Through decree 433/2018, published March 5th, the government established a new form of assessment of innovative medicines entering Colombia that includes the classification of the drug according to its therapeutic value and a cost-effectiveness analysis and its budgetary impact. The decree will come into force in December 2018.
Decree 433, which partially regulates Article 72 of Law 1753 of 2015, establishes the criteria for the evaluation carried out by the Technological Health Assessment Institute (IETS) and the National Institute for Food and Drug Surveillance (INVIMA) to obtain the sanitary registration of a new drug for commercialization in the country.
According to the decree, in the first place the Technological Health Assessment Institute (IETS), the ational Institute for Food and Drug Surveillance (INVIMA) and the Ministry of Health will carry out a horizon scan with the purpose of identifying the new medicines that would enter the country. After the scan or at the request of an interested party, early dialogues may be held between the applicant and state agencies to exchange information and discuss the scope of the evaluation.
Regarding the evaluation done by the Technological Health Assessment Institute (IETS), the decree establishes that the agency must classify the new medication according to “the classification of the therapeutic value of the new drugs and their economic evaluation, which may include both a cost-effectiveness and a budget impact analysis”.
The classification of the therapeutic value of a new medicine will be determined according to its level of safety or efficacy from the comparison with a similar medicine, being category 1 more effective than the chosen therapeutic comparator and category 6 as non-classifiable medicine.
The categories are:
Category 1: Significantly more effective and greater or similar safety than the therapeutic comparator (best therapeutic option used routinely in the country, in light of the best available scientific evidence) chosen in the critical clinical outcomes.
Category 2: More effective and greater or similar safety than the chosen therapeutic comparator in critical clinical outcomes.
Category 3: Relationship between safety and effectiveness favorable with respect to the therapeutic comparator chosen for clinical outcomes and that can not be classified in category 1 or 2.
Category 4: safety and effectiveness similar to the therapeutic comparator chosen in clinical outcomes.
Category 5: Relationship between safety, efficacy and effectiveness unfavorable compared to the therapeutic comparator in clinical outcomes.
Category 6: Non-classifiable drug.
Meanwhile, for orphan diseases, the document clarifies that this evaluation will take into account the therapeutic value and the budget impact analysis, but not its cost.
Once the evaluation procedure has been completed by the IETS, it will be sent to the National Price Commission for Medicines and Medical Devices to determine the price of the new drug.