The German Ministry of Health has recently published its final bill concerning changes to the market access and pricing legislation for pharmaceuticals (Gesetz zur Stärkung der Arzneimittelversorgung in der GKV). Please find the text of the bill here (available in German). The bill is expected to be adopted in 2017.
Key points:
Extension of the price moratorium until the end of 2022
The bill includes the extension of the price moratorium until the end of 2022 which basically keeps the prices for pharmaceuticals at the level of 2009. The new bill does introduce compensation for inflation, but given the current low levels of German inflation, this is unlikely to compensate for the losses from the price moratorium.
Free pricing in the first year remains, but only up to €250 million threshold
The principle of free pricing in the first year will remain, but a revenue threshold of €250 million will be introduced. If this threshold is exceeded within the first twelve months, the price negotiated between the manufacturer and the National Association of Statutory Health Insurance Funds will apply retrospectively as of the first month following the month in which the threshold was exceeded. Nevertheless, it has to be expected that there is only a limited number of products that will be affected by this new rule.
Benefit assessments for products with a known active substance for new indications
The bill also includes the option for the Joint Federal Committee (G-BA) to initiate a benefit assessment for medicinal products with a known active substance if the product is authorised for a new indication which triggers a new ten years’ period of data exclusivity or if the data exclusivity period is still running for the medicinal product firstly authorised with this active substance. Since the current wording leaves the decision to initiate the process with the G-BA it will lead to a high degree of uncertainty.
Negotiated reimbursement discounts will remain confidential
The Ministry of Health clarified in the bill that reimbursable amounts negotiated between companies and the payers shall not be published but only made available to public bodies that require this information “to fulfil their legal obligations”. However, the draft lacks a definition what these legal obligations could be and whether also third countries’ public bodies shall have access to this information for the purpose of international reference pricing.
No change to added benefit assessment for orphan drugs
The bill does not suggest any changes concerning the rule that for orphan medicinal products with a yearly turnover of less than €50 million the additional benefit (usually subject to an early benefit assessment by the G-BA) is considered to be already proven through the grant of the market authorisation. This is clearly an important sign in the current debate around the regulatory incentives for orphan products.
Overall, these changes represent more an evolution of the current laws, rather than radical changes. Obviously the extension of the price moratorium and the potential for benefit assessments for new indications are less favourable for pharmaceuticals companies. However, this should be balanced by the preservation of free pricing in the first year, the maintenance of the orphan drug added benefit status and the introduction of confidential price discounts with payers.