These objectives are established for the following:
1) Development of a methodology for the evaluation of new medicines and for procedural standardization
2) Implementation of shared evaluations of new medicines
3) Disclosure of information
4) Research
1) Development of a methodology for the evaluation of new medicines and for procedural standardization
A) Application for including a new drug in a hospital’s formulary. Click here
The GINF Guidelines on how to request inclusion of a medicinal product are proposed as a reference model.
B) New Medicine Evaluation Report Template. Click here
An evaluation report template is defined, the structure of which is based on a Technical Evaluation Phase, a Therapeutic Positioning Phase and Conclusions
C) MADRE Program. Click here
A program to assist in the drafting of the evaluation report for a new medicinal product is developed. Guidance is available for filling in each section of the report. Algorithms, calculation formulas, links to external internet sources, etc. can also be accessed.
D) Therapeutic and bioequivalent medicines interchange program
Methods and criteria are proposed for defining therapeutic equivalence protocols and a list of homologous medicines, relevant to therapeutic interchange programs and to the management and procurement processes. The goal is to develop a list of therapeutically equivalent medicines that can be used in therapeutic interchange programs and of useful bioequivalent medicines for public procurement tenders..
Therapeutic interchange program. Click here
Biosimilar medicines. Click here
2) Implementation of shared evaluations of new medicines
Drafting of the detailed procedures of the evaluation process for the preparation of shared reports. The evaluation reports on new medicines will be prepared collaboratively among the members of each specific working group.
3) Disclosure of information
SEFH will provide its members with free access to a website for sharing documents and reports.
Initial phase:
- there will be a space for uploading evaluation reports prepared by hospitals wishing to make their reports public and with links to hospital evaluation reports that have their own websites. Hospitals will be responsible for drafting their own evaluations. SEFH will offer a portal for uploading and sharing such evaluations.
- completed methodological models
- links of interest
In a second phase:
Reports drafted by the GENESIS workgroup will be uploaded. On this page you will find:
- list of medicines under study
- the final reports produced by the workgroup (Full version and summary version).
- Therapeutic interchange program
- List of bioequivalent medicines
4) Research
Different studies will be completed to ascertain the reality of the selection process in Spanish hospitals, the impact of the workgroup’s recommendations, the evaluation reports, standardization, etc.
Some examples
a) Current situation of medicines selection in Spanish hospitals:
A study will be undertaken to find out the current state of affairs in our country:
Structure, process and results of existing evaluation and selection systems. CF&T: -Composition, -Activity, -Criteria, - Results of last year's evaluation, pharmacotherapeutic guidelines, etc.
b) Impact of the hospital report
- Measure degree of acceptance of the reports produced by the workgroup
- Degree of follow-up of recommendations