When Congress passed the Inflation Reduction Act in 2022, it empowered the Centers for Medicare & Medicaid Services (CMS) to determine the price Medicare is willing to pay for a limited number of pharmaceuticals. 

For these drugs, companies are given a set number of years before CMS can negotiate a price. The concept allows the company a grace period to recoup development costs before CMS sets a price. 

A failure of this concept, however, is that it applies only to the initial FDA approval of the drug, and there is no grace period for any subsequent indications (indications refer to the specific conditions, diseases, or medical scenarios for which a drug is developed to treat, prevent, or diagnose). This creates a significant disincentive to pursue additional uses of the drug and is particularly problematic for cancer drugs. 

Over six years, 61% of new cancer drugs received additional indications, and 22% of those received three or more. In other words, a drug found beneficial for one form of cancer may help patients with different forms of cancer. To demonstrate this to the FDA, companies must conduct a whole new set of clinical trials requiring a significant investment. 

The Colorectal Cancer Alliance is concerned that companies will not pursue FDA approval for new indications if the price already set by Medicare does not justify the additional investment in further clinical trials. 

As a positive step in reducing this disincentive, the Ensuring Pathways to Innovative Cures Act (EPIC) has been introduced in Congress. This bi-partisan legislation would remove the distinction between small molecule drugs (pills, tablets), which are the majority of approved cancer drugs, and large molecule biologics. 

The EPIC Act would provide small molecule drugs the same thirteen-year grace period afforded biologics, thus encouraging investment in further clinical trials for additional indications. 

The Colorectal Cancer Alliance appreciates the leadership of Representatives Greg Murphy, M.D. (R-NC), Don Davis, (D-NC), and Brett Guthrie (R-NC) for introducing the EPIC Act and we strongly support this bi-partisan legislation which will help eliminate some of the disincentive to seek new applications for FDA approved drugs. 

The Alliance will aggressively advocate with House members for passage of the EPIC Act, but what will make the biggest impact is if members hear from voters. You can make that happen and it won’t take more than five minutes. 

To advocate for EPIC, send an email to your representative asking that they sign on as a co-sponsor of the EPIC Act (HR 7174). Let your representative know that finding new cancer treatments is important and there should not be unnecessary barriers to making these available to patients. You can find the address for your representative at www.house.gov.