Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective.

In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation.

The landscape of systemic lupus erythematosus in Brazil: An expert panel review and recommendations.

PURPOSE: The objective of this review is to address the barriers limiting access to diagnosis and treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN) in Brazil, specifically for patients in the public healthcare system, arguably those with the least access to innovation. DESIGN: A selected panel of Brazilian experts in SLE/LN were provided with a series of relevant questions to address in a multi-day conference. During the conference, responses were discussed and edited by the entire group through numerous drafts and rounds of discussion until a consensus was achieved. RESULTS: The authors propose specific and realistic recommendations for implementing access to innovative diagnostic tools and treatment alternatives for SLE/LN in Brazil. Moreover, in creating these recommendations, the authors strived to address barriers and impediments for technology adoption. The multidisciplinary care required for SLE/LN necessitates the collective participation of all involved stakeholders. CONCLUSION: A great need exists to expand the adoption of innovative diagnostic tools and treatments for SLE/LN not only in Brazil but also in most countries, as access issues remain an urgent demand. The recommendations presented in this article can serve as a strategy for new technology adoption in other countries in a similar situation.

Comparing time and motion methods to study personnel time in the context of a family planning supply chain intervention in Senegal.

BACKGROUND: A family planning (FP) supply chain intervention was introduced in Senegal in 2012 to reduce contraceptive stock-outs. Labour is the highest cost in low- and middle-income country supply chains. In this paper, we (1) understand time use of personnel working in the FP supply chain at health facilities in Senegal, (2) estimate the validity of self-administered timesheets (STs) relative to continuous observations (COs), and (3) describe the cost of data collection for each method. METHODS: We collected time use data for seven stockroom managers in six facilities using both ST and CO. Activities were categorized as follows: stock management associated with FP, non-FP stock management, other productive activities, non-productive activities, and waiting time. Paired t tests were used to compare the mean differences between the two methods in all categories and in productive time alone. RESULTS: Among all activities, the absolute and relative time spent on productive activities was higher when estimated by ST compared to CO. Conversely, waiting time was underestimated by STs. There was no difference in the relative time spent on non-productive activities. When comparing the distribution of the three productive activity categories, we found no evidence of a difference in relative time percentage estimates between CO and ST (FP stockroom management - 3.0%, 95% CI - 7.4 to 1.4%; non-FP stockroom management 3.4%, 95% CI - 2.8 to 9.6%; and other productive activities - 0.1%, 95% CI - 6.3 to 6.0%). Data collection costs for CO are 140% more than ST. CONCLUSION: STs were not a reliable method for measuring absolute labour time at health facilities in Senegal due to considerable underestimates of time waiting for clients. However, ST had acceptable reliability when examining distribution of productive time. Although CO provides more accurate absolute time estimates, the unit costs for data collection using this method are more than triple those for STs in Senegal.

Atopic Dermatitis in Latin America: A Roadmap to Address Data Collection, Knowledge Gaps, and Challenges.

BACKGROUND: Atopic dermatitis (AD) is a systemic, multifactorial disease that causes significant morbidity and health care burden in Latin America (LA). Data on AD are scarce in LA. Lack of disease registries and non-standardized study methodologies, coupled with region-specific genetic, immunological, and environmental factors, hamper data collection. A panel of LA experts in AD was given a series of relevant questions to address before a conference. Each narrative was discussed and edited through numerous rounds of deliberation until achieving consensus. Identified knowledge gaps in AD research were updated prevalence, adult-disease epidemiology, local phenotypes and endotypes, severe-disease prevalence, specialist distribution, and AD public health policy. Underlying reasons for these gaps include limited funding for AD research, from epidemiology and public policy to clinical and translational studies. Regional heterogeneity requires that complex interactions between race, ethnicity, and environmental factors be further studied. Informed awareness, education, and decision making should be encouraged.

The Unmet Needs in Atopic Dermatitis Control in Latin America: A Multidisciplinary Expert Perspective.

INTRODUCTION: Adoption of control tools for atopic dermatitis (AD) in Latin America (LA) is currently very limited. Clinical assessment tools represent a practical method to measure the impact of treatment on disease activity and on the quality of life of patients. However, the use of these tools in the LA clinical practice setting is limited. METHODS: A selected panel of Latin American experts in fields related to atopic dermatitis were provided with a series of relevant questions to address prior to the multi-day conference. Within this conference, each narrative was discussed and edited by the entire group, through numerous drafts and rounds of discussion, until a consensus was achieved. RESULTS: The panel proposes specific and realistic recommendations for implementing control tools for AD care in LA. In creating these recommendations, the authors strove to address all barriers to the widespread use of these tools. CONCLUSION: This article includes a narrative analysis of barriers to AD control in LA and provides necessary recommendations to integrate and increase the use of validated AD control assessment tools throughout the region.