RA in Latin America. Special concerns, similarities and differences with developed regions.

RA in Latin America. Special concerns, similarities and differences with developed regions.

Carlo Vinicio Caballero Uribe MDCarlo Vinicio Caballero Uribe MDUnidad de Reumatología. Universidad del Norte. Unidad de Reumatología. Universidad del Norte. Barranquilla. ColombiaBarranquilla. ColombiaEx Presidente. Asociación Colombiana de Ex Presidente. Asociación Colombiana de Reumatología. Miembro GladarReumatología. Miembro GladarEditor Salud Uninorte Journal (Scopus journal)Editor Salud Uninorte Journal (Scopus journal)Twitter: @carvicabTwitter: @carvicabPunta Cana Abril 2011Punta Cana Abril 2011

Rheumatoid Arthritis in the Latin American Context. Objectives

● Review Current Algorithms employed to manage Rheumatoid Arthritis in major world regions

● Analyze Challenges in the Management of Rheumatoid Arthritis in developing countries

● Observe similarities and differences in the management of Rheumatoid Arthritis among Latin America and develope world.

● Analysis , Conclusions and proposals.

USA

USA:American College of Rheumatology 2008

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines 2008

● Update 2002 Guidelines, Including Information about Biologics

●  Formal group process to develop recommendations that were as evidence-based as possible.

● Addressing 5 domains prespecified by the ACR: (1) indications for use, (2) screening for TB (3) monitoring for adverse effects, (4) evaluating clinical response, and (5) the roles of cost and patient preferences in decision making (for biologic DMARDs only).

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines 2008

● A Task Force Panel that critiqued and rated proposed recommendations included internationally recognized clinicians, methodologists, and patient representatives with broad expertise in the use of nonbiologic and biologic DMARDs, evidence-based medicine, patient preference, and healthcare economics.

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines 2008

● Nonbiologic DMARD combinations best supported by evidence and used most commonly are MTX+Hclq, MTX+SSZ, MTX+LEF, SSZ+Hclq, SSZ+Hclq followed by MTX.

● The triple DMARD combination of SSZ, Hcql, and MTX is recommended for all patients with poor prognostic features and moderate or high levels of disease activity, regardless of disease duration.

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines 2008

● Biologic DMARDs should be used only after failure of nonbiologic DMARDs. Patients with RA should be seen regularly to evaluate disease activity and severity and to determine whether alternative therapies should be used

● Methotrexate or leflunomide monotherapy should be started for patients with all disease durations and for all degrees of disease activity irrespective of poor prognostic features.

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines 2008

● The use of biologic DMARDs are separated according to disease duration (< 6 months and ≥ 6 months). The use of antitumor necrosis factor–alpha (TNFα) agents (etanercept, infliximab, and adalimumab) is stratified for durations of 3 months or longer or 3 to 6 months.

● Anti-TNFα agents can be used interchangeably with methotrexate in patients with early RA who have never received DMARDs and have high disease activity.

American College of Rheumatology Updates Rheumatoid Arthritis Guidelines

2008

● An anti-TNFα agent plus methotrexate is recommended for patients with high disease activity for 3 months or longer with poor prognosis and no barriers related to treatment cost and no insurance restrictions to accessing medical care.

● Contraindications to the use of nonbiologic and biologic DMARDs may include infectious disease or pneumonitis, or both; and hematologic, oncologic, cardiac, liver, renal, neurologic, and pregnancy and breast-feeding contraindications.

Europe

Europe: Eular Recommendations (2009)

Eular Recommendations 2009 (Principles)

• Rheumatologists are the specialists who should primarily care for patients with RA.

• Treatment of patients with RA should aim at the best care and must be based on a shared decision between the patient and the rheumatologist. 

• RA is expensive in regards to medical costs and productivity costs, both of which should be considered by the treating doctor. 

● Synthetic DMARDs early● Treatment targeting remission or low disease activity● MTX as initial choice● Leflunomide, SSZ or injectable gold—Alternatives● Synthetic DMARD monotherapy or combination

therapy—● Glucocorticoids ok.● Addition of a biological DMARD or switch to

another synthetic DMARD

Eular Recommendations 2009

Eular Recomendations 2009

● Initiation of a TNF inhibitor● Abatacept, rituximab or tocilizumab● Azathioprine, ciclosporin A or cyclophosphamide● Intensive medication strategies● Tapering biological DMARDs● Tapering of synthetic DMARDs● Biological treatment in DMARD naive patients● Adjustment of treatment

Eular Recomendations 2009

Eular 2009: Phase 1. Initiate

Eular 2009: Phase 2. Change

Eular 2009: Phase 3. Change again

Latin America

“Certain issues affect the implementation of early and effective treatment, including the lack of definite diagnosis criteria in early RA, delay in qualified medical attention, and difficulty in identifying patients likely to develop persistent disease or with risk factors for severe or erosive disease”

•First LA Position Paper. Experts Consensus Rheumatology 2006

•Qualified manpower availability to treat RA is insufficient

•Deficient drug availability and access to therapy

•Inadequate medical records and information

•Infections are special concern

Community Education Needs To Be Improved

● Inexistance of Gov. Programs (93%)

● Inexistance of public education programs (86%)

● Lack of media information (82%)

● Lack of information among people (81%)

● Massive media difussion is necessary (75%)

Second Consensus PANLAR/GLADAR on Education and treatment of RA. Chile 2005

Latin America:: Strategic areas identified as priorities for our region

• Early diagnosis and access to care by

multidisciplinary teams.

• Creation of databases to identify infections with the use of biologic agents in RA

• Overall efforts to improve the care of RA patients in accordance with international standards.

• Implementation of educational programs aimed to improve self-management.

This Consensus Addressed by first time specifically economic issues in LA

Gasto Público en salud como % del PIB y Gasto Gasto Público en salud como % del PIB y Gasto per capita en Salud per capita en Salud (En US Dólares)(En US Dólares)

$102

$1.310

$1.628

$1.314

Canada

USA

OECD - Europe

Latin America andthe Caribbean

Source: IDB, “Latin America after a decade of reforms,” Londoño and Székely (1997).

3,0%

6,6% 6,3%7,0%

Canada

USA

OECD - Europe

Latin America andthe Caribbean

•GP % PIB •Gasto per capita

Composición de los Gastos Nacionales de Salud por Subsector en Latino America

15,8%

8,5%

17,2%39,0%

19,5%

Gobierno Central GOB LOCAL

Seguridad Social Gasto de Bolsillo

Gastos Indirectos

Source: IDB, “Latin America after a decade of reforms,” Londoño and Székely (1997).

Cost matters. How important and how much do we know about Cost effectiveness of Biologics?

Cost Effectiveness Evaluation ofRheumatoid Arthritis treatment with

Biologics

• Economic evidence suggests that biologics are not cost effective compared to DMARDs for RA in adults at a cost effectiveness threshold of $50,000 per QALY.

• There is mixed evidence of cost-effectiveness in selected populations at a willingness to pay threshold of $100,000 per QALY.

• Definitive conclusions are difficult to make given the lack of consistent, high-quality studies.

• Economic evaluations of biologics are hindered by lack of data on longterm responses and consequence of responses on downstream health utilization and productivity.

• Algorithms employed in USA, Europe and Latin America are similar. Need updates to track current knowledge.

• Cost is an important variable in all economies

• Suboptimal undergraduate education, inadequate diagnosis, late referrals, lack of human and technical resources, poor access to rheumatologists, and some deficiencies in drug availability are specific problems in LA.

Analysis

ACR Paper: 268 Citations

Eular Paper: 49 Citations

Panlar Papers: 12 Citations

• Rheumatological community has to establish RA as a health priority to improve access to care and to a ‘’window of opportunity”

• Although there are several papers establishing importance and guidelines to help manage disease in the continent they need update, follow up, diffusion and impact but they exists and represent a great collaborative work

Analysis

Challenges for the treatment of Rheumatoid Arthritis is now in

Google Books

•http://retosar.blogspot.com/

Challenges for the treatment of Rheumatoid Arthritis in Latin America

● Establish RA as a public health priority

● Encourage acces to prompt diagnosis and treatment

● Develope algorithms according our realities

● Establish routine epidemiological surveillance

● Educate people , patients and doctors

Rheumatoid Arthritis in Latin AmericaSome Proposals

● Keep working in multinational and multiregional efforts. It´s Web 2.0 era¡¡¡.

● Guidelines are important but need updates periodically (each 2 years)

● More “real life” studies including economic evaluations in subgroups of patients.

● Test established hypothesis● Promote utilization of objective

outcome measure and Evaluate “overall” outcomes