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The Official News & Technical Journal Of The International Society For Pharmacoeconomics And Outcomes Research
Policy Analysis

Towards A Cost-Effectiveness Framework for Decision Making: The Challenges in Mexico

Ariadna Juarez-Garcia PhD, MSc and Luciano Zylberberg BS; Bristol Myers Squibb, Mexico D.F., Mexico


The importance of economic evaluation of new health care drugs and technologies as criteria for public funding of pharmaceuticals in the Mexican health care system has been officially recognized since 2003 [1]. At that time, the General Health Council (a Constitutional body that provides national guidance on health care policy priorities in Mexico) introduced as a requisite for formulary listing the evaluation of the assessment of pharmacoeconomic criteria, ranging from cost minimization, cost effectiveness, cost utility, cost-benefit analyses and even cost per price studies (Internal regulation of the Inter-institutional Basic Formulary Board for Health Care Products). Notwithstanding this important milestone, the actual implementation of economic health evaluation principles has not yet become a generalized practice in the Mexican health care system due to several factors including:

  • Lack of clear guidelines for the preparation of pharmacoeconomic studies aligned with transparency, inclusiveness and evidence based criteria;
  • Complex overlay of functions and responsibilities between different health entities and the existence of multiple formularies within the public sector;
  • Little availability of reliable and validated local data; and
  • Insufficient availability of trained specialists in pharmacoeconomic analysis both in the public and private sectors.

In order to overcome these gaps, the General Health Council has made important efforts to create a positive, open and collaborative strategic alliance between relevant stakeholders in the public, academic and private sectors. The metric of success to those efforts will be evidenced by the enactment of fair, generally accepted and standardized analytical approaches that are inserted in the decision making processes of the Council and health entities in the near future.

In Mexico, a new drug or technology can be publicly dispensed through the health care system upon inclusion in the Inter-institutional Formulary (IF). In order to obtain said inclusion, manufacturers must submit a formulary dossier, which includes evidence-based benefits of the treatment to the Interinstitutional Formulary Board, which is responsible for generating and updating the Inter-institutional Formulary. The Board is comprised of the General Secretary of the General Health Council and representatives from public institutions responsible for providing health care services in Mexico (which is part of General Health Council; SSA, IMSS, ISSSTE, ISSFAM, and DIF).

Since 2003 [1], the General Health Council has required the inclusion of a pharmacoeconomic analysis in the formulary dossiers. This requirement was well received by the pharmaceutical industry, since the introduction of pharmacoeconomic criteria in the evaluation of new health care drugs and technologies for purposes of public funding is a common practice internationally. Nevertheless, the implementation of this new requirement has been very gradual in Mexico and has added an extra complication to the process due to the following factors to be described in this article.

Lack of Clear Guidelines
The requirement to include pharmacoeconomic studies in dossiers for formulary inclusion review was made without an accompanying guidance document. The General Health Council did not provide documentation identifying key items that must be included or considered for inclusion in the pharmacoeconomic analysis, in order to ensure alignment and transparency. Manufacturers therefore do not have a technical document outlining information required or format in which data should be presented for review. This has resulted in the implementation of criteria and methodologies that are variable and open to interpretation as well as the possibility for variability in decisions.

Complex Overlay of Functions and Duplications
As soon as a new product is listed on the IF, the dossier has to be submitted again to the main public health provider institutions (IMSS, ISSSTE, ISSFAM), which internally and independently re-evaluate the proposal to decide whether the product will be listed in their internal institutional formularies. The former situation results in a repetitive bureaucratic process that is inefficient, wastes resources and adds unneeded levels of approval, thus delaying the generalized access to innovation drugs or technologies to patients in dear need for them. The process also disregards the pharmacoeconomic evaluation of the Inter-institutional Formulary Board since ultimate public provision decisions are taken by each independent health care public provider institution.

Also, at the institutional level decision makers are not concentrated on the achievement of objective specific common goals from the public health perspective, which derives in a lack of specific shared guidelines or evaluation criteria. These funding decisions end up driven mostly by a unitary cost containment approach focused in short-term gains with little attention to the overall disease management cost. The result is the existence of different formularies for each public health institution. This ultimately is translated into an inefficient and inequitable provision of public health care for institutional beneficiaries.

Little Availability of Reliable and Validated Local Data
As soon as a new product is listed on the IF, the dossier has to be submitted again to the main public health provider institutions (IMSS, ISSSTE, ISSFAM), which internally and independently re-evaluate the proposal to decide whether the product will be listed in their internal institutional formularies. The former situation results in a repetitive bureaucratic process that is inefficient, wastes resources and adds unneeded levels of approval, thus delaying the generalized access to innovation drugs or technologies to patients in dear need for them. The process also disregards the pharmacoeconomic evaluation of the Inter-institutional Formulary Board since ultimate public provision decisions are taken by each independent health care public provider institution.

For the purposes of comparability and validation of data it is critical that the health authorities have a centralized reservoir of health cost data (including reference costs by health episodes and unit costs).This does not exist. There are many deficiencies in the Mexican health system with regards to the collection of routine cost data by health care providers. The type and quantity of resources used by any patient during their hospitalization, even basic data about number of diagnostic tests, theater time etc. are difficult and time consuming to obtain. The scarcity of unit costs information and the variability and reliability of data sources is of concern when conducting a pharmacoeconomic assessment. The General Health Council must provide clear specifications regarding acceptable use of data for cost effectiveness studies.

Little Availability of Reliable and Validated Local Data
For the purposes of comparability and validation of data it is critical that the health authorities have a centralized reservoir of health cost data (including reference costs by health episodes and unit costs).This does not exist. There are many deficiencies in the Mexican health system with regards to the collection of routine cost data by health care providers. The type and quantity of resources used by any patient during their hospitalization, even basic data about number of diagnostic tests, theater time etc. are difficult and time consuming to obtain. The scarcity of unit costs information and the variability and reliability of data sources is of concern when conducting a pharmacoeconomic assessment. The General Health Council must provide clear specifications regarding acceptable use of data for cost effectiveness studies.

Insufficient Availability of Trained Specialists in Pharmacoeconomic Analysis both In the Public and Private Sectors
The mandate for manufactures to submit dossiers with a pharmacoeconomic analysis of the products in question has added an extra complication to the process, due mainly to the high level of technical capacity needed to prepare and evaluate the economic and effectiveness related contents of the dossiers. In 2003 when this requisite was established, there was no technical institution/group (e.g. independent academic bodies) created, with the expertise needed to methodologically and scientifically evaluate the new requirements. In addition, it was not defined how the technical cost effectiveness appraisal process would be completed.

Following the 2006 change in government, the Council has revealed a commitment to address the challenges of mandating cost-effectiveness requirements for the inclusion of products in the IF. The Council has been working towards the creation of guidelines for manufacturers (expected to be published in the Official Gazette later in 2008) and have established forums where manufacturers, academics, decisions makers and interested parties have a voice and communicate, share and propose guideline/assessment ideas. The Council also has a work agenda where the creation of databases with key relevant local information (such as unit costs) and the constitution of unique evidence review technical group.

The key challenge facing the Council with implementation of these policies is ensuring public institutions (strong, separate health Institutions following an internal agenda) understand the importance of collaboration and alignment of interests and incentives. Despite the magnitude of challenges, we believe these changes are needed and with the current work-stream by the Council, their efforts will be successful in generating an open and accepted assessment process. We are confident that the final guidelines will eliminate any potential for duplication and encourage collaboration between institutions with the goal of a standardized, unique and open evaluation system and formulary.

Reference
[1] Diario Oficial de la Federación (Official Gazette), 27th of May 2003.


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