Access and barriers to MS care in Latin America

Abstract

Multiple sclerosis (MS), an epidemiologically emergent disorder in Latin America (LATAM), poses substantial socioeconomic challenges to a region where most countries remain as economies in development. MS is not health priority despite its economic and communitarian impact with a relatively low prevalence. MS treatments in LATAM have evolved from earlier long-term oral steroids and immunosuppression protocols, to platform disease modifying therapies (DMTs), to the current landscape with more advanced therapeutic molecules. Following FDA approval, a DMT may eventually become available in LATAM conditioned to industrial marketing interest. Most countries do not count all medications in their armamentarium. Access to therapy by the MS population in the region is low (9.5%–42.8%). Generic treatments, biosimilars, and follow-on complex non-biological drugs (CNBD) are commonly available in institutional formularies in LATAM despite their lack of supportive efficacy and safety data and reported molecular differences with the innovators. Savings to health systems thus far have been negligible. Medicine licensing agencies in LATAM, despite limitations in resources, have considerably improved their assessments by incorporating more modern criteria and methodology. Access to symptomatic management, rehabilitation procedures, and the role of patients associations are discussed.

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…In Latin America, medical societies have expressed concern about pharmacy-level substitution of biosimilars, 145,146 given its potential implications for pharmacovigilance and safety. 144 The product provided to the patient may be unknown to the recipient and the prescriber in many cases, 154 and substitution is a particular concern in countries where intended copies are in use. 2,84 Information on pharmacy-mediated substitution of biosimilars was collected for 13 Latin American countries in a 2017 global survey; Peru was the only country in the region for which it was indicated that substitution could occur.…”

Disease-modifying therapies in multiple sclerosis in Latin America

“…A likely explanation for this finding, beyond the inherent nature of injectable drugs, is the interchangeability that has been observed in LATAM with the use of biosimilars. 2 , 12 , 13 …”

“…Once these biosimilars are commercially available, rigorous pharmacovigilance programs will be necessary to ensure that safety and efficacy is maintained. 12 However, these programs are nonexistent for most of the drugs in the majority of LATAM countries.…”

Actitudes terapéuticas hacia la esclerosis múltiple en Centroamérica y el Caribe frente a la pandemia de SARS-CoV-2

“…La esclerosis múltiple (EM) en Centroamérica y el Caribe mantiene una baja prevalencia 1 , mientras que el impacto socioeconómico ejercido por esta enfermedad en los sistemas de salud de la región es severo considerando el nivel de crecimiento económico de estos países. A pesar de esta limitación, en años recientes la mayoría de los sistemas de seguridad social y algunos de atención pública en esta zona han dedicado una gran porción de sus presupuestos a la adquisición de las variadas y onerosas terapias aprobadas por agencias internacionales para el manejo de la EM 2 . Esta situación se ha desarrollado gradualmente en respuesta institucional al clamor público apoyado por la necesidad neurológica de una atención moderna y adecuada de los pacientes con EM.…”