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Why is it important to know the German health care market?

About 70 million people in Germany are national health insured, while only 11 % have private health insurance. The reimbursement of the statutory insured patients is determined by decision of a governmental organization called „Gemeinsamer Bundesausschuss“ (GBA). This committee provides legally binding guidance for the public health insurance system for drugs that qualify for reimbursement and those that do not for the more than 70 million people covered by the national health insurance in Germany.

The decisions of the GBA are clearly influenced by in depth cost-benefit analyses, which are made by an independent committee of medical health care experts called “Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen” (IQWiG). This institute is the “watchdog” for quality and profitability in the statutory health service.

Unfortunately in the past the decision making process was not always clear with regards to the detailed data analysis process. Therefore, the outcome of the decision making process could be unpredictable as to whether, after the evaluation process, a drug would be approved or rejected for reimbursement.

For example:

In Germany about 7 Million people suffer from diabetes, 90 % of them with type 2 diabetes. The majority of the Type 2 diabetes patients will still continue to the original insulin formulation. However in recent years 400.000 patients have been switched to the longer lasting insulin analogue products “Glargin” and about 100.000 to the similar “Detemir”.

In March 2010, the GBA decided, based on the IQWiG recommendation, that the two new long term diabetic formulations should no longer be reimbursed by the public health system. The decision was driven by the negative outcome of the cost- benefit analysis performed by the IQWiG. Compared to the original insulin formulation, the IQWiG concluded that the treatment goal of controlling the blood sugar level could effectively be achieved with the original formulation. The more user-friendly application of the long term diabetic medication does not justify a higher price, and therefore would not qualify for reimbursement through the public health insurance.

As a consequence, these 500,000 patients no longer have access to a innovative medicine, which is much easier to use and enhances not only compliance, but also increases the quality of life of the targeted patient population. Physicians are no longer allowed to prescribe these innovative drugs for patients covered within the legal health insurance system.

Second example:

The new Hepatitis-C-therapeuticum “Boceprevir” (Victrelis®/ Merck Sharp & Dohme MSD), which is a protease inhibitor used for the treatment of hepatitis C genotype, also underwent the cost-benefit-analysis process within the IQWIG Institute. It was decided that only two of the four Hepatitis-C-patient groups could benefit from the new medication. Surprisingly this time the GbA did not follow the IQWiG recommendation and as a result, Merck Sharp & Dohme had to go in new price negotiations with the health insurances.

What can we do?

The Lyck & Pätzold Medizinanwälte attorneys are familiar with the reimbursement system as well as the national and private health insurance system. As the examples above show, GBA or IQWiG decisions are very unpredictable. Even the larger pharmaceutical companies with their tremendous in-house expertise struggle to predict the outcome of the GbA and IQWiG decisions making process. However with our in depth knowledge of the German health care system and incorporation of lessons learned from past decisions of similar products, our firm has an excellent understanding of current “reimbursement trends”. That, along with our strong communication strategies, enable us to minimize the risk of negative GBA/IQWiG decisions.

Lyck & Pätzold can provide a risk analysis and develop a communication package for you addressing the challenges you are facing in the German Health Care market.

(Christine Stenner, Attorney at law)

Christine Stenner

Autor: Christine Stenner

Rechtsanwältin Christine Stenner ist Fachanwältin für Sozialrecht und Medizinrecht.

Sie ist seit 1996 in Deutschland als Rechtsanwältin zugelassen und hat als Spezialistin im deutschen und europäischen Gesundheitsrecht gearbeitet. Sie ist nun unsere Kooperationspartnerin in den USA, wo sie international tätige pharmazeutische Unternehmer und Medizinproduktehersteller in Fragen des deutschen Arzneimittelzulassungsrechts und bei Fragen zu Kostenerstattungen im deutschen Gesundheitswesen berät. —

Christine Stenner is a board certified healthcare lawyer.
She has a German bar admission since 1996 and has worked as attorney at law specialized in health legislation of Germany and the European Union. Now she is our cooperative partner in the United States of America, where she counsels medicinal products and medical devices companies in all questions of German drug approval and market authorization law and statutory health insurance law in Germany.

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