Is naloxone the new EpiPen?
As the opioid epidemic continued growing — claiming tens of thousands of lives in overdoses — so did the prices of an old drug that acts as a silver bullet to immediately resurrect dying patients.
The cost of that drug, naloxone, now is drawing renewed attention as public officials complain the cost of products containing it is limiting the acquisition and use of the medication, and thus potentially costing lives of people OD'ing on prescription painkillers, heroin or fentanyl.
"Why should we be priced out of a lifesaving medication at a time of public health emergency when we need it the most?" asked Dr. Leana Wen, the Baltimore City Health Commissioner. "It's unethical and inhumane to deny our patients and our cities lifesaving medications, and watch hundreds of thousands of citizens in our cities die."
Wen, who wants to get naloxone into the hands of all Baltimore residents, says her department has seen its cost of acquiring the medication double in the past three years.
At the same time, she said, "naloxone is available by the pennies in other countries. It's on the World Health Organization's list of essential medications. It's been a generic medication for years."
Wen said Baltimore, like a number of other cities and municipal services, has benefited from donations that some naloxone makers have made.
"For certain, they have saved lives as a result of their donations," she said, "but we should not be dependent on their donations that are given by companies."
Daniel Raymond, policy director of the Harm Reduction Coalition, said that the price increase of naloxone in recent years "poses a dilemma, because we're seeing more demand for naloxone."
"Usually when you see increases in the price of pharmaceuticals, they're somewhat cushioned or buffered by the fact that they're covered by third-party payer's insurance," Raymond said.
"In the case of naloxone, when it's purchased directly by health departments, or community organizations or police departments, there's no buffer, they pay the whole cost, so any increase in price erodes their purchasing power, and they're either able to purchase fewer or they're gonna need to find additional dollars to keep pace with the demand," he said.
Naloxone, which counteracts the effect of an opioid overdose, has been available for treating opioid overdose for more than four decades, and is a generic medication, meaning that no company holds the right to exclusively market it.
There are seven commonly used products or devices that contain naloxone, delivering it either as an injection, or, in the case of Narcan, as a nasal spray.
Prices for those products vary widely, as do the number of doses contained in a given product. They range from $150 for a two-pack of single-dose Narcan, up to $396 for a 10-syringe set from Amphastar subsdiary International Medication Systems, and then to a high of a whopping $4,500 for two single-dose Evzio injectors from Kaleo, according to data from Truven Health Analytics.
Evzio's price has grown more than six-fold from mid-2014, when it was selling for $690. The product's price was raised to $900 late in November 2015, and then quintupled in price to its current level less than three months later.
A set of 10 vials of naloxone sold by Hospira was selling for $45 in 2009. The price eventually grew nearly 600 percent up to $263.88 in early 2014, before drifting down to its current level of $189.96. International Medication System's price has almost doubled since 2008, and the company has seen the number of prescriptions for its naloxone products almost double from 2009 to 2014.
Those price hikes have been noticed by Congress, which since last year has become increasingly concerned about the price of drugs, particularly ones like naloxone that have been around for years and which do not have patent protection.
In June, the Senate's Special Committee on Aging, wrote five companies asking about their efforts to preserve accessibility to naloxone.
The letter asked for insight about "actions [they] are taking to ensure continued and improved access to naloxone, an explanation for price changes in [their] company's naloxone product, and a description of the available resources and tools to prevent barriers to access and shortages of this critical and life-saving medication."
Earlier this week, a House committee grilled the CEO of Mylan over her company hiking the price of lifesaving anti-allergy EpiPens more than 500 percent in recent years. EpiPens contain epineprhine, which like naloxone is a decades-old, generic medication.
On Thursday, a day after that Mylan hearing, members of a House subcommittee cited the cost of naloxone as a reason that competition between drugmakers should be encouraged.
"On the one hand, we want to encourage pharmaceutical companies to invest in expensive research and development in order to bring innovative and lifesaving drugs to market," Rep. Bob Goodlatte (R-Va.) said, according to an account of that hearing by the Morning Consult. "On the other hand, we also want to encourage sufficient competition to ensure that there is an appropriate check on consumer prices."
At that same hearing, Dr. Eric Ketcham of New Mexico noted that while a 1 milliliter syringe of naloxone sells for the equivalent of $1.17 in India, the same product's cost in the northwest section of his state has risen from about $12 in 2012 to around $30 this year.
And Ketcham said that a 2-ml syringe product sold by Amphastar, which is used by many fire departments and emergency medical service, "is now priced at approximately $49" per dose "and has risen incrementally from $17" per dose in 2014.
"The consequence of these rising prices may force naloxone out of the budget for rural fire or EMS service that doesn't have the buying power of a hospital or larger municipal agency," said Ketcham, who is medical director of the emergency department at the San Juan Regional Medical Center in Farmington, New Mexico.
Paul Ripp, the fire department chief in Madison, Wisconsin, said that naloxone price increases have put "the squeeze on other areas [in the budget] such as safety equipment."
"Gear for our firefighters has to be put off into the future because of the money being spent on the extra drugs that we need to handle overdoses," Ripp said.
Kaleo, when asked about its naloxone product's cost, said that the list price of Evzio was increased earlier this year to cover the cost of a program that "dramatically changed our patient access program for Evzio."
"Unlike some access programs that utilize coupons to bring down out-of-pocket costs by a set amount, Kaleo's access program ensures all patients and caregivers with commercial insurance and a prescription can obtain Evzio at no cost, even if their commercial insurance does not cover it," spokesman Mark Herzog said. "With our new access program, no matter the pharmacy price for Evzio, a patient with commercial insurance and a prescription will obtain Evzio. To cover the cost of this program for patients, we increased the list price for Evzio."
Herzog also noted that Evzio "was the first naloxone product specifically designed, FDA- approved and labeled for use by individuals without medical training. It is the only intelligent auto-injection system that provides simple, on-the-spot voice and visual instruction to help guide people through the injection process."
A spokeswoman for Pfizer, whose divisions include naloxone maker Hospira, said,"Hospira has long recognized the critical need for naloxone as a potentially life-saving drug. As other manufacturers have exited the naloxone market over the years, Hospira worked hard for more than three decades to maintain the availability of this important, medically necessary product to patients and physicians."
"Throughout that period, Hospira often served as the sole supplier of this critical medicine," the spokeswoman said. "Hospira (and now Pfizer) has responsibly priced naloxone; we believe our actions have reflected sensitivity to the need for the product, and also take into account the investments necessary to produce high-quality generic drugs as well as ensure appropriate distribution through licensed medical professionals."