YOUR MARKET-ACCESS GUIDE FOR THE GERMAN HEALTHCARE MARKET
More success for your product
Market access for new products in the German health care market is clearly regulated. The regulations can be found in Social Code Book No. 5 (SGB V). In principle, the German market is open to all health products and services. However, this freedom does not mean automatic funding by statutory or private health insurances. In Germany, about 85% of the population is insured by the statutory health insurance (GKV); this is what makes this market so interesting for the funding of health products.
Olaf Pirk Consult guides you through the SGB V and supports you in obtaining the relevant funding for your product. Your product can be a drug, a medical device or a new service.
Market Access for Medicinal Products & Medical Devices
Access to the health care market in Germany is initially incredibly simple:
A drug needs to be approved by a regulatory authority (European Medicines Agency, EMA, Federal Institute for Drugs and Medical Devices, BfArM, or Paul Ehrlich Institute, PEI) and then it can be prescribed by a physician in Germany. However, whether it is then paid for by the statutory health insurance (GKV) depends on various factors. You can find more on this topic under “Market Access Pharmaceuticals”.
A medical device also requires some form of market-authorisation; usually this is a CE mark. A medical device with a CE mark can be introduced and sold on the German health care market. However, whether it is then also paid for by the statutory health insurance (GKV) depends on various factors. You can find more on this topic under “Market Access Medical Devices”.
Market access for drugs in Germany has been newly regulated since January 2011. The Medicines Market Restructuring Act (AMNOG) requires that the manufacturer must submit a benefit dossier for pharmaceuticals at the time of market entry. The Federal Joint Committee (G-BA) evaluates this benefit dossier and subsequently decides on the additional benefit of the product compared to an appropriate comparative therapy that it has determined in advance. If the G-BA determines an additional benefit, a “price negotiation” takes place on a reimbursement amount that applies to all health insurance companies in Germany from month 7 after submission of the benefit dossier. Negotiations are conducted by the German National Association of Statutory Health Insurance Funds (Spitzenverband Bund der Gesetzlichen Krankenversicherung, GKV-SV) with the manufacturer. If no additional benefit is stated, the new drug is either assigned to a reference price group – if this is possible – or the reimbursement price is set at a level that does not lead to higher costs than treatment with the appropriate comparative therapy. For drugs for rare diseases (so-called orphan drugs), the additional benefit is considered proven by law as long as the sales do not exceed the limit of EUR 30 million at the pharmacy retail price incl. VAT within 12 months; a benefit dossier must also be submitted here with the market launch so that the extent of the additional benefit can be assessed. The additional benefit assessment must be carried out for all drugs with new active substances.
Olaf Pirk Consult advises you on the entire benefit assessment process.
About Dr. Pirk
The founder of Olaf Pirk Consult is Dr. Olaf Pirk. Dr. Pirk is a medical doctor, health economist and systemic consultant and has been working in the health sector for more than 30 years. In the past 25 years, he has mainly worked as a consultant for market access of new drugs and medical devices, for health economic and health policy issues as well as for questions of care management.
Dr. Pirk started his professional career as a consultant for clinical research, medical-scientific issues, drug safety and marketing authorisation. His next steps led him into drug marketing and pharmacoeconomics. Based on this broad knowledge, Dr. Pirk was the co-founder of the German department for health economics and pricing of medicinal products at one of the largest international pharmaceutical companies. This step was followed by the leap into self-employment, Dr. Pirk was co-founder and managing director of a consulting company that dealt with questions on health economics, health system research, pricing of drugs and medical products, market access of medical services and care management. The company grew into a successful and well-known service company within only five years and was sold by the founders to the world’s leading US market research company for the pharmaceutical industry. After the sale, Dr. Pirk took over the management of the company, as the newly acquired company now functioned as an independent division. In this role, Dr. Pirk was responsible for marketing, business development, human resources, business management issues and, of course, numerous projects. In addition, he also took on tasks in training and mentoring. In 2011, Dr. Pirk left this company to become an independent consultant again with Olaf Pirk Consult.
Dr. Pirk has decided to make his experience and his knowledge available in future as a freelance consultant to interested companies operating in the health market. With his experience and his knowledge, Dr. Pirk will guide you and your product through the pitfalls of market access in the health care market in Germany.
The pitfalls of market access can be overcome with the right support. This means identifying the different competences that are needed and bundling them for the benefit of the product and the upcoming market access.
Both the market access process for pharmaceuticals and the market access process for medical devices or other medical services require different expertise depending on the process step.
Olaf Pirk Consult advises you and is your guide through the health care system. In the function as a guide, you will also be supported in the search for further service providers that are relevant for you and your product for Market Access.
Olaf Pirk Consult cooperates with almost all renowned service providers in this field and also assists you in the selection of further service providers relevant for you and your product in order to master all pitfalls.
Market Access Trainer
In simulation trainings, Olaf Pirk Consult prepares you to appear confidently and achieve your goals, e.g. , in a hearing before a sub-committee of the Federal Joint Committee (G-BA) or in a price negotiation with health insurers or the National Association of Statutory Health Insurance (GKV-SV). For this purpose, Olaf Pirk Consult is supported by other experienced trainers.
In the simulation trainings, content is trained on the one hand and tactical procedures on the other, with non-verbal communication also being extremely important.
When it comes to contract negotiations, tactics and negotiating skills are particularly important. Here, Olaf Pirk Consult is supported by Mr. Henning Anders. You can find out more about him below.
Every interaction with other people (e.g. , hearing, negotiation, etc.) is about communication. Non-verbal communication plays an important role in this. Here Olaf Pirk Consult is supported by Mr. Harald Bierlein-Neußinger. You can find out more about the trainers below.
Harald Bierlein-Neußinger is a director, actor and soft skills trainer. He has been working as an acting coach in adult education for over 25 years. Among other things, he conducts presentation training with a focus on sustainable and authentic presenting. Since the introduction of the AMNOG, he has supported Olaf Pirk Consult in numerous simulations on the hearing procedure and price negotiation. He is used as an observer in the simulations and trains the so-called soft skills such as facial expressions, gestures, body posture and expression, as well as inner attitude and how this influences our behaviour and appearance and how this can be used to advantage.
The founder of Olaf Pirk Consult is Dr. Olaf Pirk. Dr. Pirk is a trained physician, health economist and systemic consultant and has been working in the health sector for more than 30 years. In the past 25 years, he has mainly worked as a consultant for market access of new pharmaceuticals and medical devices, for health economic and health policy issues as well as for questions of care management.
Henning Anders is a lawyer and has been dealing with market access of drugs for more than 25 years. He has supported a large number of companies since the introduction of the additional benefit assessment through the German Medicines Market Restructuring Act (AMNOG). He is also actively involved in the entire AMNOG process. He has actively supported and also participated in about a quarter of all price negotiations; in addition, he has become acquainted with about half of all arbitration board proceedings from his own perspective. Mr. Anders supports Olaf Pirk Consult in particular in trainings on price negotiations and in trainings on preparation for arbitration proceedings as well as in trainings on hearings.
Further information: www.mhl.de