Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil

Abstract

ObjectiveIn São Paolo, Brazil, patients can appeal to the courts, registering law suits against the government claiming the need for biological agents for treatment of psoriasis. If the lawsuits are successful, which is usually the case, the government then pays for the biologic agent. The extent to which the management of such patients, after gaining access to government payment for their biologic agents, adheres to authoritative guidelines, is uncertain.MethodsWe identified patients through records of the State Health Secretariat of São Paulo from 2004 to 2011. We consulted guidelines from five countries and chose as standards only those recommendations that the guidelines uniformly endorsed. Pharmacy records provided data regarding biological use. Guidelines not only recommended biological agents only in patients with severe psoriasis who had failed to respond to topical and systemic therapies (eg, ciclosporin and methotrexate) but also yearly monitoring of blood counts and liver function.ResultsOf 218 patients identified in the database, 3 did not meet eligibility criteria and 12 declined participation. Of the 203 patients interviewed, 91 were still using biological medicine; we established adherence to laboratory monitoring in these patients. In the total sample, management failed to meet standards of prior use of topical and systemic medication in 169 (83.2%) patients. Of the 91 patients using biological medicine at the time of the survey, 23 (25.2%) did not undergo appropriate laboratory tests.ConclusionsImportant discrepancies exist between clinical practice and the recommendations of guidelines in the management of plaintiffs using biological drugs to treat psoriasis.

Psoriasis in Latin America and the Caribbean: a systematic review

“…Also in Brazil, a cross‐sectional study including 203 patients that had, through lawsuits filed against the state of São Paulo in the period 2004–2010, gained access to biologics for treatment of psoriasis with adalimumab (6.9%), efalizumab (21.2%), etanercept (17.2%) and infliximab (54.7%), evaluated the standards and adherence of management of psoriasis common to major international guidelines . Their results showed that access to biologics is largely through prescriptions by private practitioners, and that only 16.7% of patients met the guidelines before beginning biologic treatment with topical and non‐biological systemic therapy.…”

Editorial: New Horizons in Health-Promoting Technologies: From Development to Rational Use

“…Interventions, including effective drug monitoring and regulations, and encouraging rational use, have been well described in studies that have addressed, among others, the translation of knowledge through a brief political and deliberative discourse (de Araujo et al; Fulone et al). In addition, aspects related to the challenges and impact of control policies were addressed in the study by Ranabhat et al Some authors have shown that when there is a lack of effective drug control and monitoring, either due to wrong selection of essential drugs for reimbursement or lack of demand-side measures (Godman et al, 2014;Fulone et al, 2016;Osorio-De-Castro et al, 2018) or lack of adherence of official guidelines, health and expenditures (Silveira et al, 2014;De Camargo et al, 2016) may be compromised.…”

“…In addition, aspects related to the challenges and impact of control policies were addressed in the study by Ranabhat et al. Some authors have shown that when there is a lack of effective drug control and monitoring, either due to wrong selection of essential drugs for reimbursement or lack of demand-side measures ( Godman et al., 2014 ; Fulone et al., 2016 ; Osorio-De-Castro et al., 2018 ) or lack of adherence of official guidelines, health and expenditures ( Silveira et al., 2014 ; De Camargo et al., 2016 ) may be compromised.…”

Ten Years On

“…12 Evidence, however, continues to accumulate to support that the full potential of these magic bullets has not been realized because patients continue to be considerably undertreated globally. [13][14][15] In a series of US surveys performed by the National Psoriasis Foundation from 2003 to 2011, the proportion of patients with moderate to severe psoriasis who remain untreated has plateaued at approximately 30%. 13 Moreover, more than 20% of patients with moderate to severe psoriasis continue to be treated with topical therapies alone and more than 50% of patients are dissatisfied with their treatment.…”

“…14 In Brazil, similar discrepancies exist between actual clinical practice and the recommendations included in the relevant guidelines, thus negatively influencing optimal patient care. 15 The reasons for these inconsistencies include low awareness of therapy availability; lack of understanding of therapy use or monitoring; concerns over adverse effects; lack of effectiveness; and the inability to secure appropriate national insurance coverage or payment for the recommended biological therapies. This finding begs the question as to whether the much-heralded new era for disease management from 2003 has actually been fulfilled.…”