“In recent years, the results of the Innovation Reports have been rather depressing,” says health scientist Professor Glaeske. “This has now visibly changed.” The expert also attributes this to the introduction of the German Act on the Reform of the Market for Medicinal Products (AMNOG), which requires an early assessment of all medicines up for approval. The Bremen study is a late evaluation that incorporates study results, new findings, and field reports on the efficacy of therapies. In addition, prescription data from persons insured by the Techniker Krankenkasse, which is a cooperation partner, is evaluated over a period of two years.
Red, Yellow, and Green Lights
The results of the individual appraisals are represented by traffic light colors. A green light is awarded when the new medicine shows advantages in terms of additional benefit and cost-effectiveness. A yellow light is awarded if there is at least an indication of such benefits, and a red light is issued if none of the benefits mentioned are shown in comparison to medicines already available.
Which Medicines Were Tested?
The current Innovation Report highlights 32 new medicines introduced in 2015 to the German pharmaceutical market of the statutory health insurance and subjects them to a critical evaluation. For years, the focus of newly approved medicines has been on the treatment of cancer, in addition to medicines for the treatment of chronic joint inflammation (rheumatism), multiple sclerosis, and psoriasis. One-third of the medicines analyzed were orphan drugs for rare diseases, which, according to the European definition, do not affect more than five people per 10,000 inhabitants.
Results of the Report:
Four of the 21 non-orphan drugs achieved a green light in the overall evaluation. Three of the 11 orphan drugs tested also received a green light. The increasing marketing of orphan drugs, which can only rarely be sold but at very high prices, can also be seen in this year’s Innovation Report. “Rote-Hand-Briefe” – informational letters – were sent for a total of six medicines. They point to side effects that only became known after market authorization. For eight medicines, “Blaue-Hand-Briefe” with further information for doctors and patients were written. “Although these measures were necessary to improve treatment safety, the medicines were recommended as part of guidelines,” said Glaeske.
Special Chapter – Alzheimer’s Dementia
The special chapter of the Innovation Report 2018 deals with the clinical picture of Alzheimer’s dementia and the current medicinal treatment of this age-related neurological disease. Worldwide, 15 million people are currently affected by this – primarily in societies with longer life expectancies such as those in European countries, Japan, China, Canada, and the United States. According to the forecast in the report, by 2030 the number will have risen to 75 million people. The medicine market would thus grow by 17.5 percent annually. Contrary to this trend, however, pharmaceutical manufacturers are ending their research commitment after years of activity in this field, because the setbacks of recent years have shown how difficult it is to find a scientifically successful path in medicinal treatment.
Promoting Dignified Living
Currently – and the evaluations in the special chapter of the Innovation Report 2018 show this – people with Alzheimer’s dementia are more often prescribed sedative psychotropic drugs than antidementia drugs. The increased risk of premature death in people with dementia has been known for many years, especially with the use of antipsychotics. Such medications, in combination with tranquilizers and sleeping pills, do indeed calm people and therefore mean less care expenditure (“clean, fed, and calm”), but they are not means to promote a dignified life for Alzheimer’s patients. Other measures are necessary in this regard, such as activating care, which is intended to maintain the everyday abilities of these patients for as long as possible. “Medication therapy should be beneficial and not harmful – but this seems to be forgotten with the far-too-frequent use of neuroleptics for people with Alzheimer’s dementia,” criticized Professor Gerd Glaeske.
Additional Information:
http://www.socium.uni-bremen.de/
Contact:
Professor Gerd Glaeske
Co-Head of the Department of Health, Long-Term Care, and Pensions
SOCIUM – Research Center on Inequality and Social Policy
University of Bremen
Tel.: +49 421 218-58559
E-mail: gglaeske@uni-bremen.de
buero-glaeske@uni-bremen.de
