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Pharmacoeconomic Guidelines Around The World

Country/Region: Spain - Catalonia Region

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:
http://www.catsalut.cat

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.

Last Webpage Update: Monday, January 29, 2018

Submission Guidelines Key Features:

Key Features:  
Title and year of the documentGuidance For Economic Evaluation and Budget Impact Analysis For Pharmaceuticals in Catalonia (Spain) (Spanish Version October 2014). 
Affiliation of authorsJaume 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 documentMain 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 includedYes 
DisclosureNo 
Target audience of funding/ author's interestsPharmaceutical Industry  
PerspectiveThe perspective of the funder-CatSalut is the preferred perspective. Complementary, also it may reflect social perspective.  
IndicationNo indication, general  
Target populationIt is recommended that if there was clinical evidence of differences between subgroups, a stratified analysis of subgroups with homogeneous population is carried out  
Subgroup analysisYes 
Choice of comparatorMost used and most effective clinical practice (effective) / safe. The choice of alternative for comparison should be justified.   
Time horizonThe 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 requiredYes 
Preferred analytical techniqueCost-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 includedHealth care costs. Non-health costs (job losses, social services, non-professional-informal caregivers), when used, should be expressed differentially to healthcare costs.  
Source of costsUnit 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.  
ModelingModeling 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 evidencesYes 
Preference for effectiveness over efficacyResults 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 measureIf 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 utilityRegarding 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 statedThe underlying equity criterion will be the valuation of equal health outcomes (a QALY is a QALY).  
Discounting costsAn annual discount rate of 3% should be used for the base case, and 0% can be applied to the sensitivity analysis.   
Discounting outcomesAn 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 rangeUncertainty should be analyzed by a sensitivity analysis covering the parameters, structure and methodological choices or the model.  
Sensitivity analysis-methodsAt 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 resultsResults 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 analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
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 analysisThis Guideline also includes the recommendations for BIA to be submited to the Catsalut.  
Mandatory or recommended or voluntaryRecommended  

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

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