Germany's main pharmaceutical industry association, the BPI, has rejected proposals for changes to the AMNOG act published in the latest Barmer GEK medicines report.
IHS Life Sciences perspective | |
Implications | Most of the proposals made in the report have already been put forward previously, including the idea of a "later" benefit assessment, to take place 3–5 years after the early assessment. |
Outlook | However, the German government appears unwilling to make changes to AMNOG at present, as it considers the current level of spending growth on drug reimbursement sustainable, for now. |
The statutory health insurance fund Barmer GEK published the Medicines Report (Arzneimittelreport) for 2015 on 9 December. The influential annual report, prepared by Gerd Glaeske and Christel Schiktanz of the Centre for Social Policy Research at the University of Bremen, focused on a number of familiar themes, relating to inefficiencies in drug pricing and reimbursement policy, while also making new proposals for solutions.
Introduction of "later" benefit assessment put forward again
In the report, proposals have been put forward for changes to the system of benefit assessments that started with the introduction into law of the Pharmaceutical Market Restructuring Act (AMNOG). Once again, the report's authors proposed a "later" benefit assessment system, which would require that new innovative medicines that have undergone an early benefit assessment process should undergo another benefit assessment after three to five years. This, according to the report's authors, would confirm a drug's patient-oriented additional benefits more effectively. The authors also proposed that price negotiations should take place at this stage, and that they should have a retroactive impact on the previously agreed price.
The authors give as an example of this the multiple sclerosis medicine Tecfidera (dimethyl fumarate; Biogen Idec, US), which was judged to show no additional benefit by the Federal Joint Committee (G-BA), but nevertheless progressed to price negotiations and is now among the medicines incurring the highest levels of spending by the statutory health insurance (GKV) funds. According to the report, the drug drew the eighth-highest spending by the GKV funds in 2014 (excluding cancer drugs in preparations – not in finished forms), amounting to EUR240.1 million (USD262.6 million). The report's authors point to the fact that the drug has been subject to safety warnings.
The chairman of the board of the Barmer GEK Christoph Straub states in his foreword to the report that, indeed, a "quick" benefit assessment should be brought into the process, similar to that in Scotland, which lasts 18 weeks. This compares with the 13-month early benefit assessment process in Germany. Straub also argues that reimbursed price negotiated by the funds and producers should be applied retroactively to the date of market entry, unlike in the current situation.
Greater control over parenteral preparations in oncology proposed
The report also strongly focused on the high level of expenditure on medicines delivered through parenteral preparations, as opposed to finished-form pharmaceuticals. The report's authors state that for the first time, its expenditure analysis also takes into account expenditure for individual parenteral preparations, used in oncology treatment. Particular medicines that incur the highest amounts of spending in this area are the monoclonal antibodies trastuzumab, bevacizumab, and rituximab. The report's authors state that spending on medicines in this context should always be included in assessments of expenditure, and estimate that they account for around 10% of the Barmer GEK's entire annual drug spending, amounting to around EUR424 million. They also estimate that spending on these has tripled since 2004. The authors do not rule out the use of discount contracts for these preparations, while also calling for stricter requirements for pharmaceutical manufacturers to provide price information to GKV funds in this area.
BPI critical of report's suggestions
The German Pharmaceutical Industry Association (BPI) issued a press release in response to the report, in which it criticises the methodology used by the Barmer GEK for assessing the growth in pharmaceutical spending by the funds. According to the BPI, it does not take into account the mandatory discounts or savings from discount contracts. According to the managing director of the BPI, Henning Fahrenkamp, when these figures are repeated many times, it distorts the real picture.
Fahrenhkamp agrees that AMNOG needs further development, but he takes issue with the proposals of the Barmer GEK report. He argues that the idea of the report – to take patent benefits into account even more than before – is questionable, since this is already the fundamental aim of the AMNOG assessment process. He contends that the introduction of more economic evaluation stages – as proposed by the report's authors – simply places the emphasis on the costs and not the benefits of medicines. Arguing that medicines are already being withdrawn from the German market because of the AMNOG assessment process, Fahrenkamp criticises the fact that the process is seen almost exclusively in economic terms by the GKV funds.
The full Barmer GEK report can be accessed here, in German, and the full BPI press release can be accessed here.
Outlook and implications
Glaeske has already called for a "later" assessment, and the proposal for reimbursement prices to be retroactively imposed back to market entry is a suggestion that has been made on many occasions. The Barmer GEK report also calls for the reintroduction of the benefit assessment of drugs marketed before AMNOG came into effect. These arguments are now familiar, and are reiterated by the GKV funds and some health professionals in Germany. However, at this stage, there seems to be very little sign of anything so radical happening to the AMNOG system. Recent figures showed GKV drug spending rising 5.1% year on year in the first three quarters of the year; this may be considered to be within the realms of acceptability.
The arguments of the BPI's managing director are equally credible as those of the Barmer GEK report's authors. Essentially, AMNOG is already doing its job. There remains a period in which a number of high-turnover innovative drugs retain a free price because they were marketed before the act's introduction. However, this period will end soon, and the administrative complication involved with assessing these drugs – or adding further layers of economic assessment to the existing system – may not translate into the levels of savings expected. Innovative drugs assessed under AMNOG are already priced at around the EU average, as opposed to those that were not assessed under the act, which remain high.