Objective: To evaluate the frequency of drug discount card utilization and to estimate cost savings associated with heart failure (HF) medication prescriptions. Methods: We conducted a retrospective study of all HF prescriptions filled through the NeedyMeds.org drug discount card program nationwide, from January 2009 to December 2016. We evaluated the frequency of drug discount card prescriptions (across pharmacy types, pharmacy location, by prescriber specialty and by drug class) and calculated cost savings (average per drug discount card and total program dollars saved) for entire study period and for each year (from 2009 to 2016). Findings: A total of 381,347 prescriptions for medications that can be used for HF with drug discount cards were identified during the study period (83.7% at national, 5.7% at regional and 9.8% at local pharmacies). Most prescriptions were filled at urban locations (89.1% in urban clusters, 7.6% in urbanized areas) and in ZIP-codes with lower median household income (65.5%). Angiotensin-converting enzyme inhibitors and selected angiotensin receptor blockers were the most prescribed drugs with discount cards (44.1%) followed by beta blockers (27.5%), diuretics (21.5%), and mineralocorticoid receptor agonists (3.9%). The number of HF prescriptions with drug discount cards increased from 2577 in 2009 to 64,750 in 2016. Increase in the number of prescriptions was also noted for all drug classes from 2009 to 2016. Overall 224,049 prescriptions for HF medications (59% of the total) benefited from the program resulting in total savings of $4,739,204 with a median cost saving of $9.30 (41.5%) per prescription. Conclusion: Use of a drug discount program resulted in cost savings on HF prescription medications (approximately $9 in savings per prescription) compared to the original cost charged by pharmacies. While these drug assistance programs may reduce financial burden, continued efforts should be made to improve adherence to medications and for better outcomes.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Kerry Mansell ◽  
Hishaam Bhimji ◽  
Dean Eurich ◽  
Holly Mansell

Abstract Background In 2014 and 2015, biosimilars for the drugs filgrastim, infliximab, and insulin glargine were approved for use in Canada. The introduction of biosimilars in Canada could provide significant cost savings for the Canadian healthcare system over originator biologic drugs, however it is known that the use of biosimilars varies widely across the world. The aim of this study was to estimate the use of biosimilars in Canada and potential cost-savings from their use. Methods We performed a retrospective analysis of Canadian drug purchases for filgrastim, infliximab, and insulin glargine from July 2016 to June 2018. This was a cross-sectional study and the time horizon was limited to the study period. As a result, no discounting of effects over time was included. Canadian drugstore and hospital purchases data, obtained from IQVIA™, were used to estimate the costs per unit and unit volume for biosimilars and originator biologic drugs within each province. Potential cost-savings were calculated as a product of the units of reference originator product purchased and the cost difference between the originator biologic and its corresponding biosimilar. Results The purchase of biosimilars varied by each province in Canada, ranging from a low of 0.1% to a high of 81.6% of purchases. In total, $1,048,663,876 Canadian dollars in savings could have been realized with 100% use of biosimilars over the originator products during this 2 year time period. The potential savings are highest in the province of Ontario ($349 million); however, even in smaller markets (PEI and Newfoundland), $28 million could have potentially been saved. Infliximab accounted for the vast majority of the potential cost-savings, whereas the purchases of the biosimilar filgrastim outpaced that of the originator drug in some provinces. In sensitivity analyses assuming only 80% of originator units would be eligible for use as a biosimilar, $838 million dollars in cost savings over this two-year time period would still have been realized. Conclusions The overall use of biosimilar drugs in Canada is low. Policy makers, healthcare providers, and patients need to be informed of potential savings by increased use of biosimilars, particularly in an increasingly costly healthcare system.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6550-6550
Author(s):  
Di Maria Jiang ◽  
Nazanin Fallah-Rad ◽  
Roy Lee ◽  
Pamela Ng ◽  
Alan D. Smith ◽  
...  

6550 Background: Cabazitaxel is indicated for mCRPC, but is associated with substantial DW and financial strain on hospital budgets. It is only available in single-dose 60mg vials and has short reconstituted drug stability of < 24 hours. We aimed to determine feasibility and cost savings of an aggressive batching strategy to facilitate vial sharing of Cabazitaxel. Methods: Our mitigation strategy was to administer Cabazitaxel 20mg/m2 q3-weekly (without prophylactic G-CSF) on a single weekday whenever possible. Drug was prepared after patient (pt) arrival. Remaining amount from each vial was saved for subsequent pts on the same day. Amount administered, discarded and number of (#) vials used were obtained from pharmacy records. We estimated drug cost without batching by assigning 1 vial/treatment, and drug cost with batching from the actual # vials used. Cost of DW was determined from the amount discarded. All cost calculations were based on market price ($96.7CAD/mg) accounting for Sanofi’s discount incentive (5 vials for the price of 4), allowing a real-world cost assessment. Results: Between 09/2015 and 09/2018, 74 pts received 404 Cabazitaxel treatments on 164 days using 319 vials. Multiple pts were batched on 68% treatment days. Every 3 pts batched saved 1 vial. Average dose/treatment was 37mg (20-45mg). Among 10 treatment cancellations, prepared drug was administered for subsequent pts in 9 cases. Drug and DW costs over the 3-year period with and without batching are shown in Table. Conclusions: Batching ≥3 pts on a single weekday was feasible and significantly lowered drug cost of Cabazitaxel by reducing wastage. This strategy could help mitigate costs associated with wastage for other oncology drugs. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11609-11609
Author(s):  
Christopher Daugherty ◽  
Julie Johnson ◽  
Stacie K. Levine ◽  
Kristen Wroblewski ◽  
Bradford Lane ◽  
...  

11609 Background: Outpatient PC improves ACP symptom burdens, end-of-life care transitions, and mortality thereby enhancing quality of life. Yet, the financial implications, discharge disposition, and survival benefits of early, inpatient PC compared to SOC remains less understood. Methods: Retrospective cohort analysis of ACP receiving either PC or SOC between Jan 2015-Dec 2015 (N = 810). ACP cohorts were compared for demographics, costs, disposition, and survival. Financial costs collected included: fixed (overhead expenditures, facility maintenance, hospital property); variable (patient care supplies, diagnostic/therapeutic supplies, medications); operating (fixed, variable, breaking-even costs); direct (labor, materials, commissions, piece-rate wages, manufacturing supplies); indirect (production-supervision salaries, quality control, insurance, depreciation). Univariate and multivariate analyses were completed. Results: 468 were admitted to PC and 342 to SOC. Compared with SOC, PC were more likely to be: younger (61.1±13.2 v. 62.5±13.0, p = 0.02); African American (48% v. 36%, p = 0.0045); female (50% v. 40%, p = 0.005); and have shorter length of stay (5.7±4.9 v. 6.2±6.5, p = 0.01). PC had significantly less 30-day readmissions (16% v 23%, p = 0.03) and lower costs: direct ($9,478 v. $10,416, p = 0.01); indirect ($9,538 v. $10,999, p = 0.002); fixed ($10,308 v. $12,076, p = 0.001); variable ($8,709 v. $ 9,339, p = 0.02); operating ($19,017 v. $21,416, p = 0.003).Compared with SOC, ACP receiving PC were more likely to be discharged to: home (55% v.45%, p = 0.01); healthcare facilities (e.g. skilled nursing, inpatient rehabilitation) (36.1% v. 20%, p = 0.04); and hospice (home and inpatient) (7.7% v 5.8%, p = 0.02). PC had overall greater median survival from the time of discharge (106.8±99.95 v. 73.8±61.93, p = 0.03) compared to SOC. Conclusions: Early PC results in less financial strain, greater cost savings, and improved outcomes for younger and underserved inpatient ACP. Our results provide additional evidence for policies supporting that ACP access to routine PC must become a healthcare priority.


Author(s):  
Anne-Marie Nicol ◽  
Corlann Gee Bush ◽  
Ellen Balka

Abstract:Background and Objectives: The advent of the Internet has made in-home monitoring a possibility for patients suffering from chronic disease, although few studies have examined this phenomena across different disease states. The goal of this review is to identify and evaluate studies where randomized control trials were used to evaluate Internet-mediated home monitoring systems designed to manage and support patients with chronic diseases.Methods and Results: We reviewed 454 abstracts of articles describing computerbased health interventions and read forty-three articles in depth. Seventeen articles met inclusion criteria and were selected for this review. Only completed randomized, controlled trials that reported physiological health outcomes of the intervention were included. Other results reviewed included the populations studied, the short and long term effectiveness of the interventions, costs and technology-related issues and health care provider communication. Internet-mediated home monitoring interventions appear to have some benefit for specific chronic diseases in specific circumstances. Few studies documented cost savings; none of those that did used consistent measures. Studies seldom addressed the challenges of introducing sophisticated interactive-monitoring systems into patients’ homes, the reasons for attrition from trials, or the effects of the intervention on the work of care providers or interprofessional practices.Conclusions: The interventions reviewed showed potential to enhance chronic disease management in some cases. However, the short duration of the studies made it difficult to generalize the results to wider home care settings or predict the effectiveness of such systems over the long and complicated courses of chronic diseases. Thus, despite hopes for significant cost and labour savings, Internet-mediated systems for monitoring chronic diseases in patients’ homes will likely complement rather than replace usual care.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2124-2124
Author(s):  
Cherupolil R. Santhosh-Kumar ◽  
Stephanie Struve ◽  
Sue Freier

Abstract Background: Rising health care costs - especially those of new medications for cancer treatment - have caused a severe financial strain on patients, leading to significant alteration of lifestyles. Published information regarding financial distress is scant with data only from large tertiary care institutions that may not be relevant to smaller communities. We sought to analyze the extent of financial toxicity over time in a community cancer clinic staffed by two medical oncologists. Methods: Since 2010, a team of two oncology social workers prospectively collected data on financial assistance for patients treated at our community cancer clinic. Data regarding medication assistance is available for 2012-2014. Results: Approximately 500 new patients and 1600 unique follow-up patients are evaluated and treated at the clinic annually. From January 2010 through December 2014, 1,012 requests for assistance were processed. The number of requests increased from 134 in 2010 to 320 in 2014. Most common requests were for medications and financial aid. Trends are shown in the table. Though the number of patients applying for medication assistance increased in 2014, the amount requested was less than previous years because of the influx of specialty pharmacies in the market with their own assistance programs. Conclusions: Financial toxicity for cancer patients is a real issue in the community clinic setting.Requests for financial assistance have increased over time. The number of FDA approvals for new cancer medications seem to correlate with the increase. Studies are in progress to further clarify the financial impact of cancer on patients.Table.Trends in requests for assistance and aid and FDA approval for new medications.Requests for20102011201220132014Financial aid6411686101143Service311112733Equipment1311111823Transport312357Medications51534449114Patient cost of medications for which aid requested$731,891$1,554,684$1,253,827FDA approvals for new Oncology medications61181513 Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22076-e22076
Author(s):  
Elena Parvez ◽  
Teodora Dumitra ◽  
Dimitra Panagiotoglou ◽  
Sarkis H. Meterissian ◽  
Sinziana Dumitra

e22076 Background: The MSLT-II trial demonstrated no survival benefit of completion lymphadenectomy (CLND) compared to nodal observation (NO) and subsequent therapeutic lymphadenectomy (TLND) in the case of macroscopic nodal relapse in patients with melanoma and SLN metastases. NO avoids the upfront cost and morbidity of CLND. However, patients followed with NO must undergo intensive surveillance and if TLND is required, it is associated with a higher complication rate than CLND. The cost-effectiveness of NO versus CLND in light of data from MSLT-II has not been previously studied. Methods: A Markov model with a 10-year time horizon was constructed to simulate two hypothetical cohorts of patients with SLN metastases undergoing NO and subsequent TLND for nodal recurrence or upfront CLND. Transition probabilities between disease states were derived from the MSLT-II trial. Remaining parameters including complication rates and health state utilities were obtained from an extensive review of the literature. Direct health care system costs were obtained from published US Medicare cost data and the literature. Primary outcomes were cost and quality-adjusted life years (QALYs) saved. Incremental cost-effectiveness ratio (ICER) was used to compare treatment strategies. Sensitivity analysis was performed in order to evaluate model uncertainty. A threshold of acceptance of $100,000/QALY was used. Results: Total projected cost over the study period for CLND was $28,609.87, while that of NO was lower at $20,865.27, resulting in $7,744.60 saved for the NO treatment strategy. Ten-year utility was 4.840 for CLND compared to 5.379 for NO, resulting in a gain of 0.539 QALYs in the NO arm. The NO strategy is dominant in the model as it results in both cost-savings and a gain in health effects, with an average ICER of -$14,368.46/QALY gained. Conclusions: From the payer perspective, the strategy of NO compared to CLND in patients with melanoma and SLN metastases is associated with an improvement in health outcomes and reduction in cost. Taking into account MSLT-II trial data, this study demonstrates NO is more cost-effective than CLND.


Sign in / Sign up

Export Citation Format

Share Document