By Michael Dresser, The Baltimore Sun
Baltimore officials and others are alarmed at a nearly a fourfold jump in the cost of a drug used to save the lives of people who have overdosed on heroin — a price spike that has prompted calls for state and federal action.
City Health Commissioner Dr. Leana S. Wen says a leading manufacturer of naloxone has since spring raised the 10-dose cost from $97 to $370, with the most recent hike coming last week.
In a letter this week to a congressional committee, Wen said the increase by Amphastar Pharmaceuticals has contributed to a near-doubling in the overall cost of delivering more than 1,000 doses annually of naloxone, which she calls a "miracle drug" for preventing overdose deaths.
"This means we can only save half the lives of patients we were able to before," Wen told the House Committee on Oversight and Government Reform.
Rep. Elijah E. Cummings of Baltimore, the ranking Democrat on the panel, responded Tuesday by urging Gov. Larry Hogan to take a hard line on price negotiations with Amphastar on behalf of the city and other jurisdictions.
Cummings told the Republican governor that he has been investigating the company's pricing and has found that public health officials are facing "sticker shock" over recent increases.
"Maryland should not let Amphastar jeopardize the positive steps the state has already taken by overcharging for this critical drug," Cummings wrote. "I encourage you to take the same aggressive action as other states to negotiate an agreement with this company and then use these savings to make naloxone more available."
A spokeswoman for Hogan said the governor will approach the manufacturer for possible relief.
Meanwhile, the company defended its pricing but said it would consider such an agreement.
Jason Shandell, president of Rancho Cucamonga, Calif.-based Amphastar, defended his company's price increases.
"Like other companies in the industry, manufacturing costs for our entire portfolio of products, including naloxone, have been steadily increasing due to the continued rise in costs for raw materials, energy, and labor over the recent several years," he said by email.
The drug has become an increasingly important component in a national, state and local response to the wave of overdose deaths from heroin and related drugs that has swept the country in recent years.
Wen said that as an emergency room doctor she has administered naloxone to dozens of patients whose lives have been saved as the anti-opiate drug took hold in seconds.
"There are very few poisons in the world for which there is a complete antidote," she said. But for heroin, fentanyl, oxycontin and other opioid drugs, naloxone is just that, Wen said.
"For me it's a very visceral issue," she said. "We should not delay in getting this medication available to everyone."
Kelly E. Dunn, assistant professor at Johns Hopkins Medicine's department of psychiatry and behavioral services, said price increases and shortages have been hampering nationwide efforts to reduce overdose deaths. She said the matter has raised concerns at the Food and Drug Administration.
"It could be a supply issue, a production issue or just an opportunity to drive the price up," she said. "Whatever is causing the price increases … it is a very real and serious problem."
Wen called it "a federal problem that requires a federal response," though she did not suggest what that would be.
Shandell said his company has reached agreements with New York, New Jersey and Ohio under which it contributed to the costs of their naloxone programs. He said Amphastar is in discussions with other states — as of now, not Maryland — about similar deals.
Neither the states nor Baltimore are actually customers, Shandell said, because the drug is typically purchased through middlemen who repackage it for distribution.
"We have done our best to help out the states where we can and we will continue to act in good faith," Shandell said.
Both Hogan and his predecessor, former Democratic Gov. Martin O'Malley, took steps to remove barriers to the use of naloxone in an effort to respond to the wave of overdose deaths that has followed an influx of cheap heroin in the last five years. Hogan's Heroin and Opioid Emergency Task Force has estimated that deaths from heroin and related drugs increased by 95 percent from 2010 to 2013. There were a reported 578 deaths in Maryland in 2014, 192 of them in Baltimore.
During this campaign for governor, Hogan promised to take on what he described as a heroin overdose epidemic in every part of the state.
Shareese Churchill, a Hogan spokeswoman, noted that shortly after taking office, the governor established the task force to confront the statewide public health crisis. At the same time, Hogan announced a donation to the state from another company of 5,000 two-dose kits to deliver naloxone.
"In the coming days, the administration will approach the manufacturer of naloxone to determine if action can be taken to address the rising cost of this life-saving treatment, as other states have successfully done," she said.
According to the governor's office, Amphastar has received almost all of Maryland's business for naloxone, a generic drug with multiple manufacturers. Matthew A. Clark, Hogan's communications director, said that is because Amphastar's product is fitted with a "needle-less" syringe that makes it easier for laypeople to administer.
Cummings also directed his letter to Maryland Attorney General Brian E. Frosh.
Frosh, a Democrat, could potentially play a role in any negotiations by bringing legal pressure on the company. Cummings pointed out that in other states, attorneys general reached agreements under which the company gave rebates to public agencies to help offset price increases.
David Nitkin, a spokesman for Frosh, said the attorney general thinks Cummings is offering "a great idea." Nitkin said Frosh has been in discussion with his top staff about how to replicate such a settlement in Maryland.
"We hope to get a positive result," Nitkin said.