In which cases is it prescribed to monitor the effect of drug therapy?

Medicinal products belonging to a new international non-proprietary name for which a health technology assessment has been carried out and for which no evidence of therapeutic effectiveness has been presented and/or the cost-effectiveness ratio is not cost-effective shall be included in the corresponding application of the PHC with a follow-up obligation of the effect of the therapy. Additionally, The Council may ex officio establish an obligation to monitor the effect of therapy also for medicinal products already included in the PLS, when: 1. the medicinal product is a comparative alternative to a medicinal product designated for monitoring; 2. a need has arisen for the relevant paying institution to carry out an analysis of the effective and appropriate spending of public funds for a medicinal product.