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Analysis – Most New Drugs Not Adding Patient Benefits

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11 July 2019. An analysis of drugs approved for use in Germany since 2011 shows no evidence most treatments provide new or added benefits to patients compared to standard care. The findings are reported by a team from Germany’s Institute for Quality and Efficiency in Health Care, in yesterday’s issue of the journal BMJ.

The Institute for Quality and Efficiency in Health Care is Germany’s health technology assessment agency, which reviews  the benefits of new drugs for the country’s patients, approved largely by the European Medicines Agency, a body of the European Union. A 2011 law for reforming pharmaceutical markets in Germany calls for the Institute to evaluate the benefits of newly approved medications over the standard of care for the diseases treated.

Drug developers are required to submit evidence indicating added benefits of new treatments compared to standard care. In their assessments, the Institute, based in Cologne, shows if the drug provides minor, considerable, or major new benefits to patients. Orphan drugs are exempt from this evaluation.

The researchers, led by Beate Wieseler, who heads the Institute’s drug assessment department, reviewed 216 new drugs entering the German market between 2011 and 2017. Of the 216 new treatments, 125 or 58 percent showed no evidence of added benefits compared to the standard of care. For another 17 approved drugs (8%), the evidence was not quantifiable or showed even less benefit to patients.

A quarter (25%) of the new approved drugs, 54 of 216, showed major or considerable added benefits, while 20 of the new drugs (9%) reported minor added benefits. New treatments for cancer, cardiovascular, and infectious diseases were most likely to display added benefits compared to standard care, although for infectious diseases, much of that evidence was not quantifiable. Drugs to treat diabetes and psychiatric or neurological disorders were more likely to show no added benefits.

In some cases, says Wieseler in an Institute statement, evidence from studies comparing new drugs to the standard of care is just not available, and in a few instances suitable data are available, but show no evidence of benefits. And in still other cases data are available, but the comparison treatment, notes Wieseler, “is unsuitable, for example, because it is not approved for the patients investigated. In this situation, there is no information that could support the decision by patients and physicians for one of the available treatment alternatives.”

The team attributes much of this situation to pressure on regulatory authorities to speed up the approval process for new drugs. One reason given for accelerated regulatory reviews are requirements for post-marketing studies, further evaluations of new drugs after initial approval is given. The researchers point to reviews showing only about half of these post-marketing studies are completed within the required time, some taking as long as five or six years. In other cases, new drugs may show evidence of added benefits to patients, but address similar targets or with similar mechanisms of action as other new drugs.

The researchers acknowledge many of the genome-driven new cancer treatments that address specific genetic variations responsible for some cancers serve only a minority of patients, although that’s the nature of precision medicine. The authors recommend a more proactive approach by stakeholders, including payers (e.g. insurance companies and health authorities) requiring more solid evidence of outcomes that benefit patients to qualify for reimbursements. And for the longer term, the researchers suggest more early direction from health authorities on new drugs, encouraging development of therapies meeting high priority needs rather than leaving those decisions to drug makers.

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