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Do you want to understand well the famous article 72 of the National Development Plan? Here we tell you

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By: Fabian Hernandez
Pharmaceutical chemist
Researcher in Health Economics
Neuroeconomix

The National Development Plan, whose goal is to outline the objectives of the National Government and therefore evaluate its management, establishes in article 72 the conditioning of granting sanitary registration to: New health technologies and Registration renewals for health technologies already marketed in the country

articulo 72

 

The National Development Plan, whose goal is to outline the objectives of the National Government and therefore evaluate its management, establishes in article 72 the conditioning of granting sanitary registration to:

 

  • New healthcare technologies
  • Registration renewals for health technologies already marketed in the country

 

What this conditioning seeks is to fix the price of the technology according to its therapeutic contribution, that is, price fixing value based. In this way, when a pharmaceutical company, owner of a technology, makes a request to obtain a sanitary registration, it will be subject to a parallel evaluation by INVIMA and the IETS.

 

Taking into account that the regulation process of this article is currently taking place, below we show you the most important points contained in the information published so far:

 

  • The IETS will define and evaluate the therapeutic value of the technology, in order to issue a judgment that will determine the definition of price based on value. According to the IETS evaluation, the Ministry of Health will establish a price for the technology. Both the IETS evaluation and the price determined by the ministry will be requirements for the issuance of the corresponding sanitary registration and / or its renewal by INVIMA.

 

  • The methodology for defining the therapeutic value will begin with the evaluation of the efficacy / effectiveness and safety of the technology by the IETS.. Subsequently, a panel of experts will be convened, in accordance with the guidelines of the Methodological Manual of Participation and Deliberation of the IETS, whose objective will be to define the category of value of the technology based on the evidence provided by the IETS. Once the panel is completed, the IETS will draft a technical report that will be sent to INVIMA.

 

  • The categories of therapeutic value proposed for Colombia of a new technology, compared to a reference technology are the following:
    1. Medicines or medical devices with exceptional therapeutic value
    2. Medicines or medical devices with important therapeutic value
    3. Medicines or medical devices with similar therapeutic value
    4. Medicines or medical devices with lower therapeutic value
    5. Medications or devices without any therapeutic value

 

  • The link between value and price is proposed as follows:

Categories 1 and 2: the technology will be marketed at a higher value than the reference technology

Category 3: the price of the technology will be established according to the price of the members of the same therapeutic group

Categories 4 and 5: their possible exclusion from the list of technologies that are financed with public resources assigned to health will be evaluated

 

If you want to delve into the subject, we recommend reading the draft of the methodology for defining the value of new drugs in Colombia, published by the IETS

 

Link: http://www.iets.org.co/Documents/Metodologia_definicion_valor.pdf

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