Healthcare resource utilization and costs among patients with steroid-resistant chronic graft-versus-host disease in the United States: a retrospective claims database analysis

Yu, Jingbo; Lal, Lincy S.; Anderson, Amy; DuCharme, Mary; Parasuraman, Shreekant; Weisdorf, Daniel J.

doi:10.1080/03007995.2021.1893676

Cited by 12 publications

(9 citation statements)

References 18 publications

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“…In addition, access to inpatient health care may also differ between US and Germany due to different reimbursement systems. A recent claims database study by Yu et al [ 20 ] found hospitalization rates for corticosteroid-resistant cGvHD patients to be twice as high compared with patients who did not develop a cGvHD after allo-HCT, which is in line with our results.…”

Section: Discussionsupporting

confidence: 92%

Treatment Pathways and Health Outcomes of German Patients with Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation: A Retrospective Health Claims Data Analysis

Scheid

Kudernatsch

Eckart

et al. 2022

Drugs - Real World Outcomes

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Background Although chronic graft-versus-host-disease (cGvHD) is an important long-term complication after allogenic hematopoietic cell transplantation (allo-HCT) and is associated with increased healthcare resource utilization, real-world evidence is scarce. Objectives The aim of the study was to evaluate survival of patients with cGvHD in Germany and to analyze hospitalization and treatment patterns. Patients and Methods Based on a German claims database with 4.9 million enrollees, a retrospective longitudinal analysis covering a 6-year period between 2013 and 2018 was conducted. Patients with allo-HCT in 2014 or 2015 (index date) and no record of transplantation or documentation of GvHD 365 days prior to index were included. Patients who subsequently developed a cGVHD were compared with those who did not develop a cGVHD within 3 years after index date. cGVHD cases were identified based on documented International Classification of Diseases, Tenth Revision (ICD-10) diagnosis and treatment algorithms. Since the onset of cGvHD is defined at 100 days after allo-HCT, only those alive beyond day 100 were considered in the survival analysis. Patients who did not survive the first 100 days after allo-HCT were censored to prevent a selection bias due to early mortality within patients without GvHD. Survival rates were plotted using the Kaplan-Meier estimator. The number of hospitalizations and average lengths of stay as well as treatment patterns were descriptively examined. Results Overall, 165 cGvHD patients were identified and compared with 43 patients without cGVHD. Short-term survival rates were better for patients with cGvHD; the 6-month survival probability was 95.8% for patients with cGVHD and 83.7% for patients without cGVHD. However, long-term survival was better in patients without GvHD; The 30-month survival probability was 65.5% for patients with cGVHD and 76.7% for patients without cGVHD. While overall 90% of cGvHD patients were hospitalized at least once, the share was only half for patients without GvHD (44%). 78.2% of patients with cGVHD received corticosteroids in combination with other predefined immunosuppressants. Conclusion Findings from this study reveal a high disease burden associated with cGvHD. This underlines the high medical need for new interventional strategies to improve survival and morbidity after allo-HCT.

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Section: Discussionsupporting

confidence: 92%

Treatment Pathways and Health Outcomes of German Patients with Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation: A Retrospective Health Claims Data Analysis

Scheid

Kudernatsch

Eckart

et al. 2022

Drugs - Real World Outcomes

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“…Despite improved long-term survival, mortality and re-hospitalisation rates remain substantial, especially in the first year post-alloSCT [43]. In particular, the first months post-alloSCT constitute the most complex phase in terms of life-threatening complications such as infections, acute graft-versus-host disease (aGvHD) and gastrointestinal complications [44][45][46][47][48][49]. Avoiding re-hospitalisations or at least shortening re-hospitalisation stays will require early detection and treatment of complications [50,51].…”

Section: The Smile Project: a Two-phase Implementation Science Projectmentioning

confidence: 99%

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

Geest

Valenta

Ribaut

et al. 2022

BMC Health Serv Res

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Background While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe–ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders). Methods Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe–ICM’s effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods). Discussion The SMILe–ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations. Trial registration ClinicalTrials.gov. Identifier: NCT04789863. Registered April 01, 2021.

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“…This may be because increasing severity indicates steroid-resistant GvHD. Such steroid-resistant GvHD had been shown to double the costs of patients compared to those without GvHD [ 45 ]. The mean total initial hospitalisation costs of patients with aGvHD who were either steroid-resistant or high risk were $205,880 compared to $97,417 ( P < 0.001) for those with no aGvHD as reported in a US retrospective claims database analysis [ 46 ].…”

Section: Graft-versus-host Disease (Gvhd) Is a Life-threatening And Expensive Complication Of Allogeneic Haematopoietic Stem Cell Transplmentioning

confidence: 99%

“…The mean total initial hospitalisation costs of patients with aGvHD who were either steroid-resistant or high risk were $205,880 compared to $97,417 ( P < 0.001) for those with no aGvHD as reported in a US retrospective claims database analysis [ 46 ]. For patients with steroid-resistant cGvHD, mean total costs were $532,673 versus no cGvHD costs of $252,909 ( P < 0.001) in the 2 years following alloHSCT in another US retrospective claims database analysis [ 45 ].…”

Section: Graft-versus-host Disease (Gvhd) Is a Life-threatening And Expensive Complication Of Allogeneic Haematopoietic Stem Cell Transplmentioning

confidence: 99%

Improved Therapeutic Approaches are Needed to Manage Graft-versus-Host Disease

Hooker¹,

Grabe-Heyne

Henne

et al. 2021

Clin Drug Investig

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Allogeneic haematopoietic stem cell transplantation (alloHSCT) offers a potentially curative therapy for patients suffering from diseases of the haematopoietic system but requires a high level of expertise and is both resource intensive and expensive. A frequent and life-threatening complication is graft-versus-host disease (GvHD). Acute GvHD (aGvHD) generally causes skin, gastrointestinal and liver symptoms, but chronic GvHD (cGvHD) has a different pathophysiology and may affect nearly every organ or tissue of the body. In Europe, GvHD prophylaxis is generally a calcineurin inhibitor in combination with methotrexate, with high-dose systemic steroids used for advanced GvHD treatment. Between 39% and 59% of alloHSCT patients will develop aGvHD and around 36-37% will develop cGvHD. Steroid response decreases with increasing disease severity, which in turn leads to an increase in non-relapse mortality. GvHD imposes a financial burden on healthcare systems, significantly increasing post-alloHSCT costs. Increased GvHD disease severity magnifies this. Balancing immunosuppression to control the GvHD whilst maintaining a degree of immunocompetence against infection is critical. European GvHD guidelines acknowledge the lack of evidence to support a standard second-line therapy, and improved long-term outcomes and quality-of-life (QoL) remain an unmet need. Evidence generation for potential treatments is challenging. Issues to overcome include choice of comparator (extensive off-label usage); blinding; selection of relevant patient-reported outcome measures (PROMs); and rarity of the condition, which may infeasibly increase timescales to achieve clinical and statistical relevance.

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Healthcare resource utilization and costs among patients with steroid-resistant chronic graft-versus-host disease in the United States: a retrospective claims database analysis

Cited by 12 publications

References 18 publications

Treatment Pathways and Health Outcomes of German Patients with Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation: A Retrospective Health Claims Data Analysis

Treatment Pathways and Health Outcomes of German Patients with Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation: A Retrospective Health Claims Data Analysis

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

Improved Therapeutic Approaches are Needed to Manage Graft-versus-Host Disease

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