Administrative Access Agreements in Colombia: in search of greater access and more efficiency
Ornella Moreno Mattar
MSc in Public Policy,
health economics lead
With their respective variations and different names in each country, Managed Entry Agreements, Administrative Agreement Schemes or Administrative Access Agreements are, in general, a set of instruments to reduce uncertainty and the budgetary impact of new drugs with high price (1)
We know that due to their taxonomy they can be financial or performance-based and that they can occur at the level of patients or populations through various designs (2). These agreements have been implemented in countries such as Australia, Italy, Estonia, South Korea and, mainly, in England through various approaches (Read: Introduction to Managed Entry Agreements (MEAs): Tools for access management).
In Colombia, since 2021, the national government has held working groups to establish a methodology to implement these Administrative Access Agreements, establishing an operating model AAA, by the initials of the agreements. The objective of this initiative is to reduce the administrative and financing barriers of some technologies, contributing to the guarantee of the right to health.
According to the government proposal, for a health technology to be included in an administrative access agreement, it must meet one of the following established criteria:
Once the technology has been identified, progress must be made in an operational route that ranges from the presentation of the agreement proposal to its evaluation, the foregoing in a series of five stages:
- Presentation of the proposal: that can occur through different doors such as the nomination of the Ministry of Health and Social Protection or by various actors such as the pharmaceutical industry, patient associations, EAPB, among others.
- Negotiation: In this stage, variables such as the number of patients who require the technology, the costs associated with its use, the type of agreement that would be carried out, the payment conditions, the operation of the agreement and the audit plan of the system are analyzed. same.
- Formalization: If the negotiation advances to this stage, a clinical-operative route would be designed for the implementation and follow-up of the agreement. At this point, the agreements and contracts between the EAPB and the technology providers and other actors involved in the process should be formalized, however, the role of these actors is not yet explicitly defined within the description of the model proposed by the government. .
- Implementation and monitoring: It would begin with the signing of the administrative act of the agreement and its subsequent implementation.
- Evaluation and impact: In presentations made with actors from the health sector, the Ministry of Health had proposed that the evaluation of the results of the agreement be carried out by the IETS on a regular basis until concluding with a final evaluation after the termination of the agreement, and the analysis of the report of Evaluation of the agreement would be in charge of the Ministry of Health. However, the details about this stage are also not defined to date.
Regarding this proposal, which is still under construction and discussion, one of the questions that arises is how would it be articulated with the new price methodology based on therapeutic value? In this regard, within the prioritization criteria, it can be identified that the drugs included in category 6 “not classifiable” would be considered candidates for these agreements.
It is worth clarifying that in the draft circular on price based on value published on April 11 of the current year, in article 8, paragraph 4, a broader vision of the categories was proposed, establishing that: “The holders of medicines classified in categories 1, 2 and 6, may request the Ministry of Health and Social Protection, an Managed Access Agreement in order to achieve an adequate balance between financial sustainability, affordability and health results, in a framework of transparency in the supply of health technologies necessary to protect the fundamental right to health.”
Another concern that arises is the role of different actors within the drug supply chain. Although in previous proposals the Ministry of Health had somewhat defined the role of the EAPBs in the nomination, negotiation and formalization process, some actors such as logistics operators and pharmaceutical services remain a question mark within the proposed process.
Similarly, it is important to establish within the regulatory framework that frames this proposal, the implications of non-compliance with said agreements, since in previous discussions it had been reported that, if there is a breach of the agreement, the respective superintendence, either the Superintendency of Health or the Superintendence of Industry and Commerce, would carry out the corresponding investigation. As two superintendencies are involved, their participation would be defined by the actor who has incurred in non-compliance, for which defining the role of the actors is fundamental.
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1. Zampirolli Dias C, Godman B, Gargano LP, Azevedo PS, Garcia MM, Souza Cazarim M, et al. Integrative Review of Managed Entry Agreements: Chances and Limitations. Vol. 38, PharmacoEconomics. Goodbye; 2020. p. 1165–85.
2. Wenzl M, Chapman S. Performance-based managed entry agreements for new medicines in OECD countries and EU member states: How they work and possible improvements going forward. OECD Health Working Papers [Internet]. 2019;(115). Available from: https://dx.doi.org/10.1787/6e5e4c0f-en