Country/Region: Spain - Regions
Submission Guidelines

Guidance For Economic Evaluation and Budget Impact Analysis For Pharmaceuticals in Catalonia (Spain) (Spanish Version October 2014).
PDF in Spanish

Submission Guidelines Source:

Additional Information:

Submitted to ISPOR: R. Mora-Ripoll, A. Gilabert-Perramon, J. Oliva-Moreno, J. Puig-Junoy. Guidance For Economic Evaluation and Budget Impact Analysis For Pharmaceuticals in Catalonia (Spain). Value in Health. 2014; 17:A447.

This guideline also includes a checklist for EE and another for BIA to evaluate the quality of the EE and BIM submited to the Catsalut.

Osteba Guidelines for Economic Evaluation in the Health Sector (March 1999)
PDF in Spanish

Information up to date as of Tuesday, January 21, 2020

Submission Guidelines Key Features:

Key Features:  
Title and year of the document
Guidance For Economic Evaluation and Budget Impact Analysis For Pharmaceuticals in Catalonia (Spain) (Spanish Version October 2014). 
Affiliation of authors
Jaume Puig Junoy Centre d’Investigació en Economia i Salut (CRES). Universitat Pompeu Fabra, Barcelona. Juan Oliva Moreno Departamento de Análisis Económico. Facultad de Ciencias Jurídicas y Sociales. Universidad de Castilla la Mancha, Toledo. Marta Trapero Bertran Centre d’Investigació en Economia i Salut (CRES). Universitat Pompeu Fabra, Barcelona. Facultad de Terapia Ocupacional, Logopedia y Enfermería. Universidad de Castilla la Mancha, Talavera de la Reina. José María Abellán Perpiñán Facultad de Economía y Empresa. Universidad de Murcia. Max Brosa Riestra Oblikue Consulting, Barcelona.  
Purpose of the document
Main aim of providing authors with recommendations, in the form of a checklist, to optimise design and reporting of EE and BIA to be submitted to the Catalan Health System (CatSalut) within its harmonization program for pharmaceutical innovation.  
Standard reporting format included
Target audience of funding/ author's interests
Pharmaceutical Industry  
The perspective of the funder-CatSalut is the preferred perspective. Complementary, also it may reflect social perspective.  
No indication, general  
Target population
It is recommended that if there was clinical evidence of differences between subgroups, a stratified analysis of subgroups with homogeneous population is carried out  
Subgroup analysis
Choice of comparator
Most used and most effective clinical practice (effective) / safe. The choice of alternative for comparison should be justified.   
Time horizon
The time horizon used in the base case must be one that allows, in the most appropriate way to capture all differential treatment effects on health and resources used, contemplating life of the patient if necessary. It is also recommended to use, in a complementary manner to the long-term time horizon, a shorter-term horizon (3-5 years). When the analysis was based on a clinical trial of short duration, it is recommended to use models to extrapolate the results to the relevant period.  
Assumptions required
Preferred analytical technique
Cost-utility analysis (CUA) is the preferred type of evaluation. Only when it is not possible for justified reasons, it would be possible to make a cost-effectiveness (CEA) analysis.  
Costs to be included
Health care costs. Non-health costs (job losses, social services, non-professional-informal caregivers), when used, should be expressed differentially to healthcare costs.  
Source of costs
Unit costs will preferably come from public prices, publications, tariffs applied to contracts for provision of services to CatSalut or accounting costs from centers. It must adequately justify the data source and specify the year used in the analysis.  
Modeling techniquesare recommended: (i) extrapolating the progression of clinical outcomes beyond what is observed in one trial; (ii) obtaining results of final character from intermediate measures; (iii) modeling of data from various sources to assemble the necessary parameters for decision analysis; (iv) modeling of observed results from trials or systematic reviews of trials to reflect what might be the circumstances in a clinical situation, or a different study population. In case of applying modeling techniques, the choice of model, structural assumptions and key parameters used should justify.  
Systematic review of evidences
Preference for effectiveness over efficacy
Results can be obtained in ideal conditions (efficacy) or in real conditions (effectiveness). It is recommended to accept, in principle, both the sources of effectiveness as effective and, if possible, both, since the information provided is complementary.  
Preferred outcome measure
If CUA, Adjusted Life Years (QALY). Instruments to valuation of recommended preferences are the EQ-5D and SF-6D. If CEA, life years gained (LYG).  
Preferred method to derive utility
Regarding valuation methods, there are two approaches to measuring preferences. One option is to measure them directly in the relevant population, identified with the general population or with a certain group of patients, resulting very costly in time and resources. In addition, comparability between studies is limited to the extent thatutility measures may differ each time, even in the case of the same health states. Another possibility is to use indirect methods of valuation. These instruments associated with a set of utilities to all possible health states described by some HRQoL questionnaire. They are classified as indirect methods because the rate is estimated either by statistical inference techniques, either by applying the theory of multi-attribute utility from the direct assessment of a selection of health states by a sample of the general population .  
Equity issues stated
The underlying equity criterion will be the valuation of equal health outcomes (a QALY is a QALY).  
Discounting costs
An annual discount rate of 3% should be used for the base case, and 0% can be applied to the sensitivity analysis.   
Discounting outcomes
An annual discount rate of 3% should be used for the base case, and 0% and 5% can be applied to the sensitivity analysis.   
Sensitivity analysis-parameters and range
Uncertainty should be analyzed by a sensitivity analysis covering the parameters, structure and methodological choices or the model.  
Sensitivity analysis-methods
At least one deterministic sensitivity analysis, univariate type and extreme values (best and worst scenarios) must be carried out, justifying the choice of variables and parameters for sensitivity analysis and the interval at which vary. Whenever possible, performing a probabilistic sensitivity analysis with the plane of cost-utility (or cost-effectiveness) and acceptability curve is recommended.  
Presenting results
Results must be presented by an incremental analysis of costs and incremental health benefits (separately) and the incremental cost-result ratio comparing the relevant alternatives. Costs and results should be provided indicating the standard deviation and the confidence interval at a level of 95%. All costs and health outcomes should be calculated according to the perspective of analysis used.  
Incremental analysis
Total costs vs effectiveness (cost/effectiveness ratio)
Portability of results (Generalizability)
The sources of data on costs and outcomes should be as close to their potential through use. Transparency in the description of the data and assumptions followed in the model is one of the most remarkable qualities to judge the validity of the analysis and whether it is possible to generalize or transfer its findings and conclusions to other different contexts different to the original.  
Financial impact analysis
This Guideline also includes the recommendations for BIA to be submited to the Catsalut.  
Mandatory or recommended or voluntary

Acknowledgement: Carme Pinyol, MD, PhD, MSc, Founder and Director, INNOVA - Strategic Consulting and the ISPOR Spain Chapter.

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