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The innovation report 2017 of the “Techniker” SHI and the counter-reactions of the pharmaceutical industry

Wed, 2017 / 10 / 11
The main objective of the report is to answer the question whether or not a drug improves the existing therapy, if there is an additional benefit and if the costs for the new product are reasonable. This year, none of the products were categorized with an overall green light. Instead, 17 of the drugs received an overall yellow light and 15 an overall red light.

The main point of criticism is surging drug prices and treatment costs and simultaneously the lack of innovation and the lack of development of drugs in areas where there is a very high "medical need".

In addition to the early benefit assessment, the authors demand a late assessment and a systematic care research to maintain long-term quality in the drug sector.

Furthermore, they stated that the previous mandatory manufacturer’s rebate should be increased from 7% to 10% to ensure profitability. The authors of the report dedicate a special chapter to the topic of biological and biosimilars. Biosimilars are imitational preparations for which the same requirements apply as for the reference biologicals. However, they are much cheaper which means that high savings can be achieved.

Shortly after the press conference, the association of research-based pharmaceutical companies (vfa) clearly expressed its opinion on the topics and points of criticism addressed in the innovation report 2017: The innovations of the past few years are not to be ignored in regard to the achieved therapeutic advances, for example in the field of oncology, which also justifies the reasonable drug costs (according to the vfa). A higher quality of life and rising survival rates are only one part of the visible success. It is criticized that the innovations would be systematically played down by the health insurance companies and that the traffic light system used is not suitable for an adequate assessment. This leads to the fact that drugs which are of high relevance for the day-to-day provision as well as for guidelines are sometimes categorized with red traffic lights in the report. The vfa moreover disagrees with the conclusion of the report that the categorization of some drugs as ‘orphan drugs’ by splitting diseases and attaining a conditional approval are accompanied by an underestimation of possible risks. It is rather necessary, especially for rare diseases, to continue to develop drugs, since there are little or no therapy alternatives for the patients. The safety and the additional benefit are already checked during the approval by the EMA.

The pharmaceutical industry, in turn, refers with the “AMNOG-Check 2017”, a report from the German Pharmaceutical Industry Association (BPI), to other weaknesses of the AMNOG. For example, every third innovative drug, which has passed the AMNOG process since 2011, is no longer available in Germany. Nearly 30 products have been taken off the market after or already during the AMNOG process. Considering both the EMA approved but not in Germany imported drugs as well as the drugs withdrawn from the market, only about 70% of the drugs approved in Europe between 2011 and 2015 are available to German patients according to the BPI. The fact that these drugs are partly available in other European countries is due, among other things, to a highly divergent assessment of medicinal products. The assessment by the G-BA shows that the basis for a non-attested additional benefit is partly due to purely formal reasons. The AMNOG procedure is also attributable to the fact that drugs arrive late at the patient despite attestation of additional benefits.

Ultimately, the main issue of the two parties remains how the future cost development of drugs should be discussed. While the TK advocates further austerity, the BPI argues that such a cost pressure has a detrimental effect; in addition, the expenditures of the statutory health insurance for drugs in the outpatient sector would have constituted a constant share of less than 10% for decades. An early consensus between the different parties therefore seems questionable.

More about the debate can be found under the following links:

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