Did you know OTC drugs are reimbursed in Germany in exceptional circumstances?
OTC drugs are those that don’t need to be prescribed by a clinician and can be bought in a pharmacy.
Since 1 January 2004, all OTC drugs are excluded from coverage by SHI funds and thus reimbursement. This was introduced within the health care reform 2003 to save costs in the German health care system.
However, there is an exception to this rule: in exceptional cases where the OTC product is considered to be the standard therapy for the treatment of serious illnesses, it will be reimbursed. The legal basis is in §34 (6) SGB V.
Appendix I of the drug directive lists these exceptions. For these drugs, the prescribing clinicians can request reimbursement with sufficient justification.
Application for OTC reimbursement
The appendix of exceptions is maintained by the G-BA and pharmaceutical companies can apply for their OTC products to be added. The evaluation criteria and application procedure are detailed in the G-BA’s rules of procedure in sub-section 4. The main points are:
Definition of serious illness
- The drug needs a license for the treatment of the serious illness.
- The illness is serious, if it is life-threatening or permanently affects the HRQL due to its severity.
- The severity and extent of not life-threating serious illnesses is comparable to those of life-threatening diseases.
- The pharmaceutical companies need to submit respective literature to prove that the illness is serious. However, this is not necessary if the serious illness with the same severity had already previously been included in §34 (2) SGB V.
Definition of therapy standard
- A drug is considered the therapy standard, if the therapeutic benefit that it offers for treating the serious illness reflects current accepted medical knowledge.
- A systematic literature review of scientific studies is needed to demonstrate a consensus amongst relevant specialists on the benefit of the OTC drug for the treatment of the serious illness. Here, priority is given to clinical trials, in particular those with direct comparison using patient-relevant endpoints, especially mortality, morbidity and HRQL.
Required documentation
- The applying company needs to submit the application form (Appendix II Number 1) as well as study extraction sheets for individual studies (Appendix II Number 3.2) and for SLRs (Appendix II Number 3.3). The form covers:
- name of the product
- active substance (with synonyms)
- active substance group
- illness applied for
- approved indications
- ATC code
- restrictions on sale of the product
- duration of the marketability
- current SPCs
- proof of the serious illness
- proof of the therapy standard based on systematic literature review
- The application needs to be submitted electronically.
- The application incurs a fee of €10,394 according to §34 (1) sentence 2 SGB V.
If all the required documentation was submitted, the G-BA will then decide on each application within 90 days.