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FDA drug approvals oncology cancer drugs

Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018


Summary

The new, expensive cancer drugs approved by the FDA in 2018 could drastically increase U.S. healthcare spending if widely adopted, but industry forecasts suggest low-level market uptake, maintaining current budget trends. The healthcare system's financial stability partially relies on many eligible patients not receiving the latest treatments, highlighting a tension between advancing medical therapies and managing economic realities. Addressing this issue requires systemic solutions, including drug pricing reform and improved insurance coverage, to ensure equitable and sustainable access to new treatments.

Rising drug prices and national expenditures are receiving increasing attention after 2018 yielded a record 59 novel drug approvals by the US Food and Drug Administration (FDA). In the US, cancer drug spending has grown 12% to 15% annually and is projected to continue on this trajectory in the coming years. Cancer drug spending outpaces spending in other common sectors with growth of 3.3% for all prescription drugs and 4.4% for hospital spending in 2018. For 2020 through 2027, US prescription drug spending is projected to grow 6.1% annually. Many factors contribute to the exceptional growth in cancer drug spending, including changing demographics, improved survival, and rising drug prices.

Currently, 35% of the drug development pipeline is dedicated to cancer drugs—a 30% increase over the past decade. The increasing interest in the development of anticancer therapeutics is presumably a product of technologic advances and perceived financial opportunity for manufacturers. Marketing authorization for a new cancer drug can yield a significant financial return irrespective of the clinical benefit demonstrated in pivotal trials with median launch price more than $100, 000 per treatment course...

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FDA, drug approvals, oncology, cancer drugs