Pharmacoeconomic Guidelines: Mexico
Country/Region: Mexico
PE Guidelines
Guidance on how to conduct economic evaluations to update the national health supplies compendium (national formulary)
PE Guidelines Source:
Comisión del Compendio Nacional de Insumos para la Salud.
PDF file in Spanish
Information current as of Wednesday, March 6, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| Title and year of the document | Guidance on how to conduct economic evaluations to update the national health supplies compendium (national formulary) January 2023 |
| Affiliation of authors | Comisión del Compendio Nacional de Insumos para la Salud; Instituto Mexicano del Seguro Social; Comisión Coordinadora de los Institutos Nacionales de Salud y Hospitales de Alta Especialidad; Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado; Defensa Nacional; Marina; Petróleos Mexicanos; Instituto de Salud para el Bienestar, Secretaría de Salud; Comisionado Federal para la Protección contra Riesgos Sanitarios; and Consejo de salubridad nacional |
| Purpose of the document | To provide guidance and set standardized methods for conducting economic evaluations to be presented before the National Health Supplies Compendium Committee. The document aims to assist decision makers from the public health sector make better use of resources. |
| Standard reporting format included | Yes. |
| Disclosure | Funding sources should be declared on a separate section. Authors and contributions should also be stated. |
| Target audience of funding/ author's interests | 3 main groups of users: 1. Committee members tasked with reviewing economic evaluations and budget impact analysis of health products that will be assessed for inclusion/exclusion or undergo modifications within the national health supplies compendium. 2. People or institutions (such as academia, medical colleges, Mexican secretariat of health, members of the committee, among others) who are allowed by internal committee regulations to request an update of the national health supplies compendium. 3. Pharmaceutical industry, medical devices companies, academia members, health or hospital authorities, among others, who wish to undertake an economic evaluation that could lead to changes in what is provided under the national health supplies compendium. |
| Perspective | The analysis should take the perspective of the payer (the whole public health sector which includes: the Secretariat of health, the Mexican Social Security Institute, the Institute for Social Security and Services for State Workers, the Secretariat of National Defense, the Naval secretariat, and Mexican Petroleum). The societal perspective or the perspective of any of the above institutions mentioned can be presented as a separate case, if the submitting party wishes to do so. |
| Indication | As approved by COFEPRIS (Federal Commission for Protection against Health Risks) |
| Target population | The population considered should preferrably be aligned with COFEPRIS' approved indication. Detailed description of the population in terms of clinical and demographic characteristics; risk factors and/or comorbidities; geographic location and risk profiles within one same disease/clinical condition is expected. |
| Subgroup analysis | Yes. |
| Choice of comparator | Comparators should be alternatives that will be displaced either completely or partially or will complement the new technology within the national health supplies compendium and routine clinical practice. If there is no standard alternative within the compendium with the same indication, a comparator can be chosen from either a National (preferred) or international Clinical Practice Guideline. Choices made must be clearly justified. In the absence of guidelines, a Delphi panel can be used to select the best comparator, clearly justifying why this methodology was chosen. Comparison against ""doing nothing"" is allowed, as long as this is clearly justified. |
| Time horizon | Long enough to capture all the costs and health benefits. The natural history of disease and the "lifetime" of the materials/technologies assessed should be considered. |
| Assumptions required | Yes. |
| Preferred analytical technique | Required: Cost-effectiveness analysis. Cost minimization analysis is accepted only when there is enough evidence from systematic reviews with meta-analysis, and/or head-to-head randomized trials to prove that the comparators are equivalent. A cost-utility analysis can be presented alongside the cost-effectiveness analysis if the applicant wishes to do so. This is not mandatory. Cost-benefit analysis can also be presented alongside the mandatory cost-effectiveness analysis. |
| Costs to be included | Only direct medical costs from the perspective of the public health sector should be included. Direct non-medical costs and indirect costs can be presented as part of a separate analysis if the applicant wishes to do so. |
| Source of costs | Costs should reflect the public payer perspective. Referring to the new alternative under analysis, "the costs should be relevant to the payer, this means the price the applicant would want the public sector to pay for the new technology". |
| Modeling | Recommended. The model selected should be appropriate to the decision problem. Suggested scenarios in which models can be used: when there is a need to extrapolate from clinical efficacy to efficiency; to extrapolate long-term results in cases where follow up from clinical trials is not long enough to reach an acceptable time-horizon; in the absence of relevant head-to-head trials; to extrapolate data from literature to the decision context. The model, data sources, methods, assumptions and limitations should be presented in a clear, transparent manner. |
| Systematic review of evidences | Yes. To get information on effectiveness, efficacy and safety of medical products. Detailed protocol with justification of choices should be included and the methods should be transparent and reproducible. |
| Preference for effectiveness over efficacy | Effectiveness data preferred. |
| Preferred outcome measure | Incremental Cost-Effectiveness Ratio (ICER). |
| Preferred method to derive utility | Not explicitly stated. A recommendation is given to use utility values from Mexico. Clear justification is needed if using other values. |
| Equity issues stated | Yes. |
| Discounting costs | Base case: 5% Univariate sensitivity analysis: 3% - 7% |
| Discounting outcomes | Base case: 5% Univariate sensitivity analysis: 0% - 7% |
| Sensitivity analysis-parameters and range | Parameters with associated uncertainty should be varied along their plausible range of variation. |
| Sensitivity analysis-methods | Univariate sensitivity analysis including parameters with associated uncertainty varied along their plausible range of variation. Multivariate sensitivity analysis considering a pessimistic and optimistic scenario. Probabilistic sensitivity analysis to explore robustness. |
| Presenting results | Besides the ICER, total costs and total health benefits of the alternatives under consideration should be presented in a separate disaggregated way. |
| Incremental analysis | Yes. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes. |
| Portability of results (Generalizability) | Yes. "The economic evaluation should be transparent enough in the description of data and hypothesis used to allow the portability of results to a different context." |
| Financial impact analysis | Yes. |
| Mandatory or recommended or voluntary | Mandatory. |
Acknowledgement:
E. Abril Seyahian, PhD, MSc. HEHTA, University of Glasgow.