Whilst conducting research on the Brazilian market for our latest multi-client study: The New REAlity of Relative Effectiveness — International Comparison of Evolving Requirements, I looked in detail at the major reform that has led to the newly formed HTA body, CONITEC.
CONITEC stands for the National Commission for Incorporation of Technologies in the Unified Healthcare System (SUS), a Ministry of Health agency that manufacturers have to get acquainted with if they wish to obtain public reimbursement for a new drug in the fast-growing, fast-evolving Brazilian market. CONITEC’s main role is to assist the MoH on SUS reimbursement decisions to include, exclude or restrict the use of a new medicine.
More Than Just a Name Change for CITEC
CONITEC officially replaced CITEC (the Commission for Incorporation of Technologies) in December 2011. Law 12.401/2011 and decree 7.646 have delineated key changes aimed at improving decision-making and access to medicines, including:
- Speedier analysis: CONITEC has to make a recommendation within 180 days from receipt of a funding request, which can be extended by an additional 90 days
- Greater transparency: Obligatory public consultation to obtain contributions and suggestions on evaluated topics
- Improved drug access: Following the publication of a MoH positive funding decision, the new medicine has to be made available by SUS within 180 days
… With Stricter Requirements
Besides a marketing approval from regulator ANVISA, the new legislative reform wants new drug funding requests to include:
- Scientific evidence showing efficacy and safety of the new medicine versus existing SUS funded drugs for the same indication
- Economic evaluation study of the new medicine compared with existing alternatives in SUS
- Estimation of budget impact in SUS
But Still Influences Private Health
CONITEC deliberations are based on a consensus of its plenary assembly, which amongst others includes a representative of the Federal Regulatory Agency for Private Health Insurance and Plans (ANS), that oversees supplementary health assistance in Brazil. This is a practice also common to CITEC days. About 30% of the Brazilian population has subscribed to a private health plan.
2012: The First Days of CONITEC
Since the start of the year, the MoH has been busy setting the basic administrative framework under which CONITEC will operate. Following its first inaugural meeting in early February, CONITEC has been engaging with key stakeholders including participation in a Brazilian Research-Based Pharmaceutical Manufacturers Association Interfarma sponsored event. During this event, CONITEC answered crucial questions on the requisites of drug funding submissions and their deadlines for final decision-making.
Outlook and Implications
The legislation behind CONITEC has notably introduced compulsory requirements, particularly the need of an economic evaluation study, for manufacturers seeking funding for new medicines from SUS. But firms should now expect faster deliberations from the new agency, which has to obey to a strict 180 days deadline. The protracted analysis by CITEC used to previously constitute a huge bottleneck.
The latest reform also aims for greater transparency, which will see CONITEC follow in the footsteps of the NICE, the UK’s HTA agency, with regards to public consultations and hearings. This represents yet another influence from NICE following a crucial visit of key Brazilian stakeholders to the UK agency in February 2010.
What it means for Manufacturers
Manufacturers, however, are more interested in transparency when it comes to CONITEC publishing the rationale behind its reimbursement recommendations similarly to NICE. The new agency, which has yet to make a deliberation on a drug funding request, has currently only made available old top-line outcomes from CITEC.
Despite Brazil’s booming economy, the inception of CONITEC shows that the MoH is still faced with severely limited public funding. The new agency will try to ensure to get value for money when making positive drug reimbursement recommendations. This particularly affects secondary care drugs since public funding of those for the primary care is even more severely restricted. Relevant CONITEC recommendations will also have an impact in the private health supplementary insurance sector since it also suffers from financial constraints.
Manufacturers are not expected to have an easy ride whilst navigating the newly reformed Brazilian public reimbursement system, particularly for more expensive secondary care drugs. Nonetheless, those manufacturers seeking to plug revenues gaps created by stagnating economies in mature pharmaceutical markets should still look at Brazil as an attractive market that is largely driven by the increasing disposable income of the expanding middle class.