Study: Recent Drug Approvals Offer Less Therapeutic Value


American consumers have access to the most advanced pharmaceutical systems in the world. Recent medical and technical advances seem to support that reputation.

According to Medical Xpress, a Swiss and U.S. study that was published in the British Medical Journal (BMJ) examined 124 indications that had been approved. Results showed that from 2011 to 2020 over half of the new drugs that are approved do not add value to existing treatment.

In addition, approximately one-third of drugs that are repurposed (used to treat other diseases) were found to add substantial value compared to their first approvals. Less than half (47% in Europe and 41% in the U.S.) of first indications resulted in high [therapeutic value] ratings.

Disappointing Supplemental Indications

Only one-third of the 335 supplemental indications were rated as having high therapeutic value. The authors of the study recommended not only should the patients be properly informed, but the lower value should be reflected in the unit price when the drug’s therapeutic value is not higher than other available treatments.

Kerstin Vokinger, a law professor at Zurich University, led the study and relied on therapeutic values using ratings from HTA groups. The U.S. does not generally use the HTA system, which is a tool for improving healthcare efficiency.

Beate Wieseler, the head of Germany’s drug assessment unit, contributed an editorial linked to the study stating that several attempts have been made to close the gap. Professor Wieseler suggests the framework only covers one aspect of healthcare. He expressed his disappointment that the US has not adopted HTA more widely.

Professor Wieseler further stated that the EMA and FDA do not mandate that new drugs must provide evidence of value over existing treatments. He said that a positive risk-benefit is needed, not greater value.

A Call for a Change

Some in the profession are suggesting that requirements be changed and that drugmakers must show greater benefit over current treatments. They point out that a number of drugs are approved based on tumor response only, with no requirements for overall survival or an improvement in the patient’s quality of life.

Professor Wieseler said that the findings are sobering. He said that the study confirms prior research on the uncertain value of new drugs.

Recent cost estimates put the price of developing a new drug at approximately $ 2 billion. Therefore, collecting supplemental indications for a drug that has already been approved is not only less risky but less costly. He further suggests that the drug maker be rewarded with potential solutions such as extended market exclusivity and expedited approval.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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