Drug pricing and reimbursement in Germany | Health Technology Assessment in Germany

  • It is mandatory to have health insurance in Germany.

  • Statutory Health Insurance covers 90% of the German population, and the rest, 10%, is covered by private insurance and other health schemes.

  • G-BA is involved in deciding the goods and services that need to be covered by the health insurance

  • Private health insurances may cover the same good and services that G-BA covers, extend the services, or reduce the number of services covered by Statutory Health Insurance.

Co-payment: Generally, patients are required to do the co-payments. However, there is a limit for the co-payment. They are required to contribute 10% on prescription drugs. The minimum contribution of EUR5, and the maximum contribution is EUR10.

Pharmaceuticals:

In the case of inpatients, the pharmaceuticals are completely covered.

Since 2007, prices of branded drugs are being negotiated in Germany. For generics, tendering and price contracting are usually followed.

Pricing and reimbursement:

In January 2011, AMNOG was introduced in Germany. As per the AMNOG, there will be free pricing in the six months after the launch of any drug. After that, the price will be based on the systemic and formal assessment of the added therapeutic benefit of the pharmaceutical product. Until 2021, the free pricing was maintained for one year.

  • There will be price negotiation if the new product has the same added therapeutic benefit as the standard of care.

  • A reference price cluster is used if the new product has no added benefit compared to the standard of care.

There are a few exemptions for the AMNOG evaluations.

  • If the annual expenditure of the particular pharmaceutical is less than EUR 1 million, there will be no assessment for that specific product.

  • If the drug is orphan and the annual cost is less than EUR 50 million, then there will be no assessment for that product. However, if the yearly costs exceed EUR 50 million, the manufacturer will submit the therapeutic evaluation.

Drugs that are indicated in the hospitals are negotiated directly with the pharmaceutical companies.

Discounts:

Outpatients:

  • 7% for the patented pharmaceuticals that are not included in the reference group

  • Minimum of 6% and not more than 10% for generics

  • 16% for retail discounts

Decision-making process

Germany's pharmaceutical policy is having a positive impact on pharmaceutical innovation. In Germany, free pricing is available for six months after the drug is approved.

G-BA:

It is involved in making the decisions regarding the coverage of health goods and services. It is also involved in establishing the guidelines.

It is an association umbrella, including physicians, dentists, hospitals, and health insurance funds.

IQWIG:

The body is mainly involved in the clinical evaluation of the products.

Benefit types:

  • Major added benefit

  • Considerable added benefit

  • Minor added benefit

  • Added benefit not quantifiable

  • No additional benefit

  • Less added benefit

Price negotiation:

G-KV is involved in the price negotiation with the pharmaceutical companies. The price negotiation is based on

  • G-BA assessment

  • The annual cost of therapy for other pharmaceuticals

  • Prices in other European countries

References:

HTA road maps Available from: https://tools.ispor.org/htaroadmaps/Germany.asp

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