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How Good Are New Drugs Compared to Previous Treatments?
(Thursday, March 28, 2024) A question as old as the modern drug industry is about the true benefit provided by new treatments. This is an important argument to justify the high cost of newly approved drugs compared to those available in the prior days and years. A study by researchers in Europe raises some interesting questions about the added clinical benefits to patients from new drugs. The findings should trigger a robust debate among policymakers, public interest groups, and most importantly payors. There is no question that the last 50 years have seen the biggest medical advancement in the history of mankind, which has led to almost doubling of life expectancy and quality of life, compared to less than a hundred years ago. But the last two decades have also seen the rise of expedited approval pathways, abbreviated development programs, approvals based on partial or selected data such as with accelerated approvals, and similar programs that rely on strategic measures aimed to introduce new treatments to the patients. It is fair to question if these measures are indeed helping the patients. A study of about 632 new drugs introduced in Europe, using France as a test country, from 2008-2018, found that more than two-thirds of new drugs approved by the regulators in those years presented little or no clinical benefit over available therapies. The data was most damning for anti-psychotropic and anti-respiratory disease drugs where more than 96% of the new drugs did not exhibit added clinical benefits. The antineoplastic drugs such as most cancer drugs exhibited the most added clinical benefits with about 40% showing significant added clinical benefit. The results of the study have been challenged and acknowledged by the original authors to have some limitations, but the authors stand by their assertion that the added clinical benefits of new drugs are critical information to be considered by the prescribers, patients, and payors. While the study looked at data in France, these findings apply to the US market as well where the expedited approval pathways have been milked extensively by the industry to get more and more new drugs approved in shorter times. A justification of the cost based on added clinical benefits seems fair, although we are a long way from requiring it. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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