Market Access Consulting
We offer comprehensive advice and services on all questions regarding market access and reimbursement of drugs and medical devices. Every drug or medical device faces specific reimbursement challenges. The challenges arise from the respective indication, the pivotal trial data, the comparative therapy, the price level in the respective markets, the competitive situation, and the legal requirements. We support you in developing the optimal market access strategy and the market access road map. Our services include the preparation of necessary applications, documents and the compilation of the AMNOG benefit dossier.
Reimbursement of Medicinal Products
Since 2011, new drugs have been subject to the requirements of early benefit assessment according to AMNOG. Special regulations are applied for orphan drugs, ATMPs (advanced therapeutic medicinal products) and new indications of known active substances for which a data protection is granted. Market access of generic drugs is often subject to maximum reimbursement prices as determined by fixed prices. Furthermore, the generic market in Germany is often regulated by rebate contracts of the single statutory health insurance funds, generally implemented in the form of tenders. Medicines that are not subject to the Drug Price Regulation by alternative regulations, provided that the statutory health insurances are generally eligible for reimbursement. Before marketing a drug, it is therefore always necessary to analyse the framework conditions in relation to the respective product in order to develop and implement the optimal strategy for market access and reimbursement.
Reimbursement of Medical Devices
In the recent past, medical devices have increasingly moved into focus of the benefit assessment. New legal procedures for the assessment of medical devices of higher risk classes (2b and 3) impose new challenges for market access and reimbursement. The procedures according to §§ 137e and 137h SGB V are complex and generally of long duration, so that careful planning of the reimbursement process seems indispensable.
Clinical Study Design
In general, clinical studies are the basis of the early benefit assessment according to AMNOG. For medicinal products, randomised controlled trials are considered the gold standard for Health Technology Assessments in Germany. Further important criteria are defined by the relevant authorities, the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG). Most importantly, these include the determination of an appropriate comparative therapy and the consideration of patient-relevant endpoints in the respective indication.
Thus, the clinical trial design is not only important for the market authorization but also for market access and reimbursement of new drugs and medical devices. We are offering consultancy service with respect to clinical trial planning in terms of optimal market access and reimbursement. Based on systematic literature research, we examine potential comparators and clinical endpoints in terms of the requirements of the benefit assement.
We support you in the strategic preparation of and application for G-BA scientic advice meetings in order to achieve an optimal market access.
Reimbursement in Hospitals
Reimbursement of drugs and medical devices in hospitals follows both a health economic evaluation and a benefit assessment. Since 2018, the AMNOG benefit assessment has been extend to hospital only products. In terms of health economics, new drugs and treatment methods (NUB) are examined to see whether they are already covered by the current lump sum compensations of the DRG system (diagnosis-related groups). The Institute for the Hospital Remuneration System (InEK) is responsible for this evaluation, which is carried out at the request of hospitals wishing to use a new service. The health economic consideration by the InEK takes place both for drugs and medical devices, provided that hospitals have submitted concrete NUB applications for reimbursement of these services in addition to the DRGs (lump compensation). While prices for medicines or medical devices are negotiated directly between manufacturers and hospitals, reimbursement of new drugs and medical devices is negotiated between hospitals and the statutory health insurances.
In addition to the cost analysis, a benefit assessment according to § 137h SGB V takes place for medical devices, if NUB applications have been submitted for a new medical device of risk classes 2b or 3. We are offering all services related to the reimbursement of drugs or medical devices in hospitals. This includes the preparation of NUB applications, applications for medical devices according to § 137h Social Code Book V and the compilation of benefit dossiers according to the AMNOG requirements.