By Andrew Spiegel
The rate of colorectal cancer in Americans under 55 has nearly doubled since the 1990s, and scientists don’t really know why. By 2030, colorectal cancer is predicted to become the leading cause of cancer deaths for people under 50, and is already the second leading cause of all cancer deaths, behind only lung cancer.
We need more and better treatments, and we need them now.
Unfortunately, the new drug-pricing rules enacted in last year’s Inflation Reduction Act will stymie efforts to develop new cancer treatments.
Under the IRA, Medicare will be able to negotiate with drug makers for lower prices on an expanding list of brand-name medications. Drugs are divided into two categories: small- molecule drugs, which are chemical compounds typically available in pill form that patients pick up at the pharmacy and take at home; and biologics, which are extracted from living organisms and usually need to be administered by infusion or injection in a healthcare facility.
Both types of drugs are crucial to oncology treatment. Unfortunately, the IRA all but ensures that investment will pivot away from small molecule drugs towards biologics in the coming years. The IRA makes small molecule drugs eligible for price controls nine years after FDA approval — four years sooner than biologics.
Those four additional years are critical for investors when deciding whether to invest in researching and developing a medication.
Small-molecule drugs happen to be the only way to target certain cancers. Large molecule biologics are too big to penetrate cell walls and attack cancers with intracellular targets. So it’s not as if researchers always have a choice of which type of drug to focus on.
Biologics also come with added complexity in administration. Because they have to be taken under medical supervision, patients often need to travel repeatedly to a hospital, clinic, or infusion center to receive treatment.
Promising small molecule oncological research could lessen this burden. The ability to treat cancer with pills taken at home would not only benefit patients in rural and low-income communities, but also provide relief for our increasingly short-staffed hospitals.
Prior to the IRA, research into targeted small-molecule cancer therapies was robust, with new studies and drugs popping up all over. One small molecule treatment even showed promise to stave off metastasis in colorectal cancer.
The future of small molecule research, however, isn’t nearly as bright today.
Surely the IRA wasn’t intended to curtail this research. In order to protect this treatment pipeline, lawmakers need to amend the IRA to exempt both small-molecule drugs and biologics from price controls for 13 years after approval. It’s a simple fix that will allow us to deploy all our scientific and medical resources against cancer.
Andrew Spiegel, Esquire is the Executive Director of the Global Colon Cancer Association.