Washington, DC – In an effort to ensure that lifesaving overdose prevention drugs remain accessible and affordable, U.S. Senators Jack Reed and Sheldon Whitehouse are pressing for answers from a leading pharmaceutical company about the dramatic price hike for a life-saving medication used to respond to opioid overdoses.
Recent reports unveiled that drug maker Kaléo Pharmaceuticals, which manufactures an easy-to-use injector device containing the overdose-reversing drug naloxone, raised its price from $690 in 2014, to $4,500 currently. While the Evzio device has the potential to help thousands of people survive drug overdoses, the Senators wrote that the inexplicable price hike “threatens to price-out families and communities that depend on naloxone to save lives.”
Reed, Whitehouse, and 27 of their colleagues sent a letter to Kaléo Pharmaceuticals CEO Spencer Williamson, noting: “At a time when Congress has worked to expand access to naloxone products and to assist state and local communities to equip first responders with this life-saving drug, this startling price hike appears to be beyond exploitative.”
Senator Whitehouse is an author of the Comprehensive Addiction and Recovery Act, which was signed into law last year to establish a range of policies to prevent and treat addiction to opioid drugs, including programs to increase education on drug use, to expand medication-assisted treatment, to improve prescription drug monitoring programs, and to promote comprehensive state responses to the opioid crisis. Senator Reed cosponsored that law, and, as a member of the Appropriations Committee, has worked to deliver resources to combat opioid addiction.
According to the U.S. Centers for Disease Control and Prevention (CDC), 91 Americans die every day from an opioid overdose. In Rhode Island, 239 people died from accidental opioid-related overdoses in 2015.
The letter was also signed by Senators Patrick Leahy (D-Vt.), Al Franken (D-Minn.), Christopher Murphy (D-Conn.), Dick Durbin (D-Ill.), Maria Cantwell (D-Wash.), Dianne Feinstein (D-Calif.), Tammy Baldwin (D-Wis.), Claire McCaskill (D-Mo.), Jeanne Shaheen (D-N.H.), Angus King (I-Maine), Richard Blumenthal (D-Conn.), Edward J. Markey (D-Mass.), Maggie Hassan (D-N.H.), Amy Kobuchar (D-Minn.), Heidi Heitkamp (D-N.D.), Elizabeth Warren (D-Mass.), Tammy Duckworth (D-Ill.), Kirsten Gillibrand (D-N.Y.), Joe Donnelly (D-Ind.), Jon Tester (D-Mont.), Bernie Sanders (I-Vt.), Sherrod Brown (D-Ohio), Debbie Stabenow (D-Mich.), Tom Udall (D-N.M.), Tim Kaine (D-Va.), Mark Warner, (D-Va.), and Gary Peters (D-Mich.)
A copy of the February 8 letter to Kaléo Pharmaceuticals is available below.
February 8, 2017
Mr. Spencer Williamson
President and Chief Executive Officer
Kaléo Pharmaceuticals
111 Virginia Street, Suite 300
Richmond, VA 23219
Dear Mr. Williamson:
We are deeply concerned about reports that Kaléo dramatically increased the cost of its naloxone injector device, Evzio, an FDA approved medication used for the emergency treatment of an opioid overdose—from $690 for a two pack in 2014 to $4,500 today. This drug is now in the hands of first responders and families struggling with substance use disorder across the country. It is particularly needed in rural areas where access to life-saving emergency services can be limited. Such a steep rise in the cost of this drug threatens to price-out families and communities that depend on naloxone to save lives.
Addiction to heroin and other opioids has reached epidemic levels. More than 30,000 Americans are estimated to die each year due to opioid overdoses. Through increased access to community education, treatment and recovery programs, so many of these deaths could be preventable. Naloxone products are an important part of any community’s response to our nation’s opioid crisis, and demand for naloxone products has increased significantly in recent years. Evzio was designed to be simple to administer, making it particularly well suited for use by laypersons such as families looking to protect loved ones from overdose. Unfortunately, reports indicate Kaléo has responded to the increased need for naloxone devices by ratcheting up the price for Evzio.
At a time when Congress has worked to expand access to naloxone products and to assist state and local communities to equip first responders with this life-saving drug, this startling price hike is very concerning. In response to press reports about the price increase, Kaléo has argued that the list price is not a “true gauge” for what consumers are actually paying for the device, because through program discounts and coupons patients often have a low or even zero cost share for Evzio. We are concerned about the impact the high list price may have for those who do not qualify for the program and for state and local entities who hope to purchase large quantities of your product.
To help us understand Kaléo’s actions, we would appreciate your response to the following:
- 1. Please detail your pricing structure for Evzio since the product received FDA approval and provide documentation for why the company has chosen to adjust the pricing structure, including information on if the production costs of Evzio contribute to the price increases.
- 2. How many devices does Kaléo set aside for your donation program compared to your total production and how are you ensuring that it meets the demand for devices among first responders, state health departments, and other public entities across the country? Please explain what steps Kaléo has taken to inform consumers of their eligibility for these donation programs.
- 3. What is the total amount Evzio received in reimbursements from the federal government in the past 12 months? Approximately what percentage of your customers relied on federally funded dollars, through reimbursements or otherwise, to purchase Evzio during that period?
We look forward to working with you to ensure patients across the country have access to this life-saving device.
Sincerely,
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