G-BA announces list of first six pre-AMNOG drug groups to undergo benefit assessment

G-BA reveals list of first pre-AMNOG drugs to be reviewed under AMNOG rules

Germany's Federal Joint Committee (G-BA) has revealed a list of the first six groups of drugs launched before the implementation of the Pharmaceutical Market Restructuring Act (AMNOG) that will be subject to benefit assessments, as well as the criteria by which they have been selected. Thus, starting in July, the first resolutions from the G-BA will be delivered regarding the first two drug groups, and the manufacturers will have three months in which to prepare a dossier.

The G-BA's criteria for deciding which drugs marketed before AMNOG are to undergo benefit assessments first are based on a combination of the economic value of the drug's sales (80% of the calculation) and the number of prescribed packages (20% of the calculation). The official drug prescription reports from 2012 were used as the basis for calculation, with 188 drugs assessed. Additionally, the selection was also based on a prediction of the growth rate of the drugs' future sales value, and a prediction of the number of prescriptions while the drug remains subject to data-exclusivity protection. The full explanation of the criteria used can be found at the G-BA's website, in German, here.

The first pre-AMNOG marketed drug groups to undergo benefit assessments, ordered on the basis of the criteria, will be as shown below – not including the dipeptidyl peptidase-4 (DPP-4) inhibitor group, which has already undergone a benefit assessment. The original version of the list can be accessed at the G-BA's website, in German, here.

Blockbusters absent from list

The impartial chairman of the G-BA, Josef Hecken, is reported by Deutsche Apotheke Zeitung as saying that the annual value of the sales of the drugs involved in the first six groups in Germany is around EUR5 billion (USD6.5 billion). The source also comments that there are no blockbuster drugs on the list, and explains that this is because in most cases these drugs were the standard of care, making it impossible to determine an appropriate comparator therapy.

In its general press release, the G-BA states that the following categories of drugs (marketed before AMNOG) are excluded from consideration for benefit assessments:

• Drugs that have been identified by the G-BA as appropriate comparator therapies
• Drugs subject to internal reference pricing
• Drugs excluded from regulation of the Association of Statutory Health Insurance Funds

The press release can be accessed, in German, here.

Outlook and implications

As had always been envisaged under AMNOG, drugs that were marketed before the act's implementation in 2011 will also be subject to benefit assessments. This has been the subject of some considerable debate and controversy recently, as in the case of the first group of drugs marketed before AMNOG for which a benefit assessment was initiated – DPP-4 inhibitors, in June 2012 – the process ended up in a legal battle that ultimately has been curtailed by the German authorities (see Germany - Switzerland: 4 March 2013: German court overturns Novartis's emergency appeal against benefit assessment for DPP-4 inhibitors). Indeed, in the past few days, it has been announced that the government plans legal changes to make it impossible to bring a legal case against an individual benefit assessment, thus closing a legal loophole that had made Novartis's lawsuit possible, which had delayed the entire process of benefit assessments for pre-AMNOG marketed drugs (see Germany: 15 April 2013: German government moves to close legal loophole for pre-AMNOG approved drugs).

For the producers of the drugs set to undergo benefit assessments, they are highly likely to see some quite considerable reductions in prices in some cases, while it is also likely that in most cases, an additional benefit will be identified. The fact that there are few "blockbuster" drugs on the list, and that drugs considered to be the standard of care in particular areas are not going to undergo benefit assessments is significant too. This raises the bar in terms of the relation between price and effectiveness, with only a selected few set to be exempt from the benefit assessment process.