This directive specifies details on the prescription of pharmaceuticals, medical devices, and bandages or dressings by SHI funds within the contract health care setting in Germany. The overall aim is to ensure economical and quality-assured health care. To this end, the G-BA conducts, for example, early benefit assessments of new active ingredients, forms reference price groups, issues therapy instructions, prescription restrictions, or regulations on the exchange of drugs with the same active ingredients.
The directive includes multiple appendices (I to XII) covering details relating to indications and active ingredients.
- Appendix I: OTC overview
- Appendix II: Lifestyle products
- Appendix III: Overview of prescription restrictions and exclusions
- Appendix IV: Therapy information
- Appendix V: Overview of medical devices that can be prescribed
- Appendix Va: Dressings and other products for wound treatment
- Appendix VI: Off-label use
- Appendix VII: Aut idem
- Appendix VIIa: Biosimilars
- Appendix VIII: Notes on analogous preparations
- Appendix IX: Reference price groups
- Appendix X: Update of comparative values
- Appendix XI: Ordinance on special medicinal products (previously: Annex 13) (no longer valid)
- Appendix XII: Benefit assessment according to § 35a SGB V
- Appendix XIII: Balanced diets for enteral nutrition (not yet in force)
- Overview of drugs on the so-called negative list
- Prescription of off-label drugs in clinical studies