The German Bundestag has adopted the new German Act on Strengthening Pharmaceutical Supply in the Statutory Health Insurance (AMVSG). The Act is expected to come into effect in May 2017.
Also to note is that the rules on the dossier for orphan medicines (with an outpatient turnover in Germany of less than €50 million) remains untouched.
- The principle of free pricing in the first year after launch is kept:
Originally, it was proposed that once a revenue threshold of €250 million is exceeded within the first twelve months, the price negotiated between the manufacturer and the GKV-Spitzenverband will apply retrospectively as of the first month following the month in which the threshold was exceeded. While, in general, the deletion of the respective provision is positive, the suggested threshold would have most likely affected only a small number of products but could have been lowered at later stages. Hence, the deletion is positive for industry.
- No confidentiality of the reimbursed price negotiated between companies and GKV-SV:
In exchange for the abandonment of the €250 million threshold, the provision to keep the negotiated prices confidential was set aside. Against the background of international reference pricing the proposed confidentiality of prices was widely welcomed by industry albeit the draft provided access to this information to “public bodies that require this information to fulfil their legal obligations”. De facto, the negotiated price would have been available to many stakeholders in the GKV system and hence could have hardly be seen as being really “confidential”. Nevertheless, the deletion of the “confidentiality” is a setback for industry and it is concerning that the legislators do not acknowledge the negative effects international reference pricing can have on market and patient access to new innovative products.
Other aspects have already been included in the bill such as:
A. Price moratorium until the end of 2022:
The new law will also extend of the price moratorium until the end of 2022. The prices for pharmaceuticals will be kept at the level of 2009, i.e. manufacturers are barred from increasing their prices for another five years. Although the bill provides for a compensation for inflation, this cannot balance the losses incurred since the introduction of the price freeze in 2010.
B. New information system for physicians
An electronic system is introduced to inform physicians about the outcome of the AMNOG process. It is not clear yet to what extend and for which additional purposes this system will be used in the future but the infrastructure will be set up. Some (future) purposes of this information system could be to educate the physician about the cheapest products available so it could become rather relevant for generic and biosimilar markets.
C. Pricing in multiple indications / subpopulations
The new law also deals with the fact that GBA often granted different degrees of additional benefit for different patient populations. It is intended to allow for more flexibility in this respect: The manufacturer could apply for an exclusion of reimbursement for certain subpopulations but can also differentiate in the price negotiations in § 130b SGB V by conducting price / volume agreement per indication / subpopulation.
D. New indications of APIs launched prior to 2011
Additional indications of APIs launched prior to 2011 have not triggered an AMNOG assessment in the past. This will change and this could become one of the most relevant changes in the bill for innovative pharma and biotech companies. If new regulatory data protection exists for the new indication a dossier needs to be submitted to GBA. However, it is not clear which implications this has on the price of the old indications and whether only the new indication is subject to the GBA assessment (which is likely but unclear). Hence, this can be a very relevant change of the law if companies have follow-on indications in the pipeline.
Another bill after the elections in September might change that setting over the year of 2018 but for the time being the most relevant provisions of AMNOG remain.