ANALYSIS OF BRAZILIAN PUBLIC FUNDING PROCESS FOR NEW BIOLOGIC DRUGS
Author(s)
Rodrigues T*1;Izmirlieva M2, Ando G1 1IHS, London, United Kingdom, 2IHS, London, UK, United Kingdom
OBJECTIVES: To ascertain if the Brazilian HTA body CONITEC, which replaced CITEC in December 2011, is delivering on Ministry of Health (MoH) promises of transparency and set assessment timelines whilst adopting mandatory evidence requirements for new biologic drug funding decisions via the Unified Healthcare System (SUS). METHODS: Secondary research based on CONITEC’s final reimbursement recommendation reports, evaluating existing and sponsor submitted data. These reports include deliberations from a plenary assembly of representatives from the MoH, drug regulator ANVISA and supplementary health regulator ANS, as well as public consultation contributions. RESULTS: CONITEC has delivered on transparency with publications of the rationale behind each of its recommendations, thus enabling pharmaceutical firms to understand how to respond. The 180 day initial analysis phase deadline is being met but evaluation of the implementation phase timeline is premature. Out of the final recommendations published to date for biologics, about 40% correspond to a funding rejection. Biologic medicines have been denied funding from psoriasis to wet AMD due to lack of cost-effectiveness as well as efficacy and safety studies of short duration and small patient populations. The rejection of everolimus for a rare brain tumour shows that orphan drugs are not being treated differently. Positive endorsements of biologics from breast cancer to rheumatoid arthritis come with recommendations of significant price cuts and creation of clinical guidelines. CONCLUSIONS: Manufacturers are struggling to adjust to evidence requirements needed in supporting funding applications for new biologics, including orphan drugs. Transparency is evident in CONITEC’s analysis phase but is absent after a positive recommendation, when the MoH ascertains how the medicine will be offered by SUS. Nonetheless, this is an advance compared to the CITEC process, whereby decisions were not made public and there were no clear timelines.
Conference/Value in Health Info
2013-09, ISPOR Latin America 2013, Buenos Aires, Argentina
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PHP42
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases