Reimbursement & Market Access

Innovative Pharmaceuticals

Germany is crucial for Market Access in Europe due to its market size and International Reference Pricing. 17 European countries alone reference to the German price. A successful AMNOG submission and price negotiation is therefore a cornerstone for any market launch in Europe.

The AMNOG process introduced a mandatory early benefit assessment for any new active pharmaceutical ingredient (API) launched in Germany after January 1^st, 2011. Manufacturers will only achieve reasonable reimbursement prices for their products if they obtain a favorable additional benefit rating by G-BA. After a period of 6 months for the health technology assessment by the G-BA price negotiations with the German payer group GKV-Spitzenverband follow if an additional benefit is acknowledged by the G-BA.

The price negotiations might take up to 6 months and are regulated partly by law (SGB V) but also allow for some discretion for the company and the payer group (regarding risk-sharing and/or price volume agreements for example). If price negotiations fail an arbitration board sets the price on the basis of the comparator’s price, the G-BA assessment, other similar drugs in Germany and the product price in 15 other European countries. If no additional benefit is acknowledged by the G-BA the price of the standard generic therapy applies.

Contracting and tendering for pharmaceuticals

For innovative APIs contracting with individual payer groups is possible under § 130a VIII SGB V but rarely takes place as the rebates given in the AMNOG process to all health insurers are usually significant.

By contrast, generic markets since 2006 are mainly driven by tenders of individual health insurances such as the AOK group (approx. 40 % market share) which are governed by EU public procurement law. The company succeeding in tenders obtains superiority at the pharmacy dispensing point (generic substitution) and thus usually gains volume. Even though various forms of tenders exist (one or three partner models / open house contracts) a solid knowledge about the provisions on generic substitution and procurement law are crucial to succeed in tenders and gain market share.

Reimbursement of medical devices in the homecare sector

From an economic perspective, the homecare market for medical devices is larger than the hospital market. However, the homecare market is much more complicated in its regulation. While the law provides for direct reimbursement mechanisms for prescribed products such as so-called medical aids, most medical devices are subject to rather indirect reimbursement as they are part of medical treatments rendered by doctors. As a consequence, these products are governed by mechanisms addressing doctors (general practice expenses, Uniform Scale for Doctors, special agreements for cost for materials, additional expenses etc.). Furthermore, relevant parts of the homecare market are dominated by tenders and specific framework agreements for homecare providers. That being said, in practice tailor-made approaches are needed reflecting not only the various legal rules and diverging contractual landscape but taking into account the different influencing factors (budgets, cost-effectiveness monitoring instruments) that have a say when doctors are providing treatment to patients.

Hospitals: Innovative Medical Devices and Pharmaceuticals

The reimbursement in the German hospital market is governed by so-called Diagnosis-Related Groups (DRGs). DRG’s are indication-specific lump-sums which are triggered by certain operating procedures (so-called OPS-Codes). For methods that cannot be adequately compensated in this manner, the DRG-system provides for regular additional payments; this is particularly important for medical interventions with high material costs. Since new innovative drugs and medical devices are not immediately integrated in the DRG-system, hospitals are entitled under certain conditions (NUB-status 1 granted by InEK) to agree temporarily on so-called NUB-payments. Recent experience shows that access of new diagnostic and treatment methods becomes increasingly difficult and public health insurances increasingly refuse to pay for methods that have not yet demonstrated their patient-relevant benefits on the basis of sufficient evidence. It is all the more important that companies properly deal with new instruments that have been introduced by the legislator in the last years, such as the so-called testing mechanism in § 137e SGB V or the early benefit assessment in § 137h SGB V.

Our services particularly include:

Full-service legal support throughout all phases of the AMNOG-procedure, including drafting of dossier, G-BA benefit assessment, price negotiations with GKV-Spitzenverband, arbitration board proceedings and possible court action
Legal advice as well as court litigation regarding other reimbursement constraining measures such as reference-price groups, therapy guidance, prescription restrictions or aut-idem-substitution
Legal advice as to how to deal with cost-effectiveness targets for doctors, API quotas, financial prescription incentives by public health insurances, doctor information and other prescription-steering measures by doctors’ associations on a regional level
Full-service legal advice to succeed in tenders, negotiate contracts for innovative compounds with payers as well as taking legal action by way of public procurement law procedures at state and federal award chambers
Legal support regarding reimbursement of medical devices, in particular with listing of products in medical devices register and joining framework agreements
Legal advice on issues related to reimbursement of diagnostic methods, special agreements on practice materials, separate costs for materials etc.
Legal support for obtaining NUB status 1 for new diagnostic and treatment methods in connection with agreement of so-called NUB-payment
Legal review and development of strategy regarding payment refusals by public health insurances vis-a-vis hospitals regarding new diagnostic and treatment methods
Legal advice and support on new diagnostic and treatment methods throughout all phases of early benefit assessment as per § 137h SGB V as well as of testing mechanism as per § 137e SGB V