The Evaluation of Pharmaceutical Products Introduced in 2013 and The Pharmaceutical Market Restructuring Act (AMNOG) Five Years on.
This is the fourth edition of the Innovation Report, drawn up by researchers at SOCIUM since 2013 (authors of the present edition are Daniela Boeschen, Dörte Fuchs, Judith Günther and Gerd Glaeske). The volume focuses primarily on 23 pharmaceutical produts that were launched on the German market in 2013, evaluating them in terms of their therapeutic benefit according to the standards of evidence-based medicine (EBM), their development on the market, and actual medical outcomes in the years 2013-14 on the basis of routine data from the Techniker Krankenkasse health insurance fund (TK).
The Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz, or AMNOG) came into force on 1st January 2011, and requires that, without exception, all new prescription drugs available to patients covered by statutory health insurance must be tested for efficacy and above all for added benefits to patients that comparable existing therapies do not achieve. Altogether 156 testing procedures have been completed since 2011.
Overall, in 56.4 per cent of the procedures it was confirmed that the new drugs had an added benefit over a comparable therapy. This conclusion had already been reached by the Federal Joint Committee (Gemeinsamer Bundesausschuss, or G-BA, the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany) when it assessed the 100th active substance in late 2014. At the time, even the degree of additional benefit was differentiated: in 21 per cent of cases, and in the oncological drug market segment as much as 43 per cent, a significant additional benefit was ascertained. Negligible additional benefit was ascertained in 26 per cent of the cases assessed, and in eight per cent of the cases the benefit was not quantifiable. Frequently, however, there was no additional benefit for all of the patients with the indications in question, but rather only for certain subpopulations (approx. 40 per cent of cases), which meant that only a relatively small proportion of the patients benefited from the new drug (22 per cent).
The political intent of the legislation was to introduce a differentiation, regulated by statutory law, of the innovative degree of new pharmaceutical products in order to distinguish whether and to what extent they may be found to have a more positive therapeutic effect than approved comparative therapies. This objective was fulfilled in most cases, but experts were not always unanimous in their assessments. In fact, there were, and still are, discrepancies between the assessments of the German Institute for Quality and Cost Effectiveness in the Health Care Sector (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, or IQWiG), which compiles the dossiers preparatory to the decisions, and the conclusive decisions of the G-BA. For example, in 2014, IQWiG compiled 36 assessments for 33 active substances (not including orphan drugs). The G-BA did not endorse these assessments in all cases; in ten cases the G-BA reached a different conclusion on added benefits, and in five cases it increased or reduced the maximal degree of beneficial effects, which amounts to an adjustment rate of 30.3 per cent. It is conceivable that IQWiG carries out very strict assessments of the available evidence, while the G-BA takes aspects of provision more strongly into account.
As in the Innovation Report 2015, almost half of the new active substances introduced are for use in oncology. A close look at the TK’s expenditure for new drugs in 2013 shows that many of these new oncology products follow close behind the front runner Teriflunomid, a product for treating multiple sclerosis. The soaring costs of pharmacotherapy, brought on by high-priced pharmaceuticals now available on the market, especially in the areas of oncology and immunology, is causing excessive budgetary strain on Germany’s solidarity-based healthcare system, and there is an urgent need to amend the criteria for pricing new substances – that is one of the major conclusions drawn in the Innovation Report. The AMNOG was introduced as a learning system, and should therefore be amended when shortcomings and weaknesses become clear. This also applies to the tardy assessment of many pharmaceuticals of which too little is known about benefits to patients directly after approval. This is true of the majority of drugs newly available on the market – namely oncology products. Studies are urgently needed that document treatment outcomes in the three years following authorisation, thus allowing a more comprehensive assessment of the benefits and risks of the drugs in question. Reimbursement prices should ultimately be negotiated on the basis of that assessment. In terms of assessing new pharmaceutical products, AMNOG is undoubtedly a step in the right direction, but the legislation should be improved on an ongoing basis to establish more a reliable basis for decision-making.
Downloads (in German only):
Long Version: Innovationsreport 2016
Short Version: Innovationsreport 2016
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