Debate Over the Inflation Reduction Act Is Heating Up

John M. Burke, MD

Hematologist and Medical Oncologist

Rocky Mountain Cancer Centers

Associate Chair

US Oncology

Hematology Research Program

Aurora, CO

For as long as I have been a physician, meaning more than 20 years, we in the medical field have been bemoaning the high prices of prescription drugs. I recall in 2003 having a discussion over lunch with colleagues about the new antiemetic drug aprepitant [Emend]. Although there was no question about its efficacy for prevention of emesis after highly emetogenic chemotherapy administration, we had a debate about whether aprepitant was worth what we considered to be its staggeringly high cost of $310 per cycle of treatment, or $100 per tablet. Little did we know at the time that the cost of aprepitant would pale in comparison to the costs of the countless drugs that have been developed in the ensuing 20 years. In 2022, Rome et al showed that the median launch price of drugs has increased from $2115 per year in 2008 to $180,007 per year in 2021.¹

In 2022, President Joseph R. Biden signed the Inflation Reduction Act into law. The Act has several provisions that affect all those involved in cancer care, including patients, physicians, and pharmaceutical companies. First, the law allows the Centers for Medicare & Medicaid Services to negotiate the prices of drugs with manufacturers after a brand-name drug has experienced a period of market exclusivity, with the period being 9 years in the case of small molecules or 13 years in the case of biologics. Second, the law significantly changes how drugs covered under Part D are paid for. Third, the law puts an annual cap on patient out-of-pocket spending of $2000 beginning in 2025.

The new law has caused no lack of controversy and debate. In the past few months, pharmaceutical companies have been fi ling lawsuits challenging the constitutionality of the drug negotiation provision. Separate from the legal issues, other criticisms have been leveled about the new law. The most obvious is that, by reducing the profi ts that pharmaceutical companies can make from developing drugs, the law reduces the incentives for such companies to innovate and develop new treatments.

All these issues have been brought up in recent articles in the New England Journal of Medicine, JAMA, and elsewhere. As we get closer to our government beginning to negotiate (or set?) drug prices for the fi rst time, the debate is certainly heating up.