Following the German government’s plan to introduce various changes to the market access and pricing legislation in Germany, please be informed that yesterday the German Federal Ministry of Health has sent a respective draft bill (Gesetz zur Stärkung der Arzneimittelversorgung in der GKV) to other Ministries and industry associations.
This bill, inter alia, provides that if the revenues for a new drug exceed a threshold of EUR 250 million the first year, the reimbursable amount will be lowered also within this period. In such cases, 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 said threshold was exceeded. Currently, the pharmaceutical entrepreneur is free to set its prices in the first year while the negotiated price only applies as of the 13th month after the market entry. During the Pharmadialogue meetings, the pharmaceutical industry and Germany’s government discussed thresholds between EUR 100 million and EUR 500 million. According to the Ministry, in 2015 the costs for three products exceeded the now proposed EUR 250 million threshold. Hence, the suggested threshold will only affect a few products and, in general, not OMPs.
The bill also explicitly prohibits a public listing of the prices negotiated between the manufacturer and insurance funds. This price may only be made available to those bodies that “need this data to fulfil their public obligations”. The current bill does not give further details on this topic but refers to a to-be drafted statutory ordinance. By forgoing the publication of this price, the Ministry satisfies an important demand vital to the pharmaceutical industry. However, it has to be seen how the rules on the confidentiality of the prices will be phrased and as to when these rules will apply. This could be considered a major step forward to secure differential pricing if it is implemented effectively.
Furthermore, the bill also includes the extension of the price moratorium until the end of 2022. From 2018, a compensation for inflation will be introduced. The Ministry expects savings of 1.5 to two billion euros from the extension of the price moratorium.
The bill also foresees the possibility for the G-BA to arrange for a benefit assessment for medicinal products with known active compounds, namely, when the authorisation of a new indication is sought that is substantially different from the first indication. Again, the draft does not give further details as to under which circumstances “substantial differences” will be assumed but refers to the G-BA which shall amend its rules of procedure accordingly.
The draft bill does not question the current rules for the benefit assessment of OMPs, i.e. that the G-BA determines the extent of additional benefit for OMPs with revenues not exceeding EUR 50 million based on their market authorisation. The fact that the bill does not touch these rules is positive although it cannot be excluded that respective amendments are introduced during the further legislative process.
According to the Ministry, the government is expected to adopt the bill in September 2016 initiating the parliamentary legislative process. The Ministry expects that it will enter into force in the spring of 2017. It has to be seen, however, to what extent the current draft will be amended. We will further analyse its text and keep you updated on any new development.