PANLAR consensus statement on biosimilars.

INTRODUCTION: Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. OBJECTIVE: The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). METHODS: Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. RESULTS: Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. CONCLUSION: The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. KEY POINTS: • Biologics have improved the treatment of rheumatic diseases. • Their high cost limits access for many patients in both North America and Latin America. • Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. • PANLAR presents its consensus on biosimilars in rheumatology.

Correction to: PANLAR consensus statement on biosimilars.

The two co-authors of the mentioned above article were incorrect. The correct are authors should have been "P. A. Beltrán" instead of "P. A. B. Roa" and "J. F. Diaz-Coto" instead of "L. Diaz Soto".

Resource utilization and the cost of rheumatoid arthritis in Brazil.

OBJECTIVE: To describe and analyze resource utilization in patients with rheumatoid arthritis (RA) treated at a tertiary public health facility over a one-year period. Costs for the patient and for society associated with the treatment of RA were also investigated. METHODS: One hundred consecutively selected RA patients were included. Resource utilization was evaluated retrospectively for one year. Systematic interviews were used in all patients and demographic, socioeconomic and clinical variables were recorded. RESULTS: One hundred patients were included. Most of the patients were women (92%) and had mean age and disease duration of 51 and 11 years, respectively. The majority of the patients were Steinbroker functional class I (48%). Mean HAQ score for the sample was 0.95 and mean Short-Form-36 scores were between 49.64 (bodily pain) and 70.00 (social functioning). The average monthly household income for the group was US$ 359. The patients had on average 4 outpatient visits and 21 laboratory exams per year. Drugs accounted for 59% of the total cost associated with RA. The average total cost for society was US$ 424.14 per patient per year, of which 95% were direct and 5% indirect costs. CONCLUSION: The management of RA patients is an important financial burden in Brazil. The effort to couple resource utilization with the best available evidence, associated with the limited funds available in the healthcare system (particularly in a developing country), emphasizes the importance of studies that critically evaluate resource utilization and cost in these chronic patients. The systematic use of such studies may prove helpful to optimize the health system.

Cross-cultural adaptation of the Behçet's Disease Current Activity Form (BDCAF) to Brazilian Portuguese language.

The Behçet's Disease Current Activity Form (BDCAF) is a clinical instrument used to assess the activity of Behçet's disease (BD), which was originally developed in English. The aim of the present study was to perform a cross-cultural adaptation of the BDCAF to Brazilian Portuguese language and to evaluate its reliability in a population of Brazilian patients with BD. Brazilian Portuguese version of the BDCAF, named BR-BDCAF, was obtained according to established guidelines. Forty Brazilian patients with BD diagnosed according to the International Study Group for Behçet's Disease criteria were assessed by two rheumatologists in independent sessions and submitted to the BR-BDCAF. Inter- and intraobserver agreement were then evaluated by kappa scores (values higher than 0.6 indicated good agreement). Good inter- and intraobserver agreements were achieved for the most common manifestations of BD: kappa scores higher than 0.6 were obtained for oral and genital ulcerations, skin lesions, and articular and general complaints. Moderate interobserver agreement was obtained for ocular activity (kappa 0.483) and fair interobserver agreement was obtained for gastrointestinal (kappa 0.322), major vessel (kappa 0.281), and central nervous system activity (kappa 0.304). BR-BDCAF was found to be a reliable instrument for the classic mucocutaneous and articular manifestations of BD and for general complaints, but complementary assessment is needed to evaluate specific visceral involvement for disease activity.

[Resource utilization and costs in osteoporosis]. / Utilização de recursos e custos em osteoporose.

BACKGROUND: Osteoporosis is characterized by low bone mass, deterioration of the microarchitecture of the bone tissue and increase susceptibility to fractures. Clinical manifestations are fractures and their complications. The most common fractures are hip,spine and wrist, although any bone is susceptible. OBJECTIVES: To assess the resource utilization and the annual costs incurred by patients with postmenopausal osteoporosis METHODS: One hundred consecutive patients were studied in the Universidade Federal de São Paulo. The inclusion criteria were: postmenopausal osteoporosis (WHO 1994) for at least one year b) at least one year attending the outpatient clinic, minimal comprehensive and speaking conditions. The socioeconomic and clinical characteristics, the resource utilization and costs in the last year were assessed using 2 questionnaires. The unitary costs were based in the Public Healthcare System Index (1998). RESULTS: The mean age was 66 years and the monthly family income was R$ 534.14 (US$ 456 - in 1998). There was a mean of 7 visits/patient/ year. 77% of the patients used calcium and 38% used estrogens. The mean total annual costs for osteoporosis treatment, considering societal perspective, were R$ 908.18 (US$ 776-in 1998) per patient per year. CONCLUSION: The costs related to osteoporosis treatment represented 11% of the mean monthly household income from the patients' perspective (R$ 534=US$ 456). As the population is ageing and the osteoporosis incidence is increasing, health policy should be implemented to rationally allocate the scarce resources available, based on economic analysis.

Utilizaçäo de recursos e custos em osteoporose / Resource utilization and costs in osteoporosis

A osteoporose é uma doença caracterizada por baixa massa óssea e deterioraçäo da microarquitetura do tecido ósseo, com conseqüente aumento da fragilidade óssea e suscetibilidade a fraturas . Os recursos utilizados no tratamento de fraturas por osteoporose säo siginificativos e com custos elevados. OBJETIVO: Dimensionar a utilizaçäo de recursos e custo anual por pacientes com osteoporose pós-menopausa. MÉTODOS: Cem pacientes foram consecutivamente selecionados do ambulatório de doenças osteometabólicas da Universidade Federal de Säo Paulo-Escola Paulista de Medicina (UNIFESP-EPM), entre abril de 1997 a agosto de 1998. Os critérios de inclusäo foram: osteoporose pós-menopausa (OMS, 1994) há pelo menos um ano; mínimo de um ano em acompanhamento ambulatorial; mínimas condiçöes de entendimento e expressäo verbal para responder aos questionários. Características socio-econômicas, clínicas, utilizaçäo de recursos e custos no último ano foram levantadas através de entrevistas empregando-se dois questionários. Os custos unitários dos recursos utilizados no Serviço Público de Assistência à Saúde basearam-se na Tabela SUS de agosto de 1998. RESULTADOS: A média de idade foi 65,85 anos e a renda familiar média-mensal, R$ 534,14. Foram realizadas em média sete consultas/paciente/ano. Das pacientes, 77 por cento usaram cálcio e 38 por cento estrógenos por algum período durante o último ano. Os custos médios totais anuais para o tratamento das pacientes com osteoporose pós-menopausa, sob a perspectiva da sociedade, no Sistema Público em Säo Paulo, foram de R$ 908,18/paciente/ano. CONCLUSÄO: Os custos com o tratamento de osteoporose pagos pelas pacientes representaram 11 por cento da renda familiar mensal média (R$ 534). Em funçäo do envelhecimento da populaçäo e aumento da incidência de osteoporose, políticas de alocaçäo racional de recursos basedas em análises econômicas devem ser implementadas