Welcome to the start of our 3-part series on reimbursement, starting with reimbursement of drugs in Germany. Today, you will learn about:
Check out the additional reading, if you want to dive deeper or can’t wait for next week’s post on the reimbursement of medical devices.
Level of reimbursement of drugs in Germany
In the vast majority of cases, the outcome of German HTAs does not impact the reimbursement of drugs in Germany.
The SHI funds in Germany reimburse most medicines (that we our our clients are working on) at 100% from the day of launch. That means that a market authorization for a product automatically ensures coverage by the SHI funds. This coverage applies from the day of market entry onwards.
This reimbursement 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 there is practically a guarantee of reimbursement from the day of launch in Germany, historically, pharmaceutical companies often chose Germany as one of the first launch markets.
Exclusions
I said above that SHI funds reimburse most, but not all, medicines at 100% from the day of launch.
However, there are some exceptions: SHI funds do not cover OTC or lifestyle products (of note: this includes obesity drugs!). In addition, when the G-BA considers the use of products as not economical, it can
- exclude products from reimbursement or
- restrict the reimbursement to specific patients.
This happens very rarely.
The G-BA issues a binding regulation, the so-called drug directive (German: Arzneimittel-Richtlinie). This directive describes how to prescribe the product and in which situations SHI funds will reimburse it. Until now, the G-BA restricted reimbursement only to three products after an early benefit assessment: alirocumab, evolocumab, and inclisiran. All three are indicated for the treatment of hypercholesterolemia or mixed dyslipidemia.
The table below summarizes all product categories excluded from reimbursement.
| 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 (Drug 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 (Drug directive, Appendix II) |
| Products considered to not be economical; for these, the G-BA issues a binding regulation, a so-called drug directive (German: Arzneimittel-Richtlinie), which describes how to prescribe the product and in which situations it is reimbursed; as of 25 Jan 2022, this was applied to only three products assessed through a G-BA HTA; i.e., alirocumab, evolocumab and inclisiran | Restrictions and exclusions of prescriptions (Drug directive, Appendix III) |
OTC drugs
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 with the health care reform in 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.
Lifestyle drugs
Drugs that primarily aim to increase the quality of life are so-called “lifestyle” drugs. SHI funds do not cover these, and they are excluded from reimbursement based on §34(1) SGB V. Lifestyle drugs are, for example, products that
- are used to lose weight, control appetite or to regulate body weight
- are used to quit smoking
- improve hair growth
- treat erectile dysfunction and
- increase sexual potency.
SHI funds do not reimburse these products because they
- don’t or don’t exclusively treat diseases,
- serve to satisfy individual needs or to enhance self-esteem,
- serve to treat consequences of natural aging processes and whose treatment is not medically necessary, or
- are used for cosmetic reasons, and are not medically necessary.
Since it is largely a person’s lifestyle that determines the use or need for these products, they are personally responsible for their funding.
Appendix II of the drug directive lists all excluded lifestyle drugs.
Off-label use
Physicians are free to prescribe a drug “off-label”, i.e. in an indication not covered by its label. However, the physicians are solely liable unless the manufacturer has agreed to this off-label use.
Before SHI funds would reimburse the cost of a product used off-label, the G-BA assesses the reimbursement for each off-label indication individually.
To this end, an off-label experts group, including members of the BfArM, makes recommendations to the G-BA based on their assessment of the current scientific and medical knowledge. Their assessment follows this template (available in German only).
The off-label expert group includes:
- 40 – 50 experts from various medical disciplines, including internal medicine, oncology and neurology/psychiatry,
- 5 – 6 biostatisticians or biometricians,
- 2 – 3 clinical pharmacologists,
- 8 – 10 representatives of the Medical Service (German: “Medizinischer Dienst”)
- 3 representatives from patient groups and 1 – 2 representatives from the pharmaceutical industry, but they have no voting rights
The G-BA then lists the findings on this exceptional use in a directive (Drug directive, Appendix VI). The directive has two parts:
- Part A contains detailed information on each active ingredient and its off-label use that is allowed for reimbursement. It covers exactly the patient groups, indication, dosage and duration of accepted off-label use. In addition, it states which pharmaceutical company has agreed to the off-label use of its drug and thus assumes liability according to § 84 AMG.
- Part B lists active ingredients that are excluded from the reimbursement in the off-label indication.
References:
Reimbursement in practice
How does reimbursement of drugs work in the real world in Germany? How do the pharmaceutical companies get their money, and what’s the role of the SHI funds?
- Pharmaceutical companies sell their products to wholesalers or directly to pharmacies.
- About 90% of the German population are insured with one of the SHI funds and pay insurance contributions.
- The treating 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. They are covered by SHI funds, if this off-label use was approved.
- Patients with a statutory health insurance 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 of the patient.
- This means SHI funds do NOT directly pay pharmaceutical companies.
Further reading related to reimbursement in Germany
- The four most important things to know about pricing in Germany
- NUB method assessments to become faster
- 8 NUB assessments of high-risk medical devices (§ 137h)
- Another reimbursement restriction in Germany
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