WASHINGTON- U.S. Senators Amy Klobuchar (D-MN), Richard Blumenthal (D-CT) and Tammy Baldwin (D-WI) wrote to the CEO of NextSource Pharmaceuticals demanding the company take immediate steps to lower the price of a life-saving cancer drug that has skyrocketed by 1,400 percent since the company acquired it in 2013. Lomustine, which is used to treat brain tumors and Hodgkin lymphoma, cost just $50 per capsule when NextSource acquired the drug. By January of this year each capsule cost $922, putting it out of reach for many patients.
“We are troubled that these exploitative pricing practices follow a disturbing trend of systematic price increases by pharmaceutical companies on decades-old, lifesaving off-patent drugs. These actions have resulted in delayed treatment and extreme financial burden for many families that have already been stricken by severe, life-threatening illnesses,” the senators wrote. “In light of the urgent need for this potentially lifesaving product and its history of availability at a much lower price, we call on you to immediately lower the price of lomustine to guarantee continued patient access.”
Klobuchar has championed efforts to protect consumers and lower prescription drug costs by promoting competition in the healthcare system, authoring multiple pieces of bipartisan legislation that would address the high cost of prescription drugs. Klobuchar introduced legislation—that has 33 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 41 million seniors enrolled in Medicare Part D. Last year, Klobuchar and Senator John McCain (R-AZ) introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar has also introduced the bipartisan Preserve Access to Affordable Generics Act with Senator Chuck Grassley (R-IA) to expand consumers’ access to the cost-saving generic drugs they need and increase competition by ending “pay for delay” deals—the practice of brand-name drug companies using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. Klobuchar’s Short on Competition Act, introduced with Senator Mike Lee (R-UT), would allow temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S. The bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would prevent abusive tactics that prevent affordable drugs from entering the market.
The full text of the letter is copied below:
Dear Mr. DiCrisi:
We write to express concern about reports that the price of the potentially lifesaving cancer drug has ballooned by 1,400 percent since NextSource Pharmaceuticals acquired the product in 2013 and to call on your company to lower the price immediately for all Americans who rely on this critical cancer therapy.
As you know, lomustine is commonly used to treat brain tumors and Hodgkin lymphoma. Recent government-funded studies suggest that the drug can significantly prolong survival in patients with certain brain tumors. Yet, the skyrocketing prices for this drug—from around $50 per capsule in 2013 to nearly $800 per capsule at the beginning of 2018—has placed a significant financial strain on health care providers, patients, and their families nationwide. In fact, the Wall Street Journal recently reported that NextSource raised the price of lomustine to $922 per capsule in February 2018—representing a 52 percent price increase since August 2017 alone.
We are troubled that these exploitative pricing practices follow a disturbing trend of systematic price increases by pharmaceutical companies on decades-old, lifesaving off-patent drugs. These actions have resulted in delayed treatment and extreme financial burden for many families that have already been stricken by severe, life-threatening illnesses.
We ask that you respond to the following inquiries regarding why a drug that has been on the market for nearly four decades has now been placed out of reach for many consumers by May 25, 2018:
- What are the specific factors that led NextSource to increase the price of lomustine by 52 percent since August 2017?
- NextSource has pointed to “product development costs” as a contributing factor towards the pricing of lomustine. Please provide a list of these development costs. How have they have contributed to a more safe or effective product for consumers?
- NextSource also claims that offering lomustine “at a significantly reduced cost to uninsured patients and patients who lack the resources to pay for the product…represent a substantial cost to the company.” Please provide a detailed description of all patient assistance programs offered for this product.
- NextSource has suggested that the price of lomustine is related to an increase in Food and Drug Administration (FDA) user fees, but FDA user fees decreased during the time in which NextSource acquired the product and raised the price by nearly 1,400 percent. Specifically, for fiscal year (FY) 2017, prescription drug user fees were lower during fiscal year (FY) 2017 than any year since FY 2013. To address this disparity, please provide documentation regarding how much NextSource paid in FDA user fees annually since acquiring lomustine in 2013.
In light of the urgent need for this potentially lifesaving product and its history of availability at a much lower price, we call on you to immediately lower the price of lomustine to guarantee continued patient access. We hope we can work together to bring this product within reach of cancer patients who need it across the country.