"Entrance door": Decree 433 of 2018
By: Diana González-Bravo
Decree 433 of 2018 regulates article 72 of Law 1753 of 2015 in the mechanism called "entry door" for new drugs. Here we explain what it is about.
The law 1753 of 2015 in its article 72 indicates that both the evaluation carried out by the IETS to the medicines and medical devices defined by the Ministry of Health and Social Protection, as well as the price determined based on that evaluation, will be requirements for the issuance of the sanitary registration or its renewal by of INVIMA.
In order to promote efficiency and equity in access and sustainability of the SGSSS and to guarantee universal health coverage, it was necessary to set the criteria to determine the mechanism of entry of new health technologies to the country. This is how the decree 433 of 2018 establishes these guidelines.
What does it decree?
- Who are the stakeholders:
1. Interested in obtaining the health registration of medicines new
2. National Institute for Food and Drug Surveillance - INVIMA
3. Institute for Health Technology Assessment- IETS
4. National Commission for the Prices of Medicines and Medical Devices
- Definitions are established for: new drug, therapeutic comparator, critical outcome, clinical outcome, horizon scan (verification of variables related to non-commercialized health technologies), and PICOT question.
- Entrance door mechanism:
The Ministry of Health and Social Protection, together with INVIMA and the IETS, will carry out the horizon scan, in order to identify the new drugs that would enter the country. From this and before filing the application to INVIMA, dialogues may be held between the applicant, the IETS and INVIMA (early dialogues), in order to exchange information and discuss the scope of the evaluation that the interested party must submit. to the IETS.
The evaluation includes the classification of therapeutic value of new drugs and their economic evaluation, which may include a cost-effectiveness analysis and of budget impact. The classification will be carried out in accordance with the manuals that the IETS defines for this purpose. Evaluation of new drugs for orphan diseases You will only understand the therapeutic value classification, and the budget impact analysis.
- The IETS will classify new drugs into categories of therapeutic value, based on the level of safety and efficacy or comparative effectiveness, as follows:
Category 1. Significantly more efficient or effective and greater or similar safety than the chosen therapeutic comparator, in critical clinical outcomes.
Category 2. More efficient or effective and greater or similar safety than the chosen therapeutic comparator in critical clinical outcomes.
Category 3. Relationship between safety, efficacy or favorable effectiveness with respect to the therapeutic comparator chosen in clinical outcomes and that cannot be classified in category 1 or 2.
Category 4. Similar safety and efficacy or effectiveness than the chosen therapeutic comparator in clinical outcomes
Category 5. Unfavorable relationship between safety, efficacy or effectiveness with respect to the therapeutic comparator in clinical outcomes.
Category 6. Non-classifiable drug
- Those interested in obtaining health registration of new drugs They must present a technical document to INVIMA that includes the comparative analysis of safety and efficacy or efficiency of the new drug, in accordance with the methodological manuals established by the IETS.
- The documentation must settle in INVIMA together with the request for pharmacological evaluation. After this, INVIMA will send it within five (5) days to the IETS, in order for it to carry out the evaluation of the new health technology.
- The term for the issuance of the sanitary registration, without any requirements being presented by the corresponding sanitary authority, is 180 days skillful for the pharmacological evaluation and 3 months for the pharmaceutical and legal evaluation, from the filing date.
- The total term to fix the price of the medicine, based on the evaluation made by the IETS, are 180 business days plus 3 months.
For more information, download HERE Decree 433 of 2018.
If you want to read article 72 of Law 1753 of 2015, download HERE the file.
In our blog entry «Price regulation: Tool proposed by the health system to control spending«, We explain the circular 03 of 2017 that talks about drug regulation.
Also, in our blog entry «Regulation of drug prices II How are they regulated in Colombia?«, we complement the knowledge about the process of drug regulation.