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HEALTH CARE SYSTEM IN GERMANY

It is mandatory to have health insurance in Germany. 90% of the German population was covered by Statuatory Helath Insurance and 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 are covered by G-BA, extend the services or may 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 limi for the co-payment. They are required to contribute 10% on the prescription drugs. The minimum contribution of EUR5 and maximum contribution is EUR10.

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

Since 2007, prices of the branded drugs are being negotiated in Germany.

For generics, tendering and price contracting is usually followed.

Pricing and reimbursement:

In January 2011, AMNOG has been introduced in Germany. As per the AMNOG, in the first year after the launch of any drug, there will be free pricing. From second year, the price will be based on the systemic and formal assessment of the added therapeutic benefit of the pharmaceutical product.

if the the new product have the same added therapeutic benefit as standard of care, there will be price negotiation. If the new product has no added benefit compared to the standard of care, reference price cluster is used.

There are 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 particular 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 annual costs exceeds EUR 50 million, then the manufacturer is expected to submit the therapeutic assessment.

Drugs that are indicated in the hospitals are negotiated directly with the pharmaceutical companies. Since 2017, prices of drugs that are given for outpatients acts as ceiling.

Discounts:

Outpatients:

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

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

16% for retail discounts

Decision making process

Germany pharmaceutical policy is having positive impact on the pharmaceutical innovation. In Germany, free pricing is available for the fist year 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 umbrella of association including physicians, dentists, hospitals and health insurance funds.

IQWIG:

It is the body that is mainly involved in clinical evaluation of the products.

Benefit types:

Major added benefit

Cosiderable added benefit

Minor added benefit

Added benefit not quantifiable

No additional benefit

Price negotiation:

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

G-BA assessment

Annual cost of therapy for other pharmaceuticals

Prices in other European countries

Reference:

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

Image source: https://www.free-country-flags.com/countries.php

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