Brazil's health technology assessment (HTA) body CONITEC has issued guidelines for the inclusion and exclusion of healthcare technologies in the Brazilian Public Health System (SUS).
Implications | The published document outlines guidelines and priorities to support manufacturers in the development of health technology assessment dossiers and help them understand how funding decisions are made. |
Outlook | These guidelines render the funding process and allocation of health resources more transparent, which should make the entire process more predictable. |
Brazil's health technology assessment (HTA) body CONITEC issued on 2 December guidelines for the development and evaluation of HTA dossiers. The document provides detailed information on how medical products are selected and then prioritised for HTA evaluation.
Requests for inclusion or exclusion of healthcare technologies in the Brazilian Public Health System (SUS) come from various stakeholders, including manufacturers, public institutions, and patient associations. According to the guidelines, CONITEC selects technologies for HTA evaluation based on the following criteria, before prioritising which ones will be assessed first:
Safety | Unacceptable safety risk; risk/benefit balance; or evidence that new technologies achieve same outcome at an acceptable cost with lower safety risks |
Effectiveness | Lack of evidence; or low level of efficacy and effectiveness; evidence of inefficiency and non-effectiveness in one or more indications; evidence that new technologies demonstrate higher level of effectiveness at similar cost |
Cost | Cost of technology does not translate into proposed benefit; other technologies provide same outcome at lower price/cost; no price decrease over time |
Cost effectiveness | Evidence that a competitor is more cost effective |
Misuse | Evidence that the technology is no longer used, or is being used inappropriately |
Logistics | A competitor with the same therapeutic outcome requires simplified logistic measures with proven lower costs |
Availability | Supply shortage due to production issues, non-renewal of marketing authorisation, or interruption of production |
Acceptability | Evidence that the technology is associated with significant discomfort/pain or other undesirable adverse effect that causes discontinuation of treatment; evidence that the technology considered very invasive, or irrelevant to clinical practice |
Contra-indications | Contra-indication jeopardises or limits use in clinical practice |
Source: IHS Markit based on CONITEC, HTA guidelines, "Diretrizes Metodológicas// avaliação de desempenho de tecnologias em saúde", December 2016 | |
On top of the above standards, CONITEC also highlights the need to rely on horizon scanning to optimise the selection and evaluation process, and avoid evaluating a drug that could be replaced in the short term.
CONITEC also emphasises the importance of real-world studies, and recommends establishing a schedule for monitoring the clinical effectiveness of medicines over time. The Committee insists that the co-ordination and execution of real-life studies should not be performed by entities or participants that are subject to conflict of interest. If necessary, manufacturers can provide comments and clarify the scientific evidence during the evaluation process, but should not participate in the real-life studies.
The guidelines also mention what role pricing plays in the evaluation process. Brazil follows a value-based pricing approach, where prices are negotiated based on cost effectiveness, safety, adherence, and use. Price comparison is also performed with references to local and regional acquisition prices, and, whenever available, international markets. The use of risk-sharing agreements is also encouraged for the inclusion of new technologies in the SUS.
Outlook and implications
These guidelines on the inclusion and exclusion of health technologies into the SUS render the entire process more transparent for all stakeholders involved. Manufacturers will certainly benefit from such an initiative, as the selection and prioritisation process will become more predictable. This will allow manufacturers to be better prepared for the HTA process, for their established and new medicines.
Horizon scanning activities are relatively new among HTA bodies and highlight the importance of a long-term view on how to allocate health resources. New innovations have never been so expensive, and although this puts substantial pressure on healthcare budget worldwide, it encourages healthcare authorities to prioritise and disinvest in order to reallocate funding to new therapies. Another sign of transparency is that CONITEC pledged to indicate, whenever possible, how funds would be reallocated in case of product disinvestment.
The full document is available here, in Portuguese.