The planning of how to follow up a new medicine included in the national managed introduction process is started at an early stage, approximately 18 months before marketing authorisation. This is done in collaboration between the county councils working group, clinical experts and governmental agencies like the TLV and the MPA. The aim is to identify questions, agree on roles and responsibilities and identify sources of data.
The purpose of following up the new drug at a national level is to understand whether it has been used according to the recommendation, thus, for the right patient (indication, counter-indication), and in the right way (dose, duration of treatment). This is the base level that should be followed for all drugs included in the national managed introduction process. If possible, safety and efficacy sometimes need to be followed.
The follow-up protocol describes how long the drug needs to be followed before the results are evaluated and communicated. In general, the drugs are followed for between one and three years. The results are communicated by the New Therapies Council to the county councils and are published on this website. Based on the results, the New Therapies Council determines whether the drug should continue to be followed according to the protocol, whether the recommendation needs updating or whether the introduction can be considered to be completed.
Senast ändrad 2018-10-12