|
Key
Features: |
|
| Title and year of the Document | Guidelines for economic evaluation, 2001 |
| Affiliation of authors | Italian Group for Pharmacoeconomic Studies |
| Main policy objective | Pricing and reimbursement |
| Standard reporting format included | Yes, includes Summary, Synthesis, and Detailed version of the EE |
| Disclosure | Not specific, mentioned to list the authors and sponsor of the EE |
| Target audience of funding/ author’s interests | Pharmaceutical companies. Italian National Health Service. researchers |
| Perspective | Societal, Italian National Health Service |
| Indication | Yes |
| Target population | Yes |
| Subgroup analysis | Yes |
| Choice of comparator | Most wide-spread treatment. Solid evidence for a scientifically-based comparison must be available. |
| Time horizon | Not specific |
| Assumptions required | Not stated |
| Preferred analytical technique | CEA, CUA |
| Costs to be included | Societal: both direct costs and indirect costs. Use human capital method for indirect costing. |
| Source of costs | Use microcosting carried out through studies performed at health care structures |
| Modeling | Yes, requires details |
| Systematic review of evidences | Yes, check internal and external validity |
| Preference for effectiveness over efficacy | Yes, studies must refer to the national context. |
| Preferred outcome measure | Effectiveness by intention-to-treat principle, and expressed in natural units or QALY |
| Preferred method to derive utility | Standard gamble, time trade-off |
| Equity issues stated | Not stated |
| Discounting costs | Base:3%; SA: 0%~8% |
| Discounting outcomes | Base:3%; SA: 0%~8% |
| Sensitivity analysis-parameters and range | Those parameters which have the most influence on the final results. Effectiveness use CI, range of cost decided by author. |
| Sensitivity analysis-methods | Better showing simultaneous effect of the variations for the more important parameters |
| Presenting results | Must be able to provide adequate response to three questions: Valid and acceptable? What information emerges? What can be applied to actual situations? |
| Incremental analysis | Yes |
| Total C/E | Yes |
| Portability of results (Generalizability) | Studies must refer to the national context (treatment for comparison, medical practice, costs, institutional structure, epidemiological structure, and reference population) |
| Financial impact analysis | Yes, first and second year of marketing |
| Mandatory or recommended or voluntary | |
