Pharmacoeconomic Guidelines: Switzerland
Country/Region: Switzerland
PE Guidelines
Operationalization of the Terms Effectiveness, Appropriateness and Economic Efficiency (2022).
PE Guidelines Source:
Additional Information:
The objective of this document is to operationalize the three criteria “Effectiveness, Appropriateness, Economic Efficiency”, abbreviated as EAE criteria (In German: Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit, WZW) embedded in Article 32 of the Federal Law on Health Insurance (Bundesgesetz über die Krankenversicherung, KVG; SR 832.10).
In order to be reimbursed by the national health insurance health technologies, including pharmaceuticals, have to fulfill the EAE criteria. This document is the conceptual basic document within a group of documents addressing operationalization of the criteria "Effectiveness, Appropriateness and Economic Efficiency".
The paper starts with defining the EAE criteria within the context of reimbursement questions. The paper includes a generic step-wise operationalization approach of the EAE criteria regarding health technology assessment and health technology appraisal. Health technology-specific aspects of the EAE criteria may need further operationalization. Further documents will describe the different conditions for specific technologies.
This document intends to support technology applicants, interest groups, advising federal commissions, policy makers and insurers when applying the three criteria within the context of the law.
Information current as of Tuesday, January 16, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | PE Guidelines |
| Title and year of the document | 1. Operationalisation document regarding the terms Effectiveness, Appropriateness and Economic Efficiency (In German: Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit), effective as of September 1st, 2022. 2. Set of forms for filing submissions (with instructions), effective as of 2016 - 2021. https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-bezeichnung-der-leistungen/antragsprozesse/AntragsprozessArzneimittel.html 3. Manual concerning the list of specialties 2017 |
| Affiliation of authors | Swiss Federal Office of Public Health (BAG) |
| Purpose of the document | Guidance on how to apply the criteria "Effectiveness, Appropriateness and Economic Efficiency in the appraisal of submissions for reimbursement of medical services. |
| Standard reporting format included | Yes. |
| Disclosure | Yes |
| Target audience of funding/ author's interests | Federal Commission of Pharmaceuticals |
| Perspective | Health services |
| Indication | Yes |
| Target population | Yes, usually determined by a precise indication for the medical technology application, and defined by inclusion and exclusion criteria |
| Subgroup analysis | No. According to Swissmedic (national licensing authority) authorization. |
| Choice of comparator | Typical standard of care that presents the closest therapeutic equivalent. |
| Time horizon | Desicion 60 days after market authorization. |
| Assumptions required | Economic assumptions required. |
| Preferred analytical technique | HTA |
| Costs to be included | Comparison of prices with therapeutic equivalent pharmaceutical and external price referencing with nine reference countries. |
| Source of costs | 1. Reimbursement rates established by health insurers, tariffs and other administratively fixed rates. 2. market prices if 1 is not available |
| Modeling | Yes |
| Systematic review of evidences | Yes |
| Preference for effectiveness over efficacy | Yes |
| Preferred outcome measure | Not specified. |
| Preferred method to derive utility | Not specified. |
| Equity issues stated | Not specified. |
| Discounting costs | Not specified. |
| Discounting outcomes | Not specified. |
| Sensitivity analysis-parameters and range | Not specified. |
| Sensitivity analysis-methods | Not specified. |
| Presenting results | Not specified |
| Incremental analysis | Not specified. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Not specified. |
| Portability of results (Generalizability) | Not specified. |
| Financial impact analysis | Required |
| Mandatory or recommended or voluntary | Mandatory |
Acknowledgement: