Proposed HTA agency AGNETS: The creation of a fourth hurdle in Argentina?
AGNET could be a new acronym that manufacturers will have to become acquainted with as a result of new Argentinean President Mauricio Macri's bill for the creation of a formal HTA agency, the Agencia Nacional de Evaluación de Tecnologías de Salud. Macri presented the bill to the Senate in July 2016 with the aim of starting to evaluate health technologies for reimbursement decisions based on scientific rationale (centered on efficacy, effectiveness, equity and cost-effectiveness criteria). If it is enacted into law, the evaluations will apply to the Obligatory Medical Plan (PMO) and the basic basket of services to be determined for the public sector.
The PMO, an outdated compulsory package of services, is the minimum coverage for the Obras Sociales (similar to Sickness Funds, covering 47% of health expenses), and private insurance providers, known as Prepagas (covering 10%). Aside from these two systems of coverage in Argentina's fragmented healthcare landscape, there are also the National Institute of Social Services for Pensioners (PAMI, covering 8%), providing insurance for the elderly, and the 24 provincial public systems (covering the remaining 35% of expenditure).
According to the bill, AGNET will intervene after the Argentinian National Administration of Medicines, Food and Medical Technology (ANMAT) has rendered its decision on a particular technology. Acting before any reimbursement decision is made, the agency's main responsibilities will include:
- Analysis of scientific information related to evaluation of health technologies and their dissemination among professionals and health services (from public, private and Obras Sociales spheres);
- Promotion of research to fine-tune the methodology for the evaluation of health technologies;
- Publication of deliberations through technical evaluation reports on the exclusion (when lacking adequate scientific evidence) or inclusion of health technologies and how they should be used;
- Coordination, elaboration and dissemination of evaluation reports (recommendations) for health technologies and clinical practice guidelines (protocols of use);
- Follow-up and monitoring of the outcome of reimbursed health technologies; and
- Evaluation of the economic and social impact of the inclusion of health technologies into the obligatory coverage.
AGNET decisions will be based mainly on a simple majority from its Directorate members, made up by the President, the Vice-President and three directors designated by the national Ministry of Health (MoH). However, there is heated discussion regarding who should be involved in the evaluations, with critics arguing against inclusion of manufacturer associations and calling for a clear declaration of conflicts of interests. This is relevant as Directorate decisions are to be supported by two councils:
- Advisory Council (advises the Directorate and suggests HTA evaluations): 9 members, including representatives from academic and scientific institutions, manufacturer associations, medical associations and NGOs as well as the COSSPRA, an organization overseeing beneficiaries of the provincial Obras Sociales;
- Evaluation Council (prioritizes Advisory Council HTA proposals, which it can also contest): representatives from the National Ombudsman's Office, the national MoH's Superintendence of Health Services (responsible for the revision of the PMO), payers (from the private sector, the national system of health insurance and each province of the Federal Health Council, COFESA).
Provinces have been invited to adhere to this bill and voluntarily subject themselves to the agency's directives, which will allow for the adaptation of the HTA reports to the local context. The 24 Argentinean provinces are responsible for their public budgets and overall health provision management but critics argue their influence will be quite restricted within the AGNET.
As a decentralized institution of the MoH, AGNET has been modelled on international experience and WHO/PAHO recommendations, as well as harmonization with regional HTA agencies. Although the agency will have its own economic and financial authority, there are questions regarding whether it will be susceptible to political changes and pressures. Other challenges lying ahead, even if AGNET is approved, include constraints in terms of budget as well as reliable, timely and accessible information to guide evaluations.
AGNET's directorate appears to be the ultimate decision-making authority as the proposal does not mention the MoH in that context. AGNET decisions will have a binding character by law, according to Minister of Health Jorge Lemus, so this should help reduce the growing issue of health judicialization, whereby patients launch lawsuits to obtain access to unfunded drugs. The proposed legislation highlights the agency will be a consultation body in judicial cases related to health technology reimbursement.
AGNET is one the 12 key policies underpinning Lemus's National Health Plan for 2016-2019. If the bill does not become law, the ambitious reform of the national healthcare system would be in jeopardy, notably the other governmental flagship policy of establishing Universal Health Coverage (Cobertura Universal de Salud, CUS). It is important for the pharmaceutical industry to actively engage in the discussion over the potential introduction of a formal fourth hurdle in Argentina, following in the footsteps of Brazil's influential HTA body CONITEC created in 2011.
Tania Rodrigues is a consultant in the IHS Life Sciences consulting team specializing in healthcare policy, market access, pricing and reimbursement and corporate strategies.
Posted 28 October 2016
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