Severe Asthma and Biological Therapy: When, Which, and for Whom

Rogliani, Paola; Calzetta, Luigino; Matera, Maria Gabriella; Laitano, Rossella; Ritondo, Beatrice Ludovica; Hanania, Nicola A.; Cazzola, Mario

doi:10.1007/s41030-019-00109-1

Cited by 71 publications

(57 citation statements)

References 68 publications

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“…It is far above the accepted threshold between US$100,000 and US$150,000 per quality-adjusted life year (QALY) gained and confirms the high cost of biological asthma therapy. 17 Similar to our study, a systematic review of cost-effectiveness analyses found that biological therapy should be carefully targeted to specific populations such as responders in order to further improve value. 18 This macro-costing approach possess some limitations because it focuses only on the pharmacotherapy cost and does not include any other costs, due to their unavailability in the country of such an information at central level.…”

Section: Discussionsupporting

confidence: 75%

Availability and reimbursement of biological products for severe asthma in Bulgaria

2020

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Objectives: This study aims to analyze the reimbursement and cost of biological therapy for severe asthma in Bulgaria during 2014–2019 from the perspective of the National Health Insurance Fund. Methods: It is a retrospective, Marco-costing, top-down study of the expenditures for biological products for severe asthma. The changes in the cost paid by the National Health Insurance Fund per year, per product, and per patient during 2015–2020 were systematized and calculated. The utilization of biologicals was analyzed by calculating the defined daily dose/1000inh/day. Three databases were searched—the European Medicines Agency for the date of marketing authorization of biological products, National Council of Prices and Reimbursement for the date of their respective inclusion in the positive drug list, and National Health Insurance Fund about the number of patients with asthma, reimbursed sum for all asthma patients, and number of packages sold of biological products. Results: At the end of 2019, five international non-proprietary names of biologicals with indication for severe asthma had received European marketing authorization, and three of them were included in the Bulgarian positive drug list—omalizumab, mepolizumab, and benralizumab with a 75% reimbursement. Upon their introduction into the positive drug list, the reimbursed expenditures for asthma therapy started to increase from 27 million in 2014 to 33 million BGN in 2019 (€13.5–€16.5 million). The cost of therapy with biologicals rose from 16% to 24% of all anti-asthmatic medicines budget. The National Health Insurance Fund database reported that between 47,000 and 52,000 of patients with asthma, 466 are on biological therapy. The yearly cost of one asthma patient ranges between 512 and 615 BGN (€258–€307), and the yearly per-patient cost of severe asthma is 16,666 BGN (appr. €8333). Total utilization in defined daily dose/1000inh/day increases from 0.0199 to 0.0383 from 2015 to 2019. Conclusion: The access to biological therapy through the reimbursement system has improved during the last 3 years. The cost of therapy is posing a high burden on the National Health Insurance Fund and on the patients and is expected to increase due to the small number of patients on biological therapy currently in comparison to all reimbursed asthmatics.

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Section: Discussionsupporting

confidence: 75%

Availability and reimbursement of biological products for severe asthma in Bulgaria

2020

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“…This complex disease is usually triggered by genetic or environmental factors, such as allergen exposure and infections. An estimated 300 million people suffer from asthma worldwide [ 1 ]. Over the past decades, the incidence and prevalence of asthma is increasing, especially in children.…”

Section: Introductionmentioning

confidence: 99%

Suppression of autophagy through JAK2/STAT3 contributes to the therapeutic action of rhynchophylline on asthma

Li¹,

Cui³

et al. 2021

BMC Complement Med Ther

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Background Asthma is a chronic inflammatory disease characterized by airway remodeling and inflammation. Rhynchophylline is a kind of indole alkaloid isolated from Uncaria rhynchophylla. Here we investigated the effect of rhynchophylline on autophagy in asthma. Methods A mice model of asthma was established by ovalbumin challenge. Histopathological changes were assessed by hematoxylin-eosin staining, periodic acid-schiff staining and Masson staining. The levels of IgE in serum, interleukin-6 and interleukin-13 in bronchoalveolar lavage fluid, as well as the activities of superoxide dismutase and catalase in lung tissues were detected. The expression of autophagy-related genes and Janus kinase (JAK) 2/ signal transducer and activator of transcription (STAT) 3 signal was detected by western blot and immunofluorescence. Airway smooth muscle cells (ASMCs) were isolated, and the effect rhynchophylline on autophagy in ASMCs was explored. Results Our data showed that rhynchophylline treatment alleviated inflammation, airway remodeling, and oxidative stress in asthma. In addition, autophagy, which was implicated in asthma, was suppressed by rhynchophylline with decreased level of autophagy-related proteins. Furthermore, rhynchophylline suppressed the JAK2/STAT3 signaling pathway, which was activated in asthma. In vitro study showed that rhynchophylline suppressed ASMC autophagy through suppressing the activation of JAK2/STAT3 signal. Conclusions Our study demonstrated that rhynchophylline can alleviate asthma through suppressing autophagy in asthma, and that JAK2/STAT3 signal was involved in this effect of rhynchophylline. This study indicates that rhynchophylline may become a promising drug for the treatment of asthma.

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“…It is also during this timeframe that discussion and evaluation to see if switching to another asthma biologic or the addition of a non-biologic (ie, bronchial thermoplasty) treatment should be attempted at the end of four months. 5,47…”

Section: Best Practices With Follow-upmentioning

confidence: 99%

<p>Self-Administered Mepolizumab in the Management of Severe Asthma: Usability and Patient Acceptance</p>

Miyokawa¹,

Kivler²,

Louie³

et al. 2020

PPA

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The increasing use of advanced biologic therapies for patients with severe asthma is transforming the standard of care, clinic workflow, and the clinic business model. Expanded patient access to at-home injection treatment possibilities with some biologics has the potential to improve patient adherence and outcomes. Simultaneously, transition to the home setting can address the escalating costs that limit access for certain patients and healthcare facilities. Such moves come with recognized risks. Garnering input from physicians and other healthcare specialists as well as scrutinizing best practice position statements are vital to implementing truly patient-safe and cost-effective strategies in medicine. Mepolizumab is the first anti-IL-5 inhibitor to receive FDA approval in late 2015. We focus on this injectable medication and discuss the specific indications and contraindications for transitioning patients to at-home injection with mepolizumab. In doing so, we review our recent real-world experiences in the University of California, Davis and Loma Linda University severe asthma clinics, which can provide the foundation for building a comprehensive clinic and home-based biologics asthma program. In addition, we offer insight into the barriers to implementing a successful program and strategies for overcoming them.

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Severe Asthma and Biological Therapy: When, Which, and for Whom

Cited by 71 publications

References 68 publications

Availability and reimbursement of biological products for severe asthma in Bulgaria

Availability and reimbursement of biological products for severe asthma in Bulgaria

Suppression of autophagy through JAK2/STAT3 contributes to the therapeutic action of rhynchophylline on asthma

<p>Self-Administered Mepolizumab in the Management of Severe Asthma: Usability and Patient Acceptance</p>

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