Article type
Abstract
Background: In Brazil, the pharmaceutical sector has requested an individual incorporation in the Brazilian public health system (SUS) for each new drug for multiple sclerosis (MS) that receives sanitary authorisation for marketing. Horizon scanning within the Brazilian Ministry of Health has played a key role in the recommendations made by the National Committee for Health Technology Incorporation (CONITEC). Horizon scanning seeks to predict which technologies have potential to impact on healthcare in SUS, before their formal request.
Objectives: Present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat MS.
Methods: Grey literature was searched to find new and emerging drugs for MS treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardised form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.
Results: In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for MS. In this case, the drug’s administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.
Conclusions: Horizon scanning has proven to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon-scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC’s members and a horizon-scanning section in all CONITEC’s reports became mandatory.
Objectives: Present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat MS.
Methods: Grey literature was searched to find new and emerging drugs for MS treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardised form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.
Results: In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for MS. In this case, the drug’s administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.
Conclusions: Horizon scanning has proven to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon-scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC’s members and a horizon-scanning section in all CONITEC’s reports became mandatory.