Regulatory Focus™ > News Articles > 2019 > 7 > German Study Finds Most New Drugs Fail to Improve on Standard of Care

German Study Finds Most New Drugs Fail to Improve on Standard of Care

Posted 12 July 2019 | By Michael Mezher 

German Study Finds Most New Drugs Fail to Improve on Standard of Care

A study published Wednesday in The BMJ by officials from Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.
 
“Although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs. Most studies put the proportion of true innovation at under 15% with no clear improvement over time,” the authors write.
 
Going forward, the authors suggest the situation could be improved by requiring drugmakers to conduct more clinical trials with active controls and by exploring new models to promote the development of drugs based on health system needs.
 
Background
 
In Germany, IQWiG is charged with assessing new drugs to determine their added benefit compared to the standard of care on behalf of the Federal Joint Committee (G-BA), the main decision-making body for the country’s national health insurance system.
 
The requirement for all newly approved drugs to undergo a benefit assessment stems from the 2010 Act on the Reform of the Market for Medicinal Products (AMNOG), which went into effect in 2011.
 
The outcome of the benefit assessment is a major factor in the price negotiations that follow between health insurance authorities and drugmakers.
 
“In general, a new drug with no added benefit should not cost more than standard care,” the authors write.
 
Study

For the study, the authors looked at the outcomes of the 216 benefit assessments IQWiG conducted from 2011-2017.
 
Notably, the analysis does not consider orphan drugs with an annual revenue below €50 million, which in Germany are assessed under a different procedure.
 
More than half (125/216, 58%) of IQWiG’s assessments found no evidence of added benefit for the drug compared to the standard of care. A quarter (54/216, 25%) of the assessments found there was major or considerable added benefit and one-sixth (35/216, 16%) of the assessments determined there was only minor or non-quantifiable added benefit. In two cases IQWiG determined that the new drug provided less benefit than the standard of care.
 
While G-BA’s determinations rely on IQWiG’s assessments, its final conclusions after a comment procedure do not always line up, and thus there are some differences between it and IQWiG’s conclusions.
 
Across the 216 assessments, G-BA found no added benefit for 115 drugs, considerable added benefit for 55 drugs, minor added benefit for 33 drugs, non-quantifiable benefit for 12 drugs. G-BA did not find any of the drugs to have less benefit than the standard of care, but only found a single drug to provide major added benefit.
 
The level of evidence showing added benefit varied across specialties. According to the study, only one of the 18 (6%) psychiatry/neurology drugs had evidence of added benefit and only four of the 24 (17%) diabetes drugs had evidence of added benefit.
 
“Presumably, this is because regulators still allow placebo controlled studies even though health technology assessment bodies have long recommended active controlled trials, which provide more useful information,” the authors write.
 
On the other hand, oncology drugs and infectious disease drugs were the only categories with evidence of added benefit for more than half the products assessed.
 
For the 125 drugs with no evidence of added benefit, the authors say there were no studies comparing the drug to the standard care in about half (64, 51%) of the cases. For the remaining assessments, the authors say the comparator in the study was either inappropriate or the drug was tested against an appropriate comparator but the data “did not show an advantage (or clear disadvantage) of the new drug.”
 
Study

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe