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.

For medical devices, so-called “devices”, diagnostics, etc., market access is regulated in Social Code Book No. 5 (SGB V) to the extent that financing by the statutory health insurance (GKV) is possible without further requirements under certain conditions; the prerequisite is an already existing service paid for by the GKV in which the product is used. It is succinctly stated that the product is already part of the catalogue of services.

If the product is missing from the services catalogue or if there is no service with this product, there is no automatic financing by the GKV. There are, however, various possibilities in the GKV-system to still obtain financing. However, there is no silver bullet for financing, so it is important to sound out the different possibilities offered by the SGB V and to identify and use the ideal approach for market access and financing for the product.

Olaf Pirk Consult will be happy to advise you on the best way to obtain funding for your product.

The market access for a health service, whether it is a drug or a medical device, must be planned as early as possible. Ideally, this planning begins during product development, otherwise the surprise is huge when the product is to be launched on the market and important data for this step are missing. For almost every health service that is to be financed by health insurances, it is necessary to show the benefit. In particular, it is about the benefit that is really relevant for the patient. This benefit is best presented in such a way that it is recognisable what difference the new health service offers compared to what has been used so far (“gold standard”).

The strategic consulting services of Olaf Pirk Consult therefore start even before the actual study development, in order to taking into account, the relevant benefit aspects in studies in good time.

Before market introduction, it is checked whether all relevant data are available and what possibilities exist to provide the missing data.
If formal requirements have to be taken into account for the market launch, these are addressed by Olaf Pirk Consult in good time and, if necessary, implemented in cooperation with partners.
For steps that take place after the actual market access, Olaf Pirk Consult provides both advisory and operational support.
For further product development, e.g., in the case of indication extensions etc., it is also important to recognise and avoid the relevant pitfalls in good time. Olaf Pirk Consult is your guide in the market access process.

Olaf Pirk Consult offers different trainings. All trainings are individually tailored to the needs of each client, so that different topics can also be combined. The following general topics are offered:

• How does the German health system work?
• Market access and reimbursement of pharmaceuticals
• Market access and reimbursement of medical products

Special training topics are oriented towards formal requirements in the market access process:

• Training on G-BA consultation in the process according to §35a SGB V (AMNOG) or in the process according to §137e SGB V (testing of a new method)
• Training on hearings before subcommittees of the G-BA
• Training on price negotiations with the GKV-SV

The special trainings, especially the hearing training and the price negotiation training, are designed in such a way that, in addition to the preparation of the content, the communicative aspect can also be trained as an option. Here, Olaf Pirk Consult is supported by an acting coach who takes care of team-building and non-verbal communication.
The price negotiation training can also be supported by a lawyer who has been practised in many price negotiations and who brings the important aspect of contract negotiation into the training.