Reimbursement of pharmaceutical products
How is the level of reimbursement determined?
In short, German HTAs do not impact the reimbursement of a pharmaceutical product. But let’s explore this in a bit more detail:
Most medicines are reimbursed at 100% from the day of launch in Germany, i.e. coverage by SHI funds is granted with the marketing authorization and applicable from market entry onwards.
This coverage is granted for the full patient population covered by the license of the marketing authorization. There is no restriction on the patient population for reimbursement.
Because reimbursement is practically guaranteed from the day the product is launched in Germany, historically, pharmaceutical companies often chose Germany as one of the first markets for launch.
Exceptions
I noted above that most, but not all, medicines are reimbursed at 100% from the day of launch. The SHI funds do not reimburse the following types of products:
| Product category | Up-to-date reference list |
| Drugs for infections, colds, laxatives, travel sickness etc., e.g. cough medication, pain relief, over-the-counter [OTC] products | OTC products (Medicines directive, Appendix I) |
| Lifestyle products, i.e. those considered to primarily improve the quality of life, e.g. improve self-confidence, stop signs of aging, cosmetic enhancements, etc.; these products are not intended for the treatment of an illness) | Lifestyle products (Medicines directive, Appendix II) |
| Products considered to not be economical; for these, the G-BA issues a binding regulation, a so-called medicines directive (German: Arzneimittel-Richtlinie), which describes how to prescribe the product and in which situations it is reimbursed; as of 16 May 2023, this was applied to only three products assessed through a G-BA HTA; i.e., alirocumab, evolocumab, and inclisiran. All three of them are indicated for the treatment of hypercholesterolemia or mixed dyslipidemia. | Restrictions and exclusions of prescriptions (Medicines directive, Appendix III) |
Off-label use
Pharmaceutical companies have to agree to the use of their product “off-label”, i.e., the use of a product in an indication outside of its label.
The G-BA then assesses the reimbursement of this off-label use for each indication individually. The G-BA determines whether the product can be reimbursed in the off-label indication as well and lists this exceptional use in a directive. This directive (Medicines directive, Appendix VI) lists all products and their off-label indications, which are accepted for reimbursement.
Reimbursement in practice
How does reimbursement work in the real world in Germany? How do the pharmaceutical companies get paid, and what’s the role of the SHI funds?
- Pharmaceutical companies sell their products to pharmacies. This can be done either directly or via wholesalers.
- About 90% of the German population are insured with one of the SHI funds and pay insurance contributions.
- The physician of a patient makes a diagnosis and can prescribe a drug. Physicians are encouraged to review the result of the early benefit assessment for this drug, but they are not restricted in their decision-making. The prescription should be for the indication matching the patient’s diagnosis, but off-label products can also be prescribed and covered by SHI funds, if this off-label use was approved.
- Patients that are insured with an SHI fund take this prescription to the pharmacy and receive the drug for only a small co-payment.
- The pharmacies then invoice the drug to the SHI fund that the patient is insured with.
- This means pharmaceutical companies do NOT directly get reimbursed by the SHI funds.
Reimbursement of new diagnostic or treatment methods (NUB) and medical devices
In Germany, the reimbursement of methods and medical devices by SHI funds differs for outpatient and inpatient care.
Outpatient care
The G-BA needs to first assess the method and determine that it has a benefit for patients, is required, and is economical. Only then, the method can be offered by physicians and will be reimbursed by the SHI funds. Thus, outpatient methods follow a “reservation for allowance” (“Erlaubnisvorbehalt”).
Inpatient care
Methods used in inpatient care can be offered and are reimbursed by the SHI funds unless they have explicitly been excluded from reimbursement by the G-BA. This principle is therefore described as “reservation for prohibition” (“Verbotsvorbehalt”). This means all methods and medical devices used in the hospital setting are reimbursed from the point they become available in the German market until the G-BA determines that they are excluded from reimbursement.
Exceptions
In very specific cases, the SHI funds will also have to reimburse the use of a method, even if the G-BA had excluded the method from reimbursement. According to a ruling from December 2005, basic rights mean that a person with statutory health insurance can’t be excluded from receiving a treatment method, if
- they have a life-threatening and generally fatal illness
- a generally recognized medical standard treatment is not available
- the chosen method shows some prospect of a cure or a noticeable positive effect on the course of the disease.
Furthermore, SHI funds can offer and reimburse additional methods for their insured population. However, this is not possible for methods that have been excluded from reimbursement by the G-BA. Examples of such special offers by SHI funds are vaccinations or IVF treatments.