Shortage of Albendazole and Its Consequences for Patients with Cystic Echinococcosis Treated at a Referral Center in Italy

Manciulli, Tommaso; Vola, Ambra; Mariconti, Mara; Lissandrin, Raffaella; Maestri, Marcello; Budke, Christine M.; Tamarozzi, Francesca; Brunetti, Enrico

doi:10.4269/ajtmh.18-0245

Cited by 8 publications

(3 citation statements)

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“…Costs for albendazole are volatile and differ massively even between neighboring countries. In a recent study from Italy, the problem of albendazole drug shortages was also highlighted [20]. This has, to our knowledge, not yet occurred in Austria, but may potentially endanger treatment success.…”

Section: Discussionmentioning

confidence: 98%

Evaluation of direct costs associated with alveolar and cystic echinococcosis in Austria

et al. 2019

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BackgroundCystic echinococcosis (CE) is a globally occurring zoonosis, whereas alveolar echinococcosis (AE) is endemic only in certain parts of the Northern Hemisphere. The socioeconomic impact of human echinococcosis has been shown to be considerable in highly endemic regions. However, detailed data on direct healthcare-related costs associated with CE and AE are scarce for high income countries. The aim of this study was to evaluate direct costs of human disease caused by CE and AE in Austria.MethodsClinical data from a registry maintained at a national reference center for echinococcosis at the Medical University of Vienna were obtained for the years 2012–2014. These data were used in conjunction with epidemiological data from Austria’s national disease reporting system and diagnostic reference laboratory for echinococcosis to assess nationwide costs attributable to CE and AE.ResultsIn Austria, total modelled direct costs were 486,598€ (95%CI 341,825€ – 631,372€) per year for CE, and 683,824€ (95%CI 469,161€ - 898,486€) for AE. Median costs per patient with AE from diagnosis until the end of a 10-year follow-up period were 30,832€ (25th– 75th percentile: 23,197€ - 31,220€) and 62,777€ (25th– 75th percentile: 60,806€ - 67,867€) for inoperable and operable patients, respectively. Median costs per patients with CE from diagnosis until end of follow-up after 10 years were 16,253€ (25th– 75th percentile: 8,555€ - 24,832€) and 1,786€ (25th– 75th percentile: 736€ - 2,146€) for patients with active and inactive cyst stages, respectively. The first year after inclusion was the most cost-intense year in the observed period, with hospitalizations and albendazole therapy the main contributors to direct costs.ConclusionsThis study provides detailed information on direct healthcare-related costs associated with CE and AE in Austria, which may reflect trends for other high-income countries. Surgery and albendazole therapy, due to surprisingly high drug prices, were identified as important cost-drivers. These data will be important for cost-effectiveness analyses of possible prevention programs.

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Section: Discussionmentioning

confidence: 98%

Evaluation of direct costs associated with alveolar and cystic echinococcosis in Austria

et al. 2019

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“…Since research to find new compounds against these parasites is progressing very slowly [ 11 , 34 ], change in ABZ licensing is urgently needed to revise its administration schedule. A change in packaging would also be needed because in many countries the only presentation currently available is 1- or 3-tablet boxes that are extremely impractical for long therapies [ 30 ], adding to the very high cost of the drug and frequent “out-of-stock” situation, regularly putting patients at risk of therapy discontinuation and disease progression [ 35 , 36 ].…”

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A case for adoption of continuous albendazole treatment regimen for human echinococcal infections

et al. 2020

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Cystic (CE) and alveolar (AE) echinococcosis are chronic, neglected parasitic diseases burdened by high morbidity and, for AE, by high mortality, if left untreated. CE and AE have a widespread distribution, including Europe. Albendazole (ABZ), a broad-spectrum benzimidazole drug widely used to treat parasitic infections, is the drug of choice for the management of CE and AE, and is parasitostatic on echinococcal metacestodes. In Europe, ABZ is licensed for interrupted “cyclic” treatment, for a maximum of 3 cycles. However, better efficacy with no increased side effects has been shown when the drug is administered continuously and for longer periods. Current international recommendations, on the basis of clinical, pharmacological, and biological studies, recommend continuous administration of ABZ for months to years for the treatment of CE and AE, and this schedule has been widely in use for the past 20 years. However, in Europe this internationally recommended schedule, with the exception of France, is technically “off-label”, and, as such, requires an informed consent by the patient and, in some countries, even precludes the reimbursement of the drug cost. Adding to the very high cost of the drug, frequent “out-of-stock” situation, and packaging format impractical for long therapies, these conditions put patients with CE and AE regularly at risk of treatment discontinuation and disease progression. European regulations envisage variations to marketing authorization, but postauthorization studies should be carried out by the holder of the license of the drug, in the form of randomized controlled trials. While such studies do not seem feasible and would probably not be ethically justified for CE and AE, European regulations envisage other possibilities in particular situations, which apply to CE and AE, but there is limited interest to invest in this perspective. We urge a coordination between stakeholders to find effective and feasible ways to take action to revise the benzimidazole dosage regimens for CE and AE and to ensure a fair, regular, and easy access to the appropriate treatment to those suffering from these serious diseases.

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“…Manciulli and others, 1 in this issue, show that even when albendazole is theoretically available, as in Italy, it is not always possible to obtain it, and patients face either intermittent availability or must go to extraordinary lengths to obtain their drug supplies. Irregular treatment is far from ideal in terms of efficacy, and it is likely that some patients suffer reduced efficacy or require more prolonged treatment as a result.…”

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Echinococcosis and Albendazole: A Case for Suitable Treatment

Horton

2018

The American Journal of Tropical Medicine and Hygiene

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Shortage of Albendazole and Its Consequences for Patients with Cystic Echinococcosis Treated at a Referral Center in Italy

Cited by 8 publications

References 41 publications

Evaluation of direct costs associated with alveolar and cystic echinococcosis in Austria

Evaluation of direct costs associated with alveolar and cystic echinococcosis in Austria

A case for adoption of continuous albendazole treatment regimen for human echinococcal infections

Echinococcosis and Albendazole: A Case for Suitable Treatment

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