Focus on Germany
As an aid to clients we have prepared a number of landscape pieces in which we share a summary of the key aspects which affect pricing and reimbursement rates, as well as market access in each of the markets. This article focuses on Germany.
In Germany the most important bodies to be aware of are:
• The Federal Institute for Drugs and Medical Devices (BfArM) - the authority responsible for licensing medicinal products in Germany.
• The Federal Joint Committee (G-BA) - a national self-governing body of physicians, dentists, hospitals and health insurance funds. It is the central decision making body concerned with drug provision for those with statutory health insurance, or GKV, (about 90% of the population). The G-BA’s resolutions and directives are audited by the Federal Ministry of Health and binding for all GKV stakeholders.
• The Federal Association of the Statutory Health Insurances (GKV-Spitzenverband) - this is an umbrella organisation that represents the interests of all the individual Krankenkassen, the statutory, non-profit, health and nursing care insurance funds, which are legally required to accept all applicants. Key processes in new drug approval:
The BfArM licences the drug. Then within three months of market authorisation, the G-BA initiates the early benefit assessment, for which the manufacturer submits a dossier demonstrating additional benefit of the product over the comparator the G-BA has selected. After the initial assessment, pharmaceutical companies and experts may submit statements on the results. After another three months the G-BA issues a resolution on the benefit assessment, which includes the extent of additional benefit and eligible patient groups.
If the new therapy offers no additional benefit over the existing standard therapy, its active ingredient group will be used as the basis for the reference price. If there is no such reference group, the GKV-Spitzenverband will negotiate a refund rate with the pharmaceutical company so that it does not cost more than the existing standard therapy. If there is additional benefit, the GKV-Spitzenverband negotiates a reimbursement price, paid to the pharmaceutical company on top of the price of the existing standard therapy.
Implications for Research Projects:
Given the rigorous nature of pricing and reimbursement assessment in Germany, it is essential to undertake research throughout the development process in order to gain insights into the possible outcomes and - crucially - to understand how to influence them. This requires we recruit the right respondents:
- For projects which are primarily market access studies, the appropriate national targets are professionals related to the G-BA i.e. members, ex-members and advisors.
- For projects which are focused on pricing, Medicys’ recommendation would be to target both the G-BA (to identify what would be the likely comparative therapy for additional benefit assessments), and the GKV (to explore achievable target prices based on the likely outcome of the benefit assessment).
- At a regional level the Krankenkassen are important regional payors; usual respondents tend to be medical directors or budget managers. Another important group of regional stakeholders are the physician association representatives, or KVs, who manage and administer the budget allocation and individual reimbursement of sick fund physicians.
- If likely local uptake needs to be assessed, the local level payors for hospital drugs will be the head of pharmacy or formulary pharmacist and the budget holder or head of clinical department.