News

Cover Innovationsreport 2019Cover Innovationsreport 2019
Study on innovative medicines of the year 2016 in day to day care

This year's Innovation Report rates 21 active ingredients of the total of 31 medicines launched in 2016.

Oncologics were most frequently evaluated, five drugs contain antiviral drugs, three are recombinant coagulation factors. The remaining active ingredients cover eight further indications. For the first time, a vaccine (the HPV vaccine, which i.a. protects against cervical cancer) was rated in this report. Eight medicines were launched with a fast track assessment.

The special chapter of the report is dedicated to the current topic "vaccination and compulsory vaccination" and discusses measles, HPV and flu vaccines in particular.

The data of the RKI, the KiGGS study and the WHO state that the measles vaccination rates have still not been reached. They show that compulsory vaccination, which has already been introduced in some European countries, has not eliminated measles. The Innovation Report 2019 presents various approaches how an increase in vaccination rates could succeed and how the potential arguments of the anti-vaxxers could be. It illustrates the great importance of physician-patient communication in this context. Compulsory measles vaccination should be the ultima ratio - education and information campaigns need to be developed and strengthened in the public.

Although five medicines were rated with a green overall traffic light, the increase in red traffic lights (61% of all assessed medicines) has degraded the hope of a positive development of newly licensed medicines compared to the last year. For six medicines red hand letters with important information for physicians and patients were sent. This also confirms the assumption that current approval studies provide only a limited picture of effects and side effects, therefore pharmacovigilance studies in the "aftermarket" are urgently needed.

Medicines that represent a true therapeutic innovation and have been assessed with a green (added) benefit signal are human papillomavirus vaccines and medicines in cancer treatment of multiple myeloma (Daratumumab and Elotuzumab) and in the treatment of chronic heart failure with reduced ejection fraction (Sacubitril/Valsartan). Only one medicine (Elbasvir/Grazoprevir) is cheaper than the ACT and has been given a green light in this category. Regarding the price twelve medicines were rated as equally expensive (marked with a yellow traffic light) and four medicines as more expensive (marked with a red traffic light). In comparison with already available therapies, five medicines are marked in green, four in yellow, and 14 in red. Thus, only nine of the new medicines on the market contribute to already approved pharmaceuticals in a positive way.

 

Innovation Report 2019:

long version

short version

Presentation of Prof. Dr. Gerd Glaeske


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Cover Hautkrebsreport 2019Cover Hautkrebsreport 2019
On 29th May Prof. Dr. Gerd Glaeske, Co-editor, presented the "Skin cancer report 2019" together with Techniker Krankenkasse and University Medical Center Hamburg-Eppendorf.

Skin cancer is the most common cancer in Germany with 270,000 new cases a year. In every seventh skin cancer, the most dangerous is black skin cancer (malignant melanoma), which accounts for around 14% of skin cancers, with 86% white or pale skin cancers. The number increases every year - in the years 2009 to 2015, 50% additional diagnoses of light skin cancer and 30% of black skin cancer were made. Skin cancer is often curable if diagnosed early enough.

Longer Better Living.-InstituteLonger Better Living.-Institute
Topical Issues and Renowned Speakers Guarantee Gerd Glaeske and the BKK24 a Full Audience

How can we motivate people of different social backgrounds to change their life style, their fitness behavior and their eating habits in order to live a healthier, longer and more satisfying life? The Second Congress for “A Longer Better Life” offers an interesting program put together by Professor Gerd Glaeske of SOCIUM and the BKK24. The congress will commence on May 14th, 2019 at the Adademie des Sports in Hanover. Since it is still the social background which determines the life expectancy the congress aims at exploring the possibilities to improve the individual motivation. The topical question guaranteed that the congress was fully booked in short time.

The Congress for “A Longer Better Life” is part of the preventive work of the Institute for “A Longer Better Life” which organized by the SOCIUM together with the BKK24.

More information: Longer Better Living.-Institute


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Cover Cover "Longer better living."-Book (in German)
Prevention recommendations implemented in everyday life.

The EPIC study, a long-term 13-year study of 20,000 participants in Norfolk, which showed the positive effects of four different health behaviors, forms the basis of this publication. Sufficient exercise, abstinence from smoking, five servings of vegetables and fruit per day, and limited alcohol consumption resulted in a life-time gain of up to 14 years. In order to facilitate the implementation of these rules in everyday life instructions, tips and evidence-based expert advice have been compiled here (in German).

Prof. Dr. Gerd Glaeske and Friederike Höfel from the "Longer better living."-Institute, which is dedicated to the implementation of these prevention goals, published this book together with Friedrich Schütte and Jörg Nielaczny of the BKK24.

More information about publication: Glaeske, Gerd; Höfel, Friederike; Schütte, Friedrich; Nielaczny, Jörg (Ed.), 2019: "Länger besser leben." Für eine bessere Gesundheit und mehr Wohlbefinden, "Länger besser leben."-Institut, BKK24, Bremen, Obernkirchen: Selbstverlag


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Dipl.-Soz. Friederike Höfel
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58520
E-Mail: fhoefel@uni-bremen.de

Cover Innovation Report 2018Cover Innovation Report 2018
More green traffic lights than in recent years.

The Innovation Report has been published annually since 2013 by Professor Gerd Glaeske und Professor Wolf-Dieter Ludwig with the support of the Techniker Krankenkasse (TK). This report combines healthcare provision research with the evaluation of new medicines that were first offered three years ago and that have undergone an early assessment by AMNOG criteria. In this respect, the innovation report offers a kind of "late assessment" of the drugs from the year 2015. The increasing marketing of orphan drugs can also be seen in this year's Innovation Report, as well as the trend towards accelerated market entry of pharmaceuticals.

The Innovation Report 2018 critically evaluates the new drugs launched in 2015 into the pharmaceutical market for German health insurance. Many patients with serious diseases that have been only symptomatically treatable live in the hope of being cured by newly developed medicines. These include, for example, drug therapies for Alzheimer’s dementia - which are dealt with in a separate chapter in this Report - but also new medicines for the treatment of malignant diseases. In particular, with regard to the former condition, information is regularly promulgated that raises hopes of a cure, but so far there has been no real therapeutic breakthrough with regard to finding a cure for Alzheimer’s dementia.

Altogether, 32 of the 37 pharmaceutical products introduced in 2015 are included in the Innovation Report 2018. In the report, there are 7 positive and 10 negative evaluations (indicated by a green or red traffic light respectively). Numbering nearly 50 % of the products, the largest proportion is registered as having at least partial additional benefits, which is indicated by a yellow traffic light.

Orphan drugs, used to treat rare diseases which afflict no more than 5 persons per 10,000 according to the EU definition, account for a third of the new drugs. In addition, there is a clear lack of new antibiotics or drugs available in the market for treating most “other neurological diseases” and mental disorders. 

Download Innovation Report 2018:
Long version (in German)
Short version (in German)

Download:
Statement for the press conference by Gerd Glaeske (in German)
Slides for the press conference by Gerd Glaeske (in German)


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Cover Cannabis-ReportCover Cannabis-Report
First Study on new Cannabis Medicines and their use presented in Berlin on May 17th, 2018.

Since March 2017, the prescription of cannabis at the expense of statutory health funds has been possible, although studies on the efficacy and safety of cannabis medicines are fragmentary. The Cannabis Report was drawn up by the University of Bremen, with the support of the TK, in order to be better able to assess cannabis as a therapy option for various diseases. Preliminary representative data on prescribed cannabis shed light on actual outcomes and contribute towards an objective debate over this new medicine.

In principle, cannabis treatment is assessed as positive, although in comparison to most proven therapies it is not a good alternative. In isolated cases, however, cannabis medicine does help patients.

This is one of the outcomes of the Cannabis Report presented on 17th May 2018 in Berlin. 

Further information:
Gerd Glaeske/Kristin Sauer, Cannabis Report, 2018
Presentation at the Press Conference Cannabis Report, May 17, 2018, Berlin 


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Institute for Longer, Better LifeInstitute for Longer, Better Life
This is the topic of the first "Live Better, Live Longer" Congress organised by the University of Bremen and BKK24 on 26th April, 2018, in Hanover.

There have long been calls for the promotion and improvement of prevention, which - alongside medical treatment, rehabilitation and long-term care - is the fourth pillar of our healthcare system. However, despite the Prevention Act, which came into force in July 2015, the potential benefits of prevention are still underutilized. The "Länger besser leben." Institut (Institute for Longer, Better Life) - a joint cooperation between the University of Bremen and the BKK24 health insurance fund - has organised the Congress with the aim of making a recognizable contribution to the promotion of prevention.

More Information:
Länger besser leben." Institut (Institute for Longer, Better Life)


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Innovation Report 2017Innovation Report 2017
Health experts from SOCIUM Research Center on Inequality and Social Policy at the University of Bremen present the Innovation Report 2017 at the Federal Press Conference on 20 September in Berlin.

Professor Gerd Glaeske (SOCIUM Research Center on Equality and Social Policy) and Professor Wolf-Dieter Ludwig (Chairman of the Medical Committee of the German Medical Association), published the Innovationreport with the support of the Techniker Krankenkasse for the fifth time. The research report reviews drugs that have been prescribed in Germany since three years and have been reimbursed by the statutory health insurance (GKV). The results of assessments of 32 new drugs evaluated were mediocre - no single product receiving the overall "green traffic light".

In the Innovationsreport 2017, different aspects of the new medicines are analyzed according to their daily usage:

  • Is the medicine the only one to treat the disease concerned?

  • Is there more benefit and / or less risk to patients and how expensive is it?

  • Are there further references published that may change the assessments of the new drugs since the authorization of the respective agent?

These questions are answered by means of a traffic light system. There is a "red" traffic light for a critical assessment, a "yellow" for a more open classification and a "green" for a positive overall assessment.


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Lehrbuch VersorgungsforschungLehrbuch Versorgungsforschung
Gerd Glaeske (SOCIUM, University of Bremen) is a co-publisher of the updated guide for health services research and the optimization of health care.

In cooperation with Professor Holger Pfaff (IMVR, University of Cologne), Professor Edmund Neugebauer (Medical University of Brandenburg) and Professor Matthias Schrappe (University of Cologne), the "Lehrbuch Versorgungsforschung" is published by Schattauer. The second edition is completely revised and provides a comprehensive and systematic overview of the methods and possibilities of health care research. It represents an important transfer of science in practice.


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de

Innovation Report 2016Innovation Report 2016
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

Press Conference statement by Gerd Glaeske
Press Conference presentation by Gerd Glaeske


Contact:
Prof. Dr. Gerd Glaeske
SOCIUM Research Center on Inequality and Social Policy
Mary-Somerville-Straße 3
28359 Bremen
Phone: +49 421 218-58559
E-Mail: gglaeske@uni-bremen.de