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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. |
